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United States Court of Appeals
for the Fifth Circuit
___________
No. 21-30734
___________
State of Louisiana; State of Montana; State of
Arizona; State of Alabama; State of Georgia; State of
Idaho; State of Indiana; State of Mississippi; State of
Oklahoma; State of South Carolina; State of Utah;
State of West Virginia; Commonwealth of Kentucky;
State of Ohio,
Plaintiffs—Appellees,
versus
Xavier Becerra, Secretary, U.S. Department of Health
and Human Services; United States Department of
Health and Human Services; Chiquita Brooks-Lasure;
Centers for Medicare and Medicaid Services,
Defendants—Appellants.
______________________________
Appeal from the United States District Court
for the Western District of Louisiana
USDC No. 3:21-CV-3970
______________________________
Before Southwick, Graves, and Costa, Circuit Judges.
Per Curiam:
The Secretary of the Department of Health and Human Services and
other federal government defendants move to stay a district court’s
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nationwide, preliminary injunction that bars enforcement of one of the
federal COVID-19 vaccination mandates. The enjoined mandate applies to
the staff of many Medicare- and Medicaid-certified providers such as
hospitals, long-term care facilities, home-health agencies, and hospices.
We DENY the motion insofar as the order applies to the 14 Plaintiff
States. We GRANT a stay as to the order’s application to any other
jurisdiction. Briefly, we will explain.
When analyzing a request to stay a district court’s preliminary
injunction, we are to consider the following factors:
(1) whether the stay applicant has made a strong showing that
he is likely to succeed on the merits; (2) whether the applicant
will be irreparably injured absent a stay; (3) whether issuance
of the stay will substantially injure the other parties interested
in the proceeding; and (4) where the public interest lies.
Veasey v. Perry, 769 F.3d 890, 892 (5th Cir. 2014) (quoting Nken v. Holder,
556 U.S. 418, 426 (2009)). Likelihood of success and irreparable injury to
the movant are the most significant factors. Id.
The district court cited a number of reasons for enjoining the rule.
Especially in light of a recent, precedential opinion from this court, see BST
Holdings, L.L.C. v. OSHA, 17 F.4th 604 (5th Cir. 2021), it appears that the
Secretary will have the most difficulty overcoming the part of the ruling that
applied the “major questions doctrine.” We thus focus on that issue in
assessing whether the Secretary has made a strong showing of likely success.
The district court held that the Secretary’s decision to enter the
vaccine regulatory space for the first time implicates what some courts and
commentators have called the “major questions doctrine,” though
apparently not (yet) so designated in a majority opinion for the Supreme
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Court. 1 It appears to us not so much a new doctrine but a new label for
courts’ method of analyzing federal agencies’ novel assertions of authority.
For example, the Supreme Court did not give deference to the Food and
Drug Administration’s 1996 decision that it had implicit authority under its
governing statutes to regulate tobacco. FDA v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 159–60 (2000).
Our court relied in part on this doctrine in recently staying the
COVID-19 vaccination mandate the Occupational Safety and Health
Administration (“OSHA”) issued for employers of a certain size. BST
Holdings, 17 F.4th at 617; see also Alabama Ass’n of Realtors v. Department of
HHS, 141 S. Ct. 2485, 2489 (2021) (staying CDC’s eviction moratorium
based in part on the need for Congress “to speak clearly when authorizing an
agency to exercise powers of ‘vast economic and political significance’”
(quoting Brown & Williamson, 592 U.S. at 160)). The Secretary identifies
meaningful distinctions between its rule for Medicare and Medicaid-funded
facilities and the broader OSHA rule — the statutory authority for the rule is
different; Medicare and Medicaid were enacted under the Spending Clause
rather than the Commerce Clause; and the targeted health care facilities,
especially nursing homes, are where COVID-19 has posed the greatest risk.
It is a close call whether these distinctions (or others) of BST Holdings will
ultimately convince the panel hearing this appeal. Nonetheless, the first stay
factor requires more than showing a close call. We cannot say that the
Secretary has made a strong showing of likely success on the merits.
1
Able researchers for this panel have discovered that this doctrinal label has been
used only twice at the Supreme Court in merits opinions on a case — once in a concurrence
and the other in a dissent. Department of Homeland Sec. v. Regents of the Univ. of Cal., 140
S. Ct. 1891, 1925 (2020) (Thomas, J., concurring); Gundy v. United States, 139 S. Ct. 2116,
2141–42 (2019) (Gorsuch, J., dissenting).
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The other three factors for a stay — injury to the movant, injury to the
opponent, and the public interest — are important but, regardless of the
outcome of analyzing them, they will not overcome our holding that the
merits of the injunction will not likely be disturbed on appeal. That is
especially so because preserving the status quo “is an important” equitable
consideration in the stay decision. Dayton Bd. of Educ. v. Brinkman, 439 U.S.
1358, 1359 (1978)). Here, the Secretary’s vaccine rule has not gone into
effect.
Though we deny the stay generally, we also consider whether the
preliminary injunction should remain in effect beyond the 14 states that have
brought this suit. Principles of judicial restraint control here. Other courts
are considering these same issues, with several courts already and
inconsistently ruling. Compare Florida v. Department of HHS, — F.4th —,
2021 WL 5768796 (11th Cir. Dec. 6, 2021) (declining to enjoin rule after
district court refused to do so), with Missouri v. Biden, — F. Supp. 3d —, 2021
WL 5564501 (E.D. Mo. Nov. 29, 2021) (enjoining rule in the ten plaintiff
states). In addition, the many states that have not brought suit may well have
accepted and even endorsed the vaccination rule.
The question posed is whether one district court should make a
binding judgment for the entire country. At times, we have answered the
question affirmatively. For example, we allowed nationwide injunctions in
an immigration case. See Texas v. United States, 809 F.3d 134, 188 (5th Cir.
2015). That decision, though, does not hold that nationwide injunctions are
required or even the norm. As is true for all injunctive relief, the scope of the
injunction must be justified based on the “circumstances.” Id. That
justification existed in Texas because of the constitutional command for
“uniform” immigration laws and a concern that “a geographically-limited
injunction would be ineffective because DAPA beneficiaries would be free to
move among states.” Id. at 187–88.
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The district court here gave little justification for issuing an injunction
outside the 14 States that brought this suit. It stated that “due to the
nationwide scope of the CMS Mandate, a nationwide injunction is necessary
due to the need for uniformity” and noted that “there are unvaccinated
workers in other states who also need protection.” Lacking is either the
constitutional uniformity principle in Texas or that case’s concern that
patchwork rulings would undermine an injunction limited to certain
jurisdictions.
Justice Gorsuch recently critiqued the frequency of the imposition of
nationwide injunctions. Such injunctions at times can constitute “rushed,
high-stake, low-information decisions,” while more limited equitable relief
can be beneficial:
The traditional system of lower courts issuing interlocutory
relief limited to the parties at hand may require litigants and
courts to tolerate interim uncertainty about a rule’s final fate
and proceed more slowly until this Court speaks in a case of its
own. But that system encourages multiple judges and multiple
circuits to weigh in only after careful deliberation, a process
that permits the airing of competing views that aids this
Court’s own decisionmaking process.
Department of Homeland Sec. v. New York, 140 S. Ct. 599, 600 (2020)
(Gorsuch, J., concurring in the grant of a stay).
This vaccine rule is an issue of great significance currently being
litigated throughout the country. Its ultimate resolution will benefit from
“the airing of competing views” in our sister circuits. See id. Though here
too, as with the other issues before us, we are not in a position to make
definitive pronouncements about the outcome of this appeal, we do predict
that the Secretary is likely to prevail in limiting the scope of the injunction.
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IT IS THEREFORE ORDERED that the opposed motion for
stay of the district court’s preliminary injunction order pending appeal is
DENIED insofar as the order applies to the 14 Plaintiff States. A stay is
GRANTED as to the order’s application to any other jurisdiction.
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UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF LOUISIANA
LAKE CHARLES DIVISION
STATE OF LOUISIANA ET AL CASE NO. 3:21-CV-03970
VERSUS JUDGE TERRY A. DOUGHTY
XAVIER BECERRA ET AL MAG. JUDGE KAYLA D. MCCLUSKY
MEMORANDUM ORDER
Pending before the Court is a Motion for a Stay Pending Appeal [Doc. No. 32] filed by
Government Defendants1 in this matter regarding the Preliminary Injunction issued in this
proceeding on November 30, 2021 [Doc. No. 29] in favor of Plaintiff States2.
Courts must consider four factors in assessing the propriety of granting a motion for stay
pending appeal. Those are (1) the likelihood of prevailing on the merits of the appeal; (2) whether
the movant will suffer irreparable damage absent a stay; (3) the harm that other parties will suffer
if a stay is granted; and (4) the public interest. Planned Parenthood of Greater Tex. Surgical Health
Servs. v. Abbott, 734 F.3d 406, 410 (5th Cir. 2013).
Considering the four factors, this Court, for the reason more fully set out in the
Memorandum Ruling [Doc. No. 28], believes that the likelihood of Government Defendants’
success on the merits is low.
This Court further finds Government Defendants will not suffer irreparable harm if a stay
is not entered.
1
The Government Defendants consist of Xavier Becerra, in his official capacity as Secretary of Health and Human
Services, The U.S. Department of Health and Human Services (“DHH”), Chiquita Brooks–Lasure, in her official
capacity as Administrator of the Center for Medicare and Medicaid Services (“CMS”).
2
Plaintiff States consist of Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma,
South Carolina, Utah, West Virginia, Kentucky, and Ohio.
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This Court further finds that other parties will be harmed if the stay is granted. As set forth
in the Memorandum Ruling, Government Defendants’ vaccine mandate requires over 10.3 million
employees of Medicare and Medicaid healthcare providers to obtain the first COVID-19 vaccine
by December 6, 2021, and the second COVID-19 vaccine by January 4, 2022. If a stay is entered,
the unvaccinated employees (an estimated 2.4 million) would be required to either receive the
vaccine or be terminated from their employment. A stay would defeat the purpose of the
preliminary injunction.
This Court further finds that the public interest is in favor of Plaintiff States and against a
stay. The public interest is better served by maintaining the liberty interests of employees who do
not wish to take the COVID-19 vaccine, pending the final resolution of the matter.
For the reasons set forth herein, Government Defendants’ Motion for a Stay Pending
Appeal [Doc. No. 32] is DENIED.
MONROE, LOUISIANA, this 1st day of December 2021.
Terry A. Doughty
United States District Judge
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UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF LOUISIANA
MONROE DIVISION
STATE OF LOUISIANA ET AL CASE NO. 3:21-CV-03970
VERSUS JUDGE TERRY A. DOUGHTY
XAVIER BECERRA ET AL MAG. JUDGE KAYLA D. MCCLUSKY
MEMORANDUM RULING
The issue before this Court is whether the Plaintiff States1 are entitled to a preliminary
injunction against the Government Defendants2 as a result of a COVID-19 CMS vaccine
mandate (“CMS Mandate”) implemented by the Government Defendants on November 5, 2021.
86 Fed. Reg. 61555-01. The CMS Mandate requires the staff of twenty-one types of Medicare
and Medicaid healthcare providers to receive one vaccine by December 6, 2021, and to receive
the second vaccine by January 4, 2022. Failure to comply with the CMS Mandate may result in
penalties up to and including “termination of the Medicare/Medicaid Provider Agreement.” 86
Fed. Reg. at 61574.
According to the CMS, the CMS Mandate regulates over 10.3 million health care
workers in the United States. Id. at 61603. Of those 10.3 million, 2.4 million healthcare workers
are currently unvaccinated. Id. at 61607.
Implicit in determining whether a preliminary injunction should be granted is
determining whether the Government Defendants have the statutory and/or constitutional
authority to implement the CMS Mandate. Finding that the Government Defendants do not have
1
Plaintiff States consist of Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma,
South Carolina, Utah, West Virginia, Kentucky, and Ohio.
2
The Government Defendants consist of Xavier Becerra, in his official capacity as Secretary of Health and Human
Services, The U.S. Department of Health and Human Services (“DHH”), Chiquita Brooks–Lasure, in her official
capacity as Administrator of the Center for Medicare and Medicaid Services (“CMS”).
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the authority to implement the CMS Mandate, this Court GRANTS Plaintiff States’ Motion for
Preliminary Injunction [Doc. No. 2] and IMMEDIATELY ENJOINS and RESTRAINS the
Government Defendants from implementing the CMS Mandate.
I. BACKGROUND
This case is about COVID-19 vaccine mandates. The CMS Mandate requires over 10.3
million healthcare workers to be fully vaccinated with one of the COVID-19 vaccines in two
months. The first of two COVID-19 vaccines is required by December 6, 2021, and the second
by January 4, 2022. The factual statements made herein should be considered as findings of fact
and legal conclusions should be considered conclusions of law. This Court’s job is to examine
the appropriate statutes and/or constitutional authority for the Government Defendants to issue
the specific CMS Mandate discussed herein. The opinion expressed hereto is legal, not political
or personal.
On March 13, 2020, President Trump declared the COVID-19 pandemic a national
emergency. On March 11, 2020, the World Health Organization (“WHO”) declared COVID-19
a global pandemic.
On December 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued an
Emergency Use Authorization (“EUA”) for the Pfizer-BioNTech vaccine. The FDA issued an
EUA for the Moderna COVID-19 vaccine on December 18, 2020, and issued an EUA for the
Janssen COVID-19 vaccine on February 27, 2021.3 The Pfizer-BioNTech COVID-19 vaccine
received FDA approval on August 23, 2021 for individuals sixteen years of age and older.4 On
3
https://www.fda.gov>COVID19-fre.
4
https://www.cdc.gov>vaccines.
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November 19, 2021, the FDA authorized Pfizer-BioNTech and Moderna COVID-19 boosters for
all adults ages eighteen and older.5
The first cases of COVID-19 in the United States were recorded in January 2020.6 Cases
began surging thereafter with the highest surge from October 2020 to February 2021. The seven-
day average for cases in the United States recorded a high on January 12, 2021, at 250,512 cases.
For the last ninety days, the seven-day average has declined from 164,374 on September 2, 2021,
to 94,335 on November 23, 2021.7
In response to the pandemic, CMS issued six previous rules with regard to COVID-19.
These rules were issued on April 6, 2020, May 8, 2020, September 2, 2020, November 6, 2020,
May 13, 2021, and June 21, 2021. 86 Fed. Reg. at 61561. These previous actions dealt with
revision of regulations, data reporting, and infection control requirements to protect healthcare
workers from exposure to COVID-19. The June 21, 2021, Healthcare Emergency Temporary
Standard (“ETS”) required healthcare workers to develop a plan for each workplace, which
included patient screening, protective equipment, aerosol procedures, physical distancing,
physical barriers, cleaning and disinfecting, ventilation, health screening, training,
recordkeeping, and reporting. Id.
A. November 5, 2021 CMS Mandate
On November 5, 2021, CMS issued the disputed Interim Final Rule (“IFR”), which
contained the requirements for mandating COVID-19 vaccines. The IFR was described by CMS
as “revises the requirements that Medicare and Medicaid certified providers and suppliers must
meet to participate in the Medicare and Medicaid Programs.”
5
https://www.nbcnews.com>health.
6
https://www.history.com>first-conf.
7
https://www.nytimes.com>us>cov.
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The Mandate was effective on November 5, 2021, and established COVID-19
vaccination requirements for staff, and this included Medicare and Medicaid – certified providers
and suppliers. The Mandate implemented the COVID-19 vaccinations in two phases. The first
vaccine is to be required by December 6, 2021, and the second vaccine is to be required by
January 4, 2022. The CMS Mandate went into effect immediately; there was no notice and
comment under the Administrative Procedures Act 5 U.S.C. 553.
The mandate applies to the employees of Medicare and Medicaid providers and suppliers
listed. 86 Fed. Reg. at 61556. CMS claimed authority to issue the mandate pursuant to §§ 1102,
1863, and 1871 of the Social Security Act. 86 Fed. Reg. at 61560, 61567. The reasoning for the
mandate was: “In light of our responsibility to protect the health and safety of individuals
providing and receiving care and services from the Medicare and Medicaid certified providers
and suppliers, and CMS’s broad authority to establish health and safety regulations, we are
compelled to require staff vaccinations for COVID-19 in these settings.” 86 Fed. Reg. 61560.
CMS indicated its mandate was “complementary to the OSHA ETS”,8 which also
requires mandatory vaccinations. (Occupational Safety and Health Administration (“OSHA”)).
CMS admittedly has not previously required any vaccinations. 86 Fed. Reg. 61567. The
mandate discussed the potential effect of health care workers choosing to leave their jobs rather
than be vaccinated but concluded9 there was insufficient evidence to quantify and compare
adverse impacts on patient and residential care associated with temporary staffing losses. 86
Fed. Reg. at 61569.
8
The United States Court of Appeals for the Fifth Circuit has stayed the implementation of the OSHA ETS pending
adequate judicial review of the motions for preliminary injunction. BST Holding’s LLC v. Occupational Safety and
Health Administration 21-60845 (November 12, 2021).
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Despite approximately 2.4 million unvaccinated healthcare workers.
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Like the OSHA mandate,10 the CMS mandate is described as a “common set of
provisions for each applicable provider and supplier as there are no substantive regulatory
differences across settings.” 86 Fed. Reg. at 61570.
The CMS mandate also requires that the medical providers and suppliers “track and
securely document” the vaccination status of each staff member, including storing staff
members’ medical records showing proof of vaccination. 86 Fed. Reg. 61572. The CMS
mandate allows exemptions that are based upon existing Federal law. The mandate specifically
states that it “preempts” the applicability of any state or local law providing for exemptions. 86
Fed. Reg. 61572.
In not inviting notice and comment pursuant to the Administrative Procedures Act, 5
U.S.C. 553, CMS found “good cause” that notice and comment procedures are impracticable,
unnecessary, or contrary to the public interest based upon the reasons set out at 86 Fed. Reg.
61583 to 61585.
B. The Executive Branch’s Vaccine Policy
President-Elect Biden initially did not think vaccines should be mandatory11. On
September 9, 2021, President Biden changed his mind announcing his intention to impose a
national mandate12.
Both the OSHA Mandate and the CMS Mandate were imposed approximately two
months later on November 5, 2021.
10
Described by the Fifth Circuit as a “one size-fits-all sledgehammer.” BTS Holdings, LLC 21-60145@8.
11
Jacob Jarvis Fact Check: Did Joe Biden Reject Idea of Mandatory Vaccines in December 2020, Newsweek (Sept.
10, 2021), https://bit.ly/3ndyTn.5
12
Kevin Liptak & Kaitlan Collins, Biden Announces New CMS Mandates that could cover 100 Million Americans,
CNN (Sept. 9, 2021).
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C. Medicare and Medicaid
Medicare is a federal program that pays for healthcare for the elderly. Medicaid is a
cooperative state-funded program that helps States finance medical care for their poor and
disabled citizens. The Secretary of Health and Human Resources is charged through the Social
Security Act with administrative responsibilities related to maintaining the Medicare and
Medicaid Programs. 42 U.S.C. 301, et al.
The Social Security Act also delegates to the Secretary certain rule-making authority. As
relevant here, 42 U.S.C. 1302(a) gives the Secretary the authority to make and publish rules and
regulations that may be necessary to the efficient administration of the functions with which the
Secretary is charged.
II. JURISDICTION
The Government Defendants maintain this Court does not have jurisdiction to hear the
Plaintiff States’ claims based upon the Medicare Act’s channeling requirement, 42 U.S.C. 405(g)
as incorporated by 42 U.S.C. 1395ii. The Government Defendants argue that Medicare and
Medicaid’s exclusive review scheme bars pre-enforcement challenges. The Government
Defendants further claim the Plaintiff States are required to go through the statute’s
administrative review scheme and have an administrative hearing before filing suit in district
court. Plaintiff States’ claims arise under both the Medicare and Medicaid statutes, the United
States Constitution, the Administrative Procedure Act, and the Congressional Review Act.
The Government Defendants cite Shalala v. Illinois Council on Long Term Care, Inc.,
529 U.S. 1 (2000) for the proposition that any “arising under” jurisdictional claims must undergo
the SSA’s administrative process and that Congress made the review exclusive.
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However, both 42 U.S.C. 405(g) and 42 U.S.C. 1395ii do not apply in this case. 42
U.S.C. 405(h) states that the SSA administrative process only applies to actions “to recover on
any claim arising under this subchapter.” The “subchapter” refers to claims for benefits under
the SSA. It does not apply to a claim for declaratory and injunctive relief as to the authority of
CMS to make regulations. Plaintiff States are neither “institutions” nor “agencies” who are
“dissatisfied” with the Secretary’s determination regarding eligibility or receipt of benefits. The
channeling requirement does not apply to “state governments.” Since Plaintiff States would be
unable to use this statutory scheme (even if they wanted to) it would mean “no review at all”
under Shalala, which would allow Plaintiff States to have jurisdiction in this Court.
Additionally, the Medicare Act’s channeling requirement only applies to Medicare and
not to Medicaid claims. Avon Nursing & Rehab. V. Becerra, 995 F.3d 305, 311 (2d. Cir. 2021).
Therefore, this Court has jurisdiction to hear these claims.
III. STANDING
Although the Plaintiff States’ standing has not been challenged by the Government
Defendants, this Court must next determine whether it has judicial power to hear the case. The
United States Constitution limits exercise of judicial power to certain “cases” and
“controversies.” U.S. Constitution Article III Section 2.
Under the doctrine of “standing,” a federal court can exercise judicial power only where a
plaintiff has demonstrated that it (1) suffered an injury in fact, (2) fairly traceable to the
challenged conduct of the defendant, and (3) likely to be redressed by a favorable decision.
Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61, 112 S. Ct. 2130, 119 L. Ed. 2d 351 (1992).
The party invoking federal jurisdiction bears the burden of establishing these elements. Id. at
561.
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The Plaintiffs in this case are fourteen (14) states. States are not normal litigants for
purposes of invoking federal jurisdiction. Massachusetts v. E.P.A., 549 U.S. 497, 518, 127 S. Ct.
1438, 167 L. Ed. 2d 248 (2007). Rather, a state is afforded “special solicitude” in satisfying its
burden to demonstrate the traceability and redressability elements of the traditional standing
inquiry whenever its claims and injury meet certain criteria. Id. at 520; Texas v. United States,
809 F.3d 134, 151–55 (5th Cir. 2015), as revised (Nov. 25, 2015). Specifically, a state seeking
special solicitude standing must allege that a defendant violated a congressionally accorded
procedural right that affected the state’s “quasi-sovereign” interests in, for instance, its physical
territory or lawmaking function. Massachusetts, 549 U.S. at 520–21; Texas, 809 F.3d at 151–55.
Plaintiff States have standing under the normal inquiry because they are entitled to
special solicitude. Plaintiff States have standing to challenge the CMS Mandate because the
Government Defendants’ actions harm Plaintiff States’ sovereign, proprietary, and parens
patriae interests.
In State of Florida v. Becerra, __ F. Supp. 3d _, 2021 WL 2514138 (M.D. Fla. June 18,
2021) the State of Florida attacked a Centers for Disease Control and Prevention (“CDC”)
“conditional order,” which required a series of steps before cruise ships were allowed to sail.
The Court found Florida had standing to protect its proprietary interests and its sovereign
interests.
The State of Texas was found to have standing in a suit against the U.S. Dept. of
Homeland Security’s 100 day pause of the removal of illegal aliens in Texas v. U.S., 524 F.
Supp. 3d 598 (S.D. Tex., February 23, 2021). In State v. Biden, 10 F. 4th 538 (5th Cir. 2021), the
State of Texas was also found to have standing based on “special solicitude.” (Injunction request
against the U.S. Dept. of Homeland Security to suspend its Migrant Protection Protocols.)
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Texas was again found to have standing under “special solicitude” in Texas v. U.S., 809
F. 3d 134 (5th Cir. 2015). Texas sued to prevent implementation of a DAPA Program by the
Department of Homeland Security. The Fifth Circuit further noted that, pursuant to their
sovereign interest, states may have standing based on federal assertions of authority to regulate
matters they believe they control, federal preemption of state law, and interference with the
enforcement of state law. Id. at 153.
In Alfred L. Snapp & Son, Inc. v. Puerto Rico, 458 U.S. 592 (1982), the U.S. Supreme
Court held Puerto Rico, like a state, had “parens patriae” standing to bring an action against east
coast apple growers for allegedly violating federal law in preferring domestic laborers over
foreign temporary workers. Puerto Rico was found to have a “quasi-sovereign” interest on
behalf of its residents.
In Texas v. Equal Employment Opportunity Commission, 933 F.3d 433 (5th Cir. 2019),
the Fifth Circuit found standing for Texas after there was an increased regulatory burden,
pressure to change state law, and deprivation of a procedural right to protect its concrete
interests.
A. Injury in Fact
A plaintiff seeking to establish injury in fact must show that it suffered “an invasion of a
legally protected interest” that is “concrete,” “particularized,” and “actual or imminent, not
conjectural or hypothetical.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1548, 194 L. Ed. 2d 635
(2016), as revised (May 24, 2016). For an injury to be “particularized,” it “must affect the
plaintiff in a personal and individual way.” Id. at 1548. A “concrete” injury must be “de facto,”
that is, it must “actually exist.” “Concrete” is not, however necessarily synonymous with
“tangible.” Intangible injuries can nevertheless be “concrete.” Id., at 1548-49.
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This Court finds the Plaintiff States’ alleged injuries are both particularized and concrete.
Plaintiff States have a “parens patriae” standing and/or a quasi-sovereign interest in protecting
its citizens from being required to submit to vaccinations. Additionally, the Plaintiff States have
standing to regulate matters they believe they control, to attack preemption of state law by a
federal agency, and to protect the enforcement of state law. The CMS Mandate specifically
preempts state laws with regard to COVID-19 Vaccine requirements and/or exemptions.
The Plaintiff States also have standing and injury, based upon the alleged loss of jobs,
loss of businesses, loss of tax revenue, and other damages allegedly resulting from employees
being fired for refusing the vaccine and/or providers being terminated by CMS from the
Medicare/Medicaid provider agreement.
B. Traceability
Plaintiff States must show a “fairly traceable” link between their alleged injuries and the
CMS Mandate. As a general matter, the causation required for standing purposes can be
established with “no more than de facto causality.” Dep't of Com. v. New York, 139 S. Ct. 2551,
2556, 204 L. Ed. 2d 978 (2019). The plaintiff need not demonstrate that the defendant’s actions
are “the very last step in the chain of causation.” Bennett v. Spear, 520 U.S. 154, 169–70, 117 S.
Ct. 1154, 137 L. Ed. 2d 281 (1997).
Here, there is an obvious link between the CMS Mandate and the Plaintiff States’ alleged
injuries. All of the above alleged injuries are “fairly traceable” to CMS’s Mandate.
C. Redressability
The redressability element of standing to sue requires a plaintiff to demonstrate “a
substantial likelihood that the requested relief will remedy the alleged injury in fact.” El Paso
Cty., Texas v. Trump, 982 F.3d 332, 341 (5th Cir. 2020).
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The Plaintiff States have demonstrated a substantial likelihood that the requested relief
would remedy the alleged injury in fact. If Plaintiff States are successful in having the CMS
Mandate declared invalid, this would redress their alleged injuries.
4. Special Solicitude
Although this Court has found that Plaintiff States have proven standing through the
normal inquiry, they also can establish standing as a result of special solicitude. Plaintiff States
assert a congressionally bestowed procedural right, the Administrative Procedures Act (“the
APA”), and the government action at issue affects the Plaintiff States’ quasi-sovereign interests
(damage to citizens, loss of jobs, businesses, loss of tax funding and/or protection of State laws).
Massachusetts, 549 U.S. at 519–20.
Therefore, any infirmity in Plaintiff States’ demonstration of traceability or redressability
are remedied by the Plaintiff States’ special solicitude.
IV. PRELIMINARY INJUNCTION
A preliminary injunction is an extraordinary remedy never awarded of right. Benisek v.
Lamone, 138 S. Ct. 1942, 1943, 201 L. Ed. 2d 398 (2018). In each case, the courts must balance
the competing claims of injury and must consider the effect on each party of the granting or
withholding of the requested relief. Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 24, 129 S.
Ct. 365, 172 L. Ed. 2d 249 (2008).
The standard for a preliminary injunction requires a movant to show (1) the substantial
likelihood of success on the merits, (2) that he is likely to suffer irreparable harm in the absence
of a preliminary injunction, (3) that the balance of equities tips in his favor, and (4) that an
injunction is in the public interest. Benisek, 138 S. Ct. at 1944. The party seeking relief must
satisfy
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restraining order or preliminary injunction can be granted. Clark v. Prichard, 812 F.2d 991, 993
(5th Cir. 1987). None of the four prerequisites has a quantitative value. State of Tex. v. Seatrain
Int'l, S. A., 518 F.2d 175, 180 (5th Cir. 1975).
A. Likelihood of Success on the Merits
Plaintiff States argue that (1) the Government Defendants issued the CMS Mandate
without following statutorily required processes (5 U.S.C. 553), (2) the CMS Mandate is beyond
the authority of the Government Defendants, (3) the CMS Mandate is contrary to law, (4) the
CMS Mandate is arbitrary and capricious in violation of 5 U.S.C. 706(2)(A), and (5) the CMS
Mandate violates the Spending Clause, Tenth Amendment and Anti-Commandeering Doctrine.
BST Holdings, LLC v. OSHA
It is not often a Court has such a recent Circuit Court case addressing an almost identical
issue. We do here. In BST Holdings, LLC v. Occupational Safety and Health Administration,
No. 21-60845 17 F.4th 604 (5th Cir. November 12, 2021), the Fifth Circuit addressed a request
for a stay as to the OSHA vaccine mandate which was put into place by way of an EST on
November 5, 2021. The OSHA vaccine mandate required employees of covered employers to
undergo a COVID-19 vaccination or to take weekly COVID-19 tests and wear a mask.13
The Court initially stayed the OSHA Mandate because of perceived grave statutory and
Constitutional issues pending briefing and an expedited judicial review.14 The Court, after
conducting the expedited judicial review, reaffirmed the initial stay. Many of the issues are
similar to the issues here included in the CMS Mandate. The factors the Court evaluate for a
stay are similar to factors that are evaluated for a preliminary injunction, including a strong
13
86 Fed. Reg. 61402 (Nov. 5, 2021).
14
2021 WL 5166656.
12
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likelihood of success on the merits, irreparable injury to the applicant, and where the public
interest lies .15
In finding the applicants were likely to succeed on the merits, the Court made the
following findings:
1) the OSHA Mandate was both overinclusive (“one-size-fits-all sledgehammer”)
and underinclusive (did not apply to employers with 98 or fewer workers;16
2) the OSHA Mandate was not an “emergency” response under 29 U.S.C. 655,
since OSHA spent nearly two months (September 9, 2021 to November 5, 2021)
responding to it;
3) the OSHA Mandate grossly exceeded OSHA’s statutory authority, No. 21-60845
at 7.
The Court stated the Applicants had made a compelling argument that, although 29
U.S.C. 655 gave broad authority to OSHA, to avoid “giving unintended breadth to Acts of
Congress” the Court should use the principle of “noscitur a sociis” – meaning, a word is known
by the company it keeps – to limit OSHA’s authority.17
The Court also found the COVID-19 pandemic was not the type of grave danger 29
U.S.C. 655 contemplates, noting that the OSHA Mandate made no attempt to explain why
OSHA and the President were against CMS Mandates previously. The Court noted it is
generally “arbitrary and capricious” to depart from a prior policy without providing a detailed
explanation.
The Court further noted the OSHA Mandate raised serious constitutional concerns that
either make it more likely that the petitioners will succeed on the merits, or at least counsel
15
No. 21-60845 of 5.
16
“The underinclusive nature of the Mandate implies that the Mandate’s true purpose is not to ensure workplace
safety, but instead to ramp up vaccine uptake by any means necessary. No. 21-60845 at 15.
17
Neighboring phrase of “toxicity” and “poisonousness” in the statute did not give OSHA authority to mandate
vaccines.
13
22a
against adopting OSHA’s broad reading of Section 655(c) as a matter of statutory interpretation.
The “serious Constitutional concerns” found by the Court in BST Holdings are some of the same
ones at issue in the case at bar.
The “serious Constitutional concerns” noted by the Court in BST Holdings were:
(a) that the OSHA Mandate exceeded the federal government’s authority under the
Commerce Clause because it regulated noneconomic inactivity (person’s choice
to remain unvaccinated) that falls squarely within the State’s police power;
(b) that separation of powers principles (“the major questions doctrine”)18 casts
doubt over the OSHA Mandate’s assertion of virtually unlimited power to control
individual conduct under the guise of a workplace regulation.
Additionally, the Court found “irreparable harm” to the petitioners’ liberty interests19 of
having to choose between their jobs and the vaccine. The Court noted that the loss of
constitutional freedoms for even minimal periods of time constitutes irreparable injury.20
The Court also found a stay of the OSHA Mandate to be in the public interest in
maintaining the country’s constitutional structure and maintaining the liberty of individuals and
to make intensely personal decisions, even when those decisions frustrate government officials.
1. Statutorily Required Processes – 5 U.S.C. 553
The Court will now address Plaintiff States’ five arguments. Title 5 U.S.C. 553 of the
Administrative Procedures Act requires federal agency rules to undergo notice and comment
unless they are exempt. The federal agency is required to give general notice of proposed
rulemaking to be published in the Federal Register not more than thirty days before the proposed
rules’ effective date and to give interested persons an opportunity to participate in the rule
18
The “major questions doctrine” holds that Congress must speak clearly if it wishes to assign to an agency,
decisions of vast economic and political significance. Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014).
19
In addition to the free religious exercise of certain employees.
20
Elrod v. Burns 427 U.S. 347, 373 (1976).
14
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making through submission of written data, views, or arguments. Failure to give required notice
and comment requires the rule to be vacated.
This “notice and comment” procedure does not apply to interpretive rules, general
statements of policy, rules of agency organization, procedure, or practice, or when the agency
finds “good cause” for not requiring notice and comment. The Government Defendants did not
go through the notice and comment process with regard to the CMS Mandate. The CMS
Mandate became effective on November 5, 2021, which is the same day it was published in the
Federal Register.
The vaccine mandate is not alleged to be an interpretive rule, a general statement or
policy, or a rule of agency organization, procedure, or practice. The failure to perform the
required notice and comment is entirely based upon the “good cause” exception.
Title 5 U.S.C. 553(b)(3)(B) states:
(B) this section does not apply -- when the agency for good cause finds (and
incorporates the finding and a brief statement of reasons thereafter in the rules issued) that notice
and public procedure therein are impracticable, unnecessary, or contrary to the public interest.
In failing to perform the notice and comment procedure, CMS found good cause. 86 Fed.
Reg. 61583-86. The reasons given by CMS for failing to perform the notice and comment
procedure were:
1. 2021 outbreaks associated with the SARS-Cov-2 Delta variant have shown that
current levels of vaccination coverage have been inadequate, requiring no delay;
2. Encouraging vaccinations through public education campaigns and through State
and employer-based efforts among healthcare staff to has been inadequate;
3. The COVID-19 pandemic continues to strain the U.S. healthcare systems, most of
which patients are unvaccinated;
4. Although hospitalizations and deaths have begun to trend downward, there are
emerging indications of potential increases during the upcoming colder months;
15
24a
5. The upcoming 2021-2022 influenza season could be more severe than normal,
and vaccinations would decrease stress on the U.S. health care system;
6. The upcoming 2021-2022 influenza season could result in infections of both
influenza and COVID-19, which would result in more severe medical outcomes;
7. Since health care workers were among the first groups provided access to the
vaccinations, many did not get vaccinations due to the initial emergency use
authorization. Now that one of the vaccines (Pfizer-BioNTech) has been fully
approved by the FDA, more healthcare workers will want to get the vaccine;
8. The estimates of healthcare workers deaths and/or positive tests for COVID-19
have likely been underestimated since healthcare workers status has only been
reported in approximately 18% of cases;
9. Healthcare workers who are unvaccinated may pose a direct threat to patients;
10. The COVID-19 vaccines have been shown to be highly effective in preventing
COVID-19 cases and severe outcomes;
11. The COVID-19 vaccines have been shown to be highly effective in preventing
infections; and
12. It would be impracticable and contrary to the public interest to delay imposing the
CMS Mandate due to a combination of all factors.
The “good cause” exception in 5 U.S.C. 553 is read narrowly in order to avoid providing
agencies with an escape clause from the ADA notice and comment requirements. United States
v. Johnson, 632 F.3d 912 (5th Cir. 2011). Circumstances justifying reliance on this exception are
“indeed rare.” Council of Southern Mountains, Inc. v. Donovan, 653 F.2d 573 (D.C.C. 1981).
The good cause exception was described in Sorenson Communications, Inc. v. F.C.C., 755 F.3d
702 (D.C.C. 2014) as “meticulous and demanding,” “narrowly construed,” “reluctantly
countenanced,” and evoked only in “emergency situations.”
Due to this stringent standard, the good cause exception to notice and comment is rarely
upheld. See U.S. v. Johnson 632 F.3d 912, 928 (5th Cir. 2011) (need for immediate guidance
under the Sex Offender Registration and Notification Act and in prior attempts to protect the
public were not good cause); Mack Trucks, Inc. v. E.P.A. 682 F.3d 87, 94-95 (D.C. Cir. 2012)
16
25a
(EPA interim final rule requiring penalties for sellers of non-compliant diesel engines not good
cause when one manufacturer would be unable to sell the engines without the interim rule);
Sorenson Communications, Inc. v. F.C.C., 755 F.3d 702, 706-07 (D.C. N.Y.
Cir. 2014) (FCC did not have good cause to issue interim and final rules for reimbursement for
telecommunication services due to potential depletion of the fund used to pay for
reimbursement); State v. Becerra, _ F.Supp. 3d _, 2021 WL 2514138 at 35-36 (M.D. Florida,
June 18, 2021) (CDC did not have good cause for a rule issuing a conditional sailing order for
cruise ships due to COVID-19); Regeneron Pharmaceuticals, Inc. v. United States Dept. of
Health and Human Resources, 510 F.Supp. 3d, 29, 48 (S.D. NY. December 30, 2020) (CMS’s
rule regulating drug prices based on the Most Favored Nation Rule was not good cause where
reasons were general risks of high drug prices and the COVID-19 pandemic); Regeneron
Pharmaceuticals, Inc. v. United States Dept. of Health and Human Resources, 510 F.Supp. 3d,
29, 48 (S.D. NY. December 30, 2020) (not good cause where reasons by DHS for an interim
final rule regarding prevailing wages with regard to the VISA program were based on the
COVID-19 pandemic and economic consequences of it); Chamber of Commerce of the United
States v. United States Dept. of Homeland Security, 504 F. Supp. 3d 1077, 1094 (N.D. Cal.,
December 1, 2020); Association of Community Cancer Centers v. Azar, 509 F. Supp. 3d 482,
496 (D. Maryland, December 23, 2020) (not good cause where CMS claimed reduced costs
would help alleviate financial instability caused by the COVID-19 pandemic).
There are fewer cases where the good cause exception was upheld. In Council of
Southern Mountains, Inc. v. Donovan, 653 F.2d 573 (D.C. Cir. 1981), calling it an “extremely
close case,” the Court upheld the Secretary of Labor postponing the implementation of Mine
Safety and Health Adm. Regulations dealing with self-contained self-rescuers which provided
17
26a
oxygen to miners after a cave-in. The deadline was extended for six months due to only a small
number of the devices being available, the agency acted with diligence, it was deferred for a very
short period of time, and circumstances were beyond the agency’s control.
It should be noted that this issue was discussed in BST Holdings at 8, but OSHA had
authority for a six-month “emergency temporary standard” (“ETS”) pursuant to 29 U.S.C.,
655(a)(1). Although the notice and comment requirements of 5 U.S.C. 553 did not apply, the
Court did not believe COVID-19 posed the kind of grave danger required for an ETS. The Court
stated:
The Mandate’s stated impetus – a purported “emergency” that the entire
globe has now endured for nearly two years, and which OSHA itself
spent nearly two months responding to-is unavailing as well.
No. 21-60845 at 7.
Government Defendants maintain they had “good cause” for the reasons set forth by
CMS in the CMS Mandate. The Government Defendants argue that the Secretary is entitled to
deference as to his predictive judgment that COVID-19 cases would increase during the winter
months and put a burden on the healthcare system.
After reviewing the reasons listed by CMS for bypassing the notice and comment
requirement, the Court finds Plaintiff States are likely to succeed on the merits on this claim. It
took CMS almost two months, from September 9, 2021 to November 5, 2021, to prepare the
interim final rule at issue. Evidently, the situation was not so urgent that notice and comment
were not required. It took CMS longer to prepare the interim final rule without notice than it
would have taken to comply with the notice and comment requirement. Notice and comment
would have allowed others to comment upon the need for such drastic action before its
implementation.
18
27a
It does not appear to this Court that the Government Defendants will be able to meet the
stringent requirements for the good cause exception in 5 U.S.C. 553 to apply.
2. Authority of The Government Defendants
Plaintiff States maintain that the CMS Mandate must also be enjoined because it exceeds
the Government Defendants’ authority. The U.S. DHH and the CMS are a part of the Executive
Branch of the government.
Only Congress, as the Legislative branch, has the authority to make laws.21 The
Executive branch must take care that the laws be faithfully executed.22 Because the Executive
branch cannot make laws, it is given its powers through Acts of Congress.
The CMS claims authority to issue the CMS Mandate through Sections 1102 and 1871 of
the Social Security Act. 86 Fed. Reg. at 61560. Sections 1102 and 1871 are set out in 42 U.S.C.
1302 and 42 U.S.C. 1395hh. Title 42 U.S.C. 1395hh gives the Secretary authority to “prescribe
such regulations as may be necessary to carry out the administration of the insurance programs
under this subchapter.” The remaining portions of 1395hh deal with procedure for the
regulations.
42 U.S.C. 1302 states:
(a) The Secretary of the Treasury, the Secretary of Labor, and the
Secretary of Health and Human Services, respectively, shall make and
publish such rules and regulations, not inconsistent with this chapter, as
may be necessary to the efficient administration of the functions with
which each is charged under this chapter.
Additionally, the Government Defendants reference “Table 1: Authorities for All
Providers and Suppliers,” 86 Fed. Reg. at 61567, which sets out statutory authority for each
specific category of Provider/Supplier.
21
Article I, Section 8, United States Constitution.
22
Article II, Section 3, United States Constitution.
19
28a
Sections 1102 and Section 1871 are general authorizations to prescribe rules and
regulations that may be necessary to carry out the Medicaid and Medicare programs. The
Statutes listed in Table 1 are also general authority to specify “standards” for the various types of
providers and suppliers. None of these statutes give the Government Defendants the
“superpowers” they claim. Not only do the statutes not specify such superpowers, but principles
of separation of powers weigh heavily against such powerful authority being transferred to a
government agency by general authority.
Major Questions Doctrine
The “major questions doctrine” requires that Congress must “speak clearly if it wishes to
assign to an agency, decisions of vast economic and political significance.” Utility Air
Regulatory Group v. EPA, 573 U.S. 302, 324 (2014). In Utility Air, the U.S. Supreme Court
found that EPA exceeded its authority when the EPA adjusted levels set forth in the Clean Air
Act regarding greenhouse-gas emissions.
Like the present case, EPA used general authority to expand its power. Justice Scalia
wrote:
EPA’s interpretation is also unreasonable because it would bring about
an enormous and transformative expansion in EPA’s regulatory authority
without clear congressional authorization. When an agency claims to
discover in a long-extant statute an unheralded power to regulate “a
significant portion of the American economy,” Brown & Williamson,
529 U.S. at 159, 120 S. Ct. 1291, we typically greet its announcement
with a measure of skepticism. We expect Congress to speak clearly if it
wishes to assign an agency decision of vast “economic and political
significance.” 573 U.S. at 324.
This is exactly what has occurred in this case. Government Defendants have used
general authority statutes to mandate COVID-19 vaccines for over 10.3 million healthcare
workers. Certainly, this is a decision of vast economic and political significance.
20
29a
The Fifth Circuit Court of Appeals found the same with the similar OSHA Vaccine
Mandate in BST Holdings. Judge Engelhardt wrote:
There is no clear expression of Congressional intent in Section 655(c) to
convey OSHA such broad authority, and this Court will not infer one.
Nor can the Article II executive breathe new power into OSHA’s
authority – no matter how thin patience wears. No. 21-60845, at 18.
See also Food and Drug Admin. v. Brown & Williamson Tobacco Corp. 529 U.S. 120, 159
(2000); Alabama Association of Realtors v. Dept. of Health and Human Resources, 141 S.Ct.
2485, 2489 (2021); Tiger Lily, LLC v. United States Department of Housing and Urban
Development, 5 F.4th 666, (6th Cir. 2021); Paul v. United States, 140 S.Ct. 342 (2019); State of
Florida v. Becerra, 2021 WL 2514138 at 20 (M.D. Fla. June 18, 2021); and King v. Burwell, 576
U.S. 473, 486 (2015).
The Government Defendants maintain this general authorization gives them authority to
mandate vaccines to 10.3 million healthcare workers arguing CMS can do almost anything the
Secretary feels is necessary to ensure the health and safety of patients. The “major questions
doctrine” is not addressed.
Alabama Association of Realtors supra warrants discussion. In finding the nationwide
eviction moratorium enacted by the CDC beyond the CDC’s authority, the CDC had a statute
that was more broadly worded than the ones the CMS uses in this case. The Supreme Court
called the expansive authority of CDC “unprecedented,” and stated “Section 361(a)23 is a wafer-
thin reed on which to rest such sweeping power.” 141 S.Ct. at 2489.
There is no question that mandating a vaccine to 10.3 million healthcare workers is
something that should be done by Congress, not a government agency. It is not clear that even
23
The statute used for CDC’s authority.
21
30a
an Act of Congress mandating a vaccine would be constitutional. Certainly, CMS does not have
this authority by a general authorization statue.
Plaintiff States are likely to succeed on their claim that the Government Defendants
exceeded their authority in enacting the CMS Mandate.
3. Contrary to Law
The Plaintiff States additionally claim that the CMS Mandate is contrary to law, arguing
that it violates additional provisions in the Social Security Act. The first provision Plaintiff
States claim the mandate violates is 42 U.S.C. 1395z, which requires the Secretary to consult
with appropriate state agencies relating to conditions of participation by providers of services.
The Government Defendants concede that the CMS Mandate was issued without complying with
this directive, but state they will meet with the State agencies FOLLOWING the issuance of this
rule.24
The second provision Plaintiff States claim the mandate violates is 42 U.S.C. 1395,
which provides that nothing in the Social Security Act shall be construed to exercise any
supervision or control over the practice of medicine or the manner in which medical services are
provided, or over the situation, tenure or compensation of any officer or employee of any
institution, agency, or person providing health services; or to exercise any supervision or control
over the administration or operation of any such institution, agency, or person. Plaintiff States
argue these provisions prohibit the dictation of the hiring and firing policies of these institutions
for unvaccinated workers. The statute also prohibits supervision and control over both the
“selection” and “tenure” of unvaccinated employees.
24
86 Fed. Reg. at 61567.
22
31a
The third provision Plaintiff States claim the mandate violates is 42 U.S.C. 1302(b)(1),
which requires that whenever the Secretary publishes a general notice of proposed rulemaking
for any rule or regulation proposed that “may” have a significant impact on the operations of a
substantial number of small rural hospitals, an initial regulatory impact analysis is to be
conducted. Plaintiff States argue the CMS Mandate “may” have a significant impact on a
substantial number of small rural hospitals due to loss of workers and/or income due to the CMS
Mandate. No regulatory impact analysis for rural hospitals was conducted in this case.
Because the Government Defendants did not comply with any of the above provisions,
the Plaintiff States are likely to succeed on the merits that the CMS Mandate is contrary to
law.
4. Arbitrary and Capricious
Federal administrative agencies are required to engage in reasoned decision-making.
Allentown Mack Sales & Serv., Inc. v. N.L.R.B., 522 U.S. 359, 374, 118 S. Ct. 818, 139 L. Ed. 2d
797 (1998). The Plaintiff States allege the CMS Mandate is arbitrary and capricious under Title
5 U.S.C. 706(2)(A).
If an administrative agency does not engage in reasoned decision making, a court, under
the APA, shall hold unlawful and set aside agency action, findings and conclusions found to be
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 5 U.S.C.
706(2)(A).
The grounds upon which an administrative order must be judged are those upon which
the record discloses that its action was based. Sec. & Exch. Comm'n v. Chenery Corp., 318 U.S.
80, 87, 63 S. Ct. 454, 87 L. Ed. 626 (1943).
23
32a
Plaintiff States argue Government Defendants’ CMS Mandate ignores the Social Security
Act’s focus on patient wellbeing and instead focuses on the health of healthcare providers. The
Plaintiff States further maintain the goal of the CMS Mandate is to increase individual vaccine
rates, which will actually have the effect of harming patient well-being due to staff shortages of
providers and suppliers.
This is backed up by a number of declarations of various individuals that verify
healthcare worker shortages, a significant number of healthcare workers that remain
unvaccinated, and the harm that will be caused to these facilities in the event that even a few of
the unvaccinated healthcare workers quit or are fired as a result of the CMS Mandate.25 Some of
the declarations also verify the huge percentage of money paid to these facilities through the
Medicare and Medicaid Programs, showing these facilities would have to shut down or severely
cut back on healthcare services if funding is cut off by the Government Defendants to these
facilities.26 The Plaintiff States also provided a declaration which shows the increased
enforcement costs that would result if required to survey and enforce the CMS Mandate.27
In other words, the Plaintiff States maintain that although the purpose of the Social
Security Act is to help healthcare patients, the CMS Mandate would have the opposite effect due
to the loss of healthcare workers and funding to healthcare facilities. This is not the “reasoned
decision-making” required by the APA. Requiring COVID-19 vaccinations to healthcare
workers covered by the mandate would hurt the patients the Social Security Act was meant to
help.
25
Doc. No. 2-2, 2-3, 2-6, 2-7, 2-8, 2-9, 2-10, 2-11, 2-12 and 2-16.
26
Doc. No. 2-4, 2-5, 2-15.
27
Doc. No. 2-14.
24
33a
Additionally, the Plaintiff States argue the Government Defendants failed to consider or
arbitrarily rejected obvious alternatives to the CMS Mandate. These alternatives include daily or
weekly COVID-19 testing, wearing masks or shields, natural immunity and/or social distancing.
The Plaintiff States maintain the apparent rejection of these alternatives to COVID-19 vaccines
is unsupported by evidence. The Declaration of Tracy Gruber28 declares that since July 2021,
employees at the Utah State Hospital and Utah State Development Center have been required to
be vaccinated or take a weekly COVID-19 test. That alternative has caused no apparent harm to
patients or staff.
The rejection of natural immunity as an alternative is puzzling. Natural immunity is the
immunity of people who have been infected with the COVID-19 virus. In rejecting this
alternative, the CMS Mandate stated:
While a significant number of healthcare staff have been infected with
SARS-Co-V2, evidence indicates their infection-induced immunity, also
called “natural immunity” is not equivalent to receiving the COVID-19
vaccine.
86 Fed. Reg. at 61559.
The “evidence” CMS relied upon in rejecting that alternative is not provided. The
Declaration of Dr. Jay Bhattachary,29 Director of Stanford University’s Center for Demography
and Economics of Health and Aging disputes CMS’s assertion that natural immunity is not
equivalent to receiving a COVID-19 vaccine. Citing studies from Qatar (which tracked 927,321
individuals for six months after COVID-19 vaccinations), California (which tracked the infection
rates from over 5 million patients vaccinated with two Pfizer doses), and U.S. Veterans (which
tracked 620,000 vaccinated U.S. Veterans), Plaintiff States assert these studies overwhelmingly
28
Doc. No. 2-8.
29
Doc. No. 2-13.
25
34a
conclude that natural immunity provides equivalent or greater protection against severe infection
than immunity generated by COVID-19 vaccines.
The CMS Mandate does not yet require boosters to the COVID-19 vaccines. However,
the CDC recently recommended boosters.30 If boosters are needed six months after being “fully
vaccinated,” then how good are the COVID-19 vaccines, and why is it necessary to mandate
them?
Additionally, the Plaintiff States provided evidence in the Declaration of Dr. Peter A.
McCullough31 that the COVID-19 vaccines do not prevent transmission of the disease among the
vaccinated or mixed vaccinated/unvaccinated populations, and that mandatory COVID-19
vaccines for hospitals do not increase safety for employees or hospital patients. McCullough
declared that additional treatment with other drugs and supplements has resulted in an 85%
reduction in hospitalizations and death of high-risk individuals presenting with COVID-19.
Of note, Dr. McCullough declared the Delta variant of SARS-Cov-2 accounts for 98.9%
of the present cases in the United States, United Kingdom, and Israel. Dr. McCullough further
declared that because of the progressive mutation of the spike protein, the virus has achieved an
immune escape from COVID-19 vaccines. He stated the Delta variant is not adequately covered
by the vaccines. In other words, even if you are fully vaccinated, you still may become infected
with the COVID-19 virus32.
The Plaintiff States further argue that CMS failed to adequately explain its departure
from its prior position of not requiring mandatory vaccines. An agency must provide a more
detailed justification when a new policy rests upon factual findings that contradict those which
30
cdc.gov (November 19, 2021).
31
Doc. No. 2-17.
32
CDC also noted the WHO (World Health Organization) has classified a new variant named Omicron, cdc.gov
(November 29, 2021).
26
35a
underlay its prior policy. State v. Biden, 10 F.4th 538, 554 (5th Cir. 2021); FCC v. Fox
Television Stations, Inc., 556 U.S. 502, 515 (2009).
Although CMS spent pages and pages attempting to explain the need for mandatory
COVID-19 vaccines, when infection and hospitalizations rates are dropping, millions of people
have already been infected, developing some form of natural immunity, and when people who
have been fully vaccinated still become infected, mandatory vaccines as the only method of
prevention make no sense.
The Plaintiff States also argue that CMS’s rationale is flagrantly pretextual. The
Government Defendants say it is not pretextual, but it is obvious that the mandate was enacted as
a result of President Biden’s September 9, 2021, declaration of his intention to impose a national
CMS Mandate.33 Both the CMS and OSHA vaccine mandates were published on the same day,
November 5, 2021. However, the 46-page CMS Mandate does not even mention President
Biden’s declaration of a national vaccine mandate. The presence of pretext is enough to render a
rule arbitrary and capricious.34
The Plaintiff States also argue the CMS Mandate ignores the Plaintiff States’
overwhelming reliance interests in their Medicare and Medicaid programs. The CMS Mandate is
arbitrary and capricious if CMS ignores those reliance interests. DHS v. Regents of the
University of California, 140 S.Ct. 1891, 1913-14 (2020). The Plaintiff States have substantial
reliance interests in those programs.35 The threatened cutoff of federal funding would be
devastating to the Plaintiff States’ healthcare facilities. CMS’s plan to meet with the appropriate
state agency after the rule is issued (86 Fed. Reg. at 61567) would be too late. By that time,
33
See FN 11.
34
Department of Commerce v. New York, 139 S.Ct. at 2575-76.
35
No. 2-4.
27
36a
unwilling healthcare employees would have had to decide whether to take the vaccine or quit
their jobs.
Lastly, the Plaintiff States allege the “scope” of the CMS Mandate is arbitrary and
capricious. The Plaintiff States argue that the CMS Mandate applies to all ages, even to
psychiatric residential treatment facilities for individuals under twenty-one years of age,36 which
is not related to CMS’s asserted interest in protecting elderly and infirm patients from COVID-
19 transmissions.37 As noted by the Court in BST Holdings in regard to the OSHA Mandate:
The Mandate is a one-size-fits-all sledgehammer that makes hardly any
attempt to account for differences in workplaces (and workers) that have
more than a little bearing on workers’ varying degrees of susceptibility
to the supposedly “grave danger” the Mandate purports to address.
No. 21-60845 at 8.
The Plaintiff States have made a substantial showing that they are likely to succeed on
the merits of their arbitrary and capricious claim.
5. Other Constitutional Issues
Other arguments made by the Plaintiff States are based upon a violation of the States’
police power, violation of the Spending Clause, violation of the Tenth Amendment and violation
of the Anti-Commandeering Doctrine.
(a) Police Power/Tenth Amendment
In the federal system, the federal government has limited powers. The States and the
people retain the remainder.38 The States have broad authority to enact legislation for the public
good (“police power”), but the federal government has no such authority, and can only exercise
the powers granted to it, including the power to make all laws which may be necessary and
36
86 Fed. Reg. at 61576.
37
86 Fed. Reg. at 61610.
38
10th Amendment to the United States Constitution.
28
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proper for carrying into execution the enumerated powers. If the federal government would
radically readjust the balance of state and national authority, those charged with the duty of
legislating must be reasonably explicit about it. The Supreme Court will not be quick to assume
Congress has meant to effect a significant change into the sensitive state and federal relations.
Congress does not normally intrude upon the police power of States. Bond v. United States, 572
U.S. 844, 857-58 (2014).
Absent a clear statement of intention from Congress, there is a presumption against
statutory construction that would significantly affect the federal-state balance. Boelens v.
Redman Homes, Inc. 748 F.2d 1058, 1067 (5th Cir. 1984).
The CMS Mandate specifically preempts state and local law. 86 Fed. Reg. at 61572. As
noted by the Fifth Circuit in BST Holdings:
First, the Mandate likely exceeds the federal government’s authority
under the Commerce Clause because it regulates noneconomic inactivity
that falls squarely within the States’ police power. A person’s choice to
remain unvaccinated and forego regular testing is noneconomic
inactivity. Cf. NFIB v. Sebelius, 567 U.S. 519, 522 (2012) (Roberts, C.J.
concurring); see also Id. at 652-53 (Scalia, J., dissenting). And to
mandate that a person receive a vaccine or undergo testing falls squarely
within the States’ police power. Zucht v. King, 260 U.S. 174, 176 (1922)
(noting that precedent had long “settled that it is within the police power
of a state to provide for compulsory vaccination”); Jacobson v.
Massachusetts, 197 U.S. 11, 25-26 (1905) (Similar). No. 21-60845 at 16-
17.
The Plaintiff States make a strong case that the CMS Mandate violates the States’ police
power.
(b) Anti-Commandeering Doctrine
The Anti-Commandeering Doctrine is simply the expression of a fundamental structural
decision incorporated into the Constitution, i.e., the decision to withhold from Congress the
power to issue orders directly to the States. Congress cannot command a state government to
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enact state legislation. The Tenth Amendment confirms that all other power is reserved to the
States. Murphy v. National Collegiate Athletics Ass’n., 138 S.Ct. 1461, 1476 (2018).
In Printz v. U.S., 521 U.S. 898, 928 (1997), the Court held invalid a federal law that
commanded state and local enforcement officers to conduct background checks on prospective
handgun purchasers and to perform certain related tasks.
Although many of the health care facilities required to track and regulate the CMS
Mandate are private, many are likely run by some or all of the Plaintiff States, which could result
in violation of the Anti-Commandeering Doctrine. As this Court is unable to tell (at this point)
whether and/or how many of the providers and suppliers are run by states, there is no evidence to
prove the violation.
(c) Non-Delegation Doctrine
Under the Non-Delegation Doctrine, Congress lacks the authority to delegate “unfiltered
power” over the American economy to an executive agency. Solid Waste Agency of Northern
Cook County v. U.S. Army Corps of Engineers, 121 S.Ct. 675 (2001).39
This is a similar doctrine to the Major Questions Doctrine, but if the Government
Defendants have the power and authority they claim (to mandate vaccines for 10.3 million
workers), these government agencies would have almost “unfiltered power” over any healthcare
provider, supplier, and employees that are covered by the CMS Mandate. If CMS has the
authority by a general authorization statute to mandate vaccines, they have authority to do almost
anything they believe necessary, holding the hammer of termination of the Medicare/Medicaid
Provider Agreement over healthcare facilities and suppliers.
The Plaintiff States are likely to succeed on the merits of this claim.
39
There is a serious constitutional question of whether Congress could even transfer “unfettered power” to a
government agency. Paul v. United States 140 S.Ct. 342 (2019) (Kavanaugh, J. Statement).
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(d) Spending Clause
The Spending Clause protects the status of States as independent sovereigns in our
federal system. Under the Spending Clause,40 Congress may use its spending power to create
incentives for states to act in accordance with federal policies, but when the pressure turns into
compulsion, the legislation runs contrary to our system of federalism. The Constitution simply
does not give Congress the authority to require the States to regulate. NFIB v. Sebelius, 567 U.S.
519, 577 (2012).
In NFIB, a provision in the Affordable Care Act which required States that participated in
Medicaid to expand their Medicaid programs with the threatened loss of all Medicaid funds to
states that refused to expand was held to be unconstitutionally coercive. Since it is unclear at this
time whether there is state involvement with the providers, suppliers or employers, the Plaintiff
States are at this time not likely to succeed on the merits of this issue.
B. Irreparable Injury
The second requirement for a preliminary injunction is irreparable injury. The Plaintiff
States must demonstrate “a substantial threat of irreparable injury” if the injunction is not issued.
Texas v. U.S., 809 F.3d 134, 150 (5th Cir. 2015). For injury to be “irreparable,” plaintiffs need
only show it cannot be undone through monetary remedies. Burgess v. Fed. Deposit Inc., Corp.,
871 F.3d 297, 304 (5th Cir. 2017).
Being deprived of a procedural right to protect its concrete interests (by violation of the
ADA’s notice and comment requirements) is irreparable injury. Texas v. EEOC, 933 F.3d 433,
447 (5th Cir. 2019).
40
Article I, Section 8, United States Constitution
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The Plaintiff States will suffer irreparable injury by not being able to enforce their laws
which have been preempted by the CMS Mandate, by incurring the increased cost of training and
of enforcing the CMS Mandate, and by having their police power encroached. The Plaintiff
States’ citizens will suffer irreparable injury by having a substantial burden placed on their
liberty interests because they will have to choose between losing their jobs or taking the vaccine.
Additionally, the health care facilities and suppliers will be burdened with the task of tracking
and enforcing the mandate or else face the loss of Medicare and Medicaid funding
The Plaintiff States have shown irreparable injury.
C. The Balance of Equities and The Public’s Interest
The Plaintiff States have satisfied the first two elements to obtain a preliminary
injunction. The final two elements they must satisfy are that the threatened harm outweighs any
harm that may result to the Government Defendants and that the injunction will not undermine
the public interest. Valley v. Rapides Par. Sch. Bd., 118 F.3d 1047, 1051 (5th Cir. 1997). These
two factors overlap considerably. Texas, 809 F.3d at 187. In weighing equities, a court must
balance the competing claims of injury and must consider the effect on each party of the granting
or withholding of the requested relief. Winter, 555 U.S. at 24. The public interest factor requires
the court to consider what public interests may be served by granting or denying a preliminary
injunction. Sierra Club v. U.S. Army Corps of Engineers, 645 F.3d 978, 997–98 (8th Cir. 2011).
This Court believes the balance of equities and the public interest favors the issuance of a
preliminary injunction. The public interest is served by maintaining the constitutional structure
and maintaining the liberty of individuals who do not want to take the COVID-19 vaccine. This
interest outweighs Government Defendants’ interests. It is very important that the public’s
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interest be taken into account by the Court before allowing the Government Defendants to
mandate the vaccines.
V. CONCLUSION
If the separation of powers meant anything to the Constitutional framers, it meant that the
three necessary ingredients to deprive a person of liberty or property – the power to make rules,
to enforce them, and to judge their violations – could never fall into the same hands. Tiger Lily,
LLC v. United States Housing and Urban Development, 5 F.4th 666 (6th Cir. 2021). (Thapar, J.
Concurrence). If the Executive branch is allowed to usurp the power of the Legislative branch to
make laws, two of the three powers conferred by the Constitution would be in the same hands.
If human nature and history teach anything, it is that civil liberties face grave risks when
governments proclaim indefinite states of emergency. Does 1-3 v. Mills, _ S.Ct. _, 2021 WL
5027177 at 3 (October 29, 2021) (Gorsuch, J. dissenting).
During a pandemic such as this one, it is even more important to safeguard the separation
of powers set forth in our Constitution to avoid erosion of our liberties. Because the Plaintiff
States have satisfied all four elements required for a preliminary injunction to issue, this Court
has determined that a preliminary injunction should issue against the Government Defendants.
This matter will ultimately be decided by a higher court than this one. However, it is
important to preserve the status quo in this case. The liberty interests of the unvaccinated
requires nothing less.
In addressing the geographic scope of the preliminary injunction, due to the nationwide
scope of the CMS Mandate, a nationwide injunction is necessary due to the need for uniformity.
Texas, 809 F.3d at 187-88. Although this Court considered limiting the injunction to the
fourteen Plaintiff States, there are unvaccinated healthcare workers in other states who also need
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protection. Therefore, the scope of this injunction will be nationwide, except for the states of
Alaska, Arkansas, Iowa, Kansas, Missouri, New Hampshire, Nebraska, Wyoming, North Dakota,
South Dakota, since these ten states are already under a preliminary injunction order dated
November 29, 2021, out of the Eastern District of Missouri.
This Court will additionally address security under Fed. R. Civ. P. 65. The requirement
of security is discretionary. Kaepa, Inc. v. Achilles Corp., 76 F.3d 624, 628 (5th Cir. 1996).
Plaintiff States are fourteen sovereign states. This Court will not require Plaintiff States to post
security for this Preliminary Injunction.
For the reasons set forth in this Court’s ruling, Plaintiff States’ Motion for Preliminary
Injunction [Doc. No. 2] is GRANTED. Therefore, the U.S. Department of Health and Human
Services and the Center for Medicare and Medicaid Services, along with their directors,
employees, Administrators and Secretaries are hereby ENJOINED and RESTRAINED from
implementing the CMS Mandate set forth in 86 Fed. Reg. 61555-01 (November 5, 2021) as to
all healthcare providers, suppliers, owners, employees, and all others covered by said CMS
Mandate.
This preliminary injunction shall remain in effect pending the final resolution of this case,
or until further orders from this Court, the United States Court of Appeals for the Fifth Circuit, or
the United States Supreme Court.
No security bond shall be required under Federal Rule of Civil Procedure 65.
MONROE, LOUISIANA, this 30th day of November 2021.
____________________________________
TERRY A. DOUGHTY
UNITED STATES DISTRICT JUDGE
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61555
Authority: 33 U.S.C. 941; 29 U.S.C. 653, (29 U.S.C. 653, 655, 657); Secretary of Labor’s DATES:
655, 657; Secretary of Labor’s Order No. 12– Order No. 12–71 (36 FR 8754), 8–76 (41 FR Effective date: These regulations are
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83 25059), 9–83 (48 FR 35736), 1–90 (55 FR effective on November 5, 2021.
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 9033), 6–96 (62 FR 111), 3–2000 (65 FR Implementation dates: The
FR 111), 3–2000 (65 FR 50017), 5–2002 (67 50017), 5–2002 (67 FR 65008), 4–2010 (75 FR
regulations included in Phase 1 [42 CFR
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75 55355), or 8–2020 (85 FR 58393), as
FR 55355), 1–2012 (77 FR 3912), or 8–2020 applicable; and 29 CFR 1911. 416.51(c) through (c)(3)(i) and (c)(3)(iii)
(85 FR 58393), as applicable; and 29 CFR Section 1928.21 also issued under 49 through (x), 418.60(d) through (d)(3)(i)
1911. U.S.C. 1801–1819 and 5 U.S.C. 553. and (d)(3)(iii) through (x), 441.151(c)
Sections 1918.90 and 1918.110 also issued through (c)(3)(i) and (c)(3)(iii) through
under 5 U.S.C. 553. Subpart B—Applicability of Standards (x), 460.74(d) through (d)(3)(i) and
Section 1918.100 also issued under 49 (d)(3)(iii) through (x), 482.42(g) through
U.S.C. 5101 et seq. and 5 U.S.C. 553. ■ 16. Amend § 1928.21 by adding (g)(3)(i) and (g)(3)(iii) through (x),
■ 12. Add subpart K to part 1918 to read
paragraph (a)(8) to read as follows: 483.80(d)(3)(v) and 483.80(i) through
as follows: § 1928.21 Applicable standards in 29 CFR (i)(3)(i) and (i)(3)(iii) through (x),
part 1910. 483.430(f) through (f)(3)(i) and (f)(3)(iii)
Subpart K—COVID–19. (a) * * * through (x), 483.460(a)(4)(v), 484.70(d)
(8) COVID–19—§ 1910.501, but only through (d)(3)(i) and (d)(3)(iii) through
Sec.
1918.107–1918.109 [Reserved] with respect to— (x), 485.58(d)(4), 485.70(n) through
1918.110 COVID–19. (i) Agricultural establishments where (n)(3)(i) and (n)(3)(iii) through (x),
1918.107 through 1918.109 [Reserved] eleven (11) or more employees are 485.640(f) through (f)(3)(i) and (f)(3)(iii)
engaged on any given day in hand-labor through (x), 485.725(f) through (f)(3)(i)
§ 1918.110 COVID–19. operations in the field; and through (f)(3)(iii) through (x), 485.904(c)
The requirements applicable to (ii) Agricultural establishments that through (c)(3)(i) and (c)(3)(iii) through
longshoring work under this section are maintain a temporary labor camp, (x), 486.525(c) through (c)(3)(i) and
identical to those set forth at 29 CFR regardless of how many employees are (c)(3)(iii) through (x), 491.8(d) through
1910.501. engaged on any given day in hand-labor (d)(3)(i) and (d)(3)(iii) through (x),
operations in the field. 494.30(b) through (b)((3)(i) and (b)(3)(iii)
PART 1926—SAFETY AND HEALTH through (x) must be implemented by
* * * * *
REGULATIONS FOR CONSTRUCTION [FR Doc. 2021–23643 Filed 11–4–21; 8:45 am] December 6, 2021.
The regulations included in Phase 2
■ 13. The authority citation for part BILLING CODE 4510–26–P
[42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii),
1926 is revised to read as follows: 441.151(c)(3)(ii), 460.74(d)(3)(ii),
Authority: 40 U.S.C. 3704; 29 U.S.C. 653, DEPARTMENT OF HEALTH AND 482.42(g)(3)(ii), 483.80(i)(3)(ii),
655, and 657; and Secretary of Labor’s Order HUMAN SERVICES 483.430(f)(3)(ii), 484.70(d)(3)(ii),
No. 12–71 (36 FR 8754), 8–76 (41 FR 25059), 485.70(n)(3)(ii), 485.640(f)(3)(ii),
9–83 (48 FR 35736), 1–90 (55 FR 9033), 6– Centers for Medicare & Medicaid 485.725(f)(3)(ii), 485.904(c)(3)(ii),
96 (62 FR 111), 3–2000 (65 FR 50017), 5–
2002 (67 FR 65008), 5–2007 (72 FR 31159), Services 486.525(c)(3)(ii), 491.8(d)(3)(ii),
4–2010 (75 FR 55355), 1–2012 (77 FR 3912), 494.30(b)(3)(ii)] must be implemented
or 8–2020 (85 FR 58393), as applicable; and 42 CFR Parts 416, 418, 441, 460, 482, by January 4, 2022. Staff who have
29 CFR part 1911. 483, 484, 485, 486, 491 and 494 completed a primary vaccination series
Sections 1926.58, 1926.59, 1926.60, and by this date are considered to have met
[CMS–3415–IFC]
1926.65 also issued under 5 U.S.C. 553 and these requirements, even if they have
29 CFR part 1911. RIN 0938–AU75 not yet completed the 14-day waiting
Section 1926.61 also issued under 49
period required for full vaccination.
U.S.C. 1801–1819 and 5 U.S.C. 553. Medicare and Medicaid Programs;
Section 1926.62 also issued under sec.
Comment date: To be assured
Omnibus COVID–19 Health Care Staff consideration, comments must be
1031, Public Law 102–550, 106 Stat. 3672 (42 Vaccination
U.S.C. 4853). received at one of the addresses
Section 1926.65 also issued under sec. 126, AGENCY: Centers for Medicare & provided below, no later than 5 p.m. on
Public Law 99–499, 100 Stat. 1614 (reprinted Medicaid Services (CMS), HHS. January 4, 2022.
at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553. ACTION: Interim final rule with comment ADDRESSES: In commenting, please refer
period. to file code CMS–3415–IFC.
Subpart D—Occupational Health and Comments, including mass comment
Environmental Controls SUMMARY: This interim final rule with submissions, must be submitted in one
comment period revises the of the following three ways (please
■ 14. Add § 1926.58 to read as follows:
requirements that most Medicare- and choose only one of the ways listed):
§ 1926.58 COVID–19. Medicaid-certified providers and 1. Electronically. You may submit
The requirements applicable to suppliers must meet to participate in the electronic comments on this regulation
construction work under this section are Medicare and Medicaid programs. to http://www.regulations.gov. Follow
identical to those set forth at 29 CFR These changes are necessary to help the ‘‘Submit a comment’’ instructions.
1910.501 Subpart U. protect the health and safety of 2. By regular mail. You may mail
residents, clients, patients, PACE written comments to the following
PART 1928—OCCUPATIONAL SAFETY participants, and staff, and reflect address ONLY: Centers for Medicare &
lessons learned to date as a result of the Medicaid Services, Department of
jspears on DSK121TN23PROD with RULES2
AND HEALTH STANDARDS FOR
AGRICULTURE COVID–19 public health emergency. Health and Human Services, Attention:
The revisions to the requirements CMS–3415–IFC, P.O. Box 8016,
■ 15. The authority citation for part establish COVID–19 vaccination Baltimore, MD 21244–8016.
1928 is revised to read as follows: requirements for staff at the included Please allow sufficient time for mailed
Authority: Sections 4, 6, and 8 of the Medicare- and Medicaid-certified comments to be received before the
Occupational Safety and Health Act of 1970 providers and suppliers. close of the comment period.
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61556 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
3. By express or overnight mail. You • Ambulatory Surgical Centers (ASCs) Occupational Safety and Health
may send written comments to the (§ 416.51) Administration (OSHA) for certain
following address ONLY: Centers for • Hospices (§ 418.60) employers.
Medicare & Medicaid Services, • Psychiatric residential treatment Currently, the United States (U.S.) is
Department of Health and Human facilities (PRTFs) (§ 441.151) responding to a public health
Services, Attention: CMS–3415–IFC, • Programs of All-Inclusive Care for the emergency (PHE) of respiratory disease
Mail Stop C4–26–05, 7500 Security Elderly (PACE) (§ 460.74) caused by a novel coronavirus that has
Boulevard, Baltimore, MD 21244–1850. • Hospitals (acute care hospitals, now been detected in more than 190
For information on viewing public psychiatric hospitals, hospital swing countries internationally, all 50 States,
comments, see the beginning of the beds, long term care hospitals, the District of Columbia, and all U.S.
SUPPLEMENTARY INFORMATION section. children’s hospitals, transplant territories. The virus has been named
centers, cancer hospitals, and ‘‘severe acute respiratory syndrome
FOR FURTHER INFORMATION CONTACT:
rehabilitation hospitals/inpatient coronavirus 2’’ (SARS–CoV–2), and the
For press inquiries: CMS Office of rehabilitation facilities) (§ 482.42) disease it causes has been named
Communications, Department of Health • Long Term Care (LTC) Facilities, ‘‘coronavirus disease 2019’’ (COVID–
and Human Services; email press@ including Skilled Nursing Facilities 19). On January 30, 2020, the
cms.hhs.gov. (SNFs) and Nursing Facilities (NFs), International Health Regulations
For technical inquiries: Contact CMS generally referred to as nursing homes Emergency Committee of the World
Center for Clinical Standards and (§ 483.80) Health Organization (WHO) declared
Quality, Department of Health and • Intermediate Care Facilities for the outbreak a ‘‘Public Health
Human Services, (410) 786–6633. Individuals with Intellectual Emergency of International Concern.’’
SUPPLEMENTARY INFORMATION: Disabilities (ICFs–IID) (§ 483.430) On January 31, 2020, pursuant to
Inspection of Public Comments: All • Home Health Agencies (HHAs) section 319 of the Public Health Service
comments received before the close of (§ 484.70) Act (PHSA) (42 U.S.C. 247d), the
the comment period are available for • Comprehensive Outpatient Secretary of the Department of Health
viewing by the public, including any Rehabilitation Facilities (CORFs) and Human Services (Secretary)
personally identifiable or confidential (§§ 485.58 and 485.70) determined that a PHE exists for the
business information that is included in • Critical Access Hospitals (CAHs) U.S. (hereafter referred to as the PHE for
a comment. We post all comments (§ 485.640) COVID–19). On March 11, 2020, the
received before the close of the • Clinics, rehabilitation agencies, and WHO publicly declared COVID–19 a
comment period on the following public health agencies as providers of pandemic. On March 13, 2020, the
website as soon as possible after they outpatient physical therapy and President of the United States declared
have been received: http:// speech-language pathology services the COVID–19 pandemic a national
www.regulations.gov. Follow the search (§ 485.725) emergency. The January 31, 2020
instructions on that website to view • Community Mental Health Centers determination that a PHE for COVID–19
public comments. CMS will not post on (CMHCs) (§ 485.904) exists and has existed since January 27,
Regulations.gov public comments that • Home Infusion Therapy (HIT) 2020, lasted for 90 days, and was
make threats to individuals or suppliers (§ 486.525) renewed on April 21, 2020; July 23,
institutions or suggest that the • Rural Health Clinics (RHCs)/Federally 2020; October 2, 2020; January 7, 2021;
individual will take actions to harm the Qualified Health Centers (FQHCs) April 15, 2021; July 19, 2021; and
individual. CMS continues to encourage (§ 491.8) October 18, 2021. Pursuant to section
individuals not to submit duplicative • End-Stage Renal Disease (ESRD) 319 of the PHSA, the determination that
comments. We will post acceptable Facilities (§ 494.30) a PHE continues to exist may be
comments from multiple unique This IFC directly applies only to the renewed at the end of each 90-day
commenters even if the content is Medicare- and Medicaid-certified period.1
identical or nearly identical to other providers and suppliers listed above. It COVID–19 has had significant
comments. does not directly apply to other health negative health effects—on individuals,
care entities, such as physician offices, communities, and the nation as a whole.
I. Background
that are not regulated by CMS. Most Consequences for individuals who have
The Centers for Medicare & Medicaid states have separate licensing COVID–19 include morbidity,
Services (CMS) establishes health and requirements for health care staff and hospitalization, mortality, and post-
safety standards, known as the health care providers that would be COVID conditions (also known as long
Conditions of Participation, Conditions applicable to physician office staff and COVID). As of mid-October 2021, over
for Coverage, or Requirements for other staff in small health care entities 44 million COVID–19 cases, 3 million
Participation for 21 types of providers that are not subject to vaccination new COVID–19 related hospitalizations,
and suppliers, ranging from hospitals to requirements under this IFC. We have and 720,000 COVID–19 deaths have
hospices and rural health clinics to long not included requirements for Organ been reported in the U.S.2 Indeed,
term care facilities (including skilled Procurement Organizations or Portable COVID–19 has overtaken the 1918
nursing facilities and nursing facilities, X-Ray suppliers, as these only provide influenza pandemic as the deadliest
collectively known as nursing homes). services under contract to other health disease in American history.3
Most of these providers and suppliers care entities and would thus be
are regulated by this interim final rule indirectly subject to the vaccination
jspears on DSK121TN23PROD with RULES2
1 https://www.phe.gov/emergency/events/
with comment period (IFC). requirements of this rule, as discussed COVID19/Pages/2019-Public-Health-and-Medical-
Specifically, this IFC directly regulates in section II.A.1. of this rule. We note Emergency-Declarations-and-Waivers.aspx.
2 https://covid.cdc.gov/covid-data-
the following providers and suppliers, that entities not covered by this rule
tracker#datatracker-home.
listed in the numerical order of the may still be subject to other State or 3 https://www.statnews.com/2021/09/20/covid-
relevant CFR sections being revised in Federal COVID–19 vaccination 19-set-to-overtake-1918-spanish-flu-as-deadliest-
this rule: requirements, such as those issued by disease-in-american-history.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61557
Given recent estimates of estimated reduction for Black and attributed to healthcare-associated
undiagnosed infections and under- Latino populations is 3–4 times the transmission.19 In outbreaks reported
reported deaths, these figures likely estimate for the White population, from acute care settings in the U.S.
underestimate the full impact.4 In reversing over 10 years of progress in following implementation of universal
addition, these figures fail to capture the reducing the gaps in life expectancy masking, unmasked exposures to other
significant, detrimental effects of post- between Black and White populations health care workers were frequently
acute illness, including nervous system and reducing the Latino mortality implicated.20 A retrospective cohort
and neurocognitive disorders, advantage by over 70 percent. The study study of health care staff behaviors,
cardiovascular disorders, further expects that reductions in life exposures, and cases between June and
gastrointestinal disorders, and signs and expectancy may persist because of December 2020 in a large health system
symptoms related to poor general well- continued COVID–19 mortality and found more employees were exposed
being, including malaise, fatigue, term health, social, and economic via coworkers than patients—and
musculoskeletal pain, and reduced impacts of the pandemic.7 Because secondary cases among employees
quality of life. Recent estimates suggest SARS–CoV–2, the virus that causes typically followed unmasked
more than half of COVID–19 survivors COVID–19 disease, is highly interactions with infected colleagues
experienced post-acute sequelae of transmissible,8 Centers for Disease (for example, convening in breakrooms
COVID–19 6 months after recovery.5 Control and Prevention (CDC) has without proper source control).21 The
The individual and public health recommended, and CMS reiterated, that same study found that cases of health
ramifications of COVID–19 also extend health care providers and suppliers care worker infection associated with
beyond the direct effects of COVID–19 implement robust infection prevention patient exposures could often be
infections. Several studies have and control practices, including source attributed to failure to adhere to PPE
demonstrated significant mortality control measures, physical distancing, requirements (for example, eye
increases in 2020, beyond those universal use of personal protective protection). Past experience with
attributable to COVID–19 deaths. In equipment (PPE), SARS–CoV–2 testing, influenza, and available evidence,
some percentage, this could be a environmental controls, and patient suggest that vaccination of health care
problem of misattribution (for example, isolation or quarantine.9 10 11 12 Available staff offers a critical layer of protection
the cause of death was indicated as evidence suggests these infection against healthcare-associated COVID–19
‘‘heart disease’’ but in fact the true cause prevention and control practices have (HA–COVID–19). For example, evidence
was undiagnosed COVID–19), but some been highly effective when has shown that influenza vaccination of
proportion are also believed to reflect implemented correctly and health care staff is associated with
increases in other causes of death that consistently.13 14 declines in nosocomial influenza in
are sensitive to decreased access to care Studies have also shown, however, hospitalized patients,22 23 24 and among
and/or increased mental/emotional that consistent adherence to nursing home residents.25 26 27 28 29 30 31
strain. One paper quantifies the net recommended infection prevention and 19 https://www.medrxiv.org/content/10.1101/
impact (direct and indirect effects) of control practices can prove 2021.02.16.21251625v1.
the pandemic on the U.S. population challenging—and those lapses can place 20 https://jamanetwork.com/journals/jama/full
during 2020 using three metrics: excess patients in jeopardy.15 16 17 18 A article/2773128.
deaths, life expectancy, and total years retrospective analysis from England 21 https://www.ncbi.nlm.nih.gov/pmc/articles/
of life lost. The findings indicate there found up to 1 in 6 SARS–CoV–2 PMC8349432/.
22 Weinstock DM, Eagan J, Malak SA, et al.
were 375,235 excess deaths, with 83 infections among hospitalized patients
Control of influenza A on a bone marrow transplant
percent attributable to direct, and 17 with COVID–19 in England during the unit. Infect Control Hosp Epidemiol. 2000; 21:730–
percent attributable to indirect effects of first 6 months of the pandemic could be 732.
COVID–19. The decrease in life 23 Salgado CD, Giannetta ET, Hayden FG, Farr
expectancy was 1.67 years, translating 7 Andrasfay, T., & Goldman, N. (2021). BM. Preventing nosocomial influenza by improving
Reductions in 2020 US life expectancy due to the vaccine acceptance rate of clinicians. Infect
to a reversion of 14 years in historical Control Hosp Epidemiol 2004; 25:923–928.
COVID–19 and the disproportionate impact on the
life expectancy gains. Total years of life Black and Latino populations. Proceedings of the 24 https://pubmed.ncbi.nlm.nih.gov/31384750/.
lost in 2020 was 7,362,555 across the National Academy of Sciences of the United States 25 Hayward AC, Harling R, Wetten S, et al.
U.S. (73 percent directly attributable, 27 of America, 118(5), e2014746118. https://doi.org/ Effectiveness of an influenza vaccine programme for
percent indirectly attributable to 10.1073/pnas.2014746118 Accessed 10/17/2021. care home staff to prevent death, morbidity, and
8 https://www.npr.org/sections/goatsandsoda/ health service use among residents: cluster
COVID–19), with considerable randomised controlled trial. BMJ 2006; 333: 1241–
2021/08/11/1026190062/covid-delta-variant-
heterogeneity at the individual State transmission-cdc-chickenpox. 1246.
level.6 9 https://www.cdc.gov/coronavirus/2019-ncov/ 26 Potter J, Stott DJ, Roberts MA, et al. Influenza
One analysis published in February hcp/infection-control-recommendations.html. vaccination of healthcare workers in long-term-care
hospitals reduces the mortality of elderly patients.
2021 found that Black and Latino 10 https://www.cms.gov/files/document/qso-21-
J Infect Dis. 1997; 175:1–6.
Americans have experienced a 08-nltc.pdf.
27 Thomas RE, Jefferson TO, Demicheli V, et al.
11 https://www.cms.gov/files/document/qso-21-
disproportionate burden of COVID–19 07-psych-hospital-prtf-icf-iid.pdf. Influenza vaccination for health-care workers who
morbidity and mortality, reflecting 12 https://www.cms.gov/files/document/qso-20-
work with elderly people in institutions: a
persistent structural inequalities that systematic review. Lancet Infect Dis. 2006; 6:273–
38-nh-revised.pdf. 279.
increase risk of exposure to COVID–19 13 https://jamanetwork.com/journals/jamanet
28 Van den Dool C, Bonten MJM, Hak E, Heijne
and mortality risk for those infected. workopen/fullarticle/2770287. JCM, Wallinga J. The effects of influenza
14 https://jamanetwork.com/journals/jamanet
The authors projected that COVID–19 vaccination of health care workers in nursing
workopen/fullarticle/2777317. homes: insights from a mathematical model. PLoS
would reduce U.S. life expectancy in
jspears on DSK121TN23PROD with RULES2
15 https://www.pnas.org/content/pnas/118/1/
Medicine. 2008; 5:1453–1460.
2020 by 1.13 years. Furthermore, the e2015455118.full.pdf. Lemaitre M, Meret T, Rothan-Tondeur M, et al.
16 https://jamanetwork.com/journals/
Effect of influenza vaccination of nursing home staff
4 https://www.ncbi.nlm.nih.gov/pmc/articles/ jamanetworkopen/article-abstract/2782430. on mortality of residents: a cluster-randomized trial.
PMC8354557/. 17 https://www.medrxiv.org/content/10.1101/ J Am Geriatr Soc. 2009; 57:1580–1586.
5 https://jamanetwork.com/journals/jamanet 2021.09.08.21263057v1. 29 Lemaitre M, Meret T, Rothan-Tondeur M, et al.
workopen/fullarticle/2784918. 18 https://journals.plos.org/plosmedicine/ Effect of influenza vaccination of nursing home staff
6 https://pubmed.ncbi.nlm.nih.gov/34469474/. article?id=10.1371/journal.pmed.1003816. Continued
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61558 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
As a result, CDC, the Society for in facilities with lower vaccination for ongoing healthcare-associated
Healthcare Epidemiology of America, coverage among staff; specifically, COVID–19 transmission risk is
and others recommend—and a number residents of LTC facilities in which sufficiently alarming in and of itself to
of states require— annual influenza vaccination coverage of staff is 75 compel CMS to take action.
vaccination for health care staff.32 33 34 percent or lower experience higher rates The threats that unvaccinated staff
In addition to preventing morbidity of preventable COVID–19.38 Several pose to patients are not, however,
and mortality associated with COVID– articles published in CDC’s Morbidity limited to SARS–CoV–2 transmission.
19, currently approved or authorized and Mortality Weekly Reports Unvaccinated staff jeopardize patient
vaccines also demonstrate effectiveness (MMWRs) regarding nursing home access to recommended medical care
against asymptomatic SARS–CoV–2 outbreaks have also linked the spread of and services, and these additional risks
infection. A recent study of health care COVID–19 infection to unvaccinated to patient health and safety further
workers in 8 states found that, between health care workers and stressed that warrant CMS action.
December 14, 2020 through August 14, maintaining a high vaccination rate is Fear of exposure to and infection with
2021, full vaccination with COVID–19 important for reducing COVID–19 from unvaccinated health
vaccines was 80 percent effective in transmission.39 40 41 care staff can lead patients to
preventing RT–PCR–confirmed SARS– There is also some published themselves forgo seeking medically
CoV–2 infection among frontline evidence from other settings that suggest necessary care. In a small but
workers.35 Emerging evidence also similar dynamics can be expected in informative qualitative study of 33
suggests that vaccinated people who other health care delivery settings. For home health care workers in New York
become infected with the SARS–CoV–2 example, a recent analysis from Yale City, one of the key themes to emerge
Delta variant have potential to be less New Haven Hospital (YNHH) found from interviews with those workers was
infectious than infected unvaccinated health care units with at least 1 a keen recognition that ‘‘providing care
people, thus decreasing transmission inpatient case of HA–COVID–19 had to patients placed them in a unique
risk.36 For example, in a study of lower staff vaccination rates.42 position with respect to COVID–19
breakthrough infections among health Similarly, a small study in Israel transmission. They worried . . . about
care workers in the Netherlands, SARS– demonstrated that transmission of transmitting the virus to [their clients].’’
CoV–2 infectious virus shedding was COVID–19 was linked to unvaccinated They also noted that care for home
lower among vaccinated individuals persons. In 37 cases, patients for whom bound clients might involve other
with breakthrough infections than data were available regarding the source health care staff, and they worried about
among unvaccinated individuals with of infection, the suspected source was ‘‘transmitting COVID–19 . . . to one
primary infections.37 Fewer infected an unvaccinated person; in 21 patients another.’’ 44
staff and lower transmissibility equates (57 percent), this person was a Anecdotal evidence suggests health
to fewer opportunities for transmission household member; in 11 cases (30 care consumers have drawn similar
to patients, and emerging evidence percent), the suspected source was an conclusions—and this, too, has
indicates this is the case. The best data unvaccinated fellow health care worker implications for overall health and
come from long term care facilities, as or patient.43 While similarly welfare in health care settings. For
early implementation of national comprehensive data are not available for example, CMS has received anecdotal
reporting requirements have resulted in all Medicare- and Medicaid-certified reports suggesting individuals in care
a comprehensive, longitudinal, high provider types, the available evidence are refusing care from unvaccinated
quality data set. Data from CDC’s staff, limiting the extent to which
National Healthcare Safety Network 38 https://emergency.cdc.gov/han/2021/ providers and suppliers can effectively
(NHSN) have shown that case rates han00447.asp. meet the health care needs of their
39 COVID–19 Outbreak Associated with a SARS–
among LTC facility residents are higher patients and residents. Further,
CoV–2 R.1 Lineage Variant in a Skilled Nursing
Facility After Vaccination Program — Kentucky,
nationwide there are reports of
on mortality of residents: a cluster-randomized trial. March 2021.’’ April 21, 2021. Available at https:// individuals avoiding or forgoing health
J Am Geriatr Soc. 2009; 57:1580–1586. www.cdc.gov/mmwr/volumes/70/wr/ care due to fears of contracting COVID–
Van den Dool C, Bonten MJM, Hak E, Heijne JCM, mm7017e2.htm. 19 from health care workers.45 46 47
Wallinga J. The effects of influenza vaccination of 40 Postvaccination SARS–CoV–2 Infections
health care workers in nursing homes: insights from While avoidance of necessary care
Among Skilled Nursing Facility Residents and Staff
a mathematical model. PLoS Medicine. 2008; Members — Chicago, Illinois, December 2020– appears to have abated somewhat since
5:1453–1460. March 2021.’’ April 30, 2021. Available at https:// the first months of the COVID–19
30 Oshitani H, Saito R, Seiki N, et al. Influenza
www.cdc.gov/mmwr/volumes/70/wr/ pandemic, it remains an area of concern
vaccination levels and influenza-like illness in mm7017e1.htm.
long-term–care facilities for elderly people in 41 Effectiveness of the Pfizer-BioNTech COVID–19
for many individuals.48 49 Because
Niigata, Japan, during an influenza A (H3N2) Vaccine Among Residents of Two Skilled Nursing
epidemic. Infect Control Hosp Epidemiol. 2000; Facilities Experiencing COVID–19 Outbreaks —
44 https://jamanetwork.com/journals/
21:728–730. Connecticut, December 2020–February 2021.’’ jamainternalmedicine/fullarticle/2769096).
31 https://pubmed.ncbi.nlm.nih.gov/31384750/. 45 J Anxiety Disord. 2020 Oct; 75: 102289.
March 19, 2021. Available at: https://www.cdc.gov/
32 https://www.cdc.gov/flu/professionals/
mmwr/volumes/70/wr/mm7011e3.htm. Published online 2020 Aug 19. Doi: 10.1016/
infectioncontrol/healthcaresettings.htm. 42 Roberts, S., Aniskiewicz, M., Choi, S., Pettker, j.janxdis.2020.102289
33 https://www.cambridge.org/core/journals/ 46 https://www.cdc.gov/mmwr/volumes/69/wr/
C., & Martinello, R. (2021). Correlation of healthcare
infection-control-and-hospital-epidemiology/ worker vaccination on inpatient healthcare- pdfs/mm6936a4-H.pdf.
article/revised-shea-position-paper-influenza- associated COVID–19. Infection Control & Hospital 47 https://www.nahc.org/wp-content/uploads/
vaccination-of-healthcare-personnel/E83D4D87 Epidemiology, 1–6. Doi:10.1017/ice.2021.414. 2020/03/NATIONAL-SURVEY-SHOWS-HOME-
FBBBD80C66A2A4926D00F4B8. 43 Moriah Bergwerk, M.B., B.S., Tal Gonen, B.A., HEALTH-CARE-ON-THE-FRONTLINES-OF-COVID-
34 https://www.cdc.gov/phlp/publications/topic/ 19-AND-CONTINUES-TO-BE-IN-A-FRAGILE-
Yaniv Lustig, Ph.D., Sharon Amit, M.D., Marc
jspears on DSK121TN23PROD with RULES2
vaccinationlaws.html. Lipsitch, Ph.D., Carmit Cohen, Ph.D., Michal FINANCIAL-STATE.pdf.
35 https://www.cdc.gov/mmwr/volumes/70/wr/ 48 https://www.urban.org/sites/default/files/
Mandelboim, Ph.D., Einav Gal Levin, M.D., Carmit
mm7034e4.htm?s_cid=mm7034e4_w. Rubin, N.D., Victoria Indenbaum, Ph.D., Ilana Tal, publication/103651/delayed-and-forgone-health-
36 https://www.cdc.gov/coronavirus/2019-ncov/
R.N., Ph.D., Malka Zavitan, R.N., M.A., et al. Covid– care-for-nonelderly-adults-during-the-covid-19-
science/science-briefs/fully-vaccinated- 19 Breakthrough Infections in Vaccinated Health pandemic_1.pdf.
people.html#ref43. Care Workers. N Engl J Med 2021; 385:1474–1484. 49 Gale R, Eberlein S, Fuller G, Khalil C, Almario
37 https://www.medrxiv.org/content/10.1101/ DOI: 10.1056/NEJMoa2109072. https:// CV, Spiegel BM. Public Perspectives on Decisions
2021.08.20.21262158v1.full.pdf. www.nejm.org/doi/full/10.1056/NEJMoa2109072. About Emergency Care Seeking for Care Unrelated
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61559
unvaccinated staff are at greater risk for include: Longstanding shortages in 19 cases and hospitalizations are
infection, they also present a threat to certain fields and professions; occurring among individuals who are
health care operations—absenteeism prolonged physical, mental, and not fully vaccinated. In a recent study
due to COVID–19-related exposures or emotional stress and trauma associated of reported COVID–19 cases,
illness can create staffing shortages that with responding to the ongoing PHE; hospitalizations, and deaths in 13 U.S.
disrupt patient access to recommended and competing personal or professional jurisdictions that routinely link case
care. Data suggest the current surge in obligations (such as child care) or surveillance and immunization registry
COVID–19 cases associated with opportunities (for example, new data, CDC found that unvaccinated
emergence of the Delta variant has careers). But illnesses and deaths individuals accounted for over 85
exacerbated health care staffing associated with COVID–19 are percent of all hospitalizations in the
shortages. For example, 1 in 5 hospitals exacerbating staffing shortages across period between June and July 2021,
report that they are currently the health care system. Over half a when Delta became the predominant
experiencing a critical staffing million COVID–19 cases and 1,900 circulating variant.61
shortage.50 Through the week ending deaths among health care staff have Unfortunately, health care staff
September 19, 2021, approximately 23 been reported to CDC since the start of vaccination rates remain too low in too
percent of LTC facilities reported a the PHE.56 When submitting case-level many health care facilities and regions.
shortage in nursing aides; 21 percent COVID–19 reports, State and territorial For example, national COVID–19
reported a shortage of nurses; and 10 to jurisdictions may identify whether vaccination rates for LTC facility,
12 percent reported shortages in other individuals are or are not health care hospital, and ESRD facility staff are 67
clinical and non-clinical staff workers. Since health care worker status percent, 64 percent, and 60 percent,
categories.51 And while some studies has only been reported for a minority of respectively. Moreover, these averages
suggest overall staffing levels (as cases (approximately 18 percent), these obscure sizable regional differences.
defined by nurse hours per resident day) numbers are likely gross underestimates LTC facility staff vaccination rates range
have been relatively stable, this appears of true burden in this population. from lows of 56 percent to highs of over
to be associated with concurrent COVID–19 case rates among staff have 90 percent, depending upon the State.
decreases in patient demand (for also grown in tandem with broader Similar patterns hold for ESRD facility
example, resident census in nursing national incidence trends since the and hospital staff.62 63 64 Given slow but
homes)—decreases that have emergence of the Delta variant. For steady increases in vaccination rates
ramifications for patient access to example, as of mid-September 2021, among staff working in these settings
recommended and medically COVID–19 cases among LTC facility and over time,65 widespread availability of
appropriate services.52 53 Over half (58 ESRD facility staff have increased by vaccines, and targeted efforts to
percent) of nursing homes participating over 1400 percent and 850 percent, facilitate vaccine access like the Federal
in a recent survey conducted by the respectively, since their lows in June Retail Pharmacy program,66 vaccine
American Health Care Association and 2021.57 Similarly, the number of cases hesitancy,67 rather than other factors
National Center for Assisted Living among staff for whom case-level data (for example, staff turnover) is likely to
(AHCA/NCAL) indicated that they are were reported by State and territorial account for suboptimal staff vaccination
limiting new admissions due to staffing jurisdictions to CDC increased by nearly rates.
shortages.54 Similarly, hospital 600 percent between June and August While a significant number of health
administrators responding to an OIG 2021.58 Vaccination is thus a powerful care staff have been infected with
pulse survey conducted during February tool for protecting health and safety of SARS–CoV–2,68 evidence indicates
22–26, 2021, reported difficulty patients, and, with the emergence and their infection-induced immunity, also
discharging COVID–19 patients to post- spread of the highly transmissible Delta called ‘‘natural immunity,’’ is not
acute facilities (for example, nursing variant, it has been an increasingly equivalent to receiving the COVID–19
homes, rehabilitation hospitals, and critical one to address the extraordinary vaccine. Available evidence indicates
hospice facilities) following the acute strain the COVID–19 pandemic that COVID–19 vaccines offer better
stage of the patient’s illness. These continues to place on the U.S. health protection than infection-induced
delays in discharge affected available
system. While COVID–19 cases, immunity alone and that vaccines, even
bed space throughout the hospital (for
hospitalizations, and deaths declined after prior infection, help prevent
example, creating bottlenecks in ICUs
over the first 6 months of 2021, the
and EDs) and delayed patient access to
emergence of the Delta variant reversed 61 https://www.cdc.gov/mmwr/volumes/70/wr/
specialized post-acute care (such as mm7037e1.htm?s_cid=mm7037e1_w.
these trends.59 Between late June 2021
rehabilitation).55 The drivers of this 62 LTC facility rates derived from data reported
and September 2021, daily cases of
staffing crisis are multi-factorial. They through CDC’s NHSN and posted online at the
COVID–19 increased over 1200 percent; Nursing Home COVID–19 Vaccination Data
to COVID–19 During the COVID–19 Pandemic. new hospital admissions, over 600 Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-
JAMA Netw Open. 2021;4(8):e2120940. percent; and daily deaths, by nearly 800 vaccination-dashboard.html; accessed September
15, 2021.
Doi:10.1001/jamanetworkopen.2021.20940. percent.60 Available data also continue 63 Dialysis facility rates derived from data
50 Analysis of data submitted by hospitals through
to suggest that the majority of COVID– reported through CDC’s NHSN and posted online at
HHS Protect; accessed September 20, 2021.
51 Data reported through CDC’s NHSN. the Dialysis COVID–19 Vaccination Data
52 https://www.healthaffairs.org/doi/full/10.1377/
56 https://covid.cdc.gov/covid-data-tracker/ Dashboard: https://www.cdc.gov/nhsn/covid19/
#health-care-personnel; accessed September 24, dial-vaccination-dashboard.html; accessed
hlthaff.2020.02351.
53 https://www.npr.org/sections/health-shots/ 2021. September 15, 2021.
57 Analysis of dialysis facility and nursing home 64 Hospital data come from unpublished analyses
2021/10/14/1043414558/with-hospitals-crowded-
jspears on DSK121TN23PROD with RULES2
from-covid-1-in-5-american-families-delays-health- data reported through NHSN. of data reported to HHS and posted on HHS Protect.
58 Ibid. 8footnote 56. 65 Ibid. footnotes 62–64.
care.
54 https://www.ahcancal.org/News-and- 59 https://emergency.cdc.gov/han/2021/ 66 https://www.cdc.gov/vaccines/covid-19/retail-
Communications/Fact-Sheets/FactSheets/ han00447.asp. pharmacy-program/index.html.
67 https://www.cdc.gov/vaccines/imz-managers/
Workforce-Survey-September2021.pdf. 60 Internal estimates based on data published at:
55 See HHS OIG reports OEI–09–21–00140 and https://www.cdc.gov/coronavirus/2019-ncov/covid- coverage/covidvaxview/interactive.html..
OEI–06–20–00300, both accessed September 26, data/covidview/index.html; accessed September 24, 68 https://covid.cdc.gov/covid-data-tracker/
2021. 2021. #health-care-personnel.
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61560 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
reinfections.69 Consequently, CDC findings have implications regarding staff vaccinations for COVID–19 in these
recommends that all people be occupational safety and health outcome settings. For these reasons, we are
vaccinated, regardless of their history of equity—national data indicates that issuing this IFC based on these
symptomatic or asymptomatic SARS– aides in nursing homes are authorities and in accordance with
CoV–2 infection.70 disproportionately women and members established rule making processes.
Further, the risks of unvaccinated of racial and ethnic communities with Specifically, sections 1102 and 1871 of
health care staff may disproportionately lower hourly wages than physicians and the Social Security Act (the Act) grant
impact communities who experience advance practice clinicians,75 and are the Secretary of Health and Human
social risk factors and populations also more likely to have underlying Services authority to make and publish
described under Executive Order 13985, conditions that put them at risk for such rules and regulations, not
Advancing Racial Equity and Support adverse outcomes from COVID–19.76 inconsistent with the Act, as may be
for Underserved Communities Through Ensuring full vaccination coverage necessary to the efficient administration
the Federal Government, including across health care settings is critical to of the functions with which the
members of racial and ethnic addressing these disparities among Secretary is charged under this Act and
communities; individuals with health care workers, particularly those as may be necessary to carry out the
disabilities; individuals with limited from communities who experience administration of the insurance
English proficiency; Lesbian, Gay, social risk, and to equitably protecting programs under the Act. The
Bisexual, Transgender, and Queer individuals CMS serves from discussions of the provider- and
(LGBTQ+) individuals; individuals unnecessary and significant harm supplier-specific provisions in section
living in rural areas; and others associated with COVID–19 cases and the II. of this IFC set out the specific
adversely affected by persistent poverty ongoing pandemic. authorities for each provider or supplier
or inequality. CDC data show that across It is essential to reduce the type. Provider and supplier compliance
the U.S., physicians and advanced transmission and spread of COVID–19, with the Federal rules issued under
practice providers have significantly and vaccination is central to any multi- these statutory authorities are
higher vaccination rates than aides.71 72 pronged approach for reducing health mandatory for participation in the
Among aides, lower vaccination system burden, safeguarding health care Medicare and Medicaid programs.
coverage was observed in those facilities workers and the people they serve, and To the extent a court may enjoin any
located in zip codes where communities ending the COVID–19 pandemic. part of the rule, the Department intends
experience greater social risk factors. Currently FDA-approved and FDA- that other provisions or parts of
The finding that vaccination coverage authorized vaccines in use in the U.S. provisions should remain in effect. Any
among aides was lower among those are both safe and highly effective at provision of this section held to be
working at LTC facilities located in zip protecting vaccinated people against invalid or unenforceable by its terms, or
code areas with higher social symptomatic and severe COVID–19.77 as applied to any person or
vulnerability is consistent with an Higher rates of vaccination, especially circumstance, shall be construed so as
earlier analysis of overall county-level in health care settings, will contribute to to continue to give maximum effect to
vaccination coverage by indices of a reduction in the transmission of the provision permitted by law, unless
social vulnerability.73 CDC notes that SARS–CoV–2 and associated morbidity such holding shall be one of utter
together, these data suggest that and mortality across providers and invalidity or unenforceability, in which
vaccination disparities among job communities, contributing to event the provision shall be severable
categories are likely to mirror social maintaining and increasing the amount from this section and shall not affect the
disparities as well as disparities in of healthy and productive health care remainder thereof or the application of
surrounding communities. In addition, staff, and reducing risks to patients, the provision to persons not similarly
nurses and aides who may have the resident, clients, and PACE program situated or to dissimilar circumstances.
most patient contact have the lowest participants.
rates of vaccination coverage among In light of our responsibility to protect A. Regulatory Responses to the PHE
health care staff. COVID–19 outbreaks the health and safety of individuals 1. Waivers
have occurred in LTC facilities in which providing and receiving care and
services from for Medicare- and CMS and other Federal agencies have
residents were highly vaccinated, but taken many actions and exercised
transmission occurred through Medicaid-certified providers and
suppliers, and CMS’s broad statutory extensive regulatory flexibilities to help
unvaccinated staff members.74 These health care providers contain the spread
authority to establish health and safety
69 https://www.cdc.gov/mmwr/volumes/70/wr/ regulations, we are compelled to require of SARS–CoV–2. When the President
mm7032e1.htm?s_cid=mm7032e1_w. declares a national emergency under the
70 https://www.cdc.gov/vaccines/covid-19/
mmwr.mm7017e2external≤ icon National Emergencies Act or an
clinical-considerations/covid-19-vaccines- PMID:33914720external icon. emergency or disaster under the Stafford
us.html#CoV-19-vaccination. 75 Bureau of Labor Statistics. May 2020 national Act, CMS is empowered to take
71 https://www.cdc.gov/mmwr/volumes/70/wr/
occupational employment and wage estimates. proactive steps by waiving certain CMS
mm7030a2.htm. Washington, DC: US Department of Labor, Bureau
72 https://doi.org/10.7326/M21-3150. of Labor Statistics; 2021. Accessed May 1, 2021.
regulations, as authorized under section
73 Hughes MM, Wang A, Grossman MK, et al. https://www.bls.gov/oes/current/oes_nat.htm#00- 1135 of the Act (‘‘1135 waivers’’). CMS
County-level COVID–19 vaccination coverage and 0000externalicon. may also grant certain flexibilities to
social vulnerability—United States, December 14, 76 Silver SR, Li J, Boal WL, Shockey TL,
skilled nursing facilities (SNFs) under
2020–March 1, 2021. MMWR Morb Mortal Wkly Groenewold MR. Prevalence of underlying medical Medicare, as authorized separately
Rep 2021;70:431–6. https://doi.org/10.15585/ conditions among selected essential critical
under section 1812(f) of the Act
jspears on DSK121TN23PROD with RULES2
mmwr.mm7012e1external icon infrastructure workers—behavioral risk factor
PMID:33764963external icon. surveillance system, 31 states, 2017–2018. MMWR (‘‘1812(f) flexibilities’’). The 1135
74 Cavanaugh AM, Fortier S, Lewis P, et al. Morb Mortal Wkly Rep 2020;69:1244–9. https:// waivers and 1812(f) flexibilities allowed
COVID–19 outbreak associated with a SARS–CoV– doi.org/10.15585/mmwr.mm6936a3external icon us to rapidly expand efforts to help
2 R.1 lineage variant in a skilled nursing facility PMID:32914769external icon.
after vaccination program—Kentucky, March 2021. 77 https://www.cdc.gov/coronavirus/2019-ncov/ control the spread of SARS–CoV–2. We
MMWR Morb Mortal Wkly Rep 2021;70:639–43. science/science-briefs/fully-vaccinated-people.html. have issued PHE waivers for most
https://doi.org/10.15585/ Accessed 10/14/2021. Medicare- and Medicaid-certified
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61561
providers and suppliers, with the goal of an add-on payment for cases involving are screened prior to entry, and people
supporting each facility’s operational the use of new COVID–19 treatments with suspected or confirmed COVID–19
flexibility while preserving health and under the Medicare Inpatient are not permitted to enter, (4) well-
safety and core health care functions. Prospective Payment System (IPPS). defined hospital ambulatory care
Most recently, on May 13, 2021, we settings where all employees are fully
2. Rulemaking
issued the fifth IFC (Medicare and vaccinated, all non-employees are
Since the onset of the PHE, we have Medicaid Programs; COVID–19 Vaccine screened prior to entry, and people with
issued five IFCs to help contain the Requirements for Long-Term Care (LTC) suspected or confirmed COVID–19 are
spread of SARS–CoV–2. On April 6, Facilities and Intermediate Care not permitted to enter, (5) home health
2020, we issued an IFC (Medicare and Facilities for Individuals with care settings where all employees are
Medicaid Programs; Policy and Intellectual Disabilities (ICFs-IID) fully vaccinated, all non-employees are
Regulatory Revisions in Response to the Residents, Clients, and Staff (86 FR screened prior to entry, and people with
COVID–19 Public Health Emergency (85 26306)) (‘‘May 13, 2021 COVID–19 suspected or confirmed COVID–19 are
FR 19230 through 19292), which IFC’’), that revised the infection control not present, (6) health care support
established that certain requirements for requirements that LTC facilities and services not performed in a health care
face-to-face/in-person encounters will ICFs-IID must meet to participate in the setting (for example, offsite laundry, off-
not apply during the PHE for COVID–19 Medicare and Medicaid programs. site medical billing), and (7) telehealth
effective for claims with dates of service OSHA has also engaged in rulemaking services performed outside of a setting
on or after March 1, 2020, and for the in response to the PHE for COVID–19. where direct patient care occurs.
duration of the PHE for COVID–19. On On June 21, 2021, OSHA issued the
May 8, 2020, we issued a second IFC Furthermore, in well-defined areas
COVID–19 Healthcare Emergency
(Medicare and Medicaid Programs, where there is no reasonable
Temporary Standard (ETS) at 29 CFR
Basic Health Program, and Exchanges; expectation that any person with
1910 subpart U (86 FR 32376) to protect
Additional Policy and Regulatory suspected or confirmed COVID–19 will
health care and health care support
Revisions in Response to the COVID–19 be present, the ETS exempts fully
service workers from occupational
Public Health Emergency and Delay of exposure to COVID–19.78 Health care vaccinated workers from masking,
Certain Reporting Requirements for the employers covered by the ETS must distancing, and barrier requirements.
Skilled Nursing Facility Quality develop and implement a COVID–19 Moreover, the ETS requires employers
Reporting Program (85 FR 27550 plan for each workplace to identify and to immediately remove employees from
through 27629)) (‘‘May 8, 2020 COVID– control COVID–19 hazards in the the workplace if they (1) have tested
19 IFC’’). This second IFC contained workplace and implement requirements positive for COVID–19, (2) have been
additional information on changes to reduce transmission of SARS–CoV–2 diagnosed with COVID–19 by a licensed
Medicare made to existing regulations to in their workplaces related to the health care provider, (3) have been
provide flexibilities for Medicare following: (1) Patient screening and advised by a licensed health care
beneficiaries and providers to respond management, (2) standard and provider that they are suspected to have
effectively to the PHE for COVID–19. On transmission-based precautions, (3) COVID–19, or (4) are experiencing
September 2, 2020, we issued a third personal protective equipment certain symptoms (defined as either loss
IFC (Medicare and Medicaid Programs, (including facemasks, and respirators), of taste and/or smell with no other
Clinical Laboratory Improvement (4) controls for aerosol-generating explanation, or fever of at least 100.4
Amendments (CLIA), and Patient procedures performed on persons with degrees Fahrenheit and new
Protection and Affordable Care Act; suspected or confirmed COVID–19, (5) unexplained cough associated with
Additional Policy and Regulatory physical distancing, (6) physical shortness of breath). Employers must
Revisions in Response to the COVID–19 barriers, (7) cleaning and disinfection, also immediately remove an employee
Public Health Emergency (85 FR 54820 (8) ventilation, (9) health screening and who was not wearing a respirator and
through 54874)) (‘‘September 2, 2020 medical management, (10) training, (11) any other required PPE and had been in
COVID–19 IFC’’), that included new anti-retaliation, (12) recordkeeping, and, close contact with a COVID–19 positive
requirements for hospitals and CAHs to (13) reporting. In addition, the ETS person in the workplace. However,
report data in accordance with a requires covered employers to support removal from the workplace due to
frequency and in a standardized format COVID–19 vaccination for each instances of close contact exposure in
as specified by the Secretary during the employee by providing reasonable time the workplace is not required for
PHE for COVID–19. On November 6, and paid leave for employees to receive asymptomatic employees who either
2020, we issued a fourth IFC vaccines and recover from side effects. had COVID–19 and recovered with the
(Additional Policy and Regulatory The ETS generally applies to all last 3 months, or have been fully
Revisions in Response to the COVID–19 workplace settings where any employee vaccinated (that is, 2 or more weeks
Public Health Emergency (85 FR 71142 provides health care services or health have passed since the final dose).
through 71205)). This IFC discussed care support services; however, because
CMS’s implementation of section 3713 Complementary to the OSHA ETS,
the ETS targets settings where care is
of the Coronavirus Aid, Relief, and this interim final rule requires certain
provided for individuals with known or
Economic Security Act (CARES Act), providers and suppliers participating in
suspected COVID–19, the rule contains
which established Medicare Part B Medicare and Medicaid programs to
several exceptions. The ETS does not
coverage and payment for Coronavirus ensure staff are fully vaccinated for
apply to: (1) Provision of first aid by any
Disease 2019 (COVID–19) vaccine and COVID–19, unless exempt, because
employee who is not a licensed health
its administration. This IFC vaccination of staff is necessary for the
jspears on DSK121TN23PROD with RULES2
care provider, (2) dispensing of
implemented requirements in the health and safety of individuals to
prescriptions by pharmacists in retail
CARES Act that providers of COVID–19 whom care and services are furnished.
settings, (3) non-hospital ambulatory
diagnostic tests make public their cash Health care staff are at high risk for
care settings where all non-employees
prices for those tests and established an SARS–CoV–2 exposure, the virus that
enforcement scheme to enforce those 78 https://www.osha.gov/coronavirus/ets. causes COVID–19, due to interactions
requirements. This IFC also established Accessed 10/6/2021. with patients and individuals in the
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61562 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
community.79 Receiving a complete coronaviruses, such as those that cause (ACIP) and CDC have concluded the
primary vaccination series reduces the severe acute respiratory syndrome lifesaving benefits of COVID–19
risk of COVID–19 by 90 percent or more (SARS) and Middle East respiratory vaccination outweigh the risks or
thereby inhibiting the spread of disease syndrome (MERS). SARS–CoV–2, the possible side effects.86
to others.80 Furthermore, a COVID–19 virus that causes COVID–19, is related The COVID–19 vaccines currently
vaccination requirement reduces the to these other coronaviruses and the licensed or authorized for use in the
likelihood of medical removal of health knowledge that was gained through past U.S. are generally administered as either
care staff from the workplace, as research on coronavirus vaccines helped a single dose or a two-dose series given
required by the OSHA COVID–19 speed up the initial development of the at least 21 or 28 days apart. Following
Healthcare ETS. This is yet another way current COVID–19 vaccines. After initial completion of that primary series, a
in which this interim final rule protects development, vaccines go through three subsequent dose or doses may be
the individuals who receive services phases of clinical trials to make sure recommended for one of two purposes.
from the providers and suppliers to they are safe and effective. For other In the first instance, an additional dose
whom the rule applies by minimizing vaccines routinely used in the U.S., the of vaccine is administered when the
unpredictable disruptions to operations three phases of clinical trials are immune response following a primary
and care. performed one at a time. During the vaccine series is likely to be insufficient.
OSHA is the Federal agency development of COVID–19 vaccines, In other words, the additional dose
responsible for setting and enforcing these phases overlapped to speed up the augments the original primary series.
standards to ensure safe and healthy process so the vaccines could be used as Currently, the EUA for the Moderna
working conditions for workers. The quickly as possible to control the mRNA COVID–19 vaccine has been
COVID–19 Healthcare ETS addresses pandemic. No trial phases were amended to include the use of a third
protections for health care and health skipped.82 primary series dose (that is, ‘‘additional
care support service workers from the All COVID–19 vaccines currently dose’’) in certain immunocompromised
grave danger of COVID–19 exposure in licensed (approved) 83 or authorized for individuals 18 years of age or older.
certain workplaces. CMS is the Federal use in the U.S. were tested in clinical Similarly, the EUA for the Pfizer
agency responsible for establishing trials involving tens of thousands of BioNTech mRNA COVID–19 vaccine
health and safety regulations for people. FDA evaluated all of the has been amended to include the use of
Medicare- and Medicaid-certified information submitted to it in requests an additional, or third primary series,
providers and suppliers. Hence, we are for Emergency Use Authorization (EUA) dose in certain immunocompromised
establishing a final rule requiring for the authorized COVID–19 vaccines individuals 12 years of age and older.
COVID–19 vaccination of staff to and, for the Comirnaty COVID–19 In the second instance, a booster dose
safeguard the health and safety of Vaccine, in a Biologics License of vaccine is administered when the
patients, residents, clients, and PACE Application (the conventional path to initial immune response to a primary
program participants who receive care FDA approval of a vaccine). FDA vaccine series is likely to have waned
and services from those providers and determined that these vaccines meet over time. In other words, although an
suppliers. Providers and suppliers may FDA’s standards for safety, adequate immune response occurred
be covered by both the OSHA ETS and effectiveness, and manufacturing quality after the primary vaccine series, over
our interim final rule. Although the needed to support emergency use time, immunity decreases.87 88 89 On
requirements and purpose of each authorization and licensure, as September 22, 2021, the FDA amended
regulation text are different, they are applicable. The clinical trials included the EUA for the Pfizer BioNTech mRNA
complementary. participants of different races, COVID–19 vaccine to allow for use of a
ethnicities, and ages, including adults single booster dose in certain
B. COVID–19 Vaccine Development and over the age of 65.84 Because COVID–19 individuals, to be administered at least
Approval continues to be widespread, researchers 6 months after completion of the
FDA analysis has shown that all of the have been able to conduct vaccine primary series. Specifically, this booster
currently approved or authorized clinical trials more quickly than if the dose is authorized for individuals 65
vaccines are safe and CDC reports that disease were less common. Side effects years of age and older, individuals 18
over 408 million doses of the vaccine following vaccination are dependent on through 64 years of age at high risk of
have been given through October 18, the specific vaccine that an individual severe COVID–19, and individuals 18
2021.81 Bringing a new vaccine to the receives, and the most common include through 64 years of age whose frequent
public involves many steps, including pain, redness, and swelling at the institutional or occupational exposure
vaccine development, clinical trials, and injection site, tiredness, headache, to SARS–CoV–2 puts them at high risk
U.S. Food and Drug Administration muscle pain, nausea, vomiting, fever, of serious complications of COVID–19
(FDA) authorization or approval. While and chills.85 After a review of all including severe COVID–19.90
COVID–19 vaccines were developed available information, the Advisory
rapidly, all steps have been taken to Committee on Immunization Practices 86 See Centers for Disease Control and Prevention.
ensure their safety and effectiveness. Benefits of Getting a COVID–19 Vaccine. https://
82 https://www.cdc.gov/coronavirus/2019-ncov/ www.cdc.gov/coronavirus/2019-ncov/vaccines/
Scientists have been working for many vaccines/distributing/steps-ensure-safety.html. vaccine-benefits.html. Updated January 5, 2021.
years to develop vaccines against 83 ‘‘Licensed’’ is the statutory term under section Accessed January 14, 2021.
87 Summaries of evidence presented to CDC’s
351 of the Public Health Service Act for what is
79 https://www.cdc.gov/mmwr/volumes/69/wr/ commonly referred to as approval of a biological Advisory Council on Immunization Practices
mm6938a3.htm?s_cid=mm6938a3_w. Accessed10/ product. For purposes of this rulemaking, the terms available at https://www.cdc.gov/vaccines/acip/
jspears on DSK121TN23PROD with RULES2
16/2021. ‘approved’ or ‘licensed’ and ‘approval’ or ‘licensure’ meetings/slides-2021-09-22-23.html.
80 https://www.cdc.gov/coronavirus/2019-ncov/ are being used interchangeably with respect to 88 https://www.nejm.org/doi/full/10.1056/
vaccines/effectiveness/work.html. Accessed 10/16/ COVID–19 vaccines. NEJMoa2114583.
2021. 84 https://www.kff.org/racial-equity-and-health- 89 https://www.medrxiv.org/content/10.1101/
81 https://www.cdc.gov/coronavirus/2019-ncov/ policy/issue-brief/racial-diversity-within-covid-19- 2020.10.26.20219725v1.
vaccines/safety/safety-of-vaccines.html# vaccine-clinical-trials-key-questions-and-answers/. 90 https://www.fda.gov/emergency-preparedness-
:∼:text=Millions%20of%20people%20in%20the, 85 https://www.cdc.gov/coronavirus/2019-ncov/ and-response/coronavirus-disease-2019-covid-19/
monitoring%20in%20US%20history. vaccines/expect/after.html. comirnaty-and-pfizer-biontech-covid-19-vaccine.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61563
Throughout this rule, we will use the second dose of a two-dose primary C. Administration of Vaccines Outside
terms ‘‘additional dose’’ and ‘‘booster’’ vaccination series (Pfizer-BioNTech/ the U.S., Listed for Emergency Use by
to differentiate between the two use Comirnaty or Moderna). This guidance the WHO, Heterologous Primary Series,
cases outlined above. can also be applied to COVID–19 and Clinical Trials
Every person who receives a COVID– vaccines listed for emergency use by the We expect the majority of staff will
19 vaccine receives a vaccination record World Health Organization (WHO) and likely receive a COVID–19 vaccine
card noting which vaccine and the dose some vaccines used in COVID–19 authorized for emergency use by the
that was received. Vaccine materials clinical trials conducted in the U.S. FDA or licensed by the FDA. Currently,
specific to each vaccine are located on this would include the authorized
These circumstances are addressed in
CDC 91 and FDA 92 websites. CDC has Pfizer-BioNTech (interchangeable with
more detail in section I.C. of this IFC.
posted a collection of informational the licensed Comirnaty vaccine made by
toolkits for specific communities and To improve immune response for those
individuals with moderately to severely Pfizer for BioNTech), Moderna, and
settings at https://www.cdc.gov/ Janssen (Johnson & Johnson) COVID–19
coronavirus/2019-ncov/vaccines/ compromised immune systems who
receive the Pfizer-BioNTech Vaccine, vaccines. We also expect COVID–19
toolkits.html. These toolkits provide vaccine administration will likely occur
staff, facility administrators, clinical Comirnaty, or Moderna Vaccine, the
CDC advises an additional (third) dose within the U.S. for the majority of staff.
leadership, caregivers, and health care However, some staff may receive FDA
consumers with information and of an mRNA COVID–19 vaccine after
approved or authorized COVID–19
resources. completing the primary vaccination
vaccines outside of the U.S., vaccines
While we are not requiring series.96 In addition, certain individuals administered outside of the U.S. that are
participation, we encourage staff who who received the Pfizer-BioNTech listed by the WHO for emergency use
use smartphones to use CDC’s COVID–19 Vaccine may receive a that are not approved or authorized by
smartphone-based tool called ‘‘v-safe booster dose at least 6 months after the FDA, or vaccines during their
After Vaccination Health Checker’’ (v- completing the primary vaccination participation in a clinical trial at a site
safe) 93 to self-report on one’s health series.97 in the U.S. For these staff, we defer to
after receiving a COVID–19 vaccine. V-
This IFC requires Medicare- and CDC guidance for COVID–19
safe is a program that differs from the
Medicaid-certified providers and vaccination briefly discussed here. For
Vaccine Adverse Event Reporting
suppliers to ensure that staff are fully more information, providers and
System (VAERS), which we discuss in
vaccinated for COVID–19, unless the suppliers should consult the CDC
section I.C. of this rule. Individuals may
individual is exempted. Consistent with website at https://www.cdc.gov/
report adverse reactions to a COVID–19
CDC guidance, we consider staff fully vaccines/covid-19/clinical-
vaccine to either program. Enrollment in
considerations/covid-19-vaccines-
v-safe allows any participating vaccine vaccinated if it has been 2 or more
us.html#.
recipient to directly and efficiently weeks since they completed a primary Repeat vaccine doses are not
report to CDC how they are feeling after vaccination series for COVID–19. We recommended by CDC for individuals
receiving a specific vaccine, including define completion of a primary who previously completed the primary
any problems or adverse reactions. vaccination series as having received a series of a vaccine approved or
When an individual receives the single-dose vaccine or all doses of a authorized by the FDA, even if
vaccine, they should also receive a v- multi-dose vaccine. Currently, CDC administration of the vaccine occurred
safe information sheet telling them how guidance does not include either the outside of the U.S. Individuals who
to enroll in v-safe or they can register at additional (third) dose of an mRNA receive a COVID–19 vaccine for which
http://www.vsafe.cdc.gov. Individuals COVID–19 vaccine for individuals with two doses are required to complete the
who enroll will receive regular text moderately or severely primary vaccination series should
messages providing links to surveys adhere as closely as possible to the
immunosuppression or the booster dose
where they can report any problems or recommended intervals. Following
adverse reactions after receiving a for certain individuals who received the
Pfizer-BioNTech Vaccine in their completion of their second dose, certain
COVID–19 vaccine, as well as receive individuals who had received the
‘‘check-ins,’’ and reminders for a second definition of fully vaccinated.98
Therefore, for purposes of this IFC, Pfizer-BioNTech COVID–19 vaccine
dose if applicable.94 We note again that may receive a booster dose at least 6
participation in v-safe is not mandatory, neither additional (third) doses nor
booster doses are required. The OSHA months after completion of the primary
and further that staff participation and vaccination series. Moderately to
any health information provided is not Emergency Temporary Standard for
severely immunocompromised
traced to or shared with employers. Healthcare discussed in section I.A.2. of
individuals who have received 2 doses
Based on current CDC guidance,95 this IFC also defines fully vaccinated in
of an mRNA vaccine may receive a third
individuals are considered fully accordance with CDC guidance. Hence, dose at least 28 days after the second
vaccinated for COVID–19 14 days after definitions of fully vaccinated are dose. Vaccine administration may occur
receipt of either a single-dose vaccine consistent among the requirements in inside or outside of the U.S.
(Janssen/Johnson & Johnson) or the these regulations. Furthermore, the WHO maintains a
91 https://www.cdc.gov/coronavirus/2019-ncov/
list of COVID–19 vaccines for
vaccines/different-vaccines.html. emergency use.99 The CDC advises that
92 https://www.fda.gov/emergency-preparedness- doses of an FDA approved or authorized
and-response/coronavirus-disease-2019-covid-19/ 96 https://www.cdc.gov/coronavirus/2019-ncov/ COVID–19 vaccine are not
jspears on DSK121TN23PROD with RULES2
covid-19-vaccines. vaccines/recommendations/immuno.html. recommended for individuals who have
93 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/vsafe.html.
Accessed 10/14/2021. previously completed the primary series
94 https://www.cdc.gov/coronavirus/2019-ncov/
97 https://www.cdc.gov/coronavirus/2019-ncov/
of a vaccine listed for emergency use by
vaccines/faq.html. vaccines/booster-shot.html. Accessed 10/16/2021.
95 https://www.cdc.gov/coronavirus/2019-ncov/ 98 https://www.cdc.gov/coronavirus/2019-ncov/ 99 https://www.who.int/emergencies/diseases/
vaccines/fully-vaccinated.html. Accessed 10/16/ vaccines/fully-vaccinated.html. Accessed 10/16/ novel-coronavirus-2019/covid-19-vaccines.
2021. 2021. Accessed September 14, 2021.
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61564 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
the WHO. For those who have not series of a vaccine approved or Section 564 of the Federal Food, Drug,
completed the primary series of a authorized by FDA, or listed for and Cosmetic Act authorizes FDA to
vaccine listed for emergency use by the emergency use by the WHO. Likewise, issue EUAs. An EUA is a mechanism to
WHO, they may receive an FDA for individuals who participated in a facilitate the availability and use of
approved or authorized COVID–19 clinical trial at a site in the U.S. and medical countermeasures, including
vaccination series. In addition, received the full series of an ‘‘active’’ vaccines, during public health
individuals who have received a vaccine candidate (not placebo) and emergencies, such as the current
COVID–19 vaccine that is neither ‘‘vaccine efficacy has been COVID–19 pandemic. FDA may
approved nor authorized by the FDA, independently confirmed (for example, authorize certain unapproved medical
nor listed on the WHO emergency use by a data and safety monitoring board),’’ products or unapproved uses of
list, may receive an FDA approved or CDC does not recommend repeat approved medical products to be used
authorized vaccination series. The CDC doses.101 in an emergency to diagnose, treat, or
guidelines recommend at least 28 days prevent serious or life-threatening
D. FDA Emergency Use Authorization
between administration of an FDA diseases or conditions caused by threat
(EUA) and Licensure of COVID–19
licensed or authorized vaccine, a non- agents when certain criteria are met,
Vaccines
FDA approved or authorized vaccine, including there are no adequate,
and a vaccine listed by WHO for The FDA provides scientific and approved, and available alternatives.106
emergency use. regulatory advice to vaccine developers
The safety of the approved and
For the completion of the primary and undertakes a rigorous evaluation of
authorized COVID–19 vaccines is
series of COVID–19 vaccination, the scientific information it receives
closely monitored. VAERS is a safety
individuals should generally avoid from all phases of clinical trials; such
and monitoring system that can be used
using heterologous vaccines—meaning evaluation continues after a vaccine has
by anyone to report adverse events after
receiving doses of different vaccines—to been licensed by FDA or authorized for
vaccines. For COVID–19 vaccines,
complete a primary COVID–19 emergency use. On August 23, 2021,
vaccination providers and licensed and
vaccination series. Nevertheless, CDC FDA licensed the first COVID–19
vaccine. The vaccine had been known authorized vaccine manufacturers, must
does recognize that, in certain situations
as the Pfizer-BioNTech COVID–19 report select adverse events to VAERS
(for example, when the vaccine product
vaccine, and will now be marketed as following receipt of COVID–19 vaccines
given for the first dose cannot be
Comirnaty, for the prevention of (including serious adverse events, cases
determined or is no longer available), a
COVID–19 in individuals 16 years of age of multisystem inflammatory syndrome
different vaccine may be used to
and older.102 The vaccine continues to (MIS), and COVID–19 cases that result
complete the primary COVID–19
be available in the U.S. under EUA, in hospitalization or death).107
vaccination series. Accordingly, staff
including for individuals 12 through 15 Providers also must adhere to any
may be considered compliant with the
years of age. This EUA has been revised safety reporting requirements.
requirements within this regulation if
amended to allow for the use of a third FDA’s website includes letters of
they have received any combination of
two doses of a vaccine licensed or dose for certain immunocompromised authorization and fact sheets and these
authorized by the FDA or listed on the individuals 12 years of age and older. documents should be checked for any
WHO emergency use list as part of a This EUA has also been amended to updates that may occur. Other adverse
two-dose series. Of note, the allow for use of a single booster dose in events following vaccination may also
recommended interval between the first certain individuals. FDA has issued be reported to VAERS. Additionally,
and second doses of a vaccine licensed EUAs for two additional vaccines for the adverse events are also monitored
or authorized by FDA, or listed on the prevention of COVID–19, one for the through electronic health record- and
WHO emergency use list, varies by Moderna COVID–19 vaccine (December claims-based systems (through CDC’s
vaccine type. For interpretation of 18, 2020) (indicated for use in Vaccine Safety Datalink and FDA’s
vaccination records and compliance individuals 18 years of age and older), Biologics Effectiveness and Safety
with this rule, people who received a and the other for Janssen (Johnson & System (BEST)).
heterologous primary series (with any Johnson) COVID–19 Vaccine (February FDA is closely monitoring the safety
combination of FDA-authorized, FDA- 27, 2021) (indicated for use in of the COVID–19 vaccines both
approved, or WHO EUL-listed products) individuals 18 years of age and older). authorized for emergency use and
can be considered fully vaccinated if the The EUA for the Moderna COVID–19 licensed use. Vaccination providers are
second dose in a two dose heterologous vaccine has been amended to allow for responsible for mandatory reporting to
series must have been received no the use of a third dose in certain VAERS of certain adverse events as
earlier than 17 days (21 days with a 4 immunocompromised individuals. listed on the Health Care Provider Fact
day grace period) after the first dose.100 Package inserts and fact sheets for Sheets for the authorized COVID–19
Because the science and clinical health care providers administering vaccines and for Comirnaty.
recommendations are evolving rapidly, COVID–19 vaccines are available for Vaccine safety is critically important
we refer individuals to CDC’s Interim each licensed and authorized vaccine for all vaccination programs. Side
Public Health Recommendations for from the FDA.103 104 105 effects following vaccinations often
Fully Vaccinated People for additional include swelling, redness, and pain at
101 https://www.cdc.gov/vaccines/covid-19/
details. the injection site; flu-like symptoms;
clinical-considerations/covid-19-vaccines-us.html#
Some staff may receive COVID–19 Accessed 9/14/2021.
headache; and nausea; all typically of
vaccines due to their participation in a 102 https://www.fda.gov/news-events/press-
jspears on DSK121TN23PROD with RULES2
clinical trial at a site in the U.S. Repeat announcements/fda-approves-first-covid-19-vaccine 106 https://www.fda.gov/emergency-
vaccine doses are not recommended by Accessed 10/14/2021. preparedness-and-response/mcm-legal-regulatory-
103 Pfizer Fact Sheet—https://www.fda.gov/ and-policy-framework/emergency-use-
CDC for participants in a clinical trial media/144413/download. authorization.
who previously completed the primary 104 Moderna Fact Sheet—https://www.fda.gov/ 107 Department of Health and Human Services.
media/144637/download. VAERS—Vaccine Adverse Event Reporting System.
100 https://www.cdc.gov/coronavirus/2019-ncov/ 105 Janssen Fact Sheet—https://www.fda.gov/ Accessed at https://vaers.hhs.gov/. Accessed on
vaccines/fully-vaccinated-guidance.html. media/146304/download. January 26, 2021.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61565
short duration.108 Serious adverse E. COVID–19 Vaccine Effectiveness safeguarding patients, residents, clients,
reactions also have been reported COVID–19 vaccines currently PACE program participants, and staff.
following COVID–19 vaccines; however, approved or authorized by FDA are F. Stakeholder Response to Vaccines
they are rare.109 110 For example, it is highly effective in preventing serious
estimated that anaphylaxis following outcomes of COVID–19, including There has been growing national
the mRNA COVID–19 vaccines occurs severe disease, hospitalization, and interest in COVID–19 vaccination
in 2–5 individuals per million death.115 Moreover, available evidence requirements among health care
vaccinated (https://www.cdc.gov/ suggests that these vaccines offer workers, including requests from
coronavirus/2019-ncov/vaccines/safety/ protection against known variants, various national health care
including the Delta variant (B.1.617.2), stakeholders. In a joint statement
adverse-events.html). For these
particularly against hospitalization and released on July 26, 2021, more than 50
individuals, another shot of an mRNA
death.116 117 Furthermore, a recent study health care professional societies and
COVID–19 vaccine is not
found that, between December 14, 2020, organizations called for all health care
recommended,111 and they should employers and facilities to require that
discuss receiving a different type of and August 14, 2021, full vaccination
with COVID–19 vaccines was 80 percent all their staff be vaccinated against
COVID–19 vaccine with their health COVID–19. Included as signatories to
care practitioner.112 Other rare serious effective in preventing RT–PCR–
confirmed SARS-CoV–2 infection this statement were organizations
adverse reactions that have been representing millions of workers
among frontline workers, further
reported to occur following COVID–19 throughout the U.S. health care
affirming the highly protective benefit of
vaccines include thrombosis with full vaccination up to and through the industry, including those representing
thrombocytopenia syndrome (TTS) 2021 summer COVID–19 pandemic doctors, nurses, pharmacists, physician
following the Janssen COVID–19 waves in the U.S.118 While vaccine assistants, public health workers, and
vaccine and myocarditis and/or effectiveness point estimates did decline epidemiologists as well as long term
pericarditis following the mRNA over the course of the study as the Delta care, home care, and hospice
COVID–19 vaccines (https:// variant became predominant, the workers.122
www.cdc.gov/coronavirus/2019-ncov/ protection afforded by vaccination In addition, a large nonprofit,
vaccines/safety/adverse-events.html). In remained significant, underscoring the nonpartisan organization focused on
the face of the COVID–19 pandemic, continued importance and benefits of empowering Americans over the age of
global researchers were able to build COVID–19 vaccination.119 50 recently called on all LTC facilities
upon decades of vaccine development, Like most vaccines, COVID–19 to require vaccinations for staff and
research, and use to produce safe vaccines are not 100 percent effective in residents.123 A non-profit organization
vaccines that have been highly effective preventing COVID–19. Consequently, dedicated to advancing dignity in aging
in protecting individuals from COVID– some ‘‘breakthrough’’ cases are expected issued a statement in support of
19. From December 14, 2020, through and, as the number of people who have COVID–19 vaccine mandates for staff
October 12, 2021, over 403 million completed a primary vaccination series and residents of long-term care
and are considered fully vaccinated for facilities.124 In a policy statement dated
doses of COVID–19 vaccine have been
COVID–19 increases, breakthrough July 21, 2021, a large long term care
administered in the U.S. https://
COVID–19 cases will also increase association, ‘‘strongly urges all residents
www.cdc.gov/coronavirus/2019-ncov/
commensurately. However, the risk of and staff in long-term care to get
vaccines/safety/safety-of-vaccines.html. vaccinated’’ and ‘‘supports requiring
developing COVID–19, including severe
‘‘CDC recommends everyone 12 years vaccines for current and new staff in
illness, remains much higher for
and older get vaccinated as soon as long-term care and other healthcare
unvaccinated than vaccinated people.
possible to help protect against COVID– Vaccinated people with a breakthrough settings. COVID–19 vaccination should
19 and the related, potentially severe COVID–19 case are less likely to be a condition of employment for all
complications that can occur.’’ 113 They develop serious disease, be hospitalized, healthcare workers, including
state that the ‘‘potential benefits of and die than those who are employees, contract staff and others,
COVID–19 vaccination outweigh the unvaccinated and get COVID–19.120 The with appropriate exemptions for those
known and potential risks, including combined protections offered by with medical reasons or as specified by
the possible risk of myocarditis or vaccination and ongoing federal or state law.’’ 125 The statement
pericarditis.’’ 114 implementation of other infection further notes that ‘‘COVID–19 vaccines
control measures, especially source are safe . . . effective for preventing
108 https://www.cdc.gov/coronavirus/2019-ncov/
control (masking),121 remain critical to infection, and especially severe illness
vaccines/safety/safety-of-vaccines.html. Accessed and death [and] reduce the risk of
10/17/2021. 115 https://www.cdc.gov/coronavirus/2019-ncov/ spreading the virus.’’ 126 Moreover, the
109 Ibid.
vaccines/effectiveness/work.html.
110 https://www.cdc.gov/coronavirus/2019-ncov/ 116 https://www.cdc.gov/mmwr/volumes/70/wr/ 122 https://www.hematology.org/newsroom/press-
vaccines/safety/adverse-events.html. Access 10/17/ mm7034e2.htm?s_cid=mm7034e2_w. releases/2021/joint-statement-in-support-of-covid-
2021. 117 https://www.cdc.gov/mmwr/volumes/70/wr/ 19-vaccine-mandates-for-all-workers-in-health.
111 https://www.cdc.gov/coronavirus/2019-ncov/
mm7034e1.htm?s_cid=mm7034e1_w. 123 https://press.aarp.org/2021-8-12-New-AARP-
vaccines/safety/allergic-reaction.html. Accessed 10/ 118 https://www.cdc.gov/mmwr/volumes/70/wr/ Analysis-Shows-Nursing-Homes-Vaccination-Rates-
17/2021. mm7034e4.htm#contribAff. Still-Well-Short-of-Benchmark-as-COVID-Cases-
112 https://www.cdc.gov/coronavirus/2019-ncov/ 119 https://www.cdc.gov/coronavirus/2019-ncov/ Trend-Upwards.
vaccines/recommendations/specific-groups/ variants/delta-variant.html?s_cid=11504:cdc% 124 https://justiceinaging.org/justice-in-aging-
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allergies.html#anchor_1624541541034. Accessed 20delta%20variant%20vaccine%20effectiveness: supports-mandatory-covid-vaccinations-in-long-
10/17/2021. sem.ga:p:RG:GM:gen:PTN:FY21. term-care-facilities/, accessed 10/6/21, 1:02 p.m.
113 https://www.cdc.gov/coronavirus/2019-ncov/ 120 https://www.cdc.gov/coronavirus/2019-ncov/ EDT.
vaccines/safety/adverse-events.html. Accessed 10/ vaccines/effectiveness/why-measure-effectiveness/ 125 https://leadingage.org/sites/default/files/
17/2021. breakthrough-cases.html. LeadingAge%20Statement%20on%20Vaccine
114 https://www.cdc.gov/coronavirus/2019-ncov/ 121 https://www.cdc.gov/coronavirus/2019-ncov/ %20Mandates%20for%20Healthcare
vaccines/safety/safety-of-vaccines.html. Accessed hcp/infection-control-recommendations.html. %20Workers.pdf.
10/17/2021. Accessed 10/15/2021. 126 Ibid.
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61566 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
statement observes that ‘‘the COVID strong vaccination policies. Despite the certain populations. For example,
crisis exacerbated long-standing successes of these organizations in evidence clearly indicates that racial
workforce challenges, and some in the increasing levels of staff vaccination, and ethnic minority groups, including
sector fear that a vaccine mandate could there remains an inconsistent Black and Hispanic or Latino, have
lead to worker resignations. But patchwork of requirements and laws disproportionately higher
providers that have required staff that is only effective at local levels and hospitalization rates among every age
vaccination have reported high vaccine has not successfully raised staff group, including children aged younger
accepted by previously hesitant care vaccination rates nationwide. Patients, than 18 years.136 These same groups are
professionals, and many providers residents, clients, PACE program disproportionately affected by long-
report that when staff vaccination rates participants, and staff alike are not standing inequities in social
are high, they become providers of adequately protected from COVID–19. determinants of health, such as poverty
choice in their communities.’’ 127 A non- In September 2021, Jeffrey Zients, the and health care access, that increase risk
profit federation of affiliated State White House Coronavirus Response of severe illness and death from COVID–
health organizations, representing more Coordinator, noted that ‘‘vaccination 19.137 People with intellectual
than 14,000 non-profit and for-profit requirements work . . . and are the best disabilities are more likely to have
nursing homes, assisted living path out of the pandemic.’’ He further chronic health conditions, live in
communities, and facilities for noted that vaccination requirements are congregate settings, and face more
individuals with disabilities expressed not only key to the nation’s path out of barriers to health care; some studies
support for all health care ‘‘strongly the pandemic, but also accelerate our suggest they are also more likely to get
urges the vaccination of all health care economic recovery, keeping workplaces COVID–19 and have worse outcomes.138
personnel’’ to ‘‘protect all residents, safer, and helping to curb the spread of Finally, rural communities often have a
staff and others in our communities the virus in communities, and boost job higher proportion of residents who live
from the known and substantial risks of growth, the labor market, and the with comorbidities or disabilities and
COVID–19.’’ They also assert that nation’s overall economy. are aged ≥65 years; these risk factors,
‘‘COVID–19 vaccines protect health care G. Populations at Higher Risk for Severe combined with more limited access to
personnel when working both in health COVID–19 Outcomes health care facilities with intensive care
care facilities and in the community,’’ capabilities, place rural dwellers at
COVID–19 can affect anyone, with
and ‘‘provide strong protection against increased risk for COVID–19-associated
symptoms ranging from mild (infections
workers unintentionally carrying the morbidity and mortality.139
not requiring hospitalization) to very
disease to work and spreading it to In addition, CDC data indicate that
severe (requiring intensive care in a
patients and peers.’’ 128 vaccination rates are disproportionately
hospital). Nonetheless, studies have
Numerous health systems and shown that COVID–19 does not affect all low among nurses and health care aides
individual health care employers across population groups equally.133 Age in long term care settings, particularly
the country have implemented vaccine remains a strong risk factor for severe in communities that experience social
mandates independent of this rule. For COVID–19 outcomes. Approximately risk factors. Further, CDC data indicate
example, a health care system that is the 54.1 million people aged 65 years or that nurses and aides in these settings
largest private employer in Delaware older reside in the U.S.; this age group are more likely to be members of racial
with more than 14,000 employees, a accounts for more than 80 percent of and ethnic minority communities.140
health care system and academic U.S. COVID–19 related deaths. This disparity in vaccination coverage
medical center with over 26,000 Residents of LTC facilities make up less may be exacerbating existing and
employees in Texas, and an integrated than 1 percent of the U.S. population emerging disparities related to COVID–
health system in North Carolina with but accounted for more than 35 percent 19 cases and impact, placing members
more than 35,000 employees, to name a of all COVID–19 deaths in the first 12 of communities who experience social
few, have all preceded this rule with months of the pandemic.134 risk factors—those in rural areas with
their own vaccination requirements, Additionally, adults of any age with geographic and transportation barriers
achieving rates of at least 97 percent certain underlying medical conditions to care, those in low income areas who
vaccination among their are at increased risk for severe illness experience persistent poverty and
staff.129 130 131 132 These organizations are from COVID–19. These include, but are inequality, and others—at further
already realizing the effectiveness of not limited to, cancer, cerebrovascular increased risk for COVID–19-associated
disease, diabetes (Type 1 and Type 2), morbidity and mortality.141 This
127 Ibid.
128 https://www.ahcancal.org/News-and-
chronic kidney disease, COPD, heart disparity may be, in part, reduced by the
Communications/Press-Releases/Pages/ conditions, Down Syndrome, obesity, potential positive health equity impacts
AHCANCAL-Issues-Policy-Statement-Regarding- substance use, smoking status, and of requiring staff vaccination among
COVID-19-Vaccinations-of-Long-Term-Care- pregnancy.135 The risk of severe provider and supplier types subject to
Personnel.aspx. Accessed 10/16/2021. COVID–19 also increases as the number rulemaking.
129 https://news.christianacare.org/2021/09/safe-
care-safe-workplace-we-are-vaccinated/. Accessed
of underlying medical conditions
10/15/2021. increases in a particular individual. 136 https://www.cdc.gov/coronavirus/2019-ncov/
130 https://www.delawareonline.com/story/news/ A confluence of structural and community/health-equity/racial-ethnic-disparities/
disparities-hospitalization.html.
health/2021/09/27/christianacare-fires-employees- epidemiological factors has also 137 https://www.cdc.gov/coronavirus/2019-ncov/
not-complying-vaccine-mandate/5887784001/. contributed to disparate risk for COVID–
Accessed 10/15/2021. community/health-equity/racial-ethnic-disparities/
131 https://www.houstonmethodist.org/leading-
19 infection, severe illness, and death in disparities-illness.html.
jspears on DSK121TN23PROD with RULES2
138 https://catalyst.nejm.org/doi/full/10.1056/
medicine-blog/articles/2021/jun/houston-
methodist-requires-covid-19-vaccine-for- 133 https://www.cdc.gov/coronavirus/2019-ncov/ CAT.21.0051.
hcp/clinical-care/underlyingconditions.html. 139 https://www.cdc.gov/mmwr/volumes/70/wr/
credentialed-doctors/. Accessed 10/15/202021.
132 https://www.novanthealth.org/home/about-us/ 134 https://www.cdc.gov/coronavirus/2019-ncov/ mm7020e3.htm.
hcp/clinical-care/underlyingconditions.html. 140 https://www.cdc.gov/mmwr/volumes/70/wr/
newsroom/press-releases/newsid33987/2576/
novant-health-update-on-mandatory-covid-19- 135 https://www.cdc.gov/coronavirus/2019-ncov/ mm7030a2.htm.
vaccination-program-for-employees.aspx. Accessed science/science-briefs/underlying-evidence- 141 https://www.cdc.gov/coronavirus/2019-ncov/
10/15/2021. table.html. community/health-equity/vaccine-equity.html.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61567
CMS believes that the developing data H. CMS Authority To Require Staff Secretary is charged under the Act.
about staff vaccination rates and rates of Vaccinations Section 1871 of the Act grants the
COVID–19 cases, and the urgent need to CMS has broad statutory authority to Secretary of Health and Human Services
address COVID-related staffing establish health and safety regulations, authority to prescribe regulations as
shortages that are disrupting patient which includes authority to establish may be necessary to carry out the
access to care, provides strong vaccination requirements. Section 1102 administration of the Medicare program.
justification as to the need to issue this of the Act grants the Secretary of Health The statutory authorities to establish
IFC requiring staff vaccination for most and Human Services authority to make health and safety requirements for
provider and supplier types over which and publish such rules and regulations, COVID–19 vaccination for each provider
we have authority. not inconsistent with the Act, as may be and supplier included in this IFC are
necessary to the efficient administration listed in Table 1 and discussed in
of the functions with which the sections II.C. through II.F. of this IFC.
Section 1863 of the Act provides that implementation of this rule would this rule, however, we do not believe
‘‘[i]n carrying out his functions, relating result in additional deaths and serious that there exists an entity with which it
to determination of conditions of illnesses among health care staff and would be appropriate to engage in these
participation by providers . . . the consumers, further exacerbating the consultations in advance of issuing this
Secretary shall consult with appropriate newly-arising, and ongoing, strain on IFC, nor do we understand the statute to
State agencies and recognized national the capacity of health care facilities to impose a temporal requirement to do so
listing or accrediting bodies[.]’’ For the serve the public. For these reasons, in in advance of the issuance of this rule.
reasons discussed in greater detail carrying out the agency’s functions We have not previously required any
throughout sections I. through III. this relating to determination of conditions vaccinations, but we recognize that
IFC, the COVID–19 pandemic presents a of participation, conditions for coverage, many health care workers already
serious and continuing threat to the and requirements, we intend to engage comply with employer or State
jspears on DSK121TN23PROD with RULES2
health and to the lives of staff of health in consultations with appropriate State government vaccination requirements
care facilities and of consumers of these agencies and listing or accrediting (for example, influenza, and hepatitis B
providers’ and suppliers’ services. This bodies following the issuance of this virus (HBV)) and invasive employer or
threat has grown to be particularly rule, and toward that end we invite State government-required screening
severe since the emergence of the Delta these entities to submit comments on procedures (such as tuberculosis
ER05NO21.022</GPH>
variant. Any delay in the this IFC. Given the urgent need to issue screening). Further, most of these
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61568 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
individuals met State and local for CMS to impose such requirements vaccination, but the primary reason that
vaccination requirements in order to because other entities, including we are issuing this IFC requiring health
attend school to complete the necessary employers, states, and licensing care workers be vaccinated against
education to qualify for health care organizations, already impose sufficient COVID–19 is for the protection of
positions. In addition to these standards for those specific diseases. We residents, clients, patients, and PACE
longstanding vaccination requirements, believe that, given the fast-moving program participants.
many now require vaccination for nature of the COVID–19 pandemic and
I. Vaccination Requirements and
COVID–19 as well. However, studies on its ongoing threat to the health and
Employee Protections
annual seasonal influenza vaccine safety of individuals receiving health
uptake consistently show that half of care services in Medicare- and This IFC requires most Medicare- and
health care workers may resist seasonal Medicaid-certified providers and Medicaid-certified providers and
influenza vaccination nationwide.142 suppliers, our intervention is warranted. suppliers to ensure that their staff are
Other ongoing CMS staff vaccination We understand that some states and fully vaccinated for COVID–19. The U.S.
programs include hospital quality localities have established laws that Equal Employment Opportunity
improvement contractors that provide would seem to prevent Medicare- and Commission (EEOC) enforces workplace
educational resources to help hospitals Medicaid-certified providers and anti-discrimination laws and has
and staff overcome vaccine hesitancy, suppliers from complying with the established that employers can mandate
coordinate with State health requirements of this IFC. We intend, COVID–19 vaccination for all employees
departments to support vaccine uptake consistent with the Supremacy Clause that physically enter their facility.148
(for COVID–19 and flu), and monitor of the United States Constitution, that We are expanding upon that to include
staff vaccination rates for additional this nationwide regulation preempts all of the staff described in section
action. ESRD networks also provide inconsistent State and local laws as II.A.1. of this IFC, for the providers and
education on patient influenza and applied to Medicare- and Medicaid- suppliers addressed by this IFC, not just
pneumococcal vaccinations as a part of certified providers and suppliers. CDC those staff who perform their duties
their work and also recently (in 2020) estimates that 45.4 percent of U.S. within a health care facility, as many
added a goal of 85 percent of patients adults are at increased risk for health care staff routinely care for
vaccinated for flu while also complications from coronavirus disease patients and clients outside of such
encouraging vaccinations for staff because of cardiovascular disease, facilities, such as home health, home
within ESRD facilities. While we have diabetes, respiratory disease, infusion therapy, hospice, and therapy
not, until now, required any health care hypertension, or cancer. Rates increased staff. In addition, there may be other
staff vaccinations, we have established, by age, from 19.8 percent for persons times that staff encounter fellow
maintained, and regularly updated 18–29 years of age to 80.7 percent for employees, such as in an administrative
extensive health and safety persons >80 years of age, and varied by office or at an off-site staff meeting, who
requirements (CfCs, CoPs, requirements, State, race/ethnicity, health insurance will themselves enter a health care
etc.) for Medicare- and Medicaid- status, and employment.143 We expect facility or site of care for their job
certified providers and suppliers. These that individuals seeking health care responsibilities. Thus, we believe it is
requirements focus a great deal on services are more likely to fall into the necessary to require vaccination for all
high-risk category. While we do not staff that interact with other staff,
infection prevention and control
have provider- or supplier-specific patients, residents, clients, or PACE
standards, often incorporating
estimates, we would anticipate the program participants in any location,
guidelines as recommended by CDC and
percentage of high-risk individuals in beyond those that physically enter
other expert groups, as CMS’s highest
health care settings is much higher than facilities or other sites of patient care.
duty is to protect the health and safety In implementing the COVID–19
of patients, clients, residents, and PACE the general population. Health care
consumers seeking services from the vaccination policies and procedures
program participants in all applicable required by this IFC, however,
settings. provider and suppliers included in this
rule are often at significantly higher risk employers must comply with applicable
The Medicare statute’s various
of severe disease and death than their Federal anti-discrimination laws and
provisions authorizing the Secretary to civil rights protections. Applicable laws
impose requirements necessary in the paid care givers.144 As discussed in
section I.F. of this IFC, COVID–19 has include: (1) The Americans with
interest of the health and safety of Disabilities Act (ADA); (2) Section 504
beneficiaries encompass authority to disproportionally affected minority and
underserved populations, who will of the Rehabilitation Act (RA); (3) Title
require that staff working in and for VII of the Civil Rights Act of 1964; (4)
Medicare-certified providers and receive safer care and better outcomes
through this requirement.145 Families, the Pregnancy Discrimination Act; and
suppliers be vaccinated against specific (5) the Genetic Information
diseases. In addition, parallel Medicaid unpaid caregivers, and communities
will also experience overall Nondiscrimination Act.149 In addition,
statutes provide authority to establish other Federal laws may provide
requirements to protect beneficiary benefit.146 147 Staff will directly benefit
from the protective effects of COVID–19 employees with additional protections.
health and safety, as reflected in Table These Federal laws continue to apply
1. We acknowledge that we have not 143 https://wwwnc.cdc.gov/eid/article/26/8/20- during the PHE and, in some instances,
previously imposed such requirements, 0679_article. require employers to offer
but, as discussed throughout section I. 144 https://www.cdc.gov/coronavirus/2019-ncov/
of this rule, this is a unique pandemic hcp/clinical-care/underlyingconditions.html. 148 What You Should Know About COVID–19 and
scenario with unique access to effective 145 https://www.cdc.gov/coronavirus/2019-ncov/
the ADA, the Rehabilitation Act, and Other EEO
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community/health-equity/racial-ethnic-disparities/ Laws. U.S. Equal Opportunity Commission.
vaccines. In addition, for many disparities-impact.html. Accessed at https://www.eeoc.gov/wysk/what-you-
infectious diseases, it is not necessary 146 https://www.cdc.gov/coronavirus/2019-ncov/ should-know-about-covid-19-and-ada-rehabilitation
science/science-briefs/fully-vaccinated-people.html. -act-and-other-eeo-laws. Accessed on October 16,
142 Field R.I. (2009). Mandatory vaccination of 147 https://www.cdc.gov/coronavirus/2019-ncov/ 2021, 2:20 p.m. EDT. Updated October 13, 2021.
health care workers: whose rights should come variants/delta-variant.html?s_cid=11509:cdc% Section K. Vaccinations.
first? P & T: a peer-reviewed journal for formulary 20guidance%20delta%20variant:sem.ga:p:RG: 149 Genetic Information Nondiscrimination Act of
management, 34(11), 615–618. GM:gen:PTN:FY21. 2008. Public Law 110–233.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61569
accommodations for some individual and prioritize the health and well-being based health system also instituted a
staff members in some circumstances. of those they are caring for, as well as vaccine mandate, and reported that 98
These laws do not interfere with or not exposing them to threats that can be percent of the system’s 33,000 workers
prevent employers from following the avoided. This holds true not only for were fully or partially vaccinated or in
guidelines and suggestions made by health care professionals, but also for all the process of obtaining a religious or
CDC or public health authorities about who provide health care services or medical exemption when the
steps employers should take to promote choose to work in those settings. The requirement went into effect, with
public health and safety in light of ethical duty of receiving vaccinations is exemptions comprising less than 1
COVID–19, to the extent such guidelines not new, as staff have long been percent of staffers.157 In addition, a LTC
and suggestions are consistent with the required by employers to be vaccinated parent corporation established a
requirements set forth in this regulation. against certain diseases, such as COVID–19 vaccine mandate for its more
In other words, employers following influenza, hepatitis B, and other than 250 LTC facilities, leading to more
CDC guidelines and the new infectious diseases. than 95 percent of their workers being
requirements in this IFC may also be We are aware of concerns about vaccinated. Again, they noted that very
required to provide appropriate health care workers choosing to leave few workers quit their jobs rather than
accommodations, to the extent required their jobs rather than be vaccinated. be vaccinated.158 New York enacted a
by Federal law, for employees who While we understand that there might State-wide health care worker COVID–
request and receive exemption from be a certain number of health care 19 vaccine mandate and recorded a
vaccination because of a disability, workers who choose to do so, there is jump in vaccine compliance in the final
medical condition, or sincerely held insufficient evidence to quantify and days before the requirements took effect
religious belief, practice, or observance. compare adverse impacts on patient and on October 1, 2021.159
Vaccination against COVID–19 is a resident care associated with temporary We believe that the COVID–19
critical protective action for all staffing losses due to mandates and vaccine requirements in this IFC will
individuals, especially health care absences due to quarantine for known result in nearly all health care workers
workers, because the SARS-Cov-2 virus COVID–19 exposures and illness. We being vaccinated, thereby benefiting all
poses direct threats to patients, clients, encourage providers and suppliers, individuals in health care settings. This
residents, PACE program participants, where possible, to consider on-site will greatly contribute to a reduction in
and staff. COVID–19 disease at this time vaccination programs, which can the spread of and resulting morbidity
is resulting in much higher morbidity significantly reduce barriers that health and mortality from the disease, positive
and mortality than seasonal flu.150 151 152 care staff may face in getting vaccinated, steps towards health equity, and an
These individual vaccinations provide including transportation barriers, need improvement in the numbers of health
protections to the health care system as to take time off of work, and scheduling. care staff who are healthy and able to
a whole, protecting capacity and However, vaccine declination may perform their professional
operations during disease outbreaks. continue to occur, albeit at lower rates, responsibilities. For individual staff
We also recognize ethical reasons to due to hesitancy among particular members that have legally permitted
issue these vaccination requirements. communities, and the Assistant justifications for exemption, the
All health care workers have a general Secretary for Planning and Evaluation providers and suppliers covered by this
ethical duty to protect those they (ASPE) indicates that vaccination IFC can address those individually.
encounter in their professional promotion and outreach efforts focused
II. Provisions of the Interim Final Rule
capacity.153 Patient safety is a central on groups and communities who
With Comment Period
tenet of the ethical codes and practice experience social risk factors could help
standards published by health care address inequities.154 Through this IFC, we are requiring
professional associations, licensure and Despite these hesitations, many that the following Medicare- and
certification bodies, and specialized COVID–19 vaccination mandates have Medicaid-certified providers and
industry groups. Health care workers already been successfully initiated in a suppliers, listed here in order of their
also have a special ethical and variety of health care settings, systems, appearance in 42 CFR, ensure that all
professional responsibility to protect and states. In general, workers across applicable staff are vaccinated for
the economy are responding to COVID–19:
150 Comparison of the characteristics, morbidity, mandates by getting vaccinated.155 A • Ambulatory Surgical Centers (ASCs)
and mortality of COVID–19 and seasonal influenza: large hospital system in Texas instituted • Hospices
a nationwide, population-based retrospective cohort a vaccine mandate and 99.5 percent of • Psychiatric residential treatment
study, The Lancet, Published Online December 17, its staff received the vaccine. Further, facilities (PRTFs)
2020 https://doi.org/10.1016/ S2213-
only a few of their staff resigned rather • Programs of All-Inclusive Care for the
2600(20)30527-0.
151 Comparative evaluation of clinical than receive the vaccine.156 A Detroit- Elderly (PACE)
manifestations and risk of death in patients
admitted to hospital with covid–19 and seasonal 154 Kolbe A. Disparities in COVID–19 vaccination 19 Vaccine Mandates for All Workers in Health and
influenza: cohort study, BMJ 2020;371:m4677. rates across racial and ethnic minority groups in the Long-Term Care’’ that is signed by 88 organizations.
157 https://www.bridgemi.com/michigan-health-
152 Klompas, M, Pearson, M, and Morris, C. The United States. Washington, DC: US Department of
Case for Mandating COVID–19 Vaccines for Health Health and Human Services, Office of the Assistant watch/despite-protests-98-henry-ford-hospital-
Care Workers. Annuals of Internal Medicine. Secretary for Planning and Evaluation; 2021. workers-get-covid-vaccinations accessed 09/15/
Annals.org. Accessed at https:// https://aspe.hhs.gov/system/files/pdf/265511/ 2021 at 2:24 p.m. EDT.
www.acpjournals.org/doi/10.7326/M21-2366. vaccination-disparities-brief.pdf. 158 Emanuel, E and Skorton, D. Mandating
Accessed on August 30, 2021. Published on July 13, 155 https://theconversation.com/half-of- COVID–19 Vaccination for Health Care Workers.
2021. unvaccinated-workers-say-theyd-rather-quit-than- Annuals of Internal Medicine. Annals.org. Accessed
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153 Emanuel, E and Skorton, D. Mandating get-a-shot-but-real-world-data-suggest-few-are- at https://www.acpjournals.org/doi/10.7326/M21-
COVID–19 Vaccination for Health Care Workers. following-through-168447. 3150. Accessed on August 30, 2021. Article
Annuals of Internal Medicine. Annals.org. Accessed 156 Emanuel, E and Skorton, D. Mandating includes the ‘‘Joint Statement in Support of COVID–
at https://www.acpjournals.org/doi/10.7326/M21- COVID–19 Vaccination for Health Care Workers. 19 Vaccine Mandates for All Workers in Health and
3150. Accessed on August 30, 2021. Article Annuals of Internal Medicine. Annuals.org. Long-Term Care’’ that is signed by 88 organizations.
includes the ‘‘Joint Statement in Support of COVID– Accessed https://www.acpjournals.org/doi/10.7326/ 159 https://www.nytimes.com/2021/09/28/
19 Vaccine Mandates for All Workers in Health and M21-3150. Accessed on August 30, 2021. Article nyregion/vaccine-health-care-workers-
Long-Term Care’’ that is signed by 80 organizations. includes the ‘‘Joint Statement in Support of COVID– mandate.html.
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61570 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
• Hospitals (acute care hospitals, 1. Staff Subject to COVID–19 the May 13, 2021 COVID–19 IFC, we
psychiatric hospitals, long term care Vaccination Requirements considered applying the § 483.80(h)
hospitals, children’s hospitals, The provisions of this IFC require definition to the staff vaccination
hospital swing beds, transplant applicable providers and suppliers to requirements in this rule, but previous
centers, cancer hospitals, and develop and implement policies and public feedback and our own experience
rehabilitation hospitals) procedures under which all staff are tells us the definition in § 483.80(h) was
• Long Term Care (LTC) Facilities, vaccinated for COVID–19. Each facility’s overbroad for these purposes.
including SNFs and NFs, generally COVID–19 vaccination policies and Stakeholders across settings have
referred to as nursing homes procedures must apply to the following reported that there are many individuals
• Intermediate Care Facilities for facility staff, regardless of clinical providing occasional health care
Individuals with Intellectual services under arrangement, and that
responsibility or patient contact and
Disabilities (ICFs-IID) the requirements may be excessively
including all current staff as well as any
• Home Health Agencies (HHAs) burdensome for facilities to apply the
new staff, who provide any care,
definition at § 483.80(h) because it
• Comprehensive Outpatient treatment, or other services for the
includes many individuals who have
Rehabilitation Facilities (CORFs) facility and/or its patients: Facility
very limited, infrequent, or even no
• Critical Access Hospitals (CAHs) employees; licensed practitioners;
contact with facility staff and residents.
• Clinics, rehabilitation agencies, and students, trainees, and volunteers; and
Stakeholders also report that applying
public health agencies as providers of individuals who provide care,
the staff vaccination requirements to
outpatient physical therapy and treatment, or other services for the
these individuals who may only make
speech-language pathology services facility and/or its patients, under unscheduled visits to the facility would
• Community Mental Health Centers contract or other arrangement. These be extremely burdensome. That said, the
(CMHCs) requirements are not limited to those description in this rule still includes
• Home Infusion Therapy (HIT) staff who perform their duties within a many of the individuals included in
suppliers formal clinical setting, as many health § 483.80(h). In addition to facility-
• Rural Health Clinics (RHCs)/Federally care staff routinely care for patients and employed staff, many facilities have
Qualified Health Centers (FQHCs) clients outside of such facilities, such as services provided directly, on a regular
home health, home infusion therapy,
• End-Stage Renal Disease (ESRD) basis, by individuals under contract or
hospice, PACE programs, and therapy arrangement, including hospice and
Facilities
staff. Further, there may be staff that dialysis staff, physical therapists,
For discussion purposes, we have primarily provide services remotely via occupational therapists, mental health
grouped these providers and suppliers telework that occasionally encounter professionals, social workers, and
into four categories below: (1) fellow staff, such as in an administrative portable x-ray suppliers. Any of these
Residential congregate care facilities; (2) office or at an off-site staff meeting, who individuals who provide such health
acute care settings; (3) outpatient will themselves enter a health care care services at a facility would be
clinical care and services; and (4) home- facility or site of care for their job included in ‘‘staff’’ for whom COVID–19
based care. We note that the appropriate responsibilities. Thus, we believe it is vaccination is now required as a
term for the individual receiving care necessary to require vaccination for all condition for continued provision of
and/or services differs depending upon staff that interact with other staff, those services for the facility and/or its
the provider or supplier. For example, patients, residents, clients, or PACE patients.
for hospitals and CAHs, the appropriate program participants in any location, In order to best protect patients,
term is patient, but for ICFs-IID, it is beyond those that physically enter families, caregivers, and staff, we are not
client. Further, LTC facilities have facilities, clinics, homes, or other sites limiting the vaccination requirements of
residents and PACE Programs have of care. Individuals who provide this IFC to individuals who are present
participants. The appropriate term is services 100 percent remotely, such as in the facility or at the physical site of
used when discussing each individual fully remote telehealth or payroll patient care based upon frequency.
provider or supplier, but when we are services, are not subject to the Regardless of frequency of patient
discussing all or multiple providers and vaccination requirements of this IFC. contact, the policies and procedures
suppliers we will use the general term In the May 13, 2021 COVID–19 IFC, must apply to all staff, including those
‘‘patient.’’ Similarly, despite the we included an extensive discussion on providing services in home or
different terms used for specific the subject of ‘‘staff’’ in relation to the community settings, who directly
provider and supplier entities (such as LTC facility staff and to whom the provide any care, treatment, or other
campus, center, clinic, facility, testing, reporting, and education and services for the facility and/or its
organization, or program), when we are offering of COVID–19 vaccine patients, including employees; licensed
discussing all or multiple providers and requirements of that rule might apply. practitioners; students, trainees, and
suppliers, we will use the general term In that discussion, we considered LTC volunteers; and individuals who
‘‘facility.’’ facility staff to be those individuals who provide care, treatment, or other
work in the facility on a regular (that is, services for the facility and/or its
A. Provisions of the Interim Final Rule
at least once a week) basis. We note that patients, under contract or other
With Comment Period
this includes those individuals who arrangement. This includes
In this IFC, we are issuing a common may not be physically in the LTC administrative staff, facility leadership,
set of provisions for each applicable facility for a period of time due to volunteer or other fiduciary board
provider and supplier. As there are no illness, disability, or scheduled time off, members, housekeeping and food
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substantive regulatory differences across but who are expected to return to work. services, and others. We considered
settings, we discuss the provisions We also note that this description of excluding individual staff members who
broadly in this section of the rule, along staff differs from that in § 483.80(h), are present at the site of care less
with their rationales. In subsequent established for the LTC facility COVID– frequently than once per week from
sections of the rule we discuss any 19 testing requirements in the these vaccination requirements, but
unique considerations for each setting. September 2, 2020 COVID–19 IFC. As in were concerned that this might lead to
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confusion or fragmented care. Therefore, restroom or service area and correctly in the U.S., the primary vaccination
any individual that performs their wears a mask for the entirety of the visit series consists of a defined number of
duties at any site of care, or has the may not be an appropriate candidate for doses administered a certain number of
potential to have contact with anyone at mandatory vaccination. On the other weeks apart; therefore, we have made
the site of care, including staff or hand, a crew working on a construction this particular requirement effective in
patients, must be fully vaccinated to project whose members use shared two different phases. We discuss these
reduce the risks of transmission of facilities (restrooms, cafeteria, break implementation phases further in
SARS–CoV–2 and spread of COVID–19. rooms) during their breaks would be section II.B. of this IFC, but note here
Facilities that employ or contract for subject to these requirements due to the that Phase 1, effective 30 days after
services by staff who telework full-time fact that they are using the same publication of this IFC, includes the
(that is, 100 percent of their time is common areas used by staff, patients, requirement that staff receive the first
remote from sites of patient care, and and visitors. Again, we strongly dose, or only dose as applicable, of a
remote from staff who do work at sites encourage facilities, when the COVID–19 vaccine, or have requested or
of care) should identify and monitor opportunity exists and resources allow, been granted an exemption to the
these individuals as a part of to facilitate the vaccination of all vaccination requirements of this IFC.
implementing the policies and individuals who provide services Phase 2, effective 60 days after
procedures of this IFC, documenting infrequently and are not otherwise publication of this IFC, requires that the
and tracking overall vaccination status, subject to the requirements of this IFC. primary vaccination series has been
but those individuals need not be completed and that staff are fully
subject to the vaccination requirements 2. Determining When Staff Are
vaccinated, except for those staff have
of this IFC. Note, however, that these Considered ‘‘Fully Vaccinated’’
been granted exemptions, or those staff
individuals may be subject to other In consideration of the different for whom COVID–19 vaccination must
Federal requirements for COVID–19 vaccines available for COVID–19, we be temporarily delayed, as
vaccination. require that providers and suppliers recommended by CDC, due to clinical
We recognize that many infrequent ensure that staff are fully vaccinated for precautions and considerations. As
services and tasks performed in or for a COVID–19, which, for purposes of these discussed in section II.B. of this IFC,
health care facility are conducted by requirements, is defined as being 2 staff who have completed the primary
‘‘one off’’ vendors, volunteers, and weeks or more since completion of a series for the vaccine received by the
professionals. Providers and suppliers primary vaccination series. This Phase 2 implementation date are
are not required to ensure the definition of ‘‘fully vaccinated’’ is considered to have met these
vaccination of individuals who consistent with the CDC definition. requirements, even if they have not yet
infrequently provide ad hoc non-health Additionally, the completion of a completed the 14-day waiting period
care services (such as annual elevator primary vaccination series for COVID– required for full vaccination.
inspection), or services that are 19 is defined in the requirements as the
performed exclusively off-site, not at or administration of a single-dose vaccine, 3. Infection Prevention and Control
adjacent to any site of patient care (such or the administration of all required We require through this IFC that all
as accounting services), but they may doses of a multi-dose vaccine. applicable providers and suppliers have
choose to extend COVID–19 vaccination We note that the concept of a a process for ensuring the
requirements to them if feasible. Other ‘‘primary series’’ is commonly implementation of additional
individuals who may infrequently enter understood with respect to vaccinations, precautions, intended to mitigate the
a facility or site of care for specific particularly among health care transmission and spread of COVID–19,
limited purposes and for a limited professionals as well as the providers for all staff who are not fully vaccinated
amount of time, but do not provide and suppliers regulated by this rule. For for COVID–19. While every health care
services by contract or under purposes of this IFC, and if permitted or facility should be following
arrangement, may include delivery and recommended by CDC, COVID–19 recommended infection control and
repair personnel. vaccine doses from different prevention measures as recommended
We believe it would be overly manufacturers may be combined to meet by CDC as part of their provision of safe
burdensome to mandate that each the requirements for a primary health care services, not all of the
provider and supplier ensure COVID–19 vaccination series. providers and suppliers subject to the
vaccination for all individuals who We further note that requirements of this IFC have specific
enter the facility. However, while recommendations for booster doses infection control and prevention
facilities are not required to ensure currently vary by vaccine and regulations in place. Specifically, there
vaccination of every individual, they population, and expect that they will are no infection prevention and control
may choose to extend COVID–19 continue to vary for the foreseeable requirements for PRTFs, RHCs/FQHCs,
vaccination requirements beyond those future. We also require that providers and HIT suppliers. Therefore, for
persons that we consider to be staff as and suppliers must have a process for PRTFs, RHCs/FQHCs, and HIT
defined in this rulemaking. We do not tracking and securely documenting the suppliers, we require that they have a
intend to prohibit such extensions and COVID–19 vaccination status of any process for ensuring that they follow
encourage facilities to require COVID– staff who have obtained any booster nationally recognized infection
19 vaccination for these individuals as doses as recommended by the CDC. prevention and control guidelines
reasonably feasible. Additionally, some staff members may intended to mitigate the transmission
When determining whether to require have been vaccinated during and spread of COVID–19. This process
COVID–19 vaccination of an individual participation in a clinical trial, or in must include the implementation of
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who does not fall into the categories countries other than the U.S. We discuss additional precautions for all staff who
established by this IFC, facilities should the applicability of these less common are not fully vaccinated for COVID–19.
consider frequency of presence, services vaccination pathways in section I.B. of For the providers and suppliers
provided, and proximity to patients and this IFC. included in this IFC that are already
staff. For example, a plumber who Currently, for two of the three subject to meeting specific infection
makes an emergency repair in an empty vaccines licensed or authorized for use prevention and control requirements on
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61572 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
an ongoing basis, we require that they there are some individuals who might For staff members who request a
have a process for ensuring the be eligible for exemptions from the medical exemption from vaccination, all
implementation of additional COVID–19 vaccination requirements in documentation confirming recognized
precautions, intended to mitigate the this IFC under existing Federal law. clinical contraindications to COVID–19
transmission and spread of COVID–19, Accordingly, we require that providers vaccines, and which supports the staff
for all staff who are not fully vaccinated and suppliers included in this IFC member’s request, must be signed and
for COVID–19. establish and implement a process by dated by a licensed practitioner, who is
which staff may request an exemption not the individual requesting the
4. Documentation of Staff Vaccinations from COVID–19 vaccination exemption, and who is acting within
In order to ensure that providers and requirements based on an applicable their respective scope of practice as
suppliers are complying with the Federal law. Certain allergies, defined by, and in accordance with, all
vaccination requirements of this IFC, we recognized medical conditions, or applicable State and local laws. Such
are requiring that they track and religious beliefs, observances, or documentation must contain all
securely document the vaccination practices, may provide grounds for information specifying which of the
status of each staff member, including exemption. With regard to recognized authorized COVID–19 vaccines are
those for whom there is a temporary clinical contraindications to receiving a clinically contraindicated for the staff
delay in vaccination, such as recent COVID–19 vaccine, facilities should member to receive and the recognized
receipt of monoclonal antibodies or refer to the CDC informational clinical reasons for the
convalescent plasma. Vaccine document, Summary Document for contraindications; and a statement by
exemption requests and outcomes must Interim Clinical Considerations for Use the authenticating practitioner
also be documented, discussed further of COVID–19 Vaccines Currently recommending that the staff member be
in section II.A.5. of this IFC. This Authorized in the United States, exempted from the facility’s COVID–19
documentation will be an ongoing accessed at https://www.cdc.gov/ vaccination requirements based on the
process as new staff are onboarded. vaccines/covid-19/downloads/ recognized clinical contraindications.
While provider and supplier staff may summary-interim-clinical- Under Federal law, including the
not have personal medical records on considerations.pdf. ADA and Title VII of the Civil Rights
file with their employer, all staff As described in section I.I. of this IFC, Act of 1964 as noted previously,
COVID–19 vaccines must be there are Federal laws, including the workers who cannot be vaccinated or
appropriately documented by the ADA, section 504 of the Rehabilitation tested because of an ADA disability,
provider or supplier. Examples of Act, section 1557 of the ACA, and Title medical condition, or sincerely held
appropriate places for vaccine VII of the Civil Rights Act, that prohibit religious beliefs, practice, or observance
documentation include a facilities discrimination based on race, color, may in some circumstances be granted
immunization record, health national origin, religion, disability and/ an exemption from their employer. In
information files, or other relevant or sex, including pregnancy. We granting such exemptions or
documents. All medical records, recognize that, in some circumstances, accommodations, employers must
including vaccine documentation, must employers may be required by law to ensure that they minimize the risk of
be kept confidential and stored offer accommodations for some transmission of COVID–19 to at-risk
separately from an employer’s personnel individual staff members. individuals, in keeping with their
files, pursuant to ADA and the Accommodations can be addressed in obligation to protect the health and
Rehabilitation Act. the provider or supplier’s policies and safety of patients. Employers must also
Examples of acceptable forms of proof procedures. follow Federal laws protecting
of vaccination include: Applicable staff of the providers and employees from retaliation for
• CDC COVID–19 vaccination record suppliers included in this IFC must be requesting an exemption on account of
card (or a legible photo of the card), able to request an exemption from these religious belief or disability status. For
• Documentation of vaccination from COVID–19 vaccination requirements more information about these situations,
a health care provider or electronic based on an applicable Federal law, employers can consult the Equal
health record, or such as the Americans with Disabilities Employment Opportunity Commission’s
• State immunization information Act (ADA) and Title VII of the Civil website at https://www.eeoc.gov/wysk/
system record. Rights Act of 1964. Providers and what-you-should-know-about-covid-19-
If vaccinated outside of the U.S., a suppliers must have a process for and-ada-rehabilitation-act-and-other-
reasonable equivalent of any of the collecting and evaluating such requests, eeo-laws.
previous examples would suffice. including the tracking and secure We also direct providers and
Providers and suppliers have the documentation of information provided suppliers to the Equal Employment
flexibility to use the appropriate by those staff who have requested Opportunity Commission (EEOC)
tracking tools of their choice. For those exemption, the facility’s decision on the Compliance Manual on Religious
who would like to use it, CDC provides request, and any accommodations that Discrimination 160 for information on
a staff vaccination tracking tool that is are provided. evaluating and responding to such
available on the NHSN website (https:// Requests for exemptions based on an requests. While employers have the
www.cdc.gov/nhsn/hps/weekly-covid- applicable Federal law must be flexibility to establish their own
vac/index.html). This is a generic Excel- documented and evaluated in processes and procedures, including
based tool available for free to anyone, accordance with applicable Federal law forms, we point to The Safer Federal
not just NHSN participants, that and each facility’s policies and Workforce Task Force’s ‘‘request for a
procedures. As is relevant here, this IFC
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facilities can use to track COVID–19 religious exception to the COVID–19
vaccinations for staff members. preempts the applicability of any State vaccination requirement’’ template as an
or local law providing for exemptions to example. This template can be viewed
5. Vaccine Exemptions the extent such law provides broader at https://
While nothing in this IFC precludes exemptions than provided for by
an employer from requiring employees Federal law and are inconsistent with 160 https://www.eeoc.gov/laws/guidance/section-
to be fully vaccinated, we recognize that this IFC. 12-religious-discrimination.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61573
www.saferfederalworkforce.gov/ might also address special precautions 19 vaccine, or requested and/or been
downloads/RELIGIOUS%20REQUEST% to be taken when, for example, there is granted a lawful exemption, prior to
20FORM%20-%2020211004%20- a regional or local emergency staff providing any care, treatment, or
%20MH508.pdf. declaration, such as for a hurricane or other services for the facility and/or its
flooding, which necessitates the patients. Phase 1 also includes the
6. Planning
temporary utilization of unvaccinated requirements for facilities to have
Despite the near-universal staff, in order to assure the safety of appropriate policies and procedures
applicability of the requirements patients. For example, expedient developed and implemented, and the
described in sections II.A.1. through 5 of evacuation of a flooding LTC facility requirement that all staff must have
this IFC, we recognize that the course of may require assistance from local received a single dose COVID–19
the COVID–19 pandemic remains community members of unknown vaccine or the initial dose of a primary
unpredictable. Due to likely unforeseen vaccination status. Facilities may
circumstances, we require that series by December 6, 2021.
already have contingency plans that
providers and suppliers make meet the requirements of this IFC in Phase 2, effective 60 days after
contingency plans in consideration of their existing Emergency Preparedness publication, consists of the requirement
staff that are not fully vaccinated to policies and procedures. that all applicable staff are fully
ensure that they will soon be vaccinated vaccinated for COVID–19, except for
and will not provide care, treatment, or B. Implementation Dates those staff who have been granted
other services for the provider or its Due to the urgent nature of the exemptions from COVID–19 vaccination
patients until such time as such staff vaccination requirements established in or those staff for whom COVID–19
have completed the primary vaccination this IFC, we have not issued a proposed vaccination must be temporarily
series for COVID–19 and are considered rule, as discussed in section III. of this delayed, as recommended by the CDC,
fully vaccinated, or, at a minimum, have IFC. While some IFCs are effective due to clinical precautions and
received a single-dose COVID–19 immediately upon publication, we considerations). Although an individual
vaccine, or the first dose of the primary understand that instantaneous is not considered fully vaccinated until
vaccination series for a multi-dose compliance, or compliance within days, 14 days (2 weeks) after the final dose,
COVID–19 vaccine. This planning with these regulations is not possible. staff who have received the final dose of
should also address the safe provision of Vaccination requires time, especially a primary vaccination series by the
services by individuals who have those vaccines delivered in a series, and Phase 2 effective date are considered to
requested an exemption from facilities may wish to coordinate have meet the individual vaccination
vaccination while their request is being scheduling of staff vaccination requirements, even if they have not yet
considered and by those staff for whom appointments in a staggered manner so completed the 14-day waiting period.
COVID–19 vaccination must be that appropriate coverage is maintained.
For example, an individual may receive
temporarily delayed, as recommended The policies and procedures required by
the first dose of the Moderna mRNA
by the CDC, due to clinical precautions the IFC will also take time for facilities
COVID–19 Vaccine 2 or 3 days prior to
and considerations. to develop. However, in order to
While the nature of this rulemaking provide protection to residents, patients, the Phase 1 deadline, but must wait at
suggests the potential that virtually all clients, and PACE program participants least 28 days before receiving the
health care staff in the U.S. will be (as applicable), we believe it is second dose. This second dose could
vaccinated for COVD–19 within a matter necessary to begin staff vaccinations as (and must, for purposes of this IFC) be
of months, local outbreaks, new viral quickly as reasonably possible. administered prior to the Phase 2
variations, changes in disease In order to provide protection as soon effective date, but the individual would
manifestation, or other factors as possible, we are establishing two still be subject to meeting additional
necessitate contingency planning. implementation phases for this IFC. precautions as described in section
Contingency planning may extend Phase 1, effective 30 days after II.A.3. of this IFC until 14 days had
beyond the specific requirements of this publication, includes nearly all passed. This timing flexibility applies
rule to address topics such as staffing provisions of this IFC, including the only to the initial implementation of
agencies that can supply vaccinated requirements that all staff have received, this IFC and has no bearing on ongoing
staff if some of the facility’s staff are at a minimum, the first dose of the compliance. This information is also
unable to work. Contingency plans primary series or a single dose COVID– presented in Table 2.
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We note that although this IFC is rulemaking and make this rule reviewed to ensure each component of
being issued in response to the PHE for permanent. the requirement has been addressed. We
COVID–19, we expect it to remain C. Enforcement will also provide guidance on how
relevant for some time beyond the end surveyors should cite providers and
of the formal PHE. Depending on the As we do with all new or revised suppliers when noncompliance is
future nature of the COVID–19 requirements, CMS will issue identified. Lastly, providers and
interpretive guidelines, which include
pandemic, we may retain these suppliers that are cited for
survey procedures, following
provisions as a permanent requirement noncompliance may be subject to
publication of this IFC. We will advise
for facilities, regardless of whether the and train State surveyors on how to enforcement remedies imposed by CMS
Secretary continues the ongoing PHE assess compliance with the new depending on the level of
declarations. Therefore, this requirements among providers and noncompliance and the remedies
rulemaking’s effectiveness is not suppliers. For example, the guidelines available under Federal law (for
associated with or tied to the PHE will instruct surveyors on how to example, civil money penalties, denial
declarations, nor is there a sunset determine if a provider or supplier is of payment for new admissions, or
clause. Pursuant to section 1871(a)(3) of compliant with the requirements by termination of the Medicare/Medicaid
the Act, Medicare interim final rules reviewing the entity’s records of staff provider agreement). CMS will closely
expire 3 years after issuance unless vaccinations, such as a list of all staff monitor the status of staff vaccination
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finalized. We expect to make a and their individual vaccination status rates, provider compliance, and any
determination based on public or qualifying exemption. The guidelines other potential risks to patient, resident,
comments, incidence, disease outcomes, will also instruct surveyors to conduct client, and PACE program participant
and other factors regarding whether it interviews staff to verify their health and safety.
will be necessary to conduct final vaccination status. Furthermore, the
ER05NO21.023</GPH>
entity’s policy and procedures will be
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D. Residential Congregate Care Facilities 1819 and 1919 of the Act, Medicare- and • The third IFC, ‘‘Medicare and
Individuals residing in congregate Medicaid-participating LTC facilities Medicaid Programs; COVID–19 Vaccine
care settings such as LTC facilities, ‘‘must meet such other requirements Requirements for Long-Term Care (LTC)
intermediate care facilities for relating to the health, safety, and well- Facilities and Intermediate Care
individuals with intellectual disabilities being of residents or relating to the Facilities for Individuals with
(ICFs-IID), and psychiatric residential physical facilities thereof as the Intellectual Disabilities (ICFs-IID)
treatment facilities for individuals Secretary may find necessary.’’ 161 More Residents, Clients, and Staff’’
under 21 years of age (PRTFs), specifically, the infection control (86FR26306) was published on May 13,
regardless of health or medical requirements for LTC facilities are based 2021. We received 71 public comments
on sections 1819(d)(3)(A) (for skilled in response to the May 13, 2021 COVID–
conditions, are at greater risk of
nursing facilities) and 1919(d)(3)(A) (for 19 IFC, of which most addressed the
acquiring infections. This higher risk
nursing facilities) of the Act, which both requirements for COVID–19 educating,
applies to most bacterial and viral
require that a facility establish and offering, and reporting of the uptake of
infections, including SARS–CoV–2.
maintain an infection control program COVID–19 vaccine for LTC facility
Staff working in these facilities often
designed to provide a safe, sanitary, and residents and staff set forth at
work across facility types (that is, LTC
comfortable environment in which §§ 483.80(d)(3) and 483.80(g)(1). In that
facilities, group homes, assisted living
residents reside and to help prevent the rule, we also required the educating,
facilities, in home and community-
development and transmission of offering, and recommended voluntary
based services settings, and even
disease and infection. reporting of COVID–19 vaccine uptake
different congregate settings within the in ICFs-IID facility clients and staff set
employer’s purview), and for different Since the onset of the PHE, we have
revised the requirements for LTC forth at §§ 483.430, Facility Staffing
providers, which may contribute to requirements, and 483.460, Health Care
virus transmission. Other factors facilities through three IFCs focused on
COVID–19 testing, data reporting and Services for Clients.
impacting virus transmission in these Under § 483.80(d)(3), as established in
settings might include: Clients or vaccine requirements for residents and
the May 13, 2021 IFC, we require LTC
residents who are employed outside the staff. Specifically, we have published facilities to educate residents and staff
congregate living setting; clients or the following IFCs:
on the COVID–19 vaccines and also to
residents who require close contact with • The first IFC, ‘‘Medicare and offer the vaccine, when available, to all
staff or direct service providers; clients Medicaid Programs, Basic Health residents and staff. The May 13, 2021
or residents who have difficulty Program, and Exchanges; Additional IFC also required LTC facilities to report
understanding information or practicing Policy and Regulatory Revisions in both resident and staff vaccine uptake
preventive measures; and clients or Response to the COVID–19 Public and status to CDC’s National Healthcare
residents in close contact with each Health Emergency and Delay of Certain Safety Network (NHSN)
other in shared living or working Reporting Requirements for the Skilled (§ 483.80(d)(3)(vii)); this has been a
spaces. Nursing Facility Quality Reporting requirement since May 21, 2021. The
Program’’ (FR27550) was published on CDC data collected under this
1. Long Term Care Facilities (Skilled
May 8, 2020. The May 8, 2020 COVID– requirement show that vaccination rates
Nursing Facilities and Nursing
19 IFC established requirements for LTC for LTC facility staff have stalled, with
Facilities)
facilities to report information related to a 64 percent national average of
Long term care (LTC) facilities, a COVID–19 cases among facility vaccinated staff according to CDC data
category that includes Medicare skilled residents and staff, we received 299 as of August 28, 2021, while the number
nursing facilities (SNFs) and Medicaid public comments. About 161, or over of new LTC facility resident COVID–19
nursing facilities (NFs), also collectively one-half of those comments, addressed cases reported per week has risen by
called nursing homes, must meet the the requirement for COVID–19 reporting just over 1455 percent from recorded
consolidated Medicare and Medicaid for LTC facilities set forth at § 483.80(g). lows in June 2021 (323 cases in the
requirements for participation • The second IFC, ‘‘Medicare and week ending June 27, 2021; 4701 in the
(requirements) for LTC facilities (42 CFR Medicaid Programs, Clinical Laboratory week ending August 22, 2021). There is
part 483, subpart B) that were first Improvement Amendments (CLIA), and wide variation among states in staff
published in the Federal Register on Patient Protection and Affordable Care vaccination rates.
February 2, 1989 (54 FR 5316). These Act; Additional Policy and Regulatory With this IFC, we are amending the
regulations have been revised and Revisions in Response to the COVID–19 requirements at § 483.80, Infection
added to since that time, principally as Public Health Emergency’’ (FR54873) Control, by revising paragraph (d)(3)(v)
a result of legislation or a need to was published on September 2, 2020. by deleting the words, ‘‘or a staff
address specific issues. The The September 2, 2020 COVID–19 IFC member,’’ and adding the word, ‘‘or’’
requirements were comprehensively strengthened CMS’ ability to enforce before ‘‘resident representative,’’ so that
revised and updated in October 2016 compliance with LTC facility reporting the provision now reads, ‘‘the resident,
(81 FR 68688), including a requirements and established a new or resident representative, has the
comprehensive update to the requirement for LTC facilities to test opportunity to accept or refuse a
requirements for infection prevention facility residents and staff for COVID– COVID–19 vaccine, and change their
and control. 19. We received 171 public comments decision.’’ Retaining the language
CMS establishes requirements for in response to the September 2, 2020 permitting staff to refuse vaccination
acceptable quality in the operation of COVID–19 IFC, of which 113 addressed would be inconsistent with the goals of
health care entities. LTC facilities are this IFC. We are further amending the
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the requirement for COVID–19 testing of
required to comply with the LTC facility residents and staff set forth requirements at § 483.80 to add a new
requirements in 42 CFR part 483, at § 483.80(h). paragraph (i), titled ‘‘COVID–19
subpart B, to receive payment under the Vaccination of facility staff,’’ to specify
Medicare or Medicaid programs. In 161 Section 1819(d)(4)(B) of the Act. Section that facilities must now develop and
addition to several discrete 1919(d)(4)(B) is nearly identical, but omitting ‘‘well- implement policies and procedures to
requirements set out under sections being’’. ensure that all staff are fully
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61576 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
vaccinated—that is, staff for whom it services in facilities for individuals with Among the requirements for the psych
has been 2 weeks or more since they intellectual disabilities or persons with under 21 benefit are certification of
completed a primary vaccination series related conditions. The ICFs-IID need for inpatient care and a plan of
for COVID–19, with the completion of a Conditions of Participation were issued care for active treatment developed by
primary vaccination series for COVID– on June 3, 1988 (53 FR 20496) and were an interdisciplinary team. The psych
19 defined as the administration of a last updated on May 13, 2021 (86 FR under 21 benefit is significant as a
single-dose vaccine, or the 20448). There are currently 5,768 means for Medicaid to cover the cost of
administration of all required doses of a Medicare- and/or Medicaid-certified inpatient behavioral health services.
multi-dose vaccine. ICFs-IID. As of April 2021, 4,661 of the The Federal Medicaid program does not
For this rule, we have also added a 5,770 are small (1 to 8 beds) in size, but reimburse states for the cost of covered
new paragraph at § 483.80(i)(2), which there are 1,107 that are larger (14 or services provided to beneficiaries in
specifies which staff for whom the more beds) facilities. These facilities institutions for mental diseases (IMDs)
requirements for staff COVID–19 serve over 64,812 individuals with except in specific, statutorily-authorized
vaccination will not apply: (1) Staff who intellectual disabilities and other related exceptions, including for young people
exclusively provide telehealth or conditions. All must qualify for who receive this service, and
telemedicine services outside of the Medicaid coverage. While national data individuals age 65 or older served in an
facility setting and who do not have any about ICFs-IID clients is limited, we take IMD. A PRTF provides comprehensive
direct contact with residents and other an example from Florida where almost behavioral health treatment to children
staff (for whom the requirements do one quarter of clients (23 percent) and adolescents (youth) who, due to
apply) and (2) staff who provide support require 24-hour nursing services and a mental illness, substance use disorders,
services for the facility that are medical care plan in addition to their or severe emotional disturbance, need
performed exclusively outside of the services plans.163 Data from a single treatment that can most effectively be
facility setting and who do not have any State are not nationally representative provided in a residential treatment
direct contact with residents and other and thus we are unable to generalize, facility. PRTF programs are designed to
staff (for whom the requirements do but it is illustrative. offer a short term, intense, focused
apply). Currently, the Conditions of behavioral health treatment program to
Additionally, under the requirements promote a successful return of the youth
Participation: ‘‘Health Care Services’’ at
of this IFC, we are adding § 483.80(i)(3) to the community.
§ 483.460(a)(4)(i) require that ICFs-IID
to now require that a facility’s policies As a congregate living setting, PRTFs
offer clients and staff vaccination
and procedures for COVID–19 are subject to many of the same elevated
against COVID–19 when vaccine
vaccination of staff must include, at a transmission risk factors as LTC
supplies are available (86 FR 26306).
minimum, the components specified in facilities and ICFs-IID as set forth in
Based on anecdotal reports, this new
section II.A. of this IFC. New section I. of this IFC. Section 1905(h) of
requirement has not significantly
§§ 483.80(i)(3)(i) through (x) specify the Act defines inpatient psychiatric
increased vaccination among ICFs-IID
these required minimum components of hospital services for individuals under
staff. We conclude that additional
the facility’s policies and procedures. 21 as any inpatient facility that the
regulatory action is necessary to achieve
Secretary has prescribed in regulations
2. Intermediate Care Facilities for widespread vaccination among ICFs-IID
that in the case of any individual
Individuals With Intellectual staff to protect ICFs-IID clients.
involve active treatment which meets
Disabilities (ICFs-IID) For these reasons and the reasons set such standards as may be prescribed in
ICFs-IID are residential facilities that forth in section II.A. of this IFC, we are regulations by the Secretary.
provide services for people with adding a new regulatory requirement at Implementing essential infection control
intellectual disabilities. ICF–IID clients § 483.430(g) related to establishing and practices, including vaccination, is a
with certain underlying medical or implementing policies and procedures basic infection control treatment
psychiatric conditions may be at for COVID–19 vaccination of all staff standard.
increased risk of serious illness from (includes employees; licensed For these reasons and the reasons set
COVID–19.162 On March 2, 2021, CDC practitioner; students, trainees, and forth in section II.A. of this IFC, we are
issued Interim Considerations for volunteers; and other individuals) who adding a new regulatory requirement at
Phased Implementation of COVID–19 provide care, treatment, or other § 441.151(c) related to establishing and
Vaccination and Sub Prioritization services for the provider or its patients. implementing policies and procedures
Among Recommended Populations, 3. Psychiatric Residential Treatment for COVID–19 vaccination of all staff
which notes that increased rates of Facilities (PRTFs) (includes employees; licensed
transmission have been observed in practitioner; students, trainees, and
these settings, and that jurisdictions PRTFs are non-hospital facilities that volunteers; and other individuals) who
may choose to prioritize vaccination of provide inpatient psychiatric services to provide care, treatment, or other
persons living in congregate settings Medicaid-eligible individuals under the services for the provider or its clients.
based on local, State, tribal, or territorial age of 21 (also called the ‘‘psych under
21 benefit’’). There are 357 PRTFs in the E. Acute Care Settings
epidemiology. CDC further notes that
congregate living facilities may choose U.S. The facilities must meet Acute care settings are those
to vaccinate residents and clients at the accreditation standards, the providers who generally provide active
same time as staff, due to numerous requirements in §§ 441.151 through care for short-term medical needs. For
factors, such as convenience or shared 441.182, and the Condition of our discussion purposes acute care
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increased risk of disease. Participation on the use of restraint and settings include: Hospitals, critical
Sections 1905(c) and (d) of the Act seclusion at § 483.350 through access hospitals (CAHs), and
gave the Secretary authority to prescribe § 483.376. ambulatory surgical centers (ASCs).
regulations for intermediate care facility 1. Hospitals
163 http://www.floridaarf.org/assets/Files/ICF-
162 https://www.cdc.gov/coronavirus/2019-ncov/ IID%20Info%20Center/ICFHandoutonWebsite2- Hospitals are large health care
need-extra-precautions/index.html. 14.pdf. providers that treat patients with acute
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61577
care needs including emergency Transplant centers, psychiatric skilled nursing care, may offer hospice
medicine, surgery, labor and delivery, hospitals, and swing beds are governed care under the Medicare hospice
cardiac care, oncology, and a wide by the infection control CoPs for benefit, and may operate a psychiatric
variety of other services. Hospitals also hospitals, and are thus subject to the and/or rehabilitation distinct part unit
administer general and specialty care staff vaccination requirements issued in of up to 10 beds each. CAHs also
that cannot safely be provided in other this IFC. We are particularly concerned administer general and specialty care
settings, under the supervision of about transplant center patients, who that cannot safely be provided in other
physicians and licensed practitioners. are among the most severely settings, under the supervision of
They may operate as independent immunocompromised individuals due physicians and licensed practitioners.
institutions or as part of a larger health to anti-rejection medications that ensure They may operate as independent
care system or learning institution. the function of transplanted organs. An institutions or as part of a larger health
Section 1861(e) of the Act provides additional member of the transplant care system. Generally, they serve to
that hospitals participating in Medicare ecosystem, Organ Procurement help ensure access to health-care
and Medicaid must meet certain Organizations (OPOs) coordinate and services in rural communities.
specified requirements, and the support donation, recovery, and Section 1820 of the Act sets forth the
Secretary may impose additional placement of organs. As OPO staff do conditions for certifying a facility as a
requirements if they are found necessary not provide patient care, and typically CAH to include meeting such other
in the interest of the health and safety work in locations removed from health criteria as the Secretary may require.
of the individuals who are furnished care facilities, we are not issuing Medicare-certified CAHs must meet the
services in hospitals. Medicare- vaccination requirements for OPOs in Conditions of Participation (CoPs) at 42
participating hospitals, which include this IFC. That said, we note that the CFR part 485 subpart F, originally
nearly all hospitals in the U.S., must vaccination policies required in this IFC issued May 26, 1993 (58 FR 30630).
meet the Conditions of Participation apply to all individuals who provide These CoPs contain specific
(CoPs) at 42 CFR part 482, originally care, treatment, or other services for the requirements for infection control and
issued June 17, 1986. In addition to hospital and/or its patients, under prevention at § 485.640. Much like a
smaller updates over the years, these contract or other arrangement. standard hospital, infection control
CoPs were reformed in 2012 (77 FR Accordingly, OPO staff members that within a CAH is especially important,
29034). Hospital CoPs identify infection provide organ transplantation services because CAHs treat individuals with
control and prevention as a basic directly to hospital and transplant infectious diseases (such as COVID–19)
hospital function and lay out specific center patients and families must meet and healthy yet higher-risk individuals
requirements at 42 CFR 482.42. the vaccination requirements of this (for example, pregnant and post-partum
Infection control within a hospital IFC. individuals, infants, transplant
campus is especially important, because For these reasons and the reasons set recipients, etc.) within the same facility.
hospitals treat individuals with forth in section II.A. of this IFC, we are While organ transplants are not
infectious diseases (such as COVID–19) adding a new regulatory requirement at performed in CAHs, we note that organ
and healthy yet higher-risk individuals § 482.42(g) related to establishing and donors may be CAH patients, and organ
(for example, pregnant and post-partum implementing policies and procedures donation and recovery may occur in
individuals, infants, transplant for COVID–19 vaccination of all staff CAHs. We note that the vaccination
recipients, etc.) within the same facility. (including employees; licensed policies required in this IFC apply to all
Hospitals that provide emergency care practitioner; students, trainees, and individuals who provide care,
must do so in accordance with the volunteers; and other individuals) who treatment, or other services for the
requirements of the Emergency Medical provide care, treatment, or other hospital and/or its patients, under
Treatment and Labor Act (EMTALA) of services for the provider or its patients. contract or other arrangement.
1986. Accordingly, OPO staff members that
Hospitals have borne the brunt of 2. Critical Access Hospitals (CAHs)
provide organ donation and
caring for patients with acute COVID–19 CAHs are rural hospitals that have transplantation services directly to CAH
during the PHE. Individuals been designated as critical access patients and families must meet the
experiencing respiratory problems, hospitals by the State, in a State that has vaccination requirements of this IFC in
cardiac events, kidney failure, and other established a State Medicare Rural the same manner as they meet such
serious effects of COVID–19 illness have Hospital Flexibility Program. These requirements for hospitals.
required in-hospital care in large hospitals have 25 or fewer acute care For these reasons and the reasons set
numbers, to the point of occupying or inpatient beds (except as permitted for forth in section II.A. of this IFC, we are
even exceeding most or all critical care CAHs having distinct part units under adding a new regulatory requirement at
or ICU capacity in a facility, city, or § 485.647, where the beds in the distinct § 485.640(f) related to establishing and
region. Despite emergency expansion of part are excluded from the 25 inpatient- implementing policies and procedures
critical care units, these waves of bed count limit specified in for COVID–19 vaccination of all staff
severely ill patients have overwhelmed § 485.620(a)), must be more than 35 (including employees; licensed
hospitals, health care systems, and the miles away from another hospital, and practitioner; students, trainees, and
professionals and other staff who work provide emergency care services 24 volunteers; and other individuals) who
in them. This has had the disastrous hours a day, 7 days a week. On average, provide care, treatment, or other
effect of limiting access and increasing acute patients stay in CAHs for less than services for the provider or its patients.
risk to both routine and emergency 96 hours. CAHs may be granted
hospital care across the U.S.164 165 166 167 approval to provide post-hospital 3. Ambulatory Surgical Centers (ASCs)
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ASCs are distinct entities that operate
164 https://www.nytimes.com/live/2021/09/23/ 166 https://www.aamc.org/news-insights/worst-
exclusively for the purpose of providing
world/covid-delta-variant-vaccine#covid-alaska- surge-we-ve-seen-some-hospitals-delta-hot-spots- surgical services to patients not
hospital, accessed 10/18/2021. close-breaking-point, accessed 10/18/2021.
165 https://www.healthline.com/health-news/how- 167 https://www.washingtonpost.com/health/ requiring hospitalization, and in which
surging-delta-variant-is-leading-to-rationed-care-at- 2021/08/18/covid-hospitals-delta/, accessed 10/18/ the expected duration of services would
hospitals, accessed 10/18/2021. 2021. not exceed 24 hours following an
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61578 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
admission. The surgical services of other health care organizations and extended periods of time (12–15 hours
performed in ASCs generally are facilities. per week). Because dialysis patients are
scheduled, non-life-threatening For these reasons and the reasons set not able to defer dialysis sessions, in-
procedures that can be safely performed forth in section II.A. of this IFC, we are center dialysis patients are at increased
in either a hospital setting (inpatient or adding a new regulatory requirement at risk for developing COVID–19 due in
outpatient) or in an ASC. Currently, § 416.51(c) related to establishing and part to difficulty maintaining physical
there are 6,071 Medicare-certified ASCs implementing policies and procedures distancing.169 Many ESRD patients are
in the U.S. for COVID–19 vaccination of all staff also residents of LTC facilities or other
Section 1833(i)(1)(A) of the Act (includes employees; licensed congregate living settings, which is also
authorizes the Secretary to specify those practitioner; students, trainees, and a risk factor for COVID–19.170 Further,
surgical procedures that can be volunteers; and other individuals) who individuals with kidney failure on
performed safely in an ASC. Section provide care, treatment, or other dialysis may have a higher risk of worse
1832(a)(2)(F)(i) of the Act defines an services for the provider or its patients. outcomes.171
ASC as a facility ‘‘which meets health, Dialysis health care personnel are
F. Outpatient Clinical Care & Services
safety, and other standards specified by considered a priority population for
These clinical settings provide vaccination by the Advisory Committee
the Secretary in regulations . . .’’.
necessary, ongoing care for individuals on Immunization Practices (ACIP), yet
The ASC Conditions for Coverage who need ongoing therapeutic, and in ESRD facilities are currently reporting
(CfCs) at 42 CFR part 416, subpart C, are some cases life-sustaining, care. While low COVID–19 vaccination coverage
the minimum health and safety many of these settings have been able to among ESRD facility health care
standards a center must meet to obtain provide some services safely and personnel, at less than 63 percent as of
Medicare certification. The ASC CfCs effectively via telehealth during the September 26, 2021.172 Ensuring health
were issued on August 5, 1982 (47 FR PHE, many of the services they provide care personnel have access to COVID–19
34082), and the Conditions related to require patients and clients to see staff vaccination is critical to protect both
infection control were last updated on in person. them and their medically fragile
November 18, 2008 (73 FR 68502, patients.173
68813). Section 416.51, Infection 1. End-Stage Renal Disease (ESRD)
Facilities For these reasons and the reasons set
control, requires ASCs to maintain an forth in section II.A. of this IFC, we are
infection control program that seeks to ESRD facilities provide a set of life- adding a new regulatory requirement at
minimize infections and communicable sustaining services to individuals § 494.30(b) related to establishing and
diseases. In this IFC we are adding new without kidney function, including implementing policies and procedures
§ 416.51(c) which requires ASCs to meet dialysis, medication, routine for COVID–19 vaccination of all staff
the same COVID–19 vaccination of staff evaluations and monitoring, nutritional (includes employees; licensed
requirements as those we are issuing for counselling, social support, and organ practitioner; students, trainees, and
the other providers and suppliers transplantation evaluation and referral. volunteers; and other individuals) who
identified in this rule. Section 1881(b)(1)(A) of the Act provide care, treatment, or other
During the COVID–19 pandemic and authorizes the Secretary to pay only services for the provider or its patients.
PHE, hospitals moved many non- those dialysis facilities ‘‘which meet
elective surgical procedures to ASCs such requirements as the Secretary shall 2. Community Mental Health Centers
and other outpatient settings. Such by regulation prescribe for institutional (CMHCs)
movement conserves hospital resources dialysis services and supplies . . .’’ also CMHCs are entities that meet
for treating severe COVID–19, known as CfCs. The ESRD facility CfCs applicable enrollment requirements,
performing more urgent procedures, and at 42 CFR part 494 are the minimum and applicable licensing or certification
caring for patients with more critical health and safety rules that all requirements in the State in which they
health needs. Moreover, referring Medicare- and Medicaid-certified are located. CMHCs provide the set of
patients in need of suitable procedures dialysis facilities must meet in order to mental health care services specified in
to ASCs limits the overall number of participate in the programs. The ESRD section 1913(c)(1) of the PHS Act (or, in
individuals visiting the hospital setting, CfCs were initially issued in 1976 and limited circumstances, provides for
thereby inhibiting spread of infection. were comprehensively revised in 2008 such service by contract with an
ASCs also offer an alternative setting for (73 FR 20370). There are currently 7,893 approved organization or entity).
outpatient surgery for individuals Medicare-certified ESRD facilities in the Section 4162 of the Omnibus Budget
reluctant to enter a hospital due to fears U.S., serving over 500,000 patients. Reconciliation Act of 1990 (Pub. L. 101–
of COVID–19 exposure. Based on these Routine dialysis treatments, typically 508, enacted November 5, 1990) (OBRA
and other factors, the demand for ASC delivered 3 times per week, remove 1990), which added sections 1861(ff)
services has increased.168 toxins from a patient’s blood and are and 1832(a)(2)(J) to the Act, includes
In response to the COVID–19 necessary to sustain life. Dialysis CMHCs as entities that are authorized to
pandemic, ASCs assumed new roles. treatments are most often delivered in provide partial hospitalization services
CMS’s Hospital Without Walls initiative the ESRD facility but can be performed under Part B of the Medicare program,
permitted hospitals to provide inpatient by the patients themselves at home, or
care in ASCs and other temporary sites. in the patient’s nursing facility with 169 Am J Kidney Dis. 2020 Nov;76(5):690–695.e1.
assistance. ESRD facilities serve patients doi: 10.1053/j.ajkd.2020.07.001. Epub 2020 Jul 15.
ASCs have assisted with COVID–19 170 https://www.jhunewsletter.com/article/2020/
testing. They provided staff to work in whether they are diagnosed with 09/hopkins-finds-dialysis-patients-at-greater-risk-
COVID–19 or not, and people receiving
jspears on DSK121TN23PROD with RULES2
COVID–19 hot spots. These efforts of-covid-19.
illustrate that staff and patients of ASCs dialysis cannot always be adequately 171 CJASN March 2021, 16 (3) 452–455; DOI:
distanced from one another during https://doi.org/10.2215/CJN.12360720.
regularly interact with staff and patients 172 http://www.synas.plus/nhsn/covid19/dial-
treatment. In-center dialysis precludes
vaccination-dashboard.html#anchor_1594393306.
168 https://www.beckersasc.com/asc-news/5-ways- social distancing because it involves 173 https://www.cdc.gov/vaccines/covid-19/
covid-19-affected-ascs-in-2020.html. Accessed 10/ being in close proximity (<6 feet) to planning/vaccinate-dialysis-patients-hcp.html,
17/2021. caregivers and fellow patients for accessed 09/08/2021 22:00 EDT.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61579
effective for services provided on or vaccinated against COVID–19 not only 1861(cc)(2)(J) of the Act states that the
after October 1, 1991. Section to protect themselves but to prevent the CORF must ‘‘meet such conditions of
1861(ff)(3)(B)(iv)(I) of the Act spread of COVID–19 to CMHC patients. participation as the Secretary may find
specifically requires CMHCs providing For these reasons and the reasons set necessary in the interest of the health
partial hospitalization services under forth in section II.A. of this IFC, we are and safety of individuals who are
Medicare to meet such additional adding a new regulatory requirement at furnished services by such facility,
conditions as the Secretary specifies to § 485.904(c) related to establishing and including conditions concerning
ensure the health and safety of implementing policies and procedures qualifications of personnel in these
individuals being furnished such for COVID–19 vaccination of all staff facilities.’’ Under this authority, the
services. Section 1866(e)(2) of the Act (includes employees; licensed Secretary has established in regulations,
and 42 CFR 489.2(c)(2) recognize practitioner; students, trainees, and at 42 CFR part 485, subpart B, the
CMHCs as providers of services for volunteers; and other individuals) who minimum health and safety standards a
purposes of provider agreement provide care, treatment, or other CORF must meet to obtain Medicare
requirements but only with respect to services for the provider or its patients. certification. The CORF Conditions of
providing partial hospitalization 3. Comprehensive Outpatient Participation were issued on December
services. Pursuant to 42 CFR 410.2 and Rehabilitation Facilities (CORFs) 15, 1982 (47 FR 56282). Section 485.70,
410.110, a CMHC may receive Medicare Personnel qualifications, sets forth the
payment for partial hospitalization CORFs are non-residential facilities qualifications that various personnel
services only if it demonstrates that it that are established and operated must meet, as a condition of
provides the core services identified in exclusively for the purpose of providing participation. We are adding a new
the requirements. To qualify for diagnostic, therapeutic, and restorative paragraph (n) at § 485.70 which requires
Medicare reimbursement, CMHCs must services to outpatients for the the CORF to meet the same COVID–19
comply with requirements for coverage rehabilitation of injured persons, sick
vaccination of staff requirements as
of partial hospitalization services at persons, and persons with disabilities,
those we are issuing for the other
§ 410.110 and conditions for Medicare at a single fixed location, by or under
providers and suppliers identified in
payment of partial hospitalization the supervision of a physician. In
this rule.
services at 42 CFR 424.24(e). response to the PHE, outpatient
rehabilitation facilities suspended Our rules at § 485.58(d)(4), state that
Currently there are 129 Medicare- personnel that do not meet the
certified CMHCs in the U.S. The operations, reduced their patient care
capacity, and transitioned from in- qualifications specified in § 485.70 may
Secretary has established in regulations,
person to telecommunications as able. be used by the facility in assisting
at 42 CFR part 485, subpart J, the
However, certain rehabilitation services qualified staff. We recognize this
minimum health and safety standards a
require physical contact with patients, sentence is inconsistent with newly
CMHC must meet to obtain Medicare
such as fitting or adjusting a prosthesis added § 485.70(n) which requires
certification. CMHC CoPs were issued
or assistive device and assessing vaccination of all facility staff. We also
on October 29, 2013 (78 FR 64604).
strength with manual resistance. During recognize that assisting personnel are
Section 485.904, Personnel
the pandemic, some patients in need of used by CORFs. We established our
qualifications, establishes requirements
rehabilitation chose to delay care and requirements at § 485.70 (a) through (m)
for CMHC personnel. In this IFC we are
others encountered delays in accessing to provide a role for personnel that
adding new § 485.904(c) which requires
the CMHC to meet the same COVID–19 care. These delays likely contributed to might not meet our education and
vaccination of staff requirements as increased disability or illness.174 experience qualifications. We do not
those we are issuing for the other Moreover, patients admitted to the believe that this exception for
providers and suppliers affected by this hospital have been discharged as soon employees that do not meet our
rule. as possible to provide beds for professional requirements should
CMHCs provide mental health individuals with more critical prohibit us from issuing staff
services to treat patients under the conditions, including COVID–19. For qualifications referencing infection
Medicare partial hospitalization those patients recovering from severe prevention, which we intend to apply to
program and other patients for various COVID–19 illness with long-term all personnel. Hence, we are revising
mental health conditions. Partial symptoms, prompt comprehensive § 485.58(d)(4) to state that personnel
hospitalization programs provide outpatient rehabilitation services upon that do not meet the qualifications
structured, outpatient mental health their discharge from inpatient care is specified in § 485.70(a) through (m) may
services that are more intense than necessary to restore physical and mental be used by the facility in assisting
office visits with physicians or health.175 All of these factors stress the qualified staff. However, such assisting
therapists. Patients in partial importance of rehabilitation facilities staff will not be exempt from the newly
hospitalization programs receive who are treating patients with increased added requirements in paragraph (n).
treatment for several hours during the morbidity and complex needs. CORFs As with other parallel regulations for
day, multiple days a week. In response have resumed operations and are our facilities, we are revising
to the PHE, CMHCs continued to treat providing services to an increasing § 485.58(d)(4) as previously discussed.
patients by using telecommunications, number of patients; therefore, COVID– For these reasons and the reasons set
and some centers paused their partial 19 vaccination of staff is pivotal for forth in section II.A. of this IFC, we are
hospitalization programs or reduced the inhibiting spread of infection and adding a new regulatory requirement at
frequency and duration of treatment. ensuring health and safety of patients. § 485.70(n) related to establishing and
However, many centers have begun to Currently, there are 159 Medicare- implementing policies and procedures
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see and treat patients in person again certified CORFs in the U.S. Section for COVID–19 vaccination of all staff
and have resumed their customary (includes employees; licensed
174 https://gh.bmj.com/content/bmjgh/5/5/
partial hospitalization programming practitioner; students, trainees, and
e002670.full.pdf. Accessed 9/23/2021.
schedules. With increased in-person 175 https://www.cdc.gov/mmwr/volumes/70/wr/
volunteers; and other individuals) who
services being offered in the CMHC, it mm7027a2.htm?s_cid=mm7027a2_w Accessed 9/ provide care, treatment, or other
is essential to ensure all staff are 23/2021. services for the provider or its patients.
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61580 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
4. Rural Health Clinics (RHCs) and Clinic Vaccine Distribution Program 5. Clinics, Rehabilitation Agencies, and
Federally Qualified Health Centers which strengthens COVID–19 vaccine Public Health Agencies as Providers of
(FQHCs) allocations for RHCs; (3) the Rural Outpatient Physical Therapy and
Section 1861(aa) and 1905(l)(2)(B) of Health Clinic Vaccine Confidence Speech-Language Pathology Services
the Act sets forth the RHC and FQHC Program that helps RHCs with outreach Under the authority of section 1861(p)
services covered by the Medicare efforts to improve vaccination rates in of the Act, the Secretary has established
program; section 1905(l) cross- rural areas with nearly 2,000 RHCs CoPs that clinics, rehabilitation
references the Medicare provision for across the nation participating; (4) the agencies, and public health agencies
Medicaid program purposes. The Act Health Center COVID–19 Vaccine (collectively, ‘‘organizations’’) must
requires that RHCs be located in an area Program whereby FQHCs receive direct meet when they provide outpatient
that is both rural and underserved, are allocations of vaccines; (5) the physical therapy (OPT) and speech-
not rehabilitation agencies or facilities Department of Defense (DoD) and HHS language pathology (SLP) services.
primarily for the care and treatment of partnered to provide point-of-care rapid Under section 1861(p) of the Act, the
mental diseases, and meet such other COVID–19 testing supplies to FQHCs Secretary is responsible for ensuring
requirements as the Secretary may find through the Health Center COVID–19 that the CoPs and their enforcement are
necessary in the interest of the health Testing Supply Distribution Program; adequate to protect the health and safety
and safety of the individuals who are and (6) delivery of 5.1 million adult and of individuals receiving OPT and SLP
furnished services by the clinic. 7.4 million child masks between April services from these entities. The CoPs
Likewise, 42 CFR 491.2 defines a FQHC and August 2021 to FQHCs at no cost are set forth at 42 CFR part 485, subpart
as an entity as defined in § 405.2401(b). H. Section 1861(p) of the Act describes
for subsequent distribution to patients,
The definition at § 405.2401 includes an outpatient physical therapy services to
staff, and community members. To
entity that has entered into an mean physical therapy services
implement these programs and to
agreement with CMS to meet Medicare furnished by a provider of services, a
Program requirements under § 405.2434. provide services and care, RHC/FQHC clinic, rehabilitation agency, or a public
And at 42 CFR 405.2434, the content staff must interact with patients and health agency, or by others under an
and terms of the agreement require members of the community at large. arrangement with, and under the
FQHCs to maintain compliance with Hence, a requirement for these staff to supervision of, such provider, clinic,
requirements set forth in part 491, receive COVID–19 vaccination is rehabilitation agency, or public health
except the provisions of § 491.3 necessary to assure health and safety for agency to an individual as an
Certification procedures. Conditions for the individuals residing in their outpatient. The patient must be under
certification for RHCs and Conditions of respective service areas and their the care of a physician. The term
Coverage for FQHCs are found at 42 CFR patients. ‘‘outpatient physical therapy services’’
part 491, subpart A. Currently, there are 4,933 Medicare- also includes physical therapy services
RHCs and FQHCs, as essential and Medicaid-certified RHCs and 10,384 furnished to an individual by a physical
contributors to the health care FQHCs that participate in the Medicare therapist (in the physical therapist’s
infrastructure in the U.S., provide care and Medicaid programs in the U.S. The office or the patient’s home) who meets
and services to medically underserved Conditions at 42 CFR part 491, subpart licensing and other standards prescribed
areas and populations. They play a by the Secretary in regulations, other
A are the minimum health and safety
critical role in helping to alleviate than under arrangement with and under
standards a center or clinic must meet
access to care barriers and health equity the supervision of a provider of services,
gaps in these communities. RHCs and to participate in the Medicare and
clinic, rehabilitation agency, or public
FQHCs provide primary care, diagnostic Medicaid programs. The conditions health agency. Pursuant to the statutory
laboratory, and immunization services, were issued on June 12, 1992 (57 FR requirement set out at section
and they have incorporated COVID–19 27106), and the conditions related to 1861(p)(4)(A) and (B) of the Act, the
screening, triage, testing, diagnosis, staffing and staff responsibilities were furnishing of such services by a clinic,
treatment, and vaccination into these last updated on May 12, 2014 (79 FR rehabilitation agency, or public health
services. However, the medically 27106). Section 491.8, Staffing and staff agency must meet such conditions
underserved communities in the U.S. responsibilities, establishes relating to health and safety as the
have been disproportionately affected requirements for RHC and FQHC Secretary may find necessary. The term
by COVID–19. Hence, the Health staffing and staff responsibilities. We are also includes SLP services furnished by
Resources and Services Administration adding new § 491.8(d) which requires a provider of services, a clinic,
(HRSA) has established new programs the clinic or center to meet the same rehabilitation agency, or by a public
to help RHCs and FQHCs meet the COVID–19 vaccination of staff health agency, or by others under an
needs of their communities and ensure requirements as those we are issuing for arrangement.
continuity of health care services during the other providers and suppliers Currently, there are 2,078 clinics,
the PHE.176 177 178 For example: (1) The identified in this rule. rehabilitation agencies, and public
Rural Health Clinic COVID–19 Testing health agencies that provide outpatient
For these reasons and the reasons set
and Mitigation Program which helps physical therapy and speech-language
forth in section II.A. of this IFC, we are services. In the remainder of this rule
RHCs with COVID–19 testing and
mitigation strategies to prevent the adding a new regulatory requirement at and throughout the requirements, we
spread of infection; (2) the Rural Health § 491.8(d) related to establishing and use the term ‘‘organizations’’ instead of
implementing policies and procedures ‘‘clinics, rehabilitation agencies, and
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176 https://www.hrsa.gov/coronavirus/rural- for COVID–19 vaccination of all staff public health agencies as providers of
health-clinics. Accessed 9/24/2021. (includes employees; licensed outpatient physical therapy and speech-
177 https://bphc.hrsa.gov/emergency-response/
practitioner; students, trainees, and language pathology services’’ for
coronavirus-frequently-asked-questions. Accessed
9/24/2021.
volunteers; and other individuals) who consistency with current regulatory
178 https://www.hrsa.gov/coronavirus/health- provide care, treatment, or other language. Patients receive services from
center-program. Accessed 10/6/2021. services for the provider or its patients. organizations due to loss of functional
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61581
ability associated with injury or illness. provide care, treatment, or other Secretary may find necessary in the
Hence, these patients experience services for the provider or its patients. interest of the health and safety of
episodic issues and seek care to restore individuals who are furnished services
G. Home-Based Care
their level of functioning and wellness by such agency or organization.’’ The
to baseline. In response to the PHE, Home-based care providers provide CoPs for home health services are found
organizations experienced a reduction necessary care and services for in Title 42, Part 484, subparts A through
in patients. They supplemented in- individuals who need ongoing C, §§ 484.40 through 484.115. HHAs
person care with telecommunications. therapeutic, and in some cases life- provide care and services for qualifying
However, just over 50 percent of sustaining, care. These settings require older adults and people with disabilities
physical therapists report in-person care that health care staff enter the patient’s who are beneficiaries under the Hospital
results in better outcomes than care personal home (regardless of location in Insurance (Part A) and Supplemental
provided virtually and the majority of a private home, assisted living facility, Medical Insurance (Part B) benefits of
patients are less satisfied with care or another setting) to provide services the Medicare program. These services
received by telecommunications.179 and care in person, thus exposing include skilled nursing care, physical,
Although the data is limited, we believe patients and other members of their occupational, and speech therapy,
these findings are consistent with other household, to the staff. Home-based medical social work and home health
therapeutic services including provider staff also often serve multiple aide services which must be furnished
occupational therapy and speech patients in different homes in the same by, or under arrangement with, an HHA
pathology. Comprehensive assessment day, week, or month, which presents that participates in the Medicare
of balance, strength, range-of-motion, opportunities for transmission of program and must be provided in the
and proper exercise technique is infectious diseases across households. beneficiary’s home. As of September 1,
supported by physical touch, and three- Because home-based providers work 2021, there were 11,649 HHAs
dimensional visualization of the patient. outside of a regulated health care participating in the Medicare program.
Organizations have begun seeing more facility, there is also the potential for The majority of HHAs are for-profit,
patients, and those patients are staff to either not use the appropriate privately owned agencies. The effective
presenting with more severe functional PPE or use it improperly because on-site delivery of quality home health services
issues. Organizations care for patients oversight mechanisms are not in place, is essential to the care of the HHA’s
recovering from COVID–19 and those that could increase the risk of patients to provide necessary care and
transmission of COVID–19 or other services and prevent hospitalizations.
who delayed receiving non-COVID–19
infectious diseases across households. Since patients and other members of
related care due to fears of exposure to
We also believe these patients are their households will be exposed to
illness after the onset of the pandemic.
especially vulnerable to COVID–19 due HHA staff, it is essential that staff be
These factors underscore the need to
to receiving care in their homes. Many vaccinated against COVID–19 for the
ensure safety and health of individuals
patients have serious illnesses that safety of the patients, members of their
who receive care from organizations
increases the risk of morbidity and households, and the staff themselves.
with a requirement for COVID–19
mortality from COVID–19. For hospice With so many patients depending on
vaccination of staff.
patients that are receiving non-curative the services of HHAs nationwide, it is
The CoPs for organizations at 42 CFR but supportive care, we are concerned imperative that HHAs have processes in
part 485, subpart H are the minimum that contracting COVID–19 could place to address the safety of patients
health and safety standards an increase their discomfort, decrease their and staff and the continued provision of
organization must meet to obtain quality of life, or perhaps even hasten services. Because these patients are at
Medicare certification. The CoPs were their death. In addition, the patients’ home, essential care must be provided,
first issued May 21, 1976 (41 FR 20863), homes may have poor ventilation or regardless of COVID–19 vaccination or
and the Conditions related to infection members of the household may not be infection status. In addition, by going
control were last updated on September complying with recommended safety into patients’ homes, HHA employees
29, 1995 (60 FR 50446). Section precautions. Thus, COVID–19 are exposed to numerous individuals
485.725, Infection control, requires vaccination mandates will provide who might not be vaccinated or perhaps
organizations to establish an infection- patients and their household members are asymptomatic but infected.
control committee with responsibility with safety assurances that will Therefore, it is imperative that HHAs
for overall infection control. We are facilitate acceptance of home care have appropriate procedures to ensure
adding new paragraph (f) to § 485.725, services, and will protect the patients, the continued provision of care and
which requires the organizations to staff, and the other members of the services for their patients. Section
meet the same COVID–19 vaccination of patients’ households. 484.70 Condition of participation:
staff requirements as those we are Infection prevention and control (a)
issuing for the other providers and 1. Home Health Agencies (HHAs)
requires that the ‘‘HHA must follow
suppliers identified in this rule. Under the authority of sections accepted standards of practice,
For these reasons and the reasons set 1861(m), 1861(o), and 1891 of the Act, including the use of standard
forth in section II.A. of this IFC, we are the Secretary has established in precautions, to prevent the transmission
adding a new regulatory requirement at regulations the requirements that a of infections and communicable
§ 485.725(f) related to establishing and home health agency (HHA) must meet to diseases.’’
implementing policies and procedures participate in the Medicare program, our For these reasons and the reasons set
for COVID–19 vaccination of all staff regulations at 42 CFR 440.70(d) require forth in section II.A. of this IFC, we are
that Medicaid-participating home health adding a new regulatory requirement at
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(includes employees; licensed
practitioner; students, trainees, and agencies meet Medicare conditions of § 484.70(d) related to establishing and
volunteers; and other individuals) who participation. Section 1861(o)(6) of the implementing policies and procedures
Act requires that home health agencies for COVID–19 vaccination of all staff
179 American Physical Therapy Association. May ‘‘meet the conditions of participation (includes employees; licensed
2021. Impact of COVID–19 on the Physical Therapy specified in section 1891(a) and such practitioner; students, trainees, and
Profession Over One Year. other conditions of participation as the volunteers; and other individuals) who
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61582 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
provide care, treatment, or other individual during the final days, weeks, needed to perform home infusion
services for the provider or its patients. or months of a terminal illness. include the drug (for example, immune
Contracting any infectious disease, globulin), equipment (a pump), and
2. Hospice
especially COVID–19, could result in supplies (for example, tubing and
Section 122 of the Tax Equity and additional pain or perhaps even catheters) which are covered under the
Fiscal Responsibility Act of 1982 (Pub. accelerate a patient’s death. Thus, it is Durable Medical Equipment benefit.
L. 97–248, enacted September 3. 1982) critical that hospices protect patients Skilled professional visits, such as those
(TEFRA), added section 1861(dd) to the and staff from contracting or from nurses, often play a critical role in
Act to provide coverage for hospice care transmitting COVID–19. As of the provision of home infusion and are
to terminally ill Medicare beneficiaries September 1, 2021, there were 5,556 covered under the home infusion
who elect to receive care from a hospices. Section 418.60(a), Condition therapy benefit. For example, nurses
Medicare-participating hospice. Under of participation: Infection Control, typically train the patient or caregiver to
the authority of section 1861(dd) of the requires that the ‘‘hospice must follow self-administer the drug, educate on
Act, the Secretary has established the accepted standards of practice to side effects and goals of therapy, and
CoPs that a hospice must meet in order prevent the transmission of infections visit periodically to provide catheter
to participate in Medicare and and communicable disease, including and site care. Depending on patient
Medicaid. Under section 1861(dd)(2)(G) the use of standard precautions.’’ acuity or the complexity of the drug
of the Act, the Secretary may impose The effective delivery of hospice administration, certain skilled
‘‘such requirements as the Secretary services is essential to the care of the professional visits may require more
may find necessary in the interest of the hospice’s patients and their families and time. The HIT infusion process typically
health and safety of the individuals who caregivers. Since patients and other requires coordination among multiple
are provided care and services by such members of their households will be entities, including patients, the
agency or organization.’’ The CoPs exposed to hospice staff, it is essential responsible physicians and
found at part 418, subparts C and D that staff be vaccinated against COVID– practitioners, hospital discharge
apply to a hospice, as well as to the 19 for the safety of the patients, planners, pharmacies, and, if applicable,
services furnished to each patient under members of their households, and the home health agencies.
hospice care. These requirements are set staff themselves. The current requirements for HIT
forth in §§ 418.52 through 418.116. For these reasons and the reasons set suppliers do not contain specific
Hospice care provides palliative care forth in section II.A. of this IFC, we are infection prevention and control
rather than curative treatment to adding a new regulatory requirement at requirements. However, § 486.525,
terminally ill patients. Palliative care § 418.60(d) related to establishing and Required services, does state that these
improves the quality of life of patients implementing policies and procedures providers must ‘‘provide home infusion
and their families and caregivers facing for COVID–19 vaccination of all staff therapy services in accordance with
the challenges associated with terminal (including employees; licensed nationally recognized standards of
illness through the prevention and relief practitioner; students, trainees, and practice, and in accordance with all
of suffering by means of early volunteers; and other individuals) who applicable state and federal laws and
identification, assessment, and provide care, treatment, or other regulations.’’ We believe that
treatment of pain and other issues. services for the provider or its patients. ‘‘nationally recognized standards of
Hospice care allows the patient to practice’’ include appropriate policies
remain at home by providing support to 3. Home Infusion Therapy Suppliers
(HIT) Suppliers and procedures for infection prevention
the patient and family and caregiver and and control.
by keeping the patient as comfortable as Section 5012 of the 21st Century For these reasons and the reasons set
possible while maintaining his or her Cures Act (Pub. L. 114–255, enacted forth in section II.A. of this IFC, we are
dignity and quality of life. Hospices use December 13, 2016) (Cures Act) created adding a new regulatory requirement at
an interdisciplinary approach to deliver a separate Medicare Part B benefit § 486.525(c) related to establishing and
medical, social, physical, emotional, category under 1861(s)(2)(GG) of the Act implementing policies and procedures
and spiritual services through the use of for coverage of home infusion therapy- for COVID–19 vaccination of all staff
a broad spectrum of support. associated professional services for (includes employees; licensed
Hospices are unique health care certain drugs and biologicals practitioner; students, trainees, and
providers because they serve patients, administered intravenously or volunteers; and other individuals) who
families, and caregivers in a wide subcutaneously for periods of 15 provide care, treatment, or other
variety of settings. Hospice patients may minutes or more in the patient’s home services for the provider or its patients.
be served in their place of residence, through a pump that is an item of
whether that residence is a private durable medical equipment. Section 4. Programs of All-Inclusive Care for the
home, an LTC facility, an assisted living 1861(iii)(3)(D)(i)(IV) of the Act requires Elderly (PACE) Organizations
facility, or even a recreational vehicle, qualified home infusion therapy (HIT) The Programs of All-Inclusive Care for
as long as such locations are determined suppliers to meet, in addition to the Elderly (PACE) program provides a
to be the patient’s place of residence. specified qualifications, ‘‘such other model of managed care service delivery
Hospice patients may also be served in requirements as the Secretary for frail older adults, most of whom are
inpatient facilities, including those determines appropriate.’’ The regulatory dually eligible for Medicare and
operated by the hospice itself. requirements for home therapy infusion Medicaid benefits, and all of whom are
With so many patients depending on (HIT) suppliers are located at 42 CFR assessed as being eligible for LTC
the services of hospice services part 486, subpart I, §§ 486.500 through facility placement according to the
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nationwide, it is imperative that 486.525. Medicaid standards established by their
hospices have processes in place to The nature of the home setting respective states. PACE organizations
address the safety of patients and staff presents different challenges than in- furnish comprehensive medical, health,
and the continued provision of services. center services as well as the and social services that integrate acute
The goal of hospice care is to provide administration of the particular and long-term care, and these services
non-curative, but supportive care of an medications. The items and equipment must be furnished in at least the PACE
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61583
center, the home, and inpatient a notice of the proposed rule in the Medicaid-certified providers and
facilities. The PACE model involves a Federal Register that includes a suppliers, particularly given the advent
multidisciplinary team of providers reference to the legal authority under of the Delta variant and the potential for
known as the interdisciplinary team which the rule is proposed, and the new variants.
(IDT) that comprehensively assesses and terms and substance of the proposed As discussed throughout the preamble
meets the needs of each PACE rule or a description of the subjects and of this IFC, the PHE continues to strain
participant by planning and issues involved. Section 553(c) further the U.S. health care system. Over the
coordinating all participant care. PACE requires the agency to give interested first 6 months of 2021, COVID–19 cases,
organizations must provide all parties the opportunity to participate in hospitalizations and deaths declined.
Medicare-covered items and services, all the rulemaking through public comment The emergence of the Delta variant
Medicaid-covered items and services, before the provisions of the rule take reversed these trends.180 Between late
and any other services determined effect. Similarly, section 1871(b)(1) of June 2021 and September 2021, daily
necessary by the IDT to improve and the Act requires the Secretary to provide cases of COVID–19 increased over 1200
maintain the participant’s overall health for notice of the proposed rule in the percent; new hospital admissions, over
status, either directly or under contract Federal Register and a period of not less 600 percent; and daily deaths, by nearly
with third party service providers. than 60 days for public comment. 800 percent.181 Available data also
The statutory authorities that permit Section 553(b)(B) of the APA and continue to suggest that the majority of
Medicare payments and coverage of section 1871(b)(2)(C) of the Act COVID–19 cases and hospitalizations
benefits under the PACE program, as authorize the agency to waive these are occurring among individuals who
well as the establishment of PACE procedures, however, if the agency finds are not fully vaccinated. From January
organizations as a State option under good cause that notice and comment through May 2021, of the more than
Medicaid to provide for Medicaid procedures are impracticable, 32,000 laboratory-confirmed COVID–19-
payments and coverage of benefits unnecessary, or contrary to the public associated hospitalizations in adults
under the PACE program, are under interest and incorporates a statement of over 18 years of age for whom
sections 1894 and 1934 of the Act. the finding and its reasons in the rule vaccination status is known, less than 3
These statutory authorities are issued. percent of hospitalizations occurred in
implemented at 42 CFR part 460, where The 2021 outbreaks associated with fully vaccinated persons.182 More
CMS has set out the minimum the SARS–Cov–2 Delta variant have recently published data continue to
requirements an entity must meet to shown that current levels of COVID–19
suggest that fully vaccinated persons
operate a PACE program under vaccination coverage up until now have
account for a minority (∼10 percent) of
Medicare and Medicaid. been inadequate to protect health care
There are 141 PACE organizations COVID–19 related hospitalizations.183
consumers and staff. The data showing
nationally. These organizations serve For all adults aged 18 years and older,
the vital importance of vaccination
approximately 52,000 participants, all the cumulative COVID–19-associated
indicate to us that we cannot delay
in need of the comprehensive services hospitalization rate was about 12-times
taking this action in order to protect the
provided by PACE organizations. Due to higher in unvaccinated persons.184
health and safety of millions of people
their health status, PACE participants Consequently, some hospitals and
receiving critical health care services,
are at high risk of severe COVID–19 and health care systems are currently
the workers providing care, and our
as such have been among the fellow citizens living and working in experiencing tremendous strain due to
populations prioritized for vaccination communities across the nation. high case volume coupled with
since the vaccines were authorized. Although section 564 of the FDCA persistent staffing shortages due, at least
Participants’ regular interactions with does not prohibit public or private in part, to COVID–19 infection or
PACE organization staff and contractors entities from imposing vaccination quarantine following exposure.
indicate that those staff and contractors requirements, even when the only We recognize that newly reported
should also be vaccinated against vaccines available are those authorized COVID–19 cases, hospitalizations, and
COVID–19. under EUAs (https://www.justice.gov/ deaths have begun to trend downward
For these reasons and the reasons set olc/file/1415446/download), CMS at a national level; nonetheless, they
forth in section II.A. of this IFC, we are initially chose, among other actions, to remain substantially elevated relative to
adding new regulatory requirements at encourage rather than mandate numbers seen in May and June 2021,
§ 460.74(d) related to establishing and vaccination, believing that a when the Delta variant became the
implementing policies and procedures combination of other Federal actions, a predominant strain circulating in the
for COVID–19 vaccination of all staff variety of public education campaigns, U.S.185 And while cases are trending
(includes employees; licensed and State and employer-based efforts
practitioner; students, trainees, and would be adequate. However, despite all 180 https://emergency.cdc.gov/han/2021/
volunteers; and other individuals) who of these efforts, including CMS’s han00447.asp.
181 Internal estimates based on data published at
provide care, treatment, or other mandate for vaccination education and
https://www.cdc.gov/coronavirus/2019-ncov/covid-
services on behalf of a PACE offering of vaccines to LTC facility and data/covidview/index.html; accessed September 24,
organization. ICF–IID staff, residents, and clients (86 2021.
FR 26306), OSHA’s June 21, 2021 ETS 182 https://www.cdc.gov/coronavirus/2019-ncov/
III. Waiver of Proposed Rulemaking to protect health care and health care science/science-briefs/fully-vaccinated-people.html
We ordinarily publish a notice of https://www.cdc.gov/coronavirus/2019-ncov/
support service workers from science/science-briefs/fully-vaccinated-people.html,
proposed rulemaking in the Federal occupational exposure to COVID–19 (86 accessed October 18, 2021.
Register and invite public comment on FR 3276), and ongoing CDC information
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183 https://www.cdc.gov/mmwr/volumes/70/wr/
the proposed rule before the provisions and encouragement, vaccine uptake mm7037e1.htm?s_cid=mm7037e1_w, accessed
of the rule take effect, in accordance among health care staff has not been as October 18, 2021.
184 https://covid.cdc.gov/covid-data-tracker/
with the Administrative Procedure Act robust as hoped for and have been
#covidnet-hospitalizations-vaccination, accessed
(APA), 5 U.S.C. 553, and section 1871 insufficient to protect the health and October 18, 2021.
of the Act. Specifically, section 553(b) of safety of individuals receiving health 185 https://covid.cdc.gov/covid-data-tracker/
the APA requires the agency to publish care services from Medicare- and #datatracker-home.
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61584 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
downward in some states, there are more infectious and has greater rates of achieve sufficiently high levels of
emerging indications of potential mortality, hospitalizations, and severe vaccination based on voluntary efforts
increases in others—particularly illness than influenza. Accordingly, it is and patchwork requirements; ongoing
northern states where the weather has imperative that the risk for healthcare- risk of new COVID–19 variants;
begun to turn colder. This is not associated COVID–19 transmission be potential harmful impact of
surprising: Respiratory virus infections minimized during the influenza season. unvaccinated healthcare workers on
typically circulate more frequently Influenza is most common during the patients; continuing strain on the health
during the winter months, with peaks in fall and winter with the highest care system, particularly from Delta-
pneumonia and influenza deaths incidence of cases reported between variant-driven surging case counts
typically during winter months.186 December through March.194 COVID–19 beginning in summer 2021;
Similarly, the U.S. experienced a large vaccines require time after demonstrated efficacy, safety and real-
COVID–19 wave in the winter of 2020. administration for the body to build an world effectiveness of available
Approximately 1 in 3 people 12 years of immune response. Hence, given that the vaccines; FDA’s full licensure of the
age and older in the U.S. remain influenza season is imminent, a staff Pfizer-BioNTech’s Comirnaty vaccine;
unvaccinated—and they could pose a COVID–19 vaccination requirement for our observations of the efficacy of
threat to the country’s progress on the the providers and suppliers identified in COVID–19 vaccine mandates in other
COVID–19 pandemic, potentially this rule cannot be further delayed. The settings; and the calls from numerous
incurring a fifth wave of COVID–19 impact of unvaccinated populations on stakeholders for Federal intervention.
infections.187 the health-care system and the Moreover, a further delay in imposing a
The onset of the 2021–2022 influenza inconsistent web of State, local, and vaccine mandate would endanger the
season presents an additional threat to employer COVID–19 vaccination health and safety of additional patients
patient health and safety. Although requirements have established a and be contrary to the public interest.
influenza activity during the 2020–2021 pressing need for a consistent Federal We note that health care workers were
season was low throughout the U.S.,188 policy mandating staff vaccination in among the first groups provided access
the intensity of the upcoming 2021– health care settings that receive to vaccinations, which were initially
2022 influenza season cannot be Medicare and Medicaid funds. The authorized for emergency use. EUA
predicted. Several factors could make current patchwork of regulations
status may have been a factor in some
this flu season more severe; these undermines the efficacy of COVID–19
individual decisions to delay or refuse
include return to school by children vaccine mandates by encouraging
vaccination. The Pfizer-BioNTech
with no prior exposure to flu (and unvaccinated workers to seek
COVID–19 vaccine was first authorized
therefor lower immunity), waning employment at providers that do not
for emergency use on December 11,
protection over time from previous have such patient protections,
2020. The vaccine continues to be
seasonal influenza vaccination, and the exacerbating staffing shortages, and
available in the U.S. under EUA, and
fact that adult immunity (especially creating disparities in care across
the EUA was subsequently amended to
among those who were not vaccinated populations. This includes workers
include use in individuals 12 through
last season) will now partly depend on moving between various types of
providers, such as from LTC facilities to 15 years of age, to allow for the use of
exposure to viruses two or more seasons an additional dose in the primary series
earlier.189 190 COVID–19 vaccination HHAs and others, creating imbalances.
As discussed in section I. of this IFC, we for certain immunocompromised
thus remains an important tool for individuals, and to allow for use of a
decreasing stress on the U.S. health care have received numerous requests from
diverse stakeholders for Federal single booster dose to be administered at
system during ongoing circulation of least 6 months after completion of the
influenza. As previously noted, health intervention to implement a health-care
staff vaccine mandate.195 Of particular primary series in certain individuals.
system strain can adversely impact FDA has issued EUAs for two additional
patient access to care and care quality. note, several representatives of the long-
term care community (not limited to vaccines for the prevention of COVID–
Furthermore, data on the health 19, one to Moderna (December 18, 2020)
consequences of coinfection with Medicare- and Medicaid-certified LTC
facilities) expressed concerns about (indicated for use by individuals 18
influenza and SARS–CoV–2 are limited. years of age and older), and the other to
Preliminary evidence suggests that a inequities that would result from
imposition of a mandate on only one Janssen (Johnson & Johnson) (February
combination of infections with 27, 2021) (indicated for use by
influenza and SARS–CoV–2 would type of provider and strongly
recommended a broad approach.196 individuals 18 years of age and older).
result in more severe health outcomes Fact sheets for health care providers
for patients than either infection While there is opposition to the vaccine
mandate, a combination of factors now administering vaccine are available for
alone.191 192 193 However, COVID–19 is each vaccine product from FDA.
have persuaded us that a vaccine
186 https://www.cdc.gov/flu/professionals/acip/ mandate for health care workers is an However, on August 23, 2021, FDA
background-epidemiology.htm. essential component of the nation’s licensed Pfizer-BioNTech’s Comirnaty
187 Ibid.
COVID–19 response, the delay of which Vaccine. Health care workers whose
188 CDC. FluView. Weekly influenza surveillance
would contribute to additional negative hesitancy was related to EUA status
report. Atlanta, GA: U.S. Department of Health and
health outcomes for patients including now have a fully licensed COVID–19
Human Services, CDC. Accessed February 11, 2021. vaccine option. Despite this, as noted
https://www.cdc.gov/flu/weekly/index.htm. loss of life. These include, but are not
189 https://www.medrxiv.org/content/10.1101/ limited to, the following: Failure to earlier, health care staff vaccination
2021.08.29.21262803v1. rates remain sub-optimal in too many
health care facilities and regions. For
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190 https://www.cdc.gov/mmwr/volumes/70/wr/ 194 Ibid.
mm7029a1.htm. 195 https://www.aamc.org/news-insights/press- example, national COVID–19
191 https://academic.oup.com/cid/article/72/12/
releases/major-health-care-professional- vaccination rates for LTC facility,
e993/6024509?login=true. organizations-call-covid-19-vaccine-mandates-all-
192 https://onlinelibrary.wiley.com/doi/epdf/
hospital, and ESRD facility staff are 67
health-workers. Accessed 10/06/2021.
10.1002/jmv.26163. 196 https://www.kff.org/coronavirus-covid-19/poll- percent, 64 percent, and 60 percent,
193 https://www.cdc.gov/flu/about/season/flu- finding/kff-covid-19-vaccine-monitor-september- respectively. Moreover, these averages
season.htm. 2021/. Accessed 10/06/2021. obscure sizeable regional differences.
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LTC facility staff vaccination rates range among LTC facility residents are higher outcomes including hospitalization and
from lows of 56 percent to highs of over in facilities with lower vaccination death. The ASPE analysis of individual-
90 percent, depending upon the State. coverage among staff; specifically, level health data and county-level
Similar patterns hold for ESRD facility residents of LTC facilities in which vaccination rates found that higher
and hospital staff.197 198 199 vaccination coverage of staff is 75 county vaccination rates were
Over half a million COVID–19 cases percent or lower experience higher associated with significant reductions in
and 1,900 deaths among health care staff crude rates of preventable SARS–CoV– the odds of COVID–19 infection,
have been reported to CDC since the 2 infection.206 Similarly, several articles hospitalization, and death among
start of the PHE.200 When submitting published in CDC’s Morbidity and Medicare fee-for-service (FFS)
case-level COVID–19 reports, State and Mortality Weekly Reports (MMWRs)
beneficiaries between January and May
territorial jurisdictions may identify regarding nursing home outbreaks have
whether individuals are or are not 2021. Further, comparing the rates of
also linked the spread of COVID–19
health care workers. Since health care infection to unvaccinated health care these outcomes to what ASPE modeling
worker status has only been reported for workers and stressed that maintaining a predicted would have happened
a minority of cases (approximately 18 high vaccination rate is important for without any vaccinations, we estimate
percent), these numbers are likely gross reducing transmission.207 208 209 And COVID–19 vaccinations were linked to
underestimates of true burden in this multiple studies have demonstrated estimated reductions of approximately
population. COVID–19 case rates among SARS–CoV–2 transmissions between 107,000 infections, 43,000
staff have also grown in tandem with health-care workers and patients in hospitalizations, and 16,000 deaths in
broader national incidence trends since hospitals, despite universal masking our study sample of 25.3 million
the Delta variant’s emergence. For and other protocols.210 211 212 213 Acute beneficiaries. The report also noted that
example, as of mid-September 2021, and LTC facilities engage many, if not the difference in vaccination rates for
COVID–19 cases among LTC facility and all, of the same health care professionals those age 65 and older between the
ESRD facility staff have increased by and support services of other provider lowest (34 percent) and highest (85
over 1400 percent and 850 percent, and supplier types. As a result, while percent) counties and states by the end
respectively, since their lows in June similarly comprehensive data are not of May highlights the continued
2021.201 Similarly, the number of cases available for all Medicare- and opportunity to leverage COVID–19
among staff for whom case-level data Medicaid-certified provider and vaccinations to prevent COVID–19
were reported by State and territorial supplier types, we believe the LTC hospitalizations and deaths.215 Vaccines
jurisdictions to CDC increased by nearly facilities experience may generally be continue to be effective in preventing
600 percent between June and August extrapolated to other settings. COVID–19 associated with the now-
2021.202 Because they are at greater risk The efficacy of COVID–19
dominant Delta variant.216 217
for developing COVID–19 infection and vaccinations has been demonstrated.214
severe disease,203 204 205 unvaccinated An ASPE report published on October 5, In addition to preventing morbidity
staff present a risk of exacerbating 2021, found that COVID–19 vaccines are and mortality associated with COVID–
ongoing staffing shortages—particularly a key component in controlling the 19, the vaccines also appear to be
during periods of community surges in COVID–19 pandemic. Clinical data effective against asymptomatic SARS–
SARS–CoV–2 infection, when demand show vaccines are highly effective in CoV–2 infection. A recent study of
for health care services is most acute. preventing COVID–19 cases and severe health care workers in 8 states found
Health care staff who remain that, between December 14, 2020,
unvaccinated may also pose a direct 206 https://emergency.cdc.gov/han/2021/
through August 14, 2021, full
threat to patient, resident, workplace, han00447.asp.
207 COVID–19 Outbreak Associated with a SARS–
vaccination with COVID–19 vaccines
family, and community safety and was 80 percent effective in preventing
CoV–2 R.1 Lineage Variant in a Skilled Nursing
population health. Data from CDC’s Facility After Vaccination Program—Kentucky, RT–PCR–confirmed SARS–CoV–2
National Healthcare Safety Network March 2021.’’ April 21, 2021. Available at https:// infection among frontline workers.218
(NHSN) have shown that case rates www.cdc.gov/mmwr/volumes/70/wr/
Emerging evidence also suggests that
mm7017e2.htm.
197 LTC facility rates derived from data reported
208 Postvaccination SARS–CoV–2 Infections vaccinated people who become infected
through CDC’s NHSN and posted online at the
Among Skilled Nursing Facility Residents and Staff with Delta have potential to be less
Members—Chicago, Illinois, December 2020–March infectious than infected unvaccinated
Nursing Home COVID–19 Vaccination Data
2021.’’ April 30, 2021. Available at https://
Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-
www.cdc.gov/mmwr/volumes/70/wr/ people, thus decreasing transmission
vaccination-dashboard.html; accessed September
15, 2021.
mm7017e1.htm. risk.219 For example, in a study of
198 Dialysis facility rates derived from data
209 Effectiveness of the Pfizer-BioNTech COVID–
breakthrough infections among health
19 Vaccine Among Residents of Two Skilled
reported through CDC’s NHSN and posted online at Nursing Facilities Experiencing COVID–19
care workers in the Netherlands, SARS–
the Dialysis COVID–19 Vaccination Data Outbreaks—Connecticut, December 2020–February CoV–2 infectious virus shedding was
Dashboard: https://www.cdc.gov/nhsn/covid19/
dial-vaccination-dashboard.html; accessed
2021.’’ March 19, 2021. Available at https:// lower among vaccinated individuals
www.cdc.gov/mmwr/volumes/70/wr/ with breakthrough infections than
September 15, 2021. mm7011e3.htm.
199 Hospital data come from unpublished analyses
210 Klompas M, Baker MA, Griesbach D, et al.
of data reported to HHS and posted on HHS Protect. Transmission of SARS–CoV–2 from asymptomatic 215 https://aspe.hhs.gov/sites/default/files/
200 https://covid.cdc.gov/covid-data-tracker/
and presymptomatic individuals in healthcare documents/c5d0dde224c224dd726694367846b609/
#health-care-personnel; accessed September 24, settings despite medical masks and eye protection. aspe-covid-medicare-vaccine-analysis.pdf.
2021. Clin Infect Dis. 2021. [PMID: 33704451] Accessed 10/06/2021.
201 Analysis of dialysis facility and nursing home doi:10.1093/cid/ciab218. 216 https://www.nejm.org/doi/full/10.1056/
jspears on DSK121TN23PROD with RULES2
data reported through NHSN. 211 https://www.medrxiv.org/content/10.1101/ nejmoa2108891.
202 Ibid. 110. 2021.02.16.21251625v1. 217 https://www.mayoclinic.org/coronavirus-
203 https://www.cdc.gov/coronavirus/2019-ncov/ 212 https://jamanetwork.com/journals/jama/ covid-19/covid-variant-vaccine.
science/science-briefs/fully-vaccinated-people.html. fullarticle/2773128. 218 https://www.cdc.gov/mmwr/volumes/70/wr/
204 https://www.cdc.gov/mmwr/volumes/70/wr/ 213 https://www.ncbi.nlm.nih.gov/pmc/articles/ mm7034e4.htm?s_cid=mm7034e4_w.
mm7037e1.htm?s_cid=mm7037e1_w. PMC8349432/. 219 https://www.cdc.gov/coronavirus/2019-ncov/
205 https://www.cdc.gov/mmwr/volumes/70/wr/ 214 https://www.cdc.gov/coronavirus/2019-ncov/ science/science-briefs/fully-vaccinated-
mm7034e4.htm?s_cid=mm7034e4_w. science/science-briefs/fully-vaccinated-people.html. people.html#ref43.
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among unvaccinated individuals with section 801 of the CRA. Therefore, we • The need for the information
primary infections.220 find there is good cause to waive the collection and its usefulness in carrying
As noted earlier in this section, a CRA’s delay in effective date pursuant out the proper functions of our agency.
combination of factors, including but to section 808(2) of the CRA. • The accuracy of our estimate of the
not limited to failure to achieve information collection burden.
IV. Collection of Information • The quality, utility, and clarity of
sufficiently high levels of vaccination
Requirements the information to be collected.
based on voluntary efforts and
patchwork requirements, potential harm Under the Paperwork Reduction Act • Recommendations to minimize the
to patients from unvaccinated health- of 1995 (PRA), we are required to information collection burden on the
care workers, and continuing strain on provide 30-day notice in the Federal affected public, including automated
the health care system and known Register and solicit public comment collection techniques.
efficacy and safety of available vaccines, We are soliciting public comment on
before a collection of information
have persuaded us that a vaccine each of these issues for the following
requirement (ICR) is submitted to the
mandate for health care workers is an sections of this document that contain
Office of Management and Budget
essential component of the nation’s information collection requirements
(OMB) for review and approval. The
COVID–19 response. Further, it would (ICRs):
ICRs in this section will be included in
endanger the health and safety of For the estimated costs contained in
an emergency revision of the the analysis below, we used data from
patients, and be contrary to the public information collection request currently
interest to delay imposing it. Therefore, the U.S. Bureau of Labor Statistics (BLS)
approved under the appropriate OMB to determine the mean hourly wage for
we believe it would be impracticable Control number. All PRA-related
and contrary to the public interest for us the positions used in this analysis.221
comments received in response to this For the total hourly cost, we doubled
to undertake normal notice and IFC will be reviewed and addressed in
comment procedures and to thereby the mean hourly wage for a 100 percent
a subsequent, non-emergency, increase to cover overhead and fringe
delay the effective date of this IFC. We
submission of the information collection benefits, according to standard HHS
find good cause to waive notice of
request. The emergency approval is only estimating procedures. If the total cost
proposed rulemaking under the APA, 5
valid for 6 months. Within that 6-month after doubling resulted in 0.50 or more,
U.S.C. 553(b)(B), and section
approval period, CMS will seek a the cost was rounded up to the next
1871(b)(2)(C) of the Act. For those same
regular, non-emergency, approval and as dollar. If it was 0.49 or below, the total
reasons, as authorized by the Small
required by the PRA, this action will be cost was rounded down to the next
Business Regulatory Enforcement
announced in the requisite 60-day and dollar. The total costs used in this
Fairness Act of 1996 (the Congressional
30-day Federal Register notices. analysis are indicated in Table 3.
Review Act or CRA), 5 U.S.C. 808(2), we
find it is impracticable and contrary to In order to fairly evaluate whether an BILLING CODE 4120–01–P
the public interest not to waive the information collection should be
221 BLS. May 2020 National Occupational
delay in effective date of this IFC under approved by OMB, section 3506(c)(2)(A)
Employment and Wage Estimates United States.
of the Paperwork Reduction Act of 1995 United States Department of Labor. Accessed at
220 https://www.medrxiv.org/content/10.1101/ requires that we solicit comment on the https://www.bls.gov/oes/current/oes_nat.htm.
2021.08.20.21262158v1.full.pdf. following issues: Accessed on August 25, 2021.
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BILLING CODE 4120–01–C
numbers for the providers and suppliers Estimates of Number of Staff by Type of
In this analysis, we used specific in this analysis were located on Provider (thousands) located in section
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resources to estimate the burden for the September 1, 2021 on the Quality, VI.B. of this IFC.
providers and suppliers in this rule. Certification & Oversight Reports This analysis is also based upon
Based upon our experience, there are (QCOR) website at https://qcor.cms.gov/ certain assumptions. We believe that
minimal fluctuations in the numbers of main.jsp. For the number of employees many of the providers and suppliers
providers and suppliers monthly. Thus, for each provider and supplier, those covered in this rule have already either
unless otherwise indicated, all of the numbers were obtained from Table 5:
ER05NO21.025</GPH>
encouraged their employees to get
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vaccinated for COVID–19 or have provider or supplier and whether the policies and procedures and modify
mandates for the vaccine. Mandates for employee requested an exemption. If the them, if necessary, to ensure compliance
employees to be vaccinated for COVID– employee has been vaccinated in with the requirements in this IFC,
19 can result from State, county, or local compliance with this rule, an especially that their policies and
actions or result from a decision by the administrative support person might procedures cover all of the center staff
facility. These facilities would likely review their vaccination card and as identified in this IFC. Hence, we will
have already developed policies and document that the employee has been base our estimate for this ICR on all
procedures, as well as documentation vaccinated. However, if an 6,071 ASCs. We believe activities
requirements, related to their employees administrative support person performs associated with this IFC would be
being vaccinated for COVID–19. these activities, we believe an performed by the RN functioning as the
However, we have no reliable method to administrator or another member of the designated and qualified infection
estimate the number or percentage of health care staff would be responsible control professional (ICP) and ASC
these facilities. In addition, it is likely for overseeing these activities. For other administrator as analyzed below.
that those facilities would not comply providers and suppliers, a nurse would The ICP would conduct research and
with all of the requirements in this rule. likely be assigned to verify and then either modify or develop the
For example, many facilities might not document vaccination status. If an policies and procedures needed to
define ‘‘employees’’ as set forth in this employee requests an exemption, we comply with this section’s
rule. Each facility would have to review believe that a nurse, another health care requirements. The ICP would work with
its policies, procedures, and professional, or an administrator would the ASC administrator in developing
documentation requirements to ensure likely review the request and document these policies and procedures. For the
that they comply with the requirements it. Some other providers or suppliers ICP, we estimate this would require 8
in this rule. Hence, based upon these might have an administrator or another hours initially to perform research and
assumptions, this analysis will assess member of the health care staff perform revise or develop the policies and
the burden for all facilities and these activities. Thus, for this analysis, procedures to meet these requirements.
employees for each provider and if a provider is required to have at least According to Table 3, the ICP’s total
supplier type. one infection preventionist (IP), such as hourly cost is $77. Thus, for each ASC,
We also made some assumption hospitals, we believe the IP would be the burden for the ICP would be 8 hours
regarding analysis of the burden for the responsible for documenting the at a cost of $616 (8 × $77). For the ICPs
documentation requirements. If an vaccination status for all employees. For in all 6,071 ASCs, the burden would be
employee receives the appropriate other providers and suppliers, we 48,568 hours (8 × 6,071) at an estimated
vaccinations, reviewing and assessed the burden using a registered cost of $3,739,736 ($616 × 6,071).
documenting that the employee has As discussed above, the revision and
nurse (RN), another member of the
been vaccinated would likely only approval of these initial policies and
health care staff, such as a physical
require 1 to 3 minutes, depending upon procedures would also require activities
therapist, or an administrator.
how the facility is documenting the The estimates that follow are largely by the ASC administrator. The
vaccination, which is likely to vary based on our experience with these administrator would need to have
substantially between facilities. various providers. However, given the meetings with the ICP to discuss the
However, for employees that request uncertainty and rapidly changing nature revisions and approve the final policies
exemptions or have to be contacted and procedures. We estimate this would
of the current pandemic, we
repeatedly for the appropriate require 2 hours for the administrator.
acknowledge that there will likely need
documentation, it would likely take According to Table 3, the total hourly
to be revisions to these requirements
more time to comply with this cost for the administrator is $98. The
over time. We welcome comments that
requirement. At a minimum, both the burden for the administrator in each
might improve these estimates.
initial request for the exemption and the ASC would be 2 hours at an estimated
final determination would have to be A. ICRs Regarding the of Development cost of $196 (2 × $98). For the
documented. In cases where the of Policies and Procedures for ASCs administrators in all 6,071 ASCs, the
exemption was denied and the § 416.51(c), ‘‘COVID–19 Vaccination of burden would be 12,142 hours (2 ×
employee receives the appropriate Staff’’ 6,071) at an estimated cost of $1,189,916
vaccinations, those vaccine doses would ($196 × 6,071).
1. Policies and Procedures
also have to be documented. There Therefore, for all 6,071 ASCs, the
might also be additional documentation At § 416.51(c), we require ASCs to estimated burden associated with the
that would need to be copied or scanned develop and implement policies and requirement for policies and procedures
for their records. While the procedures to ensure their staff are would be 67,010 hours (48,568 +
documentation for employees vaccinated for COVID–19 and track and 12,142) at a cost of $4,929,652
requesting an exemption would require maintain documentation of their ($3,739,736 + $1,189,916).
more burden, we believe that there vaccination status. Each ASC must also
have a contingency plan for any staff 2. Documentation and Storage
would only be a small percentage of
employees that would request an that are not fully vaccinated according Section 416.51(c) also requires ASCs
exemption. Since we have no reliable to this rule. to track and securely maintain the
method for estimating a number or The ICRs for this section would required documentation of staff COVID–
percentage of employees who would be require each ASC to develop the 19 vaccination status. Any burden for
in each category, we will analyze the policies and procedures needed to modifying the center’s policies and
satisfy all of the requirements in this procedures for these activities is already
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burden for the documentation
requirements using 5 minutes or 0.0833 section. Based upon our experience accounted for above. We believe that
hours for each employee. with ASCs, we believe some centers this would require an RN 5 minutes or
The position of the individual who have already developed policies and 0.0833 hours to perform the required
would perform the activities related to procedures requiring COVID–19 documentation an adjusted hourly wage
the documentation requirement would vaccination for staff. However, each of $77 for each employee. According to
also vary depending upon the type of ASC will need to review their current Table 3, ASCs have 200,000 employees.
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61590 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Hence, the burden for these and procedures. Thus, for each hospice, elderly (PACE) organizations to develop
documentation requirements for all the burden for the RN would be 8 hours and implement policies and procedures
6,071 ASCs would be 16,660 (0.0833 × at a cost of $632 (8 hours × $79). For all to ensure their staff are vaccinated for
200,000) hours at an estimated cost of 5,556 hospices, the burden would be COVID–19 and that appropriate
$1,282,820 (16,660 × $77). 44,448 hours (8 hours × 5,556) at an documentation of those vaccinations are
The total burden for all 6,071 ASCs estimated cost of $3,511,392 ($632 × tracked and maintained. Each PACE
for this IFC would be 83,670 (67,010 + 5,556). organization must also have a
16,660) hours at an estimated cost of As discussed above, the revision and contingency plan for all staff not fully
$6,212,472 ($4,929,652 + $1,282,820). approval of these policies and vaccinated according to this rule.
The requirements and burden will be procedures would also require activities The ICRs for this section would
submitted to OMB under OMB control by an administrator. The administrator require each PACE organization to
number 0938–0266 (expiration date July would need to work with the RN to develop the policies and procedures
31, 2024). develop the policies and procedures, needed to satisfy all of the requirements
and then review and approve the in this section. Current regulations at
B. ICRs Regarding the Development of § 460.74 already require that each PACE
Policies and Procedures for Hospices changes. We estimate this would require
2 hours. According to Table 3, the total organization follow accepted policies
§ 418.60(d), ‘‘COVID–19 Vaccination of and standard procedures with respect to
Facility Staff’’ hourly cost for the administrator in this
setting is $122. Hence, for each hospice, infection control in place. Thus, all
1. Policies and Procedures the burden would be 2 hours at an PACE organizations should have
estimated cost of $244 (2 × $122). For all policies and procedures regarding
At § 418.60(d), we require hospices to infection prevention and control. We
develop and implement policies and 5,556 hospices, the total burden would
be 11,112 hours (2 × 5,556) at an also believe that many have already
procedures to ensure their staff are addressed COVID–19 vaccination
vaccinated for COVID–19 and that estimated cost of $1,355,664 (5,556 ×
$244). policies for their staff. However, since
appropriate documentation of those we do not have a reliable method to
vaccinations are tracked and Thus, the total burden for hospices to
comply with the requirements for estimate how many have, we will assess
maintained. The hospice must also have the burden for all 141 PACE
a contingency plan for all staff not fully policies and procedures in this IFC is
55,560 hours (44,448 + 11,112) at an organizations.
vaccinated according to this rule. All PACE organizations would need
The ICRs for this section would estimated cost of $4,867,056 ($3,511,392
+ $1,355,664). to review their current infection
require each hospice to develop the prevention and control policies and
policies and procedures needed to 2. Documentation and Storage procedures and develop or modify them
satisfy all of the requirements in this to satisfy the requirements in this
section. Current regulations are set forth Section 418.60(d) also requires
hospices to track and securely maintain section. We believe these activities
at § 418.60 Condition of participation: would require an RN and an
Infection control, and require each the required documentation of staff
COVID–19 vaccination status. Any administrator. According to Table 3, an
hospice to maintain and document an RN’s total hourly cost is $74. Since there
infection control program to prevent burden for modifying the hospice’s
policies and procedures for these are not any current requirements that
and control infections and address COVID–19 vaccination, we
communicable diseases. The hospice activities is already accounted for above.
We believe that this would require an estimate it would require 8 hours for the
must also follow accepted standards of RN to research, draft, and work with an
practice, including the use of standard RN 5 minutes or 0.0833 hours to
perform the required documentation an administrator to finalize the policies
precautions to prevent the transmission and procedures. Thus, for each PACE
of infections and communicable adjusted hourly wage of $79 for each
employee. According to Table 3, organization, the burden for the RN
diseases. Thus, all hospices should would be 8 hours at a cost of $592 (8
hospices have 340,000 employees.
already have infection prevention and
Hence, the burden for these hours × $74). For all 141 PACE
control policies and procedures, but organizations, the burden would be
documentation requirements for all
they likely do not comply with all of the 1,128 hours (8 hours × 141) at an
5,556 hospices would be 28,322 (0.0833
requirements in this IFC. estimated cost of $83,472 (592 × 141).
All hospices would need to review × 340,000) hours at an estimated cost of
As discussed above, the revision and
their current policies and procedures $2,237,438 (28,322 × 79). approval of these policies and
and modify them to comply with all of Therefore, the total burden for all
procedures would also require activities
the requirements in § 418.60(d) as set 5,556 hospices for this rule would be
by an administrator. The administrator
forth in this IFC. While we believe that 83,882 (55,560 + 28,322) hours at an
would need to work with the RN to
many hospices have already addressed estimated cost of $7,104,494 (4,867,056
develop the policies and procedures,
COVID–19 vaccination with their staff, + 2,237,438).
and then review and approve the
we have no reliable means to estimate The requirements and burden will be
changes. We estimate this would require
that number. Therefore, we will assess submitted to OMB under OMB control
2 hours. According to Table 3, the total
the burden for these requirements for all number 0938–1067 (expiration date
hourly cost for the administrator is
5,556 hospices. We believe these March 31, 2024).
$122. Hence, for each PACE
activities would be performed by the RN C. ICRs Regarding the Development of organization, the burden would be 2
and an administrator. According to Policies and Procedures for PACE hours at an estimated cost of $244 (2 ×
Table 3, an RN in these settings has a 122). For all 141 PACE organizations,
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Organizations § 460.74(d), ‘‘COVID–19
total hourly cost of $79. Since there are Vaccination of PACE Organization the total burden would be 282 hours (2
not any current requirements that Staff’’ × 141) at an estimated cost of $34,404
address COVID–19 vaccination, we (141 × $244).
estimate it would require 8 hours for the 1. Policies and Procedures Thus, the total burden for all 141
RN to research, draft, and work with an Section 460.74(d) requires that PACE organizations to comply with the
administrator to finalize the policies programs for all-inclusive care for the requirements for the policies and
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61591
procedures is 1,410 hours (1,128 + 282) compliance with all of the requirements employees so they are included here
at an estimated cost of $117,876 (83,472 in this IFC, especially that their policies with the hospital employees. Hence, the
+ 34,404). and procedures cover all of the eligible burden for these documentation
facility staff identified in this IFC. Based requirements for all 5,194 hospital and
2. Documentation and Storage
upon our experience with hospitals, we 1,358 CAHs would be 505,631 (0.0833 ×
Section 460.74(d) also requires PACE believe many hospitals have already 6,070,000) hours at an estimated cost of
organizations to track and securely developed policies and procedures $39,944,849 (505,631 × 79).
maintain the required documentation of requiring COVID–19 vaccination for Therefore, the total burden for this
staff COVID–19 vaccination status. Any staff. Since we have no reliable means rule for all 5,194 hospitals and 1,358
burden for modifying the PACE to estimate the number of hospitals that CAHs (documentation burden only)
organization’s policies and procedures may have already addressed COVID–19 would be 567,959 (62,328 + 505,631)
for these activities is already accounted vaccination of their staff, we will base hours at an estimated cost of
for above. We believe that this would our estimate for these requirements on $45,762,129 (5,817,280 + 39,944,849).
require an RN 5 minutes or 0.0833 hours all 5,194 hospitals. The requirements and burden will be
to perform the required documentation We believe these activities would be submitted to OMB as an emergency
an adjusted hourly wage of $74 for each performed by the IP, the director of reinstatement of an existing OMB
employee. According to Table 3, PACE nursing (DON), and an administrator. control number 0938–0328.
organizations have 10,000 employees. The IP would need to research COVID–
19 vaccines, modify the policies and E. ICRs Regarding the Development of
Hence, the burden for these
procedures, as necessary, and work with Policies and Procedures for LTC
documentation requirements for all 141
the DON and administrator to develop Facilities § 483.80(i), ‘‘COVID–19
PACE organizations would be 833
Vaccination of Facility Staff’’
(0.0833 × 10,000) hours at an estimated the policies and procedures and obtain
cost of $61,642 (833 × 74). appropriate approval. For the IP, we 1. Policies and Procedures
Therefore, the total burden for all 141 estimate these activities would require 8
hours. According to Table 3, the IP’s At § 483.80(i), we require LTC
PACE organizations for this rule would facilities to develop and implement
be 2,243 (1,410 + 833) hours at an total hourly cost is $79. Thus, for each
hospital, the burden for the IP would be policies and procedures to ensure their
estimated cost of $179,518 (117,876 + staff are vaccinated for COVID–19 and
61,642). 8 hours at a cost of $632 (8 hours × 79).
For the IPs in all 5,194 hospitals, the that appropriate documentation of those
The requirements and burden will be vaccinations are tracked and
submitted to OMB under OMB control burden would be 41,552 hours (8 hours
× 5,194) at an estimated cost of maintained. The LTC facility must also
number 0938–1326 (expiration date have a contingency plan for all staff not
April 20, 2023). $3,282,608 (632 × 5,194).
As discussed above, the revision and fully vaccinated according to this rule.
D. ICRs Regarding the Development of approval of these policies and The ICRs for this section would
Policies and Procedures for Hospitals procedures would also require activities require each LTC facility to develop the
§ 482.42(g), ‘‘COVID–19 Vaccination of by the DON and an administrator. We policies and procedures needed to
Hospital Staff’’ believe these activities would require 2 satisfy all of the requirements in this
hours each for the DON and an section. Current regulations at
1. Policies and Procedures § 483.80(d)(1) and (2) already require
administrator. According to Table 3, the
At § 482.42(g), we require hospitals to total adjusted hourly wage for both the LTC facilities to have policies and
develop and implement policies and DON and an administrator is $122. procedures to educate, offer, and
procedures to ensure their staff are Hence, for each hospital, the burden document vaccination status for
vaccinated for COVID–19 and that would be 4 hours (2 × 2) at an estimated residents regarding the influenza and
appropriate documentation of those cost of $488 (4 × $122). The total burden pneumococcal immunizations. In
vaccinations are tracked and for all 5,194 hospitals would be 20,776 addition, § 483.80(d)(3) requires LTC
maintained. The hospital must also have hours (4 × 5,194) at an estimated cost of facilities to educate, offer, and
a contingency plan for all staff not fully $2,534,672 (5,194 × 488). document the vaccination status for
vaccinated according to this rule. Therefore, for all 5,194 hospitals, the residents and staff for the COVID–19
The ICRs for this section would total burden for the requirements for immunizations. Based upon our
require each hospital to develop the policies and procedures is 62,328 hours experience with LTC facilities, we
policies and procedures needed to (41,552 + 20,776) at an estimated cost of believe some facilities have already
satisfy all of the requirements in this $5,817,280 (3,282,608 + 2,534,672). developed policies and procedures
section. Current regulations at § 482.42 requiring COVID–19 vaccination for
Condition of participation: Infection 2. Documentation and Storage staff, including COVID–19 vaccine
prevention and control and antibiotic Section 482.42(g) also requires mandates. However, we have no reliable
stewardship programs already require hospitals to track and securely maintain means to estimate the number or
hospitals to have an infection the required documentation of staff percentage of LTC facilities that have
prevention and control program (IPCP) COVID–19 vaccination status. Any already mandated vaccination. Hence,
and an infection preventionist (IP). The burden for modifying the hospital’s we will base our estimate for this ICR
IPCP must have methods to prevent and policies and procedures for these on all 15,401 LTC facilities.
control the transmission of infection activities is already accounted for above. Each LTC facility would need to
within the hospital and between the We believe that this would require an review its policies and procedures for
hospital and other settings. Thus, all RN 5 minutes or 0.0833 hours to § 483.80(d) and modify them to comply
jspears on DSK121TN23PROD with RULES2
5,194 hospitals should already have perform the required documentation an with the requirements in this rule at
infection prevention and control adjusted hourly wage of $79 for each § 483.80(i) and obtain the appropriate
policies and procedures. However, each employee. According to Table 3, review and approval. This would
hospital would need to review their hospitals have 6,070,000 employees. We require conducting research and
current policies and procedures and could not locate a reliable number for revising the policies and procedures as
modify them, if necessary, to ensure critical access hospital (CAH) needed. We believe these activities
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61592 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
would be performed by the infection for the LTC facility’s infection would be 2 hours at an estimated cost
preventionist (IP), director of nursing prevention and control program (IPCP) of $244 (2 × 122). For all 357 PRTFs, the
(DON), and medical director for the first under which the requirements in this total burden would be 714 hours (2 ×
year and the IP in subsequent years as rule will also be located. We believe the 357) at an estimated cost of $87,108 (357
analyzed below. burden for the documentation × 244).
The IP would need to work with the requirements in this rule should be Thus, the total burden for all 357
DON and medical director to revise and included in that burden. Therefore, we PRTFs to comply with the policies and
finalize the policies and procedures. For will not assess any additional burden procedures requirements in this IFC for
the IP, we estimate this would require for the documentation requirements in policies and procedures is 3,570 hours
2 hours initially to perform research and this rule. (2,856 + 714) at an estimated cost of
revise the policies and procedures to The requirements and burden will be $298,452 (211,344 + 87,108).
meet these requirements. According to submitted to OMB under OMB control
Table 3, the IP’s total hourly cost is $69. 2. Documentation and Storage
number 0938–1363 (expiration date
Thus, for each LTC facility, the burden June 30, 2022). Section 441.151(c) also requires
for the IP would be 2 hours at a cost of PRTFs to track and securely maintain
$138 (2 hours × 69). For the IPs in all F. ICRs Regarding the Development of the required documentation of staff
15,401 LTC facilities, the burden would Policies and Procedures for PRTFs COVID–19 vaccination status. Any
be 30,802 hours (2 hours × 15,401 § 441.151(c), ‘‘COVID–19 Vaccination of burden for modifying the facility’s
facilities) at an estimated cost of Facility Staff’’ policies and procedures for these
$2,125,338 (138 × 15,401). 1. Policies and Procedures activities is already accounted for above.
As discussed above, the revision and We believe that this would require an
approval of these policies and Section 441.151(c) requires
RN 5 minutes or 0.0833 hours to
procedures would also require activities psychiatric residential treatment
perform the required documentation an
by the DON and medical director. Both facilities (PRTFs) to develop and
adjusted hourly wage of $74 for each
the DON and medical director would implement policies and procedures to
employee. According to Table 3, PRTFs
need to have meetings with the IP to ensure their staff are vaccinated for
have 30,000 employees. Hence, the
discuss the revision, evaluation, and COVID–19 and that appropriate
burden for these documentation
approval of the policies and procedures. documentation of those vaccinations are
requirements for all 357 PRTFs would
We estimate this would require 1 hour tracked and maintained. The PRTF must
be 2,499 (0.0833 × 30,000) hours at an
for both the DON and medical director. also have a contingency plan for all staff
estimated cost of $184,926 (2,499 × 74).
According to Table 3, the total hourly not fully vaccinated according to this
Therefore, the total burden for all 357
cost for the DON is $96. The burden in rule.
The ICRs for this section would PRTFs for this rule would be 6,069
the first year for the DON in each LTC (3,570 + 2,499) hours at an estimated
facility would be 1 hour at an estimated require each PRTF to develop the
policies and procedures needed to cost of $483,378 (298,452 + 184,926)
cost of $96 (1 hour × 96). The burden The requirements and burden will be
would be 15,401 hours (1 × 15,401) at satisfy all of the requirements in this
submitted to OMB under OMB control
an estimated cost of $1,478,496 (96 × section. Current regulations for PRTFs
number 0938–0833 (expiration date May
15,401) for all LTC facilities. do not address infection prevention and
31, 2022).
For the medical director, we have control or vaccinations. Hence, although
estimated the revision of policies and we believe that at least some PRTFs G. ICRs Regarding the Development of
procedures would also require 1 hour. have already addressed COVID–19 Policies and Procedures for ICFs-IID
According to the chart above, the total vaccination of their staff, we will assess § 483.430(f), ‘‘COVID–19 Vaccination of
hourly cost for the medical director is the burden for all 357 PRTFs. Facility Staff’’
$171. For each LTC facility, this would We believe these activities would be
performed by an RN and an 1. Policies and Procedures
require 1 hour for the medical director
during the first year at an estimated cost administrator. According to Table 3, an At § 483.430(f), we require ICFs-IID to
of $171 (1 hour × $171). the burden for RN’s total hourly cost is $74. Since there develop and implement policies and
all LTC facilities would be 15,401 hours are not any current requirements that procedures to ensure their staff are
(1 × 15,401) at an estimated cost of address COVID–19 vaccination, we vaccinated for COVID–19 and that
$2,633,571 (171 × 15,401). estimate it would require 8 hours for the appropriate documentation of those
Therefore, for all 15,401 LTC facilities RN to research, draft, and work with an vaccinations are tracked and
in the first year, the estimated burden administrator to finalize the policies maintained. The ICFs-IID must also
for the policies and procedures and procedures. Thus, for each PRTF, have a contingency plan for all staff not
requirement would be 61,604 hours the burden for the RN would be 8 hours fully vaccinated according to this rule.
(30,802 + 15,401 + 15,401) at a cost of at a cost of $592 (8 hours × 74). For all The ICRs for this section would
$6,237,405 (2,125,338 + 1,478,496 + 357 PRTFs, the burden would be 2,856 require each ICFs-IID to develop the
2,633,571). hours (8 hours × 357) at an estimated policies and procedures needed to
cost of $211,344 (592 × 357). satisfy all of the requirements in this
2. Documentation and Storage As discussed above, the revision and section. Current regulations at
Section 483.80(i) also requires LTC approval of these policies and § 483.470(l) Standard: Infection control
facilities to track and securely maintain procedures would also require activities requires that the ICFs-IID must provide
the required documentation of staff by an administrator. The administrator a sanitary environment to avoid sources
COVID–19 vaccination status. Any would need to work with the RN to and transmission of infections. The
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burden for modifying the facility’s develop the policies and procedures, facility must also implement successful
policies and procedures for these and then review and approve the corrective action in affected problem
activities is already accounted for above. changes. We estimate this would require areas, maintain a record of incidents
The PRA package submitted under OMB 2 hours. According to Table 3, the total and corrective actions related to
Control No. 0938–1363 already provides hourly cost for the administrator is infections, and prohibit employees with
for the documentation burden for the IP $122. Hence, for each PRTF, the burden symptoms or sign of a communicable
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61593
disease from direct contact with clients H. ICRs Regarding the Development of changes. We estimate this would require
and their food. Hence, ICFs-IID should Policies and Procedures for HHAs 2 hours. According to Table 3, the total
already have policies and procedures for § 484.70(d), ‘‘COVID–19 Vaccination of hourly cost for the administrator in
infection prevention and control. Home Health Agency Staff’’ home health services is $97. Hence, for
We believe these activities would be each HHA, the burden would be 2 hours
1. Policies and Procedures
performed by the RN. According to at an estimated cost of $194 (2 × 97). For
Table 3, an RN’s total hourly cost is $69. At § 483.70(d), we require HHAs to all 11,649 HHAs, the total burden would
Since there are not any current develop and implement policies and be 23,298 hours (2 × 11,649) at an
requirements that address COVID–19 procedures to ensure their staff are estimated cost of $2,259,906 (11,649 ×
vaccination, we estimate it would vaccinated for COVID–19 and that 194).
require 8 hours for the RN to research, appropriate documentation of those Thus, the total burden for all 11,649
draft, and work with an administrator to vaccinations are tracked and HHAs to comply with the policies and
finalize the policies and procedures. maintained. The HHA must also have a procedures requirements for policies
Thus, for each ICFs-IID, the burden for contingency plan for all staff not fully and procedures is 116,490 hours (93,192
the RN would be 8 hours at a cost of vaccinated according to this rule. + 23,298) at an estimated cost of
$552 (8 hours × 69). For all 5,780 ICFs- The ICRs for this section would $9,062,922 (6,803,016 + 2,259,906).
IID, the burden would be 46,240 hours require each HHA to develop the
(8 hours × 5,780) at an estimated cost of policies and procedures needed to 2. Documentation and Storage
$3,190,560 (552 × 5,780). satisfy all of the requirements in this Section 483.70(d) also requires HHAs
As discussed above, the revision and section. Current regulations at § 483.70, to track and securely maintain the
approval of these policies and Condition of participation: Infection required documentation of staff COVID–
procedures would also require activities prevention and control require each 19 vaccination status. Any burden for
by an administrator. The administrator HHA to maintain and document an modifying the agency’s policies and
would need to work with the RN to infection control program to prevent procedures for these activities is already
develop the policies and procedures, and control infections and accounted for above. We believe that
and then review and approve the communicable diseases. The HHA must this would require an RN 5 minutes or
changes. We estimate this would require follow accepted standards of practice, 0.0833 hours to perform the required
2 hours. According to Table 3, the total including the use of standard documentation at adjusted hourly wage
hourly cost for the administrator is $96. precautions to prevent the transmission of $73 for each employee. According to
Hence, for each ICFs-IID, the burden of infections and communicable Table 3, HHAs have 2,110,000
would be 2 hours at an estimated cost diseases. Thus, all HHA should already employees. Hence, the burden for these
of $192 (2 × 96). For all 5,780 ICFs-IID, have infection prevent and control documentation requirements for all
the total burden would be 11,560 hours policies and procedures, but they likely 11,649 HHAs would be 175,763 (0.0833
(2 × 5,780) at an estimated cost of do not comply with all of the × 2,110,000) hours at an estimated cost
$1,109,760 (5,780 × 192). requirements in this IFC. of $12,830,699 (175,763 × 73).
Thus, the total burden for all 5,780 All HHAs would need to review their
Therefore, the total burden for all
ICFs-IID to comply with the current policies and procedures and
11,649 HHAs for this rule would be
requirements for policies and modify them to comply with all of the
292,253 (116,490 + 175,763) hours at an
procedures is 57,800 hours (46,240 + requirements in § 483.70(d), as set forth
estimated cost of $21,893,621 (9,062,922
11,560) at an estimated cost of in this IFC. While we believe that many
+ 12,830,699).
$4,300,320 (3,190,560 + 1,109,760). HHAs have already addressed COVID–
The requirements and burden will be
19 vaccination with their staff, we have
2. Documentation and Storage submitted to OMB under OMB control
no reliable means to estimate that
number 0938–1299 (expiration date
Section 483.430(f) also requires ICFs- number. Therefore, we will assess the
June 30, 2024).
IID to track and securely maintain the burden for these requirements for all
required documentation of staff COVID– 11,649 HHAs. We believe these I. ICRs Regarding the Development of
19 vaccination status. Any burden for activities would be performed by the RN Policies and Procedures for CORFs
modifying the facility’s policies and and an administrator. According to § 485.70(n), ‘‘COVID–19 Vaccination of
procedures for these activities is already Table 3, an RN in home health services Facility Staff’’
accounted for above. We believe that total hourly cost is $73. Since there are
1. Policies and Procedures
this would require an RN 5 minutes or not any current requirements that
0.0833 hours to perform the required address COVID–19 vaccination, we At § 485.70(n), we require CORFs to
documentation at adjusted hourly wage estimate it would require 8 hours for the develop and implement policies and
of $69 for each employee. According to RN to research, draft, and work with an procedures to ensure their staff are
Table 3, ICFs-IID have 80,000 administrator to finalize the policies vaccinated for COVID–19 and that
employees. Hence, the burden for these and procedures. Thus, for each HHA, appropriate documentation of those
documentation requirements for all the burden for the RN would be 8 hours vaccinations are tracked and
5,780 ICFs-IID would be 6,664 (0.0833 × at a cost of $584 (8 hours × 73). For all maintained. Each CORF must also have
80,000) hours at an estimated cost of 11,649 HHAs, the burden would be a contingency plan for all staff not fully
$459,816 (6,664 × $69). 93,192 hours (8 hours × 11,649) at an vaccinated according to this rule.
Therefore, the total burden for all estimated cost of $6,803,016 (584 × The ICRs for this section would
5,780 ICFs-IID for this rule would be 11,649). require each CORF to develop the
64,464 (57,800 + 6,664) hours at an As discussed above, the revision and policies and procedures needed to
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estimated cost of $4,760,136 (4,300,320 approval of these policies and satisfy all of the requirements in this
+ 459,816). procedures would also require activities section. This IFC requires CORF staff to
The requirements and burden will be by an administrator. The administrator receive the COVID–19 vaccine unless
submitted to OMB under OMB control would need to work with the RN to medically contraindicated as
number 0938–1402 (expiration date develop the policies and procedures, determined by a physician, advance
September 30, 2024). and then review and approve the practice registered nurse, or physician
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61594 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
assistant acting within their respective hourly wage of $98 for each employee. nursing (DON), and an administrator.
scope of practice as defined by and in According to Table 3, CORFs have The IP would need to research COVID–
accordance with all applicable State and 10,000 employees. Hence, the burden 19 vaccines, modify the policies and
local laws. Based upon our experience for these documentation requirements procedures, as necessary, and work with
with CORFs, we believe some facilities for all 159 CORFs would be 833 (0.0833 the DON and administrator to develop
have already developed policies and × 10,000) hours at an estimated cost of the policies and procedures and obtain
procedures requiring COVID–19 $81,634 (833 × 98). appropriate approval. For the IP, we
vaccination for staff unless medically Therefore, the total burden for all 159 estimate these activities would require 8
contraindicated. However, each CORF CORFs for this rule would be 2,105 hours. According to Table 3, the IP’s
will need to review their current (1,272 + 833) hours at an estimated cost total hourly cost is $79. Thus, for each
policies and procedures and modify of $206,290 (124,656 + 81,634). hospital, the burden for the IP would be
them, if necessary, to ensure compliance The requirements and burden will be
with the requirements in this IFC, 8 hours at a cost of $632 (8 hours × 79).
submitted to OMB under OMB control
especially that their policies and number 0938–1091 (expiration date For the IPs in all 1,358 CAHs, the
procedures cover all of the organization November 30, 2022). burden would be 10,864 hours (8 hours
staff identified in this IFC. Hence, we × 1,358) at an estimated cost of $858,256
will base our estimate for this ICR on all J. ICRs Regarding the Development of (632 × 1,358).
159 CORFs. The CORF’s governing body Policies and Procedures for CAHs
As discussed above, the revision and
appoints an administrator who § 485.640(f), ‘‘COVID–19 Vaccination of
approval of these policies and
implements and enforces the facility’s CAH Staff’’
procedures would also require activities
policies and procedures. Hence, we 1. Policies and Procedures by the DON and an administrator. We
believe activities associated with this believe these activities would require 2
At § 485.640(f), we require critical
IFC would be performed by the hours each for the DON and an
access hospitals (CAHs) to develop and
administrator as analyzed below. The administrator. According to Table 3, the
implement policies and procedures to
governing body would also need to total adjusted hourly wage for both the
ensure their staff are vaccinated for
review these policies and procedures,
COVID–19 and that appropriate DON and an administrator is $122.
which would be included in its ‘‘legal
documentation of those vaccinations are Hence, for each CAH the burden would
responsibility for establishing and
implementing policies regarding the tracked and maintained. The CAH must be 4 hours (2 × 2) at an estimated cost
management and operation of the also have a contingency plan for all staff of $488 (4 × $122). The total burden for
facility.’’ not fully vaccinated according to this all 1,358 CAHs would be 5,432 hours (4
The administrator would conduct rule. × 1,358) at an estimated cost of $662,704
research to either modify or develop The ICRs for this section would (1,358 × 488).
policies and procedures. For the require each CAH to develop the
policies and procedures needed to Therefore, for all 1,358 CAHs the total
administrator, we estimate this would burden for the requirements for policies
require 8 hours initially to perform satisfy all of the requirements in this
section. Current regulations at § 485.640 and procedures is 16,296 hours (10,864
research and revise or develop the + 5,432) at an estimated cost of
policies and procedures to meet these Condition of participation: Infection
prevention and control and antibiotic $1,520,960 ($858,256 + $662,704).
requirements. According to Table 3, the
administrator’s total hourly cost is $98. stewardship programs already require 2. Documentation and Storage
Thus, for each CORF, the burden for the CAHs to have an infection prevention
administrator would be 8 hours at a cost and control program (IPCP) and an Section 485.640(f) also requires CAHs
of $784 (8 × 98). For the administrators infection preventionist (IP). The IPCP to track and securely maintain the
in all 159 organizations, the burden must have methods to prevent and required documentation of staff COVID–
would be 1,272 hours (8 × 159) at an control the transmission of infection 19 vaccination status. Any burden for
estimated cost of $124,656 (784 × 159). within the hospital and between the modifying the CAH’s policies and
The administrator would need to hospital and other settings. Thus, all procedures for these activities is already
spend time attending governing body 1,358 CAHs should already have accounted for above. Since we were
meetings to discuss and obtain approval infection prevention and control unable to located a reliable number for
for the policies and procedures; policies and procedures. However, each CAH employees, the documentation
however, that would be a usual and CAH would need to review their current burden for CAHs resulting from the
customary business practice. Therefore, policies and procedures and modify documentation requirement in this rule
activities for the administrator them, if necessary, to ensure compliance
is included in the hospitals’ burden
associated with governing body with all of the requirements in this IFC,
above.
approval for the policies and procedures especially that their policies and
are exempt from the PRA in accordance procedures cover all of the eligible The requirements and burden for
with 5 CFR 1320.3(b)(2). facility staff identified in this IFC. Based CAHs without DPUs will be submitted
upon our experience with CAHs, we to OMB under OMB control number
2. Documentation and Storage believe many CAHs have already 0938–1043 (expiration date March 31,
Section 485.70(n) also requires CORFs developed policies and procedures 2024). The requirements and burden for
to track and securely maintain the requiring COVID–19 vaccination for CAHs with DPUs will be submitted to
required documentation of staff COVID– staff. Since we have no reliable means OMB under OMB control number 0938–
19 vaccination status. Any burden for to estimate the number of CAHs that
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0328(expired).
modifying the facility’s policies and may have already addressed COVID–19
procedures for these activities is already vaccination of their staff, we will base
accounted for above. We believe that our estimate for these requirements on
this would require an administrator 5 all 1,358 CAHs.
minutes or 0.0833 hours to perform the We believe these activities would be
required documentation at adjusted performed by the IP, the director of
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61595
K. ICRs Regarding the Development of procedures to meet these requirements. L. ICRs Regarding the Development of
Policies and Procedures for Clinics, According to Table 3, the physical Policies and Procedures for CMHCs
Rehabilitation Agencies, and Public therapist’s total hourly cost is $84. § 485.904(c), ‘‘COVID–19 Vaccination of
Health Agencies as Providers of Thus, for each organization, the burden Center Staff’’
Outpatient Physical Therapy and for the physical therapist would be 8 1. Policies and Procedures
Speech-Language Pathology Services hours at a cost of $672 (8 × 84). For the
(Organizations) § 485.725(f), ‘‘COVID– physical therapists in all 2,078 At § 485.904(c), we require CHMCs to
19 Vaccination of Organization Staff’’ develop and implement policies and
organizations, the burden would be
procedures to ensure their staff are
1. Policies and Procedures 16,624 hours (8 × 2,078) at an estimated vaccinated for COVID–19 and that
At § 485.725(f), we require cost of $1,396,416 (672 × 2,078). appropriate documentation of those
organizations to develop and implement As discussed above, the revision and vaccinations are tracked and
policies and procedures to ensure their approval of these policies and maintained. Each facility must maintain
staff are vaccinated for COVID–19 and procedures would also require activities documentation of their staff’s
the appropriate documentation is by the administrator. The administrator vaccination status. Also, each facility
tracked and maintained. The would need to have meetings with the must have a contingency plan for all
organization must also have a physical therapist to discuss the staff not fully vaccinated according to
contingency plan for all staff not fully revisions and draft any necessary this rule.
vaccinated according to this rule. policies and procedures, as well as The ICRs for this section would
The ICRs for this section would approve the final policies and require each CHMC to develop the
require each organization to develop the policies and procedures needed to
procedures. We estimate this would
policies and procedures needed to satisfy all of the requirements in this
require 2 hours for the administrator.
satisfy all of the requirements in this section. Based upon our experience
section. Current regulations at According to Table 3, the total hourly with CHMCs, we believe some centers
§ 485.725(a) require organizations to cost for the administrator is $98. The have already developed policies and
establish an infection-control committee burden for the administrator in each procedures requiring COVID–19
of representative professional staff with organization would be 2 hours at an vaccination for staff unless medically
overall responsibility for infection estimated cost of $196 (2 × 98). For the contraindicated. However, since we do
control. This committee establishes administrators in all 2,078 not have a reliable means to estimate
policies and procedures for organizations, the burden would be how many CMHCs have done so, we
investigating, controlling, and 4,156 hours (2 × 2,078) at an estimated will estimate the burden based on all
preventing infections in the cost of $407,288 (4,156 × 98). 129 CHMCs.
organization and monitors staff Therefore, for all 2,078 organizations, Each CMHC will need to review their
performance to ensure compliance with the total burden for the requirements for current policies and procedures and
those policies and procedures. Based modify them, if necessary, to ensure
policies and procedures is 20,780 hours
upon these requirements and our compliance with the requirements in
(16,624 + 4,156) at an estimated cost of
experience with organizations, we this IFC. Based on these requirements
$1,803,704 (1,396,416 + 407,288). and our experience with CHMCs, we
believe some organizations have already
developed policies and procedures 2. Documentation and Storage believe these activities would be
requiring COVID–19 vaccination for performed by the CHMC administrator
staff unless medically contraindicated. Section 485.725(f) also requires and a mental health counselor. The
However, since we have no reliable organizations to track and securely administrator would conduct research
means to estimate how many maintain the required documentation of regarding the COVID–19 vaccines and
organizations have done this, we will staff COVID–19 vaccination status. Any then either modify or develop the
assess the burden for all 2,078 burden for modifying the organization’s policies and procedures necessary to
organizations. All organizations would policies and procedures for these comply with the requirements in this
need to review their current policies activities is already accounted for above. IFC. The administrator would send any
and procedures and modify them, if We believe that this would require a recommendations for changes or
necessary, to ensure compliance with physical therapist 5 minutes or 0.0833 additional policies or procedures to the
the requirements in this IFC. hours to perform the required mental health counselor. The
The types of therapists at each documentation at adjusted hourly wage administrator and mental health
organization vary depending upon the clinician would need to make the
of $84 for each employee. According to
services offered. For the purposes of necessary revisions and draft any
Table 3, these organizations have 10,000
determining the COI burden, we will necessary policies and procedures. For
assume that the therapist is a physical employees. Hence, the burden for these
the administrator, we estimate this
therapist. We believe activities documentation requirements for all
would require 8 hours initially to
associated with this IFC would be 2,078 organizations would be 833
perform research and revise or develop
performed by a physical therapist and (0.0833 × 10,000) hours at an estimated the policies and procedures to meet
administrator. A physical therapist cost of $69,972 (833 × 84). these requirements. According to Table
would need to conduct research on the Therefore, the total burden for all 3, the administrator’s total hourly cost is
COVID–19 vaccines and then develop or 2,078 organizations for this rule would $113. Thus, for each CMHC, the burden
modify policies and procedures that be 21,613 (20,780 + 833) hours at an for the administrator would be 8 hours
comply with the requirements in this at a cost of $904 (8 × 113). The burden
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estimated cost of $1,873,676 (1,803,704
IFC. The physical therapist would need + 69,972). for the administrators in all 129 CHMCs
to work with an administrator to make
The requirements and burden will be would be 1,032 hours (8 × 129) at an
the necessary revisions. For the physical estimated cost of $116,616 (904 × 129).
therapist, we estimate this would submitted to OMB under OMB control
As discussed above, the revision and
require 8 hours to perform research and number 0938–0273 (expiration date approval of these initial policies and
revise or develop the policies and June 30, 2024). procedures would also require activities
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by the mental health counselor. The policies and procedures needed to activities is already accounted for above.
administrator would need to have satisfy all of the requirements in this We believe that this would require an
meetings with the mental health section. Current regulations at § 486.525 RN 5 minutes or 0.0833 hours to
counselor to discuss the revisions and already require that HIT suppliers perform the required documentation at
draft any necessary policies and provide their services in accordance adjusted hourly wage of $73 for each
procedures. We estimate this would with nationally recognized standards of employee. According to Table 3, HIT
require 2 hours for the mental health practice. Thus, we believe most HIT suppliers have 20,000 employees.
counselor. According to Table 3, the suppliers should already have infection Hence, the burden for these
total hourly cost for the mental health prevention and control policies and documentation requirements for all 337
counselor is $118. The burden for the procedures, including COVID–19 HIT suppliers would be 1,666 (0.0833 ×
mental health counselor in each CHMC vaccination. However, we have no 20,000) hours at an estimated cost of
would be 2 hours at an estimated cost reliable means to estimate how many $121,618 (1,666 × 73).
of $236 (2 × 118). For the mental health suppliers have done so. Thus, we will Therefore, the total burden for all 337
counselors in all 129 CMHCs, the base our burden estimate on all 337 HIT HIT suppliers for this rule would be
burden would be 258 hours (2 × 129) at suppliers. 5,036 (3,370 + 1,666) hours at an
an estimated cost of $30,444 (129 × 236). All HIT suppliers would need to estimated cost of $211,597 (89,979 +
Therefore, for all 129 CMHCs, the review their current policies and 121,618).
total burden for the requirements for procedures and develop or modify them The requirements and burden will be
policies and procedures is 1,290 hours to comply with all of the requirements submitted to OMB under OMB control
(1,032 + 258) at an estimated cost of in § 486.525(c) as set forth in this IFC. number 0938–855B (expiration date
$147,060 (116,616 + 30,444). We believe these activities would be March 31, 2024).
performed by the RN and an
2. Documentation and Storage administrator working for the HIT N. ICRs Regarding the Development of
Section 485.904(c) also requires supplier. According to Table 3, an RN Policies and Procedures for RHCs and
CMHCs to track and securely maintain working with for a HIT supplier would FQHCs § 491.8(d), ‘‘COVID–19
the required documentation of staff have a total hourly cost of $73. Since Vaccination of Staff’’
COVID–19 vaccination status. Any there are not any current requirements 1. Policies and Procedures
burden for modifying the center’s that address COVID–19 vaccination, we
estimate it would require 8 hours for the At § 491.8(d), we require RHCs/
policies and procedures for these FQHCs to develop and implement
activities is already accounted for above. RN to research, draft, and work with an
administrator to finalize the policies policies and procedures to ensure their
We believe that this would require an staff are vaccinated for COVID–19 and
administrator 5 minutes or 0.0833 hours and procedures. Thus, for each HIT
supplier, the burden for the RN would that appropriate documentation of those
to perform the required documentation vaccinations are tracked and
at adjusted hourly wage of $113 for each be 8 hours at a cost of $584 (8 hours ×
73). For all 337 HIT suppliers, the maintained. Each RHC/FQHC must also
employee. According to Table 3, CMHCs have a contingency plan for all staff not
have 140,000 employees. Hence, the burden would be 2,696 hours (8 hours
× 337) at an estimated cost of $24,601 fully vaccinated according to this rule.
burden for these documentation The ICRs for this section would
requirements for all 129 CMHCs would (337 × 73).
The development and/or revision and require each RHC/FQHC to develop the
be 11,662 (0.0833 × 140,000) hours at an policies and procedures needed to
estimated cost of $1,317,806 (11,662 × approval of these policies and
procedures would also require activities satisfy all of the requirements in this
113). section. This IFC requires clinic or
Therefore, the total burden for all 129 by an administrator. The administrator
would need to work with the RN to center staff to receive the COVID–19
CMHCs for this rule would be 12,952 vaccine unless medically
(1,290 + 11,662) hours at an estimated develop the policies and procedures,
and then review and approve the contraindicated as determined by a
cost of $1,464,866 (147,060 + physician, advance practice registered
1,317,806). changes. We estimate this would require
2 hours. According to Table 3, the total nurse, or physician assistant acting
The requirements and burden will be within their respective scope of practice
submitted to OMB under OMB control hourly cost for the administrator
working for a HIT supplier is $97. as defined by and in accordance with all
number 0938–1245 (expiration date applicable State and local laws. Based
April 30, 2023). Hence, for each HIT supplier, the
burden would be 2 hours at an upon experience with RHCs/FQHCs, we
M. ICRs Regarding the Development of estimated cost of $194 (2 × 97). For all believe some clinics or centers have
Policies and Procedures for HIT 337 HIT suppliers, the total burden for already developed policies and
Suppliers § 486.525(c), ‘‘COVID–19 the administrator would be 674 hours (2 procedures requiring COVID–19
Vaccination of Facility Staff’’ hours × 337) at an estimated cost of vaccination for staff unless medically
$65,378 (337 × 194). contraindicated. However, since we do
1. Policies and Procedures not have a reliable means to estimate
Therefore, for all 337 HIT suppliers,
Section 486.525(c) requires home the total burden for the requirements for how many facilities have already done
infusion therapy (HIT) suppliers to policies and procedures is 3,370 hours so, we will base the burden analysis for
develop and implement policies and (2,696 + 674) at an estimated cost of this estimate on all 15,317 RHC/FQHCs
procedures to ensure their staff are $89,979 (24,601 + 65,378). (4,933 RHCs and 10,384 FQHCs).
vaccinated for COVID–19 and that Each RHC/FQHC will need to review
appropriate documentation of those 2. Documentation and Storage their current policies and procedures
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vaccinations are tracked and Section 486.525(c) also requires HIT and modify them, if necessary, to ensure
maintained. The HIT supplier must also suppliers to track and securely maintain compliance with the requirements in
have a contingency plan for all staff not the required documentation of staff this IFC, especially that their policies
fully vaccinated according to this rule. COVID–19 vaccination status. Any and procedures cover all of the clinic or
The ICRs for this section would burden for modifying the supplier’s center staff identified in this IFC.
require each HIT supplier to develop the policies and procedures for these Current regulations require a physician,
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nurse practitioner, and physician physicians in all 15,317 RHCs/FQHCs, O. ICRs Regarding the Development of
assistant to participate in the the burden would be 30,634 hours (2 × Policies and Procedures for ESRD
development, execution, and periodic 15,317) at an estimated cost of Facilities § 494.30(b), ‘‘COVID–19
review of the policies and $6,494,408 (424 × 15,317). The hourly Vaccination of Facility Staff’’
procedures.222 Moreover, the RHC/ cost for the nurse practitioner is $107.
1. Policies and Procedures
FQHC operates under the medical The burden for the nurse practitioner in
direction of a physician. Based on these each RHC/FQHC would be 2 hours at an Section 494.30(b) requires the ESRD
requirements and our experience with estimated cost of $214 (2 × 107). For the facilities to develop and implement
RHCs/FQHCs, we believe activities nurse practitioners in all 15,317 RHCs/ policies and procedures to ensure their
associated with this IFC would be FQHCs, the burden would be 30,634 staff are vaccinated for COVID–19 and
performed by the RHC administrator, hours (2 × 15,317) at an estimated cost that appropriate documentation of those
physician, nurse practitioner, physician of $3,277,838 ($214 × 15,317). The vaccinations are tracked and
assistant, and medical director as hourly cost for the physician assistant is maintained. The ESRD facility must also
analyzed below. $111. The burden for the physician have a contingency plan for all staff not
The administrator would conduct assistant in each RHC/FQHC would be fully vaccinated according to this rule.
research to either modify or develop 2 hours at an estimated cost of $222 (2 The ICRs for this section would
policies and procedures. The × 111). For the physician assistants in require each ESRD facility to develop
administrator would send any all 15,317 RHCs/FQHCs, the burden the policies and procedures needed to
recommendations for changes or would be 30,634 hours (2 × 15,317) at satisfy all of the requirements in this
additional policies or procedures to the an estimated cost of $3,400,374 (15,317 section. Current regulations at § 494.30
physician, nurse practitioner, and × 222). The hourly cost for the medical already require that ESRD facilities
physician assistant. The administrator, director is $212. The burden for the follow standard infection control
physician, nurse practitioner, and medical director in each RHC/FQHC precautions. Thus, all ESRD facilities
physician assistant would need to make would be 1 hour at an estimated cost of should have infection prevention and
the necessary revisions and draft any $212. For the medical directors in all control policies and procedures. We
necessary policies and procedures. The 15,317 RHCs/FQHCs, the burden would believe that many ESRD facilities have
administrator would need to work with be 15,317 hours (1 × 15,317) at an already addressed COVID–19
the medical director to obtain approval estimated cost of $3,247,204 (15,317 × vaccination for their staff. However, we
for the policies and procedures to be 212). have no reliable means to estimate how
implemented. For the administrator, we Therefore, for all 15,317 RHCs/ many ESRD facilities have done so.
estimate this would require 8 hours FQHCs, the estimated burden associated Thus, we will base our burden estimate
initially to perform research and revise with the policies and procedures on all 7,893 ESRD facilities.
or develop the policies and procedures requirement would be 229,755 hours All ESRD facilities would need to
to meet these requirements. According (122,536 + 30,634 + 30,634 + 30,634 + review their current policies and
to Table 3, the administrator’s total 15,317) at a cost of $29,653,712 procedures and develop or modify them
hourly cost is $108. Thus, for each RHC/ (13,233,888 + 6,494,408 + 3,277,838 + to comply with all of the requirements
FQHC, the burden for the administrator 3,400,374 + 3,247,204). in § 494.30(b) as set forth in this IFC. We
would be 8 hours at a cost of $864 (8 believe these activities would be
2. Documentation and Storage performed by the RN and an
× 108). For the administrators in all
15,317 RHCs/FQHCs, the burden would Section 491.8(d) also requires RHCs/ administrator. According to Table 3, an
be 122,536 hours (8 × 15,317) at an FQHCs to track and securely maintain RN working with for an ESRD facility
estimated cost of $13,233,888 (864 × the required documentation of staff would have a total hourly cost of $73.
15,317). COVID–19 vaccination status. Any Since there are not any current
As discussed above, the revision and burden for modifying the clinic’s or requirements that address COVID–19
approval of these initial policies and center’s policies and procedures for vaccination, we estimate it would
procedures would also require activities these activities is already accounted for require 8 hours for the RN to research,
by the physician, nurse practitioner, above. We believe that this would draft, and work with an administrator to
physician assistant, and medical require an administrator 5 minutes or finalize the policies and procedures.
director. The administrator would need 0.0833 hours to perform the required Thus, for each ESRD facility, the burden
to have meetings with the physician, documentation at an adjusted hourly for the RN would be 8 hours at a cost
nurse practitioner, and physician wage of $108 for each employee. of $584 (8 hours × $73). For all ESRD
assistant to discuss the revisions and According to Table 3, RHCs have 40,000 facilities, the burden would be 63,144
draft any necessary policies and employees and FQHCs have 110,000 hours (8 hours × 7,893) at an estimated
procedures. The administrator would employees for a total of 150,000 cost of $4,609,512 (7,893 × 584).
also need to have meetings with the employees. Hence, the burden for these The development and/or revision and
medical director to obtain approval for documentation requirements for all approval of these policies and
the policies and procedures. We 15,317 RHCs and FQHCs would be procedures would also require activities
estimate this would require 2 hours 12,495 (0.0833 × 150,000) hours at an by an administrator. The administrator
each for the physician, nurse estimated cost of $1,349,460 (12,495 × would need to work with the RN to
practitioner, and physician assistant. 108). develop the policies and procedures,
For the medical director, we estimate 1 Therefore, the total burden for all and then review and approve the
hour would be required to perform this 15,317 RHCs and FQHCs for this rule changes. We estimate this would require
function. According to Table 3, the total would be 242,250 (229,755 + 12,495) 2 hours. According to Table 3, the total
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hourly cost for the physician is $212. hours at an estimated cost of hourly cost for the administrator at an
The burden for the physician in each $31,003,172 (29,653,712 + 1,349,460). ESRD facility is $97. Hence, for each
RHC/FQHC would be 2 hours at an The requirements and burden will be ESRD, the burden for the administrator
estimated cost of $424 (2 × 212). For the submitted to OMB under OMB control would be 2 hours at an estimated cost
number 0938–0334 (expiration date of $194 (2 × 97). For all ESRD facilities,
222 42 CFR 491.7. March 31, 2023). the total burden would be 15,786 hours
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(2 × 7,893) at an estimated cost of policies and procedures for these Therefore, the total burden for all
$1,531,242 (7,893 × 194). Thus, the total activities is already accounted for above. 7,893 ESRD facilities for this rule would
burden for all ESRD facilities for the We believe that this would require an be 93,091 (78,930 + 14,161) hours at an
policies and procedures requirement RN 5 minutes or 0.0833 hours to estimated cost of $ 7,174,507 (6,140,754
would be 78,930 hours (63,144 + perform the required documentation at + 1,033,753).
15,786) at an estimated cost of an adjusted hourly wage of $73 for each The requirements and burden will be
$6,140,754 ($4,609,512 + $1,531,242). employee. According to Table 3, ESRD submitted to OMB under OMB control
facilities have 170,000 employees. number 0938–0386 (expiration date
2. Documentation and Storage
Hence, the burden for these March 31, 2024).
Section 494.30(b) also requires ESRD documentation requirements for all Based upon the above analysis, the
facilities to track and securely maintain 7,893 ESRD facilities would be 14,161 total burden for all of the ICRs in this
the required documentation of staff (0.0833 × 170,000) hours at an estimated IFC is 1,555,487 hours at an estimated
COVID–19 vaccination status. Any cost of $136,088,221.
cost of $1,033,753 (14,161 × 73).
burden for modifying the facility’s BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C 2020.223 Of the approximately 656,000 become subject to requirements similar
If you comment on these information Americans estimated to have died from to those imposed in this rule.225 This
collection requirements, that is, COVID–19 through September 10, IFC will close a gap in current
reporting, recordkeeping or third-party 2021,224 30 percent are estimated to regulations for all categories of health
disclosure requirements, please submit have died during or after an LTC facility care provider whose health and safety
your comments electronically as stay, although these numbers are practices are directly regulated by CMS.
specified in the ADDRESSES section of decreasing as vaccination rates increase Almost all CMS-regulated providers and
this IFC. in residents and staff as shown in the suppliers disproportionately serve
Comments must be received on/by CDC Data Tracker. Despite the recent people who are older, disabled,
January 4, 2022. nation-wide surge in infections from the chronically ill, or who have complex
V. Response to Comments Delta variant of COVID–19, uptake of health care needs.226 Because the health
vaccines and other measures (masking, care sector has such widespread and
Because of the large number of public screening visitors, and social distancing direct contact with hundreds of millions
comments we normally receive on in particular) to prevent COVID–19, in of patients, clients, residents, and
Federal Register documents, we are not combination with available therapeutic program participants, the protective
able to acknowledge or respond to them options to treat, has reduced COVID–19- scope of this rule is far broader than the
individually. We will consider all related patient deaths in all settings. But health care staff that it directly affects.
comments we receive by the date and reductions in COVID–19-related
time specified in the DATES section of B. Overall Impact
morbidity and mortality depend
this preamble, and, when we proceed critically on continued success in We have examined the impacts of this
with a subsequent document, we will vaccination of all health care staff and rule as required by Executive Order
respond to the comments in the patients. The May 13, 2021 COVID–19 12866 on Regulatory Planning and
preamble to that document. IFC (86 FR 26306) required offering Review (September 30, 1993), Executive
vaccination to residents and staff, but Order 13563 on Improving Regulation
VI. Regulatory Impact Analysis
did not mandate vaccination. Recently, and Regulatory Review (January 18,
A. Statement of Need however the Departments of Defense 2011), the Regulatory Flexibility Act
The COVID–19 pandemic has and Veterans Affairs staff, and civilian (RFA) (September 19, 1980, Pub. L. 96–
precipitated the greatest public health Federal Government employees have 354), section 1102(b) of the Social
Security Act, section 202 of the
crisis in the U.S. since the 1918
223 For updated data, see CDC daily updates of
Influenza pandemic. The population of
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total deaths at https://www.cdc.gov/nchs/nvss/vsrr/ 225 https://www.va.gov/opa/pressrel/
older adults, and LTC facility residents COVID19/index.htm, and the Kaiser Family pressrelease.cfm?id=5703.
in particular, have been hard hit by the Foundation weekly updates on nursing home 226 For data on the massive differences in
impacts of the pandemic. Among those deaths at https://www.kff.org/coronavirus-covid-19/ healthcare usage by age, see the National Health
issue-brief/state-covid-19-data-and-policy-actions/, Expenditure Date at https://www.cms.gov/Research-
infected, the death rate for older adults among other sources. Statistics-Data-and-Systems/Statistics-Trends-and-
age 65 or higher was hundreds of time 224 https://covid.cdc.gov/covid-data-tracker/ Reports/NationalHealthExpendData/NHE-Fact-
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higher than for those in their 20s during #datatracker-home. Sheet.
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Unfunded Mandates Reform Act of 1995 the principles set forth in the Executive and approved vaccines. We cannot
(March 22, 1995; Pub. L. 104–4), Order. estimate the effects of each of the
Executive Order 13132 on Federalism A regulatory impact analysis (RIA) possible interactions among them, but
(August 4, 1999), and the Congressional must be prepared for major rules with throughout the analysis we point out
Review Act (5 U.S.C. 804(2)). economically significant effects ($100 some of the most important assumptions
Executive Orders 12866 and 13563 million or more in any 1 year). We we have made and the possible effects
direct agencies to assess all costs and estimate that this rulemaking is of alternatives to those assumptions.
‘‘economically significant’’ as measured The providers and suppliers regulated
benefits of available regulatory
by the $100 million threshold, and under this rule are diverse in nature,
alternatives and, if regulation is
hence also a major rule under the management structure, and size. That
necessary, to select regulatory
Congressional Review Act. Accordingly, said, we believe that the costs faced by
approaches that maximize net benefits
we have prepared an RIA that, taken regulated entities will be very similar on
(including potential economic,
together with COI section and other a ‘‘per person vaccinated’’ basis. Tables
environmental, public health and safety 5 and 6 show the full scope of provider
sections of the preamble, presents to the
effects, distributive impacts, and best of our ability the costs and benefits and supplier types, facility structures,
equity). Section 3(f) of Executive Order of the rulemaking. and staff sizes, taking into account part-
12866 defines a ‘‘significant regulatory This RIA focuses on the overall costs time staff (Table 5) and estimated staff
action’’ as an action that is likely to and benefits of the rule, taking into turnover (Table 6). As explained earlier
result in a rule: (1) Having an annual account vaccination uptake to date or in the preamble, this rule includes
effect on the economy of $100 million anticipated over the next year that is not facility contractors and consulting
or more in any 1 year, or adversely and due to this rule, and estimating the specialists as well as other persons
materially affecting a sector of the likely additional effects of this rule on providing part-time or occasional
economy, productivity, competition, both provider staff and the patients with services to these providers and
jobs, the environment, public health or whom they come in contact. We analyze suppliers and their patients.
safety, or State, local, or tribal both the costs of the required actions In Table 5 we provide a rough
governments or communities (also and the payment of those costs. As estimate of the likely number of full-
referred to as ‘‘economically intended under these requirements, this time employees and other employees
significant’’); (2) creating a serious RIA’s estimates cover only those costs and contractors subject to this rule. The
inconsistency or otherwise interfering and benefits that are likely to be the ‘‘total staff’’ number in the rightmost
with an action taken or planned by effects of this rule. There are also column is the number of individual staff
another agency; (3) materially altering several unknowns that may affect directly affected at the time this rule
the budgetary impacts of entitlement current progress or this rule or both. takes effect (adding the number of full-
grants, user fees, or loan programs or the These include the duration of strong time employees to the number of part-
rights and obligations of recipients vaccine protection with or without a time employees, contractors, and other
thereof; or (4) raising novel legal or booster shot and the possibility of new business persons who have recurring
policy issues arising out of legal virus variants that reduce the patient or staff interactions).
mandates, the President’s priorities, or effectiveness of currently authorized BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C This rule presents additional benefits due to the high degree to which
difficulties in estimating both costs and all current provider and supplier staff
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have already received information about Evaluation based on standard practices of 1 percent.232 In Israel, of the first 2.9
the benefits and safety of COVID–19 in cost-benefit analysis.229 million people vaccinated with two
vaccination, and the rare serious risks One additional factor affecting our doses there were only about 50
associated with it. Despite this progress, estimates is remaining life expectancy. infections involving severe conditions
the proportion of fully vaccinated health Life expectancy varies by age, being resulting from the virus after the 14th
care staff has approached but not hit the about 40 years across an entire day and of these so few deaths that they
70 percent with significant variation population, close to 80 years for a were not reported in statistical
among states. Moreover, among the younger population, and a relatively summaries. These data also show that
general population more than 600,000 fewer number of years for an older COVID–19 vaccines are effective for
persons a day are currently being population. These numbers, of course, both older and younger recipients. Of
vaccinated with the first or second shot are overall averages and mask those who have received a full primary
and about 100,000 a day have recovered substantial differences by race and sex vaccine series, after the 14th day after
from infection and are only in very rare (among other factors), including access vaccination only 46 people over the age
cases still infectious. These changes to affordable health care and prevalence of 60 became infected and had a severe
reduce the risk to both health care staff of untreated or insufficiently controlled case, compared to 6 people under the
and patients substantially, likely by disease. Individuals with diabetes, for age of 60. Given that these numbers are
about 20 million persons a month who example, are disproportionately African compared against 2.9 million recipients
are no longer sources of future American and disproportionately older, of the second dose, both rates are near
infections.227 This in turn reduces the which leads to greater risks from kidney zero.233
number of newly infected cases failure and other adverse health effects, C. Anticipated Costs of the Interim Final
(currently about 100,000 a day and including greater susceptibility to the Rule With Comment Period
decreasing rapidly). Yet another variable ravages of COVID–19.230 Health care
of importance is the increasing number staff of most types of providers and We note that our cost estimates
of providers and suppliers that are suppliers are of typical working ages. assume that all additional vaccination
mandating employee vaccination, and But hospital patients, LTC facility costs for providers and suppliers
the increasing number of states that are residents, ESRD patients treated for regulated by this rule are due to this
doing so as well. To characterize the kidney failure, and most other patients rule. We estimate on this basis because
baseline scenario of no new regulatory are heavily weighted towards older ages we have no reliable way to estimate how
action, from which we estimate the and are disproportionately members of much of these costs might be equally
incremental impacts of the interim final due to independent employer decisions,
African American and Native American
rule, we assume that when Phase 1 of to other Federal standards, to State and
minority groups. This means that the
this IFC goes into effect, 75 percent of local mandates, or even to individual
morbidity and mortality reductions from
provider staff, 90 percent of LTC facility personal choices.
this rule when they are adjusted for the In our cost estimates we cover all
residents, and 80 percent of all other age ranges affected disproportionally
patients and clients will have been providers regulated by CMS for health
benefit racial minorities. and safety standards, but we often use
vaccinated, and that these rates will In particular, LTC facility residents
improve over time as a result of both LTC facilities for examples because they
are near the upper end of the age pose some of the greatest risks for
this rule and the other factors spectrum. For a statistically average LTC
previously discussed.228 COVID–19 morbidity and mortality. As
facility resident, the average pre- documented subsequently in this
These numbers leave a large range for COVID–19 life expectancy if death
the likely effects of this rule over time. analysis and in a research report on this
occurs while in the facility is likely to issue, about 1.5 million individuals
They do indicate, however, that many be on the order of 3 years or fewer but
cases of death or severe illness can be work in LTC facilities at any one
taking into account residents who time.234 A number of these individuals
prevented by increasing the number of recover and leave the facility and those
vaccinated persons, both for those work in multiple LTC facilities which
enrolled for skilled nursing services we may play additional roles in
vaccinated and for others they might estimate overall life expectancies to be
otherwise infect. As estimated in Table transmission.235 236 These individuals
about 5 years.231 We also estimate that are at high risk both to become ill with
6, the number of unvaccinated health vaccination reduces the chance of COVID–19 and to transmit the SARS-
care workers still remains in the infection by about 95 percent, and the
millions despite recent progress. As risk of death from the virus to a fraction 232 For patients in skilled nursing facilities,
discussed later in this analysis, we use average length of stay is less than a month. Hence,
the concept of the value per statistical 229 See ‘‘Valuing COVID–19 Mortality and turnover is far higher.
life and per statistical case to capture Morbidity Risk Reductions in U.S. Department of 233 See Dvir Aran, Estimating real-world COVID–
this major potential benefit, as Health and Human Services Regulatory Impact 19 vaccine effectiveness in Israel using aggregated
Analyses, https://aspe.hhs.gov/reports/valuing- counts, medRxiv, February 28, 2021, at https://
recommended by the Office of the covid-19-risk-reductions-hhs-rias. www.medrxiv.org/content/10.1101/
Assistant Secretary for Planning and 230 For an NIH summary of the racial disparities, 2021.02.05.21251139v3.full.pdf and Noa Dagan et
see https://www.niddk.nih.gov/health-information/ al, ‘‘BNT162b2 mRNA Covid-19 Vaccine in a
227 These data are taken from or calculated from kidney-disease/race-ethnicity. Nationwide Mass Vaccination Setting,’’ The New
the CDC COVID Data Tracker. For example, in 231 At age 80, the average life expectancy of a England Journal of Medicine, 2/24/2021, at https://
recent weeks the number of new daily cases has male is about 8 years and of females about 10 years, www.nejm.org/doi/full/10.1056/NEJMoa2101765.
234 Kaiser Family Foundation, COVID–19 and
been gradually decreasing from about 150,000 to or an overall average of about 9 years. Long term
about 90,000. Once the disease runs its course, care nursing home residents, however, have shorter Workers at Risk: Examining the Long-Term Care
almost all these people will have recovered. Hence, life expectancies because they have severe health Workforce, April 23, 2020, at https://www.kff.org/
jspears on DSK121TN23PROD with RULES2
we use the rough estimate that about 100,000 a day problems or would not have been admitted to a coronavirus-covid-19/issue-brief/covid-19-and-
have recovered in recent weeks. facility. For those who remain in a facility until workers-at-risk-examining-the-long-term-care-
228 Among long term care residents, the death the average life expectancy is about 2 years. workforce/.
235 https://www.ncbi.nlm.nih.gov/pmc/articles/
vaccinated percentage is now very close to 90 But some recover and leave so we have used 5 years
percent, but other categories of patients are as a reference point. See discussion at David B. PMC7267626/.
undoubtedly lower. That said, patients are heavily Reuben, ‘‘Medical Care for the Final Years of Life: 236 https://www.anderson.ucla.edu/faculty_
age-skewed towards higher ages where vaccination When you’re 83, It’s not going to be 20 years,’’ pages/keith.chen/papers/WP_Nursing_Home_
percentages are higher. JAMA, Dec. 23, 2009, 2686–2694. Networks_and_COVID19.pdf.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61605
CoV–2 virus to residents or visitors, or each year is the same as the number and facilities change their staffing and
among themselves. Far more than most entering each year, which is a hiring patterns. One recent study found
occupations, LTC facility work requires reasonable approximation to changes in about 17% of LTC nursing staff held
sustained close contact with multiple just a few years, but do not take account second jobs, and another recent study
persons daily. of the aging of the population over time. found that about 5% held more than one
In Table 6 we present estimates of We note that our estimates do not LTC job. The second study, moreover,
total numbers of staff individuals include a deduction for the overlap found that facilities with substantial
regulated under this rule, distinguishing among individuals who work in more staff sharing were disproportionally
between numbers at the beginning of a than one LTC facility. We know that this associated with as many as 49% of
year and at any one time during the number is substantial, but have no basis
nursing home COVID–19 cases.237
year, versus the much higher numbers for estimating its precise magnitude
BILLING CODE 4120–01–P
when turnover is considered. In Table 6 and, more importantly, how it may
we assume that the number departing change after this rule goes into effect
237 See Courtney Harold Van Houtven, Nicole
DePasquale, and Norma B. Coe, ‘‘Essential Long-
Term Care Workers Commonly Hold Second Jobs
and Double- or Triple-Duty Caregiving Roles,’’
Journal of the American Geriatrics Society, 27 April
jspears on DSK121TN23PROD with RULES2
2020, at https://
agsjournals.onlinelibrary.wiley.com/doi/full/
10.1111/jgs.16509 and M. Keith Chen, Judith A.
Chevalier, and Elisa F. Long, ‘‘Nursing home staff
networks and COVID–19,’’ PNAS, January 5, 2021,
at https://www.pnas.org/content/118/1/
e2015455118.
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61606 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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BILLING CODE 4120–01–C resident populations or staff counts during the course of a year or over time.
These figures are approximations, focus on numbers of individuals Depending on the average length of stay
because none of the data that is residing or working in the facility (that is, turnover) in different facilities,
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routinely collected and published on
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61607
an average population at any one time or education, we anticipate that some position.241 But with many employers
of, for example, 100 persons could be providers and suppliers will conduct already mandating vaccination, and
consistent with radically different such activities as a part of their with nearly all local (and distant) health
numbers of individuals, such as 112 procedures for ensuring compliance care employers requiring vaccination
individuals in one facility if one person with the provisions of this rule. Some under this rule, we expect that such
left each month and was replaced by staff counseling can take place in group effects will be minimized (with
another person, compared to 365 if one settings and some will take place on a exceptions for medical or other
person left each day and was replaced one-to-one level. What works best will exemptions as required by law). That
that same day by another person. depend on the circumstance of the said, currently there are endemic staff
As a specific example, we assume that employee and the best method for shortages for almost all categories of
about 90 percent of existing LTC facility conveying the information and employees at almost all kinds of health
residents and 75 percent of existing staff answering questions. Staff education, care providers and supplier and these
will have been vaccinated by the date using CDC or FDA materials, can also may be made worse if any substantial
Phase 1 of this IFC takes effect (we use take place in various formats and ways. number of unvaccinated employees
the same or similar assumptions for all Individualized counseling, staff leave health care employment
provider types). There will be many meetings, posters, bulletin boards, and altogether. In this regard, we note that
new persons in each category during the e-newsletters are all approaches that can because CMS does not regulate health
first full year of the regulation, and be used. Informal education may also and safety in physician and dental
likely almost all of these will have been occur as staff go about their daily duties, offices, or in non-health care settings
vaccinated elsewhere (for simplicity we and some who have been vaccinated such as assisted living facilities, those
also assume a base rate 95 percent for may promote vaccination to others. entities may provide alternative places
this group, almost all of whom will have Facilities may find that reward of employment for some of the staff
previously worked in a health care techniques, among other strategies, may currently working for providers and
facility requiring vaccination). help. For example, monetary or other suppliers subject to this IFC who refuse
As presented in the third numeric benefits such as paid days off could be vaccinations. On the other hand, staff
column of Table 6, the total number of given to staff who agree to vaccination. shortages might be offset by persons
employees or otherwise compensated Even simpler, the employer can bring returning to the labor market who were
individuals working in all these vaccination providers onsite to unwilling to work at locations where
different facilities over the course of a vaccinate staff (or both staff and some other employees are unvaccinated
year is about 13 million persons, which unvaccinated patients). Of importance and hence provide some risk, to those
is almost half again larger than the in such efforts, the value of who have completed the primary
annual average number of staff shown in immunization as a crucial component of vaccination series for COVID–19.
the first numeric column. A recent keeping patients healthy and well is Despite these uncertainties, we have
study, using data from detailed payroll already conveyed to staff about developed an estimate of staffing
records, found that median turnover influenza and pneumococcal vaccines. disruption costs, primarily to provide a
rates for all nurse staff in long term care COVID–19 vaccine persuasion can build complete cost picture even if this
facilities is approximately 90 percent a upon that knowledge. The most element is particularly uncertain. We
year, although other estimates are far important inducement will be the fear of note that these costs and benefits are
lower (see subsequent discussion).238 job loss, coupled with the examples set highly dependent on whether, for
We have not seen figures this high for by fellow vaccine-hesitant workers who example, staff vaccination refusals in
other provider types but some may are accepting vaccination more or less coming months are closer to 1 percent
approach this level—home health care simultaneously. than to 10 percent, and the extent to
is well known for high turnover rates.239 One hundred percent success is which increased confidence in the
Of course, most of these persons will unlikely. The HHS Guidelines for safety of working in a health care setting
have been vaccinated through other Regulatory Impact Analysis note that leads to offsetting increases in the return
means when they enter the facilities ‘‘[i]n most cases, the analysis focuses on of former health care employees to the
during the next year. That said, it is estimating the incremental compliance workforce. Both variables, in turn, may
likely that there will be approximately costs incurred by the regulated entities, depend in significant ways on the
2.4 million staff at the beginning or assuming full compliance with the
during the first year after this rule is overall labor market and on the ability
regulation, and government costs.’’ of telehealth measures to replace in-
published who will require vaccination These guidelines further recommend
(rightmost column of Table 6), possibly person staff to patient encounters. The
that ‘‘[a]nalysts should consider the net outcomes of staff turnover over time
preceded in some cases by counseling uncertainty associated with an
efforts or employer inducements. could easily exceed or offset the
assumption of full compliance and administrative and vaccination costs we
While this IFC does not expressly
provide analysis of alternative have estimated. We welcome comments
require COVID–19 vaccine counseling
assumptions, as appropriate.’’ 240 In and information on these issues.
238 Ashvin Gandhi et al, ‘‘High Nursing Staff
preparing this analysis, we have The techniques for staff counseling,
Turnover In Nursing Homes Offers Important identified several significant sources of education, and incentives are so
Quality Information,’’ Health Affairs, March 2021, uncertainty for these full-compliance numerous and varied that there is no
pages 384–391. estimates, one of which stands out. simple way to estimate likely costs. Staff
239 Ashvin Gandhi et al, ‘‘High Nursing Staff
If only one health care provider in an hesitancy may and likely will change
Turnover In Nursing Homes Offers Important
Quality Information,’’ Health Affairs, March 2021, area required staff vaccination, then over time as the benefits of vaccination
jspears on DSK121TN23PROD with RULES2
pages 384–391. Published estimates vary widely. those who refuse vaccination could quit become clear to increasing numbers of
For example, two recent sources said home health and obtain employment at another individuals working in health care
care staff turnover is about 65 percent. See https://
www.hcaoa.org/newsletters/caregiver-turnover-rate-
location in the same field or type of
241 See https://www.washingtonpost.com/local/
is-652-2021-home-care-benchmarking-study and
https://www.leadingage.org/sites/default/files/ 240 At https://aspe.hhs.gov/sites/default/files/ covid-vaccine-mandate-hospitals-virginia/2021/10/
Direct%20Care%20Workers%20Report private/pdf/242926/HHS_RIAGuidance.pdf, page 01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_
%20%20FINAL%20%282%29.pdf. 24. story.html, and .
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61608 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
settings. For purposes of estimation, we replaced by a slightly higher number of health care settings requiring
assume that, on average, one hour of new hires than would otherwise be vaccination and accept (or more likely
staff time or the equivalent will be needed, a roughly equivalent fraction of already have) vaccination. In a dynamic
devoted to counseling or incentives for the new hires will need to be vaccinated labor market such behaviors occur
each unvaccinated staff person, at the before they have patient contact. As a continuously on a massive scale. If net
same average hourly cost of about $75 result, we estimate the total costs of employment opportunities and job-
estimated for RNs in the Information vaccination to be approximately $466 seeking behaviors do not change (and
Collection analysis. We assume that million (2,390,000 unvaccinated there is no reason to believe they will),
these efforts occur during paid working employees x $195). We note again that these continuous adjustments will leave
hours and that all costs will be borne by these estimates do not reflect the factor health care providers and suppliers
the facility. Since we estimate that about that multiple vaccine mandates already subject to this rule with their desired
2.4 million employees will need to be do or will soon apply to many and staff levels, and former employees who
vaccinated (or replaced) in the first year perhaps most providers covered by our refused vaccination in jobs that do not
(rightmost column of Table 6), most in rule (employers’ own self-imposed require vaccination. Because job seeking
the first two months after this rule is mandates, State and local mandates, and and worker seeking are already
published, total costs would be about OSHA ETS, among others). This means operating on a massive scale in the
$180 million. This estimate assumes the costs of this rule are overestimated health care sector, there is no reason to
that the 2.4 million will be some mix of due to this factor, a conservative expect any massive new costs in such
existing and replacement staff. For assumption. routine functions as advertising jobs,
example, if 95% of the existing Our fourth and final major cost checking applicant employment history,
unvaccinated staff were vaccinated, and category is staffing and service familiarizing new employees with the
5% of the unvaccinated staff terminated, disruptions. As discussed previously, it nuances of the new employment setting,
then in addition to the normal turnover is possible there may be disruptions in training, and all the other steps and
of 2.7 million new hires (second column cases where substantial numbers of costs involved in the normal workings
of Table 6) an additional 114 thousand health care staff refuse vaccination and of the labor market.
(.05 × 2,270) persons would need to be As an example of the likely
are not granted exemptions and are
hired, with 95% of them already fully magnitude of hiring costs, one analysis
terminated, with consequences for
vaccinated and the remainder getting of direct hiring costs for workers in the
employers, employees, and patients. We long-term care sector (including LTC
vaccinated as a condition of hiring. For do not have a cost estimate for those,
purposes of this estimate we ignore the facilities, home health care, and ICFs-
since there are so many variables and IID) found that the direct costs of hiring
existence of exemptions. unknowns, and it is unclear how they new workers was on average about
A third major cost component of might be offset by reductions in current $2,500 in 2004.242 Assuming that this
compliance with this IFC is the staffing disruptions caused by staff amount should be raised to $4,000
vaccination, including both illness and quarantine once vaccination based on inflation since then, that a
administration and the vaccine itself. is more widespread. We believe, comparable estimate for higher skills
We estimate that the average cost of a however, that the disruptive forces are health care professions would be
vaccination is what the government weaker than the return to normality. As $6,000, and that health care workers
pays under Medicare: $20 × 2 = $40 for shown in Table 6, it is normal for there covered by this rule are half lower
two doses of a vaccine, and $20 × 2 for to be roughly 2.66 million new hires skilled and half higher skilled, the
vaccine administration of two doses, for (column two) in the health care settings recruitment and hiring cost for
a total of $80 per employee. For we address in this rule, compared to a additional hires equal to 5 percent of the
purposes of estimation (and not baseline of roughly 10.4 million staff normal annual hiring total of 2.4 million
reflecting any more knowledge than (column one). These new hires replace workers would be $600 million (an
recent press accounts), we further a roughly equal number of employees average of $5,000 × 120,000). (Costs
assume that there will be a ‘‘booster’’ leaving for one reason or another. could actually be lower because this
shot at the same cost, for a total Health care providers are already in the study is almost a decade old and
vaccination cost of $120 per employee. business of finding and hiring internet services have in recent years
While these vaccine costs are currently replacement workers on a large scale. made recruitment and job application
incurred by the Federal Government, we The terminated or self-terminated procedures far easier.)
include them to provide an estimate of workers are not going to disappear. An additional cost category may
total costs, regardless of who pays. In They still need to earn a living. Many result from COVID–19-related staff
addition, we expect that a significant of the non-clinical staff may will find shortages, discussed extensively earlier
amount of time—one hour on average— employment situations in settings that in this IFC. Although, as noted earlier,
will be used per employee in vaccine are not subject to vaccination mandates. COVID-related staff shortages are
planning, arrangement, and Cooks, for example, may migrate to occurring absent the rule due to
administration, and related activities for restaurant jobs. But in those cases, a numerous factors, such as infection,
three vaccinations per currently cook who would otherwise have been quarantine and staff illness. Shortages at
unvaccinated employee. Together with hired by a restaurant may find a newly their most acute prevent facilities from
the additional assumption that there vacant health care position requiring admitting as patients, clients, residents,
will be an hour RN time or the vaccination and accept (or more likely or participants persons they would
equivalent needed for arranging or already have) vaccination. Similarly, normally admit for treatment of diseases
administering vaccination, at an average nurses may find jobs in health care or conditions that would in many cases
jspears on DSK121TN23PROD with RULES2
cost for that hour of $75, the total cost settings that are not subject to result in death or serious disability. We
for vaccination compliance will be $195 vaccination mandates, such as most
per employee. We apply that cost to all schools or physician offices. But that 242 Dorie Seavey, The Cost of Frontline Turnover
currently unvaccinated employees. Like means that nurses who would otherwise in Long-Term Care,’’ Better Jobs Better Care Report,
Washington, DC: Institute for the Future of Aging
counseling and incentives, if 5% of the have been hired in schools or physician Services, American Association of Homes and
existing unvaccinated staff leave and are offices may find jobs in vacant jobs in Services for the Aging. 2004.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61609
are not aware of any data that would mandates. Moreover, the benefits of which permanently eliminated those
enable a reasonably accurate estimate of vaccination are not just the lives workers as sources of future care.243
the total medical morbidity and directly saved, but the resources that Table 7 shows all of the costs that we
mortality involved, but it is certainly vaccination frees up because hospital, have estimated. As previously
massive. While it is true that LTC facility, and rehabilitation beds are explained, much and perhaps most of
compliance with this rule may create now available and because health care these costs would be incurred under
some short-term disruption of current staff themselves are not being other concurrent mandates, including
staffing levels for some providers or incapacitated or killed by COVID–19 employer-specific decisions, other
suppliers in some places, there is no infection. The data on cumulative Federal standards, and some State and
reason to think that this will be a net COVID–19 cases among health care local government mandates. Since these
minus even in the short term, given the personnel show 677,000 cases (most of efforts overlap in scope, reach, and
magnitude of normal turnover and the which incapacitated workers at least timing, there is no basis for assigning
relatively small fraction of that turnover most of these costs to this rule or any
temporarily), and 2,200 deaths, all of
that will be due to vaccination other similar rule.
There are major uncertainties in these D. Anticipated Benefits of the Interim as illustrating all the estimating issues
estimates. One obvious example is Final Rule With Comment Period involved, but the same estimates,
whether vaccine efficacy will last more uncertainties, and calculations apply to
than the approximately 1 year proven to There will be more than 180 million all types of providers and suppliers in
date and whether boosters are staff, patients, and residents employed varying degrees.
needed.244 Some in the scientific or treated each year in the facilities
covered by this rule. In our analysis of HHS’s Guidelines for Regulatory
community believe that ‘‘booster’’ Impact Analysis outline a standard
first-year benefits of this rule we focus
vaccinations after 6 or 8 months would approach to valuing the health benefits
first on prevention of death among staff
be desirable to maintain a high level of of regulatory actions. The approach for
of facilities as well as on reduction in
protection against the predominant valuing mortality risk reductions is
disease severity. Second, we focus on
Delta version of the virus. Delta may be based on the value per statistical life
resulting benefits from avoiding
overtaken by other virus mutations, infection by unvaccinated staff among (VSL), which estimates individuals’
which creates another uncertainty. patients served in these facilities, who willingness to pay (WTP) to avoid fatal
Booster vaccination or use of vaccines are likely to benefit more substantially risks. The approach to valuing
whose licenses or EUAs have been because patients receiving health care in morbidity risk reductions is based on
amended to address new variants would such facilities are disproportionately measures of the WTP to avoid non-fatal
likely maintain the effectiveness of older than working age adults and are risks when specific estimates are
vaccination for residents and staff. At therefore more susceptible to severe available, and based on measures of the
this time, as to second (and succeeding) illness or death from COVID–19. A third duration and severity of the illness,
year effects we assume no further major group of beneficiaries are staff family including quality of life consequences,
changes in vaccine effectiveness. Yet members and caregivers and many other when suitable WTP estimates are not
another uncertainty is treatment costs, persons outside the health care settings available.246 Based on this approach, the
with a recently announced antiviral pill who staff might subsequently infect if Office of the Assistant Secretary for
that could potentially provide not vaccinated. We focus initially on Planning and Evaluation published a
substantial reductions in severity of LTC facilities because their residents report that develops an approach for
illness and subsequent treatment costs, and patients have been among the most valuing COVID–19 mortality and
on a time schedule as yet unknown.245 severely affected by COVID–19 as well morbidity risk reductions.
243 CDC Data Tracker, October 17, 2021 data, at risk to patients due to staff vaccination, especially preference monetization of the rule’s effect would
https://covid.cdc.gov/covid-data-tracker/#health- in a setting such as a LTC facility, is arguably an be that it yields minimal or negative benefits for
care-personnel. externality (a canonical market failure), and thus such staff members, even the ones for whom it
244 For a discussion of this issue, see Sumathi use of a VSL or VSLY estimate per avoided fatality prevents or reduces severity of COVID–19 infection.
Reddy, ‘‘How Long Do Covid-19 Vaccines Provide or life extension does not represent a divergence However, given the dynamic nature of the
jspears on DSK121TN23PROD with RULES2
Immunity?’’, The Wall Street Journal, April 13, from the concept of revealed preference. On the
pandemic, it may be that long-run equilibrium for
2021, at https://www.wsj.com/articles/how-long-do- other hand, staff members’ own risk raises the
covid-19-vaccines-provide-immunity-11618258094. COVID–19 vaccines has not been reached, in which
question of how to interpret their hesitation or
245 See Rebecca Robbins, ‘‘Merck Says It Has the unwillingness, in the absence of regulation, to case the simplistic approach just mentioned may be
First Antiviral Pill Found to Be Effective Against accept an intervention that achieves extensive misleading—and the use of a standard VSL or VSLY
Covid,’’ The New York Times, October 1, 2021. health protection for themselves, with little or no for staff-member risk evaluation may reflect
246 As noted above, various populations are out-of-pocket cost, and ever-lessening time or misunderstandings of either vaccine risks or
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directly or indirectly affected by this rule. Lessened inconvenience cost; a simplistic revealed- vaccine benefits.
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61610 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
In addition to the avoided death and The QALY and VSLY amounts used in (These amounts might reasonably be
human suffering, one of the major any estimate of overall benefits are not halved for average LTC facility
benefits of vaccination is that it lowers meant to be precise, but instead are residents, since non-institutionalized
the cost of treating the disease among rough statistical measures that allow an U.S. adults aged 80–89 years report
those who would might otherwise be overall estimate of benefits expressed in average health-related quality of life
infected and have serious morbidity dollars. (HRQL) scores of 0.753, and this figure
consequences. The largest part of those Under a common approach to benefit is likely to be lower for LTC facility
costs is for hospitalization. As discussed calculation, we can use a Value of a residents.252) Assuming that the average
later in the analysis we provide data on Statistical Life (VSL) to estimate the life expectancy of long term care
the average costs of hospitalization of dollar value of the life-saving benefits of residents is 5 years, the monetized
these patients (it is, however, unclear as a policy intervention, for a person who benefits of saving one statistical life
to how much that cost will change over more broadly represent a mixture of would be about $3.0 million ($590,000
time due to improving treatment ages. We use the VSL of approximately x annually for 5 years) at a 3 percent
options). $11.5 million in 2021 as described in discount rate and about $4.8 million
There is a potential offset to benefits the HHS Guidelines, adjusted for ($970,000 x annually for 5 years) at a 7
that we have not estimated because we changes in real income and inflated to percent discount rate. Assuming that the
believe it is at this time not relevant in 2020 dollars using the Consumer Price average rate of death from COVID–19
the U.S. If vaccine supplies did not meet Index.250 Using LTC facilities as an (SARS–CoV–2 infection) at LTC facility
all demands for vaccination, giving example, and assuming that the average resident ages and conditions is 5
priority to some persons over others rate of death from COVID–19 (following percent, and the average rate of death
necessarily meant that some persons SARS–CoV–2 infection) at typical LTC after vaccination is essentially zero, the
would become infected who would not facility resident ages and conditions is expected life-extending value of each
have been infected had the priorities 5 percent, and the average rate of death resident who would otherwise be
been reversed. In this case, however, the after vaccination is essentially zero, the infected is $150 thousand at a 3 percent
priority for older adults (virtually all of expected value of each resident who discount rate and $240 thousand at a 7
whom have risk factors) who comprise would, in the absence of this rule, percent discount rate. A similar
the majority of hospital inpatients and otherwise be infected with SARS–CoV– calculation can be made for staff and for
the vast majority of LTC facility 2 is about $575,000 ($11.5 million × the community residents they might
residents has already been established .05). For staff, who are generally of infect, who will gain many more years
and is largely met. This rule provides a working ages in roughly the same of life but whose risk of death is far
priority for staff at a far lower risk of proportions as the population at large, smaller since their age distribution is so
mortality and severe disease that the typical rate of death for the full much younger. Deaths from COVID–19
benefits both groups.247 It achieves this course of two vaccines (or possibly three in unvaccinated LTC facility residents
benefit because by preventing the with a booster) is roughly 1 percent of during 2020 were about 130,000, or
spread of COVID–19 from provider and the older adult rate, and the expected close to one tenth of the average LTC
supplier staff, it actually provides a value for each employee receiving the facility resident census of 1.4 million, a
higher mortality and morbidity same vaccinations is about $57,500 huge contrast to the handful of deaths
reduction for patients at far higher risk ($11.5 million × .005).251 For in the vaccination results from Israel.253
than the staff who become community residents who unvaccinated We do not have sufficient data so as to
vaccinated.248 staff might infect, the resulting
accurately estimate annual resident
The HHS ‘‘Guidelines for Regulatory calculation is similar (actually
inflows and outflows over time, but it is
Impact Analysis’’ explain in some detail somewhat lower because the risk of
clear that over two million new
the concept of Quality Adjusted Life death from COVID–19 is even lower for
residents and over 700,000 new
Years (QALYs).249 QALYs, when those below employment ages).
Under a second approach to benefit employees make the total number of
multiplied by a monetary estimate such individuals involved during the year far
as the Value of a Statistical Life Year calculation, we can estimate the
monetized value of extending the life of higher than point in time or average
(VSLY), are estimates of the value that counts. Moreover, these counts do not
people are willing to pay for life- LTC facility residents, which is based
on expectations of life expectancy and include family members and other
prolonging and life-improving health visitors, whose total visits certainly
care interventions of any kind (see the value per life-year. As explained in
the HHS Guidelines, the average number in the millions.
sections 3.2 and 3.3 of the HHS Most of the preceding calculations
Guidelines for a detailed explanation). individual in studies underlying the
VSL estimates is approximately 40 years address residential long-term care. Long
247 The risk of death from infection from an of age, allowing us to calculate a value term care residents are a major group
unvaccinated 75- to 84-year-old person is 320 times per life-year of approximately $590,000 within LTC facilities and are generally
more likely than the risk for an 18- to 29-years old and $970,000 for 3 and 7 percent in the LTC facility because their needs
person. CDC, ‘‘Risk for COVID–19 Infection, discount rates respectively. This are more substantial and they need
Hospitalization, and Death by Age Group’’, at assistance with the activities of daily
https://www.cdc.gov/coronavirus/2019-ncov/covid- estimate of a value per life-year
data/investigations-discovery/hospitalization- corresponds to 1 year at perfect health. living, such as cooking, bathing, and
death-by-age.html. dressing. These long-term stays are
248 We note that as long as most of the world’s 250 We note that the VSL is based on a sample of
population remains unvaccinated, another variant 252 Hanmer, J. W.F. Lawrence, J.P. Anderson, R.M.
individuals whose average age is 40, This leads to
of the vaccine might arise and create new risks or complexities in estimates for populations who are Kaplan, D.G. Fryback. 2006. ‘‘Report of Nationally
jspears on DSK121TN23PROD with RULES2
shifts in risks within the U.S. That said, the world- much younger or older, including LTC residents. Representative Values for the Noninstitutionalized
wide shortage of vaccines is essentially over taking See Lisa Robinson and James K. Hammit, ‘‘Valuing US Adult Population for 7 Health-Related Quality-
into account both stocks and existing Reductions in Fatal Illness Risks: Implications of of-Life Scores.’’ Medical Decision Making. 26(4):
manufacturing capacity and the biggest problem Recent Research,’’ Health Economics, August 2016, 391–400.
abroad is getting the available vaccines rapidly into pp. 1039–1052. 253 Deaths are from COVID–19 Nursing Home
the billions of people who need them. 251 For the full likelihood distributions for all age Data, CMS, Week Ending 2/21/2021, at https://
249 https://aspe.hhs.gov/pdf-report/guidelines- ranges, see the CDC age distribution table data.cms.gov/stories/s/COVID-19-Nursing-Home-
regulatory-impact-analysis. previously referenced . Data/bkwz-xpvg/.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61611
primarily funded by the Medicaid vaccination against COVID–19 is hospitalization, but that fraction is now
program (also, through long term care effective for at least 1 year and use a 1- far lower for the same reasons. For our
insurance or self-financed), and the year period as our primary framework estimates, we assume a 10 percent
custodial care services these residents for calculation of potential benefits, not hospitalization rate among people aged
receive are not normally covered by as a specific prediction but as a likely 65 years or older in LTC facilities,
Medicare or any other health scenario that avoids forecasting major reflecting both that their conditions are
insurance.254 A second major group and unexpected changes that are either significantly worse than those of
within the same facilities receives short- strongly adverse or strongly beneficial. similarly aged adults living
term skilled nursing care services. These If we were adding up totals for benefits independently, and that pre-
services are rehabilitative and generally we would assume that the risk of death hospitalization treatments have
last only days, weeks, or months. They after COVID–19 infection is likely only improved. For staff we assume one fifth
usually follow a hospital stay and are one-half of one percent (one tenth of the of this rate, or 2 percent. Using LTC
primarily funded by the Medicare resident rate) or less for the facilities as our main example, the LTC
program or other health insurance. The unvaccinated members of this group, facility candidates for vaccination in the
importance of these distinctions is that reflecting the far lower mortality rates first year covered by this rule, about
the numbers of residents and typical for persons who are almost all in the 18 three-fourths are age 65 years or above.
ages in each category regulated under to 65 year old age ranges compared to Hence, the age-weighted hospitalization
this rule in each category are different. the far older residents.256 We assume rate that we project is about 8 percent.
The average number of persons in that the total number of individual Among those hospitalized at any age,
facilities for long term care over the employees is 50 percent higher than the the average cost is about $20,000.258
course of a year is about 1.2 million full-time equivalent but that only half To put these cost, benefit, and volume
residents (as is the point-in-time that number are primarily employed at numbers in perspective, vaccinating one
number), and the total number of only one nursing facility, two offsetting hundred previously unvaccinated LTC
persons over the course of a year is assumptions about the number of facility residents who would otherwise
about 1.6 million. The average number employees working at each facility become infected with SARS–CoV–2 and
in skilled nursing care at any one time (many employees are part-time have a COVID–19 illness would cost
is about 2 thousand persons, because consultants or the equivalent who serve approximately $18,000 ($183 × 100) in
the average length of stay is weeks multiple nursing facilities on a part-time vaccination costs. Using the VSL
rather than years and the median length basis). We further assume that employee approach to estimation would produce
of stay is days rather than weeks.255 The turnover is 80 percent a year, lower than life-saving benefits of about $400,000 for
annual turnover in this group is such the results for nurses previously cited. these 100 people ($20,000 × 100 × .05),
that about 2.3 million residents are Accordingly, we estimate that 80 again assuming the death rate for those
served each year. There is some overlap percent of 950,000, or 760,000, are new ill from COVID–19 of this age and
between these two populations and the employees each year and must be condition is one in twenty. Reductions
same person may be admitted on more offered vaccination (again, most are in health care costs from hospitalization
than one occasion. For purposes of this already vaccinated), for a total of would produce another $160,000
analysis (these are rough estimates 1,710,000 eligible employees over the ($20,000 × 100 × .08) in benefits for this
because there are no data routinely course of a year. (This number would group assuming that 8 percent would
published on patient and resident likely drop in future years as employers otherwise be hospitalized. However,
turnover or providing unduplicated decide to hire only persons previously this comparison should be taken as
counts of persons served), we assume vaccinated and as vaccine uptake necessarily hypothetical and contingent
that the expected longevity for each increases due to Federal, State, local, or due to the analytic, data, and
group is identical on average, and that employer requirements, as well as uncertainty challenges discussed
a total of 3.9 million different persons individual choice.) throughout this regulatory impact
are served each year. The employee staff We have some data on the costs of assessment. Patient benefits are simply
are a third group and the direct target of treating serious illness among the a consequence of fewer infections
these rules. Since both long-term and unvaccinated who become infected, are among staff. Vaccinating one hundred
short-term residents are for the most hospitalized, and survive. Among those previously unvaccinated LTC facility
part served in the same facilities, their age 65 years or above, or with severe employees would be higher than for
care is managed and provided by the risk factors, over 30 percent of those staff. Life-saving benefits to employees
same facility staff. known to be infected required would be about $5,300,000 ($10,600,000
These nursing facilities have about hospitalization in the first year of the VSL × 100 × .005) for 100 people
950,000 full-time equivalent employees pandemic.257 That fraction is far lower assuming that the death rate for these far
at any one time and another 100,000 now as treatments have improved and younger 100 people is 1 in 500 hundred.
visiting staff or the equivalent, all as vaccinations have greatly reduced Reductions in health care costs from
covered by this rule. For these persons, severity of the disease. Among adults hospitalizations of employees would
the average age is about 45, which aged 21 years to 64 years, about 10 produce another $20,000 ($20,000 × 100
creates two offsetting effects: they have percent of those infected once required × .01).
more years of life expectancy than
residents, but their risk of death from 256 See the previously cited CDC report on risks 258 This is not a robust estimate but is supported
COVID–19 is far lower. For purposes of by age group. In the age intervals used by CDC, the by several sources. See for example Jiangzhuo Chen
40–49-year-old group is in the middle of typical et al, ‘‘Medical costs of keeping the US economy
this analysis, we assume that employment age ranges. The risk of death in this open during COVID–19,’’ Scientific Reports,
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age group is one tenth that of those aged 65–74. We Nature.com, July 19 2020, at https://
254 For a discussion on this problem, see emphasize with round numbers that nothing about pubmed.ncbi.nlm.nih.gov/32743613/, and Michel
‘‘Medicare and You: at https://www.medicare.gov/ these data is fixed and unlikely to change (for Kohli et al, ‘‘The potential public health and
medicare-and-you example, as better future treatments are used to economic value of a hypothetical COVID–19
255 In fact, the average length of stay for skilled treat severe cases). vaccine in the United States: Use of cost-
nursing care is about 25 days. See MEDPAC, Report 257 The New York Times ‘‘Nearly One-Third of effectiveness modeling to inform vaccination
to the Congress: Medicare Payment Policy, March U.S. Coronavirus Deaths Are Linked to Nursing prioritization,’’ Science Direct, February 12, 2021,
2019, ‘‘Skilled nursing facility services,’’ page 200. Homes, June 1, 2021. at https://pubmed.ncbi.nlm.nih.gov/33483216/.
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61612 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
There remain difficult questions of analysis are based on inferences from level needed for benefits to exceed
estimating (1) likely numbers of scattered data on average length of stay, costs, however, we estimate that either
individuals in staff and patient mortality, job vacancies, news accounts, saving 120 lives, or preventing 600
categories who are likely to be and other sources that by happenstance hundred hospitalizations for serious
unvaccinated when the rule goes into are available for one type of facility or illness, or any combination of these two
effect and (2) numbers of staff likely to type of resident or another. Nor do we magnitudes, would produce benefits
be willing to accept vaccination in the have data on the number of persons in that exceed our estimate of costs over
coming months and years.259 Both sets these settings who will be vaccinated the next year. There have been about
of numbers vary substantially by through other means during the 200 staff deaths in the last 6 months and
provider and supplier type. LTC facility remainder of the year. this is a likely undercount for this one
and home health care patients are on All these data and estimation category of persons alone, and potential
average both the oldest and most health- limitations apply to even the short-term life-saving benefits to more than 150
impaired of those in settings covered by impacts of this rule, and major million mostly elderly patients and
this rule. At the other extreme, rural and uncertainties remain as to the future residents (about 10 percent of whom are
other community-care oriented health course of the pandemic, including but likely to remain unvaccinated) who are
centers serve the full age spectrum and not limited to vaccine effectiveness in exposed to provider staff probably
a lower fraction of severely health- preventing ‘‘breakthrough’’ disease would be many times higher. We note,
impaired. transmission from those vaccinated, the however, as discussed in the preceding
We do know that the life-saving long-term effectiveness of vaccination, section on costs, much of these benefits
benefits for staff are probably small but the emergence of treatment options, and could be as well attributed to other
significant. During the entire period of the potential for some new disease concurrent and parallel vaccination
COVID–19 infections, since March 2020, variant even more dangerous than Delta. mandates and campaigns.
there have been over 2,000 health care Another unknown is what currently
staff deaths recorded by the CDC unvaccinated employees would do E. Other Effects
through October 3, 2021.260 Of these, when the vaccination deadline is 1. Sources of Payment
the great majority were in the year 2020. reached, and how rapidly those quitting
Even during the recent Delta variant rather than being vaccinated could be The initial costs of this rule fall
surge, health care staff deaths decreased replaced. Even a small fraction of almost entirely on health care providers
to lower levels. Specifically, during the recalcitrant unvaccinated employees and suppliers and are extremely small
last 6 months, April through September could disrupt facility operations. On the in comparison to the $4 trillion a year
2021, total staff deaths were 202, an other hand, there have been significant spent on health care, mostly through
average of 34 per month and no clear reductions in provider and supplier these same entities. In particular, the
trend (the last 4 weeks, all in staffing needs in some categories. For costs of the vaccines are paid by the
September, 2021 produced fewer than example, LTC facility admissions have Federal Government and vaccine costs
20 deaths). This is not surprising as the declined in the last year, as families and are about two-thirds of the total costs we
most effective precautions other than caregivers sought to avoid the risks of have estimated. Moreover, through the
vaccination—masks, social distancing, exposing a care recipient to treatment cost savings to the hospitals
and ventilation—have been essentially unvaccinated residents and staff in LTC and other care providers resulting from
universal in the health care sector facilities. The new vaccination the vaccinations that will be made due
during all of 2021. Even more requirement may reduce such fears and to this rule, significant savings would
importantly, vaccination rates are bring higher numbers of residents to accrue to payers. It is likely that half or
considerably higher than in the these facilities and the essential services more of these savings would primarily
population at large (although still well they provide. Again, we have no way to accrue to Medicare given the age or
below optimal levels). Yet, using the last estimate such behavioral changes. disability status of most clients and
6 months of CDC Data Tracker Regardless, we believe it is clear that Medicare’s role as primary payer, but
information, on an annual basis more reductions in patient/resident fatalities there would also be substantial savings
than 400 deaths could be expected. through avoiding staff-generated to Medicaid, private insurance paid by
These data, moreover, are almost all infections are both likely to be a employers and employees, and private
among unvaccinated persons and are significantly larger benefit from staff out-of-pocket payers including patients
probably undercounted in current data. vaccination than direct benefits to staff. and residents. In some rare cases funds
A major caution about these Staff vaccination will also provide under the CARES Act and the American
estimates: None of the sources of significant community benefits when Rescue Plan Act of 2021 might be
enrollment information for these staff are not at work. Hence, total lives available at State or local discretion, but
programs regularly collect and publish saved under this rule may well reach it is hard to foresee any substantial
information on client or staff turnover several hundred a month or perhaps budgetary impact on any insurance plan
during a year. These data have not several thousand a month for all three or service provider that would justify or
previously been found useful in groups in total. Patient and resident require such assistance.
program management for individual benefits are especially likely to be many
times higher because the risks of death 2. Regulatory Flexibility Act
agencies or programs, or when needed
have been addressed through one-time and serious disease complications are so The RFA requires agencies to analyze
research projects. The estimates in this many times higher among older persons options for regulatory relief of small
and people with multiple chronic entities, if a rule has a significant impact
conditions. on a substantial number of small
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259 For a survey of the evidence on this issue, see
Gillian K. Steelfisher et al, ‘‘An Uncertain Public— As indicated by the preceding entities. Under the RFA, ‘‘small
Encouraging Acceptance of Covid–19 Vaccines,’’ analysis, predicting the full range of entities’’ include small businesses,
The New England Journal of Medicine, March 3, benefits and costs in either the short run nonprofit organizations, and small
2021.
260 CDC Data Tracker at https://covid.cdc.gov/ or the next full year with any degree of governmental jurisdictions. Individuals
covid-data-tracker/#health-care-personnel_ estimating precision is all but and states are not included in the
healthcare-deaths. impossible. As the minimum benefit definition of a small entity. For
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61613
purposes of the RFA, we estimate that early indications are that rural hospitals Constitution, the agency intends that
most health care facilities are small are having greater problems with this rule preempts State and local laws
entities as that term is used in the RFA employee vaccination refusals than to the extent the State and local laws
because they are either nonprofit urban hospitals, and we welcome conflict with this rule. The agency has
organizations or meet the SBA comments on ways to ameliorate this considered other alternatives (for
definition of a small business (having problem. example, relying entirely on measures
revenues of less than $8.0 million to such as voluntary vaccination, source
4. Unfunded Mandates Reform Act
$41.5 million in any 1 year). HHS uses control alone, and social distancing) and
an increase in costs or decrease in Section 202 of the Unfunded has concluded that the mandate
revenues of more than 3 to 5 percent as Mandates Reform Act of 1995 (UMRA) established by this rule is the minimum
its measure of ‘‘significant economic requires that agencies assess anticipated regulatory action necessary to achieve
impact.’’ The HHS standard for costs and benefits before issuing any the objectives of the statute. Given the
‘‘substantial number’’ is 5 percent or rule whose mandates will impose contagion rates of the existing strains of
more of those that will be significantly spending costs on State, local, or tribal coronavirus and their disproportionate
impacted, but never fewer than 20. governments, or by the private sector, impacts on Medicare and Medicaid
As estimated previously, the total require spending in any 1 year of $100 beneficiaries, we believe that
costs of this rule for 1 year are about million in 1995 dollars, updated vaccination of almost all staff of covered
$1.3 billion, most of which is directly annually for inflation. In 2021, that providers and suppliers is necessary to
proportional to number of employees. threshold is approximately $158 promote and protect patient health and
Spread over 10.4 million full-time million. This rule contains no State, safety. The agency has examined case
equivalent employees, this is about $125 local, or tribal governmental mandates, studies from other employers and
per employee. Assuming a fully loaded but does contain mandates on private concludes that vaccine mandates are
average wage per employee of $90,000, sector entities that exceed this amount. vastly more effective than other
the first-year cost does not approach the However, this IFC was not preceded by measures at achieving ideal vaccination
3 percent threshold. Moreover, since a notice of proposed rulemaking, and rates and the resulting patient
much of these costs (in particular, the therefore the requirements of UMRA do protections from morbidity and
vaccine costs paid by the Federal not apply. The analysis in this RIA and mortality. Given the emergency
Government) will not fall on providers the preamble as a whole would, situation with respect to the Delta
or suppliers, the financial strain on however, meet the requirements of variant detailed more fully above, time
these facilities should be negligible. UMRA.
did not permit usual consultation
Finally, as previously discussed, there 5. Federalism procedures with the States, and such
are other concurrent mandates and consultation would therefore be
much of these costs could as well be Executive Order 13132 establishes
certain requirements that an agency impracticable. We are, however, inviting
attributed to those efforts. Therefore, the State and local comments on the
Department has determined that this must meet when it promulgates a
proposed rule (and subsequent final substance as well as legal issues
IFC will not have a significant economic presented by this rule, and on how we
impact on a substantial number of small rule) that imposes substantial direct
requirement costs on State and local can fulfill the statutory requirements for
entities and that a final RIA is not health and safety protections of patients
required. Finally, this IFC was not governments, preempts State law, or
otherwise has Federalism implications. if we were to exempt any providers or
preceded by a general notice of
This rule would pre-empt some State suppliers based on State or local
proposed rulemaking and the RFA
laws that prohibit employers from opposition to this rule.
requirement for a final regulatory
flexibility analysis does not apply to requiring their employees to be F. Alternatives Considered
final rules not preceded by a proposed vaccinated for COVID–19. Consistent
rule. Regardless, this RIA and the main with the Executive Order, we find that As discussed earlier in the preamble,
preamble, taken together, would meet State and local laws that forbid a major substantive alternative that we
the requirements for either an Initial or employers in the State or locality from considered was to limit COVID–19
Final Regulatory Flexibility Analysis. imposing vaccine requirements on vaccination requirements to full-time
employees directly conflict with this employees rather than to all persons
3. Small Rural Hospitals exercise of our statutory health and who may provide paid or unpaid
Section 1102(b) of the Act requires us safety authority to require vaccinations services, such as visiting specialists or
to prepare an RIA if a proposed rule for staff of the providers and suppliers volunteers, who are not on the regular
may have a significant impact on the subject to this rule. Similarly, to the payroll on a weekly or more frequent
operations of a substantial number of extent that State-run facilities that basis that is, individuals who work in
small rural hospitals. For purposes of receive Medicare and Medicaid funding the facility and in some cases
this requirement, we define a small are prohibited by State or local law from infrequently or unpredictably, as well as
rural hospital as a hospital that is imposing vaccine mandates on their individuals who are not on the payroll
located outside of a metropolitan employees, there is direct conflict at all. We concluded that covering these
statistical area and has fewer than 100 between the provisions of this rule persons would be readily manageable
beds. Because this rule has only the (requiring such mandates) and the State without creating major issues for
small impact per employee calculated or local law (forbidding them). As is compliance, enforcement, and record-
for RFA purposes, the Department has relevant here, this IFC preempts the keeping. We did not, however, include
determined that this IFC will not have applicability of any State or local law some categories of visitors who do not
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a significant impact on the operations of providing for exemptions to the extent have a business relationship with the
a substantial number of small rural such law provides broader grounds for provider, such as family member
hospitals. This IFC is also exempt exemptions than provided for by visitors. There are also many issues
because that provision of law only Federal law and are inconsistent with such as social isolation and loneliness
applies to final rules for which a this IFC. In these cases, consistent with related to potential discouragement of
proposed rule was published. That said, the Supremacy Clause of the visiting volunteers or family members.
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61614 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
We also considered whether it would procrastination. For those few staff reconsider in the future. We considered
be appropriate to limit COVID–19 absolutely unwilling to accept alternative timelines for implementation
vaccination requirements to staff who vaccination, it would simply delay the but decided that this would not only
have not previously been infected by day of final action and the day of hiring delay badly needed live-saving
SARS–CoV–2. There remain many a vaccinated replacement. In the case of compliance, but also provide little real
uncertainties about as to the strength the OPO rule, an entire organization had management benefit to providers and
and length of this immunity compared to be slowly reformed to achieve suppliers. Staff have had almost a year
to people who are vaccinated, and—in compliance. In the context of this rule, to consider COVID–19 vaccinations that
recognizing that—the CDC recommends and the lives at stake, there is no are in their own interests as well as vital
that previously infected individuals get obvious ethical or managerial reason to to patient protections and the protection
vaccinated. Exempting previously give a relative handful of vaccination- of other workers. In this regard we note
infected individuals would have resisting individuals more time until that one of the claimed barriers to
potentially reduced benefits while they leave the organization. It would vaccination has recently been removed,
reducing costs, both roughly in give management more time to find now that one vaccine is now no longer
proportion to the number affected. It replacements, but it is not at all clear emergency-authorized, but fully
would have also, complicated that this would be a fruitful grace licensed. We believe our requirements
administration and likely require period. provide more than enough time for
standards that do not now exist for As for a variation reducing payment reasonable counselling and other
reliably measuring the declining levels to non-performing providers, perhaps by management measures.
of antibodies over time in relation to Finally, we considered requiring daily
20 percent per patient over some
risk of reinfection. Because of current or weekly testing of unvaccinated
applicable time period, this would
CDC guidance and understanding of individuals. We have reviewed
arguably provide something better than
relevant scientific findings, we found scientific evidence on testing and found
an ‘‘all of nothing’’ removal from
that it was not warranted to exempt that vaccination is a more effective
provider status. It would require
previously infected individuals. infection control measure. As such, we
legislation but that is not a barrier to
Another option would be to devise a chose not to require such testing for
meeting E.O. 12866 analysis standards
standard with graduated compliance now but welcome comment. Of course,
and in some rules may be essential to
expectations such as 90 percent and nothing prevents a provider from
a valid benefit-cost analysis. The exercising testing precautions
then 95 percent and then 100 percent of
staff vaccinated and a time period in problem with this variation, however, is voluntarily in addition to vaccination.
which to reach each level. A variation that for most providers and suppliers is We note that nothing in this rule
of this would be to put providers on a it unlikely to be a realistic choice. removes the obligation on providers and
probationary period if they failed to Rather than accept lower payment suppliers to meet existing requirements
reach 100 percent compliance by the levels, management can simply to prevent the spread of infection,
date set in the rule, and were allowed terminate the unvaccinated employees, which in practice means that these
additional time in which to cross that a power they have with or without the entities may also conduct regular testing
last threshold. Yet another variation reduced payment alternative. Moreover, alongside such actions as source control
would be to reduce payment to it would be hard to devise a system that and physical distancing. CMS will
providers and suppliers not meeting the treated equally and fairly providers of continue to review the evidence and
standard after the initial deadline. We all sizes—whether with 5 or 50 stakeholder feedback on this issue.
recently put a phased system in place employees. We further note that CMS These and some lesser options are
for Organ Procurement Organizations already has and uses discretion in presented and discussed in the main
(OPOs), so we are not reflexively enforcement when inspectors find a preamble. We do not have reliable
opposed to such options.261 violation. Termination of provider dollar estimates for either costs or
Nonetheless, there are two major status is not normally an immediate benefits of any alternatives, for the
arguments against such a system in the consequence, as entities are typically reasons already discussed in the RIA
context of this rule. First, to have any given the opportunity to correct regarding the options we chose. We
usefulness the time periods would have deficiencies. Regardless, we welcome welcome comments on these or other
to have a reasonably extensive duration, comments on this overall option and its options.
such as a month each. But that would variations, and on the closely-related
option of simply adding a month to the G. Accounting Statement and Table
be almost the same as extending this
rule’s deadline for an extra several compliance deadline in this rule. We The Accounting Table summarizes
months. We do not believe that considered what standards to apply the quantified impact of this rule. It
extending the deadline to extend the regarding proof of compliance with covers only 1 year because there will
employment of staff who will simply exemptions requests base on medical likely be many developments regarding
delay vaccination or final refusal to the contraindications and religious treatments and vaccinations and their
last possible moment is in the interest objections. We decided to establish effects in future years and we have no
of other staff, patients, and patients who minimal compliance burdens for both way of knowing which will most likely
would utilize the provider for needed categories of exemptions. This decision occur. A longer period would be even
health care if they did not fear on the evidentiary standards could be more speculative than the current
unvaccinated staff. Second, it would not revisited should an abuse problem arise estimates. Nonetheless, assuming no
only delay the achievement of both staff on a significant scale. This may open major unforeseen events that would
the door to forged documents or false impinge on our estimates, we would
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and patient safety, but encourage
statements, and therefore validation of expect lower costs in future years if for
261 See Medicare and Medicaid Programs: Organ such claims raises administrative costs. no other reason than increases in the
Procurement Organizations Conditions for Accordingly, we have allowed for fraction of new hires already vaccinated
Coverage: Revisions to the Outcome Measure
Requirements for Organ Procurement
relatively relaxed standards for as well as other positive results from the
Organizations, 85 FR page 77898, December 2, verification in our administrative President’s plan or individual
2020. provisions and cost estimates but may vaccination decisions. We further note
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61615
that the vaccinations, and hence the CoV–2 on future infection rates, medical Statement (our first-year estimates are
benefits and costs, estimated for this costs, and prevention of major illness or for the last two months of 2021 and the
rule are more or less simultaneously mortality. For example, the duration of first ten months of 2022). We also show
being created voluntarily by some vaccine effectiveness in preventing a large range for the upper and lower
employers (self-mandates), through the COVID–19, reducing disease severity, bounds of potential costs to emphasize
OSHA vaccination rule applicable to reducing the risk of death, and the the uncertainty as to several major
employers of 100 or more persons, and effectiveness of the vaccine to prevent variables, such as changes in voluntary
by some State or local mandates. There disease transmission by those vaccination levels, longer term effects,
is no simple and non-arbitrary way to vaccinated are not currently known. and others previously discussed. We
disentangle which vaccination benefits These uncertainties also impinge on welcome comments on all of our
and which vaccination costs are due to benefits estimates. For those reasons we assumptions and welcome any
which source. have not quantified into annual totals additional information that would
As explained in various places within either the life-extending or medical cost- narrow the ranges of uncertainty or
this RIA and the preamble as a whole, reducing benefits of this rule and have guide us in any important revisions to
there are major uncertainties as to the used only a 1-year projection for the the requirements established in what is
effects of current variants of SARS– cost estimates in our Accounting an ‘‘interim’’ final rule.
In accordance with the provisions of 42 CFR Part 418 42 CFR Part 482
Executive Order 12866, this regulation
Health facilities, Hospice care, Grant program—-health, Hospitals,
was reviewed by the Office of
Medicare, Reporting and recordkeeping Medicaid, Medicare, Reporting and
Management and Budget. requirements. recordkeeping requirements.
Chiquita Brooks-LaSure,
Administrator of the Centers for 42 CFR Part 441 42 CFR Part 483
Medicare & Medicaid Services, Aged, Family planning, Grant
Grant programs—health, Health
approved this document on October 19, programs—health, Infants and children,
facilities, Health professions, Health
2021. Medicaid, Penalties, Reporting and
recordkeeping requirements. records, Medicaid, Medicare, Nursing
List of Subjects homes, Nutrition, Reporting and
42 CFR Part 460 recordkeeping requirements, Safety.
42 CFR Part 416
Aged, Citizenship and naturalization,
jspears on DSK121TN23PROD with RULES2
42 CFR Part 484
Health facilities, Health professions, Civil rights, Health, Health care, Health
Medicare, Reporting and recordkeeping records, Incorporation by reference, Administrative practice and
requirements. Individuals with disabilities, Medicaid, procedure, Grant programs—health,
Medicare, Religious discrimination, Health facilities, Health professions,
Reporting and recordkeeping Medicare, Reporting and recordkeeping
ER05NO21.032</GPH>
requirements. requirements.
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61616 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
42 CFR Part 485 (2) The policies and procedures of granted, an exemption from the staff
Grant programs—health, Health this section do not apply to the COVID–19 vaccination requirements;
following center staff: (viii) A process for ensuring that all
facilities, Medicaid, Privacy, Reporting
(i) Staff who exclusively provide documentation, which confirms
and recordkeeping requirements.
telehealth or telemedicine services recognized clinical contraindications to
42 CFR Part 486 outside of the center setting and who do COVID–19 vaccines and which supports
Administrative practice and not have any direct contact with staff requests for medical exemptions
procedure, Grant programs—health, patients and other staff specified in from vaccination, has been signed and
Health facilities, Home infusion paragraph (c)(1) of this section; and dated by a licensed practitioner, who is
(ii) Staff who provide support services not the individual requesting the
therapy, Medicare, Reporting and
for the center that are performed exemption, and who is acting within
recordkeeping requirements, X-rays.
exclusively outside of the center setting their respective scope of practice as
42 CFR Part 491 and who do not have any direct contact defined by, and in accordance with, all
Grant programs—health, Health with patients and other staff specified in applicable State and local laws, and for
facilities, Medicaid, Medicare, paragraph (c)(1) of this section. further ensuring that such
Reporting and recordkeeping (3) The policies and procedures must documentation contains:
requirements, Rural and urban areas. include, at a minimum, the following (A) All information specifying which
components: of the authorized or licensed COVID–19
42 CFR Part 494 (i) A process for ensuring all staff vaccines are clinically contraindicated
Diseases, Health facilities, specified in paragraph (c)(1) of this for the staff member to receive and the
Incorporation by reference, Medicare, section (except for those staff who have recognized clinical reasons for the
Reporting and recordkeeping pending requests for, or who have been contraindications; and
requirements. granted, exemptions to the vaccination (B) A statement by the authenticating
requirements of this section, or those practitioner recommending that the staff
For the reasons set forth in the member be exempted from the center’s
preamble, the Centers for Medicare & staff for whom COVID–19 vaccination
must be temporarily delayed, as COVID–19 vaccination requirements
Medicaid Services amends 42 CFR based on the recognized clinical
chapter IV as set forth below: recommended by the CDC, due to
clinical precautions and considerations) contraindications;
(ix) A process for ensuring the
PART 416—AMBULATORY SURGICAL have received, at a minimum, a single-
tracking and secure documentation of
SERVICES dose COVID–19 vaccine, or the first
the vaccination status of staff for whom
dose of the primary vaccination series
■ 1. The authority citation for part 416 COVID–19 vaccination must be
for a multi-dose COVID–19 vaccine,
continues to read as follows: temporarily delayed, as recommended
prior to staff providing any care,
by the CDC, due to clinical precautions
Authority: 42 U.S.C. 1302 and 1395hh. treatment, or other services for the
and considerations, including, but not
center and/or its patients;
■ 2. Amend § 416.51 by adding limited to, individuals with acute
paragraph (c) to read as follows: (ii) A process for ensuring that all staff
illness secondary to COVID–19, and
specified in paragraph (c)(1) of this
individuals who received monoclonal
§ 416.51 Conditions for coverage— section are fully vaccinated, except for
antibodies or convalescent plasma for
Infection control. those staff who have been granted
COVID–19 treatment; and
* * * * * exemptions to the vaccination (x) Contingency plans for staff who
(c) Standard: COVID–19 vaccination requirements of this section, or those are not fully vaccinated for COVID–19.
of staff. The ASC must develop and staff for whom COVID–19 vaccination
implement policies and procedures to must be temporarily delayed, as PART 418—HOSPICE CARE
ensure that all staff are fully vaccinated recommended by the CDC, due to
for COVID–19. For purposes of this clinical precautions and considerations; ■ 3. The authority citation for part 418
section, staff are considered fully (iii) A process for ensuring the continues to read as follow:
vaccinated if it has been 2 weeks or implementation of additional Authority: 42 U.S.C. 1302 and 1395hh.
more since they completed a primary precautions, intended to mitigate the
■ 4. Amend § 418.60 by adding
vaccination series for COVID–19. The transmission and spread of COVID–19,
paragraph (d) to read as follows:
completion of a primary vaccination for all staff who are not fully vaccinated
series for COVID–19 is defined here as for COVID–19; § 418.60 Condition of participation:
the administration of a single-dose (iv) A process for tracking and Infection control.
vaccine, or the administration of all securely documenting the COVID–19 * * * * *
required doses of a multi-dose vaccine. vaccination status of all staff specified (d) Standard: COVID–19 Vaccination
(1) Regardless of clinical in paragraph (c)(1) of this section; of facility staff. The hospice must
responsibility or patient contact, the (v) A process for tracking and securely develop and implement policies and
policies and procedures must apply to documenting the COVID–19 vaccination procedures to ensure that all staff are
the following center staff, who provide status of any staff who have obtained fully vaccinated for COVID–19. For
any care, treatment, or other services for any booster doses as recommended by purposes of this section, staff are
the center and/or its patients: the CDC; considered fully vaccinated if it has
(i) Center employees; (vi) A process by which staff may been 2 weeks or more since they
(ii) Licensed practitioners; request an exemption from the staff completed a primary vaccination series
jspears on DSK121TN23PROD with RULES2
(iii) Students, trainees, and COVID–19 vaccination requirements for COVID–19. The completion of a
volunteers; and based on an applicable Federal law; primary vaccination series for COVID–
(iv) Individuals who provide care, (vii) A process for tracking and 19 is defined here as the administration
treatment, or other services for the securely documenting information of a single-dose vaccine, or the
center and/or its patients, under provided by those staff who have administration of all required doses of a
contract or by other arrangement. requested, and for whom the center has multi-dose vaccine.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61617
(1) Regardless of clinical (iv) A process for tracking and § 441.151 General requirements.
responsibility or patient contact, the securely documenting the COVID–19 * * * * *
policies and procedures must apply to vaccination status of all staff specified (c) COVID–19 Vaccination of facility
the following hospice staff, who provide in paragraph (d)(1) of this section; staff. The facility must develop and
any care, treatment, or other services for (v) A process for tracking and securely implement policies and procedures to
the hospice and/or its patients: documenting the COVID–19 vaccination ensure that all staff are fully vaccinated
(i) Hospice employees; status of any staff who have obtained for COVID–19. For purposes of this
(ii) Licensed practitioners; any booster doses as recommended by section, staff are considered fully
(iii) Students, trainees, and the CDC; vaccinated if it has been 2 weeks or
volunteers; and (vi) A process by which staff may more since they completed a primary
(iv) Individuals who provide care, request an exemption from the staff vaccination series for COVID–19. The
treatment, or other services for the COVID–19 vaccination requirements completion of a primary vaccination
hospice and/or its patients, under based on an applicable Federal law; series for COVID–19 is defined here as
contract or by other arrangement. (vii) A process for tracking and the administration of a single-dose
(2) The policies and procedures of securely documenting information vaccine, or the administration of all
this section do not apply to the provided by those staff who have required doses of a multi-dose vaccine.
following hospice staff: requested, and for whom the hospice (1) Regardless of clinical
(i) Staff who exclusively provide has granted, an exemption from the staff responsibility or resident contact, the
telehealth or telemedicine services COVID–19 vaccination requirements; policies and procedures must apply to
outside of the settings where hospice (viii) A process for ensuring that all the following facility staff, who provide
services are provided to patients and documentation, which confirms any care, treatment, or other services for
who do not have any direct contact with recognized clinical contraindications to the facility and/or its residents:
patients, patient families and caregivers, COVID–19 vaccines and which supports (i) Facility employees;
and other staff specified in paragraph staff requests for medical exemptions (ii) Licensed practitioners;
(d)(1) of this section; and from vaccination, has been signed and (iii) Students, trainees, and
(ii) Staff who provide support services dated by a licensed practitioner, who is volunteers; and
for the hospice that are performed not the individual requesting the (iv) Individuals who provide care,
exclusively outside of the settings where exemption, and who is acting within treatment, or other services for the
hospice services are provided to their respective scope of practice as facility and/or its residents, under
patients and who do not have any direct defined by, and in accordance with, all contract or by other arrangement.
contact with patients, patient families applicable State and local laws, and for (2) The policies and procedures of
and caregivers, and other staff specified further ensuring that such this section do not apply to the
in paragraph (d)(1) of this section. documentation contains: following facility staff:
(3) The policies and procedures must (A) All information specifying which (i) Staff who exclusively provide
include, at a minimum, the following of the authorized COVID–19 vaccines telehealth or telemedicine services
components: are clinically contraindicated for the outside of the facility setting and who
(i) A process for ensuring all staff staff member to receive and the do not have any direct contact with
specified in paragraph (d)(1) of this recognized clinical reasons for the residents and other staff specified in
section (except for those staff who have contraindications; and paragraph (c)(1) of this section; and
pending requests for, or who have been (B) A statement by the authenticating (ii) Staff who provide support services
granted, exemptions to the vaccination practitioner recommending that the staff for the facility that are performed
requirements of this section, or those member be exempted from the hospice’s exclusively outside of the center setting
staff for whom COVID–19 vaccination COVID–19 vaccination requirements for and who do not have any direct contact
must be temporarily delayed, as staff based on the recognized clinical with residents and other staff specified
recommended by the CDC, due to contraindications; in paragraph (c)(1) of this section.
clinical precautions and considerations) (ix) A process for ensuring the (3) The policies and procedures must
have received, at a minimum, a single- tracking and secure documentation of include, at a minimum, the following
dose COVID–19 vaccine, or the first the vaccination status of staff for whom components:
dose of the primary vaccination series COVID–19 vaccination must be (i) A process for ensuring all staff
for a multi-dose COVID–19 vaccine temporarily delayed, as recommended specified in paragraph (c)(1) of this
prior to staff providing any care, by the CDC, due to clinical precautions section (except for those staff who have
treatment, or other services for the and considerations, including, but not pending requests for, or who have been
hospice and/or its patients; limited to, individuals with acute granted, exemptions to the vaccination
(ii) A process for ensuring that all staff illness secondary to COVID–19, and requirements of this section, or those
specified in paragraph (d)(1) of this individuals who received monoclonal staff for whom COVID–19 vaccination
section are fully vaccinated, except for antibodies or convalescent plasma for must be temporarily delayed, as
those staff who have been granted COVID–19 treatment; and recommended by the CDC, due to
exemptions to the vaccination (x) Contingency plans for staff who clinical precautions and considerations)
requirements of this section, or those are not fully vaccinated for COVID–19. have received, at a minimum, a single-
staff for whom COVID–19 vaccination dose COVID–19 vaccine, or the first
must be temporarily delayed, as PART 441—SERVICES: dose of the primary vaccination series
recommended by the CDC, due to REQUIREMENTS AND LIMITS for a multi-dose COVID–19 vaccine
clinical precautions and considerations; APPLICABLE TO SPECIFIC SERVICES prior to staff providing any care,
jspears on DSK121TN23PROD with RULES2
(iii) A process for ensuring the ■ 5. The authority citation for part 441 treatment, or other services for the
implementation of additional continues to read as follows: facility and/or its residents;
precautions, intended to mitigate the (ii) A process for ensuring that all staff
transmission and spread of COVID–19, Authority: 42 U.S.C. 1302. specified in paragraph (c)(1) of this
for all staff who are not fully vaccinated ■ 6. Amend § 441.151 by adding section are fully vaccinated for COVID–
for COVID–19; paragraph (c) to read as follows: 19, except for those staff who have been
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61618 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
granted exemptions to the vaccination individuals who received monoclonal (3) The policies and procedures must
requirements of this section, or those antibodies or convalescent plasma for include, at a minimum, the following
staff for whom COVID–19 vaccination COVID–19 treatment; and components:
must be temporarily delayed, as (x) Contingency plans for staff who (i) A process for ensuring all staff
recommended by the CDC, due to are not fully vaccinated for COVID–19. specified in paragraph (d)(1) of this
clinical precautions and considerations; section (except for those staff who have
(iii) A process for ensuring that the PART 460—PROGRAMS OF ALL- pending requests for, or who have been
facility follows nationally recognized INCLUSIVE CARE FOR THE ELDERLY granted, exemptions to the vaccination
infection prevention and control (PACE) requirements of this section, or those
guidelines intended to mitigate the staff for whom COVID–19 vaccination
transmission and spread of COVID–19, ■ 7. The authority citation for part 460 must be temporarily delayed, as
and which must include the continues to read as follow: recommended by the CDC, due to
implementation of additional Authority: 42 U.S.C. 1302, 1395, clinical precautions and considerations)
precautions for all staff who are not 1395eee(f), and 1396u–4(f). have received, at a minimum, a single-
fully vaccinated for COVID–19; dose COVID–19 vaccine, or the first
■ 8. Amend § 460.74 by adding
(iv) A process for tracking and dose of the primary vaccination series
paragraph (d) to read as follows:
securely documenting the COVID–19 for a multi-dose COVID–19 vaccine
vaccination status of all staff specified § 460.74 Infection control. prior to staff providing any care,
in paragraph (c)(1) of this section; * * * * * treatment, or other services for the
(v) A process for tracking and securely (d) COVID–19 Vaccination of PACE PACE organization and/or its
documenting the COVID–19 vaccination organization staff. The PACE participants;
status of any staff who have obtained organization must develop and (ii) A process for ensuring that all staff
any booster doses as recommended by implement policies and procedures to specified in paragraph (d)(1) of this
the CDC; ensure that all staff are fully vaccinated section are fully vaccinated for COVID–
(vi) A process by which staff may 19, except for those staff who have been
for COVID–19. For purposes of this
request an exemption from the staff granted exemptions to the vaccination
section, staff are considered fully
COVID–19 vaccination requirements requirements of this section, or those
vaccinated if it has been 2 weeks or
based on an applicable Federal law; staff for whom COVID–19 vaccination
(vii) A process for tracking and more since they completed a primary
vaccination series for COVID–19. The must be temporarily delayed, as
securely documenting information recommended by the CDC, due to
provided by those staff who have completion of a primary vaccination
series for COVID–19 is defined here as clinical precautions and considerations;
requested, and for whom the facility has (iii) A process for ensuring the
granted, an exemption from the staff the administration of a single-dose
implementation of additional
COVID–19 vaccination requirements; vaccine, or the administration of all
precautions, intended to mitigate the
(viii) A process for ensuring that all required doses of a multi-dose vaccine.
transmission and spread of COVID–19,
documentation, which confirms (1) Regardless of clinical
for all staff who are not fully vaccinated
recognized clinical contraindications to responsibility or participant contact, the
for COVID–19;
COVID–19 vaccines and which supports policies and procedures must apply to (iv) A process for tracking and
staff requests for medical exemptions the following PACE organization staff, securely documenting the COVID–19
from vaccination, has been signed and who provide any care, treatment, or vaccination status of all staff specified
dated by a licensed practitioner, who is other services for the PACE organization in paragraph (d)(1) of this section;
not the individual requesting the and/or its participants: (v) A process for tracking and securely
exemption, and who is acting within (i) PACE organization employees; documenting the COVID–19 vaccination
their respective scope of practice as (ii) Licensed practitioners providing status of any staff who have obtained
defined by, and in accordance with, all services on behalf of the PACE any booster doses as recommended by
applicable State and local laws, and for organization; the CDC;
further ensuring that such (iii) Students, trainees, and volunteers (vi) A process by which staff may
documentation contains: providing services on behalf of the request an exemption from the staff
(A) All information specifying which PACE organization; and COVID–19 vaccination requirements
of the authorized COVID–19 vaccines (iv) Individuals who provide care, based on an applicable Federal law;
are clinically contraindicated for the treatment, or other services on behalf of (vii) A process for tracking and
staff member to receive and the the PACE organization, under contract securely documenting information
recognized clinical reasons for the or by other arrangement. provided by those staff who have
contraindications; and (2) The policies and procedures of requested, and for whom the PACE
(B) A statement by the authenticating this section do not apply to the organization has granted, an exemption
practitioner recommending that the staff following PACE organization staff: from the staff COVID–19 vaccination
member be exempted from the facility’s (i) Staff who exclusively provide requirements based on recognized
COVID–19 vaccination requirements for telehealth or telemedicine services for clinical contraindications or applicable
staff based on the recognized clinical the PACE organization and/or its Federal laws;
contraindications; participants and who do not have any (viii) A process for ensuring that all
(ix) A process for ensuring the direct contact with participants and documentation, which confirms
tracking and secure documentation of other PACE organization staff specified recognized clinical contraindications to
the vaccination status of staff for whom in paragraph (d)(1) of this section; and COVID–19 vaccines and which supports
jspears on DSK121TN23PROD with RULES2
COVID–19 vaccination must be (ii) Staff who provide support services staff requests for medical exemptions
temporarily delayed, as recommended for the PACE organization and/or its from vaccination, has been signed and
by the CDC, due to clinical precautions participants and who do not have any dated by a licensed practitioner, who is
and considerations, including, but not direct contact with participants and not the individual requesting the
limited to, individuals with acute other PACE organization staff specified exemption, and who is acting within
illness secondary to COVID–19, and in paragraph (d)(1) of this section. their respective scope of practice as
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61619
defined by, and in accordance with, all (iii) Students, trainees, and COVID–19 vaccination requirements
applicable State and local laws, and for volunteers; and based on an applicable Federal law;
further ensuring that such (iv) Individuals who provide care, (vii) A process for tracking and
documentation contains: treatment, or other services for the securely documenting information
(A) All information specifying which hospital and/or its patients, under provided by those staff who have
of the authorized COVID–19 vaccines contract or by other arrangement. requested, and for whom the hospital
are clinically contraindicated for the (2) The policies and procedures of has granted, an exemption from the staff
staff member to receive and the this section do not apply to the COVID–19 vaccination requirements;
recognized clinical reasons for the following hospital staff: (viii) A process for ensuring that all
contraindications; and (i) Staff who exclusively provide documentation, which confirms
(B) A statement by the authenticating telehealth or telemedicine services recognized clinical contraindications to
practitioner recommending that the staff outside of the hospital setting and who COVID–19 vaccines and which supports
member be exempted from the PACE do not have any direct contact with staff requests for medical exemptions
organization’s COVID–19 vaccination patients and other staff specified in from vaccination, has been signed and
requirements for staff based on the paragraph (g)(1) of this section; and dated by a licensed practitioner, who is
recognized clinical contraindications; (ii) Staff who provide support services not the individual requesting the
(ix) A process for ensuring the for the hospital that are performed exemption, and who is acting within
tracking and secure documentation of exclusively outside of the hospital their respective scope of practice as
the vaccination status of staff for whom setting and who do not have any direct defined by, and in accordance with, all
COVID–19 vaccination must be contact with patients and other staff applicable State and local laws, and for
temporarily delayed, as recommended specified in paragraph (g)(1) of this further ensuring that such
by the CDC, due to clinical precautions section. documentation contains:
and considerations, including, but not (3) The policies and procedures must (A) All information specifying which
limited to, individuals with acute include, at a minimum, the following of the authorized COVID–19 vaccines
illness secondary to COVID–19, and components: are clinically contraindicated for the
individuals who received monoclonal (i) A process for ensuring all staff staff member to receive and the
antibodies or convalescent plasma for specified in paragraph (g)(1) of this recognized clinical reasons for the
COVID–19 treatment; and section (except for those staff who have contraindications; and
(x) Contingency plans for staff who pending requests for, or who have been (B) A statement by the authenticating
are not fully vaccinated for COVID–19. granted, exemptions to the vaccination practitioner recommending that the staff
requirements of this section, or those member be exempted from the
PART 482—CONDITIONS OF staff for whom COVID–19 vaccination hospital’s COVID–19 vaccination
PARTICIPATION FOR HOSPITALS must be temporarily delayed, as requirements for staff based on the
recommended by the CDC, due to recognized clinical contraindications;
■ 9. The authority citation for part 482 clinical precautions and considerations) (ix) A process for ensuring the
continues to read as follows: have received, at a minimum, a single- tracking and secure documentation of
Authority: 42 U.S.C. 1302, 1395hh, and dose COVID–19 vaccine, or the first the vaccination status of staff for whom
1395rr, unless otherwise noted. dose of the primary vaccination series COVID–19 vaccination must be
■ 10. Amend § 482.42 by adding for a multi-dose COVID–19 vaccine temporarily delayed, as recommended
paragraph (g) to read as follows: prior to staff providing any care, by the CDC, due to clinical precautions
treatment, or other services for the and considerations, including, but not
§ 482.42 Condition of participation: hospital and/or its patients; limited to, individuals with acute
Infection prevention and control and (ii) A process for ensuring that all staff illness secondary to COVID–19, and
antibiotic stewardship programs. specified in paragraph (g)(1) of this individuals who received monoclonal
* * * * * section are fully vaccinated for COVID– antibodies or convalescent plasma for
(g) Standard: COVID–19 Vaccination 19, except for those staff who have been COVID–19 treatment; and
of hospital staff. The hospital must granted exemptions to the vaccination (x) Contingency plans for staff who
develop and implement policies and requirements of this section, or those are not fully vaccinated for COVID–.
procedures to ensure that all staff are staff for whom COVID–19 vaccination
fully vaccinated for COVID–19. For must be temporarily delayed, as PART 483—REQUIREMENTS FOR
purposes of this section, staff are recommended by the CDC, due to STATES AND LONG TERM CARE
considered fully vaccinated if it has clinical precautions and considerations; FACILITIES
been 2 weeks or more since they (iii) A process for ensuring the
■ 11. The authority citation for part 483
completed a primary vaccination series implementation of additional
for COVID–19. The completion of a precautions, intended to mitigate the continues to read as follows:
primary vaccination series for COVID– transmission and spread of COVID–19, Authority: 42 U.S.C. 1302, 1320a–7, 1395i,
19 is defined here as the administration for all staff who are not fully vaccinated 1395hh and 1396r.
of a single-dose vaccine, or the for COVID–19; ■ 12. Amend § 483.80 by revising
administration of all required doses of a (iv) A process for tracking and paragraph (d)(3)(v) and adding
multi-dose vaccine. securely documenting the COVID–19 paragraph (i) to read as follows:
(1) Regardless of clinical vaccination status of all staff specified
responsibility or patient contact, the in paragraph (g)(1) of this section; § 483.80 Infection control.
(v) A process for tracking and securely (d) * * *
jspears on DSK121TN23PROD with RULES2
policies and procedures must apply to
the following hospital staff, who documenting the COVID–19 vaccination (3) * * *
provide any care, treatment, or other status of any staff who have obtained (v) The resident or resident
services for the hospital and/or its any booster doses as recommended by representative, has the opportunity to
patients: the CDC; accept or refuse a COVID–19 vaccine,
(i) Hospital employees; (vi) A process by which staff may and change their decision; and
(ii) Licensed practitioners; request an exemption from the staff * * * * *
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61620 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
(i) COVID–19 Vaccination of facility staff for whom COVID–19 vaccination ■ 13. Amend § 483.430 by revising
staff. The facility must develop and must be temporarily delayed, as paragraph (f) to read as follows:
implement policies and procedures to recommended by the CDC, due to
ensure that all staff are fully vaccinated clinical precautions and considerations; § 483.430 Condition of participation:
Facility staffing.
for COVID–19. For purposes of this (iii) A process for ensuring the
section, staff are considered fully implementation of additional * * * * *
vaccinated if it has been 2 weeks or precautions, intended to mitigate the (f) Standard: COVID–19 Vaccination
more since they completed a primary transmission and spread of COVID–19, of facility staff. The facility must
vaccination series for COVID–19. The for all staff who are not fully vaccinated develop and implement policies and
completion of a primary vaccination for COVID–19; procedures to ensure that all staff are
series for COVID–19 is defined here as (iv) A process for tracking and fully vaccinated for COVID–19. For
the administration of a single-dose securely documenting the COVID–19 purposes of this section, staff are
vaccine, or the administration of all vaccination status of all staff specified considered fully vaccinated if it has
required doses of a multi-dose vaccine. in paragraph (i)(1) of this section; been 2 weeks or more since they
(1) Regardless of clinical (v) A process for tracking and securely completed a primary vaccination series
responsibility or resident contact, the documenting the COVID–19 vaccination for COVID–19. The completion of a
policies and procedures must apply to status of any staff who have obtained primary vaccination series for COVID–
the following facility staff, who provide any booster doses as recommended by 19 is defined here as the administration
any care, treatment, or other services for the CDC; of a single-dose vaccine, or the
the facility and/or its residents: (vi) A process by which staff may administration of all required doses of a
(i) Facility employees; request an exemption from the staff multi-dose vaccine.
(ii) Licensed practitioners; COVID–19 vaccination requirements (1) Regardless of clinical
(iii) Students, trainees, and based on an applicable Federal law; responsibility or client contact, the
volunteers; and (vii) A process for tracking and policies and procedures must apply to
(iv) Individuals who provide care, securely documenting information the following facility staff, who provide
treatment, or other services for the provided by those staff who have any care, treatment, or other services for
facility and/or its residents, under requested, and for whom the facility has the facility and/or its clients:
contract or by other arrangement. granted, an exemption from the staff (i) Facility employees;
(2) The policies and procedures of COVID–19 vaccination requirements; (ii) Licensed practitioners;
this section do not apply to the (viii) A process for ensuring that all (iii) Students, trainees, and
following facility staff: documentation, which confirms volunteers; and
(i) Staff who exclusively provide recognized clinical contraindications to
(iv) Individuals who provide care,
telehealth or telemedicine services COVID–19 vaccines and which supports
treatment, or other services for the
outside of the facility setting and who staff requests for medical exemptions
facility and/or its clients, under contract
do not have any direct contact with from vaccination, has been signed and
or by other arrangement.
residents and other staff specified in dated by a licensed practitioner, who is
paragraph (i)(1) of this section; and (2) The policies and procedures of
not the individual requesting the
(ii) Staff who provide support services this section do not apply to the
exemption, and who is acting within
for the facility that are performed following facility staff:
their respective scope of practice as
exclusively outside of the facility setting defined by, and in accordance with, all (i) Staff who exclusively provide
and who do not have any direct contact applicable State and local laws, and for telehealth or telemedicine services
with residents and other staff specified further ensuring that such outside of the facility setting and who
in paragraph (i)(1) of this section. documentation contains: do not have any direct contact with
(3) The policies and procedures must (A) All information specifying which clients and other staff specified in
include, at a minimum, the following of the authorized COVID–19 vaccines paragraph (f)(1) of this section; and
components: are clinically contraindicated for the (ii) Staff who provide support services
(i) A process for ensuring all staff staff member to receive and the for the facility that are performed
specified in paragraph (i)(1) of this recognized clinical reasons for the exclusively outside of the facility setting
section (except for those staff who have contraindications; and and who do not have any direct contact
pending requests for, or who have been (B) A statement by the authenticating with clients and other staff specified in
granted, exemptions to the vaccination practitioner recommending that the staff paragraph (f)(1) of this section.
requirements of this section, or those member be exempted from the facility’s (3) The policies and procedures must
staff for whom COVID–19 vaccination COVID–19 vaccination requirements for include, at a minimum, the following
must be temporarily delayed, as staff based on the recognized clinical components:
recommended by the CDC, due to contraindications; (i) A process for ensuring all staff
clinical precautions and considerations) (ix) A process for ensuring the specified in paragraph (f)(1) of this
have received, at a minimum, a single- tracking and secure documentation of section (except for those staff who have
dose COVID–19 vaccine, or the first the vaccination status of staff for whom pending requests for, or who have been
dose of the primary vaccination series COVID–19 vaccination must be granted, exemptions to the vaccination
for a multi-dose COVID–19 vaccine temporarily delayed, as recommended requirements of this section, or those
prior to staff providing any care, by the CDC, due to clinical precautions staff for whom COVID–19 vaccination
treatment, or other services for the and considerations, including, but not must be temporarily delayed, as
facility and/or its residents; limited to, individuals with acute recommended by the CDC, due to
jspears on DSK121TN23PROD with RULES2
(ii) A process for ensuring that all staff illness secondary to COVID–19, and clinical precautions and considerations)
specified in paragraph (i)(1) of this individuals who received monoclonal have received, at a minimum, a single-
section are fully vaccinated for COVID– antibodies or convalescent plasma for dose COVID–19 vaccine, or the first
19, except for those staff who have been COVID–19 treatment; and dose of the primary vaccination series
granted exemptions to the vaccination (x) Contingency plans for staff who for a multi-dose COVID–19 vaccine
requirements of this section, or those are not fully vaccinated for COVID–19. prior to staff providing any care,
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61621
treatment, or other services for the and considerations, including, but not patients and who do not have any direct
facility and/or its clients; limited to, individuals with acute contact with patients, families, and
(ii) A process for ensuring that all staff illness secondary to COVID–19, and caregivers, and other staff specified in
specified in paragraph (f)(1) of this individuals who received monoclonal paragraph (d)(1) of this section; and
section are fully vaccinated for COVID– antibodies or convalescent plasma for (ii) Staff who provide support services
19, except for those staff who have been COVID–19 treatment; and for the HHA that are performed
granted exemptions to the vaccination (x) Contingency plans for staff who exclusively outside of the settings where
requirements of this section, or those are not fully vaccinated for COVID–19. home health services are directly
staff for whom COVID–19 vaccination ■ 14. Amend § 483.460 by revising provided to patients and who do not
must be temporarily delayed, as paragraph (a)(4)(v) to read as follows: have any direct contact with patients,
recommended by the CDC, due to families, and caregivers, and other staff
clinical precautions and considerations; § 483.460 Condition of participation: specified in paragraph (d)(1) of this
(iii) A process for ensuring the Health care services.
section.
implementation of additional * * * * * (3) The policies and procedures must
precautions, intended to mitigate the (a) * * * include, at a minimum, the following
transmission and spread of COVID–19, (4) * * * components:
for all staff who are not fully vaccinated (v) The client, or client’s
(i) A process for ensuring all staff
for COVID–19; representative, has the opportunity to
specified in paragraph (d)(1) of this
(iv) A process for tracking and accept or refuse a COVID–19 vaccine,
section (except for those staff who have
securely documenting the COVID–19 and change their decision;
pending requests for, or who have been
vaccination status of all staff specified * * * * * granted, exemptions to the vaccination
in paragraph (f)(1) of this section; requirements of this section, or those
(v) A process for tracking and securely PART 484—HOME HEALTH SERVICES
staff for whom COVID–19 vaccination
documenting the COVID–19 vaccination must be temporarily delayed, as
status of any staff who have obtained ■ 15. The authority citation for part 484
continues to read as follows: recommended by the CDC, due to
any booster doses as recommended by clinical precautions and considerations)
the CDC; Authority: 42 U.S.C. 1302 and 1395hh.
have received, at a minimum, a single-
(vi) A process by which staff may ■ 16. Amend § 484.70 by adding dose COVID–19 vaccine, or the first
request an exemption from the staff paragraph (d) to read as follows: dose of the primary vaccination series
COVID–19 vaccination requirements
for a multi-dose COVID–19 vaccine
based on an applicable Federal law; § 484.70 Condition of participation:
(vii) A process for tracking and Infection prevention and control.
prior to staff providing any care,
securely documenting information treatment, or other services for the HHA
* * * * * and/or its patients;
provided by those staff who have (d) Standard: COVID–19 Vaccination
requested, and for whom the facility has (ii) A process for ensuring that all staff
of Home Health Agency staff. The home
granted, an exemption from the staff specified in paragraph (d)(1) of this
health agency (HHA) must develop and
COVID–19 vaccination requirements; section are fully vaccinated for COVID–
implement policies and procedures to
(viii) A process for ensuring that all 19, except for those staff who have been
ensure that all staff are fully vaccinated
documentation, which confirms granted exemptions to the vaccination
for COVID–19. For purposes of this
recognized clinical contraindications to requirements of this section, or those
section, staff are considered fully
COVID–19 vaccines and which supports staff for whom COVID–19 vaccination
vaccinated if it has been 2 weeks or
staff requests for medical exemptions must be temporarily delayed, as
more since they completed a primary
from vaccination, has been signed and recommended by the CDC, due to
vaccination series for COVID–19. The
dated by a licensed practitioner, who is clinical precautions and considerations;
completion of a primary vaccination
not the individual requesting the (iii) A process for ensuring the
series for COVID–19 is defined here as
exemption, and who is acting within implementation of additional
the administration of a single-dose
their respective scope of practice as precautions, intended to mitigate the
vaccine, or the administration of all
defined by, and in accordance with, all transmission and spread of COVID–19,
required doses of a multi-dose vaccine.
applicable State and local laws, and for (1) Regardless of clinical for all staff who are not fully vaccinated
further ensuring that such responsibility or patient contact, the for COVID–19;
documentation contains policies and procedures must apply to (iv) A process for tracking and
(A) All information specifying which the following HHA staff, who provide securely documenting the COVID–19
of the authorized COVID–19 vaccines any care, treatment, or other services for vaccination status of all staff specified
are clinically contraindicated for the the HHA and/or its patients: in paragraph (d)(1) of this section;
staff member to receive and the (i) HHA employees; (v) A process for tracking and securely
recognized clinical reasons for the (ii) Licensed practitioners; documenting the COVID–19 vaccination
contraindications; and (iii) Students, trainees, and status of any staff who have obtained
(B) A statement by the authenticating volunteers; and any booster doses as recommended by
practitioner recommending that the staff (iv) Individuals who provide care, the CDC;
member be exempted from the facility’s treatment, or other services for the HHA (vi) A process by which staff may
COVID–19 vaccination requirements for and/or its patients, under contract or by request an exemption from the staff
staff based on the recognized clinical other arrangement. COVID–19 vaccination requirements
contraindications; (2) The policies and procedures of based on an applicable Federal law;
jspears on DSK121TN23PROD with RULES2
(ix) A process for ensuring the this section do not apply to the (vii) A process for tracking and
tracking and secure documentation of following HHA staff: securely documenting information
the vaccination status of staff for whom (i) Staff who exclusively provide provided by those staff who have
COVID–19 vaccination must be telehealth or telemedicine services requested, and for whom the HHA has
temporarily delayed, as recommended outside of the settings where home granted, an exemption from the staff
by the CDC, due to clinical precautions health services are directly provided to COVID–19 vaccination requirements;
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61622 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
(viii) A process for ensuring that all care service techniques and retain treatment, or other services for the
documentation, which confirms responsibility for their activities. facility and/or its patients;
recognized clinical contraindications to * * * * * (ii) A process for ensuring that all staff
COVID–19 vaccines and which supports specified in paragraph (n)(1) of this
■ 19. Amend § 485.70 by adding
staff requests for medical exemptions section are fully vaccinated for COVID–
paragraph (n) to read as follows:
from vaccination, has been signed and 19, except for those staff who have been
dated by a licensed practitioner, who is § 485.70 Personnel qualifications. granted exemptions to the vaccination
not the individual requesting the * * * * * requirements of this section, or those
exemption, and who is acting within (n) The CORF must develop and staff for whom COVID–19 vaccination
their respective scope of practice as implement policies and procedures to must be temporarily delayed, as
defined by, and in accordance with, all ensure that all staff are fully vaccinated recommended by the CDC, due to
applicable State and local laws, and for for COVID–19. For purposes of this clinical precautions and considerations;
further ensuring that such section, staff are considered fully (iii) A process for ensuring the
documentation contains vaccinated if it has been 2 weeks or implementation of additional
(A) All information specifying which more since they completed a primary precautions, intended to mitigate the
of the authorized COVID–19 vaccines vaccination series for COVID–19. The transmission and spread of COVID–19,
are clinically contraindicated for the completion of a primary vaccination for all staff who are not fully vaccinated
staff member to receive and the series for COVID–19 is defined here as for COVID–19;
recognized clinical reasons for the the administration of a single-dose (iv) A process for tracking and
contraindications; and vaccine, or the administration of all securely documenting the COVID–19
(B) A statement by the authenticating required doses of a multi-dose vaccine. vaccination status of all staff specified
practitioner recommending that the staff (1) Regardless of clinical in paragraph (n)(1) of this section;
member be exempted from the HHA’s (v) A process for tracking and securely
responsibility or patient contact, the
COVID–19 vaccination requirements for documenting the COVID–19 vaccination
policies and procedures must apply to
staff based on the recognized clinical status of any staff who have obtained
the following facility staff, who provide
contraindications; any booster doses as recommended by
any care, treatment, or other services for
(ix) A process for ensuring the the CDC;
the facility and/or its patients: (vi) A process by which staff may
tracking and secure documentation of (i) Facility employees; request an exemption from the staff
the vaccination status of staff for whom (ii) Licensed practitioners; COVID–19 vaccination requirements
COVID–19 vaccination must be (iii) Students, trainees, and based on an applicable Federal law;
temporarily delayed, as recommended volunteers; and (vii) A process for tracking and
by the CDC, due to clinical precautions (iv) Individuals who provide care, securely documenting information
and considerations, including, but not treatment, or other services for the provided by those staff who have
limited to, individuals with acute facility and/or its patients, under requested, and for whom the facility has
illness secondary to COVID–19, and contract or by other arrangement. granted, an exemption from the staff
individuals who received monoclonal (2) The policies and procedures of COVID–19 vaccination requirements;
antibodies or convalescent plasma for this section do not apply to the (viii) A process for ensuring that all
COVID–19 treatment; and following facility staff: documentation, which confirms
(x) Contingency plans for staff who (i) Staff who exclusively provide recognized clinical contraindications to
are not fully vaccinated for COVID–19. telehealth or telemedicine services COVID–19 vaccines and which supports
outside of the facility setting and who staff requests for medical exemptions
PART 485—CONDITIONS OF do not have any direct contact with from vaccination, has been signed and
PARTICIPATION: SPECIALIZED patients and other staff specified in dated by a licensed practitioner, who is
PROVIDERS paragraph (n)(1) of this section; and not the individual requesting the
(ii) Staff who provide support services exemption, and who is acting within
■ 17. The authority citation for part 485
for the facility that are performed their respective scope of practice as
continues to read as follows:
exclusively outside of the facility setting defined by, and in accordance with, all
Authority: 42 U.S.C. 1302 and 1395(hh). and who do not have any direct contact applicable State and local laws, and for
■ 18. Amend § 485.58 by revising with patients and other staff specified in further ensuring that such
paragraph (d)(4) to read as follows: paragraph (n)(1) of this section. documentation contains
(3) The policies and procedures must (A) All information specifying which
§ 485.58 Condition of participation: include, at a minimum, the following of the authorized COVID–19 vaccines
Comprehensive rehabilitation program. components: are clinically contraindicated for the
* * * * * (i) A process for ensuring all staff staff member to receive and the
(d) * * * specified in paragraph (n)(1) of this recognized clinical reasons for the
(4) The services must be furnished by section (except for those staff who have contraindications; and
personnel that meet the qualifications of pending requests for, or who have been (B) A statement by the authenticating
§ 485.70 and the number of qualified granted, exemptions to the vaccination practitioner recommending that the staff
personnel must be adequate for the requirements of this section, or those member be exempted from the facility’s
volume and diversity of services offered. staff for whom COVID–19 vaccination COVID–19 vaccination requirements for
Personnel that do not meet the must be temporarily delayed, as staff based on the recognized clinical
qualifications specified in § 485.70(a) recommended by the CDC, due to contraindications;
jspears on DSK121TN23PROD with RULES2
through (m) may be used by the facility clinical precautions and considerations) (ix) A process for ensuring the
in assisting qualified staff. When a have received, at a minimum, a single- tracking and secure documentation of
qualified individual is assisted by these dose COVID–19 vaccine, or the first the vaccination status of staff for whom
personnel, the qualified individual must dose of the primary vaccination series COVID–19 vaccination must be
be on the premises, and must instruct for a multi-dose COVID–19 vaccine temporarily delayed, as recommended
these personnel in appropriate patient prior to staff providing any care, by the CDC, due to clinical precautions
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111a
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61623
and considerations, including, but not recommended by the CDC, due to member be exempted from the CAH’s
limited to, individuals with acute clinical precautions and considerations) COVID–19 vaccination requirements for
illness secondary to COVID–19, and have received, at a minimum, a single- staff based on the recognized clinical
individuals who received monoclonal dose COVID–19 vaccine, or the first contraindications;
antibodies or convalescent plasma for dose of the primary vaccination series (ix) A process for ensuring the
COVID–19 treatment; and for a multi-dose COVID–19 vaccine tracking and secure documentation of
(x) Contingency plans for staff who prior to staff providing any care, the vaccination status of staff for whom
are not fully vaccinated for COVID–19. treatment, or other services for the CAH COVID–19 vaccination must be
■ 20. Amend § 485.640 by adding and/or its patients; temporarily delayed, as recommended
paragraph (f) to read as follows: (ii) A process for ensuring that all staff by the CDC, due to clinical precautions
specified in paragraph (f)(1) of this and considerations, including, but not
§ 485.640 Condition of participation: section are fully vaccinated for COVID– limited to, individuals with acute
Infection prevention and control and 19, except for those staff who have been illness secondary to COVID–19, and
antibiotic stewardship programs. granted exemptions to the vaccination individuals who received monoclonal
* * * * * requirements of this section, or those antibodies or convalescent plasma for
(f) Standard: COVID–19 Vaccination staff for whom COVID–19 vaccination COVID–19 treatment; and
of CAH staff. The CAH must develop must be temporarily delayed, as (x) Contingency plans for staff who
and implement policies and procedures recommended by the CDC, due to are not fully vaccinated for COVID–19.
to ensure that all staff are fully clinical precautions and considerations; ■ 21. Amend § 485.725 by adding
vaccinated for COVID–19. For purposes (iii) A process for ensuring the paragraph (f) to read as follows:
of this section, staff are considered fully implementation of additional
vaccinated if it has been 2 weeks or precautions, intended to mitigate the § 485.725 Condition of participation:
more since they completed a primary transmission and spread of COVID–19, Infection control.
vaccination series for COVID–19. The for all staff who are not fully vaccinated * * * * *
completion of a primary vaccination for COVID–19; (f) Standard: COVID–19 vaccination
series for COVID–19 is defined here as (iv) A process for tracking and of organization staff. The organization
the administration of a single-dose securely documenting the COVID–19 that provides outpatient physical
vaccine, or the administration of all vaccination status of all staff specified therapy must develop and implement
required doses of a multi-dose vaccine. in paragraph (f)(1) of this section; policies and procedures to ensure that
(1) Regardless of clinical (v) A process for tracking and securely all staff are fully vaccinated for COVID–
responsibility or patient contact, the documenting the COVID–19 vaccination 19. For purposes of this section, staff are
policies and procedures must apply to status of any staff who have obtained considered fully vaccinated if it has
the following CAH staff, who provide any booster doses as recommended by been 2 weeks or more since they
any care, treatment, or other services for the CDC; completed a primary vaccination series
the CAH and/or its patients: (vi) A process by which staff may for COVID–19. The completion of a
(i) CAH employees; request an exemption from the staff primary vaccination series for COVID–
(ii) Licensed practitioners; COVID–19 vaccination requirements 19 is defined here as the administration
(iii) Students, trainees, and based on an applicable Federal law; of a single-dose vaccine, or the
volunteers; and (vii) A process for tracking and administration of all required doses of a
(iv) Individuals who provide care, securely documenting information multi-dose vaccine.
treatment, or other services for the CAH provided by those staff who have (1) Regardless of clinical
and/or its patients, under contract or by requested, and for whom the CAH has responsibility or patient contact, the
other arrangement. granted, an exemption from the staff policies and procedures must apply to
(2) The policies and procedures of COVID–19 vaccination requirements the following organization staff, who
this section do not apply to the based on recognized clinical provide any care, treatment, or other
following CAH staff: contraindications or applicable Federal services for the organization and/or its
(i) Staff who exclusively provide laws; patients:
telehealth or telemedicine services (viii) A process for ensuring that all (i) Organization employees;
outside of the CAH setting and who do documentation, which confirms (ii) Licensed practitioners;
not have any direct contact with recognized clinical contraindications to (iii) Students, trainees, and
patients and other staff specified in COVID–19 vaccines and which supports volunteers; and
paragraph (f)(1) of this section; and staff requests for medical exemptions (iv) Individuals who provide care,
(ii) Staff who provide support services from vaccination, has been signed and treatment, or other services for the
for the CAH that are performed dated by a licensed practitioner, who is organization and/or its patients, under
exclusively outside of the CAH setting not the individual requesting the contract or by other arrangement.
and who do not have any direct contact exemption, and who is acting within (2) The policies and procedures of
with patients and other staff specified in their respective scope of practice as this section do not apply to the
paragraph (f)(1) of this section. defined by, and in accordance with, all following organization staff:
(3) The policies and procedures must applicable State and local laws, and for (i) Staff who exclusively provide
include, at a minimum, the following further ensuring that such telehealth or telemedicine services
components: documentation contains outside of the organization setting and
(i) A process for ensuring all staff (A) All information specifying which who do not have any direct contact with
specified in paragraph (f)(1) of this of the authorized COVID–19 vaccines patients and other staff specified in
jspears on DSK121TN23PROD with RULES2
section (except for those staff who have are clinically contraindicated for the paragraph (f)(1) of this section; and
pending requests for, or who have been staff member to receive and the (ii) Staff who provide support services
granted, exemptions to the vaccination recognized clinical reasons for the for the organization that are performed
requirements of this section, or those contraindications; and exclusively outside of the organization
staff for whom COVID–19 vaccination (B) A statement by the authenticating setting and who do not have any direct
must be temporarily delayed, as practitioner recommending that the staff contact with patients and other staff
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61624 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
specified in paragraph (f)(1) of this applicable State and local laws, and for not have any direct contact with clients
section. further ensuring that such and other staff specified in paragraph
(3) The policies and procedures must documentation contains (c)(1) of this section; and
include, at a minimum, the following (A) All information specifying which (ii) Staff who provide support services
components: of the authorized COVID–19 vaccines for the center that are performed
(i) A process for ensuring all staff are clinically contraindicated for the exclusively outside of the center setting
specified in paragraph (f)(1) of this staff member to receive and the and who do not have any direct contact
section (except for those staff who have recognized clinical reasons for the with clients and other staff specified in
pending requests for, or who have been contraindications; and paragraph (c)(1) of this section.
granted, exemptions to the vaccination (B) A statement by the authenticating (3) The policies and procedures must
requirements of this section, or those practitioner recommending that the staff include, at a minimum, the following
staff for whom COVID–19 vaccination member be exempted from the components:
must be temporarily delayed, as organization’s COVID–19 vaccination (i) A process for ensuring all staff
recommended by the CDC, due to requirements for staff based on the specified in paragraph (c)(1) of this
clinical precautions and considerations) recognized clinical contraindications; section (except for those staff who have
have received, at a minimum, a single- (ix) A process for ensuring the pending requests for, or who have been
dose COVID–19 vaccine, or the first tracking and secure documentation of granted, exemptions to the vaccination
dose of the primary vaccination series the vaccination status of staff for whom requirements of this section, or those
for a multi-dose COVID–19 vaccine COVID–19 vaccination must be staff for whom COVID–19 vaccination
prior to staff providing any care, temporarily delayed, as recommended must be temporarily delayed, as
treatment, or other services for the by the CDC, due to clinical precautions recommended by the CDC, due to
organization and/or its patients; and considerations, including, but not clinical precautions and considerations)
(ii) A process for ensuring that all staff limited to, individuals with acute have received, at a minimum, a single-
specified in paragraph (f)(1) of this illness secondary to COVID–19, and dose COVID–19 vaccine, or the first
section are fully vaccinated for COVID– individuals who received monoclonal dose of the primary vaccination series
19, except for those staff who have been antibodies or convalescent plasma for for a multi-dose COVID–19 vaccine
granted exemptions to the vaccination COVID–19 treatment; and prior to staff providing any care,
requirements of this section, or those (x) Contingency plans for staff who treatment, or other services for the
staff for whom COVID–19 vaccination are not fully vaccinated for COVID–19. CMHC and/or its clients;
must be temporarily delayed, as ■ 22. Amend § 485.904 by adding (ii) A process for ensuring that all staff
recommended by the CDC, due to paragraph (c) to read as follows: specified in paragraph (c)(1) of this
clinical precautions and considerations; section are fully vaccinated for COVID–
(iii) A process for ensuring the § 485.904 Condition of participation: 19, except for those staff who have been
implementation of additional Personnel qualifications. granted exemptions to the vaccination
precautions, intended to mitigate the * * * * * requirements of this section, or those
transmission and spread of COVID–19, (c) Standard: COVID–19 vaccination staff for whom COVID–19 vaccination
for all staff who are not fully vaccinated of center staff. The CMHC must develop must be temporarily delayed, as
for COVID–19; and implement policies and procedures recommended by the CDC, due to
(iv) A process for tracking and to ensure that all center staff are fully clinical precautions and considerations;
securely documenting the COVID–19 vaccinated for COVID–19. For purposes (iii) A process for ensuring the
vaccination status for all staff specified of this section, staff are considered fully implementation of additional
in paragraph (f)(1) of this section; vaccinated if it has been 2 weeks or precautions, intended to mitigate the
(v) A process for tracking and securely more since they completed a primary transmission and spread of COVID–19,
documenting the COVID–19 vaccination vaccination series for COVID–19. The for all staff who are not fully vaccinated
status of any staff who have obtained completion of a primary vaccination for COVID–19;
any booster doses as recommended by series for COVID–19 is defined here as (iv) A process for tracking and
the CDC; the administration of a single-dose securely documenting the COVID–19
(vi) A process by which staff may vaccine, or the administration of all vaccination status for all staff specified
request an exemption from the staff required doses of a multi-dose vaccine. in paragraph (c)(1) of this section;
COVID–19 vaccination requirements (1) Regardless of clinical (v) A process for tracking and securely
based on an applicable Federal law; responsibility or client contact, the documenting the COVID–19 vaccination
(vii) A process for tracking and policies and procedures must apply to status of any staff who have obtained
securely documenting information the following center staff, who provide any booster doses as recommended by
provided by those staff who have any care, treatment, or other services for the CDC;
requested, and for whom the the center and/or its clients: (vi) A process by which staff may
organization has granted, an exemption (i) Center employees; request an exemption from the staff
from the staff COVID–19 vaccination (ii) Licensed practitioners; COVID–19 vaccination requirements
requirements; (iii) Students, trainees, and based on an applicable Federal law;
(viii) A process for ensuring that all volunteers; and (vii) A process for tracking and
documentation, which confirms (iv) Individuals who provide care, securely documenting information
recognized clinical contraindications to treatment, or other services for the provided by those staff who have
COVID–19 vaccines and which supports center and/or its clients, under contract requested, and for whom the CMHC has
staff requests for medical exemptions granted, an exemption from the staff
jspears on DSK121TN23PROD with RULES2
or by other arrangement.
from vaccination, has been signed and (2) The policies and procedures of COVID–19 vaccination requirements;
dated by a licensed practitioner, who is this section do not apply to the (viii) A process for ensuring that all
not the individual requesting the following center staff: documentation, which confirms
exemption, and who is acting within (i) Staff who exclusively provide recognized clinical contraindications to
their respective scope of practice as telehealth or telemedicine services COVID–19 vaccines and which supports
defined by, and in accordance with, all outside of the center setting and who do staff requests for medical exemptions
VerDate Sep<11>2014 22:27 Nov 04, 2021 Jkt 256001 PO 00000 Frm 00224 Fmt 4701 Sfmt 4700 E:\FR\FM\05NOR2.SGM 05NOR2
113a
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61625
from vaccination, has been signed and therapy supplier staff, who provide any guidelines intended to mitigate the
dated by a licensed practitioner, who is care, treatment, or other services for the transmission and spread of COVID–19,
not the individual requesting the qualified home infusion therapy and which must include the
exemption, and who is acting within supplier and/or its patients: implementation of additional
their respective scope of practice as (i) Qualified home infusion therapy precautions for all staff who are not
defined by, and in accordance with, all supplier employees; fully vaccinated for COVID–19;
applicable State and local laws, and for (ii) Licensed practitioners; (iv) A process for tracking and
further ensuring that such (iii) Students, trainees, and securely documenting the COVID–19
documentation contains volunteers; and vaccination status for all staff specified
(A) All information specifying which (iv) Individuals who provide care, in paragraph (c)(1) of this section;
of the authorized COVID–19 vaccines treatment, or other services for the
qualified home infusion therapy (v) A process for tracking and securely
are clinically contraindicated for the documenting the COVID–19 vaccination
staff member to receive and the supplier and/or its patients, under
contract or by other arrangement. status of any staff who have obtained
recognized clinical reasons for the any booster doses as recommended by
contraindications; and (2) The policies and procedures of
this section do not apply to the the CDC;
(B) A statement by the authenticating
practitioner recommending that the staff following qualified home infusion (vi) A process by which staff may
member be exempted from the CMHC’s therapy supplier staff: request an exemption from the staff
COVID–19 vaccination requirements for (i) Staff who exclusively provide COVID–19 vaccination requirements
staff based on the recognized clinical telehealth or telemedicine services based on an applicable Federal law;
contraindications; outside of the settings where home (vii) A process for tracking and
(ix) A process for ensuring the infusion therapy services are provided securely documenting information
tracking and secure documentation of to patients and who do not have any provided by those staff who have
the vaccination status of staff for whom direct contact with patients, families, requested, and for whom the qualified
COVID–19 vaccination must be and caregivers, and other staff specified home infusion therapy supplier has
temporarily delayed, as recommended in paragraph (c)(1) of this section; and granted, an exemption from the staff
by the CDC, due to clinical precautions (ii) Staff who provide support services COVID–19 vaccination requirements;
and considerations, including, but not for the qualified home infusion therapy (viii) A process for ensuring that all
limited to, individuals with acute supplier that are performed exclusively documentation, which confirms
illness secondary to COVID–19, and outside of the settings where home recognized clinical contraindications to
individuals who received monoclonal infusion therapy services are provided COVID–19 vaccines and which supports
antibodies or convalescent plasma for to patients and who do not have any staff requests for medical exemptions
COVID–19 treatment; and direct contact with patients, families, from vaccination, has been signed and
(x) Contingency plans for staff who and caregivers, and other staff specified dated by a licensed practitioner, who is
are not fully vaccinated for COVID–19. in paragraph (c)(1) of this section. not the individual requesting the
(3) The policies and procedures must exemption, and who is acting within
PART 486—CONDITIONS FOR include, at a minimum, the following their respective scope of practice as
COVERAGE OF SPECIALIZED components: defined by, and in accordance with, all
SERVICES FURNISHED BY (i) A process for ensuring all staff applicable State and local laws, and for
SUPPLIERS specified in paragraph (c)(1) of this further ensuring that such
section (except for those staff who have documentation contains;
■ 23. The authority citation for part 486 pending requests for, or who have been
continues to read as follows: (A) All information specifying which
granted, exemptions to the vaccination
of the authorized COVID–19 vaccines
Authority: 42 U.S.C. 273, 1302, 1320b–8, requirements of this section, or those
are clinically contraindicated for the
and 1395hh. staff for whom COVID–19 vaccination
staff member to receive and the
■ 24. Amend § 486.525 by adding must be temporarily delayed, as
recognized clinical reasons for the
paragraph (c) to read as follows: recommended by the CDC, due to
contraindications; and
clinical precautions and considerations)
§ 486.525 Required services. have received, at a minimum, a single- (B) A statement by the authenticating
* * * * * dose COVID–19 vaccine, or the first practitioner recommending that the staff
(c) COVID–19 Vaccination of facility dose of the primary vaccination series member be exempted from the qualified
staff. The qualified home infusion for a multi-dose COVID–19 vaccine home infusion therapy supplier’s
therapy supplier must develop and prior to staff providing any care, COVID–19 vaccination requirements for
implement policies and procedures to treatment, or other services for the staff based on the recognized clinical
ensure that all staff are fully vaccinated qualified home infusion therapy contraindications;
for COVID–19. For purposes of this supplier and/or its patients; (ix) A process for ensuring the
section, staff are considered fully (ii) A process for ensuring that all staff tracking and secure documentation of
vaccinated if it has been 2 weeks or specified in paragraph (c)(1) of this the vaccination status of staff for whom
more since they completed a primary section are fully vaccinated for COVID– COVID–19 vaccination must be
vaccination series for COVID–19. The 19, except for those staff who have been temporarily delayed, as recommended
completion of a primary vaccination granted exemptions to the vaccination by the CDC, due to clinical precautions
series for COVID–19 is defined here as requirements of this section, or those and considerations, including, but not
the administration of a single-dose staff for whom COVID–19 vaccination limited to, individuals with acute
jspears on DSK121TN23PROD with RULES2
vaccine, or the administration of all must be temporarily delayed, as illness secondary to COVID–19, and
required doses of a multi-dose vaccine. recommended by the CDC, due to individuals who received monoclonal
(1) Regardless of clinical clinical precautions and considerations; antibodies or convalescent plasma for
responsibility or patient contact, the (iii) A process for ensuring that the COVID–19 treatment; and
policies and procedures must apply to facility follows nationally recognized (x) Contingency plans for staff who
the following qualified home infusion infection prevention and control are not fully vaccinated for COVID–19.
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114a
61626 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
PART 491—CERTIFICATION OF clinical precautions and considerations) or center’s COVID–19 vaccination
CERTAIN HEALTH FACILITIES have received, at a minimum, a single- requirements for staff based on the
dose COVID–19 vaccine, or the first recognized clinical contraindications;
■ 25. The authority citation for part 491 dose of the primary vaccination series (ix) A process for ensuring the
continues to read as follows: for a multi-dose COVID–19 vaccine tracking and secure documentation of
Authority: 42 U.S.C. 263a and 1302. prior to staff providing any care, the vaccination status of staff for whom
treatment, or other services for the clinic COVID–19 vaccination must be
■ 26. Amend § 491.8 by adding
or center and/or its patients; temporarily delayed, as recommended
paragraph (d) to read as follows: (ii) A process for ensuring that all staff by the CDC, due to clinical precautions
§ 491.8 Staffing and staff responsibilities. specified in paragraph (d)(1) of this and considerations, including, but not
section are fully vaccinated for COVID– limited to, individuals with acute
* * * * *
19, except for those staff who have been illness secondary to COVID–19, and
(d) COVID–19 vaccination of staff.
granted exemptions to the vaccination individuals who received monoclonal
The RHC/FQHC must develop and
requirements of this section, or those antibodies or convalescent plasma for
implement policies and procedures to
staff for whom COVID–19 vaccination COVID–19 treatment; and
ensure that all staff are fully vaccinated
must be temporarily delayed, as (x) Contingency plans for staff who
for COVID–19. For purposes of this
recommended by the CDC, due to are not fully vaccinated for COVID–19.
section, staff are considered fully
clinical precautions and considerations;
vaccinated if it has been 2 weeks or (iii) A process for ensuring that the PART 494—CONDITIONS FOR
more since they completed a primary clinic or center follows nationally COVERAGE FOR END-STAGE RENAL
vaccination series for COVID–19. The recognized infection prevention and DISEASE FACILITIES
completion of a primary vaccination control guidelines intended to mitigate
series for COVID–19 is defined here as the transmission and spread of COVID– ■ 27. The authority citation for part 494
the administration of a single-dose 19, and which must include the continues to read as follows:
vaccine, or the administration of all implementation of additional Authority: 42 U.S.C. l302 and l395hh.
required doses of a multi-dose vaccine. precautions for all staff who are not
(1) Regardless of clinical ■ 28. Amend § 494.30 by—
fully vaccinated for COVID–19; ■ a. Redesignating paragraphs (b) and
responsibility or patient contact, the (iv) A process for tracking and
policies and procedures must apply to (c) as paragraphs (c) and (d)
securely documenting the COVID–19 respectively, and
the following clinic or center staff, who vaccination status for all staff specified ■ b. Adding a new paragraph (b).
provide any care, treatment, or other in paragraph (d)(1) of this section;
services for the clinic or center and/or The addition reads as follows:
(v) A process for tracking and securely
its patients: documenting the COVID–19 vaccination § 494.30 Condition: Infection control.
(i) RHC/FQHC employees; status of any staff who have obtained * * * * *
(ii) Licensed practitioners; any booster doses as recommended by (b) COVID–19 Vaccination of facility
(iii) Students, trainees, and the CDC; staff. The facility must develop and
volunteers; and (vi) A process by which staff may implement policies and procedures to
(iv) Individuals who provide care, request an exemption from the staff ensure that all staff are fully vaccinated
treatment, or other services for the clinic COVID–19 vaccination requirements for COVID–19. For purposes of this
or center and/or its patients, under based on an applicable Federal law; section, staff are considered fully
contract or by other arrangement. (vii) A process for tracking and vaccinated if it has been 2 weeks or
(2) The policies and procedures of securely documenting information more since they completed a primary
this section do not apply to the provided by those staff who have vaccination series for COVID–19. The
following clinic or center staff: requested, and for whom the facility has completion of a primary vaccination
(i) Staff who exclusively provide granted, an exemption from the staff series for COVID–19 is defined here as
telehealth or telemedicine services COVID–19 vaccination requirements; the administration of a single-dose
outside of the clinic or center setting (viii) A process for ensuring that all vaccine, or the administration of all
and who do not have any direct contact documentation, which confirms required doses of a multi-dose vaccine.
with patients and other staff specified in recognized clinical contraindications to (1) Regardless of clinical
paragraph (d)(1) of this section; and COVID–19 vaccines and which supports responsibility or patient contact, the
(ii) Staff who provide support services staff requests for medical exemptions policies and procedures must apply to
for the clinic or center that are from vaccination, has been signed and the following facility staff, who provide
performed exclusively outside of the dated by a licensed practitioner, who is any care, treatment, or other services for
clinic or center setting and who do not not the individual requesting the the facility and/or its patients:
have any direct contact with patients exemption, and who is acting within (i) Facility employees;
and other staff specified in paragraph their respective scope of practice as (ii) Licensed practitioners;
(d)(1) of this section. defined by, and in accordance with, all (iii) Students, trainees, and
(3) The policies and procedures must applicable State and local laws, and for volunteers; and
include, at a minimum, the following further ensuring that such (iv) Individuals who provide care,
components: documentation contains; treatment, or other services for the
(i) A process for ensuring all staff (A) All information specifying which facility and/or its patients, under
specified in paragraph (d)(1) of this of the authorized COVID–19 vaccines contract or by other arrangement.
section (except for those staff who have are clinically contraindicated for the (2) The policies and procedures of
jspears on DSK121TN23PROD with RULES2
pending requests for, or who have been staff member to receive and the this section do not apply to the
granted, exemptions to the vaccination recognized clinical reasons for the following facility staff:
requirements of this section, or those contraindications; and (i) Staff who exclusively provide
staff for whom COVID–19 vaccination (B) A statement by the authenticating telehealth or telemedicine services
must be temporarily delayed, as practitioner recommending that the staff outside of the facility setting and who
recommended by the CDC, due to member be exempted from the clinic’s do not have any direct contact with
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115a
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61627
patients and other staff specified in recommended by the CDC, due to defined by, and in accordance with, all
paragraph (b)(1) of this section; and clinical precautions and considerations; applicable State and local laws, and for
(ii) Staff who provide support services (iii) A process for ensuring the further ensuring that such
for the facility that are performed implementation of additional documentation contains
exclusively outside of the facility setting precautions, intended to mitigate the (A) All information specifying which
and who do not have any direct contact transmission and spread of COVID–19, of the authorized COVID–19 vaccines
with patients and other staff specified in for all staff who are not fully vaccinated are clinically contraindicated for the
paragraph (b)(1) of this section. for COVID–19; staff member to receive and the
(iv) A process for tracking and recognized clinical reasons for the
(3) The policies and procedures must
securely documenting the COVID–19 contraindications; and
include, at a minimum, the following
vaccination status for all staff specified (B) A statement by the authenticating
components:
in paragraph (b)(1) of this section; practitioner recommending that the staff
(i) A process for ensuring all staff (v) A process for tracking and securely member be exempted from the facility’s
specified in paragraph (b)(1) of this documenting the COVID–19 vaccination COVID–19 vaccination requirements for
section (except for those staff who have status of any staff who have obtained staff based on the recognized clinical
pending requests for, or who have been any booster doses as recommended by contraindications;
granted, exemptions to the vaccination the CDC; (ix) A process for ensuring the
requirements of this section, or those (vi) A process by which staff may tracking and secure documentation of
staff for whom COVID–19 vaccination request an exemption from the staff the vaccination status of staff for whom
must be temporarily delayed, as COVID–19 vaccination requirements COVID–19 vaccination must be
recommended by the CDC, due to based on an applicable Federal law; temporarily delayed, as recommended
clinical precautions and considerations) (vii) A process for tracking and by the CDC, due to clinical precautions
have received, at a minimum, a single- securely documenting information and considerations, including, but not
dose COVID–19 vaccine, or the first provided by those staff who have limited to, individuals with acute
dose of the primary vaccination series requested, and for whom the facility has illness secondary to COVID–19, and
for a multi-dose COVID–19 vaccine granted, an exemption from the staff individuals who received monoclonal
prior to staff providing any care, COVID–19 vaccination requirements; antibodies or convalescent plasma for
treatment, or other services for the (viii) A process for ensuring that all COVID–19 treatment; and
facility and/or its patients; documentation, which confirms (x) Contingency plans for staff who
(ii) A process for ensuring that all staff recognized clinical contraindications to are not fully vaccinated for COVID–19.
specified in paragraph (b)(1) of this COVID–19 vaccines and which supports * * * * *
section are fully vaccinated for COVID– staff requests for medical exemptions
19, except for those staff who have been from vaccination, has been signed and Xavier Becerra,
granted exemptions to the vaccination dated by a licensed practitioner, who is Secretary, Department of Health and Human
requirements of this section, or those not the individual requesting the Services.
staff for whom COVID–19 vaccination exemption, and who is acting within [FR Doc. 2021–23831 Filed 11–4–21; 8:45 am]
must be temporarily delayed, as their respective scope of practice as BILLING CODE 4120–01–P
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116a
Joint Statement in Support of COVID-19 Vaccine Mandates for
All Workers in Health and Long-Term Care
Due to the recent COVID-19 surge and the availability of safe and effective vaccines, our health care
organizations and societies advocate that all health care and long-term care employers require their
workers to receive the COVID-19 vaccine. This is the logical fulfillment of the ethical commitment of all
health care workers to put patients as well as residents of long-term care facilities first and take all steps
necessary to ensure their health and well-being.
Because of highly contagious variants, including the Delta variant, and significant numbers of
unvaccinated people, COVID-19 cases, hospitalizations and deaths are once again rising throughout the
United States.1 Vaccination is the primary way to put the pandemic behind us and avoid the return of
stringent public health measures.
Unfortunately, many health care and long-term care personnel remain unvaccinated. As we move
towards full FDA approval of the currently available vaccines, all health care workers should get
vaccinated for their own health, and to protect their colleagues, families, residents of long-term care
facilities and patients. This is especially necessary to protect those who are vulnerable, including
unvaccinated children and the immunocompromised. Indeed, this is why many health care and long-
term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.
We call for all health care and long-term care employers to require their
employees to be vaccinated against COVID-19.
We stand with the growing number of experts and institutions that support the requirement for
universal vaccination of health workers.2,3 While we recognize some workers cannot be vaccinated
because of identified medical reasons and should be exempted from a mandate, they constitute a small
minority of all workers. Employers should consider any applicable state laws on a case-by-case basis.
Existing COVID-19 vaccine mandates have proven effective.4,5 Simultaneously, we recognize the
historical mistrust of health care institutions, including among many in our own health care workforce.
We must continue to address workers’ concerns, engage with marginalized populations, and work with
trusted messengers to improve vaccine acceptance.
As the health care community leads the way in requiring vaccines for our employees, we hope all other
employers across the country will follow our lead and implement effective policies to encourage
vaccination. The health and safety of U.S. workers, families, communities, and the nation depends on it.
117a
SIGNATORIES
(Listed Alphabetically)
Academy of Managed Care Pharmacy (AMCP)
American Academy of Ambulatory Care Nursing (AAACN)
American Academy of Child and Adolescent Psychiatry (AACAP)
American Academy of Family Physicians (AAFP)
American Academy of Nursing (AAN)
American Academy of Ophthalmology (AAO)
American Academy of PAs (AAPA)
American Academy of Pediatrics (AAP)
American Academy of Allergy, Asthma & Immunology (AAAAI)
American Association of Clinical Endocrinology (AACE)
American Association of Colleges of Pharmacy (AACP)
American Association of Neuroscience Nurses (AANN)
American College of Clinical Pharmacy (ACCP)
American College of Physicians (ACP)
American College of Preventive Medicine (ACPM)
American College of Surgeons (ACS)
American Epilepsy Society (AES)
American Medical Association (AMA)
American Nurses Association (ANA)
American Pharmacists Association (APhA)
American Psychiatric Association (APA)
American Public Health Association (APHA)
American Society for Clinical Pathology (ASCP)
American Society for Radiation Oncology (ASTRO)
American Society of Health-System Pharmacists (ASHP)
American Society of Hematology (ASH)
American Society of Nephrology (ASN)
American Thoracic Society (ATS)
Association for Clinical Oncology (ASCO)
Association for Professionals in Infection Control and Epidemiology (APIC)
Association of Academic Health Centers (AAHC)
118a
Association of American Medical Colleges (AAMC)
Association of Rehabilitation Nurses (ARN)
Council of Medical Specialty Societies (CMSS)
HIV Medicine Association
Infectious Diseases Society of America (IDSA)
LeadingAge
National Association of Indian Nurses of America (NAINA)
National Association of Pediatric Nurse Practitioners (NAPNAP)
National Council of State Boards of Nursing (NCSBN)
National Hispanic Medical Association (NHMA)
National League for Nursing (NLN)
National Medical Association (NMA)
National Pharmaceutical Association (NPhA)
Nurses Who Vaccinate (NWV)
Organization for Associate Degree Nursing (OADN)
Pediatric Infectious Diseases Society (PIDS)
Philippine Nurses Association of America, Inc (PNAA)
Society of Gynecologic Oncology (SGO)
Society for Healthcare Epidemiology of America (SHEA)
Society of Hospital Medicine (SHM)
Society of Infectious Diseases Pharmacists (SIDP)
Society of Interventional Radiology (SIR)
Texas Nurses Association (TNA)
The John A. Hartford Foundation
Transcultural Nursing Society (TCNS)
Virgin Islands State Nurses Association (VISNA)
Wound, Ostomy, and Continence Nurses Society (WOCN)
1. Centers for Disease Control and Prevention. Covid Data Tracker Weekly Review. July 16, 2021.
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html [Accessed 22 July 2021].
2. Weber, D., Al-Tawfiq, J., Babcock, H., Bryant, K., Drees, M., Elshaboury, R., et al. (2021). Multisociety
Statement on COVID-19 Vaccination as a Condition of Employment for Healthcare Personnel. Infection
Control & Hospital Epidemiology, 1-46. doi:10.1017/ice.2021.322
119a
3. American Hospital Association. AHA Policy Statement on Mandatory COVID-19 Vaccination of Health Care
Personnel. July 21, 2021. https://www.aha.org/public-comments/2021-07-21-aha-policy-statement-
mandatory-covid-19-vaccination-health-care
4. Bacon J. ‘Condition of employment’: Hospitals in DC, across the nation follow Houston Methodist in
requiring vaccination for workers. USA Today. Available from:
https://www.usatoday.com/story/news/health/2021/06/10/dc-hospitals-others-follow-houston-
methodist-requiring-vaccination/7633481002/ [Accessed 22 July 2021].
5. Paulin E. More Nursing Homes Are Requiring Staff COVID-19 Vaccinations. AARP. Available from:
https://www.aarp.org/caregiving/health/info-2021/nursing-homes-covid-vaccine-mandate.html
[Accessed 22 July 2021].
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