Court filing

Appendix to Stay Application — Biden v. Missouri (CMS Vaccine Mandate) (U.S.)

Filed December 16, 2021 in Biden v. Missouri; one of 2 filings from this case.

Record facts

Court	Supreme Court of the United States (appendix to application)
Filed	2021-12-16

Full text

UNITED STATES COURT OF APPEALS
FOR THE EIGHTH CIRCUIT
No: 21-3725

State of Missouri, et al.

Appellees

Joseph R. Biden, Jr., in his official capacity as the President of the United States of America, et
al.

Appellants

------------------------------

Reliant Care Management Company, L.L.C.

Amicus Curiae

American Academy of Family Physicians, et al.

Amici on Behalf of Appellant(s)

______________________________________________________________________________
Appeal from U.S. District Court for the Eastern District of Missouri - St. Louis
(4:21-cv-01329-MTS)
______________________________________________________________________________
ORDER

Appellants’ Emergency Motion for Stay Pending Appeal is denied.

Judge Kelly would grant the motion.

December 13, 2021

Order Entered at the Direction of the Court:
Clerk, U.S. Court of Appeals, Eighth Circuit.
____________________________________

/s/ Michael E. Gans

(1a)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

STATE OF MISSOURI, et al.,
)

)
Plaintiffs,
)

)
vs.
)

Case No. 4:21-cv-01329-MTS

)
JOSEPH R. BIDEN, JR., in his official capacity
)
as the President of the United States of America,
)
et al.,
)
Defendants.
)

MEMORANDUM AND ORDER

Two days ago, the Court granted Plaintiffs’ Motion for Preliminary Injunction, which
preliminarily enjoined Defendants from implementing or enforcing 86 Fed. Reg. 61,555 (Nov. 5,
2021), the Interim Final Rule with Comment Period entitled “Medicare and Medicaid Programs;
Omnibus COVID-19 Health Care Staff Vaccination,” against any and all Medicare- and Medicaid-
certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri,
Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming. Doc. [28] at 32 (2021
WL 5564501, at *16). Defendants appealed, doc. [29], and now ask the Court to stay the Court’s
order granting the injunction pending the appeal, doc. [30]. Plaintiffs oppose Defendants’ motion
for Stay. See doc. [30].

Under Federal Rule of Civil Procedure 62(c), “an interlocutory or final judgment in an
action for an injunction” is “not stayed after being entered, even if an appeal is taken,” unless the
court orders otherwise. See also Fed. R. App. P. 8(a). Courts consider four factors when
determining whether a stay pending appellate review is warranted: (1) the likelihood that the
moving party will prevail on the merits of the appeal; (2) the likelihood that the moving party will
be irreparably harmed absent a stay; (3) the prospect that others will be harmed if the court grants
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- 2 -

the stay; and (4) the public interest in granting the stay. See, e.g., Banks v. Cotter Corp. (N.S.L.),
No. 4:20-cv-01227-JAR, 2021 WL 677912, at *1 (E.D. Mo. Feb. 22, 2021). The Court does not
find these factors weigh in favor of a stay in this case, so the Court will deny Defendants’ Motion
for Stay.

First, the Court does not believe that Defendants are likely to prevail on the merits of their
appeal in this case for the reasons stated in the Order. See doc. [28] at 3–23; see also Louisiana v.
Becerra, No. 3:21-cv-03970, 2021 WL 5609846 (W.D. La. Nov. 30, 2021); cf. Kentucky v. Biden,
No. 3:21-cv-00055-GFVT, 2021 WL 5587446 (E.D. Ky. Nov. 30, 2021). Second, as to irreparable
harm absent a stay, Defendants assert “hundreds or thousands of lives [will be] lost each month”
if the “vaccination rule were not implemented.” Doc. [31] at 3; but see 86 Fed. Reg. at 61,612
(noting that “predicting the full range of benefits . . . in either the short run or the next full year
with any degree of estimating precision is all but impossible”). But, in the very regulation at issue,
CMS concluded that “the effectiveness of the vaccine to prevent disease transmission by those
vaccinated [is] not currently known.” 86 Fed. Reg. at 61,615. Defendants have not shown, then,
that such harm is likely. See also doc. [28] 14–16, 29–31. Third, the Court reiterates its conclusion
that “Plaintiffs’ evidence shows that facilities—rural facilities in particular—likely would face
crisis standards of care or will have no choice but to close to new patients or close altogether,”
which “would cause significant [ ] harm to Plaintiffs’ citizens.” Doc. [28] at 27; see also id. at 23–
28. Fourth, and finally, the Court reiterates its conclusion that the preliminary injunction is in the
public’s interest, see id. at 29–31, notably, the ability of healthcare facilities to provide proper care,
and thus, save lives, such that a stay of the injunction would be against the public’s interest.

After due consideration of these four factors, this case does not warrant a stay of the
preliminary injunction pending the appeal. Accordingly,
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- 3 -

IT IS HEREBY ORDERED that Defendants’ Motion to Stay Pending Appeal, doc. [30],
is DENIED.
Dated this 1st day of December, 2021.

MATTHEW T. SCHELP

UNITED STATES DISTRICT JUDGE
4a

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

STATE OF MISSOURI, et al.,
)

)
Plaintiffs,
)

)
vs.
)
Case No. 4:21-cv-01329-MTS

)
JOSEPH R. BIDEN, JR., in his official capacity )
as the President of the United States of America, )
et al.,
)

)
Defendants.
)

MEMORANDUM AND ORDER
I.
INTRODUCTION
This case concerns the Centers for Medicare and Medicaid Services’ (“CMS”) federal
vaccine mandate on a wide range of healthcare facilities. On November 5, 2021, CMS issued an
Interim Final Rule with Comment Period (“IFC”) entitled “Medicare and Medicaid Programs;
Omnibus COVID-19 Health Care Staff Vaccination” (the “mandate”), 86 Fed. Reg. 61,555 (Nov.
5, 2021), revising the “requirements that most Medicare- and Medicaid-certified providers and
suppliers must meet to participate in the Medicare and Medicaid programs.” 86 Fed. Reg. 61,555–
601. Specifically, the mandate requires nearly every employee, volunteer, and third-party
contractor working1 at fifteen2 categories of healthcare facilities to be vaccinated against SARS-

1 The mandate applies to a wide-range of people working at the facilities, including, employees, trainees, students,
volunteers, or contractors, who provide any care, treatment, or other services for the facility. 86 Fed. Reg. at 61,570
(emphasis added).

2 The CMS vaccine mandate covers fifteen categories of Medicare- and Medicaid-certified providers and suppliers:
(1) Ambulatory Surgical Centers (ASCs); (2) Hospices; (3) Psychiatric residential treatment facilities (PRTFs); (4)
Programs of All-Inclusive Care for the Elderly (PACE); (5) Hospitals (acute care hospitals, psychiatric hospitals, long
term care hospitals, children’s hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation
hospitals); (6) Long Term Care (LTC) Facilities, generally referred to as nursing homes; (7) Intermediate Care
Facilities for Individuals with Intellectual Disabilities (ICFs-IID); (8) Home Health Agencies (HHAs); (9)
Comprehensive Outpatient Rehabilitation Facilities (CORFs); (10) Critical Access Hospitals (CAHs); (11) Clinics,
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CoV-2 (“COVID”) and to have received at least a first dose of the vaccine prior to December 6,
2021. See id. at 61,573. On November 10, 2021, Plaintiffs, the States of Missouri, Nebraska,
Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire
(collectively, “Plaintiffs”) filed a Complaint challenging the mandate. Doc. [1]. The Complaint
seeks preliminary and permanent injunctive and declaratory relief. On November 12, 2021,
Plaintiffs filed a motion for a preliminary injunction, Doc. [6], requesting that this Court issue a
preliminary injunction enjoining Defendants from imposing the mandate.
Having fully reviewed the administrative record and submitted material, the Court finds
that a preliminary injunction is warranted here.
II.
DISCUSSION
A. The Court has jurisdiction.
Defendants argue that this Court “lacks jurisdiction” over Plaintiffs’ claims because
“Congress has withdrawn federal-question jurisdiction over claims like this one that arise under
the Medicare statute,” citing 42 U.S.C. § 405(h), as incorporated by 42 U.S.C. § 1395ii. Doc. [23]
at 15–19. The Court does not agree. As Defendants readily concede, “State governments” such
as the Plaintiff States are neither “institution[s]” nor “agenc[ies]” “dissatisfied” with the
Secretary’s determination regarding eligibility or receipt of benefits under 42 U.S.C.
§ 1395cc(h)(1) and, therefore, “the States3 themselves could not use that statute’s vehicle for
judicial review.” Id. at 19; see Shalala v. Ill. Council on Long Term Care, Inc., 529 U.S. 1, 16
(2000) (explaining that § 405(h) does not apply if application “would mean no review at all”). In

rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language
pathology services; (12) Community Mental Health Centers (CMHCs); (13) Home Infusion Therapy (HIT) suppliers;
(14) Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs); and (15) End-Stage Renal Disease
(ESRD) Facilities. 86 Fed. Reg. at 61,569–70.

3 The Plaintiff States bring their claims in a number of capacities: sovereign, quasi-sovereign/parens patriae, and
proprietary. See, e.g., Doc. [1] ¶¶ 5, 7, 9.
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addition, Plaintiffs’ claims that arise under the Medicaid Act—as opposed to the Medicare Act—
are not subject to the § 405(h)’s jurisdictional bar. See Avon Nursing & Rehab. v. Becerra, 995
F.3d 305, 311 (2d Cir. 2021) (“Unlike the Medicare Act, the Medicaid Act does not incorporate
the Social Security Act’s claim-channeling and jurisdiction-stripping provisions, 42 U.S.C. §
405(g) and (h). Federal courts thus have jurisdiction over claims arising under the Medicaid Act
pursuant to 28 U.S.C. § 1331.”). Thus, all aspects of the mandate that purport to change a Medicaid
regulation are clearly not barred, even under Defendants’ arguments. Nonetheless, the Court finds
that it has jurisdiction over claims arising under both Medicare and Medicaid.
B. A preliminary injunction is warranted here.
Plaintiffs seek a preliminary injunction of the mandate’s enforcement pending a full
judicial review of the mandate’s legality. The Court addresses their request today. Whether a
court should issue a preliminary injunction involves consideration of (1) the threat of irreparable
harm to the movant; (2) the state of the balance between this harm and the injury that granting the
injunction will inflict on other parties litigant; (3) the probability that movant will succeed on the
merits; and (4) the public interest. Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109, 113 (8th
Cir. 1981). “While no single factor is determinative, the probability of success factor is the most
significant.” Home Instead, Inc. v. Florance, 721 F.3d 494, 497 (8th Cir. 2013) (internal
quotations and citations omitted).
Each of these factors favors a preliminary injunction here.
a. Plaintiffs demonstrate a likelihood of success on the merits.
i. Congress did not grant CMS authority to mandate the vaccine.

Plaintiffs are likely to succeed in their argument that Congress has not provided CMS the
authority to enact the regulation at issue here. “[A]n agency literally has no power to act, let alone
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pre-empt4 the validly enacted legislation of a sovereign State, unless and until Congress confers
power upon it.” La. Pub. Serv. Comm’n v. FCC, 476 U.S. 355, 357 (1986). While the Court agrees
Congress has authorized the Secretary of Health and Human Services (the “Secretary”) general
authority to enact regulations for the “administration” of Medicare and Medicaid and the “health
and safety” of recipients, the nature and breadth of the CMS mandate requires clear authorization
from Congress—and Congressed has provided none.5 See Ala. Ass’n of Realtors v. Dep’t of Health
& Hum. Servs., 141 S. Ct. 2485, 2486 (2021) (“It would be one thing if Congress had specifically
authorized the action that the CDC has taken. But that has not happened.”). Courts have long
required Congress to speak clearly when providing agency authorization if it (1) intends for an
agency to exercise powers of vast economic and political significance; (2) if the authority would
significantly alter the balance between federal and state power; or (3) if an administrative
interpretation of a statute invokes the outer limits of Congress’ power. Any one of those
fundamental principles would require clear congressional authorization for this mandate, but here,
all three are present. Even in exigency, the Secretary cannot “bring about an enormous and

4 CMS intends for the mandate to preempt any arguably inconsistent state and local laws regarding vaccination. See,
e.g., 86 Fed. Reg. at 61,568 (“We intend . . . that this nationwide regulation preempts inconsistent State and local laws
applied to Medicare- and Medicaid-certified providers and suppliers.”).

5 The Court notes that Congress has provided the Secretary of Health and Human Services (the “Secretary”) authority
to enact regulations “necessary to the efficient administration” of the Social Security Act and regulations “necessary
to carry out the administration of” of Medicare. 42 U.S.C. §§ 1302(a), 1395hh(a)(1). Among the regulations the
Secretary may promulgate under its power of “administration” is the setting of things like “standards,” “criteria,” or
“requirements” for specific facilities. See, e.g., Id. at § 1396d(h)(1)(B)(i) (governing Psychiatric Residential
Treatment Facilities (“PRTFs”) and mentioning “standards as may be prescribed in regulations by the Secretary”); Id.
at § 1395i–4(e) (governing Critical Access Hospitals (“CAHs”) and mentioning “criteria as the Secretary may
require”); Id. at § 1395rr(b)(1)(A) (governing End-Stage Renal Disease (“ESRD”) facilities and mentioning
“requirements as the Secretary shall by regulation prescribe”). For some facilities, Congress has authorized the
Secretary to set rules or conditions necessary to, or that will ensure, the “health and safety” of recipients of services.
See, e.g., Id. at § 1395i–3(d)(4)(B) (addressing LTC facilities and mentioning “requirements relating to the health,
safety, and well-being of residents . . . as the Secretary may find necessary”); Id. at § 1395x(e)(9) (addressing hospitals
and mentioning “requirements as the Secretary finds necessary in the interest of the health and safety of individuals
who are furnished services”). However, the Court need not decide whether those regulations are properly interpreted
by CMS to confer it authority to issue the vaccine mandate that it has. Instead, and irrespective of that determination,
the Court’s inquiry focuses on whether Congress specifically authorized such action, for reasons discussed above.
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transformative expansion in [his] regulatory authority without clear congressional authorization.”
See Util. Air Reg. Grp. v. EPA, 573 U.S. 302, 324 (2014).
1. Given the vast economic and political significance of this
vaccine mandate, only a clear authorization from Congress
would empower CMS to act.

First, Congress must “speak clearly when authorizing an agency to exercise powers of ‘vast
economic and political significance.’” Ala. Ass’n of Realtors, 141 S. Ct. at 2489 (quoting Util. Air
Reg., 573 U.S. at 324). The mandate’s economic cost is overwhelming. CMS estimates that
compliance with the Mandate—just in the first year—is around 1.38 billion dollars. 86 Fed. Reg.
at 61,613. Those costs, though, do not take into account the economic significance this mandate
has from the effects on facilities closing or limiting services and a significant exodus of employees
that choose not to receive a vaccination.6 Likewise, the political significance of a mandatory
coronavirus vaccine is hard to understate, especially when forced by the heavy hand of the federal
government. Indeed, it would be difficult to identify many other issues that currently have more
political significance at this time. Had Congress wished to assign this question fraught with deep
economic and political significance to CMS, “it surely would have done so expressly.” See King
v. Burwell, 576 U.S. 473, 486 (2015). “It is especially unlikely that Congress would have delegated
this decision to [CMS], which has no expertise in crafting” vaccine mandates. Id.
2. Because this mandate significantly alters the balance
between federal and state power, only a clear authorization
from Congress would empower CMS.

Second, Congress must use “exceedingly clear language if it wishes to significantly alter
the balance between federal and state power.” Ala. Ass’n of Realtors, 141 S. Ct. at 2489 (quoting

6 Medicare and Medicaid programs “touch[] the lives of nearly all Americans” and are two of the “largest federal
program[s]” in the country. Azar v. Allina Health Servs., 139 S. Ct. 1804, 1808 (2019). Even “minor changes” to the
way those programs are administered “can impact millions of people and billions of dollars in ways that are not always
easy for regulators to anticipate.” Id. at 1816.
9a

United States Forest Service v. Cowpasture River Preservation Assn., 140 S. Ct. 1837, 1850
(2020)); see also United States v. Bass, 404 U.S. 336, 349 (1971). The regulation at issue alters
that balance because it requires vaccination, which CMS has never attempted to do, for millions
of individuals who would otherwise be outside the reach of the federal government. This concern
is “heightened” since CMS’s “administrative interpretation alters the federal-state framework by
permitting federal encroachment upon a traditional state power.” Solid Waste Agency of N. Cook
Cty. v. U.S. Army Corps of Engineers, 531 U.S. 159, 173 (2001). It has long been the states’ power
to legislate health—including vaccination. Gibbons v. Ogden, 22 U.S. 1, 203 (1824) (noting
“health laws of every description” belong to the states); BST Holdings, L.L.C. v. Occupational
Safety & Health Admin., 17 F.4th 604, ---, 2021 WL 5279381, at *7 (5th Cir. 2021) (citing 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”)). Sometimes “the most telling
indication of [a] severe constitutional problem . . . is the lack of historical precedent” for an
agency’s action. Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 549 (2012). With such a
history of exclusive state power, the Court is far from certain that Congress intended the Center
for Medicare and Medicaid Services to require mandatory vaccinations for millions of Americans.
See Bond v. United States, 572 U.S. 844, 858 (2014) (noting “it is incumbent upon the federal
courts to be certain of Congress’ intent before finding that federal law overrides the usual
constitutional balance of federal and state powers” (internal quotations omitted)).
Truly, the impact of this mandate reaches far beyond COVID.7 CMS seeks to overtake an
area of traditional state authority by imposing an unprecedented demand to federally dictate the

7 Of course, this situation is novel and messy in that COVID has created a “unique pandemic scenario,” 86 Fed. Reg.
at 61,568, but equally problematic is that it remains unclear that COVID-19—however tragic and devastating the
pandemic has been—poses the kind of grave danger that justifies the federal government trampling on sovereign state
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private medical decisions of millions of Americans. Such action challenges traditional notions of
federalism, as discussed above. “The independent power of the States [] serves as a check on the
power of the Federal Government: by denying any one government complete jurisdiction over all
the concerns of public life, federalism protects the liberty of the individual from arbitrary power.”
NFIB, 567 U.S. at 536 (quoting Bond v. United States, 564 U.S. 211, 222 (2011)). This is
especially true, since “a healthy balance of power between the States and the Federal Government
will reduce the risk of tyranny and abuse from either front.” Gregory v. Ashcroft, 501 U.S. 452,
458 (1991).
3. In the absence of a clear indication that Congress intended
for CMS to invoke such significant authority, the Court
will not infer congressional intent.

Third, “[w]here an administrative interpretation of a statute invokes the outer limits of
Congress’ power,” Congress must provide “a clear indication that [it] intended that result.” Solid
Waste, 531 U.S. at 172. This “requirement” stems from the “prudential desire not to needlessly
reach constitutional issues.”8 Id. And this requirement is “heightened” here since CMS’s claim
“alters the federal-state framework by permitting federal encroachment upon a traditional state
power.” Id. Whether Congress itself could impose the vaccination requirement is a tough
question, cf. BST Holdings, 17 F.4th at ---, 2021 WL 5279381, at *7 (Duncan, J., concurring), one
that CMS would force to its crisis. But even if Congress has the power to mandate the vaccine

rights. Regardless, disrupting this balance of power must have been expressly authorized by Congress, and as
discussed, Congress has not.

8 A court—especially a district court—should be reluctant to opine on an unsettled constitutional issue when the court
can resolve a case on an alternative ground. See Xiong v. Lynch, 836 F.3d 948, 950 (8th Cir. 2016) (quoting Lyng v.
Nw. Indian Cemetery Protective Ass’n, 485 U.S. 439, 445, 108 (1988)) (“A fundamental and longstanding principle
of judicial restraint requires that courts avoid reaching constitutional questions in advance of the necessity of deciding
them.”). And, at the very least, the Court should “pause to consider the implications of the [State’s] arguments” when
confronted with such new conceptions of federal power. Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 550
(2012) (quoting Lopez,115 S. Ct. at 1624).
11a

and the authority to delegate such a mandate to CMS—topics on which the Court does not opine
today—the lack of congressional intent for this monumental policy decision speaks volumes.
In conclusion, even if Congress’s statutory language was susceptible to CMS’s exceedingly
broad reading—which it is most likely not—Congress did not clearly authorize CMS to enact the
this politically and economically vast, federalism-altering, and boundary-pushing mandate, which
Supreme Court precedent requires.
ii. CMS improperly bypassed notice and comment requirements.

Even if CMS has the authority to implement the vaccine mandate—which the Court finds
is unlikely, as discussed above—the mandate is likely an unlawful promulgation of regulations.
Both the Administrative Procedure Act (“APA”) and the Social Security Act ordinarily require
notice and a comment period before a rule like this one takes effect.9 5 U.S.C. § 553; 42 U.S.C.
§ 1395hh(b)(1). Failure to allow notice and comment, where required, is grounds for invalidating
the rule. Iowa League of Cities v. EPA, 711 F.3d 844, 876 (8th Cir. 2013) (vacating a rule based
on an administrative agency’s failure to abide by the APA’s notice and comment procedure). The
notice and comment requirements do not apply if “good cause” establishes that they “are
impracticable, unnecessary, or contrary to the public interest” under the circumstances. 5 U.S.C.
§ 553(b)(B). The exception is read narrowly and only used in “rare” circumstances. Nw. Airlines,
Inc. v. Goldschmidt, 645 F.2d 1309, 1321 (8th Cir. 1981) (noting that the good cause exception
should be “narrowly construed and only reluctantly countenanced”); Nat. Res. Def. Council, Inc.
v. EPA, 683 F.2d 752, 764 (3d Cir. 1982) (noting “circumstances justifying reliance on [the good
cause] exception are indeed rare and will be accepted only after the court has examined closely
proffered rationales justifying the elimination of public procedures” (internal quotations omitted)).

9 The parties do not dispute that the notice and comment requirements applied to the mandate. 86 Fed. Reg. at 61,583.
12a

CMS concedes it did not follow these requirements but attempts to justify its omission
under the “good cause” exception. 86 Fed. Reg. at 61,583. Here, Plaintiffs are likely to succeed
in their argument that CMS unlawfully bypassed the APA’s notice and comment requirements.
1. CMS’s
own
delay
undermines
its
“emergency”
justification
for
bypassing
notice
and
comment
requirements.

Use of the “good cause” exception is “limited to emergency situations” and is “necessarily
fact-or context-dependent.” Thrift Depositors of Am., Inc. v. Off. of Thrift Supervision, 862 F.
Supp. 586, 591 (D.D.C. 1994). Here, CMS’s delay in requiring mandatory vaccination undermines
its contention that COVID is an emergency such that it has the “good cause” necessary to dispense
with notice and comment requirements. In justifying the good cause exception, CMS stated that
“[t]he data showing the vital importance of vaccination” indicates that it “cannot delay taking this
action” to protect peoples’ health and safety. 86 Fed. Reg. at 61,583. Yet, CMS’s good cause
claim is undermined by its own delay in promulgating the mandate. See United States v. Brewer,
766 F.3d 884, 890 (8th Cir. 2014) (“[C]oncern for public safety further is undermined by [the
Attorney General’s] own seven-month delay in promulgating the Interim Rule.”); Chamber of
Com. v. United States Dep’t of Homeland Sec., 504 F. Supp. 3d 1077, 1089 (N.D. Cal. 2020)
(finding an agency’s six-month delay in promulgating rules relating to COVID precluded
presumption of urgency); Nat. Res. Def. Council v. Nat’l Highway Traffic Safety Admin., 894 F.3d
95, 115 (2nd Cir. 2018) (“Good cause cannot arise as a result of the agency’s own delay, because
otherwise, an agency unwilling to provide notice or an opportunity to comment could simply wait
until the eve of a statutory, judicial, or administrative deadline, then raise up the ‘good cause’
banner and promulgate rules without following APA procedures.” (internal quotations and
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alterations omitted)). The CMS mandate was announced nearly two months10 before the agency
released it, and the mandate itself prominently features yet another one-month delay. Moreover,
two vaccines were authorized under Emergency Use Authorization (“EUA”)11 more than ten
months before the CMS mandate took effect, and one vaccine was fully licensed by the FDA well
over two months before.12 It is also worth mentioning that since the onset of COVID, CMS has
issued five IFC mandates, such as the one here; the most recent on May 13, 2021. 86 Fed. Reg. at
61,561. One could query how an “emergency” could prompt such a slow response; such delay
hardly suggests a situation so dire that CMS may dispense with notice and comment requirements13
and the important purposes they serve.
The COVID pandemic is an event beyond CMS’s control, yet it was completely within its
control to act earlier than it did. See 86 Fed. Reg. at 61,583 (“CMS initially chose, among other
actions, to encourage rather than mandate vaccination[.]”); see id. (explaining CMS had authority
to impose vaccination requirements even when the only vaccines available were those authorized
under EUAs in December 2020). The mere desire or need to have the mandate does not suffice
for good cause. Nat’l Ass’n of Farmworkers Orgs. v. Marshall, 628 F.2d 604, 621 (D.C. Cir. 1980)
(“[G]ood cause to suspend notice and comment must be supported by more than the bare need to
have regulations.”); United States v. Cain, 583 F.3d 408, 421 (6th Cir. 2009) (“A desire to provide

10 On September 9, 2021, the President announced his intention to promulgate federal vaccinate mandates, including
the CMS vaccine mandate challenged here.

11 The FDA issued vaccines under Emergency Use Authorization (“EUA”) for two COVID vaccines on December
11, 2020 and December 18, 2020. According to CMS, the agency could have imposed a vaccine requirement, even
when the only vaccines available are those authorized under EUAs. See 86 Fed. Reg. at 61,583.

12 On August 23, 2021, the FDA licensed the first COVID vaccine.

13 The Court also takes note that CMS reviewed several communications from stakeholders in favor of the mandate.
Thus, CMS apparently found it quite possible to consult with the interested parties it selected. See, e.g., 86 Fed. Reg.
at 61,565.
14a

immediate guidance, without more, does not suffice for good cause.”). And good cause is not
automatically created based on an agency’s conclusion that bypassing the notice and comment
requirements is necessary to protect public safety.14 See Brewer, 766 F.3d at 889 (finding agency’s
stated reason of “protecting the public safety” was insufficient to waive notice and comment
requirement); Sorenson Commc’ns Inc. v. FCC, 755 F.3d 702, 706 (D.C. Cir. 2014) (“To accord
deference to an agency’s invocation of good cause would be to run afoul of congressional intent.”).
COVID cannot be a compelling justification forever, Does 1-3 v. Mills, --- S. Ct. ---, 2021 WL
5027177, at *3 (U.S. Oct. 29, 2021) (Gorsuch, J., dissenting), and CMS’s evidence shows COVID
no longer poses the dire emergency it once did. See, e.g., 86 Fed. Reg. at 61,583 (noting “newly
reported COVID-19 cases, hospitalizations, and deaths have begun to trend downward at a national
level”). Notably, today, there are three widely distributed vaccines. Additionally, there are several
therapeutics and treatments, and as CMS states, more are on the horizon. See, e.g., id. at 61,609.
Thus, CMS’s purported “emergency”15—one that the entire globe has now endured for nearly two
years, and to which CMS itself demonstrated ease in responding to—is unavailing. United States
v. Reynolds, 710 F.3d 498, 512–13 (3rd Cir. 2013) (“Most, if not all, laws passed . . . are designed
to eliminate some real or perceived harm. If the mere assertion that such harm will continue while

14 Other circuits, like the Eighth, have held that protecting the public, without more, is insufficient to waive procedural
requirements. United States v. Reynolds, 710 F.3d 498, 509 (3rd Cir. 2013); United States v. Johnson, 632 F.3d 912,
928 (5th Cir. 2011); United States v. Valverde, 628 F.3d 1159, 1168 (9th Cir. 2010); United States v. Cain, 583 F.3d
408, 421–24 (6th Cir. 2009).

15 CMS also asserted that there is an “emergency” now (such that CMS must immediately implement the mandate)
because “the 2021–2022 influenza season” will soon begin. 86 Fed. Reg. at 61,584. CMS offered this justification
while simultaneously admitting that “the intensity of the upcoming 2021-2022 influenza season cannot be predicted”
and that “influenza activity during the 2020-2021 season was low throughout the U.S.” Id. For a “risk of future harm”
to “justify a finding of good cause,” the “risk must be more substantial than a mere possibility.” Brewer, 766 F.3d at
890. Thus, CMS did not find a concrete “threat” to remedy but rather speculated as to a mere possibility of harm, and
there is a “difference between addressing present legal uncertainty and addressing the possibility of future legal
uncertainty.” Id. Notably, CMS did not mandate flu vaccines, despite mentioning that the flu has been daunting the
healthcare system, that recent studies show approximately half of healthcare workers refuse the flu vaccine, id. at
61,568, and that CMS has evidence that influenza vaccination of health care staff is directly associated with declines
in nosocomial influenza in hospitalized patients and nursing home residents. Id. at 61,557.
15a

an agency gives notice and receives comments were enough to establish good cause, then notice
and comment would always have to give way.”).
2. CMS failed to meet its “good cause” burden, especially in
light of the unprecedented, controversial, and health-
related nature of the mandate.

CMS also failed to meet its burden based on the unprecedented, controversial, and health-
related nature of the mandate. Alcaraz v. Block, 746 F.2d 593, 612 (9th Cir. 1984) (holding that
the inquiry into an agency invoking “good cause proceeds case-by-case, sensitive to the totality of
the factors at play”). CMS had the burden “to establish that notice and comment need not be
provided.” Nat. Res. Def. Council, 894 F.3d at 113–14. In a situation like here, where there is
significant and known opposition to the mandate, “good cause” is even more important than usual.
See, e.g., Asbestos Information Ass’n of N. Am. v. Occupational Safety & Health Admin., 727 F.2d
415, 426 (5th Cir. 1984) (explaining that rules “may be more uncritically accepted after public
scrutiny, through notice-and-comment rulemaking, especially when the conclusions it suggests are
controversial”). The fact that this mandate effects issues relating to health16 increases the
importance even further. See Nat’l Ass’n of Farmworkers, 628 F.2d at 621 (“Especially in the
context of health risks, notice and comment procedures assure the dialogue necessary to the
creation of reasonable rules.”); Cmty. Nutrition Inst. v. Butz, 420 F. Supp. 751, 754 (D.D.C. 1976)
(noting that “when a health-related standard such as this is involved, the good cause exemption
may not be used to circumvent the legal requirements designed to protect the public”).
Accordingly, CMS’s argument that undertaking normal notice and comment requirements would
be “contrary to the public interest” based on delaying the mandate, id. at 61,586, is unavailing in
light of the circumstances. Alcaraz, 746 F.2d at 612. Rather, these requirements “serve the public

16 CMS acknowledges that “[s]erious adverse reactions [] have been reported following COVID-19 vaccines.” 86
Fed. Reg. at 61,565.
16a

interest by providing a forum for the robust debate of competing and frequently complicated policy
considerations having far-reaching implications and, in so doing, foster reasoned decision
making.” Id. They are far from “mere formalities.” Id.
Moreover, the failure to take and respond to comments feeds into the very vaccine
hesitancy CMS acknowledges is so daunting. 86 Fed. Reg. at 61,559, 61,568. Besides fostering
reasoned decision making, notice and comment “provide a ‘surrogate political process’ that takes
some of the sting out of the inherently undemocratic and unaccountable rulemaking process.”
Dep’t of Homeland Sec. v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1929 n.13 (Thomas, J.,
dissenting). Requiring already hesitant individuals to get the vaccine—without giving them an
opportunity to be heard—undermines the democratic process that the APA’s procedural safeguards
are intended to protect and exacerbates the underlying hesitancy problem. Batterton v.
Marshall, 648 F.2d 694, 703 (D.C. Cir. 1980) (according notice and comment great importance
because it “reintroduce[s] public participation and fairness to affected parties after governmental
authority has been delegated to unrepresentative agencies”). Far from being “good cause” for
circumventing the normal rulemaking requirements, the unprecedented and controversial mandate
affecting personal health constitutes a compelling reason to utilize those procedures, and CMS
failed to provide the good cause necessary to overcome these factors.
In conclusion, because CMS’s “emergency” does not justify use of the “good cause”
exception, see Thrift, 862 F. Supp. at 591, and the unprecedented, controversial, and health-related
mandate requires more good cause than CMS provided, Alcaraz, 746 F.2d at 612, Plaintiffs are
likely to succeed in establishing that CMS improperly invoked the 5 U.S.C. § 553(b)(B) “good
cause” exception.

17a

iii. The mandate is arbitrary and capricious.
Finally, Plaintiffs are likely to succeed in establishing that the CMS vaccine mandate is
arbitrary or capricious. Under the APA, a court must “hold unlawful and set aside agency action”
that is “arbitrary” or “capricious.” 5 U.S.C. § 706(2)(A). The APA’s arbitrary-and-capricious
standard requires that agency action be reasonable and reasonably explained. Fed. Commc’ns
Comm’n v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021) (“A court simply ensures that
the agency has acted within a zone of reasonableness and, in particular, has reasonably considered
the relevant issues and reasonably explained the decision.”). Under this “narrow” and deferential
standard of review, a court may not substitute its own policy judgment for that of the agency. Id.
Rather, the court must ensure there is a “rational connection between the facts found and the choice
made.” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43
(1983).
1. The mandate is arbitrary and capricious because the
record is devoid of evidence regarding the covered
healthcare facilities.

CMS lacks evidence showing that vaccination status has a direct impact on spreading
COVID in the mandate’s covered healthcare facilities. CMS acknowledges its lack of
“comprehensive data” on this matter but attempts to “extrapolate” the abundant data that it does
have on Long Term Care Facilities (“LTCs”), generally referred to as nursing homes, to the other
dozen-plus Medicare and Medicaid facilities covered by the mandate. 86 Fed. Reg. at 61,585.
However, CMS’s path of analysis appears misguided and the inferences it produced are
questionable. State Farm, 463 U.S. at 43 (finding that in an arbitrary and capricious challenge,
the court will “uphold a decision of less than ideal clarity if the agency’s path may reasonably be
discerned”). As CMS’s own record shows, COVID disproportionally devastates LTC facilities.
18a

Residents of LTC facilities—who make up less than 1-percent of the U.S. population—accounted
for more than 35-percent of all COVID deaths during the first twelve months of the pandemic. 86
Fed. Reg. at 61,566. Equally staggering is that “[o]f the approximately 656,000 Americans
estimated to have died from COVID through September 10, 2021, 30-percent are estimated to have
died during or after an LTC facility stay.” Id. at 61,601. Thus, CMS’s decision to extrapolate
LTC data to justify its lack of data regarding the other fourteen facilities covered is likely not
reasonable. Michigan v. EPA, 576 U.S. 743, 750 (2015) (requiring agencies to engage in “reasoned
decision making”); Encino Motorcars, LLC v. Navarro, 579 U.S. 211, 220 (2016) (“[A]n agency
must give adequate reasons for its decisions.”). While a wide-sweeping mandate might make sense
in the context of LTCs, based on CMS’s evidence, CMS presents no similar evidence for imposing
a broad-sweeping mandate on the other fourteen covered facilities. Camp v. Pitts, 411 U.S. 138,
143 (1973) (“If [a] finding is not sustainable on the administrative record made, then the [agency’s]
decision must be vacated[.]”). Although the Court appreciates its deferential review, the Court’s
duty is not to “rubber-stamp” administrative decisions devoid of reasonableness. Alaska Oil and
Gas Ass’n v. Jewell, 815 F.3d 544 (9th Cir. 2016) (“A court must not substitute its judgment for
that of the agency, but also must not “rubber-stamp” administrative decisions.”).
In general, the overwhelming lack of evidence likely shows CMS had insufficient evidence
to mandate vaccination on the wide range of facilities that it did. Looking even beyond the
evidence deficiencies relating to the specific facilities covered, the lack of data regarding
vaccination status and transmissibility—in general—is concerning. Indeed, CMS states that “the
effectiveness of the vaccine[s] to prevent disease transmission by those vaccinated [is] not
19a

currently known.”17 86 Fed. Reg. at 61,615.18 CMS also admits that the continued efficacy of the
vaccine is uncertain. See, e.g., id. at 61,612 (“[M]ajor uncertainties remain as to the future course
of the pandemic, including but not limited to vaccine effectiveness in preventing ‘breakthrough’
disease transmission from those vaccinated, [and] the long-term effectiveness of vaccination[.]”).
No one questions that protecting patients and healthcare workers from contracting COVID is a
laudable objective. But the Court cannot, in good faith, allow CMS to enact an unprecedented
mandate that lacks a “rational connection between the facts found and the choice made.” State
Farm, 463 U.S. at 43; see also Sierra Club v. Mainella, 459 F. Supp. 2d 76, 90 (D.D.C. 2006)
(“Under the APA . . . the function of the district court is to determine whether or not as a matter
of law the evidence in the administrative record permitted the agency to make the decision it did.”).
The reasoned explanation and evidentiary requirement “of administrative law, after all, is meant
to ensure that agencies offer genuine justifications for important decisions, reasons that can be
scrutinized by courts and the interested public.” Dep’t of Com. v. New York, 139 S. Ct. 2551, 2575
(2019). If judicial review is to be more than an “empty ritual,” the Court here must demand
something more than the explanation offered for the action taken by CMS here. Id.
2. The mandate is arbitrary and capricious because CMS
improperly rejected alternatives to the mandate.

CMS failed to consider or rejected obvious alternatives to a vaccine mandate without
evidence. For example, CMS rejected daily or weekly testing—an option that even OSHA
approved in its ETS—without citing any evidence for such a conclusion. 86 Fed. Reg. at 61,614.

17 “As explained in various places within this RIA and the preamble as a whole, there are major uncertainties as to the
effects of current variants of SARS-CoV-2 on future infection rates, medical costs, and prevention of major illness or
mortality. For example, the duration of vaccine effectiveness in preventing COVID-19, reducing disease severity,
reducing the risk of death, and the effectiveness of the vaccine to prevent disease transmission by those vaccinated are
not currently known.” 86 Fed. Reg. at 61,615.

18 Also, CMS has no data showing forced vaccinations in the healthcare industry has stopped the spread of COVID in
hospitals.
20a

Rather, it assured that it “reviewed scientific evidence on testing” but “found that vaccination is a
more effective infection control measure.” Id. at 61,614. As discussed elsewhere, this conclusion
comes despite its admission that it lacks solid evidence19 regarding transmissibility of COVID by
the vaccinated. Id. at 61,615, 61,612. Although it is not the Courts duty to ask whether CMS’s
decision was “the best one possible” or even whether there were “better [] alternatives,” Federal
Energy Regulatory Commission v. Electric Power Supply Ass’n, 136 S. Ct. 760, 782 (2016), the
Court must ensure there exists a “rational connection between the facts found and the choice
made.” State Farm, 463 U.S. at 43.
As another example, CMS rejected20 mandate alternatives in those with natural immunity
by a previous coronavirus infection. 86 Fed. Reg. at 61,614 (noting “many uncertainties” about
the immunity in those previously infected “compared to people who are vaccinated”). But,
elsewhere, it plainly contradicts itself regarding the value of natural immunity. Id. at 61,604
(“[A]bout 100,000 a day have recovered from infection . . . . These changes reduce the risk to both
health care staff and patients substantially, likely by about 20 million persons a month who are no
longer sources of future infections.”) (emphasis added). Such contradictions are tell-tale signs of
unlawful agency actions. See State Farm, 463 U.S. at 43 (finding agency action arbitrary and
capricious if the agency explained its decision in a way that “runs counter to the evidence before
the agency”); see also Bethesda Health, Inc. v. Azar, 389 F. Supp. 3d 32, 41 (D.D.C. 2019) (setting
aside as arbitrary and capricious agency action that contradicts its own regulations).

19 Far from being reasonable to prohibit alternatives to vaccination, this constitutes a compelling reason to utilize,
rather than reject, other alternatives before subjecting the public to a never-before CMS vaccine mandate.

20 CMS also rejected natural immunity, despite an intense public debate and a trove of scientific data on the strength
and durability of natural immunity from COVID-19—alone and compared to vaccine-induced immunity. State Farm,
463 U.S. at 43 (noting “the agency must examine the relevant data”).
21a

3. The mandate is arbitrary and capricious because of its
broad scope.

The broad scope of healthcare facilities covered by the mandate renders it arbitrary. The
mandate applies equally to the varying healthcare facility types it covers, such as Psychiatric
Residential Treatment Facilities (“PRTFs”) for individuals under age twenty-one, see 86 Fed. Reg.
at 61,576, and LTCs, see id. at 61,575. But, at the same time, CMS acknowledges that the risk of
COVID to those in the former age group is markedly smaller. See, e.g., id. at 61,610 n.247
(recognizing that “risk of death from infection from an unvaccinated 75-to 84-year-old person is
320 times more likely than the risk for an 18- to 29-years old person”); id. at 61,601 (“Among
those infected, the death rate for older adults age 65 or higher was hundreds of time higher than
for those in their 20s during 2020.”); id. at 61,566 (noting those aged 65 years and older account
for more than 80-percent of U.S. COVID-19 related deaths). What is more, besides applying to
all facilities equally, the mandate applies to all facilities’ staff equally, “regardless of . . . patient
contact.” Id. at 61,570 (emphasis added). The mandate goes so far as to cover a third-party
vendor’s “crew working on a construction project” whose members use the same bathrooms
“during their breaks.” Id. at 61,571. CMS provides no reasoned21 explanation for this overbroad
approach, and it further belies its asserted interest in protecting patients from COVID.22 Cty. of
Los Angeles v. Shalala, 192 F.3d 1005, 1021 (D.C. Cir. 1999) (“Where the agency has failed to
provide a reasoned explanation, or where the record belies the agency’s conclusion, [the court]
must undo its action.”).

21 As explained in infra note 24, upping vaccination nation-wide is not a “reasonable” reason for CMS to enact its
mandate because the agency’s powers are limited to Medicare and Medicare—not federalizing healthcare and reaching
the general public. Rather, the overbroad approach indicates the pretextual nature of this mandate.

22 The Court also notes that recently, on November 12, 2021, CMS itself revised its pandemic guidance for nursing
home visitation, specifically opening facility visitation “for all residents at all times” by family and friends who are
not required to be vaccinated. This also belies CMS’s asserted interest in protecting patients from COVID, and
instead, shows that the mandate’s overbreadth is to increase the national vaccination rate by any means necessary.
22a

4. The mandate is arbitrary and capricious due to CMS’s
sudden change in course.

CMS failed to adequately explain its contradiction to its long-standing practice of
encouraging rather than forcing—by governmental mandate—vaccination. For years, CMS has
promulgated regulations setting the conditions for Medicare and Medicaid participation; never has
it required any vaccine for covered facilities’ employees—despite concerns over other illnesses
and their corresponding low vaccination rates.23 As recent as this May, CMS adopted an IFC
requiring education on COVID vaccines but again decided against forced vaccination.
It is generally “arbitrary or capricious” to depart from a prior policy sub silentio; when
agencies contradict a prior policy, they must show “good reasons for the new policy.” FCC v. Fox
Television Stations, Inc., 556 U.S. 502, 515 (2009); accord EPA v. EME Homer City Generation,
L.P., 572 U.S. 489, 510 (2014) (holding that agency “retained discretion to alter its course [under
a regulation] provided it gave a reasonable explanation for doing so”). Here, CMS’s purported
reason for changing its policy is to force those unwilling or hesitant to receive the vaccine into
receiving it, all under the guise of protecting recipients of Medicare and Medicaid. See 86 Fed.
Reg. at 61,583 (noting “CMS initially chose . . . to encourage rather than mandate vaccination”
but “vaccine uptake among health care staff [was not] as robust as hoped for”); id. at 61,569 (noting
that despite healthcare worker hesitation about the vaccine, “mandates have already been
successfully initiated in a variety of health care settings, systems, and states”); id. at 61,560 (noting
it was “compelled to require staff vaccinations for COVID-19” given its “responsibility to protect
the health and safety of individuals . . . receiving care and services from for Medicare- and

23 In the Mandate, CMS discusses how influenza is a major problem plaguing the healthcare industry. Nonetheless,
CMS states that half of healthcare workers resist the seasonal influenza vaccine nationwide, 86 Fed. Reg. at 61,568,
but that it continues to “recommend” influenza vaccination rather than mandate it. Id. Even though CMS has evidence
that influenza vaccination of health care staff is associated with declines in nosocomial influenza in hospitalized
patients and nursing home residents. Id. at 61,557.
23a

Medicaid-certified providers and suppliers”). But even if forcing the administration of a specific
vaccine, into the otherwise unwilling, in an effort to protect the recipients of these programs could
be a reasonable explanation to justify the extraordinary action—action that long has been the
province of the states, see Zucht, 260 U.S. at 176 (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)—CMS has not shown that it is reasonable in
this instance.24 Rather, it specifically notes that the vaccines’ effectiveness to prevent disease
transmission by those vaccinated is not currently known. 86 Fed. Reg. at 61,615 (noting “the
duration of vaccine effectiveness in preventing COVID-19, reducing disease severity, reducing the
risk of death, and the effectiveness of the vaccine to prevent disease transmission by those
vaccinated are not currently known”).
5. The mandate is arbitrary and capricious because CMS
failed to consider or properly weigh necessary reliance
interests.

Because CMS changed course, it was required to “be cognizant that longstanding policies
may have ‘engendered serious reliance interests that must be taken into account.’” Fox Television,

24 The inadequacy of the explanation for the reversal is especially true since Plaintiffs will likely succeed in
demonstrating it is a pretextual rationale. See Dep’t of Com. v. New York, 139 S. Ct. 2551, 2575–76 (2019); id. at
2583 (Thomas, J., concurring in part and dissenting in part) (noting Court “opened a Pandora’s box of pretext-based
challenges in administrative law”); id. at 2597 (Alito, J., concurring in part and dissenting in part). While a court may
not set aside an agency’s policymaking decision “solely because it might have been influenced by political
considerations or prompted by an Administration’s priorities,” Department of Commerce, 139 S. Ct. at 2573, an
agency’s change in course “cannot be solely a matter of political winds and currents.” North Carolina Growers’
Association, Inc. v. United Farm Workers, 702 F.3d 755, 772 (4th Cir. 2012) (Wilkinson, J., concurring). Plaintiffs
have demonstrated that they could likely show pretext. See, e.g., Doc. [9] at 4 (citing Joseph Biden, Remarks at the
White House (Sept. 9, 2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-
president-biden-on-fighting-the-covid-19-pandemic-3/ (decrying “nearly 80 million Americans who have failed to get
the shot” while announcing “a new plan to require more Americans to be vaccinated” and explaining that “[i]f you’re
seeking care at a health facility, you should be able to know that the people treating you are vaccinated. Simple.
Straightforward. Period.”); see also 86 Fed. Reg. at 61,601 (“the protective scope of this rule is far broader than the
health care staff that it directly affects”); see also id. at 61,612 (“Staff vaccination will also provide significant
community benefits when staff are not at work.”). The Court “cannot ignore the disconnect between the decision
made and the explanation given.” Dep’t of Com., 139 S. Ct. at 2575.
24a

556 U.S. at 515. Ignoring reliance interests is necessarily arbitrary and capricious. Id. Yet, it
appears this is what CMS did. An agency is required to assess whether there were reliance
interests, determine whether they were significant, and weigh any such interests against competing
policy concerns. Regents, 140 S. Ct. at 1915.
In concluding that the mandate’s benefits outweigh the risks to the healthcare industry,
CMS did not properly consider all necessary reliance interests of facilities, healthcare workers,
and patients. 86 Fed. Reg. at 61,607–10. CMS looked only at evidence from interested parties in
favor of the mandate, while completely ignoring evidence from interested parties in opposition.
Consumers Union of U. S., Inc. v. Consumer Prod. Safety Comm’n, 491 F.2d 810, 812 (2d Cir.
1974) (noting agency “must not ignore evidence placed before it by interested parties”). In fact,
CMS foreclosed these parties’ ability to provide information regarding the mandate’s effects on
the healthcare industry, while simultaneously dismissing those concerns based on “insufficient
evidence.” 86 Fed. Reg. at 61,569. But facts do not cease to exist simply because they are ignored,
and “[s]tating that a factor was considered25 is not a substitute for considering it.” Texas v. Biden,
10 F.4th 538, 556 (5th Cir. 2021) (internal quotations and alterations omitted); Sierra Club, 459
F. Supp. 2d at 100 (“Merely describing an impact and stating a conclusion of non-impairment is
insufficient[.]”); Gresham v. Azar, 363 F. Supp. 3d 165, 177 (D.D.C. 2019) (“The bottom line: the
Secretary did no more than acknowledge—in a conclusory manner, no less—that commenters
forecast a loss in Medicaid coverage.”). Had CMS followed the proper procedural requirements,

25 Several times throughout the mandate, CMS acknowledges the countervailing effect it will have on the healthcare
industry. See, e.g., 86 Fed. Reg. at 61,607 (“currently there are endemic staff shortages for almost all categories of
employees at almost all kinds of health care providers and supplier and these may be made worse if any substantial
number of unvaccinated employees leave health care employment altogether”); id. at 61,567 (“and the urgent need to
address COVID-related staffing shortages that are disrupting patient access to care, provides strong justification as to
the need to issue this IFC requiring staff vaccination for most provider and supplier types over which we have
authority.”). Yet, despite these acknowledged concerns about intensifying an already-existing healthcare crisis, CMS
decided to move forward anyway, without properly considering the totality of interests affected by the mandate, such
as rural hospitals.
25a

States, healthcare providers, and healthcare workers would have submitted critical information to
CMS—instead of to the Courts26—showing that the mandate portends a disaster for the healthcare
industry, particularly in rural communities. Azar v. Allina Health Servs., 139 S. Ct. 1804, 1816,
(2019) (requiring HHS to undertake notice-and-comment rulemaking, in part, because it
“neglected to acknowledge the potential countervailing benefits”); Time Warner Cable Inc. v.
FCC, 729 F.3d 137, 168 (2nd Cir. 2013) (explaining APA policies are “to ensure the agency has
all pertinent information before it when making a decision”). By dispensing with those
requirements, CMS ignored evidence showing that the mandate threatens devastating
consequences to healthcare providers, staff, and patients throughout the nation.
Even if CMS did properly consider these reliance issues—which this Court finds it most
likely did not—the scant evidence of record shows CMS was unable to adequately balance these
reliance interests because it placed a rock on one side of the scale and a feather on the other.
Regents, 140 S. Ct. at 1914 (failing to weigh reliance interests against competing policy concerns
is arbitrary and capricious). And as already explained, these evidence deficiencies are solely a
product of its own doing. So, either CMS entirely failed to consider an important aspect of the
problem or failed to weigh the interests properly; regardless, either way the pendulum swings,
CMS’s actions, or rather, inaction, violates basic tenants of administrative law. Id.; State Farm,
463 U.S. at 43 (noting that “entirely fail[ing] to consider an important aspect of the problem” is

26 It is not the job of this Court to collect evidence and opposition from affected parties; rather, this is the role, actually
a duty, of CMS when promulgating a rule. See District of Colombia v. United States Dep’t of Agriculture, 496 F.
Supp. 3d 213, 228 (D.D.C. 2020) (emphasizing that one purpose of notice and comment rulemaking is to “give affected
parties an opportunity to develop evidence in the record to support their objections to the rule and thereby enhance the
quality of judicial review”); Hoctor v. U.S. Dept. of Agriculture, 82 F.3d 165, 167 (7th Cir. 1996) (“Notice and
comment rulemaking . . . facilitates the marshaling of opposition to a proposed rule, and may result in the creation of
a very long record that may in turn provide a basis for a judicial challenge to the rule if the agency decides to
promulgate it.”).
26a

arbitrary and capricious); Michigan, 576 U.S. at 750–52 (noting “agency action is lawful only if it
rests on a consideration of the relevant factors” and “important aspects of the problem”).
In conclusion, Plaintiffs likely can show the CMS mandate is arbitrary and capricious
because the evidence does not show a rational connection to support implementing the vaccine
mandate, the mandate’s broad scope, the unreasonable rejection of alternatives to vaccination,
CMS’s inadequate explanation for its change in course, and its failure to consider or properly
weigh reliance interests.
Accordingly, Plaintiffs’ challenges to the mandate show a great likelihood of success on
the merits, and this fact weighs critically in favor of a preliminary injunction. Home Instead, 721
F.3d at 497 (“While no single factor is determinative, the probability of success factor is the most
significant.” (internal quotations and citations omitted)).
b. Plaintiffs demonstrate irreparable harm.
The Court must next determine whether Plaintiffs have shown that they are “likely to suffer
irreparable harm in the absence of preliminary relief.” Benisek v. Lamone, 138 S. Ct. 1942, 1944
(2018) (quoting Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008)). Plaintiffs must
show more than a mere “possibility,” but they need not show a certainty; rather, they need to
demonstrate “irreparable injury is likely in the absence of an injunction.” Winter, 555 U.S. at 22.
Plaintiffs have done so here.
The Plaintiff States bring their claims in a number of capacities: sovereign, quasi-
sovereign/parens patriae, and proprietary. See, e.g., Doc. [1] ¶¶ 5, 7, 9. Through their various
interests, they have shown irreparable injury is more than likely in the absence of an injunction.
27a

First, Plaintiffs sovereign interests27 are likely to suffer irreparable harm without a
preliminary injunction because they will be unable to enforce their duly enacted laws surrounding
vaccination mandates and providing proof of vaccination. See, e.g., Mo. Rev. Stat § 67.265; 2021
Alaska Sess. Laws ch. 2, § 17; Ark. Code § 20-7-143; see also, e.g., Ark. Code § 11-5-118. The
mandate notes that it “preempts inconsistent State and local laws as applied to Medicare- and
Medicaid-certified providers and suppliers.” 86 Fed. Reg. at 61,568. Generally, this preemption
would be unremarkable. See U.S. Const. art. VI, § 2. But, as here, where CMS likely did not
lawfully enact its mandate, Plaintiffs are harmed because they cannot enforce their duly enacted
laws and no lawfully enacted regulation preempts them. The injury that results when a state cannot
enforce “statutes enacted by representatives of its people” is irreparable. Maryland v. King, 567
U.S. 1301, 1303 (2012) (Roberts, C.J., in chambers) (quoting New Motor Vehicle Bd. of Cal. v.
Orrin W. Fox Co., 434 U.S. 1345, 1351 (1977) (Rehnquist, J., in chambers)); accord Org. for
Black Struggle v. Ashcroft, 978 F.3d 603, 609 (8th Cir. 2020) (“Prohibiting the State from
enforcing a statute properly passed . . . would irreparably harm the State.”).
Second, Plaintiffs quasi-sovereign interests are likely to suffer irreparable harm without a
preliminary injunction. Unlike the harm Plaintiffs likely would face to their sovereign interests—
which though significant, is more abstract—the harm Plaintiffs likely would face to their quasi-
sovereign interests would be observable and appreciable. Indeed, the likely harm would be harm
in the colloquial sense—pain, suffering, distress. Plaintiffs have a quasi-sovereign interest “in the
health and well-being—both physical and economic—of [their] residents, Alfred L. Snapp & Son,
Inc. v. Puerto Rico, 458 U.S. 592, 607 (1982), and Plaintiffs have put forth evidence that this
mandate would have a detrimental effect on the health and well-bring of their citizens.

27 The States also have an interest in seeing their constitutionally reserved police power over public health policy
defended from federal overreach, as discussed in depth in section II.B.a.i.2.
28a

Review of the affidavits filed in support of Plaintiffs’ motion for preliminary injunction
shows the harm to the physical health and well-being of their states’ citizens if the mandate is not
enjoined. The Plaintiffs’ affidavits came from varying healthcare entities and associations in their
states impacted by the mandate. The affiants describe existing and significant staffing shortages
as well as open and unfilled positions for an extended period of time, some for more than a year.
See, e.g., Doc. [9-7] at 3; Doc. [9-11] at 3; Doc. [9-25] at 3; Doc. [9-3] at 4. The affidavits also
demonstrate that the mandate will more than likely exacerbate the already-existing staffing
problem. Many of the affidavits generally describe the number of individuals employed by the
entity and the number or percentage of employees either known or reasonably known to have not
been vaccinated.28 See, e.g., Doc. [9-4] at 3, 4; Doc. [9-3] at 4. Through talks, surveys, and direct
conversations with staff, the affiants know the individuals that will leave employment if CMS goes
ahead with its mandate. See, e.g., Doc. [9-4] at 3; Doc. [9-5] at 3; Doc. [9-13] at 4; Doc. [9-19] at
3; Doc. [9-20] at 3. Already, in some cases, the mere announcement of CMS’s mandate has
compelled some to resign. See, e.g., Doc. [9-26] at 2.
Staff reductions due to implementing the mandate, especially in light of the already
understaffed healthcare facilities, will cause a cascade of consequences. See, e.g., Doc. [9-16] at
3–6. The mandate’s effect of reducing staff will decrease the quality of care provided at facilities,
compromise the safety of patients, and place even more stress on the remaining staff. See, e.g.,
Doc. [9-11] at 4. The mandate “creates a risk in patient safety” and will create “ongoing ripple
effects on . . . patients, remaining employees and [the] community for some time in the future.”
Doc. [9-18] at 5. An affiant noted that “even if we can technically staff services with extra shift
and call, we are already doing that, have been doing that for more than a year, and our vaccinated

28 CMS itself notes that rural hospitals are less vaccinated than urban. 86 Fed. Reg. at 61,613 (recognizing that “rural
hospitals are having greater problems with employee vaccination . . . than urban hospitals”).
29a

staff will not be capable of doing it for much longer. At this point, considering it is nearly
impossible to recruit clinical staff today, more will resign due to the stress and burnout that will
inevitably exist.” Doc. [9-23] at 5.
The loss of certain staffing categories will diminish entire areas of care within a facility
that inevitably implicate others. See, e.g., Doc. [9-19] at 3 (warning of the loss of the only
remaining anesthesiologist); Doc. [9-21] at 3 (warning of the loss of 80% of imaging department);
Doc. [9-14] at 3; Doc. [9-18] at 4; Doc. [9-25] at 4. Facilities in rural locations, already hard-
pressed to find qualified applicants regardless of vaccination status, will have to evaluate what
healthcare services they could still safely provide, if any at all, in the region they serve. See, e.g.,
Doc. [9-4] at 4; Doc. [9-7] at 3–4; Doc. [9-9] at 2–5; Doc. [9-12] at 4; Doc. [9-13] at 4; Doc. [9-
19] at 3; Doc. [9-23] at 4. As an example, for a general hospital located in North Platte, Nebraska,
implementation of the mandate would result in the loss of the only remaining anesthesiologist.
Doc. [9-19] at 3. Understandably, without an anesthesiologist, there could be no surgeries—at all.
Thus, such a loss irreparably causes a cascading effect on the entire facility and a wide-range of
patients. Other examples show the mandate’s far-reaching implications not just on the
administration of healthcare itself, but the functioning of the facilities in general. For example,
the building manager of a nursing home in Memphis, Missouri states he will leave if the choice is
between his job or the vaccine. Doc. [9-9] at 3–4. If the mandate takes effect, then, the nursing
home would have “no one competent enough to run [the] building and [perform] all the
complicated systems and required inspections.” Id. Also, this type of position is not the kind that
can be filled “quickly, especially with today’s workforce and being in a rural setting.” Id. Other
affidavits also detail an especially hard impact to emergency services in rural areas. See, e.g., Doc.
[9-21] at 2–3 (“If we lose our imaging department we will have to divert many of our emergency
30a

patients to other facilities; the closest one is 45 miles away.”); Doc. [9-11] at 4 (explaining that in
the event this hospital closes, the nearest one would be thirty miles away); Doc. [9-12] at 2–3
(similar); Doc. [9-16] at 6 (similar).
Further, the loss of staffing in many instances will result in no care at all, as some facilities
will be forced to close altogether. For example, the Administrator of the Scotland County Care
Center (SCCC), a nursing home located in Memphis, Missouri, notes that out of about sixty-five
employees, twenty have indicated that they are opposed to taking the vaccine, and if the mandate
is imposed, that they will quit.29 Doc. [9-9] at 2. A loss of twenty staff members will cause SCCC
to “close its doors” and displace residents that have lived in that community their entire lives. Id.
at 5; see also Doc. [9-26] at 4. Thus, if the mandate goes into effect, it will irreparably harm
patients30 by impeding access to care for the elderly and for persons who cannot afford it—directly
contrary to Medicare and Medicaid’s core objective of providing proper care. In sum, Plaintiffs’
evidence shows that facilities—rural facilities in particular—likely would face crisis standards of
care or will have no choice but to close to new patients or close altogether, both of which would
cause significant, and irreparable, harm to Plaintiffs’ citizens. Kai v. Ross, 336 F.3d 650, 656 (8th
Cir. 2003) (finding “danger to plaintiffs’ health, and perhaps even their lives, gives them a strong
argument of irreparable injury”).31

29 This includes SCCC’s billing and accounting staff members, which would create a “substantial disruption” in
SCCC’s business functions, as well as their building plant manager, “that would leave me with no one competent
enough to run my building and all the complicated systems and required inspections.” Id. at 4.

30 Medicare and Medicaid programs “touch[] the lives of nearly all Americans” and are two of the “largest federal
program[s]” in the country. See Allina Health Servs., 139 S. Ct. at 1808.

31 “No right is held more sacred, or is more carefully guarded . . . than the right of every individual to the possession
and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable
authority of law.” Union Pacific R. Co. v. Botsford, 141 U.S. 250, 251 (1891). As already explained, CMS most
likely does not have the authority to promulgate the mandate, and clear congressional authorization is also lacking.
“Irreparable harm occurs when a party has no adequate remedy at law, typically because its injuries cannot be fully
compensated through an award of damages.’” Rogers Group, Inc. v. City of Fayetteville, Ark., 629 F.3d 784, 789 (8th
Cir. 2010) (quoting Gen. Motors Corp. v. Harry Brown’s, L.L.C., 563 F.3d 312, 319 (8th Cir. 2009)). It follows then,
31a

Besides the harm to physical health that Plaintiffs have shown will likely occur absent a
preliminary injunction, the mandate also would have a negative effect on the economies in Plaintiff
states, especially, once again, in rural areas.32 While economic injuries normally would be
reparable at law, “federal agencies generally enjoy sovereign immunity for any monetary
damages.” Wages & White Lion Invs., L.L.C. v. United States Food & Drug Admin., 16 F.4th
1130, 1142 (5th Cir. 2021); see also 5 U.S.C. § 702 (providing for an action seeking relief “other
than money damages”). Therefore, the economic loses in Plaintiff states would be unrecoverable
and thus irreparable. Iowa Utls. Bd. v. FCC, 109 F.3d 418, 426 (8th Cir. 1996) (“The threat of
unrecoverable economic loss, however, does qualify as irreparable harm.”); DISH Network Serv.
L.L.C. v. Laducer, 725 F.3d 877, 882 (8th Cir. 2013).
Fourth, and finally, Plaintiffs would likely face irreparable harm to their proprietary
interests absent a preliminary injunction. Plaintiffs themselves operate healthcare facilities that
CMS’s mandate reaches. They therefore would face the same harms any private owner of a facility
faces, like the “business and financial effects of a lost or suspended employee, compliance and
monitoring costs associated with the Mandate, [or] the diversion of resources necessitated by the
Mandate.” BST Holdings, 17 F.4th at ---. As just noted, since these costs could not be recovered
from the federal government, they are irreparable. Iowa Utls. Bd., 109 F.3d at 426.
For all these reasons, the Court finds that Plaintiffs are likely to suffer significant
irreparable harm absent a preliminary injunction.

that forcing individuals to choose “between their job(s) and their jab(s),” BST Holdings, 17 F.4th at ---, substantially
burdens the liberty interests of individuals, which cannot be fully compensated through an award of damages.

32 For example, Callaway District Hospital and Medical Clinics is the largest employer in Callaway, Nebraska and is
a “significant driver of the local business and agriculture economy.” Doc. [9-12] at 4. The expected loss of staff
would “almost certainly” lead to closure of the facility. Id. “Cherry County Hospital is a leader of employment” for
its county. Doc. [9-16] at 6. “Kimball County Manor and Assisted Living employs 55 full time staff and as such is
one of the largest employers in Kimball County, a rural county located in Nebraska’s western panhandle.” Doc. [9-
22] at 3.
32a

c. The balance of equities tip in favor of Plaintiffs, and the public has an
interest in an injunction.

Finally, the Court must determine whether Plaintiffs have shown that the “balance of
equities tips in [their] favor” and that “an injunction is in the public interest.” Winter, 555 U.S. at
20. 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.” Id. at 24. When the party opposing
the injunction is the federal government, the balance-of-harms factor “merge[s]” with the public-
interest factor. Nken v. Holder, 556 U.S. 418, 436 (2009).
The public has an interest in stopping the spread of COVID. No one disputes that. But the
Court concludes that the public would suffer little, if any, harm from maintaining the “status quo”
through the litigation of this case. Defendants argue that “enjoining the rule would harm the public
interest by further exposing Medicare and Medicaid patients and staff—and the Medicare and
Medicaid programs—to unvaccinated health care workers.” Doc. [23] at 48. But CMS’s own
conclusions undercut this argument. See id. at 61,615 (“[T]he effectiveness of the vaccine to
prevent disease transmission by those vaccinated [is] not currently known.”); id. at 61,612.
Regardless, the pandemic has continued more than twenty months now. Vaccine rates rise every
day, and more therapeutics and treatments for the virus are available than ever before. The status
quo today, without the CMS mandate, is still far better than the public faced even just a few months
ago.
And while, according to CMS, the effectiveness of the vaccine to prevent disease
transmission by those vaccinated is not currently known, what is known based on the evidence
before the Court is that the mandate will have a crippling effect on a significant number of
33a

healthcare facilities in Plaintiffs’ states, especially in rural areas,33 create a critical shortage of
services (resulting in no medical care at all in some instances), and jeopardize the lives of
numerous vulnerable citizens. The prevalent, tangible, and irremediable impact of the mandate
tips the balance of equities in favor of a preliminary injunction.
To be sure, the Court looks at the principles underlying preliminary injunctions.
Dataphase, 640 F.2d at 113 n.5 (quoting Love v. Atchison, T. & S. F. Ry. Co., 185 F. 321, 331 (8th
Cir. 1911) (“The controlling reason for the existence of the judicial power to issue a [preliminary]
injunction is that the court may thereby prevent such a change in the relations and conditions of
persons and property as may result in irremediable injury to some of the parties before their claims
can be investigated and adjudicated.”). Although the parties disagree on the magnitude of the
mandate’s disruption to the healthcare industry, both agree a disruption is certain and imminent.
Thus, the importance of enjoining the mandate, and thus preserving the “status quo,” is imperative.
Dataphase, 640 F.2d at 113 (8th Cir. 1981) (“[T]he question is whether the balance of equities so
favors the movant that justice requires the court to intervene to preserve the status quo until the
merits are determined.”). And “[t]here is clearly a robust public interest in safeguarding prompt
access to health care.” Whitman-Walker Clinic, Inc. v. DHS, 485 F. Supp. 3d 1, 61 (D.D.C. 2020).
The Court finds that in balancing the equities, the scale falls clearly in favor of healthcare
facilities operating with some unvaccinated employees, staff, trainees, students, volunteers, and

33 The disproportionate impact the mandate will have on rural communities is why CMA’s “one-size-fits-all
sledgehammer” approach does not work and in fact, undermines CMA’s focus on providing proper care. See BST
Holdings, 17 F.4th at ---. This is why healthcare matters are typically left to the States, because these policy decisions
are matters dependent on local factors and conditions, and Federalism allows States to tailor such matters in the best
interests of their communities. The Court agrees with Plaintiffs point that whatever might make sense in Chicago, St.
Louis, or New York City, could be actually counterproductive and harmful in rural communities like Memphis (MO)
or McCook (NE). Doc. [1] at 1–2.
34a

contractors, rather than the swift, irremediable impact of requiring healthcare facilities to choose
between two undesirable choices—providing substandard care or providing no healthcare at all.34
It is true that the Agency would face irreparable harm if it is unable to enforce a properly
authorized and enacted regulation. But, as discussed above, the Court has concluded CMS likely
did not enact the mandate at issue lawfully. Thus, any interest CMS may have in enforcing an
unlawful rule is likely illegitimate. See BST Holdings, 17 F.4th at ---. By this same conclusion,
the public would benefit from the preliminary injunction because it would ensure that federal
agencies do not extend their power beyond the express delegation from Congress, as already
discussed. And while “it is indisputable that the public has a strong interest in combating the
spread of COVID-19,” “our system does not permit agencies to act unlawfully even in pursuit of
desirable ends.” Ala. Ass’n of Realtors, 141 S. Ct. at 2490.
In conclusion, CMS mandate raises substantial questions of law and fact that must be
determined, as discussed throughout this opinion. Because it is evident CMS significantly
understates the burden that its mandate would impose on the ability of healthcare facilities to
provide proper care, and thus, save lives, the public has an interest in maintaining the “status quo”
while the merits of the case are determined. Dataphase, 640 F.2d at 113; Love, 185 F. at 331.
III.
CONCLUSION
For the foregoing reasons, Plaintiffs’ Motion for Preliminary Injunction, Doc. [6], is
GRANTED.
Accordingly,

34 CMS also discusses that the upcoming influenza season will further exacerbate the strain on the healthcare system.
However, one would assume that the onset of flu season coupled with COVID would be a reason to avoid critical
staffing shortages at healthcare facilities—not to exacerbate them.
35a

IT IS HEREBY ORDERED that Defendants are preliminarily enjoined from the
implementation and enforcement of 86 Fed. Reg. 61,555 (Nov. 5, 2021), the Interim Final Rule
with Comment Period entitled “Medicare and Medicaid Programs; Omnibus COVID-19 Health
Care Staff Vaccination,” against any and all Medicare- and Medicaid-certified providers and
suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New
Hampshire, North Dakota, South Dakota, and Wyoming pending a trial on the merits of this action
or until further order of this Court. Defendants shall immediately cease all implementation or
enforcement of the Interim Final Rule with Comment Period as to any Medicare- and Medicaid-
certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri,
Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.
IT IS FURTHER ORDERED that no security bond shall be required under Federal Rule
of Civil Procedure 65(c).
Dated this 29th day of November, 2021.

MATTHEW T. SCHELP

UNITED STATES DISTRICT JUDGE

36a

61555
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393), as applicable; and 29 CFR
1911.
Sections 1918.90 and 1918.110 also issued
under 5 U.S.C. 553.
Section 1918.100 also issued under 49
U.S.C. 5101 et seq. and 5 U.S.C. 553.
■12. Add subpart K to part 1918 to read
as follows:
Subpart K—COVID–19.
Sec.
1918.107–1918.109
[Reserved]
1918.110
COVID–19.
1918.107 through 1918.109
[Reserved]
§ 1918.110
COVID–19.
The requirements applicable to
longshoring work under this section are
identical to those set forth at 29 CFR
1910.501.
PART 1926—SAFETY AND HEALTH
REGULATIONS FOR CONSTRUCTION
■13. The authority citation for part
1926 is revised to read as follows:
Authority: 40 U.S.C. 3704; 29 U.S.C. 653,
655, and 657; and Secretary of Labor’s Order
No. 12–71 (36 FR 8754), 8–76 (41 FR 25059),
9–83 (48 FR 35736), 1–90 (55 FR 9033), 6–
96 (62 FR 111), 3–2000 (65 FR 50017), 5–
2002 (67 FR 65008), 5–2007 (72 FR 31159),
4–2010 (75 FR 55355), 1–2012 (77 FR 3912),
or 8–2020 (85 FR 58393), as applicable; and
29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and
1926.65 also issued under 5 U.S.C. 553 and
29 CFR part 1911.
Section 1926.61 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Section 1926.62 also issued under sec.
1031, Public Law 102–550, 106 Stat. 3672 (42
U.S.C. 4853).
Section 1926.65 also issued under sec. 126,
Public Law 99–499, 100 Stat. 1614 (reprinted
at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553.
Subpart D—Occupational Health and
Environmental Controls
■14. Add § 1926.58 to read as follows:
§ 1926.58
COVID–19.
The requirements applicable to
construction work under this section are
identical to those set forth at 29 CFR
1910.501 Subpart U.
PART 1928—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
AGRICULTURE
■15. The authority citation for part
1928 is revised to read as follows:
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor’s
Order No. 12–71 (36 FR 8754), 8–76 (41 FR
25059), 9–83 (48 FR 35736), 1–90 (55 FR
9033), 6–96 (62 FR 111), 3–2000 (65 FR
50017), 5–2002 (67 FR 65008), 4–2010 (75 FR
55355), or 8–2020 (85 FR 58393), as
applicable; and 29 CFR 1911.
Section 1928.21 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Subpart B—Applicability of Standards
■16. Amend § 1928.21 by adding
paragraph (a)(8) to read as follows:
§ 1928.21
Applicable standards in 29 CFR
part 1910.
(a) * * *
(8) COVID–19—§ 1910.501, but only
with respect to—
(i) Agricultural establishments where
eleven (11) or more employees are
engaged on any given day in hand-labor
operations in the field; and
(ii) Agricultural establishments that
maintain a temporary labor camp,
regardless of how many employees are
engaged on any given day in hand-labor
operations in the field.
*
*
*
*
*
[FR Doc. 2021–23643 Filed 11–4–21; 8:45 am]
BILLING CODE 4510–26–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 416, 418, 441, 460, 482,
483, 484, 485, 486, 491 and 494
[CMS–3415–IFC]
RIN 0938–AU75
Medicare and Medicaid Programs;
Omnibus COVID–19 Health Care Staff
Vaccination
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
SUMMARY: This interim final rule with
comment period revises the
requirements that most Medicare- and
Medicaid-certified providers and
suppliers must meet to participate in the
Medicare and Medicaid programs.
These changes are necessary to help
protect the health and safety of
residents, clients, patients, PACE
participants, and staff, and reflect
lessons learned to date as a result of the
COVID–19 public health emergency.
The revisions to the requirements
establish COVID–19 vaccination
requirements for staff at the included
Medicare- and Medicaid-certified
providers and suppliers.
DATES:
Effective date: These regulations are
effective on November 5, 2021.
Implementation dates: The
regulations included in Phase 1 [42 CFR
416.51(c) through (c)(3)(i) and (c)(3)(iii)
through (x), 418.60(d) through (d)(3)(i)
and (d)(3)(iii) through (x), 441.151(c)
through (c)(3)(i) and (c)(3)(iii) through
(x), 460.74(d) through (d)(3)(i) and
(d)(3)(iii) through (x), 482.42(g) through
(g)(3)(i) and (g)(3)(iii) through (x),
483.80(d)(3)(v) and 483.80(i) through
(i)(3)(i) and (i)(3)(iii) through (x),
483.430(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 483.460(a)(4)(v), 484.70(d)
through (d)(3)(i) and (d)(3)(iii) through
(x), 485.58(d)(4), 485.70(n) through
(n)(3)(i) and (n)(3)(iii) through (x),
485.640(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 485.725(f) through (f)(3)(i)
through (f)(3)(iii) through (x), 485.904(c)
through (c)(3)(i) and (c)(3)(iii) through
(x), 486.525(c) through (c)(3)(i) and
(c)(3)(iii) through (x), 491.8(d) through
(d)(3)(i) and (d)(3)(iii) through (x),
494.30(b) through (b)((3)(i) and (b)(3)(iii)
through (x) must be implemented by
December 6, 2021.
The regulations included in Phase 2
[42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii),
441.151(c)(3)(ii), 460.74(d)(3)(ii),
482.42(g)(3)(ii), 483.80(i)(3)(ii),
483.430(f)(3)(ii), 484.70(d)(3)(ii),
485.70(n)(3)(ii), 485.640(f)(3)(ii),
485.725(f)(3)(ii), 485.904(c)(3)(ii),
486.525(c)(3)(ii), 491.8(d)(3)(ii),
494.30(b)(3)(ii)] must be implemented
by January 4, 2022. Staff who have
completed a primary vaccination series
by this date are considered to have met
these requirements, even if they have
not yet completed the 14-day waiting
period required for full vaccination.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
January 4, 2022.
ADDRESSES: In commenting, please refer
to file code CMS–3415–IFC.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to http://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3415–IFC, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
PO 00000
Frm 00155
Fmt 4701
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jspears on DSK121TN23PROD with RULES2
37a

61556
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
1 https://www.phe.gov/emergency/events/
COVID19/Pages/2019-Public-Health-and-Medical-
Emergency-Declarations-and-Waivers.aspx.
2 https://covid.cdc.gov/covid-data-
tracker#datatracker-home.
3 https://www.statnews.com/2021/09/20/covid-
19-set-to-overtake-1918-spanish-flu-as-deadliest-
disease-in-american-history.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3415–IFC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
For press inquiries: CMS Office of
Communications, Department of Health
and Human Services; email press@
cms.hhs.gov.
For technical inquiries: Contact CMS
Center for Clinical Standards and
Quality, Department of Health and
Human Services, (410) 786–6633.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: http://
www.regulations.gov. Follow the search
instructions on that website to view
public comments. CMS will not post on
Regulations.gov public comments that
make threats to individuals or
institutions or suggest that the
individual will take actions to harm the
individual. CMS continues to encourage
individuals not to submit duplicative
comments. We will post acceptable
comments from multiple unique
commenters even if the content is
identical or nearly identical to other
comments.
I. Background
The Centers for Medicare & Medicaid
Services (CMS) establishes health and
safety standards, known as the
Conditions of Participation, Conditions
for Coverage, or Requirements for
Participation for 21 types of providers
and suppliers, ranging from hospitals to
hospices and rural health clinics to long
term care facilities (including skilled
nursing facilities and nursing facilities,
collectively known as nursing homes).
Most of these providers and suppliers
are regulated by this interim final rule
with comment period (IFC).
Specifically, this IFC directly regulates
the following providers and suppliers,
listed in the numerical order of the
relevant CFR sections being revised in
this rule:
• Ambulatory Surgical Centers (ASCs)
(§ 416.51)
• Hospices (§ 418.60)
• Psychiatric residential treatment
facilities (PRTFs) (§ 441.151)
• Programs of All-Inclusive Care for the
Elderly (PACE) (§ 460.74)
• Hospitals (acute care hospitals,
psychiatric hospitals, hospital swing
beds, long term care hospitals,
children’s hospitals, transplant
centers, cancer hospitals, and
rehabilitation hospitals/inpatient
rehabilitation facilities) (§ 482.42)
• Long Term Care (LTC) Facilities,
including Skilled Nursing Facilities
(SNFs) and Nursing Facilities (NFs),
generally referred to as nursing homes
(§ 483.80)
• Intermediate Care Facilities for
Individuals with Intellectual
Disabilities (ICFs–IID) (§ 483.430)
• Home Health Agencies (HHAs)
(§ 484.70)
• Comprehensive Outpatient
Rehabilitation Facilities (CORFs)
(§§ 485.58 and 485.70)
• Critical Access Hospitals (CAHs)
(§ 485.640)
• Clinics, rehabilitation agencies, and
public health agencies as providers of
outpatient physical therapy and
speech-language pathology services
(§ 485.725)
• Community Mental Health Centers
(CMHCs) (§ 485.904)
• Home Infusion Therapy (HIT)
suppliers (§ 486.525)
• Rural Health Clinics (RHCs)/Federally
Qualified Health Centers (FQHCs)
(§ 491.8)
• End-Stage Renal Disease (ESRD)
Facilities (§ 494.30)
This IFC directly applies only to the
Medicare- and Medicaid-certified
providers and suppliers listed above. It
does not directly apply to other health
care entities, such as physician offices,
that are not regulated by CMS. Most
states have separate licensing
requirements for health care staff and
health care providers that would be
applicable to physician office staff and
other staff in small health care entities
that are not subject to vaccination
requirements under this IFC. We have
not included requirements for Organ
Procurement Organizations or Portable
X-Ray suppliers, as these only provide
services under contract to other health
care entities and would thus be
indirectly subject to the vaccination
requirements of this rule, as discussed
in section II.A.1. of this rule. We note
that entities not covered by this rule
may still be subject to other State or
Federal COVID–19 vaccination
requirements, such as those issued by
Occupational Safety and Health
Administration (OSHA) for certain
employers.
Currently, the United States (U.S.) is
responding to a public health
emergency (PHE) of respiratory disease
caused by a novel coronavirus that has
now been detected in more than 190
countries internationally, all 50 States,
the District of Columbia, and all U.S.
territories. The virus has been named
‘‘severe acute respiratory syndrome
coronavirus 2’’ (SARS–CoV–2), and the
disease it causes has been named
‘‘coronavirus disease 2019’’ (COVID–
19). On January 30, 2020, the
International Health Regulations
Emergency Committee of the World
Health Organization (WHO) declared
the outbreak a ‘‘Public Health
Emergency of International Concern.’’
On January 31, 2020, pursuant to
section 319 of the Public Health Service
Act (PHSA) (42 U.S.C. 247d), the
Secretary of the Department of Health
and Human Services (Secretary)
determined that a PHE exists for the
U.S. (hereafter referred to as the PHE for
COVID–19). On March 11, 2020, the
WHO publicly declared COVID–19 a
pandemic. On March 13, 2020, the
President of the United States declared
the COVID–19 pandemic a national
emergency. The January 31, 2020
determination that a PHE for COVID–19
exists and has existed since January 27,
2020, lasted for 90 days, and was
renewed on April 21, 2020; July 23,
2020; October 2, 2020; January 7, 2021;
April 15, 2021; July 19, 2021; and
October 18, 2021. Pursuant to section
319 of the PHSA, the determination that
a PHE continues to exist may be
renewed at the end of each 90-day
period.1
COVID–19 has had significant
negative health effects—on individuals,
communities, and the nation as a whole.
Consequences for individuals who have
COVID–19 include morbidity,
hospitalization, mortality, and post-
COVID conditions (also known as long
COVID). As of mid-October 2021, over
44 million COVID–19 cases, 3 million
new COVID–19 related hospitalizations,
and 720,000 COVID–19 deaths have
been reported in the U.S.2 Indeed,
COVID–19 has overtaken the 1918
influenza pandemic as the deadliest
disease in American history.3
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4 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC8354557/.
5 https://jamanetwork.com/journals/jamanet
workopen/fullarticle/2784918.
6 https://pubmed.ncbi.nlm.nih.gov/34469474/.
7 Andrasfay, T., & Goldman, N. (2021).
Reductions in 2020 US life expectancy due to
COVID–19 and the disproportionate impact on the
Black and Latino populations. Proceedings of the
National Academy of Sciences of the United States
of America, 118(5), e2014746118. https://doi.org/
10.1073/pnas.2014746118 Accessed 10/17/2021.
8 https://www.npr.org/sections/goatsandsoda/
2021/08/11/1026190062/covid-delta-variant-
transmission-cdc-chickenpox.
9 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/infection-control-recommendations.html.
10 https://www.cms.gov/files/document/qso-21-
08-nltc.pdf.
11 https://www.cms.gov/files/document/qso-21-
07-psych-hospital-prtf-icf-iid.pdf.
12 https://www.cms.gov/files/document/qso-20-
38-nh-revised.pdf.
13 https://jamanetwork.com/journals/jamanet
workopen/fullarticle/2770287.
14 https://jamanetwork.com/journals/jamanet
workopen/fullarticle/2777317.
15 https://www.pnas.org/content/pnas/118/1/
e2015455118.full.pdf.
16 https://jamanetwork.com/journals/
jamanetworkopen/article-abstract/2782430.
17 https://www.medrxiv.org/content/10.1101/
2021.09.08.21263057v1.
18 https://journals.plos.org/plosmedicine/
article?id=10.1371/journal.pmed.1003816.
19 https://www.medrxiv.org/content/10.1101/
2021.02.16.21251625v1.
20 https://jamanetwork.com/journals/jama/full
article/2773128.
21 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC8349432/.
22 Weinstock DM, Eagan J, Malak SA, et al.
Control of influenza A on a bone marrow transplant
unit. Infect Control Hosp Epidemiol. 2000; 21:730–
732.
23 Salgado CD, Giannetta ET, Hayden FG, Farr
BM. Preventing nosocomial influenza by improving
the vaccine acceptance rate of clinicians. Infect
Control Hosp Epidemiol 2004; 25:923–928.
24 https://pubmed.ncbi.nlm.nih.gov/31384750/.
25 Hayward AC, Harling R, Wetten S, et al.
Effectiveness of an influenza vaccine programme for
care home staff to prevent death, morbidity, and
health service use among residents: cluster
randomised controlled trial. BMJ 2006; 333: 1241–
1246.
26 Potter J, Stott DJ, Roberts MA, et al. Influenza
vaccination of healthcare workers in long-term-care
hospitals reduces the mortality of elderly patients.
J Infect Dis. 1997; 175:1–6.
27 Thomas RE, Jefferson TO, Demicheli V, et al.
Influenza vaccination for health-care workers who
work with elderly people in institutions: a
systematic review. Lancet Infect Dis. 2006; 6:273–
279.
28 Van den Dool C, Bonten MJM, Hak E, Heijne
JCM, Wallinga J. The effects of influenza
vaccination of health care workers in nursing
homes: insights from a mathematical model. PLoS
Medicine. 2008; 5:1453–1460.
Lemaitre M, Meret T, Rothan-Tondeur M, et al.
Effect of influenza vaccination of nursing home staff
on mortality of residents: a cluster-randomized trial.
J Am Geriatr Soc. 2009; 57:1580–1586.
29 Lemaitre M, Meret T, Rothan-Tondeur M, et al.
Effect of influenza vaccination of nursing home staff
Continued
Given recent estimates of
undiagnosed infections and under-
reported deaths, these figures likely
underestimate the full impact.4 In
addition, these figures fail to capture the
significant, detrimental effects of post-
acute illness, including nervous system
and neurocognitive disorders,
cardiovascular disorders,
gastrointestinal disorders, and signs and
symptoms related to poor general well-
being, including malaise, fatigue,
musculoskeletal pain, and reduced
quality of life. Recent estimates suggest
more than half of COVID–19 survivors
experienced post-acute sequelae of
COVID–19 6 months after recovery.5
The individual and public health
ramifications of COVID–19 also extend
beyond the direct effects of COVID–19
infections. Several studies have
demonstrated significant mortality
increases in 2020, beyond those
attributable to COVID–19 deaths. In
some percentage, this could be a
problem of misattribution (for example,
the cause of death was indicated as
‘‘heart disease’’ but in fact the true cause
was undiagnosed COVID–19), but some
proportion are also believed to reflect
increases in other causes of death that
are sensitive to decreased access to care
and/or increased mental/emotional
strain. One paper quantifies the net
impact (direct and indirect effects) of
the pandemic on the U.S. population
during 2020 using three metrics: excess
deaths, life expectancy, and total years
of life lost. The findings indicate there
were 375,235 excess deaths, with 83
percent attributable to direct, and 17
percent attributable to indirect effects of
COVID–19. The decrease in life
expectancy was 1.67 years, translating
to a reversion of 14 years in historical
life expectancy gains. Total years of life
lost in 2020 was 7,362,555 across the
U.S. (73 percent directly attributable, 27
percent indirectly attributable to
COVID–19), with considerable
heterogeneity at the individual State
level.6
One analysis published in February
2021 found that Black and Latino
Americans have experienced a
disproportionate burden of COVID–19
morbidity and mortality, reflecting
persistent structural inequalities that
increase risk of exposure to COVID–19
and mortality risk for those infected.
The authors projected that COVID–19
would reduce U.S. life expectancy in
2020 by 1.13 years. Furthermore, the
estimated reduction for Black and
Latino populations is 3–4 times the
estimate for the White population,
reversing over 10 years of progress in
reducing the gaps in life expectancy
between Black and White populations
and reducing the Latino mortality
advantage by over 70 percent. The study
further expects that reductions in life
expectancy may persist because of
continued COVID–19 mortality and
term health, social, and economic
impacts of the pandemic.7 Because
SARS–CoV–2, the virus that causes
COVID–19 disease, is highly
transmissible,8 Centers for Disease
Control and Prevention (CDC) has
recommended, and CMS reiterated, that
health care providers and suppliers
implement robust infection prevention
and control practices, including source
control measures, physical distancing,
universal use of personal protective
equipment (PPE), SARS–CoV–2 testing,
environmental controls, and patient
isolation or quarantine.9 10 11 12 Available
evidence suggests these infection
prevention and control practices have
been highly effective when
implemented correctly and
consistently.13 14
Studies have also shown, however,
that consistent adherence to
recommended infection prevention and
control practices can prove
challenging—and those lapses can place
patients in jeopardy.15 16 17 18 A
retrospective analysis from England
found up to 1 in 6 SARS–CoV–2
infections among hospitalized patients
with COVID–19 in England during the
first 6 months of the pandemic could be
attributed to healthcare-associated
transmission.19 In outbreaks reported
from acute care settings in the U.S.
following implementation of universal
masking, unmasked exposures to other
health care workers were frequently
implicated.20 A retrospective cohort
study of health care staff behaviors,
exposures, and cases between June and
December 2020 in a large health system
found more employees were exposed
via coworkers than patients—and
secondary cases among employees
typically followed unmasked
interactions with infected colleagues
(for example, convening in breakrooms
without proper source control).21 The
same study found that cases of health
care worker infection associated with
patient exposures could often be
attributed to failure to adhere to PPE
requirements (for example, eye
protection). Past experience with
influenza, and available evidence,
suggest that vaccination of health care
staff offers a critical layer of protection
against healthcare-associated COVID–19
(HA–COVID–19). For example, evidence
has shown that influenza vaccination of
health care staff is associated with
declines in nosocomial influenza in
hospitalized patients,22 23 24 and among
nursing home residents.25 26 27 28 29 30 31
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on mortality of residents: a cluster-randomized trial.
J Am Geriatr Soc. 2009; 57:1580–1586.
Van den Dool C, Bonten MJM, Hak E, Heijne JCM,
Wallinga J. The effects of influenza vaccination of
health care workers in nursing homes: insights from
a mathematical model. PLoS Medicine. 2008;
5:1453–1460.
30 Oshitani H, Saito R, Seiki N, et al. Influenza
vaccination levels and influenza-like illness in
long-term–care facilities for elderly people in
Niigata, Japan, during an influenza A (H3N2)
epidemic. Infect Control Hosp Epidemiol. 2000;
21:728–730.
31 https://pubmed.ncbi.nlm.nih.gov/31384750/.
32 https://www.cdc.gov/flu/professionals/
infectioncontrol/healthcaresettings.htm.
33 https://www.cambridge.org/core/journals/
infection-control-and-hospital-epidemiology/
article/revised-shea-position-paper-influenza-
vaccination-of-healthcare-personnel/E83D4D87
FBBBD80C66A2A4926D00F4B8.
34 https://www.cdc.gov/phlp/publications/topic/
vaccinationlaws.html.
35 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7034e4.htm?s_cid=mm7034e4_w.
36 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-
people.html#ref43.
37 https://www.medrxiv.org/content/10.1101/
2021.08.20.21262158v1.full.pdf.
38 https://emergency.cdc.gov/han/2021/
han00447.asp.
39 COVID–19 Outbreak Associated with a SARS–
CoV–2 R.1 Lineage Variant in a Skilled Nursing
Facility After Vaccination Program — Kentucky,
March 2021.’’ April 21, 2021. Available at https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7017e2.htm.
40 Postvaccination SARS–CoV–2 Infections
Among Skilled Nursing Facility Residents and Staff
Members — Chicago, Illinois, December 2020–
March 2021.’’ April 30, 2021. Available at https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7017e1.htm.
41 Effectiveness of the Pfizer-BioNTech COVID–19
Vaccine Among Residents of Two Skilled Nursing
Facilities Experiencing COVID–19 Outbreaks —
Connecticut, December 2020–February 2021.’’
March 19, 2021. Available at: https://www.cdc.gov/
mmwr/volumes/70/wr/mm7011e3.htm.
42 Roberts, S., Aniskiewicz, M., Choi, S., Pettker,
C., & Martinello, R. (2021). Correlation of healthcare
worker vaccination on inpatient healthcare-
associated COVID–19. Infection Control & Hospital
Epidemiology, 1–6. Doi:10.1017/ice.2021.414.
43 Moriah Bergwerk, M.B., B.S., Tal Gonen, B.A.,
Yaniv Lustig, Ph.D., Sharon Amit, M.D., Marc
Lipsitch, Ph.D., Carmit Cohen, Ph.D., Michal
Mandelboim, Ph.D., Einav Gal Levin, M.D., Carmit
Rubin, N.D., Victoria Indenbaum, Ph.D., Ilana Tal,
R.N., Ph.D., Malka Zavitan, R.N., M.A., et al. Covid–
19 Breakthrough Infections in Vaccinated Health
Care Workers. N Engl J Med 2021; 385:1474–1484.
DOI: 10.1056/NEJMoa2109072. https://
www.nejm.org/doi/full/10.1056/NEJMoa2109072.
44 https://jamanetwork.com/journals/
jamainternalmedicine/fullarticle/2769096).
45 J Anxiety Disord. 2020 Oct; 75: 102289.
Published online 2020 Aug 19. Doi: 10.1016/
j.janxdis.2020.102289
46 https://www.cdc.gov/mmwr/volumes/69/wr/
pdfs/mm6936a4-H.pdf.
47 https://www.nahc.org/wp-content/uploads/
2020/03/NATIONAL-SURVEY-SHOWS-HOME-
HEALTH-CARE-ON-THE-FRONTLINES-OF-COVID-
19-AND-CONTINUES-TO-BE-IN-A-FRAGILE-
FINANCIAL-STATE.pdf.
48 https://www.urban.org/sites/default/files/
publication/103651/delayed-and-forgone-health-
care-for-nonelderly-adults-during-the-covid-19-
pandemic_1.pdf.
49 Gale R, Eberlein S, Fuller G, Khalil C, Almario
CV, Spiegel BM. Public Perspectives on Decisions
About Emergency Care Seeking for Care Unrelated
As a result, CDC, the Society for
Healthcare Epidemiology of America,
and others recommend—and a number
of states require— annual influenza
vaccination for health care staff.32 33 34
In addition to preventing morbidity
and mortality associated with COVID–
19, currently approved or authorized
vaccines also demonstrate effectiveness
against asymptomatic SARS–CoV–2
infection. A recent study of health care
workers in 8 states found that, between
December 14, 2020 through August 14,
2021, full vaccination with COVID–19
vaccines was 80 percent effective in
preventing RT–PCR–confirmed SARS–
CoV–2 infection among frontline
workers.35 Emerging evidence also
suggests that vaccinated people who
become infected with the SARS–CoV–2
Delta variant have potential to be less
infectious than infected unvaccinated
people, thus decreasing transmission
risk.36 For example, in a study of
breakthrough infections among health
care workers in the Netherlands, SARS–
CoV–2 infectious virus shedding was
lower among vaccinated individuals
with breakthrough infections than
among unvaccinated individuals with
primary infections.37 Fewer infected
staff and lower transmissibility equates
to fewer opportunities for transmission
to patients, and emerging evidence
indicates this is the case. The best data
come from long term care facilities, as
early implementation of national
reporting requirements have resulted in
a comprehensive, longitudinal, high
quality data set. Data from CDC’s
National Healthcare Safety Network
(NHSN) have shown that case rates
among LTC facility residents are higher
in facilities with lower vaccination
coverage among staff; specifically,
residents of LTC facilities in which
vaccination coverage of staff is 75
percent or lower experience higher rates
of preventable COVID–19.38 Several
articles published in CDC’s Morbidity
and Mortality Weekly Reports
(MMWRs) regarding nursing home
outbreaks have also linked the spread of
COVID–19 infection to unvaccinated
health care workers and stressed that
maintaining a high vaccination rate is
important for reducing
transmission.39 40 41
There is also some published
evidence from other settings that suggest
similar dynamics can be expected in
other health care delivery settings. For
example, a recent analysis from Yale
New Haven Hospital (YNHH) found
health care units with at least 1
inpatient case of HA–COVID–19 had
lower staff vaccination rates.42
Similarly, a small study in Israel
demonstrated that transmission of
COVID–19 was linked to unvaccinated
persons. In 37 cases, patients for whom
data were available regarding the source
of infection, the suspected source was
an unvaccinated person; in 21 patients
(57 percent), this person was a
household member; in 11 cases (30
percent), the suspected source was an
unvaccinated fellow health care worker
or patient.43 While similarly
comprehensive data are not available for
all Medicare- and Medicaid-certified
provider types, the available evidence
for ongoing healthcare-associated
COVID–19 transmission risk is
sufficiently alarming in and of itself to
compel CMS to take action.
The threats that unvaccinated staff
pose to patients are not, however,
limited to SARS–CoV–2 transmission.
Unvaccinated staff jeopardize patient
access to recommended medical care
and services, and these additional risks
to patient health and safety further
warrant CMS action.
Fear of exposure to and infection with
COVID–19 from unvaccinated health
care staff can lead patients to
themselves forgo seeking medically
necessary care. In a small but
informative qualitative study of 33
home health care workers in New York
City, one of the key themes to emerge
from interviews with those workers was
a keen recognition that ‘‘providing care
to patients placed them in a unique
position with respect to COVID–19
transmission. They worried . . . about
transmitting the virus to [their clients].’’
They also noted that care for home
bound clients might involve other
health care staff, and they worried about
‘‘transmitting COVID–19 . . . to one
another.’’ 44
Anecdotal evidence suggests health
care consumers have drawn similar
conclusions—and this, too, has
implications for overall health and
welfare in health care settings. For
example, CMS has received anecdotal
reports suggesting individuals in care
are refusing care from unvaccinated
staff, limiting the extent to which
providers and suppliers can effectively
meet the health care needs of their
patients and residents. Further,
nationwide there are reports of
individuals avoiding or forgoing health
care due to fears of contracting COVID–
19 from health care workers.45 46 47
While avoidance of necessary care
appears to have abated somewhat since
the first months of the COVID–19
pandemic, it remains an area of concern
for many individuals.48 49 Because
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to COVID–19 During the COVID–19 Pandemic.
JAMA Netw Open. 2021;4(8):e2120940.
Doi:10.1001/jamanetworkopen.2021.20940.
50 Analysis of data submitted by hospitals through
HHS Protect; accessed September 20, 2021.
51 Data reported through CDC’s NHSN.
52 https://www.healthaffairs.org/doi/full/10.1377/
hlthaff.2020.02351.
53 https://www.npr.org/sections/health-shots/
2021/10/14/1043414558/with-hospitals-crowded-
from-covid-1-in-5-american-families-delays-health-
care.
54 https://www.ahcancal.org/News-and-
Communications/Fact-Sheets/FactSheets/
Workforce-Survey-September2021.pdf.
55 See HHS OIG reports OEI–09–21–00140 and
OEI–06–20–00300, both accessed September 26,
2021.
56 https://covid.cdc.gov/covid-data-tracker/
#health-care-personnel; accessed September 24,
2021.
57 Analysis of dialysis facility and nursing home
data reported through NHSN.
58 Ibid. 8footnote 56.
59 https://emergency.cdc.gov/han/2021/
han00447.asp.
60 Internal estimates based on data published at:
https://www.cdc.gov/coronavirus/2019-ncov/covid-
data/covidview/index.html; accessed September 24,
2021.
61 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7037e1.htm?s_cid=mm7037e1_w.
62 LTC facility rates derived from data reported
through CDC’s NHSN and posted online at the
Nursing Home COVID–19 Vaccination Data
Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-
vaccination-dashboard.html; accessed September
15, 2021.
63 Dialysis facility rates derived from data
reported through CDC’s NHSN and posted online at
the Dialysis COVID–19 Vaccination Data
Dashboard: https://www.cdc.gov/nhsn/covid19/
dial-vaccination-dashboard.html; accessed
September 15, 2021.
64 Hospital data come from unpublished analyses
of data reported to HHS and posted on HHS Protect.
65 Ibid. footnotes 62–64.
66 https://www.cdc.gov/vaccines/covid-19/retail-
pharmacy-program/index.html.
67 https://www.cdc.gov/vaccines/imz-managers/
coverage/covidvaxview/interactive.html..
68 https://covid.cdc.gov/covid-data-tracker/
#health-care-personnel.
unvaccinated staff are at greater risk for
infection, they also present a threat to
health care operations—absenteeism
due to COVID–19-related exposures or
illness can create staffing shortages that
disrupt patient access to recommended
care. Data suggest the current surge in
COVID–19 cases associated with
emergence of the Delta variant has
exacerbated health care staffing
shortages. For example, 1 in 5 hospitals
report that they are currently
experiencing a critical staffing
shortage.50 Through the week ending
September 19, 2021, approximately 23
percent of LTC facilities reported a
shortage in nursing aides; 21 percent
reported a shortage of nurses; and 10 to
12 percent reported shortages in other
clinical and non-clinical staff
categories.51 And while some studies
suggest overall staffing levels (as
defined by nurse hours per resident day)
have been relatively stable, this appears
to be associated with concurrent
decreases in patient demand (for
example, resident census in nursing
homes)—decreases that have
ramifications for patient access to
recommended and medically
appropriate services.52 53 Over half (58
percent) of nursing homes participating
in a recent survey conducted by the
American Health Care Association and
National Center for Assisted Living
(AHCA/NCAL) indicated that they are
limiting new admissions due to staffing
shortages.54 Similarly, hospital
administrators responding to an OIG
pulse survey conducted during February
22–26, 2021, reported difficulty
discharging COVID–19 patients to post-
acute facilities (for example, nursing
homes, rehabilitation hospitals, and
hospice facilities) following the acute
stage of the patient’s illness. These
delays in discharge affected available
bed space throughout the hospital (for
example, creating bottlenecks in ICUs
and EDs) and delayed patient access to
specialized post-acute care (such as
rehabilitation).55 The drivers of this
staffing crisis are multi-factorial. They
include: Longstanding shortages in
certain fields and professions;
prolonged physical, mental, and
emotional stress and trauma associated
with responding to the ongoing PHE;
and competing personal or professional
obligations (such as child care) or
opportunities (for example, new
careers). But illnesses and deaths
associated with COVID–19 are
exacerbating staffing shortages across
the health care system. Over half a
million COVID–19 cases and 1,900
deaths among health care staff have
been reported to CDC since the start of
the PHE.56 When submitting case-level
COVID–19 reports, State and territorial
jurisdictions may identify whether
individuals are or are not health care
workers. Since health care worker status
has only been reported for a minority of
cases (approximately 18 percent), these
numbers are likely gross underestimates
of true burden in this population.
COVID–19 case rates among staff have
also grown in tandem with broader
national incidence trends since the
emergence of the Delta variant. For
example, as of mid-September 2021,
COVID–19 cases among LTC facility and
ESRD facility staff have increased by
over 1400 percent and 850 percent,
respectively, since their lows in June
2021.57 Similarly, the number of cases
among staff for whom case-level data
were reported by State and territorial
jurisdictions to CDC increased by nearly
600 percent between June and August
2021.58 Vaccination is thus a powerful
tool for protecting health and safety of
patients, and, with the emergence and
spread of the highly transmissible Delta
variant, it has been an increasingly
critical one to address the extraordinary
strain the COVID–19 pandemic
continues to place on the U.S. health
system. While COVID–19 cases,
hospitalizations, and deaths declined
over the first 6 months of 2021, the
emergence of the Delta variant reversed
these trends.59 Between late June 2021
and September 2021, daily cases of
COVID–19 increased over 1200 percent;
new hospital admissions, over 600
percent; and daily deaths, by nearly 800
percent.60 Available data also continue
to suggest that the majority of COVID–
19 cases and hospitalizations are
occurring among individuals who are
not fully vaccinated. In a recent study
of reported COVID–19 cases,
hospitalizations, and deaths in 13 U.S.
jurisdictions that routinely link case
surveillance and immunization registry
data, CDC found that unvaccinated
individuals accounted for over 85
percent of all hospitalizations in the
period between June and July 2021,
when Delta became the predominant
circulating variant.61
Unfortunately, health care staff
vaccination rates remain too low in too
many health care facilities and regions.
For example, national COVID–19
vaccination rates for LTC facility,
hospital, and ESRD facility staff are 67
percent, 64 percent, and 60 percent,
respectively. Moreover, these averages
obscure sizable regional differences.
LTC facility staff vaccination rates range
from lows of 56 percent to highs of over
90 percent, depending upon the State.
Similar patterns hold for ESRD facility
and hospital staff.62 63 64 Given slow but
steady increases in vaccination rates
among staff working in these settings
over time,65 widespread availability of
vaccines, and targeted efforts to
facilitate vaccine access like the Federal
Retail Pharmacy program,66 vaccine
hesitancy,67 rather than other factors
(for example, staff turnover) is likely to
account for suboptimal staff vaccination
rates.
While a significant number of health
care staff have been infected with
SARS–CoV–2,68 evidence indicates
their infection-induced immunity, also
called ‘‘natural immunity,’’ is not
equivalent to receiving the COVID–19
vaccine. Available evidence indicates
that COVID–19 vaccines offer better
protection than infection-induced
immunity alone and that vaccines, even
after prior infection, help prevent
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69 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7032e1.htm?s_cid=mm7032e1_w.
70 https://www.cdc.gov/vaccines/covid-19/
clinical-considerations/covid-19-vaccines-
us.html#CoV-19-vaccination.
71 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7030a2.htm.
72 https://doi.org/10.7326/M21-3150.
73 Hughes MM, Wang A, Grossman MK, et al.
County-level COVID–19 vaccination coverage and
social vulnerability—United States, December 14,
2020–March 1, 2021. MMWR Morb Mortal Wkly
Rep 2021;70:431–6. https://doi.org/10.15585/
mmwr.mm7012e1external icon
PMID:33764963external icon.
74 Cavanaugh AM, Fortier S, Lewis P, et al.
COVID–19 outbreak associated with a SARS–CoV–
2 R.1 lineage variant in a skilled nursing facility
after vaccination program—Kentucky, March 2021.
MMWR Morb Mortal Wkly Rep 2021;70:639–43.
https://doi.org/10.15585/
mmwr.mm7017e2external≤ icon
PMID:33914720external icon.
75 Bureau of Labor Statistics. May 2020 national
occupational employment and wage estimates.
Washington, DC: US Department of Labor, Bureau
of Labor Statistics; 2021. Accessed May 1, 2021.
https://www.bls.gov/oes/current/oes_nat.htm#00-
0000externalicon.
76 Silver SR, Li J, Boal WL, Shockey TL,
Groenewold MR. Prevalence of underlying medical
conditions among selected essential critical
infrastructure workers—behavioral risk factor
surveillance system, 31 states, 2017–2018. MMWR
Morb Mortal Wkly Rep 2020;69:1244–9. https://
doi.org/10.15585/mmwr.mm6936a3external icon
PMID:32914769external icon.
77 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html.
Accessed 10/14/2021.
reinfections.69 Consequently, CDC
recommends that all people be
vaccinated, regardless of their history of
symptomatic or asymptomatic SARS–
CoV–2 infection.70
Further, the risks of unvaccinated
health care staff may disproportionately
impact communities who experience
social risk factors and populations
described under Executive Order 13985,
Advancing Racial Equity and Support
for Underserved Communities Through
the Federal Government, including
members of racial and ethnic
communities; individuals with
disabilities; individuals with limited
English proficiency; Lesbian, Gay,
Bisexual, Transgender, and Queer
(LGBTQ+) individuals; individuals
living in rural areas; and others
adversely affected by persistent poverty
or inequality. CDC data show that across
the U.S., physicians and advanced
practice providers have significantly
higher vaccination rates than aides.71 72
Among aides, lower vaccination
coverage was observed in those facilities
located in zip codes where communities
experience greater social risk factors.
The finding that vaccination coverage
among aides was lower among those
working at LTC facilities located in zip
code areas with higher social
vulnerability is consistent with an
earlier analysis of overall county-level
vaccination coverage by indices of
social vulnerability.73 CDC notes that
together, these data suggest that
vaccination disparities among job
categories are likely to mirror social
disparities as well as disparities in
surrounding communities. In addition,
nurses and aides who may have the
most patient contact have the lowest
rates of vaccination coverage among
health care staff. COVID–19 outbreaks
have occurred in LTC facilities in which
residents were highly vaccinated, but
transmission occurred through
unvaccinated staff members.74 These
findings have implications regarding
occupational safety and health outcome
equity—national data indicates that
aides in nursing homes are
disproportionately women and members
of racial and ethnic communities with
lower hourly wages than physicians and
advance practice clinicians,75 and are
also more likely to have underlying
conditions that put them at risk for
adverse outcomes from COVID–19.76
Ensuring full vaccination coverage
across health care settings is critical to
addressing these disparities among
health care workers, particularly those
from communities who experience
social risk, and to equitably protecting
individuals CMS serves from
unnecessary and significant harm
associated with COVID–19 cases and the
ongoing pandemic.
It is essential to reduce the
transmission and spread of COVID–19,
and vaccination is central to any multi-
pronged approach for reducing health
system burden, safeguarding health care
workers and the people they serve, and
ending the COVID–19 pandemic.
Currently FDA-approved and FDA-
authorized vaccines in use in the U.S.
are both safe and highly effective at
protecting vaccinated people against
symptomatic and severe COVID–19.77
Higher rates of vaccination, especially
in health care settings, will contribute to
a reduction in the transmission of
SARS–CoV–2 and associated morbidity
and mortality across providers and
communities, contributing to
maintaining and increasing the amount
of healthy and productive health care
staff, and reducing risks to patients,
resident, clients, and PACE program
participants.
In light of our responsibility to protect
the health and safety of individuals
providing and receiving care and
services from for Medicare- and
Medicaid-certified providers and
suppliers, and CMS’s broad statutory
authority to establish health and safety
regulations, we are compelled to require
staff vaccinations for COVID–19 in these
settings. For these reasons, we are
issuing this IFC based on these
authorities and in accordance with
established rule making processes.
Specifically, sections 1102 and 1871 of
the Social Security Act (the Act) grant
the Secretary of Health and Human
Services authority to make and publish
such rules and regulations, not
inconsistent with the Act, as may be
necessary to the efficient administration
of the functions with which the
Secretary is charged under this Act and
as may be necessary to carry out the
administration of the insurance
programs under the Act. The
discussions of the provider- and
supplier-specific provisions in section
II. of this IFC set out the specific
authorities for each provider or supplier
type. Provider and supplier compliance
with the Federal rules issued under
these statutory authorities are
mandatory for participation in the
Medicare and Medicaid programs.
To the extent a court may enjoin any
part of the rule, the Department intends
that other provisions or parts of
provisions should remain in effect. Any
provision of this section held to be
invalid or unenforceable by its terms, or
as applied to any person or
circumstance, shall be construed so as
to continue to give maximum effect to
the provision permitted by law, unless
such holding shall be one of utter
invalidity or unenforceability, in which
event the provision shall be severable
from this section and shall not affect the
remainder thereof or the application of
the provision to persons not similarly
situated or to dissimilar circumstances.
A. Regulatory Responses to the PHE
1. Waivers
CMS and other Federal agencies have
taken many actions and exercised
extensive regulatory flexibilities to help
health care providers contain the spread
of SARS–CoV–2. When the President
declares a national emergency under the
National Emergencies Act or an
emergency or disaster under the Stafford
Act, CMS is empowered to take
proactive steps by waiving certain CMS
regulations, as authorized under section
1135 of the Act (‘‘1135 waivers’’). CMS
may also grant certain flexibilities to
skilled nursing facilities (SNFs) under
Medicare, as authorized separately
under section 1812(f) of the Act
(‘‘1812(f) flexibilities’’). The 1135
waivers and 1812(f) flexibilities allowed
us to rapidly expand efforts to help
control the spread of SARS–CoV–2. We
have issued PHE waivers for most
Medicare- and Medicaid-certified
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78 https://www.osha.gov/coronavirus/ets.
Accessed 10/6/2021.
providers and suppliers, with the goal of
supporting each facility’s operational
flexibility while preserving health and
safety and core health care functions.
2. Rulemaking
Since the onset of the PHE, we have
issued five IFCs to help contain the
spread of SARS–CoV–2. On April 6,
2020, we issued an IFC (Medicare and
Medicaid Programs; Policy and
Regulatory Revisions in Response to the
COVID–19 Public Health Emergency (85
FR 19230 through 19292), which
established that certain requirements for
face-to-face/in-person encounters will
not apply during the PHE for COVID–19
effective for claims with dates of service
on or after March 1, 2020, and for the
duration of the PHE for COVID–19. On
May 8, 2020, we issued a second IFC
(Medicare and Medicaid Programs,
Basic Health Program, and Exchanges;
Additional Policy and Regulatory
Revisions in Response to the COVID–19
Public Health Emergency and Delay of
Certain Reporting Requirements for the
Skilled Nursing Facility Quality
Reporting Program (85 FR 27550
through 27629)) (‘‘May 8, 2020 COVID–
19 IFC’’). This second IFC contained
additional information on changes
Medicare made to existing regulations to
provide flexibilities for Medicare
beneficiaries and providers to respond
effectively to the PHE for COVID–19. On
September 2, 2020, we issued a third
IFC (Medicare and Medicaid Programs,
Clinical Laboratory Improvement
Amendments (CLIA), and Patient
Protection and Affordable Care Act;
Additional Policy and Regulatory
Revisions in Response to the COVID–19
Public Health Emergency (85 FR 54820
through 54874)) (‘‘September 2, 2020
COVID–19 IFC’’), that included new
requirements for hospitals and CAHs to
report data in accordance with a
frequency and in a standardized format
as specified by the Secretary during the
PHE for COVID–19. On November 6,
2020, we issued a fourth IFC
(Additional Policy and Regulatory
Revisions in Response to the COVID–19
Public Health Emergency (85 FR 71142
through 71205)). This IFC discussed
CMS’s implementation of section 3713
of the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act),
which established Medicare Part B
coverage and payment for Coronavirus
Disease 2019 (COVID–19) vaccine and
its administration. This IFC
implemented requirements in the
CARES Act that providers of COVID–19
diagnostic tests make public their cash
prices for those tests and established an
enforcement scheme to enforce those
requirements. This IFC also established
an add-on payment for cases involving
the use of new COVID–19 treatments
under the Medicare Inpatient
Prospective Payment System (IPPS).
Most recently, on May 13, 2021, we
issued the fifth IFC (Medicare and
Medicaid Programs; COVID–19 Vaccine
Requirements for Long-Term Care (LTC)
Facilities and Intermediate Care
Facilities for Individuals with
Intellectual Disabilities (ICFs-IID)
Residents, Clients, and Staff (86 FR
26306)) (‘‘May 13, 2021 COVID–19
IFC’’), that revised the infection control
requirements that LTC facilities and
ICFs-IID must meet to participate in the
Medicare and Medicaid programs.
OSHA has also engaged in rulemaking
in response to the PHE for COVID–19.
On June 21, 2021, OSHA issued the
COVID–19 Healthcare Emergency
Temporary Standard (ETS) at 29 CFR
1910 subpart U (86 FR 32376) to protect
health care and health care support
service workers from occupational
exposure to COVID–19.78 Health care
employers covered by the ETS must
develop and implement a COVID–19
plan for each workplace to identify and
control COVID–19 hazards in the
workplace and implement requirements
to reduce transmission of SARS–CoV–2
in their workplaces related to the
following: (1) Patient screening and
management, (2) standard and
transmission-based precautions, (3)
personal protective equipment
(including facemasks, and respirators),
(4) controls for aerosol-generating
procedures performed on persons with
suspected or confirmed COVID–19, (5)
physical distancing, (6) physical
barriers, (7) cleaning and disinfection,
(8) ventilation, (9) health screening and
medical management, (10) training, (11)
anti-retaliation, (12) recordkeeping, and,
(13) reporting. In addition, the ETS
requires covered employers to support
COVID–19 vaccination for each
employee by providing reasonable time
and paid leave for employees to receive
vaccines and recover from side effects.
The ETS generally applies to all
workplace settings where any employee
provides health care services or health
care support services; however, because
the ETS targets settings where care is
provided for individuals with known or
suspected COVID–19, the rule contains
several exceptions. The ETS does not
apply to: (1) Provision of first aid by any
employee who is not a licensed health
care provider, (2) dispensing of
prescriptions by pharmacists in retail
settings, (3) non-hospital ambulatory
care settings where all non-employees
are screened prior to entry, and people
with suspected or confirmed COVID–19
are not permitted to enter, (4) well-
defined hospital ambulatory care
settings where all employees are fully
vaccinated, all non-employees are
screened prior to entry, and people with
suspected or confirmed COVID–19 are
not permitted to enter, (5) home health
care settings where all employees are
fully vaccinated, all non-employees are
screened prior to entry, and people with
suspected or confirmed COVID–19 are
not present, (6) health care support
services not performed in a health care
setting (for example, offsite laundry, off-
site medical billing), and (7) telehealth
services performed outside of a setting
where direct patient care occurs.
Furthermore, in well-defined areas
where there is no reasonable
expectation that any person with
suspected or confirmed COVID–19 will
be present, the ETS exempts fully
vaccinated workers from masking,
distancing, and barrier requirements.
Moreover, the ETS requires employers
to immediately remove employees from
the workplace if they (1) have tested
positive for COVID–19, (2) have been
diagnosed with COVID–19 by a licensed
health care provider, (3) have been
advised by a licensed health care
provider that they are suspected to have
COVID–19, or (4) are experiencing
certain symptoms (defined as either loss
of taste and/or smell with no other
explanation, or fever of at least 100.4
degrees Fahrenheit and new
unexplained cough associated with
shortness of breath). Employers must
also immediately remove an employee
who was not wearing a respirator and
any other required PPE and had been in
close contact with a COVID–19 positive
person in the workplace. However,
removal from the workplace due to
instances of close contact exposure in
the workplace is not required for
asymptomatic employees who either
had COVID–19 and recovered with the
last 3 months, or have been fully
vaccinated (that is, 2 or more weeks
have passed since the final dose).
Complementary to the OSHA ETS,
this interim final rule requires certain
providers and suppliers participating in
Medicare and Medicaid programs to
ensure staff are fully vaccinated for
COVID–19, unless exempt, because
vaccination of staff is necessary for the
health and safety of individuals to
whom care and services are furnished.
Health care staff are at high risk for
SARS–CoV–2 exposure, the virus that
causes COVID–19, due to interactions
with patients and individuals in the
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79 https://www.cdc.gov/mmwr/volumes/69/wr/
mm6938a3.htm?s_cid=mm6938a3_w. Accessed10/
16/2021.
80 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/effectiveness/work.html. Accessed 10/16/
2021.
81 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/safety-of-vaccines.html#
:∼:text=Millions%20of%20people%20in%20the,
monitoring%20in%20US%20history.
82 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/distributing/steps-ensure-safety.html.
83 ‘‘Licensed’’ is the statutory term under section
351 of the Public Health Service Act for what is
commonly referred to as approval of a biological
product. For purposes of this rulemaking, the terms
‘approved’ or ‘licensed’ and ‘approval’ or ‘licensure’
are being used interchangeably with respect to
COVID–19 vaccines.
84 https://www.kff.org/racial-equity-and-health-
policy/issue-brief/racial-diversity-within-covid-19-
vaccine-clinical-trials-key-questions-and-answers/.
85 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/expect/after.html.
86 See Centers for Disease Control and Prevention.
Benefits of Getting a COVID–19 Vaccine. https://
www.cdc.gov/coronavirus/2019-ncov/vaccines/
vaccine-benefits.html. Updated January 5, 2021.
Accessed January 14, 2021.
87 Summaries of evidence presented to CDC’s
Advisory Council on Immunization Practices
available at https://www.cdc.gov/vaccines/acip/
meetings/slides-2021-09-22-23.html.
88 https://www.nejm.org/doi/full/10.1056/
NEJMoa2114583.
89 https://www.medrxiv.org/content/10.1101/
2020.10.26.20219725v1.
90 https://www.fda.gov/emergency-preparedness-
and-response/coronavirus-disease-2019-covid-19/
comirnaty-and-pfizer-biontech-covid-19-vaccine.
community.79 Receiving a complete
primary vaccination series reduces the
risk of COVID–19 by 90 percent or more
thereby inhibiting the spread of disease
to others.80 Furthermore, a COVID–19
vaccination requirement reduces the
likelihood of medical removal of health
care staff from the workplace, as
required by the OSHA COVID–19
Healthcare ETS. This is yet another way
in which this interim final rule protects
the individuals who receive services
from the providers and suppliers to
whom the rule applies by minimizing
unpredictable disruptions to operations
and care.
OSHA is the Federal agency
responsible for setting and enforcing
standards to ensure safe and healthy
working conditions for workers. The
COVID–19 Healthcare ETS addresses
protections for health care and health
care support service workers from the
grave danger of COVID–19 exposure in
certain workplaces. CMS is the Federal
agency responsible for establishing
health and safety regulations for
Medicare- and Medicaid-certified
providers and suppliers. Hence, we are
establishing a final rule requiring
COVID–19 vaccination of staff to
safeguard the health and safety of
patients, residents, clients, and PACE
program participants who receive care
and services from those providers and
suppliers. Providers and suppliers may
be covered by both the OSHA ETS and
our interim final rule. Although the
requirements and purpose of each
regulation text are different, they are
complementary.
B. COVID–19 Vaccine Development and
Approval
FDA analysis has shown that all of the
currently approved or authorized
vaccines are safe and CDC reports that
over 408 million doses of the vaccine
have been given through October 18,
2021.81 Bringing a new vaccine to the
public involves many steps, including
vaccine development, clinical trials, and
U.S. Food and Drug Administration
(FDA) authorization or approval. While
COVID–19 vaccines were developed
rapidly, all steps have been taken to
ensure their safety and effectiveness.
Scientists have been working for many
years to develop vaccines against
coronaviruses, such as those that cause
severe acute respiratory syndrome
(SARS) and Middle East respiratory
syndrome (MERS). SARS–CoV–2, the
virus that causes COVID–19, is related
to these other coronaviruses and the
knowledge that was gained through past
research on coronavirus vaccines helped
speed up the initial development of the
current COVID–19 vaccines. After initial
development, vaccines go through three
phases of clinical trials to make sure
they are safe and effective. For other
vaccines routinely used in the U.S., the
three phases of clinical trials are
performed one at a time. During the
development of COVID–19 vaccines,
these phases overlapped to speed up the
process so the vaccines could be used as
quickly as possible to control the
pandemic. No trial phases were
skipped.82
All COVID–19 vaccines currently
licensed (approved) 83 or authorized for
use in the U.S. were tested in clinical
trials involving tens of thousands of
people. FDA evaluated all of the
information submitted to it in requests
for Emergency Use Authorization (EUA)
for the authorized COVID–19 vaccines
and, for the Comirnaty COVID–19
Vaccine, in a Biologics License
Application (the conventional path to
FDA approval of a vaccine). FDA
determined that these vaccines meet
FDA’s standards for safety,
effectiveness, and manufacturing quality
needed to support emergency use
authorization and licensure, as
applicable. The clinical trials included
participants of different races,
ethnicities, and ages, including adults
over the age of 65.84 Because COVID–19
continues to be widespread, researchers
have been able to conduct vaccine
clinical trials more quickly than if the
disease were less common. Side effects
following vaccination are dependent on
the specific vaccine that an individual
receives, and the most common include
pain, redness, and swelling at the
injection site, tiredness, headache,
muscle pain, nausea, vomiting, fever,
and chills.85 After a review of all
available information, the Advisory
Committee on Immunization Practices
(ACIP) and CDC have concluded the
lifesaving benefits of COVID–19
vaccination outweigh the risks or
possible side effects.86
The COVID–19 vaccines currently
licensed or authorized for use in the
U.S. are generally administered as either
a single dose or a two-dose series given
at least 21 or 28 days apart. Following
completion of that primary series, a
subsequent dose or doses may be
recommended for one of two purposes.
In the first instance, an additional dose
of vaccine is administered when the
immune response following a primary
vaccine series is likely to be insufficient.
In other words, the additional dose
augments the original primary series.
Currently, the EUA for the Moderna
mRNA COVID–19 vaccine has been
amended to include the use of a third
primary series dose (that is, ‘‘additional
dose’’) in certain immunocompromised
individuals 18 years of age or older.
Similarly, the EUA for the Pfizer
BioNTech mRNA COVID–19 vaccine
has been amended to include the use of
an additional, or third primary series,
dose in certain immunocompromised
individuals 12 years of age and older.
In the second instance, a booster dose
of vaccine is administered when the
initial immune response to a primary
vaccine series is likely to have waned
over time. In other words, although an
adequate immune response occurred
after the primary vaccine series, over
time, immunity decreases.87 88 89 On
September 22, 2021, the FDA amended
the EUA for the Pfizer BioNTech mRNA
COVID–19 vaccine to allow for use of a
single booster dose in certain
individuals, to be administered at least
6 months after completion of the
primary series. Specifically, this booster
dose is authorized for individuals 65
years of age and older, individuals 18
through 64 years of age at high risk of
severe COVID–19, and individuals 18
through 64 years of age whose frequent
institutional or occupational exposure
to SARS–CoV–2 puts them at high risk
of serious complications of COVID–19
including severe COVID–19.90
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91 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/different-vaccines.html.
92 https://www.fda.gov/emergency-preparedness-
and-response/coronavirus-disease-2019-covid-19/
covid-19-vaccines.
93 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/vsafe.html.
94 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/faq.html.
95 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated.html. Accessed 10/16/
2021.
96 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/recommendations/immuno.html.
Accessed 10/14/2021.
97 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/booster-shot.html. Accessed 10/16/2021.
98 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated.html. Accessed 10/16/
2021.
99 https://www.who.int/emergencies/diseases/
novel-coronavirus-2019/covid-19-vaccines.
Accessed September 14, 2021.
Throughout this rule, we will use the
terms ‘‘additional dose’’ and ‘‘booster’’
to differentiate between the two use
cases outlined above.
Every person who receives a COVID–
19 vaccine receives a vaccination record
card noting which vaccine and the dose
that was received. Vaccine materials
specific to each vaccine are located on
CDC 91 and FDA 92 websites. CDC has
posted a collection of informational
toolkits for specific communities and
settings at https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/
toolkits.html. These toolkits provide
staff, facility administrators, clinical
leadership, caregivers, and health care
consumers with information and
resources.
While we are not requiring
participation, we encourage staff who
use smartphones to use CDC’s
smartphone-based tool called ‘‘v-safe
After Vaccination Health Checker’’ (v-
safe) 93 to self-report on one’s health
after receiving a COVID–19 vaccine. V-
safe is a program that differs from the
Vaccine Adverse Event Reporting
System (VAERS), which we discuss in
section I.C. of this rule. Individuals may
report adverse reactions to a COVID–19
vaccine to either program. Enrollment in
v-safe allows any participating vaccine
recipient to directly and efficiently
report to CDC how they are feeling after
receiving a specific vaccine, including
any problems or adverse reactions.
When an individual receives the
vaccine, they should also receive a v-
safe information sheet telling them how
to enroll in v-safe or they can register at
http://www.vsafe.cdc.gov. Individuals
who enroll will receive regular text
messages providing links to surveys
where they can report any problems or
adverse reactions after receiving a
COVID–19 vaccine, as well as receive
‘‘check-ins,’’ and reminders for a second
dose if applicable.94 We note again that
participation in v-safe is not mandatory,
and further that staff participation and
any health information provided is not
traced to or shared with employers.
Based on current CDC guidance,95
individuals are considered fully
vaccinated for COVID–19 14 days after
receipt of either a single-dose vaccine
(Janssen/Johnson & Johnson) or the
second dose of a two-dose primary
vaccination series (Pfizer-BioNTech/
Comirnaty or Moderna). This guidance
can also be applied to COVID–19
vaccines listed for emergency use by the
World Health Organization (WHO) and
some vaccines used in COVID–19
clinical trials conducted in the U.S.
These circumstances are addressed in
more detail in section I.C. of this IFC.
To improve immune response for those
individuals with moderately to severely
compromised immune systems who
receive the Pfizer-BioNTech Vaccine,
Comirnaty, or Moderna Vaccine, the
CDC advises an additional (third) dose
of an mRNA COVID–19 vaccine after
completing the primary vaccination
series.96 In addition, certain individuals
who received the Pfizer-BioNTech
COVID–19 Vaccine may receive a
booster dose at least 6 months after
completing the primary vaccination
series.97
This IFC requires Medicare- and
Medicaid-certified providers and
suppliers to ensure that staff are fully
vaccinated for COVID–19, unless the
individual is exempted. Consistent with
CDC guidance, we consider staff fully
vaccinated if it has been 2 or more
weeks since they completed a primary
vaccination series for COVID–19. We
define completion of a primary
vaccination series as having received a
single-dose vaccine or all doses of a
multi-dose vaccine. Currently, CDC
guidance does not include either the
additional (third) dose of an mRNA
COVID–19 vaccine for individuals with
moderately or severely
immunosuppression or the booster dose
for certain individuals who received the
Pfizer-BioNTech Vaccine in their
definition of fully vaccinated.98
Therefore, for purposes of this IFC,
neither additional (third) doses nor
booster doses are required. The OSHA
Emergency Temporary Standard for
Healthcare discussed in section I.A.2. of
this IFC also defines fully vaccinated in
accordance with CDC guidance. Hence,
definitions of fully vaccinated are
consistent among the requirements in
these regulations.
C. Administration of Vaccines Outside
the U.S., Listed for Emergency Use by
the WHO, Heterologous Primary Series,
and Clinical Trials
We expect the majority of staff will
likely receive a COVID–19 vaccine
authorized for emergency use by the
FDA or licensed by the FDA. Currently,
this would include the authorized
Pfizer-BioNTech (interchangeable with
the licensed Comirnaty vaccine made by
Pfizer for BioNTech), Moderna, and
Janssen (Johnson & Johnson) COVID–19
vaccines. We also expect COVID–19
vaccine administration will likely occur
within the U.S. for the majority of staff.
However, some staff may receive FDA
approved or authorized COVID–19
vaccines outside of the U.S., vaccines
administered outside of the U.S. that are
listed by the WHO for emergency use
that are not approved or authorized by
the FDA, or vaccines during their
participation in a clinical trial at a site
in the U.S. For these staff, we defer to
CDC guidance for COVID–19
vaccination briefly discussed here. For
more information, providers and
suppliers should consult the CDC
website at https://www.cdc.gov/
vaccines/covid-19/clinical-
considerations/covid-19-vaccines-
us.html#.
Repeat vaccine doses are not
recommended by CDC for individuals
who previously completed the primary
series of a vaccine approved or
authorized by the FDA, even if
administration of the vaccine occurred
outside of the U.S. Individuals who
receive a COVID–19 vaccine for which
two doses are required to complete the
primary vaccination series should
adhere as closely as possible to the
recommended intervals. Following
completion of their second dose, certain
individuals who had received the
Pfizer-BioNTech COVID–19 vaccine
may receive a booster dose at least 6
months after completion of the primary
vaccination series. Moderately to
severely immunocompromised
individuals who have received 2 doses
of an mRNA vaccine may receive a third
dose at least 28 days after the second
dose. Vaccine administration may occur
inside or outside of the U.S.
Furthermore, the WHO maintains a
list of COVID–19 vaccines for
emergency use.99 The CDC advises that
doses of an FDA approved or authorized
COVID–19 vaccine are not
recommended for individuals who have
previously completed the primary series
of a vaccine listed for emergency use by
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
100 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated-guidance.html.
101 https://www.cdc.gov/vaccines/covid-19/
clinical-considerations/covid-19-vaccines-us.html#
Accessed 9/14/2021.
102 https://www.fda.gov/news-events/press-
announcements/fda-approves-first-covid-19-vaccine
Accessed 10/14/2021.
103 Pfizer Fact Sheet—https://www.fda.gov/
media/144413/download.
104 Moderna Fact Sheet—https://www.fda.gov/
media/144637/download.
105 Janssen Fact Sheet—https://www.fda.gov/
media/146304/download.
106 https://www.fda.gov/emergency-
preparedness-and-response/mcm-legal-regulatory-
and-policy-framework/emergency-use-
authorization.
107 Department of Health and Human Services.
VAERS—Vaccine Adverse Event Reporting System.
Accessed at https://vaers.hhs.gov/. Accessed on
January 26, 2021.
the WHO. For those who have not
completed the primary series of a
vaccine listed for emergency use by the
WHO, they may receive an FDA
approved or authorized COVID–19
vaccination series. In addition,
individuals who have received a
COVID–19 vaccine that is neither
approved nor authorized by the FDA,
nor listed on the WHO emergency use
list, may receive an FDA approved or
authorized vaccination series. The CDC
guidelines recommend at least 28 days
between administration of an FDA
licensed or authorized vaccine, a non-
FDA approved or authorized vaccine,
and a vaccine listed by WHO for
emergency use.
For the completion of the primary
series of COVID–19 vaccination,
individuals should generally avoid
using heterologous vaccines—meaning
receiving doses of different vaccines—to
complete a primary COVID–19
vaccination series. Nevertheless, CDC
does recognize that, in certain situations
(for example, when the vaccine product
given for the first dose cannot be
determined or is no longer available), a
different vaccine may be used to
complete the primary COVID–19
vaccination series. Accordingly, staff
may be considered compliant with the
requirements within this regulation if
they have received any combination of
two doses of a vaccine licensed or
authorized by the FDA or listed on the
WHO emergency use list as part of a
two-dose series. Of note, the
recommended interval between the first
and second doses of a vaccine licensed
or authorized by FDA, or listed on the
WHO emergency use list, varies by
vaccine type. For interpretation of
vaccination records and compliance
with this rule, people who received a
heterologous primary series (with any
combination of FDA-authorized, FDA-
approved, or WHO EUL-listed products)
can be considered fully vaccinated if the
second dose in a two dose heterologous
series must have been received no
earlier than 17 days (21 days with a 4
day grace period) after the first dose.100
Because the science and clinical
recommendations are evolving rapidly,
we refer individuals to CDC’s Interim
Public Health Recommendations for
Fully Vaccinated People for additional
details.
Some staff may receive COVID–19
vaccines due to their participation in a
clinical trial at a site in the U.S. Repeat
vaccine doses are not recommended by
CDC for participants in a clinical trial
who previously completed the primary
series of a vaccine approved or
authorized by FDA, or listed for
emergency use by the WHO. Likewise,
for individuals who participated in a
clinical trial at a site in the U.S. and
received the full series of an ‘‘active’’
vaccine candidate (not placebo) and
‘‘vaccine efficacy has been
independently confirmed (for example,
by a data and safety monitoring board),’’
CDC does not recommend repeat
doses.101
D. FDA Emergency Use Authorization
(EUA) and Licensure of COVID–19
Vaccines
The FDA provides scientific and
regulatory advice to vaccine developers
and undertakes a rigorous evaluation of
the scientific information it receives
from all phases of clinical trials; such
evaluation continues after a vaccine has
been licensed by FDA or authorized for
emergency use. On August 23, 2021,
FDA licensed the first COVID–19
vaccine. The vaccine had been known
as the Pfizer-BioNTech COVID–19
vaccine, and will now be marketed as
Comirnaty, for the prevention of
COVID–19 in individuals 16 years of age
and older.102 The vaccine continues to
be available in the U.S. under EUA,
including for individuals 12 through 15
years of age. This EUA has been
amended to allow for the use of a third
dose for certain immunocompromised
individuals 12 years of age and older.
This EUA has also been amended to
allow for use of a single booster dose in
certain individuals. FDA has issued
EUAs for two additional vaccines for the
prevention of COVID–19, one for the
Moderna COVID–19 vaccine (December
18, 2020) (indicated for use in
individuals 18 years of age and older),
and the other for Janssen (Johnson &
Johnson) COVID–19 Vaccine (February
27, 2021) (indicated for use in
individuals 18 years of age and older).
The EUA for the Moderna COVID–19
vaccine has been amended to allow for
the use of a third dose in certain
immunocompromised individuals.
Package inserts and fact sheets for
health care providers administering
COVID–19 vaccines are available for
each licensed and authorized vaccine
from the FDA.103 104 105
Section 564 of the Federal Food, Drug,
and Cosmetic Act authorizes FDA to
issue EUAs. An EUA is a mechanism to
facilitate the availability and use of
medical countermeasures, including
vaccines, during public health
emergencies, such as the current
COVID–19 pandemic. FDA may
authorize certain unapproved medical
products or unapproved uses of
approved medical products to be used
in an emergency to diagnose, treat, or
prevent serious or life-threatening
diseases or conditions caused by threat
agents when certain criteria are met,
including there are no adequate,
approved, and available alternatives.106
The safety of the approved and
authorized COVID–19 vaccines is
closely monitored. VAERS is a safety
and monitoring system that can be used
by anyone to report adverse events after
vaccines. For COVID–19 vaccines,
vaccination providers and licensed and
authorized vaccine manufacturers, must
report select adverse events to VAERS
following receipt of COVID–19 vaccines
(including serious adverse events, cases
of multisystem inflammatory syndrome
(MIS), and COVID–19 cases that result
in hospitalization or death).107
Providers also must adhere to any
revised safety reporting requirements.
FDA’s website includes letters of
authorization and fact sheets and these
documents should be checked for any
updates that may occur. Other adverse
events following vaccination may also
be reported to VAERS. Additionally,
adverse events are also monitored
through electronic health record- and
claims-based systems (through CDC’s
Vaccine Safety Datalink and FDA’s
Biologics Effectiveness and Safety
System (BEST)).
FDA is closely monitoring the safety
of the COVID–19 vaccines both
authorized for emergency use and
licensed use. Vaccination providers are
responsible for mandatory reporting to
VAERS of certain adverse events as
listed on the Health Care Provider Fact
Sheets for the authorized COVID–19
vaccines and for Comirnaty.
Vaccine safety is critically important
for all vaccination programs. Side
effects following vaccinations often
include swelling, redness, and pain at
the injection site; flu-like symptoms;
headache; and nausea; all typically of
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
108 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/safety-of-vaccines.html. Accessed
10/17/2021.
109 Ibid.
110 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/adverse-events.html. Access 10/17/
2021.
111 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/allergic-reaction.html. Accessed 10/
17/2021.
112 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/recommendations/specific-groups/
allergies.html#anchor_1624541541034. Accessed
10/17/2021.
113 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/adverse-events.html. Accessed 10/
17/2021.
114 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/safety-of-vaccines.html. Accessed
10/17/2021.
115 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/effectiveness/work.html.
116 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7034e2.htm?s_cid=mm7034e2_w.
117 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7034e1.htm?s_cid=mm7034e1_w.
118 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7034e4.htm#contribAff.
119 https://www.cdc.gov/coronavirus/2019-ncov/
variants/delta-variant.html?s_cid=11504:cdc%
20delta%20variant%20vaccine%20effectiveness:
sem.ga:p:RG:GM:gen:PTN:FY21.
120 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/effectiveness/why-measure-effectiveness/
breakthrough-cases.html.
121 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/infection-control-recommendations.html.
Accessed 10/15/2021.
122 https://www.hematology.org/newsroom/press-
releases/2021/joint-statement-in-support-of-covid-
19-vaccine-mandates-for-all-workers-in-health.
123 https://press.aarp.org/2021-8-12-New-AARP-
Analysis-Shows-Nursing-Homes-Vaccination-Rates-
Still-Well-Short-of-Benchmark-as-COVID-Cases-
Trend-Upwards.
124 https://justiceinaging.org/justice-in-aging-
supports-mandatory-covid-vaccinations-in-long-
term-care-facilities/, accessed 10/6/21, 1:02 p.m.
EDT.
125 https://leadingage.org/sites/default/files/
LeadingAge%20Statement%20on%20Vaccine
%20Mandates%20for%20Healthcare
%20Workers.pdf.
126 Ibid.
short duration.108 Serious adverse
reactions also have been reported
following COVID–19 vaccines; however,
they are rare.109 110 For example, it is
estimated that anaphylaxis following
the mRNA COVID–19 vaccines occurs
in 2–5 individuals per million
vaccinated (https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/safety/
adverse-events.html). For these
individuals, another shot of an mRNA
COVID–19 vaccine is not
recommended,111 and they should
discuss receiving a different type of
COVID–19 vaccine with their health
care practitioner.112 Other rare serious
adverse reactions that have been
reported to occur following COVID–19
vaccines include thrombosis with
thrombocytopenia syndrome (TTS)
following the Janssen COVID–19
vaccine and myocarditis and/or
pericarditis following the mRNA
COVID–19 vaccines (https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/adverse-events.html). In
the face of the COVID–19 pandemic,
global researchers were able to build
upon decades of vaccine development,
research, and use to produce safe
vaccines that have been highly effective
in protecting individuals from COVID–
19. From December 14, 2020, through
October 12, 2021, over 403 million
doses of COVID–19 vaccine have been
administered in the U.S. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/safety-of-vaccines.html.
‘‘CDC recommends everyone 12 years
and older get vaccinated as soon as
possible to help protect against COVID–
19 and the related, potentially severe
complications that can occur.’’ 113 They
state that the ‘‘potential benefits of
COVID–19 vaccination outweigh the
known and potential risks, including
the possible risk of myocarditis or
pericarditis.’’ 114
E. COVID–19 Vaccine Effectiveness
COVID–19 vaccines currently
approved or authorized by FDA are
highly effective in preventing serious
outcomes of COVID–19, including
severe disease, hospitalization, and
death.115 Moreover, available evidence
suggests that these vaccines offer
protection against known variants,
including the Delta variant (B.1.617.2),
particularly against hospitalization and
death.116 117 Furthermore, a recent study
found that, between December 14, 2020,
and August 14, 2021, full vaccination
with COVID–19 vaccines was 80 percent
effective in preventing RT–PCR–
confirmed SARS-CoV–2 infection
among frontline workers, further
affirming the highly protective benefit of
full vaccination up to and through the
2021 summer COVID–19 pandemic
waves in the U.S.118 While vaccine
effectiveness point estimates did decline
over the course of the study as the Delta
variant became predominant, the
protection afforded by vaccination
remained significant, underscoring the
continued importance and benefits of
COVID–19 vaccination.119
Like most vaccines, COVID–19
vaccines are not 100 percent effective in
preventing COVID–19. Consequently,
some ‘‘breakthrough’’ cases are expected
and, as the number of people who have
completed a primary vaccination series
and are considered fully vaccinated for
COVID–19 increases, breakthrough
COVID–19 cases will also increase
commensurately. However, the risk of
developing COVID–19, including severe
illness, remains much higher for
unvaccinated than vaccinated people.
Vaccinated people with a breakthrough
COVID–19 case are less likely to
develop serious disease, be hospitalized,
and die than those who are
unvaccinated and get COVID–19.120 The
combined protections offered by
vaccination and ongoing
implementation of other infection
control measures, especially source
control (masking),121 remain critical to
safeguarding patients, residents, clients,
PACE program participants, and staff.
F. Stakeholder Response to Vaccines
There has been growing national
interest in COVID–19 vaccination
requirements among health care
workers, including requests from
various national health care
stakeholders. In a joint statement
released on July 26, 2021, more than 50
health care professional societies and
organizations called for all health care
employers and facilities to require that
all their staff be vaccinated against
COVID–19. Included as signatories to
this statement were organizations
representing millions of workers
throughout the U.S. health care
industry, including those representing
doctors, nurses, pharmacists, physician
assistants, public health workers, and
epidemiologists as well as long term
care, home care, and hospice
workers.122
In addition, a large nonprofit,
nonpartisan organization focused on
empowering Americans over the age of
50 recently called on all LTC facilities
to require vaccinations for staff and
residents.123 A non-profit organization
dedicated to advancing dignity in aging
issued a statement in support of
COVID–19 vaccine mandates for staff
and residents of long-term care
facilities.124 In a policy statement dated
July 21, 2021, a large long term care
association, ‘‘strongly urges all residents
and staff in long-term care to get
vaccinated’’ and ‘‘supports requiring
vaccines for current and new staff in
long-term care and other healthcare
settings. COVID–19 vaccination should
be a condition of employment for all
healthcare workers, including
employees, contract staff and others,
with appropriate exemptions for those
with medical reasons or as specified by
federal or state law.’’ 125 The statement
further notes that ‘‘COVID–19 vaccines
are safe . . . effective for preventing
infection, and especially severe illness
and death [and] reduce the risk of
spreading the virus.’’ 126 Moreover, the
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127 Ibid.
128 https://www.ahcancal.org/News-and-
Communications/Press-Releases/Pages/
AHCANCAL-Issues-Policy-Statement-Regarding-
COVID-19-Vaccinations-of-Long-Term-Care-
Personnel.aspx. Accessed 10/16/2021.
129 https://news.christianacare.org/2021/09/safe-
care-safe-workplace-we-are-vaccinated/. Accessed
10/15/2021.
130 https://www.delawareonline.com/story/news/
health/2021/09/27/christianacare-fires-employees-
not-complying-vaccine-mandate/5887784001/.
Accessed 10/15/2021.
131 https://www.houstonmethodist.org/leading-
medicine-blog/articles/2021/jun/houston-
methodist-requires-covid-19-vaccine-for-
credentialed-doctors/. Accessed 10/15/202021.
132 https://www.novanthealth.org/home/about-us/
newsroom/press-releases/newsid33987/2576/
novant-health-update-on-mandatory-covid-19-
vaccination-program-for-employees.aspx. Accessed
10/15/2021.
133 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/clinical-care/underlyingconditions.html.
134 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/clinical-care/underlyingconditions.html.
135 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/underlying-evidence-
table.html.
136 https://www.cdc.gov/coronavirus/2019-ncov/
community/health-equity/racial-ethnic-disparities/
disparities-hospitalization.html.
137 https://www.cdc.gov/coronavirus/2019-ncov/
community/health-equity/racial-ethnic-disparities/
disparities-illness.html.
138 https://catalyst.nejm.org/doi/full/10.1056/
CAT.21.0051.
139 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7020e3.htm.
140 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7030a2.htm.
141 https://www.cdc.gov/coronavirus/2019-ncov/
community/health-equity/vaccine-equity.html.
statement observes that ‘‘the COVID
crisis exacerbated long-standing
workforce challenges, and some in the
sector fear that a vaccine mandate could
lead to worker resignations. But
providers that have required staff
vaccination have reported high vaccine
accepted by previously hesitant care
professionals, and many providers
report that when staff vaccination rates
are high, they become providers of
choice in their communities.’’ 127 A non-
profit federation of affiliated State
health organizations, representing more
than 14,000 non-profit and for-profit
nursing homes, assisted living
communities, and facilities for
individuals with disabilities expressed
support for all health care ‘‘strongly
urges the vaccination of all health care
personnel’’ to ‘‘protect all residents,
staff and others in our communities
from the known and substantial risks of
COVID–19.’’ They also assert that
‘‘COVID–19 vaccines protect health care
personnel when working both in health
care facilities and in the community,’’
and ‘‘provide strong protection against
workers unintentionally carrying the
disease to work and spreading it to
patients and peers.’’ 128
Numerous health systems and
individual health care employers across
the country have implemented vaccine
mandates independent of this rule. For
example, a health care system that is the
largest private employer in Delaware
with more than 14,000 employees, a
health care system and academic
medical center with over 26,000
employees in Texas, and an integrated
health system in North Carolina with
more than 35,000 employees, to name a
few, have all preceded this rule with
their own vaccination requirements,
achieving rates of at least 97 percent
vaccination among their
staff.129 130 131 132 These organizations are
already realizing the effectiveness of
strong vaccination policies. Despite the
successes of these organizations in
increasing levels of staff vaccination,
there remains an inconsistent
patchwork of requirements and laws
that is only effective at local levels and
has not successfully raised staff
vaccination rates nationwide. Patients,
residents, clients, PACE program
participants, and staff alike are not
adequately protected from COVID–19.
In September 2021, Jeffrey Zients, the
White House Coronavirus Response
Coordinator, noted that ‘‘vaccination
requirements work . . . and are the best
path out of the pandemic.’’ He further
noted that vaccination requirements are
not only key to the nation’s path out of
the pandemic, but also accelerate our
economic recovery, keeping workplaces
safer, and helping to curb the spread of
the virus in communities, and boost job
growth, the labor market, and the
nation’s overall economy.
G. Populations at Higher Risk for Severe
COVID–19 Outcomes
COVID–19 can affect anyone, with
symptoms ranging from mild (infections
not requiring hospitalization) to very
severe (requiring intensive care in a
hospital). Nonetheless, studies have
shown that COVID–19 does not affect all
population groups equally.133 Age
remains a strong risk factor for severe
COVID–19 outcomes. Approximately
54.1 million people aged 65 years or
older reside in the U.S.; this age group
accounts for more than 80 percent of
U.S. COVID–19 related deaths.
Residents of LTC facilities make up less
than 1 percent of the U.S. population
but accounted for more than 35 percent
of all COVID–19 deaths in the first 12
months of the pandemic.134
Additionally, adults of any age with
certain underlying medical conditions
are at increased risk for severe illness
from COVID–19. These include, but are
not limited to, cancer, cerebrovascular
disease, diabetes (Type 1 and Type 2),
chronic kidney disease, COPD, heart
conditions, Down Syndrome, obesity,
substance use, smoking status, and
pregnancy.135 The risk of severe
COVID–19 also increases as the number
of underlying medical conditions
increases in a particular individual.
A confluence of structural and
epidemiological factors has also
contributed to disparate risk for COVID–
19 infection, severe illness, and death in
certain populations. For example,
evidence clearly indicates that racial
and ethnic minority groups, including
Black and Hispanic or Latino, have
disproportionately higher
hospitalization rates among every age
group, including children aged younger
than 18 years.136 These same groups are
disproportionately affected by long-
standing inequities in social
determinants of health, such as poverty
and health care access, that increase risk
of severe illness and death from COVID–
19.137 People with intellectual
disabilities are more likely to have
chronic health conditions, live in
congregate settings, and face more
barriers to health care; some studies
suggest they are also more likely to get
COVID–19 and have worse outcomes.138
Finally, rural communities often have a
higher proportion of residents who live
with comorbidities or disabilities and
are aged ≥65 years; these risk factors,
combined with more limited access to
health care facilities with intensive care
capabilities, place rural dwellers at
increased risk for COVID–19-associated
morbidity and mortality.139
In addition, CDC data indicate that
vaccination rates are disproportionately
low among nurses and health care aides
in long term care settings, particularly
in communities that experience social
risk factors. Further, CDC data indicate
that nurses and aides in these settings
are more likely to be members of racial
and ethnic minority communities.140
This disparity in vaccination coverage
may be exacerbating existing and
emerging disparities related to COVID–
19 cases and impact, placing members
of communities who experience social
risk factors—those in rural areas with
geographic and transportation barriers
to care, those in low income areas who
experience persistent poverty and
inequality, and others—at further
increased risk for COVID–19-associated
morbidity and mortality.141 This
disparity may be, in part, reduced by the
potential positive health equity impacts
of requiring staff vaccination among
provider and supplier types subject to
rulemaking.
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CMS believes that the developing data
about staff vaccination rates and rates of
COVID–19 cases, and the urgent need to
address COVID-related staffing
shortages that are disrupting patient
access to care, provides strong
justification as to the need to issue this
IFC requiring staff vaccination for most
provider and supplier types over which
we have authority.
H. CMS Authority To Require Staff
Vaccinations
CMS has broad statutory authority to
establish health and safety regulations,
which includes authority to establish
vaccination requirements. Section 1102
of the Act grants the Secretary of Health
and Human Services authority to make
and publish such rules and regulations,
not inconsistent with the Act, as may be
necessary to the efficient administration
of the functions with which the
Secretary is charged under the Act.
Section 1871 of the Act grants the
Secretary of Health and Human Services
authority to prescribe regulations as
may be necessary to carry out the
administration of the Medicare program.
The statutory authorities to establish
health and safety requirements for
COVID–19 vaccination for each provider
and supplier included in this IFC are
listed in Table 1 and discussed in
sections II.C. through II.F. of this IFC.
Section 1863 of the Act provides that
‘‘[i]n carrying out his functions, relating
to determination of conditions of
participation by providers . . . the
Secretary shall consult with appropriate
State agencies and recognized national
listing or accrediting bodies[.]’’ For the
reasons discussed in greater detail
throughout sections I. through III. this
IFC, the COVID–19 pandemic presents a
serious and continuing threat to the
health and to the lives of staff of health
care facilities and of consumers of these
providers’ and suppliers’ services. This
threat has grown to be particularly
severe since the emergence of the Delta
variant. Any delay in the
implementation of this rule would
result in additional deaths and serious
illnesses among health care staff and
consumers, further exacerbating the
newly-arising, and ongoing, strain on
the capacity of health care facilities to
serve the public. For these reasons, in
carrying out the agency’s functions
relating to determination of conditions
of participation, conditions for coverage,
and requirements, we intend to engage
in consultations with appropriate State
agencies and listing or accrediting
bodies following the issuance of this
rule, and toward that end we invite
these entities to submit comments on
this IFC. Given the urgent need to issue
this rule, however, we do not believe
that there exists an entity with which it
would be appropriate to engage in these
consultations in advance of issuing this
IFC, nor do we understand the statute to
impose a temporal requirement to do so
in advance of the issuance of this rule.
We have not previously required any
vaccinations, but we recognize that
many health care workers already
comply with employer or State
government vaccination requirements
(for example, influenza, and hepatitis B
virus (HBV)) and invasive employer or
State government-required screening
procedures (such as tuberculosis
screening). Further, most of these
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142 Field R.I. (2009). Mandatory vaccination of
health care workers: whose rights should come
first? P & T: a peer-reviewed journal for formulary
management, 34(11), 615–618.
143 https://wwwnc.cdc.gov/eid/article/26/8/20-
0679_article.
144 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/clinical-care/underlyingconditions.html.
145 https://www.cdc.gov/coronavirus/2019-ncov/
community/health-equity/racial-ethnic-disparities/
disparities-impact.html.
146 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html.
147 https://www.cdc.gov/coronavirus/2019-ncov/
variants/delta-variant.html?s_cid=11509:cdc%
20guidance%20delta%20variant:sem.ga:p:RG:
GM:gen:PTN:FY21.
148 What You Should Know About COVID–19 and
the ADA, the Rehabilitation Act, and Other EEO
Laws. U.S. Equal Opportunity Commission.
Accessed at https://www.eeoc.gov/wysk/what-you-
should-know-about-covid-19-and-ada-rehabilitation
-act-and-other-eeo-laws. Accessed on October 16,
2021, 2:20 p.m. EDT. Updated October 13, 2021.
Section K. Vaccinations.
149 Genetic Information Nondiscrimination Act of
2008. Public Law 110–233.
individuals met State and local
vaccination requirements in order to
attend school to complete the necessary
education to qualify for health care
positions. In addition to these
longstanding vaccination requirements,
many now require vaccination for
COVID–19 as well. However, studies on
annual seasonal influenza vaccine
uptake consistently show that half of
health care workers may resist seasonal
influenza vaccination nationwide.142
Other ongoing CMS staff vaccination
programs include hospital quality
improvement contractors that provide
educational resources to help hospitals
and staff overcome vaccine hesitancy,
coordinate with State health
departments to support vaccine uptake
(for COVID–19 and flu), and monitor
staff vaccination rates for additional
action. ESRD networks also provide
education on patient influenza and
pneumococcal vaccinations as a part of
their work and also recently (in 2020)
added a goal of 85 percent of patients
vaccinated for flu while also
encouraging vaccinations for staff
within ESRD facilities. While we have
not, until now, required any health care
staff vaccinations, we have established,
maintained, and regularly updated
extensive health and safety
requirements (CfCs, CoPs, requirements,
etc.) for Medicare- and Medicaid-
certified providers and suppliers. These
requirements focus a great deal on
infection prevention and control
standards, often incorporating
guidelines as recommended by CDC and
other expert groups, as CMS’s highest
duty is to protect the health and safety
of patients, clients, residents, and PACE
program participants in all applicable
settings.
The Medicare statute’s various
provisions authorizing the Secretary to
impose requirements necessary in the
interest of the health and safety of
beneficiaries encompass authority to
require that staff working in and for
Medicare-certified providers and
suppliers be vaccinated against specific
diseases. In addition, parallel Medicaid
statutes provide authority to establish
requirements to protect beneficiary
health and safety, as reflected in Table
1. We acknowledge that we have not
previously imposed such requirements,
but, as discussed throughout section I.
of this rule, this is a unique pandemic
scenario with unique access to effective
vaccines. In addition, for many
infectious diseases, it is not necessary
for CMS to impose such requirements
because other entities, including
employers, states, and licensing
organizations, already impose sufficient
standards for those specific diseases. We
believe that, given the fast-moving
nature of the COVID–19 pandemic and
its ongoing threat to the health and
safety of individuals receiving health
care services in Medicare- and
Medicaid-certified providers and
suppliers, our intervention is warranted.
We understand that some states and
localities have established laws that
would seem to prevent Medicare- and
Medicaid-certified providers and
suppliers from complying with the
requirements of this IFC. We intend,
consistent with the Supremacy Clause
of the United States Constitution, that
this nationwide regulation preempts
inconsistent State and local laws as
applied to Medicare- and Medicaid-
certified providers and suppliers. CDC
estimates that 45.4 percent of U.S.
adults are at increased risk for
complications from coronavirus disease
because of cardiovascular disease,
diabetes, respiratory disease,
hypertension, or cancer. Rates increased
by age, from 19.8 percent for persons
18–29 years of age to 80.7 percent for
persons >80 years of age, and varied by
State, race/ethnicity, health insurance
status, and employment.143 We expect
that individuals seeking health care
services are more likely to fall into the
high-risk category. While we do not
have provider- or supplier-specific
estimates, we would anticipate the
percentage of high-risk individuals in
health care settings is much higher than
the general population. Health care
consumers seeking services from the
provider and suppliers included in this
rule are often at significantly higher risk
of severe disease and death than their
paid care givers.144 As discussed in
section I.F. of this IFC, COVID–19 has
disproportionally affected minority and
underserved populations, who will
receive safer care and better outcomes
through this requirement.145 Families,
unpaid caregivers, and communities
will also experience overall
benefit.146 147 Staff will directly benefit
from the protective effects of COVID–19
vaccination, but the primary reason that
we are issuing this IFC requiring health
care workers be vaccinated against
COVID–19 is for the protection of
residents, clients, patients, and PACE
program participants.
I. Vaccination Requirements and
Employee Protections
This IFC requires most Medicare- and
Medicaid-certified providers and
suppliers to ensure that their staff are
fully vaccinated for COVID–19. The U.S.
Equal Employment Opportunity
Commission (EEOC) enforces workplace
anti-discrimination laws and has
established that employers can mandate
COVID–19 vaccination for all employees
that physically enter their facility.148
We are expanding upon that to include
all of the staff described in section
II.A.1. of this IFC, for the providers and
suppliers addressed by this IFC, not just
those staff who perform their duties
within a health care facility, as many
health care staff routinely care for
patients and clients outside of such
facilities, such as home health, home
infusion therapy, hospice, and therapy
staff. In addition, there may be other
times that staff encounter fellow
employees, such as in an administrative
office or at an off-site staff meeting, who
will themselves enter a health care
facility or site of care for their job
responsibilities. Thus, we believe it is
necessary to require vaccination for all
staff that interact with other staff,
patients, residents, clients, or PACE
program participants in any location,
beyond those that physically enter
facilities or other sites of patient care.
In implementing the COVID–19
vaccination policies and procedures
required by this IFC, however,
employers must comply with applicable
Federal anti-discrimination laws and
civil rights protections. Applicable laws
include: (1) The Americans with
Disabilities Act (ADA); (2) Section 504
of the Rehabilitation Act (RA); (3) Title
VII of the Civil Rights Act of 1964; (4)
the Pregnancy Discrimination Act; and
(5) the Genetic Information
Nondiscrimination Act.149 In addition,
other Federal laws may provide
employees with additional protections.
These Federal laws continue to apply
during the PHE and, in some instances,
require employers to offer
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150 Comparison of the characteristics, morbidity,
and mortality of COVID–19 and seasonal influenza:
a nationwide, population-based retrospective cohort
study, The Lancet, Published Online December 17,
2020 https://doi.org/10.1016/ S2213-
2600(20)30527-0.
151 Comparative evaluation of clinical
manifestations and risk of death in patients
admitted to hospital with covid–19 and seasonal
influenza: cohort study, BMJ 2020;371:m4677.
152 Klompas, M, Pearson, M, and Morris, C. The
Case for Mandating COVID–19 Vaccines for Health
Care Workers. Annuals of Internal Medicine.
Annals.org. Accessed at https://
www.acpjournals.org/doi/10.7326/M21-2366.
Accessed on August 30, 2021. Published on July 13,
2021.
153 Emanuel, E and Skorton, D. Mandating
COVID–19 Vaccination for Health Care Workers.
Annuals of Internal Medicine. Annals.org. Accessed
at https://www.acpjournals.org/doi/10.7326/M21-
3150. Accessed on August 30, 2021. Article
includes the ‘‘Joint Statement in Support of COVID–
19 Vaccine Mandates for All Workers in Health and
Long-Term Care’’ that is signed by 80 organizations.
154 Kolbe A. Disparities in COVID–19 vaccination
rates across racial and ethnic minority groups in the
United States. Washington, DC: US Department of
Health and Human Services, Office of the Assistant
Secretary for Planning and Evaluation; 2021.
https://aspe.hhs.gov/system/files/pdf/265511/
vaccination-disparities-brief.pdf.
155 https://theconversation.com/half-of-
unvaccinated-workers-say-theyd-rather-quit-than-
get-a-shot-but-real-world-data-suggest-few-are-
following-through-168447.
156 Emanuel, E and Skorton, D. Mandating
COVID–19 Vaccination for Health Care Workers.
Annuals of Internal Medicine. Annuals.org.
Accessed https://www.acpjournals.org/doi/10.7326/
M21-3150. Accessed on August 30, 2021. Article
includes the ‘‘Joint Statement in Support of COVID–
19 Vaccine Mandates for All Workers in Health and
Long-Term Care’’ that is signed by 88 organizations.
157 https://www.bridgemi.com/michigan-health-
watch/despite-protests-98-henry-ford-hospital-
workers-get-covid-vaccinations accessed 09/15/
2021 at 2:24 p.m. EDT.
158 Emanuel, E and Skorton, D. Mandating
COVID–19 Vaccination for Health Care Workers.
Annuals of Internal Medicine. Annals.org. Accessed
at https://www.acpjournals.org/doi/10.7326/M21-
3150. Accessed on August 30, 2021. Article
includes the ‘‘Joint Statement in Support of COVID–
19 Vaccine Mandates for All Workers in Health and
Long-Term Care’’ that is signed by 88 organizations.
159 https://www.nytimes.com/2021/09/28/
nyregion/vaccine-health-care-workers-
mandate.html.
accommodations for some individual
staff members in some circumstances.
These laws do not interfere with or
prevent employers from following the
guidelines and suggestions made by
CDC or public health authorities about
steps employers should take to promote
public health and safety in light of
COVID–19, to the extent such guidelines
and suggestions are consistent with the
requirements set forth in this regulation.
In other words, employers following
CDC guidelines and the new
requirements in this IFC may also be
required to provide appropriate
accommodations, to the extent required
by Federal law, for employees who
request and receive exemption from
vaccination because of a disability,
medical condition, or sincerely held
religious belief, practice, or observance.
Vaccination against COVID–19 is a
critical protective action for all
individuals, especially health care
workers, because the SARS-Cov-2 virus
poses direct threats to patients, clients,
residents, PACE program participants,
and staff. COVID–19 disease at this time
is resulting in much higher morbidity
and mortality than seasonal flu.150 151 152
These individual vaccinations provide
protections to the health care system as
a whole, protecting capacity and
operations during disease outbreaks.
We also recognize ethical reasons to
issue these vaccination requirements.
All health care workers have a general
ethical duty to protect those they
encounter in their professional
capacity.153 Patient safety is a central
tenet of the ethical codes and practice
standards published by health care
professional associations, licensure and
certification bodies, and specialized
industry groups. Health care workers
also have a special ethical and
professional responsibility to protect
and prioritize the health and well-being
of those they are caring for, as well as
not exposing them to threats that can be
avoided. This holds true not only for
health care professionals, but also for all
who provide health care services or
choose to work in those settings. The
ethical duty of receiving vaccinations is
not new, as staff have long been
required by employers to be vaccinated
against certain diseases, such as
influenza, hepatitis B, and other
infectious diseases.
We are aware of concerns about
health care workers choosing to leave
their jobs rather than be vaccinated.
While we understand that there might
be a certain number of health care
workers who choose to do so, there is
insufficient evidence to quantify and
compare adverse impacts on patient and
resident care associated with temporary
staffing losses due to mandates and
absences due to quarantine for known
COVID–19 exposures and illness. We
encourage providers and suppliers,
where possible, to consider on-site
vaccination programs, which can
significantly reduce barriers that health
care staff may face in getting vaccinated,
including transportation barriers, need
to take time off of work, and scheduling.
However, vaccine declination may
continue to occur, albeit at lower rates,
due to hesitancy among particular
communities, and the Assistant
Secretary for Planning and Evaluation
(ASPE) indicates that vaccination
promotion and outreach efforts focused
on groups and communities who
experience social risk factors could help
address inequities.154
Despite these hesitations, many
COVID–19 vaccination mandates have
already been successfully initiated in a
variety of health care settings, systems,
and states. In general, workers across
the economy are responding to
mandates by getting vaccinated.155 A
large hospital system in Texas instituted
a vaccine mandate and 99.5 percent of
its staff received the vaccine. Further,
only a few of their staff resigned rather
than receive the vaccine.156 A Detroit-
based health system also instituted a
vaccine mandate, and reported that 98
percent of the system’s 33,000 workers
were fully or partially vaccinated or in
the process of obtaining a religious or
medical exemption when the
requirement went into effect, with
exemptions comprising less than 1
percent of staffers.157 In addition, a LTC
parent corporation established a
COVID–19 vaccine mandate for its more
than 250 LTC facilities, leading to more
than 95 percent of their workers being
vaccinated. Again, they noted that very
few workers quit their jobs rather than
be vaccinated.158 New York enacted a
State-wide health care worker COVID–
19 vaccine mandate and recorded a
jump in vaccine compliance in the final
days before the requirements took effect
on October 1, 2021.159
We believe that the COVID–19
vaccine requirements in this IFC will
result in nearly all health care workers
being vaccinated, thereby benefiting all
individuals in health care settings. This
will greatly contribute to a reduction in
the spread of and resulting morbidity
and mortality from the disease, positive
steps towards health equity, and an
improvement in the numbers of health
care staff who are healthy and able to
perform their professional
responsibilities. For individual staff
members that have legally permitted
justifications for exemption, the
providers and suppliers covered by this
IFC can address those individually.
II. Provisions of the Interim Final Rule
With Comment Period
Through this IFC, we are requiring
that the following Medicare- and
Medicaid-certified providers and
suppliers, listed here in order of their
appearance in 42 CFR, ensure that all
applicable staff are vaccinated for
COVID–19:
• Ambulatory Surgical Centers (ASCs)
• Hospices
• Psychiatric residential treatment
facilities (PRTFs)
• Programs of All-Inclusive Care for the
Elderly (PACE)
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• Hospitals (acute care hospitals,
psychiatric hospitals, long term care
hospitals, children’s hospitals,
hospital swing beds, transplant
centers, cancer hospitals, and
rehabilitation hospitals)
• Long Term Care (LTC) Facilities,
including SNFs and NFs, generally
referred to as nursing homes
• Intermediate Care Facilities for
Individuals with Intellectual
Disabilities (ICFs-IID)
• Home Health Agencies (HHAs)
• Comprehensive Outpatient
Rehabilitation Facilities (CORFs)
• Critical Access Hospitals (CAHs)
• Clinics, rehabilitation agencies, and
public health agencies as providers of
outpatient physical therapy and
speech-language pathology services
• Community Mental Health Centers
(CMHCs)
• Home Infusion Therapy (HIT)
suppliers
• Rural Health Clinics (RHCs)/Federally
Qualified Health Centers (FQHCs)
• End-Stage Renal Disease (ESRD)
Facilities
For discussion purposes, we have
grouped these providers and suppliers
into four categories below: (1)
Residential congregate care facilities; (2)
acute care settings; (3) outpatient
clinical care and services; and (4) home-
based care. We note that the appropriate
term for the individual receiving care
and/or services differs depending upon
the provider or supplier. For example,
for hospitals and CAHs, the appropriate
term is patient, but for ICFs-IID, it is
client. Further, LTC facilities have
residents and PACE Programs have
participants. The appropriate term is
used when discussing each individual
provider or supplier, but when we are
discussing all or multiple providers and
suppliers we will use the general term
‘‘patient.’’ Similarly, despite the
different terms used for specific
provider and supplier entities (such as
campus, center, clinic, facility,
organization, or program), when we are
discussing all or multiple providers and
suppliers, we will use the general term
‘‘facility.’’
A. Provisions of the Interim Final Rule
With Comment Period
In this IFC, we are issuing a common
set of provisions for each applicable
provider and supplier. As there are no
substantive regulatory differences across
settings, we discuss the provisions
broadly in this section of the rule, along
with their rationales. In subsequent
sections of the rule we discuss any
unique considerations for each setting.
1. Staff Subject to COVID–19
Vaccination Requirements
The provisions of this IFC require
applicable providers and suppliers to
develop and implement policies and
procedures under which all staff are
vaccinated for COVID–19. Each facility’s
COVID–19 vaccination policies and
procedures must apply to the following
facility staff, regardless of clinical
responsibility or patient contact and
including all current staff as well as any
new staff, who provide any care,
treatment, or other services for the
facility and/or its patients: Facility
employees; licensed practitioners;
students, trainees, and volunteers; and
individuals who provide care,
treatment, or other services for the
facility and/or its patients, under
contract or other arrangement. These
requirements are not limited to those
staff who perform their duties within a
formal clinical setting, as many health
care staff routinely care for patients and
clients outside of such facilities, such as
home health, home infusion therapy,
hospice, PACE programs, and therapy
staff. Further, there may be staff that
primarily provide services remotely via
telework that occasionally encounter
fellow staff, such as in an administrative
office or at an off-site staff meeting, who
will themselves enter a health care
facility or site of care for their job
responsibilities. Thus, we believe it is
necessary to require vaccination for all
staff that interact with other staff,
patients, residents, clients, or PACE
program participants in any location,
beyond those that physically enter
facilities, clinics, homes, or other sites
of care. Individuals who provide
services 100 percent remotely, such as
fully remote telehealth or payroll
services, are not subject to the
vaccination requirements of this IFC.
In the May 13, 2021 COVID–19 IFC,
we included an extensive discussion on
the subject of ‘‘staff’’ in relation to the
LTC facility staff and to whom the
testing, reporting, and education and
offering of COVID–19 vaccine
requirements of that rule might apply.
In that discussion, we considered LTC
facility staff to be those individuals who
work in the facility on a regular (that is,
at least once a week) basis. We note that
this includes those individuals who
may not be physically in the LTC
facility for a period of time due to
illness, disability, or scheduled time off,
but who are expected to return to work.
We also note that this description of
staff differs from that in § 483.80(h),
established for the LTC facility COVID–
19 testing requirements in the
September 2, 2020 COVID–19 IFC. As in
the May 13, 2021 COVID–19 IFC, we
considered applying the § 483.80(h)
definition to the staff vaccination
requirements in this rule, but previous
public feedback and our own experience
tells us the definition in § 483.80(h) was
overbroad for these purposes.
Stakeholders across settings have
reported that there are many individuals
providing occasional health care
services under arrangement, and that
the requirements may be excessively
burdensome for facilities to apply the
definition at § 483.80(h) because it
includes many individuals who have
very limited, infrequent, or even no
contact with facility staff and residents.
Stakeholders also report that applying
the staff vaccination requirements to
these individuals who may only make
unscheduled visits to the facility would
be extremely burdensome. That said, the
description in this rule still includes
many of the individuals included in
§ 483.80(h). In addition to facility-
employed staff, many facilities have
services provided directly, on a regular
basis, by individuals under contract or
arrangement, including hospice and
dialysis staff, physical therapists,
occupational therapists, mental health
professionals, social workers, and
portable x-ray suppliers. Any of these
individuals who provide such health
care services at a facility would be
included in ‘‘staff’’ for whom COVID–19
vaccination is now required as a
condition for continued provision of
those services for the facility and/or its
patients.
In order to best protect patients,
families, caregivers, and staff, we are not
limiting the vaccination requirements of
this IFC to individuals who are present
in the facility or at the physical site of
patient care based upon frequency.
Regardless of frequency of patient
contact, the policies and procedures
must apply to all staff, including those
providing services in home or
community settings, who directly
provide any care, treatment, or other
services for the facility and/or its
patients, including employees; licensed
practitioners; students, trainees, and
volunteers; and individuals who
provide care, treatment, or other
services for the facility and/or its
patients, under contract or other
arrangement. This includes
administrative staff, facility leadership,
volunteer or other fiduciary board
members, housekeeping and food
services, and others. We considered
excluding individual staff members who
are present at the site of care less
frequently than once per week from
these vaccination requirements, but
were concerned that this might lead to
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confusion or fragmented care. Therefore,
any individual that performs their
duties at any site of care, or has the
potential to have contact with anyone at
the site of care, including staff or
patients, must be fully vaccinated to
reduce the risks of transmission of
SARS–CoV–2 and spread of COVID–19.
Facilities that employ or contract for
services by staff who telework full-time
(that is, 100 percent of their time is
remote from sites of patient care, and
remote from staff who do work at sites
of care) should identify and monitor
these individuals as a part of
implementing the policies and
procedures of this IFC, documenting
and tracking overall vaccination status,
but those individuals need not be
subject to the vaccination requirements
of this IFC. Note, however, that these
individuals may be subject to other
Federal requirements for COVID–19
vaccination.
We recognize that many infrequent
services and tasks performed in or for a
health care facility are conducted by
‘‘one off’’ vendors, volunteers, and
professionals. Providers and suppliers
are not required to ensure the
vaccination of individuals who
infrequently provide ad hoc non-health
care services (such as annual elevator
inspection), or services that are
performed exclusively off-site, not at or
adjacent to any site of patient care (such
as accounting services), but they may
choose to extend COVID–19 vaccination
requirements to them if feasible. Other
individuals who may infrequently enter
a facility or site of care for specific
limited purposes and for a limited
amount of time, but do not provide
services by contract or under
arrangement, may include delivery and
repair personnel.
We believe it would be overly
burdensome to mandate that each
provider and supplier ensure COVID–19
vaccination for all individuals who
enter the facility. However, while
facilities are not required to ensure
vaccination of every individual, they
may choose to extend COVID–19
vaccination requirements beyond those
persons that we consider to be staff as
defined in this rulemaking. We do not
intend to prohibit such extensions and
encourage facilities to require COVID–
19 vaccination for these individuals as
reasonably feasible.
When determining whether to require
COVID–19 vaccination of an individual
who does not fall into the categories
established by this IFC, facilities should
consider frequency of presence, services
provided, and proximity to patients and
staff. For example, a plumber who
makes an emergency repair in an empty
restroom or service area and correctly
wears a mask for the entirety of the visit
may not be an appropriate candidate for
mandatory vaccination. On the other
hand, a crew working on a construction
project whose members use shared
facilities (restrooms, cafeteria, break
rooms) during their breaks would be
subject to these requirements due to the
fact that they are using the same
common areas used by staff, patients,
and visitors. Again, we strongly
encourage facilities, when the
opportunity exists and resources allow,
to facilitate the vaccination of all
individuals who provide services
infrequently and are not otherwise
subject to the requirements of this IFC.
2. Determining When Staff Are
Considered ‘‘Fully Vaccinated’’
In consideration of the different
vaccines available for COVID–19, we
require that providers and suppliers
ensure that staff are fully vaccinated for
COVID–19, which, for purposes of these
requirements, is defined as being 2
weeks or more since completion of a
primary vaccination series. This
definition of ‘‘fully vaccinated’’ is
consistent with the CDC definition.
Additionally, the completion of a
primary vaccination series for COVID–
19 is defined in the requirements as the
administration of a single-dose vaccine,
or the administration of all required
doses of a multi-dose vaccine.
We note that the concept of a
‘‘primary series’’ is commonly
understood with respect to vaccinations,
particularly among health care
professionals as well as the providers
and suppliers regulated by this rule. For
purposes of this IFC, and if permitted or
recommended by CDC, COVID–19
vaccine doses from different
manufacturers may be combined to meet
the requirements for a primary
vaccination series.
We further note that
recommendations for booster doses
currently vary by vaccine and
population, and expect that they will
continue to vary for the foreseeable
future. We also require that providers
and suppliers must have a process for
tracking and securely documenting the
COVID–19 vaccination status of any
staff who have obtained any booster
doses as recommended by the CDC.
Additionally, some staff members may
have been vaccinated during
participation in a clinical trial, or in
countries other than the U.S. We discuss
the applicability of these less common
vaccination pathways in section I.B. of
this IFC.
Currently, for two of the three
vaccines licensed or authorized for use
in the U.S., the primary vaccination
series consists of a defined number of
doses administered a certain number of
weeks apart; therefore, we have made
this particular requirement effective in
two different phases. We discuss these
implementation phases further in
section II.B. of this IFC, but note here
that Phase 1, effective 30 days after
publication of this IFC, includes the
requirement that staff receive the first
dose, or only dose as applicable, of a
COVID–19 vaccine, or have requested or
been granted an exemption to the
vaccination requirements of this IFC.
Phase 2, effective 60 days after
publication of this IFC, requires that the
primary vaccination series has been
completed and that staff are fully
vaccinated, except for those staff have
been granted exemptions, or those staff
for whom COVID–19 vaccination must
be temporarily delayed, as
recommended by CDC, due to clinical
precautions and considerations. As
discussed in section II.B. of this IFC,
staff who have completed the primary
series for the vaccine received by the
Phase 2 implementation date are
considered to have met these
requirements, even if they have not yet
completed the 14-day waiting period
required for full vaccination.
3. Infection Prevention and Control
We require through this IFC that all
applicable providers and suppliers have
a process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19. While every health care
facility should be following
recommended infection control and
prevention measures as recommended
by CDC as part of their provision of safe
health care services, not all of the
providers and suppliers subject to the
requirements of this IFC have specific
infection control and prevention
regulations in place. Specifically, there
are no infection prevention and control
requirements for PRTFs, RHCs/FQHCs,
and HIT suppliers. Therefore, for
PRTFs, RHCs/FQHCs, and HIT
suppliers, we require that they have a
process for ensuring that they follow
nationally recognized infection
prevention and control guidelines
intended to mitigate the transmission
and spread of COVID–19. This process
must include the implementation of
additional precautions for all staff who
are not fully vaccinated for COVID–19.
For the providers and suppliers
included in this IFC that are already
subject to meeting specific infection
prevention and control requirements on
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160 https://www.eeoc.gov/laws/guidance/section-
12-religious-discrimination.
an ongoing basis, we require that they
have a process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19.
4. Documentation of Staff Vaccinations
In order to ensure that providers and
suppliers are complying with the
vaccination requirements of this IFC, we
are requiring that they track and
securely document the vaccination
status of each staff member, including
those for whom there is a temporary
delay in vaccination, such as recent
receipt of monoclonal antibodies or
convalescent plasma. Vaccine
exemption requests and outcomes must
also be documented, discussed further
in section II.A.5. of this IFC. This
documentation will be an ongoing
process as new staff are onboarded.
While provider and supplier staff may
not have personal medical records on
file with their employer, all staff
COVID–19 vaccines must be
appropriately documented by the
provider or supplier. Examples of
appropriate places for vaccine
documentation include a facilities
immunization record, health
information files, or other relevant
documents. All medical records,
including vaccine documentation, must
be kept confidential and stored
separately from an employer’s personnel
files, pursuant to ADA and the
Rehabilitation Act.
Examples of acceptable forms of proof
of vaccination include:
• CDC COVID–19 vaccination record
card (or a legible photo of the card),
• Documentation of vaccination from
a health care provider or electronic
health record, or
• State immunization information
system record.
If vaccinated outside of the U.S., a
reasonable equivalent of any of the
previous examples would suffice.
Providers and suppliers have the
flexibility to use the appropriate
tracking tools of their choice. For those
who would like to use it, CDC provides
a staff vaccination tracking tool that is
available on the NHSN website (https://
www.cdc.gov/nhsn/hps/weekly-covid-
vac/index.html). This is a generic Excel-
based tool available for free to anyone,
not just NHSN participants, that
facilities can use to track COVID–19
vaccinations for staff members.
5. Vaccine Exemptions
While nothing in this IFC precludes
an employer from requiring employees
to be fully vaccinated, we recognize that
there are some individuals who might
be eligible for exemptions from the
COVID–19 vaccination requirements in
this IFC under existing Federal law.
Accordingly, we require that providers
and suppliers included in this IFC
establish and implement a process by
which staff may request an exemption
from COVID–19 vaccination
requirements based on an applicable
Federal law. Certain allergies,
recognized medical conditions, or
religious beliefs, observances, or
practices, may provide grounds for
exemption. With regard to recognized
clinical contraindications to receiving a
COVID–19 vaccine, facilities should
refer to the CDC informational
document, Summary Document for
Interim Clinical Considerations for Use
of COVID–19 Vaccines Currently
Authorized in the United States,
accessed at https://www.cdc.gov/
vaccines/covid-19/downloads/
summary-interim-clinical-
considerations.pdf.
As described in section I.I. of this IFC,
there are Federal laws, including the
ADA, section 504 of the Rehabilitation
Act, section 1557 of the ACA, and Title
VII of the Civil Rights Act, that prohibit
discrimination based on race, color,
national origin, religion, disability and/
or sex, including pregnancy. We
recognize that, in some circumstances,
employers may be required by law to
offer accommodations for some
individual staff members.
Accommodations can be addressed in
the provider or supplier’s policies and
procedures.
Applicable staff of the providers and
suppliers included in this IFC must be
able to request an exemption from these
COVID–19 vaccination requirements
based on an applicable Federal law,
such as the Americans with Disabilities
Act (ADA) and Title VII of the Civil
Rights Act of 1964. Providers and
suppliers must have a process for
collecting and evaluating such requests,
including the tracking and secure
documentation of information provided
by those staff who have requested
exemption, the facility’s decision on the
request, and any accommodations that
are provided.
Requests for exemptions based on an
applicable Federal law must be
documented and evaluated in
accordance with applicable Federal law
and each facility’s policies and
procedures. As is relevant here, this IFC
preempts the applicability of any State
or local law providing for exemptions to
the extent such law provides broader
exemptions than provided for by
Federal law and are inconsistent with
this IFC.
For staff members who request a
medical exemption from vaccination, all
documentation confirming recognized
clinical contraindications to COVID–19
vaccines, and which supports the staff
member’s request, must be signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws. Such
documentation must contain all
information specifying which of the
authorized COVID–19 vaccines are
clinically contraindicated for the staff
member to receive and the recognized
clinical reasons for the
contraindications; and a statement by
the authenticating practitioner
recommending that the staff member be
exempted from the facility’s COVID–19
vaccination requirements based on the
recognized clinical contraindications.
Under Federal law, including the
ADA and Title VII of the Civil Rights
Act of 1964 as noted previously,
workers who cannot be vaccinated or
tested because of an ADA disability,
medical condition, or sincerely held
religious beliefs, practice, or observance
may in some circumstances be granted
an exemption from their employer. In
granting such exemptions or
accommodations, employers must
ensure that they minimize the risk of
transmission of COVID–19 to at-risk
individuals, in keeping with their
obligation to protect the health and
safety of patients. Employers must also
follow Federal laws protecting
employees from retaliation for
requesting an exemption on account of
religious belief or disability status. For
more information about these situations,
employers can consult the Equal
Employment Opportunity Commission’s
website at https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19-
and-ada-rehabilitation-act-and-other-
eeo-laws.
We also direct providers and
suppliers to the Equal Employment
Opportunity Commission (EEOC)
Compliance Manual on Religious
Discrimination 160 for information on
evaluating and responding to such
requests. While employers have the
flexibility to establish their own
processes and procedures, including
forms, we point to The Safer Federal
Workforce Task Force’s ‘‘request for a
religious exception to the COVID–19
vaccination requirement’’ template as an
example. This template can be viewed
at https://
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www.saferfederalworkforce.gov/
downloads/RELIGIOUS%20REQUEST%
20FORM%20-%2020211004%20-
%20MH508.pdf.
6. Planning
Despite the near-universal
applicability of the requirements
described in sections II.A.1. through 5 of
this IFC, we recognize that the course of
the COVID–19 pandemic remains
unpredictable. Due to likely unforeseen
circumstances, we require that
providers and suppliers make
contingency plans in consideration of
staff that are not fully vaccinated to
ensure that they will soon be vaccinated
and will not provide care, treatment, or
other services for the provider or its
patients until such time as such staff
have completed the primary vaccination
series for COVID–19 and are considered
fully vaccinated, or, at a minimum, have
received a single-dose COVID–19
vaccine, or the first dose of the primary
vaccination series for a multi-dose
COVID–19 vaccine. This planning
should also address the safe provision of
services by individuals who have
requested an exemption from
vaccination while their request is being
considered and by those staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations.
While the nature of this rulemaking
suggests the potential that virtually all
health care staff in the U.S. will be
vaccinated for COVD–19 within a matter
of months, local outbreaks, new viral
variations, changes in disease
manifestation, or other factors
necessitate contingency planning.
Contingency planning may extend
beyond the specific requirements of this
rule to address topics such as staffing
agencies that can supply vaccinated
staff if some of the facility’s staff are
unable to work. Contingency plans
might also address special precautions
to be taken when, for example, there is
a regional or local emergency
declaration, such as for a hurricane or
flooding, which necessitates the
temporary utilization of unvaccinated
staff, in order to assure the safety of
patients. For example, expedient
evacuation of a flooding LTC facility
may require assistance from local
community members of unknown
vaccination status. Facilities may
already have contingency plans that
meet the requirements of this IFC in
their existing Emergency Preparedness
policies and procedures.
B. Implementation Dates
Due to the urgent nature of the
vaccination requirements established in
this IFC, we have not issued a proposed
rule, as discussed in section III. of this
IFC. While some IFCs are effective
immediately upon publication, we
understand that instantaneous
compliance, or compliance within days,
with these regulations is not possible.
Vaccination requires time, especially
those vaccines delivered in a series, and
facilities may wish to coordinate
scheduling of staff vaccination
appointments in a staggered manner so
that appropriate coverage is maintained.
The policies and procedures required by
the IFC will also take time for facilities
to develop. However, in order to
provide protection to residents, patients,
clients, and PACE program participants
(as applicable), we believe it is
necessary to begin staff vaccinations as
quickly as reasonably possible.
In order to provide protection as soon
as possible, we are establishing two
implementation phases for this IFC.
Phase 1, effective 30 days after
publication, includes nearly all
provisions of this IFC, including the
requirements that all staff have received,
at a minimum, the first dose of the
primary series or a single dose COVID–
19 vaccine, or requested and/or been
granted a lawful exemption, prior to
staff providing any care, treatment, or
other services for the facility and/or its
patients. Phase 1 also includes the
requirements for facilities to have
appropriate policies and procedures
developed and implemented, and the
requirement that all staff must have
received a single dose COVID–19
vaccine or the initial dose of a primary
series by December 6, 2021.
Phase 2, effective 60 days after
publication, consists of the requirement
that all applicable staff are fully
vaccinated for COVID–19, except for
those staff who have been granted
exemptions from COVID–19 vaccination
or those staff for whom COVID–19
vaccination must be temporarily
delayed, as recommended by the CDC,
due to clinical precautions and
considerations). Although an individual
is not considered fully vaccinated until
14 days (2 weeks) after the final dose,
staff who have received the final dose of
a primary vaccination series by the
Phase 2 effective date are considered to
have meet the individual vaccination
requirements, even if they have not yet
completed the 14-day waiting period.
For example, an individual may receive
the first dose of the Moderna mRNA
COVID–19 Vaccine 2 or 3 days prior to
the Phase 1 deadline, but must wait at
least 28 days before receiving the
second dose. This second dose could
(and must, for purposes of this IFC) be
administered prior to the Phase 2
effective date, but the individual would
still be subject to meeting additional
precautions as described in section
II.A.3. of this IFC until 14 days had
passed. This timing flexibility applies
only to the initial implementation of
this IFC and has no bearing on ongoing
compliance. This information is also
presented in Table 2.
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We note that although this IFC is
being issued in response to the PHE for
COVID–19, we expect it to remain
relevant for some time beyond the end
of the formal PHE. Depending on the
future nature of the COVID–19
pandemic, we may retain these
provisions as a permanent requirement
for facilities, regardless of whether the
Secretary continues the ongoing PHE
declarations. Therefore, this
rulemaking’s effectiveness is not
associated with or tied to the PHE
declarations, nor is there a sunset
clause. Pursuant to section 1871(a)(3) of
the Act, Medicare interim final rules
expire 3 years after issuance unless
finalized. We expect to make a
determination based on public
comments, incidence, disease outcomes,
and other factors regarding whether it
will be necessary to conduct final
rulemaking and make this rule
permanent.
C. Enforcement
As we do with all new or revised
requirements, CMS will issue
interpretive guidelines, which include
survey procedures, following
publication of this IFC. We will advise
and train State surveyors on how to
assess compliance with the new
requirements among providers and
suppliers. For example, the guidelines
will instruct surveyors on how to
determine if a provider or supplier is
compliant with the requirements by
reviewing the entity’s records of staff
vaccinations, such as a list of all staff
and their individual vaccination status
or qualifying exemption. The guidelines
will also instruct surveyors to conduct
interviews staff to verify their
vaccination status. Furthermore, the
entity’s policy and procedures will be
reviewed to ensure each component of
the requirement has been addressed. We
will also provide guidance on how
surveyors should cite providers and
suppliers when noncompliance is
identified. Lastly, providers and
suppliers that are cited for
noncompliance may be subject to
enforcement remedies imposed by CMS
depending on the level of
noncompliance and the remedies
available under Federal law (for
example, civil money penalties, denial
of payment for new admissions, or
termination of the Medicare/Medicaid
provider agreement). CMS will closely
monitor the status of staff vaccination
rates, provider compliance, and any
other potential risks to patient, resident,
client, and PACE program participant
health and safety.
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161 Section 1819(d)(4)(B) of the Act. Section
1919(d)(4)(B) is nearly identical, but omitting ‘‘well-
being’’.
D. Residential Congregate Care Facilities
Individuals residing in congregate
care settings such as LTC facilities,
intermediate care facilities for
individuals with intellectual disabilities
(ICFs-IID), and psychiatric residential
treatment facilities for individuals
under 21 years of age (PRTFs),
regardless of health or medical
conditions, are at greater risk of
acquiring infections. This higher risk
applies to most bacterial and viral
infections, including SARS–CoV–2.
Staff working in these facilities often
work across facility types (that is, LTC
facilities, group homes, assisted living
facilities, in home and community-
based services settings, and even
different congregate settings within the
employer’s purview), and for different
providers, which may contribute to
virus transmission. Other factors
impacting virus transmission in these
settings might include: Clients or
residents who are employed outside the
congregate living setting; clients or
residents who require close contact with
staff or direct service providers; clients
or residents who have difficulty
understanding information or practicing
preventive measures; and clients or
residents in close contact with each
other in shared living or working
spaces.
1. Long Term Care Facilities (Skilled
Nursing Facilities and Nursing
Facilities)
Long term care (LTC) facilities, a
category that includes Medicare skilled
nursing facilities (SNFs) and Medicaid
nursing facilities (NFs), also collectively
called nursing homes, must meet the
consolidated Medicare and Medicaid
requirements for participation
(requirements) for LTC facilities (42 CFR
part 483, subpart B) that were first
published in the Federal Register on
February 2, 1989 (54 FR 5316). These
regulations have been revised and
added to since that time, principally as
a result of legislation or a need to
address specific issues. The
requirements were comprehensively
revised and updated in October 2016
(81 FR 68688), including a
comprehensive update to the
requirements for infection prevention
and control.
CMS establishes requirements for
acceptable quality in the operation of
health care entities. LTC facilities are
required to comply with the
requirements in 42 CFR part 483,
subpart B, to receive payment under the
Medicare or Medicaid programs. In
addition to several discrete
requirements set out under sections
1819 and 1919 of the Act, Medicare- and
Medicaid-participating LTC facilities
‘‘must meet such other requirements
relating to the health, safety, and well-
being of residents or relating to the
physical facilities thereof as the
Secretary may find necessary.’’ 161 More
specifically, the infection control
requirements for LTC facilities are based
on sections 1819(d)(3)(A) (for skilled
nursing facilities) and 1919(d)(3)(A) (for
nursing facilities) of the Act, which both
require that a facility establish and
maintain an infection control program
designed to provide a safe, sanitary, and
comfortable environment in which
residents reside and to help prevent the
development and transmission of
disease and infection.
Since the onset of the PHE, we have
revised the requirements for LTC
facilities through three IFCs focused on
COVID–19 testing, data reporting and
vaccine requirements for residents and
staff. Specifically, we have published
the following IFCs:
• The first IFC, ‘‘Medicare and
Medicaid Programs, Basic Health
Program, and Exchanges; Additional
Policy and Regulatory Revisions in
Response to the COVID–19 Public
Health Emergency and Delay of Certain
Reporting Requirements for the Skilled
Nursing Facility Quality Reporting
Program’’ (FR27550) was published on
May 8, 2020. The May 8, 2020 COVID–
19 IFC established requirements for LTC
facilities to report information related to
COVID–19 cases among facility
residents and staff, we received 299
public comments. About 161, or over
one-half of those comments, addressed
the requirement for COVID–19 reporting
for LTC facilities set forth at § 483.80(g).
• The second IFC, ‘‘Medicare and
Medicaid Programs, Clinical Laboratory
Improvement Amendments (CLIA), and
Patient Protection and Affordable Care
Act; Additional Policy and Regulatory
Revisions in Response to the COVID–19
Public Health Emergency’’ (FR54873)
was published on September 2, 2020.
The September 2, 2020 COVID–19 IFC
strengthened CMS’ ability to enforce
compliance with LTC facility reporting
requirements and established a new
requirement for LTC facilities to test
facility residents and staff for COVID–
19. We received 171 public comments
in response to the September 2, 2020
COVID–19 IFC, of which 113 addressed
the requirement for COVID–19 testing of
LTC facility residents and staff set forth
at § 483.80(h).
• The third IFC, ‘‘Medicare and
Medicaid Programs; COVID–19 Vaccine
Requirements for Long-Term Care (LTC)
Facilities and Intermediate Care
Facilities for Individuals with
Intellectual Disabilities (ICFs-IID)
Residents, Clients, and Staff’’
(86FR26306) was published on May 13,
2021. We received 71 public comments
in response to the May 13, 2021 COVID–
19 IFC, of which most addressed the
requirements for COVID–19 educating,
offering, and reporting of the uptake of
COVID–19 vaccine for LTC facility
residents and staff set forth at
§§ 483.80(d)(3) and 483.80(g)(1). In that
rule, we also required the educating,
offering, and recommended voluntary
reporting of COVID–19 vaccine uptake
in ICFs-IID facility clients and staff set
forth at §§ 483.430, Facility Staffing
requirements, and 483.460, Health Care
Services for Clients.
Under § 483.80(d)(3), as established in
the May 13, 2021 IFC, we require LTC
facilities to educate residents and staff
on the COVID–19 vaccines and also to
offer the vaccine, when available, to all
residents and staff. The May 13, 2021
IFC also required LTC facilities to report
both resident and staff vaccine uptake
and status to CDC’s National Healthcare
Safety Network (NHSN)
(§ 483.80(d)(3)(vii)); this has been a
requirement since May 21, 2021. The
CDC data collected under this
requirement show that vaccination rates
for LTC facility staff have stalled, with
a 64 percent national average of
vaccinated staff according to CDC data
as of August 28, 2021, while the number
of new LTC facility resident COVID–19
cases reported per week has risen by
just over 1455 percent from recorded
lows in June 2021 (323 cases in the
week ending June 27, 2021; 4701 in the
week ending August 22, 2021). There is
wide variation among states in staff
vaccination rates.
With this IFC, we are amending the
requirements at § 483.80, Infection
Control, by revising paragraph (d)(3)(v)
by deleting the words, ‘‘or a staff
member,’’ and adding the word, ‘‘or’’
before ‘‘resident representative,’’ so that
the provision now reads, ‘‘the resident,
or resident representative, has the
opportunity to accept or refuse a
COVID–19 vaccine, and change their
decision.’’ Retaining the language
permitting staff to refuse vaccination
would be inconsistent with the goals of
this IFC. We are further amending the
requirements at § 483.80 to add a new
paragraph (i), titled ‘‘COVID–19
Vaccination of facility staff,’’ to specify
that facilities must now develop and
implement policies and procedures to
ensure that all staff are fully
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162 https://www.cdc.gov/coronavirus/2019-ncov/
need-extra-precautions/index.html.
163 http://www.floridaarf.org/assets/Files/ICF-
IID%20Info%20Center/ICFHandoutonWebsite2-
14.pdf.
vaccinated—that is, staff for whom it
has been 2 weeks or more since they
completed a primary vaccination series
for COVID–19, with the completion of a
primary vaccination series for COVID–
19 defined as the administration of a
single-dose vaccine, or the
administration of all required doses of a
multi-dose vaccine.
For this rule, we have also added a
new paragraph at § 483.80(i)(2), which
specifies which staff for whom the
requirements for staff COVID–19
vaccination will not apply: (1) Staff who
exclusively provide telehealth or
telemedicine services outside of the
facility setting and who do not have any
direct contact with residents and other
staff (for whom the requirements do
apply) and (2) staff who provide support
services for the facility that are
performed exclusively outside of the
facility setting and who do not have any
direct contact with residents and other
staff (for whom the requirements do
apply).
Additionally, under the requirements
of this IFC, we are adding § 483.80(i)(3)
to now require that a facility’s policies
and procedures for COVID–19
vaccination of staff must include, at a
minimum, the components specified in
section II.A. of this IFC. New
§§ 483.80(i)(3)(i) through (x) specify
these required minimum components of
the facility’s policies and procedures.
2. Intermediate Care Facilities for
Individuals With Intellectual
Disabilities (ICFs-IID)
ICFs-IID are residential facilities that
provide services for people with
intellectual disabilities. ICF–IID clients
with certain underlying medical or
psychiatric conditions may be at
increased risk of serious illness from
COVID–19.162 On March 2, 2021, CDC
issued Interim Considerations for
Phased Implementation of COVID–19
Vaccination and Sub Prioritization
Among Recommended Populations,
which notes that increased rates of
transmission have been observed in
these settings, and that jurisdictions
may choose to prioritize vaccination of
persons living in congregate settings
based on local, State, tribal, or territorial
epidemiology. CDC further notes that
congregate living facilities may choose
to vaccinate residents and clients at the
same time as staff, due to numerous
factors, such as convenience or shared
increased risk of disease.
Sections 1905(c) and (d) of the Act
gave the Secretary authority to prescribe
regulations for intermediate care facility
services in facilities for individuals with
intellectual disabilities or persons with
related conditions. The ICFs-IID
Conditions of Participation were issued
on June 3, 1988 (53 FR 20496) and were
last updated on May 13, 2021 (86 FR
20448). There are currently 5,768
Medicare- and/or Medicaid-certified
ICFs-IID. As of April 2021, 4,661 of the
5,770 are small (1 to 8 beds) in size, but
there are 1,107 that are larger (14 or
more beds) facilities. These facilities
serve over 64,812 individuals with
intellectual disabilities and other related
conditions. All must qualify for
Medicaid coverage. While national data
about ICFs-IID clients is limited, we take
an example from Florida where almost
one quarter of clients (23 percent)
require 24-hour nursing services and a
medical care plan in addition to their
services plans.163 Data from a single
State are not nationally representative
and thus we are unable to generalize,
but it is illustrative.
Currently, the Conditions of
Participation: ‘‘Health Care Services’’ at
§ 483.460(a)(4)(i) require that ICFs-IID
offer clients and staff vaccination
against COVID–19 when vaccine
supplies are available (86 FR 26306).
Based on anecdotal reports, this new
requirement has not significantly
increased vaccination among ICFs-IID
staff. We conclude that additional
regulatory action is necessary to achieve
widespread vaccination among ICFs-IID
staff to protect ICFs-IID clients.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 483.430(g) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
3. Psychiatric Residential Treatment
Facilities (PRTFs)
PRTFs are non-hospital facilities that
provide inpatient psychiatric services to
Medicaid-eligible individuals under the
age of 21 (also called the ‘‘psych under
21 benefit’’). There are 357 PRTFs in the
U.S. The facilities must meet
accreditation standards, the
requirements in §§ 441.151 through
441.182, and the Condition of
Participation on the use of restraint and
seclusion at § 483.350 through
§ 483.376.
Among the requirements for the psych
under 21 benefit are certification of
need for inpatient care and a plan of
care for active treatment developed by
an interdisciplinary team. The psych
under 21 benefit is significant as a
means for Medicaid to cover the cost of
inpatient behavioral health services.
The Federal Medicaid program does not
reimburse states for the cost of covered
services provided to beneficiaries in
institutions for mental diseases (IMDs)
except in specific, statutorily-authorized
exceptions, including for young people
who receive this service, and
individuals age 65 or older served in an
IMD. A PRTF provides comprehensive
behavioral health treatment to children
and adolescents (youth) who, due to
mental illness, substance use disorders,
or severe emotional disturbance, need
treatment that can most effectively be
provided in a residential treatment
facility. PRTF programs are designed to
offer a short term, intense, focused
behavioral health treatment program to
promote a successful return of the youth
to the community.
As a congregate living setting, PRTFs
are subject to many of the same elevated
transmission risk factors as LTC
facilities and ICFs-IID as set forth in
section I. of this IFC. Section 1905(h) of
the Act defines inpatient psychiatric
hospital services for individuals under
21 as any inpatient facility that the
Secretary has prescribed in regulations
that in the case of any individual
involve active treatment which meets
such standards as may be prescribed in
regulations by the Secretary.
Implementing essential infection control
practices, including vaccination, is a
basic infection control treatment
standard.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 441.151(c) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its clients.
E. Acute Care Settings
Acute care settings are those
providers who generally provide active
care for short-term medical needs. For
our discussion purposes acute care
settings include: Hospitals, critical
access hospitals (CAHs), and
ambulatory surgical centers (ASCs).
1. Hospitals
Hospitals are large health care
providers that treat patients with acute
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164 https://www.nytimes.com/live/2021/09/23/
world/covid-delta-variant-vaccine#covid-alaska-
hospital, accessed 10/18/2021.
165 https://www.healthline.com/health-news/how-
surging-delta-variant-is-leading-to-rationed-care-at-
hospitals, accessed 10/18/2021.
166 https://www.aamc.org/news-insights/worst-
surge-we-ve-seen-some-hospitals-delta-hot-spots-
close-breaking-point, accessed 10/18/2021.
167 https://www.washingtonpost.com/health/
2021/08/18/covid-hospitals-delta/, accessed 10/18/
2021.
care needs including emergency
medicine, surgery, labor and delivery,
cardiac care, oncology, and a wide
variety of other services. Hospitals also
administer general and specialty care
that cannot safely be provided in other
settings, under the supervision of
physicians and licensed practitioners.
They may operate as independent
institutions or as part of a larger health
care system or learning institution.
Section 1861(e) of the Act provides
that hospitals participating in Medicare
and Medicaid must meet certain
specified requirements, and the
Secretary may impose additional
requirements if they are found necessary
in the interest of the health and safety
of the individuals who are furnished
services in hospitals. Medicare-
participating hospitals, which include
nearly all hospitals in the U.S., must
meet the Conditions of Participation
(CoPs) at 42 CFR part 482, originally
issued June 17, 1986. In addition to
smaller updates over the years, these
CoPs were reformed in 2012 (77 FR
29034). Hospital CoPs identify infection
control and prevention as a basic
hospital function and lay out specific
requirements at 42 CFR 482.42.
Infection control within a hospital
campus is especially important, because
hospitals treat individuals with
infectious diseases (such as COVID–19)
and healthy yet higher-risk individuals
(for example, pregnant and post-partum
individuals, infants, transplant
recipients, etc.) within the same facility.
Hospitals that provide emergency care
must do so in accordance with the
requirements of the Emergency Medical
Treatment and Labor Act (EMTALA) of
1986.
Hospitals have borne the brunt of
caring for patients with acute COVID–19
during the PHE. Individuals
experiencing respiratory problems,
cardiac events, kidney failure, and other
serious effects of COVID–19 illness have
required in-hospital care in large
numbers, to the point of occupying or
even exceeding most or all critical care
or ICU capacity in a facility, city, or
region. Despite emergency expansion of
critical care units, these waves of
severely ill patients have overwhelmed
hospitals, health care systems, and the
professionals and other staff who work
in them. This has had the disastrous
effect of limiting access and increasing
risk to both routine and emergency
hospital care across the U.S.164 165 166 167
Transplant centers, psychiatric
hospitals, and swing beds are governed
by the infection control CoPs for
hospitals, and are thus subject to the
staff vaccination requirements issued in
this IFC. We are particularly concerned
about transplant center patients, who
are among the most severely
immunocompromised individuals due
to anti-rejection medications that ensure
the function of transplanted organs. An
additional member of the transplant
ecosystem, Organ Procurement
Organizations (OPOs) coordinate and
support donation, recovery, and
placement of organs. As OPO staff do
not provide patient care, and typically
work in locations removed from health
care facilities, we are not issuing
vaccination requirements for OPOs in
this IFC. That said, we note that the
vaccination policies required in this IFC
apply to all individuals who provide
care, treatment, or other services for the
hospital and/or its patients, under
contract or other arrangement.
Accordingly, OPO staff members that
provide organ transplantation services
directly to hospital and transplant
center patients and families must meet
the vaccination requirements of this
IFC.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 482.42(g) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(including employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
2. Critical Access Hospitals (CAHs)
CAHs are rural hospitals that have
been designated as critical access
hospitals by the State, in a State that has
established a State Medicare Rural
Hospital Flexibility Program. These
hospitals have 25 or fewer acute care
inpatient beds (except as permitted for
CAHs having distinct part units under
§ 485.647, where the beds in the distinct
part are excluded from the 25 inpatient-
bed count limit specified in
§ 485.620(a)), must be more than 35
miles away from another hospital, and
provide emergency care services 24
hours a day, 7 days a week. On average,
acute patients stay in CAHs for less than
96 hours. CAHs may be granted
approval to provide post-hospital
skilled nursing care, may offer hospice
care under the Medicare hospice
benefit, and may operate a psychiatric
and/or rehabilitation distinct part unit
of up to 10 beds each. CAHs also
administer general and specialty care
that cannot safely be provided in other
settings, under the supervision of
physicians and licensed practitioners.
They may operate as independent
institutions or as part of a larger health
care system. Generally, they serve to
help ensure access to health-care
services in rural communities.
Section 1820 of the Act sets forth the
conditions for certifying a facility as a
CAH to include meeting such other
criteria as the Secretary may require.
Medicare-certified CAHs must meet the
Conditions of Participation (CoPs) at 42
CFR part 485 subpart F, originally
issued May 26, 1993 (58 FR 30630).
These CoPs contain specific
requirements for infection control and
prevention at § 485.640. Much like a
standard hospital, infection control
within a CAH is especially important,
because CAHs treat individuals with
infectious diseases (such as COVID–19)
and healthy yet higher-risk individuals
(for example, pregnant and post-partum
individuals, infants, transplant
recipients, etc.) within the same facility.
While organ transplants are not
performed in CAHs, we note that organ
donors may be CAH patients, and organ
donation and recovery may occur in
CAHs. We note that the vaccination
policies required in this IFC apply to all
individuals who provide care,
treatment, or other services for the
hospital and/or its patients, under
contract or other arrangement.
Accordingly, OPO staff members that
provide organ donation and
transplantation services directly to CAH
patients and families must meet the
vaccination requirements of this IFC in
the same manner as they meet such
requirements for hospitals.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 485.640(f) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(including employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
3. Ambulatory Surgical Centers (ASCs)
ASCs are distinct entities that operate
exclusively for the purpose of providing
surgical services to patients not
requiring hospitalization, and in which
the expected duration of services would
not exceed 24 hours following an
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
168 https://www.beckersasc.com/asc-news/5-ways-
covid-19-affected-ascs-in-2020.html. Accessed 10/
17/2021.
169 Am J Kidney Dis. 2020 Nov;76(5):690–695.e1.
doi: 10.1053/j.ajkd.2020.07.001. Epub 2020 Jul 15.
170 https://www.jhunewsletter.com/article/2020/
09/hopkins-finds-dialysis-patients-at-greater-risk-
of-covid-19.
171 CJASN March 2021, 16 (3) 452–455; DOI:
https://doi.org/10.2215/CJN.12360720.
172 http://www.synas.plus/nhsn/covid19/dial-
vaccination-dashboard.html#anchor_1594393306.
173 https://www.cdc.gov/vaccines/covid-19/
planning/vaccinate-dialysis-patients-hcp.html,
accessed 09/08/2021 22:00 EDT.
admission. The surgical services
performed in ASCs generally are
scheduled, non-life-threatening
procedures that can be safely performed
in either a hospital setting (inpatient or
outpatient) or in an ASC. Currently,
there are 6,071 Medicare-certified ASCs
in the U.S.
Section 1833(i)(1)(A) of the Act
authorizes the Secretary to specify those
surgical procedures that can be
performed safely in an ASC. Section
1832(a)(2)(F)(i) of the Act defines an
ASC as a facility ‘‘which meets health,
safety, and other standards specified by
the Secretary in regulations . . .’’.
The ASC Conditions for Coverage
(CfCs) at 42 CFR part 416, subpart C, are
the minimum health and safety
standards a center must meet to obtain
Medicare certification. The ASC CfCs
were issued on August 5, 1982 (47 FR
34082), and the Conditions related to
infection control were last updated on
November 18, 2008 (73 FR 68502,
68813). Section 416.51, Infection
control, requires ASCs to maintain an
infection control program that seeks to
minimize infections and communicable
diseases. In this IFC we are adding new
§ 416.51(c) which requires ASCs to meet
the same COVID–19 vaccination of staff
requirements as those we are issuing for
the other providers and suppliers
identified in this rule.
During the COVID–19 pandemic and
PHE, hospitals moved many non-
elective surgical procedures to ASCs
and other outpatient settings. Such
movement conserves hospital resources
for treating severe COVID–19,
performing more urgent procedures, and
caring for patients with more critical
health needs. Moreover, referring
patients in need of suitable procedures
to ASCs limits the overall number of
individuals visiting the hospital setting,
thereby inhibiting spread of infection.
ASCs also offer an alternative setting for
outpatient surgery for individuals
reluctant to enter a hospital due to fears
of COVID–19 exposure. Based on these
and other factors, the demand for ASC
services has increased.168
In response to the COVID–19
pandemic, ASCs assumed new roles.
CMS’s Hospital Without Walls initiative
permitted hospitals to provide inpatient
care in ASCs and other temporary sites.
ASCs have assisted with COVID–19
testing. They provided staff to work in
COVID–19 hot spots. These efforts
illustrate that staff and patients of ASCs
regularly interact with staff and patients
of other health care organizations and
facilities.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 416.51(c) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
F. Outpatient Clinical Care & Services
These clinical settings provide
necessary, ongoing care for individuals
who need ongoing therapeutic, and in
some cases life-sustaining, care. While
many of these settings have been able to
provide some services safely and
effectively via telehealth during the
PHE, many of the services they provide
require patients and clients to see staff
in person.
1. End-Stage Renal Disease (ESRD)
Facilities
ESRD facilities provide a set of life-
sustaining services to individuals
without kidney function, including
dialysis, medication, routine
evaluations and monitoring, nutritional
counselling, social support, and organ
transplantation evaluation and referral.
Section 1881(b)(1)(A) of the Act
authorizes the Secretary to pay only
those dialysis facilities ‘‘which meet
such requirements as the Secretary shall
by regulation prescribe for institutional
dialysis services and supplies . . .’’ also
known as CfCs. The ESRD facility CfCs
at 42 CFR part 494 are the minimum
health and safety rules that all
Medicare- and Medicaid-certified
dialysis facilities must meet in order to
participate in the programs. The ESRD
CfCs were initially issued in 1976 and
were comprehensively revised in 2008
(73 FR 20370). There are currently 7,893
Medicare-certified ESRD facilities in the
U.S., serving over 500,000 patients.
Routine dialysis treatments, typically
delivered 3 times per week, remove
toxins from a patient’s blood and are
necessary to sustain life. Dialysis
treatments are most often delivered in
the ESRD facility but can be performed
by the patients themselves at home, or
in the patient’s nursing facility with
assistance. ESRD facilities serve patients
whether they are diagnosed with
COVID–19 or not, and people receiving
dialysis cannot always be adequately
distanced from one another during
treatment. In-center dialysis precludes
social distancing because it involves
being in close proximity (<6 feet) to
caregivers and fellow patients for
extended periods of time (12–15 hours
per week). Because dialysis patients are
not able to defer dialysis sessions, in-
center dialysis patients are at increased
risk for developing COVID–19 due in
part to difficulty maintaining physical
distancing.169 Many ESRD patients are
also residents of LTC facilities or other
congregate living settings, which is also
a risk factor for COVID–19.170 Further,
individuals with kidney failure on
dialysis may have a higher risk of worse
outcomes.171
Dialysis health care personnel are
considered a priority population for
vaccination by the Advisory Committee
on Immunization Practices (ACIP), yet
ESRD facilities are currently reporting
low COVID–19 vaccination coverage
among ESRD facility health care
personnel, at less than 63 percent as of
September 26, 2021.172 Ensuring health
care personnel have access to COVID–19
vaccination is critical to protect both
them and their medically fragile
patients.173
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 494.30(b) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
2. Community Mental Health Centers
(CMHCs)
CMHCs are entities that meet
applicable enrollment requirements,
and applicable licensing or certification
requirements in the State in which they
are located. CMHCs provide the set of
mental health care services specified in
section 1913(c)(1) of the PHS Act (or, in
limited circumstances, provides for
such service by contract with an
approved organization or entity).
Section 4162 of the Omnibus Budget
Reconciliation Act of 1990 (Pub. L. 101–
508, enacted November 5, 1990) (OBRA
1990), which added sections 1861(ff)
and 1832(a)(2)(J) to the Act, includes
CMHCs as entities that are authorized to
provide partial hospitalization services
under Part B of the Medicare program,
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174 https://gh.bmj.com/content/bmjgh/5/5/
e002670.full.pdf. Accessed 9/23/2021.
175 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7027a2.htm?s_cid=mm7027a2_w Accessed 9/
23/2021.
effective for services provided on or
after October 1, 1991. Section
1861(ff)(3)(B)(iv)(I) of the Act
specifically requires CMHCs providing
partial hospitalization services under
Medicare to meet such additional
conditions as the Secretary specifies to
ensure the health and safety of
individuals being furnished such
services. Section 1866(e)(2) of the Act
and 42 CFR 489.2(c)(2) recognize
CMHCs as providers of services for
purposes of provider agreement
requirements but only with respect to
providing partial hospitalization
services. Pursuant to 42 CFR 410.2 and
410.110, a CMHC may receive Medicare
payment for partial hospitalization
services only if it demonstrates that it
provides the core services identified in
the requirements. To qualify for
Medicare reimbursement, CMHCs must
comply with requirements for coverage
of partial hospitalization services at
§ 410.110 and conditions for Medicare
payment of partial hospitalization
services at 42 CFR 424.24(e).
Currently there are 129 Medicare-
certified CMHCs in the U.S. The
Secretary has established in regulations,
at 42 CFR part 485, subpart J, the
minimum health and safety standards a
CMHC must meet to obtain Medicare
certification. CMHC CoPs were issued
on October 29, 2013 (78 FR 64604).
Section 485.904, Personnel
qualifications, establishes requirements
for CMHC personnel. In this IFC we are
adding new § 485.904(c) which requires
the CMHC to meet the same COVID–19
vaccination of staff requirements as
those we are issuing for the other
providers and suppliers affected by this
rule.
CMHCs provide mental health
services to treat patients under the
Medicare partial hospitalization
program and other patients for various
mental health conditions. Partial
hospitalization programs provide
structured, outpatient mental health
services that are more intense than
office visits with physicians or
therapists. Patients in partial
hospitalization programs receive
treatment for several hours during the
day, multiple days a week. In response
to the PHE, CMHCs continued to treat
patients by using telecommunications,
and some centers paused their partial
hospitalization programs or reduced the
frequency and duration of treatment.
However, many centers have begun to
see and treat patients in person again
and have resumed their customary
partial hospitalization programming
schedules. With increased in-person
services being offered in the CMHC, it
is essential to ensure all staff are
vaccinated against COVID–19 not only
to protect themselves but to prevent the
spread of COVID–19 to CMHC patients.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 485.904(c) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
3. Comprehensive Outpatient
Rehabilitation Facilities (CORFs)
CORFs are non-residential facilities
that are established and operated
exclusively for the purpose of providing
diagnostic, therapeutic, and restorative
services to outpatients for the
rehabilitation of injured persons, sick
persons, and persons with disabilities,
at a single fixed location, by or under
the supervision of a physician. In
response to the PHE, outpatient
rehabilitation facilities suspended
operations, reduced their patient care
capacity, and transitioned from in-
person to telecommunications as able.
However, certain rehabilitation services
require physical contact with patients,
such as fitting or adjusting a prosthesis
or assistive device and assessing
strength with manual resistance. During
the pandemic, some patients in need of
rehabilitation chose to delay care and
others encountered delays in accessing
care. These delays likely contributed to
increased disability or illness.174
Moreover, patients admitted to the
hospital have been discharged as soon
as possible to provide beds for
individuals with more critical
conditions, including COVID–19. For
those patients recovering from severe
COVID–19 illness with long-term
symptoms, prompt comprehensive
outpatient rehabilitation services upon
their discharge from inpatient care is
necessary to restore physical and mental
health.175 All of these factors stress the
importance of rehabilitation facilities
who are treating patients with increased
morbidity and complex needs. CORFs
have resumed operations and are
providing services to an increasing
number of patients; therefore, COVID–
19 vaccination of staff is pivotal for
inhibiting spread of infection and
ensuring health and safety of patients.
Currently, there are 159 Medicare-
certified CORFs in the U.S. Section
1861(cc)(2)(J) of the Act states that the
CORF must ‘‘meet such conditions of
participation as the Secretary may find
necessary in the interest of the health
and safety of individuals who are
furnished services by such facility,
including conditions concerning
qualifications of personnel in these
facilities.’’ Under this authority, the
Secretary has established in regulations,
at 42 CFR part 485, subpart B, the
minimum health and safety standards a
CORF must meet to obtain Medicare
certification. The CORF Conditions of
Participation were issued on December
15, 1982 (47 FR 56282). Section 485.70,
Personnel qualifications, sets forth the
qualifications that various personnel
must meet, as a condition of
participation. We are adding a new
paragraph (n) at § 485.70 which requires
the CORF to meet the same COVID–19
vaccination of staff requirements as
those we are issuing for the other
providers and suppliers identified in
this rule.
Our rules at § 485.58(d)(4), state that
personnel that do not meet the
qualifications specified in § 485.70 may
be used by the facility in assisting
qualified staff. We recognize this
sentence is inconsistent with newly
added § 485.70(n) which requires
vaccination of all facility staff. We also
recognize that assisting personnel are
used by CORFs. We established our
requirements at § 485.70 (a) through (m)
to provide a role for personnel that
might not meet our education and
experience qualifications. We do not
believe that this exception for
employees that do not meet our
professional requirements should
prohibit us from issuing staff
qualifications referencing infection
prevention, which we intend to apply to
all personnel. Hence, we are revising
§ 485.58(d)(4) to state that personnel
that do not meet the qualifications
specified in § 485.70(a) through (m) may
be used by the facility in assisting
qualified staff. However, such assisting
staff will not be exempt from the newly
added requirements in paragraph (n).
As with other parallel regulations for
our facilities, we are revising
§ 485.58(d)(4) as previously discussed.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 485.70(n) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
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176 https://www.hrsa.gov/coronavirus/rural-
health-clinics. Accessed 9/24/2021.
177 https://bphc.hrsa.gov/emergency-response/
coronavirus-frequently-asked-questions. Accessed
9/24/2021.
178 https://www.hrsa.gov/coronavirus/health-
center-program. Accessed 10/6/2021.
4. Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
Section 1861(aa) and 1905(l)(2)(B) of
the Act sets forth the RHC and FQHC
services covered by the Medicare
program; section 1905(l) cross-
references the Medicare provision for
Medicaid program purposes. The Act
requires that RHCs be located in an area
that is both rural and underserved, are
not rehabilitation agencies or facilities
primarily for the care and treatment of
mental diseases, and meet such other
requirements as the Secretary may find
necessary in the interest of the health
and safety of the individuals who are
furnished services by the clinic.
Likewise, 42 CFR 491.2 defines a FQHC
as an entity as defined in § 405.2401(b).
The definition at § 405.2401 includes an
entity that has entered into an
agreement with CMS to meet Medicare
Program requirements under § 405.2434.
And at 42 CFR 405.2434, the content
and terms of the agreement require
FQHCs to maintain compliance with
requirements set forth in part 491,
except the provisions of § 491.3
Certification procedures. Conditions for
certification for RHCs and Conditions of
Coverage for FQHCs are found at 42 CFR
part 491, subpart A.
RHCs and FQHCs, as essential
contributors to the health care
infrastructure in the U.S., provide care
and services to medically underserved
areas and populations. They play a
critical role in helping to alleviate
access to care barriers and health equity
gaps in these communities. RHCs and
FQHCs provide primary care, diagnostic
laboratory, and immunization services,
and they have incorporated COVID–19
screening, triage, testing, diagnosis,
treatment, and vaccination into these
services. However, the medically
underserved communities in the U.S.
have been disproportionately affected
by COVID–19. Hence, the Health
Resources and Services Administration
(HRSA) has established new programs
to help RHCs and FQHCs meet the
needs of their communities and ensure
continuity of health care services during
the PHE.176 177 178 For example: (1) The
Rural Health Clinic COVID–19 Testing
and Mitigation Program which helps
RHCs with COVID–19 testing and
mitigation strategies to prevent the
spread of infection; (2) the Rural Health
Clinic Vaccine Distribution Program
which strengthens COVID–19 vaccine
allocations for RHCs; (3) the Rural
Health Clinic Vaccine Confidence
Program that helps RHCs with outreach
efforts to improve vaccination rates in
rural areas with nearly 2,000 RHCs
across the nation participating; (4) the
Health Center COVID–19 Vaccine
Program whereby FQHCs receive direct
allocations of vaccines; (5) the
Department of Defense (DoD) and HHS
partnered to provide point-of-care rapid
COVID–19 testing supplies to FQHCs
through the Health Center COVID–19
Testing Supply Distribution Program;
and (6) delivery of 5.1 million adult and
7.4 million child masks between April
and August 2021 to FQHCs at no cost
for subsequent distribution to patients,
staff, and community members. To
implement these programs and to
provide services and care, RHC/FQHC
staff must interact with patients and
members of the community at large.
Hence, a requirement for these staff to
receive COVID–19 vaccination is
necessary to assure health and safety for
the individuals residing in their
respective service areas and their
patients.
Currently, there are 4,933 Medicare-
and Medicaid-certified RHCs and 10,384
FQHCs that participate in the Medicare
and Medicaid programs in the U.S. The
Conditions at 42 CFR part 491, subpart
A are the minimum health and safety
standards a center or clinic must meet
to participate in the Medicare and
Medicaid programs. The conditions
were issued on June 12, 1992 (57 FR
27106), and the conditions related to
staffing and staff responsibilities were
last updated on May 12, 2014 (79 FR
27106). Section 491.8, Staffing and staff
responsibilities, establishes
requirements for RHC and FQHC
staffing and staff responsibilities. We are
adding new § 491.8(d) which requires
the clinic or center to meet the same
COVID–19 vaccination of staff
requirements as those we are issuing for
the other providers and suppliers
identified in this rule.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 491.8(d) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
5. Clinics, Rehabilitation Agencies, and
Public Health Agencies as Providers of
Outpatient Physical Therapy and
Speech-Language Pathology Services
Under the authority of section 1861(p)
of the Act, the Secretary has established
CoPs that clinics, rehabilitation
agencies, and public health agencies
(collectively, ‘‘organizations’’) must
meet when they provide outpatient
physical therapy (OPT) and speech-
language pathology (SLP) services.
Under section 1861(p) of the Act, the
Secretary is responsible for ensuring
that the CoPs and their enforcement are
adequate to protect the health and safety
of individuals receiving OPT and SLP
services from these entities. The CoPs
are set forth at 42 CFR part 485, subpart
H. Section 1861(p) of the Act describes
outpatient physical therapy services to
mean physical therapy services
furnished by a provider of services, a
clinic, rehabilitation agency, or a public
health agency, or by others under an
arrangement with, and under the
supervision of, such provider, clinic,
rehabilitation agency, or public health
agency to an individual as an
outpatient. The patient must be under
the care of a physician. The term
‘‘outpatient physical therapy services’’
also includes physical therapy services
furnished to an individual by a physical
therapist (in the physical therapist’s
office or the patient’s home) who meets
licensing and other standards prescribed
by the Secretary in regulations, other
than under arrangement with and under
the supervision of a provider of services,
clinic, rehabilitation agency, or public
health agency. Pursuant to the statutory
requirement set out at section
1861(p)(4)(A) and (B) of the Act, the
furnishing of such services by a clinic,
rehabilitation agency, or public health
agency must meet such conditions
relating to health and safety as the
Secretary may find necessary. The term
also includes SLP services furnished by
a provider of services, a clinic,
rehabilitation agency, or by a public
health agency, or by others under an
arrangement.
Currently, there are 2,078 clinics,
rehabilitation agencies, and public
health agencies that provide outpatient
physical therapy and speech-language
services. In the remainder of this rule
and throughout the requirements, we
use the term ‘‘organizations’’ instead of
‘‘clinics, rehabilitation agencies, and
public health agencies as providers of
outpatient physical therapy and speech-
language pathology services’’ for
consistency with current regulatory
language. Patients receive services from
organizations due to loss of functional
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
179 American Physical Therapy Association. May
2021. Impact of COVID–19 on the Physical Therapy
Profession Over One Year.
ability associated with injury or illness.
Hence, these patients experience
episodic issues and seek care to restore
their level of functioning and wellness
to baseline. In response to the PHE,
organizations experienced a reduction
in patients. They supplemented in-
person care with telecommunications.
However, just over 50 percent of
physical therapists report in-person care
results in better outcomes than care
provided virtually and the majority of
patients are less satisfied with care
received by telecommunications.179
Although the data is limited, we believe
these findings are consistent with other
therapeutic services including
occupational therapy and speech
pathology. Comprehensive assessment
of balance, strength, range-of-motion,
and proper exercise technique is
supported by physical touch, and three-
dimensional visualization of the patient.
Organizations have begun seeing more
patients, and those patients are
presenting with more severe functional
issues. Organizations care for patients
recovering from COVID–19 and those
who delayed receiving non-COVID–19
related care due to fears of exposure to
illness after the onset of the pandemic.
These factors underscore the need to
ensure safety and health of individuals
who receive care from organizations
with a requirement for COVID–19
vaccination of staff.
The CoPs for organizations at 42 CFR
part 485, subpart H are the minimum
health and safety standards an
organization must meet to obtain
Medicare certification. The CoPs were
first issued May 21, 1976 (41 FR 20863),
and the Conditions related to infection
control were last updated on September
29, 1995 (60 FR 50446). Section
485.725, Infection control, requires
organizations to establish an infection-
control committee with responsibility
for overall infection control. We are
adding new paragraph (f) to § 485.725,
which requires the organizations to
meet the same COVID–19 vaccination of
staff requirements as those we are
issuing for the other providers and
suppliers identified in this rule.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 485.725(f) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
G. Home-Based Care
Home-based care providers provide
necessary care and services for
individuals who need ongoing
therapeutic, and in some cases life-
sustaining, care. These settings require
that health care staff enter the patient’s
personal home (regardless of location in
a private home, assisted living facility,
or another setting) to provide services
and care in person, thus exposing
patients and other members of their
household, to the staff. Home-based
provider staff also often serve multiple
patients in different homes in the same
day, week, or month, which presents
opportunities for transmission of
infectious diseases across households.
Because home-based providers work
outside of a regulated health care
facility, there is also the potential for
staff to either not use the appropriate
PPE or use it improperly because on-site
oversight mechanisms are not in place,
that could increase the risk of
transmission of COVID–19 or other
infectious diseases across households.
We also believe these patients are
especially vulnerable to COVID–19 due
to receiving care in their homes. Many
patients have serious illnesses that
increases the risk of morbidity and
mortality from COVID–19. For hospice
patients that are receiving non-curative
but supportive care, we are concerned
that contracting COVID–19 could
increase their discomfort, decrease their
quality of life, or perhaps even hasten
their death. In addition, the patients’
homes may have poor ventilation or
members of the household may not be
complying with recommended safety
precautions. Thus, COVID–19
vaccination mandates will provide
patients and their household members
with safety assurances that will
facilitate acceptance of home care
services, and will protect the patients,
staff, and the other members of the
patients’ households.
1. Home Health Agencies (HHAs)
Under the authority of sections
1861(m), 1861(o), and 1891 of the Act,
the Secretary has established in
regulations the requirements that a
home health agency (HHA) must meet to
participate in the Medicare program, our
regulations at 42 CFR 440.70(d) require
that Medicaid-participating home health
agencies meet Medicare conditions of
participation. Section 1861(o)(6) of the
Act requires that home health agencies
‘‘meet the conditions of participation
specified in section 1891(a) and such
other conditions of participation as the
Secretary may find necessary in the
interest of the health and safety of
individuals who are furnished services
by such agency or organization.’’ The
CoPs for home health services are found
in Title 42, Part 484, subparts A through
C, §§ 484.40 through 484.115. HHAs
provide care and services for qualifying
older adults and people with disabilities
who are beneficiaries under the Hospital
Insurance (Part A) and Supplemental
Medical Insurance (Part B) benefits of
the Medicare program. These services
include skilled nursing care, physical,
occupational, and speech therapy,
medical social work and home health
aide services which must be furnished
by, or under arrangement with, an HHA
that participates in the Medicare
program and must be provided in the
beneficiary’s home. As of September 1,
2021, there were 11,649 HHAs
participating in the Medicare program.
The majority of HHAs are for-profit,
privately owned agencies. The effective
delivery of quality home health services
is essential to the care of the HHA’s
patients to provide necessary care and
services and prevent hospitalizations.
Since patients and other members of
their households will be exposed to
HHA staff, it is essential that staff be
vaccinated against COVID–19 for the
safety of the patients, members of their
households, and the staff themselves.
With so many patients depending on
the services of HHAs nationwide, it is
imperative that HHAs have processes in
place to address the safety of patients
and staff and the continued provision of
services. Because these patients are at
home, essential care must be provided,
regardless of COVID–19 vaccination or
infection status. In addition, by going
into patients’ homes, HHA employees
are exposed to numerous individuals
who might not be vaccinated or perhaps
are asymptomatic but infected.
Therefore, it is imperative that HHAs
have appropriate procedures to ensure
the continued provision of care and
services for their patients. Section
484.70 Condition of participation:
Infection prevention and control (a)
requires that the ‘‘HHA must follow
accepted standards of practice,
including the use of standard
precautions, to prevent the transmission
of infections and communicable
diseases.’’
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 484.70(d) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
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provide care, treatment, or other
services for the provider or its patients.
2. Hospice
Section 122 of the Tax Equity and
Fiscal Responsibility Act of 1982 (Pub.
L. 97–248, enacted September 3. 1982)
(TEFRA), added section 1861(dd) to the
Act to provide coverage for hospice care
to terminally ill Medicare beneficiaries
who elect to receive care from a
Medicare-participating hospice. Under
the authority of section 1861(dd) of the
Act, the Secretary has established the
CoPs that a hospice must meet in order
to participate in Medicare and
Medicaid. Under section 1861(dd)(2)(G)
of the Act, the Secretary may impose
‘‘such requirements as the Secretary
may find necessary in the interest of the
health and safety of the individuals who
are provided care and services by such
agency or organization.’’ The CoPs
found at part 418, subparts C and D
apply to a hospice, as well as to the
services furnished to each patient under
hospice care. These requirements are set
forth in §§ 418.52 through 418.116.
Hospice care provides palliative care
rather than curative treatment to
terminally ill patients. Palliative care
improves the quality of life of patients
and their families and caregivers facing
the challenges associated with terminal
illness through the prevention and relief
of suffering by means of early
identification, assessment, and
treatment of pain and other issues.
Hospice care allows the patient to
remain at home by providing support to
the patient and family and caregiver and
by keeping the patient as comfortable as
possible while maintaining his or her
dignity and quality of life. Hospices use
an interdisciplinary approach to deliver
medical, social, physical, emotional,
and spiritual services through the use of
a broad spectrum of support.
Hospices are unique health care
providers because they serve patients,
families, and caregivers in a wide
variety of settings. Hospice patients may
be served in their place of residence,
whether that residence is a private
home, an LTC facility, an assisted living
facility, or even a recreational vehicle,
as long as such locations are determined
to be the patient’s place of residence.
Hospice patients may also be served in
inpatient facilities, including those
operated by the hospice itself.
With so many patients depending on
the services of hospice services
nationwide, it is imperative that
hospices have processes in place to
address the safety of patients and staff
and the continued provision of services.
The goal of hospice care is to provide
non-curative, but supportive care of an
individual during the final days, weeks,
or months of a terminal illness.
Contracting any infectious disease,
especially COVID–19, could result in
additional pain or perhaps even
accelerate a patient’s death. Thus, it is
critical that hospices protect patients
and staff from contracting or
transmitting COVID–19. As of
September 1, 2021, there were 5,556
hospices. Section 418.60(a), Condition
of participation: Infection Control,
requires that the ‘‘hospice must follow
accepted standards of practice to
prevent the transmission of infections
and communicable disease, including
the use of standard precautions.’’
The effective delivery of hospice
services is essential to the care of the
hospice’s patients and their families and
caregivers. Since patients and other
members of their households will be
exposed to hospice staff, it is essential
that staff be vaccinated against COVID–
19 for the safety of the patients,
members of their households, and the
staff themselves.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 418.60(d) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(including employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
3. Home Infusion Therapy Suppliers
(HIT) Suppliers
Section 5012 of the 21st Century
Cures Act (Pub. L. 114–255, enacted
December 13, 2016) (Cures Act) created
a separate Medicare Part B benefit
category under 1861(s)(2)(GG) of the Act
for coverage of home infusion therapy-
associated professional services for
certain drugs and biologicals
administered intravenously or
subcutaneously for periods of 15
minutes or more in the patient’s home
through a pump that is an item of
durable medical equipment. Section
1861(iii)(3)(D)(i)(IV) of the Act requires
qualified home infusion therapy (HIT)
suppliers to meet, in addition to
specified qualifications, ‘‘such other
requirements as the Secretary
determines appropriate.’’ The regulatory
requirements for home therapy infusion
(HIT) suppliers are located at 42 CFR
part 486, subpart I, §§ 486.500 through
486.525.
The nature of the home setting
presents different challenges than in-
center services as well as the
administration of the particular
medications. The items and equipment
needed to perform home infusion
include the drug (for example, immune
globulin), equipment (a pump), and
supplies (for example, tubing and
catheters) which are covered under the
Durable Medical Equipment benefit.
Skilled professional visits, such as those
from nurses, often play a critical role in
the provision of home infusion and are
covered under the home infusion
therapy benefit. For example, nurses
typically train the patient or caregiver to
self-administer the drug, educate on
side effects and goals of therapy, and
visit periodically to provide catheter
and site care. Depending on patient
acuity or the complexity of the drug
administration, certain skilled
professional visits may require more
time. The HIT infusion process typically
requires coordination among multiple
entities, including patients, the
responsible physicians and
practitioners, hospital discharge
planners, pharmacies, and, if applicable,
home health agencies.
The current requirements for HIT
suppliers do not contain specific
infection prevention and control
requirements. However, § 486.525,
Required services, does state that these
providers must ‘‘provide home infusion
therapy services in accordance with
nationally recognized standards of
practice, and in accordance with all
applicable state and federal laws and
regulations.’’ We believe that
‘‘nationally recognized standards of
practice’’ include appropriate policies
and procedures for infection prevention
and control.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 486.525(c) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services for the provider or its patients.
4. Programs of All-Inclusive Care for the
Elderly (PACE) Organizations
The Programs of All-Inclusive Care for
the Elderly (PACE) program provides a
model of managed care service delivery
for frail older adults, most of whom are
dually eligible for Medicare and
Medicaid benefits, and all of whom are
assessed as being eligible for LTC
facility placement according to the
Medicaid standards established by their
respective states. PACE organizations
furnish comprehensive medical, health,
and social services that integrate acute
and long-term care, and these services
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
180 https://emergency.cdc.gov/han/2021/
han00447.asp.
181 Internal estimates based on data published at
https://www.cdc.gov/coronavirus/2019-ncov/covid-
data/covidview/index.html; accessed September 24,
2021.
182 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html
https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html,
accessed October 18, 2021.
183 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7037e1.htm?s_cid=mm7037e1_w, accessed
October 18, 2021.
184 https://covid.cdc.gov/covid-data-tracker/
#covidnet-hospitalizations-vaccination, accessed
October 18, 2021.
185 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
center, the home, and inpatient
facilities. The PACE model involves a
multidisciplinary team of providers
known as the interdisciplinary team
(IDT) that comprehensively assesses and
meets the needs of each PACE
participant by planning and
coordinating all participant care. PACE
organizations must provide all
Medicare-covered items and services, all
Medicaid-covered items and services,
and any other services determined
necessary by the IDT to improve and
maintain the participant’s overall health
status, either directly or under contract
with third party service providers.
The statutory authorities that permit
Medicare payments and coverage of
benefits under the PACE program, as
well as the establishment of PACE
organizations as a State option under
Medicaid to provide for Medicaid
payments and coverage of benefits
under the PACE program, are under
sections 1894 and 1934 of the Act.
These statutory authorities are
implemented at 42 CFR part 460, where
CMS has set out the minimum
requirements an entity must meet to
operate a PACE program under
Medicare and Medicaid.
There are 141 PACE organizations
nationally. These organizations serve
approximately 52,000 participants, all
in need of the comprehensive services
provided by PACE organizations. Due to
their health status, PACE participants
are at high risk of severe COVID–19 and
as such have been among the
populations prioritized for vaccination
since the vaccines were authorized.
Participants’ regular interactions with
PACE organization staff and contractors
indicate that those staff and contractors
should also be vaccinated against
COVID–19.
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding new regulatory requirements at
§ 460.74(d) related to establishing and
implementing policies and procedures
for COVID–19 vaccination of all staff
(includes employees; licensed
practitioner; students, trainees, and
volunteers; and other individuals) who
provide care, treatment, or other
services on behalf of a PACE
organization.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule before the provisions
of the rule take effect, in accordance
with the Administrative Procedure Act
(APA), 5 U.S.C. 553, and section 1871
of the Act. Specifically, section 553(b) of
the APA requires the agency to publish
a notice of the proposed rule in the
Federal Register that includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substance of the proposed
rule or a description of the subjects and
issues involved. Section 553(c) further
requires the agency to give interested
parties the opportunity to participate in
the rulemaking through public comment
before the provisions of the rule take
effect. Similarly, section 1871(b)(1) of
the Act requires the Secretary to provide
for notice of the proposed rule in the
Federal Register and a period of not less
than 60 days for public comment.
Section 553(b)(B) of the APA and
section 1871(b)(2)(C) of the Act
authorize the agency to waive these
procedures, however, if the agency finds
good cause that notice and comment
procedures are impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
The 2021 outbreaks associated with
the SARS–Cov–2 Delta variant have
shown that current levels of COVID–19
vaccination coverage up until now have
been inadequate to protect health care
consumers and staff. The data showing
the vital importance of vaccination
indicate to us that we cannot delay
taking this action in order to protect the
health and safety of millions of people
receiving critical health care services,
the workers providing care, and our
fellow citizens living and working in
communities across the nation.
Although section 564 of the FDCA
does not prohibit public or private
entities from imposing vaccination
requirements, even when the only
vaccines available are those authorized
under EUAs (https://www.justice.gov/
olc/file/1415446/download), CMS
initially chose, among other actions, to
encourage rather than mandate
vaccination, believing that a
combination of other Federal actions, a
variety of public education campaigns,
and State and employer-based efforts
would be adequate. However, despite all
of these efforts, including CMS’s
mandate for vaccination education and
offering of vaccines to LTC facility and
ICF–IID staff, residents, and clients (86
FR 26306), OSHA’s June 21, 2021 ETS
to protect health care and health care
support service workers from
occupational exposure to COVID–19 (86
FR 3276), and ongoing CDC information
and encouragement, vaccine uptake
among health care staff has not been as
robust as hoped for and have been
insufficient to protect the health and
safety of individuals receiving health
care services from Medicare- and
Medicaid-certified providers and
suppliers, particularly given the advent
of the Delta variant and the potential for
new variants.
As discussed throughout the preamble
of this IFC, the PHE continues to strain
the U.S. health care system. Over the
first 6 months of 2021, COVID–19 cases,
hospitalizations and deaths declined.
The emergence of the Delta variant
reversed these trends.180 Between late
June 2021 and September 2021, daily
cases of COVID–19 increased over 1200
percent; new hospital admissions, over
600 percent; and daily deaths, by nearly
800 percent.181 Available data also
continue to suggest that the majority of
COVID–19 cases and hospitalizations
are occurring among individuals who
are not fully vaccinated. From January
through May 2021, of the more than
32,000 laboratory-confirmed COVID–19-
associated hospitalizations in adults
over 18 years of age for whom
vaccination status is known, less than 3
percent of hospitalizations occurred in
fully vaccinated persons.182 More
recently published data continue to
suggest that fully vaccinated persons
account for a minority (∼10 percent) of
COVID–19 related hospitalizations.183
For all adults aged 18 years and older,
the cumulative COVID–19-associated
hospitalization rate was about 12-times
higher in unvaccinated persons.184
Consequently, some hospitals and
health care systems are currently
experiencing tremendous strain due to
high case volume coupled with
persistent staffing shortages due, at least
in part, to COVID–19 infection or
quarantine following exposure.
We recognize that newly reported
COVID–19 cases, hospitalizations, and
deaths have begun to trend downward
at a national level; nonetheless, they
remain substantially elevated relative to
numbers seen in May and June 2021,
when the Delta variant became the
predominant strain circulating in the
U.S.185 And while cases are trending
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186 https://www.cdc.gov/flu/professionals/acip/
background-epidemiology.htm.
187 Ibid.
188 CDC. FluView. Weekly influenza surveillance
report. Atlanta, GA: U.S. Department of Health and
Human Services, CDC. Accessed February 11, 2021.
https://www.cdc.gov/flu/weekly/index.htm.
189 https://www.medrxiv.org/content/10.1101/
2021.08.29.21262803v1.
190 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7029a1.htm.
191 https://academic.oup.com/cid/article/72/12/
e993/6024509?login=true.
192 https://onlinelibrary.wiley.com/doi/epdf/
10.1002/jmv.26163.
193 https://www.cdc.gov/flu/about/season/flu-
season.htm.
194 Ibid.
195 https://www.aamc.org/news-insights/press-
releases/major-health-care-professional-
organizations-call-covid-19-vaccine-mandates-all-
health-workers. Accessed 10/06/2021.
196 https://www.kff.org/coronavirus-covid-19/poll-
finding/kff-covid-19-vaccine-monitor-september-
2021/. Accessed 10/06/2021.
downward in some states, there are
emerging indications of potential
increases in others—particularly
northern states where the weather has
begun to turn colder. This is not
surprising: Respiratory virus infections
typically circulate more frequently
during the winter months, with peaks in
pneumonia and influenza deaths
typically during winter months.186
Similarly, the U.S. experienced a large
COVID–19 wave in the winter of 2020.
Approximately 1 in 3 people 12 years of
age and older in the U.S. remain
unvaccinated—and they could pose a
threat to the country’s progress on the
COVID–19 pandemic, potentially
incurring a fifth wave of COVID–19
infections.187
The onset of the 2021–2022 influenza
season presents an additional threat to
patient health and safety. Although
influenza activity during the 2020–2021
season was low throughout the U.S.,188
the intensity of the upcoming 2021–
2022 influenza season cannot be
predicted. Several factors could make
this flu season more severe; these
include return to school by children
with no prior exposure to flu (and
therefor lower immunity), waning
protection over time from previous
seasonal influenza vaccination, and the
fact that adult immunity (especially
among those who were not vaccinated
last season) will now partly depend on
exposure to viruses two or more seasons
earlier.189 190 COVID–19 vaccination
thus remains an important tool for
decreasing stress on the U.S. health care
system during ongoing circulation of
influenza. As previously noted, health
system strain can adversely impact
patient access to care and care quality.
Furthermore, data on the health
consequences of coinfection with
influenza and SARS–CoV–2 are limited.
Preliminary evidence suggests that a
combination of infections with
influenza and SARS–CoV–2 would
result in more severe health outcomes
for patients than either infection
alone.191 192 193 However, COVID–19 is
more infectious and has greater rates of
mortality, hospitalizations, and severe
illness than influenza. Accordingly, it is
imperative that the risk for healthcare-
associated COVID–19 transmission be
minimized during the influenza season.
Influenza is most common during the
fall and winter with the highest
incidence of cases reported between
December through March.194 COVID–19
vaccines require time after
administration for the body to build an
immune response. Hence, given that the
influenza season is imminent, a staff
COVID–19 vaccination requirement for
the providers and suppliers identified in
this rule cannot be further delayed. The
impact of unvaccinated populations on
the health-care system and the
inconsistent web of State, local, and
employer COVID–19 vaccination
requirements have established a
pressing need for a consistent Federal
policy mandating staff vaccination in
health care settings that receive
Medicare and Medicaid funds. The
current patchwork of regulations
undermines the efficacy of COVID–19
vaccine mandates by encouraging
unvaccinated workers to seek
employment at providers that do not
have such patient protections,
exacerbating staffing shortages, and
creating disparities in care across
populations. This includes workers
moving between various types of
providers, such as from LTC facilities to
HHAs and others, creating imbalances.
As discussed in section I. of this IFC, we
have received numerous requests from
diverse stakeholders for Federal
intervention to implement a health-care
staff vaccine mandate.195 Of particular
note, several representatives of the long-
term care community (not limited to
Medicare- and Medicaid-certified LTC
facilities) expressed concerns about
inequities that would result from
imposition of a mandate on only one
type of provider and strongly
recommended a broad approach.196
While there is opposition to the vaccine
mandate, a combination of factors now
have persuaded us that a vaccine
mandate for health care workers is an
essential component of the nation’s
COVID–19 response, the delay of which
would contribute to additional negative
health outcomes for patients including
loss of life. These include, but are not
limited to, the following: Failure to
achieve sufficiently high levels of
vaccination based on voluntary efforts
and patchwork requirements; ongoing
risk of new COVID–19 variants;
potential harmful impact of
unvaccinated healthcare workers on
patients; continuing strain on the health
care system, particularly from Delta-
variant-driven surging case counts
beginning in summer 2021;
demonstrated efficacy, safety and real-
world effectiveness of available
vaccines; FDA’s full licensure of the
Pfizer-BioNTech’s Comirnaty vaccine;
our observations of the efficacy of
COVID–19 vaccine mandates in other
settings; and the calls from numerous
stakeholders for Federal intervention.
Moreover, a further delay in imposing a
vaccine mandate would endanger the
health and safety of additional patients
and be contrary to the public interest.
We note that health care workers were
among the first groups provided access
to vaccinations, which were initially
authorized for emergency use. EUA
status may have been a factor in some
individual decisions to delay or refuse
vaccination. The Pfizer-BioNTech
COVID–19 vaccine was first authorized
for emergency use on December 11,
2020. The vaccine continues to be
available in the U.S. under EUA, and
the EUA was subsequently amended to
include use in individuals 12 through
15 years of age, to allow for the use of
an additional dose in the primary series
for certain immunocompromised
individuals, and to allow for use of a
single booster dose to be administered at
least 6 months after completion of the
primary series in certain individuals.
FDA has issued EUAs for two additional
vaccines for the prevention of COVID–
19, one to Moderna (December 18, 2020)
(indicated for use by individuals 18
years of age and older), and the other to
Janssen (Johnson & Johnson) (February
27, 2021) (indicated for use by
individuals 18 years of age and older).
Fact sheets for health care providers
administering vaccine are available for
each vaccine product from FDA.
However, on August 23, 2021, FDA
licensed Pfizer-BioNTech’s Comirnaty
Vaccine. Health care workers whose
hesitancy was related to EUA status
now have a fully licensed COVID–19
vaccine option. Despite this, as noted
earlier, health care staff vaccination
rates remain sub-optimal in too many
health care facilities and regions. For
example, national COVID–19
vaccination rates for LTC facility,
hospital, and ESRD facility staff are 67
percent, 64 percent, and 60 percent,
respectively. Moreover, these averages
obscure sizeable regional differences.
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197 LTC facility rates derived from data reported
through CDC’s NHSN and posted online at the
Nursing Home COVID–19 Vaccination Data
Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-
vaccination-dashboard.html; accessed September
15, 2021.
198 Dialysis facility rates derived from data
reported through CDC’s NHSN and posted online at
the Dialysis COVID–19 Vaccination Data
Dashboard: https://www.cdc.gov/nhsn/covid19/
dial-vaccination-dashboard.html; accessed
September 15, 2021.
199 Hospital data come from unpublished analyses
of data reported to HHS and posted on HHS Protect.
200 https://covid.cdc.gov/covid-data-tracker/
#health-care-personnel; accessed September 24,
2021.
201 Analysis of dialysis facility and nursing home
data reported through NHSN.
202 Ibid. 110.
203 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html.
204 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7037e1.htm?s_cid=mm7037e1_w.
205 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7034e4.htm?s_cid=mm7034e4_w.
206 https://emergency.cdc.gov/han/2021/
han00447.asp.
207 COVID–19 Outbreak Associated with a SARS–
CoV–2 R.1 Lineage Variant in a Skilled Nursing
Facility After Vaccination Program—Kentucky,
March 2021.’’ April 21, 2021. Available at https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7017e2.htm.
208 Postvaccination SARS–CoV–2 Infections
Among Skilled Nursing Facility Residents and Staff
Members—Chicago, Illinois, December 2020–March
2021.’’ April 30, 2021. Available at https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7017e1.htm.
209 Effectiveness of the Pfizer-BioNTech COVID–
19 Vaccine Among Residents of Two Skilled
Nursing Facilities Experiencing COVID–19
Outbreaks—Connecticut, December 2020–February
2021.’’ March 19, 2021. Available at https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7011e3.htm.
210 Klompas M, Baker MA, Griesbach D, et al.
Transmission of SARS–CoV–2 from asymptomatic
and presymptomatic individuals in healthcare
settings despite medical masks and eye protection.
Clin Infect Dis. 2021. [PMID: 33704451]
doi:10.1093/cid/ciab218.
211 https://www.medrxiv.org/content/10.1101/
2021.02.16.21251625v1.
212 https://jamanetwork.com/journals/jama/
fullarticle/2773128.
213 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC8349432/.
214 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html.
215 https://aspe.hhs.gov/sites/default/files/
documents/c5d0dde224c224dd726694367846b609/
aspe-covid-medicare-vaccine-analysis.pdf.
Accessed 10/06/2021.
216 https://www.nejm.org/doi/full/10.1056/
nejmoa2108891.
217 https://www.mayoclinic.org/coronavirus-
covid-19/covid-variant-vaccine.
218 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7034e4.htm?s_cid=mm7034e4_w.
219 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-
people.html#ref43.
LTC facility staff vaccination rates range
from lows of 56 percent to highs of over
90 percent, depending upon the State.
Similar patterns hold for ESRD facility
and hospital staff.197 198 199
Over half a million COVID–19 cases
and 1,900 deaths among health care staff
have been reported to CDC since the
start of the PHE.200 When submitting
case-level COVID–19 reports, State and
territorial jurisdictions may identify
whether individuals are or are not
health care workers. Since health care
worker status has only been reported for
a minority of cases (approximately 18
percent), these numbers are likely gross
underestimates of true burden in this
population. COVID–19 case rates among
staff have also grown in tandem with
broader national incidence trends since
the Delta variant’s emergence. For
example, as of mid-September 2021,
COVID–19 cases among LTC facility and
ESRD facility staff have increased by
over 1400 percent and 850 percent,
respectively, since their lows in June
2021.201 Similarly, the number of cases
among staff for whom case-level data
were reported by State and territorial
jurisdictions to CDC increased by nearly
600 percent between June and August
2021.202 Because they are at greater risk
for developing COVID–19 infection and
severe disease,203 204 205 unvaccinated
staff present a risk of exacerbating
ongoing staffing shortages—particularly
during periods of community surges in
SARS–CoV–2 infection, when demand
for health care services is most acute.
Health care staff who remain
unvaccinated may also pose a direct
threat to patient, resident, workplace,
family, and community safety and
population health. Data from CDC’s
National Healthcare Safety Network
(NHSN) have shown that case rates
among LTC facility residents are higher
in facilities with lower vaccination
coverage among staff; specifically,
residents of LTC facilities in which
vaccination coverage of staff is 75
percent or lower experience higher
crude rates of preventable SARS–CoV–
2 infection.206 Similarly, several articles
published in CDC’s Morbidity and
Mortality Weekly Reports (MMWRs)
regarding nursing home outbreaks have
also linked the spread of COVID–19
infection to unvaccinated health care
workers and stressed that maintaining a
high vaccination rate is important for
reducing transmission.207 208 209 And
multiple studies have demonstrated
SARS–CoV–2 transmissions between
health-care workers and patients in
hospitals, despite universal masking
and other protocols.210 211 212 213 Acute
and LTC facilities engage many, if not
all, of the same health care professionals
and support services of other provider
and supplier types. As a result, while
similarly comprehensive data are not
available for all Medicare- and
Medicaid-certified provider and
supplier types, we believe the LTC
facilities experience may generally be
extrapolated to other settings.
The efficacy of COVID–19
vaccinations has been demonstrated.214
An ASPE report published on October 5,
2021, found that COVID–19 vaccines are
a key component in controlling the
COVID–19 pandemic. Clinical data
show vaccines are highly effective in
preventing COVID–19 cases and severe
outcomes including hospitalization and
death. The ASPE analysis of individual-
level health data and county-level
vaccination rates found that higher
county vaccination rates were
associated with significant reductions in
the odds of COVID–19 infection,
hospitalization, and death among
Medicare fee-for-service (FFS)
beneficiaries between January and May
2021. Further, comparing the rates of
these outcomes to what ASPE modeling
predicted would have happened
without any vaccinations, we estimate
COVID–19 vaccinations were linked to
estimated reductions of approximately
107,000 infections, 43,000
hospitalizations, and 16,000 deaths in
our study sample of 25.3 million
beneficiaries. The report also noted that
the difference in vaccination rates for
those age 65 and older between the
lowest (34 percent) and highest (85
percent) counties and states by the end
of May highlights the continued
opportunity to leverage COVID–19
vaccinations to prevent COVID–19
hospitalizations and deaths.215 Vaccines
continue to be effective in preventing
COVID–19 associated with the now-
dominant Delta variant.216 217
In addition to preventing morbidity
and mortality associated with COVID–
19, the vaccines also appear to be
effective against asymptomatic SARS–
CoV–2 infection. A recent study of
health care workers in 8 states found
that, between December 14, 2020,
through August 14, 2021, full
vaccination with COVID–19 vaccines
was 80 percent effective in preventing
RT–PCR–confirmed SARS–CoV–2
infection among frontline workers.218
Emerging evidence also suggests that
vaccinated people who become infected
with Delta have potential to be less
infectious than infected unvaccinated
people, thus decreasing transmission
risk.219 For example, in a study of
breakthrough infections among health
care workers in the Netherlands, SARS–
CoV–2 infectious virus shedding was
lower among vaccinated individuals
with breakthrough infections than
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220 https://www.medrxiv.org/content/10.1101/
2021.08.20.21262158v1.full.pdf.
221 BLS. May 2020 National Occupational
Employment and Wage Estimates United States.
United States Department of Labor. Accessed at
https://www.bls.gov/oes/current/oes_nat.htm.
Accessed on August 25, 2021.
among unvaccinated individuals with
primary infections.220
As noted earlier in this section, a
combination of factors, including but
not limited to failure to achieve
sufficiently high levels of vaccination
based on voluntary efforts and
patchwork requirements, potential harm
to patients from unvaccinated health-
care workers, and continuing strain on
the health care system and known
efficacy and safety of available vaccines,
have persuaded us that a vaccine
mandate for health care workers is an
essential component of the nation’s
COVID–19 response. Further, it would
endanger the health and safety of
patients, and be contrary to the public
interest to delay imposing it. Therefore,
we believe it would be impracticable
and contrary to the public interest for us
to undertake normal notice and
comment procedures and to thereby
delay the effective date of this IFC. We
find good cause to waive notice of
proposed rulemaking under the APA, 5
U.S.C. 553(b)(B), and section
1871(b)(2)(C) of the Act. For those same
reasons, as authorized by the Small
Business Regulatory Enforcement
Fairness Act of 1996 (the Congressional
Review Act or CRA), 5 U.S.C. 808(2), we
find it is impracticable and contrary to
the public interest not to waive the
delay in effective date of this IFC under
section 801 of the CRA. Therefore, we
find there is good cause to waive the
CRA’s delay in effective date pursuant
to section 808(2) of the CRA.
IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA), we are required to
provide 30-day notice in the Federal
Register and solicit public comment
before a collection of information
requirement (ICR) is submitted to the
Office of Management and Budget
(OMB) for review and approval. The
ICRs in this section will be included in
an emergency revision of the
information collection request currently
approved under the appropriate OMB
Control number. All PRA-related
comments received in response to this
IFC will be reviewed and addressed in
a subsequent, non-emergency,
submission of the information collection
request. The emergency approval is only
valid for 6 months. Within that 6-month
approval period, CMS will seek a
regular, non-emergency, approval and as
required by the PRA, this action will be
announced in the requisite 60-day and
30-day Federal Register notices.
In order to fairly evaluate whether an
information collection should be
approved by OMB, section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995
requires that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements
(ICRs):
For the estimated costs contained in
the analysis below, we used data from
the U.S. Bureau of Labor Statistics (BLS)
to determine the mean hourly wage for
the positions used in this analysis.221
For the total hourly cost, we doubled
the mean hourly wage for a 100 percent
increase to cover overhead and fringe
benefits, according to standard HHS
estimating procedures. If the total cost
after doubling resulted in 0.50 or more,
the cost was rounded up to the next
dollar. If it was 0.49 or below, the total
cost was rounded down to the next
dollar. The total costs used in this
analysis are indicated in Table 3.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
In this analysis, we used specific
resources to estimate the burden for the
providers and suppliers in this rule.
Based upon our experience, there are
minimal fluctuations in the numbers of
providers and suppliers monthly. Thus,
unless otherwise indicated, all of the
numbers for the providers and suppliers
in this analysis were located on
September 1, 2021 on the Quality,
Certification & Oversight Reports
(QCOR) website at https://qcor.cms.gov/
main.jsp. For the number of employees
for each provider and supplier, those
numbers were obtained from Table 5:
Estimates of Number of Staff by Type of
Provider (thousands) located in section
VI.B. of this IFC.
This analysis is also based upon
certain assumptions. We believe that
many of the providers and suppliers
covered in this rule have already either
encouraged their employees to get
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vaccinated for COVID–19 or have
mandates for the vaccine. Mandates for
employees to be vaccinated for COVID–
19 can result from State, county, or local
actions or result from a decision by the
facility. These facilities would likely
have already developed policies and
procedures, as well as documentation
requirements, related to their employees
being vaccinated for COVID–19.
However, we have no reliable method to
estimate the number or percentage of
these facilities. In addition, it is likely
that those facilities would not comply
with all of the requirements in this rule.
For example, many facilities might not
define ‘‘employees’’ as set forth in this
rule. Each facility would have to review
its policies, procedures, and
documentation requirements to ensure
that they comply with the requirements
in this rule. Hence, based upon these
assumptions, this analysis will assess
the burden for all facilities and
employees for each provider and
supplier type.
We also made some assumption
regarding analysis of the burden for the
documentation requirements. If an
employee receives the appropriate
vaccinations, reviewing and
documenting that the employee has
been vaccinated would likely only
require 1 to 3 minutes, depending upon
how the facility is documenting the
vaccination, which is likely to vary
substantially between facilities.
However, for employees that request
exemptions or have to be contacted
repeatedly for the appropriate
documentation, it would likely take
more time to comply with this
requirement. At a minimum, both the
initial request for the exemption and the
final determination would have to be
documented. In cases where the
exemption was denied and the
employee receives the appropriate
vaccinations, those vaccine doses would
also have to be documented. There
might also be additional documentation
that would need to be copied or scanned
for their records. While the
documentation for employees
requesting an exemption would require
more burden, we believe that there
would only be a small percentage of
employees that would request an
exemption. Since we have no reliable
method for estimating a number or
percentage of employees who would be
in each category, we will analyze the
burden for the documentation
requirements using 5 minutes or 0.0833
hours for each employee.
The position of the individual who
would perform the activities related to
the documentation requirement would
also vary depending upon the type of
provider or supplier and whether the
employee requested an exemption. If the
employee has been vaccinated in
compliance with this rule, an
administrative support person might
review their vaccination card and
document that the employee has been
vaccinated. However, if an
administrative support person performs
these activities, we believe an
administrator or another member of the
health care staff would be responsible
for overseeing these activities. For other
providers and suppliers, a nurse would
likely be assigned to verify and
document vaccination status. If an
employee requests an exemption, we
believe that a nurse, another health care
professional, or an administrator would
likely review the request and document
it. Some other providers or suppliers
might have an administrator or another
member of the health care staff perform
these activities. Thus, for this analysis,
if a provider is required to have at least
one infection preventionist (IP), such as
hospitals, we believe the IP would be
responsible for documenting the
vaccination status for all employees. For
other providers and suppliers, we
assessed the burden using a registered
nurse (RN), another member of the
health care staff, such as a physical
therapist, or an administrator.
The estimates that follow are largely
based on our experience with these
various providers. However, given the
uncertainty and rapidly changing nature
of the current pandemic, we
acknowledge that there will likely need
to be revisions to these requirements
over time. We welcome comments that
might improve these estimates.
A. ICRs Regarding the of Development
of Policies and Procedures for ASCs
§ 416.51(c), ‘‘COVID–19 Vaccination of
Staff’’
1. Policies and Procedures
At § 416.51(c), we require ASCs to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and track and
maintain documentation of their
vaccination status. Each ASC must also
have a contingency plan for any staff
that are not fully vaccinated according
to this rule.
The ICRs for this section would
require each ASC to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Based upon our experience
with ASCs, we believe some centers
have already developed policies and
procedures requiring COVID–19
vaccination for staff. However, each
ASC will need to review their current
policies and procedures and modify
them, if necessary, to ensure compliance
with the requirements in this IFC,
especially that their policies and
procedures cover all of the center staff
as identified in this IFC. Hence, we will
base our estimate for this ICR on all
6,071 ASCs. We believe activities
associated with this IFC would be
performed by the RN functioning as the
designated and qualified infection
control professional (ICP) and ASC
administrator as analyzed below.
The ICP would conduct research and
then either modify or develop the
policies and procedures needed to
comply with this section’s
requirements. The ICP would work with
the ASC administrator in developing
these policies and procedures. For the
ICP, we estimate this would require 8
hours initially to perform research and
revise or develop the policies and
procedures to meet these requirements.
According to Table 3, the ICP’s total
hourly cost is $77. Thus, for each ASC,
the burden for the ICP would be 8 hours
at a cost of $616 (8 × $77). For the ICPs
in all 6,071 ASCs, the burden would be
48,568 hours (8 × 6,071) at an estimated
cost of $3,739,736 ($616 × 6,071).
As discussed above, the revision and
approval of these initial policies and
procedures would also require activities
by the ASC administrator. The
administrator would need to have
meetings with the ICP to discuss the
revisions and approve the final policies
and procedures. We estimate this would
require 2 hours for the administrator.
According to Table 3, the total hourly
cost for the administrator is $98. The
burden for the administrator in each
ASC would be 2 hours at an estimated
cost of $196 (2 × $98). For the
administrators in all 6,071 ASCs, the
burden would be 12,142 hours (2 ×
6,071) at an estimated cost of $1,189,916
($196 × 6,071).
Therefore, for all 6,071 ASCs, the
estimated burden associated with the
requirement for policies and procedures
would be 67,010 hours (48,568 +
12,142) at a cost of $4,929,652
($3,739,736 + $1,189,916).
2. Documentation and Storage
Section 416.51(c) also requires ASCs
to track and securely maintain the
required documentation of staff COVID–
19 vaccination status. Any burden for
modifying the center’s policies and
procedures for these activities is already
accounted for above. We believe that
this would require an RN 5 minutes or
0.0833 hours to perform the required
documentation an adjusted hourly wage
of $77 for each employee. According to
Table 3, ASCs have 200,000 employees.
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Hence, the burden for these
documentation requirements for all
6,071 ASCs would be 16,660 (0.0833 ×
200,000) hours at an estimated cost of
$1,282,820 (16,660 × $77).
The total burden for all 6,071 ASCs
for this IFC would be 83,670 (67,010 +
16,660) hours at an estimated cost of
$6,212,472 ($4,929,652 + $1,282,820).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–0266 (expiration date July
31, 2024).
B. ICRs Regarding the Development of
Policies and Procedures for Hospices
§ 418.60(d), ‘‘COVID–19 Vaccination of
Facility Staff’’
1. Policies and Procedures
At § 418.60(d), we require hospices to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. The hospice must also have
a contingency plan for all staff not fully
vaccinated according to this rule.
The ICRs for this section would
require each hospice to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations are set forth
at § 418.60 Condition of participation:
Infection control, and require each
hospice to maintain and document an
infection control program to prevent
and control infections and
communicable diseases. The hospice
must also follow accepted standards of
practice, including the use of standard
precautions to prevent the transmission
of infections and communicable
diseases. Thus, all hospices should
already have infection prevention and
control policies and procedures, but
they likely do not comply with all of the
requirements in this IFC.
All hospices would need to review
their current policies and procedures
and modify them to comply with all of
the requirements in § 418.60(d) as set
forth in this IFC. While we believe that
many hospices have already addressed
COVID–19 vaccination with their staff,
we have no reliable means to estimate
that number. Therefore, we will assess
the burden for these requirements for all
5,556 hospices. We believe these
activities would be performed by the RN
and an administrator. According to
Table 3, an RN in these settings has a
total hourly cost of $79. Since there are
not any current requirements that
address COVID–19 vaccination, we
estimate it would require 8 hours for the
RN to research, draft, and work with an
administrator to finalize the policies
and procedures. Thus, for each hospice,
the burden for the RN would be 8 hours
at a cost of $632 (8 hours × $79). For all
5,556 hospices, the burden would be
44,448 hours (8 hours × 5,556) at an
estimated cost of $3,511,392 ($632 ×
5,556).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator in this
setting is $122. Hence, for each hospice,
the burden would be 2 hours at an
estimated cost of $244 (2 × $122). For all
5,556 hospices, the total burden would
be 11,112 hours (2 × 5,556) at an
estimated cost of $1,355,664 (5,556 ×
$244).
Thus, the total burden for hospices to
comply with the requirements for
policies and procedures in this IFC is
55,560 hours (44,448 + 11,112) at an
estimated cost of $4,867,056 ($3,511,392
+ $1,355,664).
2. Documentation and Storage
Section 418.60(d) also requires
hospices to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the hospice’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require an
RN 5 minutes or 0.0833 hours to
perform the required documentation an
adjusted hourly wage of $79 for each
employee. According to Table 3,
hospices have 340,000 employees.
Hence, the burden for these
documentation requirements for all
5,556 hospices would be 28,322 (0.0833
× 340,000) hours at an estimated cost of
$2,237,438 (28,322 × 79).
Therefore, the total burden for all
5,556 hospices for this rule would be
83,882 (55,560 + 28,322) hours at an
estimated cost of $7,104,494 (4,867,056
+ 2,237,438).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1067 (expiration date
March 31, 2024).
C. ICRs Regarding the Development of
Policies and Procedures for PACE
Organizations § 460.74(d), ‘‘COVID–19
Vaccination of PACE Organization
Staff’’
1. Policies and Procedures
Section 460.74(d) requires that
programs for all-inclusive care for the
elderly (PACE) organizations to develop
and implement policies and procedures
to ensure their staff are vaccinated for
COVID–19 and that appropriate
documentation of those vaccinations are
tracked and maintained. Each PACE
organization must also have a
contingency plan for all staff not fully
vaccinated according to this rule.
The ICRs for this section would
require each PACE organization to
develop the policies and procedures
needed to satisfy all of the requirements
in this section. Current regulations at
§ 460.74 already require that each PACE
organization follow accepted policies
and standard procedures with respect to
infection control in place. Thus, all
PACE organizations should have
policies and procedures regarding
infection prevention and control. We
also believe that many have already
addressed COVID–19 vaccination
policies for their staff. However, since
we do not have a reliable method to
estimate how many have, we will assess
the burden for all 141 PACE
organizations.
All PACE organizations would need
to review their current infection
prevention and control policies and
procedures and develop or modify them
to satisfy the requirements in this
section. We believe these activities
would require an RN and an
administrator. According to Table 3, an
RN’s total hourly cost is $74. Since there
are not any current requirements that
address COVID–19 vaccination, we
estimate it would require 8 hours for the
RN to research, draft, and work with an
administrator to finalize the policies
and procedures. Thus, for each PACE
organization, the burden for the RN
would be 8 hours at a cost of $592 (8
hours × $74). For all 141 PACE
organizations, the burden would be
1,128 hours (8 hours × 141) at an
estimated cost of $83,472 (592 × 141).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator is
$122. Hence, for each PACE
organization, the burden would be 2
hours at an estimated cost of $244 (2 ×
122). For all 141 PACE organizations,
the total burden would be 282 hours (2
× 141) at an estimated cost of $34,404
(141 × $244).
Thus, the total burden for all 141
PACE organizations to comply with the
requirements for the policies and
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procedures is 1,410 hours (1,128 + 282)
at an estimated cost of $117,876 (83,472
+ 34,404).
2. Documentation and Storage
Section 460.74(d) also requires PACE
organizations to track and securely
maintain the required documentation of
staff COVID–19 vaccination status. Any
burden for modifying the PACE
organization’s policies and procedures
for these activities is already accounted
for above. We believe that this would
require an RN 5 minutes or 0.0833 hours
to perform the required documentation
an adjusted hourly wage of $74 for each
employee. According to Table 3, PACE
organizations have 10,000 employees.
Hence, the burden for these
documentation requirements for all 141
PACE organizations would be 833
(0.0833 × 10,000) hours at an estimated
cost of $61,642 (833 × 74).
Therefore, the total burden for all 141
PACE organizations for this rule would
be 2,243 (1,410 + 833) hours at an
estimated cost of $179,518 (117,876 +
61,642).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1326 (expiration date
April 20, 2023).
D. ICRs Regarding the Development of
Policies and Procedures for Hospitals
§ 482.42(g), ‘‘COVID–19 Vaccination of
Hospital Staff’’
1. Policies and Procedures
At § 482.42(g), we require hospitals to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. The hospital must also have
a contingency plan for all staff not fully
vaccinated according to this rule.
The ICRs for this section would
require each hospital to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at § 482.42
Condition of participation: Infection
prevention and control and antibiotic
stewardship programs already require
hospitals to have an infection
prevention and control program (IPCP)
and an infection preventionist (IP). The
IPCP must have methods to prevent and
control the transmission of infection
within the hospital and between the
hospital and other settings. Thus, all
5,194 hospitals should already have
infection prevention and control
policies and procedures. However, each
hospital would need to review their
current policies and procedures and
modify them, if necessary, to ensure
compliance with all of the requirements
in this IFC, especially that their policies
and procedures cover all of the eligible
facility staff identified in this IFC. Based
upon our experience with hospitals, we
believe many hospitals have already
developed policies and procedures
requiring COVID–19 vaccination for
staff. Since we have no reliable means
to estimate the number of hospitals that
may have already addressed COVID–19
vaccination of their staff, we will base
our estimate for these requirements on
all 5,194 hospitals.
We believe these activities would be
performed by the IP, the director of
nursing (DON), and an administrator.
The IP would need to research COVID–
19 vaccines, modify the policies and
procedures, as necessary, and work with
the DON and administrator to develop
the policies and procedures and obtain
appropriate approval. For the IP, we
estimate these activities would require 8
hours. According to Table 3, the IP’s
total hourly cost is $79. Thus, for each
hospital, the burden for the IP would be
8 hours at a cost of $632 (8 hours × 79).
For the IPs in all 5,194 hospitals, the
burden would be 41,552 hours (8 hours
× 5,194) at an estimated cost of
$3,282,608 (632 × 5,194).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by the DON and an administrator. We
believe these activities would require 2
hours each for the DON and an
administrator. According to Table 3, the
total adjusted hourly wage for both the
DON and an administrator is $122.
Hence, for each hospital, the burden
would be 4 hours (2 × 2) at an estimated
cost of $488 (4 × $122). The total burden
for all 5,194 hospitals would be 20,776
hours (4 × 5,194) at an estimated cost of
$2,534,672 (5,194 × 488).
Therefore, for all 5,194 hospitals, the
total burden for the requirements for
policies and procedures is 62,328 hours
(41,552 + 20,776) at an estimated cost of
$5,817,280 (3,282,608 + 2,534,672).
2. Documentation and Storage
Section 482.42(g) also requires
hospitals to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the hospital’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require an
RN 5 minutes or 0.0833 hours to
perform the required documentation an
adjusted hourly wage of $79 for each
employee. According to Table 3,
hospitals have 6,070,000 employees. We
could not locate a reliable number for
critical access hospital (CAH)
employees so they are included here
with the hospital employees. Hence, the
burden for these documentation
requirements for all 5,194 hospital and
1,358 CAHs would be 505,631 (0.0833 ×
6,070,000) hours at an estimated cost of
$39,944,849 (505,631 × 79).
Therefore, the total burden for this
rule for all 5,194 hospitals and 1,358
CAHs (documentation burden only)
would be 567,959 (62,328 + 505,631)
hours at an estimated cost of
$45,762,129 (5,817,280 + 39,944,849).
The requirements and burden will be
submitted to OMB as an emergency
reinstatement of an existing OMB
control number 0938–0328.
E. ICRs Regarding the Development of
Policies and Procedures for LTC
Facilities § 483.80(i), ‘‘COVID–19
Vaccination of Facility Staff’’
1. Policies and Procedures
At § 483.80(i), we require LTC
facilities to develop and implement
policies and procedures to ensure their
staff are vaccinated for COVID–19 and
that appropriate documentation of those
vaccinations are tracked and
maintained. The LTC facility must also
have a contingency plan for all staff not
fully vaccinated according to this rule.
The ICRs for this section would
require each LTC facility to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at
§ 483.80(d)(1) and (2) already require
LTC facilities to have policies and
procedures to educate, offer, and
document vaccination status for
residents regarding the influenza and
pneumococcal immunizations. In
addition, § 483.80(d)(3) requires LTC
facilities to educate, offer, and
document the vaccination status for
residents and staff for the COVID–19
immunizations. Based upon our
experience with LTC facilities, we
believe some facilities have already
developed policies and procedures
requiring COVID–19 vaccination for
staff, including COVID–19 vaccine
mandates. However, we have no reliable
means to estimate the number or
percentage of LTC facilities that have
already mandated vaccination. Hence,
we will base our estimate for this ICR
on all 15,401 LTC facilities.
Each LTC facility would need to
review its policies and procedures for
§ 483.80(d) and modify them to comply
with the requirements in this rule at
§ 483.80(i) and obtain the appropriate
review and approval. This would
require conducting research and
revising the policies and procedures as
needed. We believe these activities
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would be performed by the infection
preventionist (IP), director of nursing
(DON), and medical director for the first
year and the IP in subsequent years as
analyzed below.
The IP would need to work with the
DON and medical director to revise and
finalize the policies and procedures. For
the IP, we estimate this would require
2 hours initially to perform research and
revise the policies and procedures to
meet these requirements. According to
Table 3, the IP’s total hourly cost is $69.
Thus, for each LTC facility, the burden
for the IP would be 2 hours at a cost of
$138 (2 hours × 69). For the IPs in all
15,401 LTC facilities, the burden would
be 30,802 hours (2 hours × 15,401
facilities) at an estimated cost of
$2,125,338 (138 × 15,401).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by the DON and medical director. Both
the DON and medical director would
need to have meetings with the IP to
discuss the revision, evaluation, and
approval of the policies and procedures.
We estimate this would require 1 hour
for both the DON and medical director.
According to Table 3, the total hourly
cost for the DON is $96. The burden in
the first year for the DON in each LTC
facility would be 1 hour at an estimated
cost of $96 (1 hour × 96). The burden
would be 15,401 hours (1 × 15,401) at
an estimated cost of $1,478,496 (96 ×
15,401) for all LTC facilities.
For the medical director, we have
estimated the revision of policies and
procedures would also require 1 hour.
According to the chart above, the total
hourly cost for the medical director is
$171. For each LTC facility, this would
require 1 hour for the medical director
during the first year at an estimated cost
of $171 (1 hour × $171). the burden for
all LTC facilities would be 15,401 hours
(1 × 15,401) at an estimated cost of
$2,633,571 (171 × 15,401).
Therefore, for all 15,401 LTC facilities
in the first year, the estimated burden
for the policies and procedures
requirement would be 61,604 hours
(30,802 + 15,401 + 15,401) at a cost of
$6,237,405 (2,125,338 + 1,478,496 +
2,633,571).
2. Documentation and Storage
Section 483.80(i) also requires LTC
facilities to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the facility’s
policies and procedures for these
activities is already accounted for above.
The PRA package submitted under OMB
Control No. 0938–1363 already provides
for the documentation burden for the IP
for the LTC facility’s infection
prevention and control program (IPCP)
under which the requirements in this
rule will also be located. We believe the
burden for the documentation
requirements in this rule should be
included in that burden. Therefore, we
will not assess any additional burden
for the documentation requirements in
this rule.
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1363 (expiration date
June 30, 2022).
F. ICRs Regarding the Development of
Policies and Procedures for PRTFs
§ 441.151(c), ‘‘COVID–19 Vaccination of
Facility Staff’’
1. Policies and Procedures
Section 441.151(c) requires
psychiatric residential treatment
facilities (PRTFs) to develop and
implement policies and procedures to
ensure their staff are vaccinated for
COVID–19 and that appropriate
documentation of those vaccinations are
tracked and maintained. The PRTF must
also have a contingency plan for all staff
not fully vaccinated according to this
rule.
The ICRs for this section would
require each PRTF to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations for PRTFs
do not address infection prevention and
control or vaccinations. Hence, although
we believe that at least some PRTFs
have already addressed COVID–19
vaccination of their staff, we will assess
the burden for all 357 PRTFs.
We believe these activities would be
performed by an RN and an
administrator. According to Table 3, an
RN’s total hourly cost is $74. Since there
are not any current requirements that
address COVID–19 vaccination, we
estimate it would require 8 hours for the
RN to research, draft, and work with an
administrator to finalize the policies
and procedures. Thus, for each PRTF,
the burden for the RN would be 8 hours
at a cost of $592 (8 hours × 74). For all
357 PRTFs, the burden would be 2,856
hours (8 hours × 357) at an estimated
cost of $211,344 (592 × 357).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator is
$122. Hence, for each PRTF, the burden
would be 2 hours at an estimated cost
of $244 (2 × 122). For all 357 PRTFs, the
total burden would be 714 hours (2 ×
357) at an estimated cost of $87,108 (357
× 244).
Thus, the total burden for all 357
PRTFs to comply with the policies and
procedures requirements in this IFC for
policies and procedures is 3,570 hours
(2,856 + 714) at an estimated cost of
$298,452 (211,344 + 87,108).
2. Documentation and Storage
Section 441.151(c) also requires
PRTFs to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the facility’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require an
RN 5 minutes or 0.0833 hours to
perform the required documentation an
adjusted hourly wage of $74 for each
employee. According to Table 3, PRTFs
have 30,000 employees. Hence, the
burden for these documentation
requirements for all 357 PRTFs would
be 2,499 (0.0833 × 30,000) hours at an
estimated cost of $184,926 (2,499 × 74).
Therefore, the total burden for all 357
PRTFs for this rule would be 6,069
(3,570 + 2,499) hours at an estimated
cost of $483,378 (298,452 + 184,926)
The requirements and burden will be
submitted to OMB under OMB control
number 0938–0833 (expiration date May
31, 2022).
G. ICRs Regarding the Development of
Policies and Procedures for ICFs-IID
§ 483.430(f), ‘‘COVID–19 Vaccination of
Facility Staff’’
1. Policies and Procedures
At § 483.430(f), we require ICFs-IID to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. The ICFs-IID must also
have a contingency plan for all staff not
fully vaccinated according to this rule.
The ICRs for this section would
require each ICFs-IID to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at
§ 483.470(l) Standard: Infection control
requires that the ICFs-IID must provide
a sanitary environment to avoid sources
and transmission of infections. The
facility must also implement successful
corrective action in affected problem
areas, maintain a record of incidents
and corrective actions related to
infections, and prohibit employees with
symptoms or sign of a communicable
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disease from direct contact with clients
and their food. Hence, ICFs-IID should
already have policies and procedures for
infection prevention and control.
We believe these activities would be
performed by the RN. According to
Table 3, an RN’s total hourly cost is $69.
Since there are not any current
requirements that address COVID–19
vaccination, we estimate it would
require 8 hours for the RN to research,
draft, and work with an administrator to
finalize the policies and procedures.
Thus, for each ICFs-IID, the burden for
the RN would be 8 hours at a cost of
$552 (8 hours × 69). For all 5,780 ICFs-
IID, the burden would be 46,240 hours
(8 hours × 5,780) at an estimated cost of
$3,190,560 (552 × 5,780).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator is $96.
Hence, for each ICFs-IID, the burden
would be 2 hours at an estimated cost
of $192 (2 × 96). For all 5,780 ICFs-IID,
the total burden would be 11,560 hours
(2 × 5,780) at an estimated cost of
$1,109,760 (5,780 × 192).
Thus, the total burden for all 5,780
ICFs-IID to comply with the
requirements for policies and
procedures is 57,800 hours (46,240 +
11,560) at an estimated cost of
$4,300,320 (3,190,560 + 1,109,760).
2. Documentation and Storage
Section 483.430(f) also requires ICFs-
IID to track and securely maintain the
required documentation of staff COVID–
19 vaccination status. Any burden for
modifying the facility’s policies and
procedures for these activities is already
accounted for above. We believe that
this would require an RN 5 minutes or
0.0833 hours to perform the required
documentation at adjusted hourly wage
of $69 for each employee. According to
Table 3, ICFs-IID have 80,000
employees. Hence, the burden for these
documentation requirements for all
5,780 ICFs-IID would be 6,664 (0.0833 ×
80,000) hours at an estimated cost of
$459,816 (6,664 × $69).
Therefore, the total burden for all
5,780 ICFs-IID for this rule would be
64,464 (57,800 + 6,664) hours at an
estimated cost of $4,760,136 (4,300,320
+ 459,816).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1402 (expiration date
September 30, 2024).
H. ICRs Regarding the Development of
Policies and Procedures for HHAs
§ 484.70(d), ‘‘COVID–19 Vaccination of
Home Health Agency Staff’’
1. Policies and Procedures
At § 483.70(d), we require HHAs to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. The HHA must also have a
contingency plan for all staff not fully
vaccinated according to this rule.
The ICRs for this section would
require each HHA to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at § 483.70,
Condition of participation: Infection
prevention and control require each
HHA to maintain and document an
infection control program to prevent
and control infections and
communicable diseases. The HHA must
follow accepted standards of practice,
including the use of standard
precautions to prevent the transmission
of infections and communicable
diseases. Thus, all HHA should already
have infection prevent and control
policies and procedures, but they likely
do not comply with all of the
requirements in this IFC.
All HHAs would need to review their
current policies and procedures and
modify them to comply with all of the
requirements in § 483.70(d), as set forth
in this IFC. While we believe that many
HHAs have already addressed COVID–
19 vaccination with their staff, we have
no reliable means to estimate that
number. Therefore, we will assess the
burden for these requirements for all
11,649 HHAs. We believe these
activities would be performed by the RN
and an administrator. According to
Table 3, an RN in home health services
total hourly cost is $73. Since there are
not any current requirements that
address COVID–19 vaccination, we
estimate it would require 8 hours for the
RN to research, draft, and work with an
administrator to finalize the policies
and procedures. Thus, for each HHA,
the burden for the RN would be 8 hours
at a cost of $584 (8 hours × 73). For all
11,649 HHAs, the burden would be
93,192 hours (8 hours × 11,649) at an
estimated cost of $6,803,016 (584 ×
11,649).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator in
home health services is $97. Hence, for
each HHA, the burden would be 2 hours
at an estimated cost of $194 (2 × 97). For
all 11,649 HHAs, the total burden would
be 23,298 hours (2 × 11,649) at an
estimated cost of $2,259,906 (11,649 ×
194).
Thus, the total burden for all 11,649
HHAs to comply with the policies and
procedures requirements for policies
and procedures is 116,490 hours (93,192
+ 23,298) at an estimated cost of
$9,062,922 (6,803,016 + 2,259,906).
2. Documentation and Storage
Section 483.70(d) also requires HHAs
to track and securely maintain the
required documentation of staff COVID–
19 vaccination status. Any burden for
modifying the agency’s policies and
procedures for these activities is already
accounted for above. We believe that
this would require an RN 5 minutes or
0.0833 hours to perform the required
documentation at adjusted hourly wage
of $73 for each employee. According to
Table 3, HHAs have 2,110,000
employees. Hence, the burden for these
documentation requirements for all
11,649 HHAs would be 175,763 (0.0833
× 2,110,000) hours at an estimated cost
of $12,830,699 (175,763 × 73).
Therefore, the total burden for all
11,649 HHAs for this rule would be
292,253 (116,490 + 175,763) hours at an
estimated cost of $21,893,621 (9,062,922
+ 12,830,699).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1299 (expiration date
June 30, 2024).
I. ICRs Regarding the Development of
Policies and Procedures for CORFs
§ 485.70(n), ‘‘COVID–19 Vaccination of
Facility Staff’’
1. Policies and Procedures
At § 485.70(n), we require CORFs to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. Each CORF must also have
a contingency plan for all staff not fully
vaccinated according to this rule.
The ICRs for this section would
require each CORF to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. This IFC requires CORF staff to
receive the COVID–19 vaccine unless
medically contraindicated as
determined by a physician, advance
practice registered nurse, or physician
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assistant acting within their respective
scope of practice as defined by and in
accordance with all applicable State and
local laws. Based upon our experience
with CORFs, we believe some facilities
have already developed policies and
procedures requiring COVID–19
vaccination for staff unless medically
contraindicated. However, each CORF
will need to review their current
policies and procedures and modify
them, if necessary, to ensure compliance
with the requirements in this IFC,
especially that their policies and
procedures cover all of the organization
staff identified in this IFC. Hence, we
will base our estimate for this ICR on all
159 CORFs. The CORF’s governing body
appoints an administrator who
implements and enforces the facility’s
policies and procedures. Hence, we
believe activities associated with this
IFC would be performed by the
administrator as analyzed below. The
governing body would also need to
review these policies and procedures,
which would be included in its ‘‘legal
responsibility for establishing and
implementing policies regarding the
management and operation of the
facility.’’
The administrator would conduct
research to either modify or develop
policies and procedures. For the
administrator, we estimate this would
require 8 hours initially to perform
research and revise or develop the
policies and procedures to meet these
requirements. According to Table 3, the
administrator’s total hourly cost is $98.
Thus, for each CORF, the burden for the
administrator would be 8 hours at a cost
of $784 (8 × 98). For the administrators
in all 159 organizations, the burden
would be 1,272 hours (8 × 159) at an
estimated cost of $124,656 (784 × 159).
The administrator would need to
spend time attending governing body
meetings to discuss and obtain approval
for the policies and procedures;
however, that would be a usual and
customary business practice. Therefore,
activities for the administrator
associated with governing body
approval for the policies and procedures
are exempt from the PRA in accordance
with 5 CFR 1320.3(b)(2).
2. Documentation and Storage
Section 485.70(n) also requires CORFs
to track and securely maintain the
required documentation of staff COVID–
19 vaccination status. Any burden for
modifying the facility’s policies and
procedures for these activities is already
accounted for above. We believe that
this would require an administrator 5
minutes or 0.0833 hours to perform the
required documentation at adjusted
hourly wage of $98 for each employee.
According to Table 3, CORFs have
10,000 employees. Hence, the burden
for these documentation requirements
for all 159 CORFs would be 833 (0.0833
× 10,000) hours at an estimated cost of
$81,634 (833 × 98).
Therefore, the total burden for all 159
CORFs for this rule would be 2,105
(1,272 + 833) hours at an estimated cost
of $206,290 (124,656 + 81,634).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1091 (expiration date
November 30, 2022).
J. ICRs Regarding the Development of
Policies and Procedures for CAHs
§ 485.640(f), ‘‘COVID–19 Vaccination of
CAH Staff’’
1. Policies and Procedures
At § 485.640(f), we require critical
access hospitals (CAHs) to develop and
implement policies and procedures to
ensure their staff are vaccinated for
COVID–19 and that appropriate
documentation of those vaccinations are
tracked and maintained. The CAH must
also have a contingency plan for all staff
not fully vaccinated according to this
rule.
The ICRs for this section would
require each CAH to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at § 485.640
Condition of participation: Infection
prevention and control and antibiotic
stewardship programs already require
CAHs to have an infection prevention
and control program (IPCP) and an
infection preventionist (IP). The IPCP
must have methods to prevent and
control the transmission of infection
within the hospital and between the
hospital and other settings. Thus, all
1,358 CAHs should already have
infection prevention and control
policies and procedures. However, each
CAH would need to review their current
policies and procedures and modify
them, if necessary, to ensure compliance
with all of the requirements in this IFC,
especially that their policies and
procedures cover all of the eligible
facility staff identified in this IFC. Based
upon our experience with CAHs, we
believe many CAHs have already
developed policies and procedures
requiring COVID–19 vaccination for
staff. Since we have no reliable means
to estimate the number of CAHs that
may have already addressed COVID–19
vaccination of their staff, we will base
our estimate for these requirements on
all 1,358 CAHs.
We believe these activities would be
performed by the IP, the director of
nursing (DON), and an administrator.
The IP would need to research COVID–
19 vaccines, modify the policies and
procedures, as necessary, and work with
the DON and administrator to develop
the policies and procedures and obtain
appropriate approval. For the IP, we
estimate these activities would require 8
hours. According to Table 3, the IP’s
total hourly cost is $79. Thus, for each
hospital, the burden for the IP would be
8 hours at a cost of $632 (8 hours × 79).
For the IPs in all 1,358 CAHs, the
burden would be 10,864 hours (8 hours
× 1,358) at an estimated cost of $858,256
(632 × 1,358).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by the DON and an administrator. We
believe these activities would require 2
hours each for the DON and an
administrator. According to Table 3, the
total adjusted hourly wage for both the
DON and an administrator is $122.
Hence, for each CAH the burden would
be 4 hours (2 × 2) at an estimated cost
of $488 (4 × $122). The total burden for
all 1,358 CAHs would be 5,432 hours (4
× 1,358) at an estimated cost of $662,704
(1,358 × 488).
Therefore, for all 1,358 CAHs the total
burden for the requirements for policies
and procedures is 16,296 hours (10,864
+ 5,432) at an estimated cost of
$1,520,960 ($858,256 + $662,704).
2. Documentation and Storage
Section 485.640(f) also requires CAHs
to track and securely maintain the
required documentation of staff COVID–
19 vaccination status. Any burden for
modifying the CAH’s policies and
procedures for these activities is already
accounted for above. Since we were
unable to located a reliable number for
CAH employees, the documentation
burden for CAHs resulting from the
documentation requirement in this rule
is included in the hospitals’ burden
above.
The requirements and burden for
CAHs without DPUs will be submitted
to OMB under OMB control number
0938–1043 (expiration date March 31,
2024). The requirements and burden for
CAHs with DPUs will be submitted to
OMB under OMB control number 0938–
0328(expired).
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K. ICRs Regarding the Development of
Policies and Procedures for Clinics,
Rehabilitation Agencies, and Public
Health Agencies as Providers of
Outpatient Physical Therapy and
Speech-Language Pathology Services
(Organizations) § 485.725(f), ‘‘COVID–
19 Vaccination of Organization Staff’’
1. Policies and Procedures
At § 485.725(f), we require
organizations to develop and implement
policies and procedures to ensure their
staff are vaccinated for COVID–19 and
the appropriate documentation is
tracked and maintained. The
organization must also have a
contingency plan for all staff not fully
vaccinated according to this rule.
The ICRs for this section would
require each organization to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at
§ 485.725(a) require organizations to
establish an infection-control committee
of representative professional staff with
overall responsibility for infection
control. This committee establishes
policies and procedures for
investigating, controlling, and
preventing infections in the
organization and monitors staff
performance to ensure compliance with
those policies and procedures. Based
upon these requirements and our
experience with organizations, we
believe some organizations have already
developed policies and procedures
requiring COVID–19 vaccination for
staff unless medically contraindicated.
However, since we have no reliable
means to estimate how many
organizations have done this, we will
assess the burden for all 2,078
organizations. All organizations would
need to review their current policies
and procedures and modify them, if
necessary, to ensure compliance with
the requirements in this IFC.
The types of therapists at each
organization vary depending upon the
services offered. For the purposes of
determining the COI burden, we will
assume that the therapist is a physical
therapist. We believe activities
associated with this IFC would be
performed by a physical therapist and
administrator. A physical therapist
would need to conduct research on the
COVID–19 vaccines and then develop or
modify policies and procedures that
comply with the requirements in this
IFC. The physical therapist would need
to work with an administrator to make
the necessary revisions. For the physical
therapist, we estimate this would
require 8 hours to perform research and
revise or develop the policies and
procedures to meet these requirements.
According to Table 3, the physical
therapist’s total hourly cost is $84.
Thus, for each organization, the burden
for the physical therapist would be 8
hours at a cost of $672 (8 × 84). For the
physical therapists in all 2,078
organizations, the burden would be
16,624 hours (8 × 2,078) at an estimated
cost of $1,396,416 (672 × 2,078).
As discussed above, the revision and
approval of these policies and
procedures would also require activities
by the administrator. The administrator
would need to have meetings with the
physical therapist to discuss the
revisions and draft any necessary
policies and procedures, as well as
approve the final policies and
procedures. We estimate this would
require 2 hours for the administrator.
According to Table 3, the total hourly
cost for the administrator is $98. The
burden for the administrator in each
organization would be 2 hours at an
estimated cost of $196 (2 × 98). For the
administrators in all 2,078
organizations, the burden would be
4,156 hours (2 × 2,078) at an estimated
cost of $407,288 (4,156 × 98).
Therefore, for all 2,078 organizations,
the total burden for the requirements for
policies and procedures is 20,780 hours
(16,624 + 4,156) at an estimated cost of
$1,803,704 (1,396,416 + 407,288).
2. Documentation and Storage
Section 485.725(f) also requires
organizations to track and securely
maintain the required documentation of
staff COVID–19 vaccination status. Any
burden for modifying the organization’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require a
physical therapist 5 minutes or 0.0833
hours to perform the required
documentation at adjusted hourly wage
of $84 for each employee. According to
Table 3, these organizations have 10,000
employees. Hence, the burden for these
documentation requirements for all
2,078 organizations would be 833
(0.0833 × 10,000) hours at an estimated
cost of $69,972 (833 × 84).
Therefore, the total burden for all
2,078 organizations for this rule would
be 21,613 (20,780 + 833) hours at an
estimated cost of $1,873,676 (1,803,704
+ 69,972).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–0273 (expiration date
June 30, 2024).
L. ICRs Regarding the Development of
Policies and Procedures for CMHCs
§ 485.904(c), ‘‘COVID–19 Vaccination of
Center Staff’’
1. Policies and Procedures
At § 485.904(c), we require CHMCs to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. Each facility must maintain
documentation of their staff’s
vaccination status. Also, each facility
must have a contingency plan for all
staff not fully vaccinated according to
this rule.
The ICRs for this section would
require each CHMC to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Based upon our experience
with CHMCs, we believe some centers
have already developed policies and
procedures requiring COVID–19
vaccination for staff unless medically
contraindicated. However, since we do
not have a reliable means to estimate
how many CMHCs have done so, we
will estimate the burden based on all
129 CHMCs.
Each CMHC will need to review their
current policies and procedures and
modify them, if necessary, to ensure
compliance with the requirements in
this IFC. Based on these requirements
and our experience with CHMCs, we
believe these activities would be
performed by the CHMC administrator
and a mental health counselor. The
administrator would conduct research
regarding the COVID–19 vaccines and
then either modify or develop the
policies and procedures necessary to
comply with the requirements in this
IFC. The administrator would send any
recommendations for changes or
additional policies or procedures to the
mental health counselor. The
administrator and mental health
clinician would need to make the
necessary revisions and draft any
necessary policies and procedures. For
the administrator, we estimate this
would require 8 hours initially to
perform research and revise or develop
the policies and procedures to meet
these requirements. According to Table
3, the administrator’s total hourly cost is
$113. Thus, for each CMHC, the burden
for the administrator would be 8 hours
at a cost of $904 (8 × 113). The burden
for the administrators in all 129 CHMCs
would be 1,032 hours (8 × 129) at an
estimated cost of $116,616 (904 × 129).
As discussed above, the revision and
approval of these initial policies and
procedures would also require activities
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by the mental health counselor. The
administrator would need to have
meetings with the mental health
counselor to discuss the revisions and
draft any necessary policies and
procedures. We estimate this would
require 2 hours for the mental health
counselor. According to Table 3, the
total hourly cost for the mental health
counselor is $118. The burden for the
mental health counselor in each CHMC
would be 2 hours at an estimated cost
of $236 (2 × 118). For the mental health
counselors in all 129 CMHCs, the
burden would be 258 hours (2 × 129) at
an estimated cost of $30,444 (129 × 236).
Therefore, for all 129 CMHCs, the
total burden for the requirements for
policies and procedures is 1,290 hours
(1,032 + 258) at an estimated cost of
$147,060 (116,616 + 30,444).
2. Documentation and Storage
Section 485.904(c) also requires
CMHCs to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the center’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require an
administrator 5 minutes or 0.0833 hours
to perform the required documentation
at adjusted hourly wage of $113 for each
employee. According to Table 3, CMHCs
have 140,000 employees. Hence, the
burden for these documentation
requirements for all 129 CMHCs would
be 11,662 (0.0833 × 140,000) hours at an
estimated cost of $1,317,806 (11,662 ×
113).
Therefore, the total burden for all 129
CMHCs for this rule would be 12,952
(1,290 + 11,662) hours at an estimated
cost of $1,464,866 (147,060 +
1,317,806).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–1245 (expiration date
April 30, 2023).
M. ICRs Regarding the Development of
Policies and Procedures for HIT
Suppliers § 486.525(c), ‘‘COVID–19
Vaccination of Facility Staff’’
1. Policies and Procedures
Section 486.525(c) requires home
infusion therapy (HIT) suppliers to
develop and implement policies and
procedures to ensure their staff are
vaccinated for COVID–19 and that
appropriate documentation of those
vaccinations are tracked and
maintained. The HIT supplier must also
have a contingency plan for all staff not
fully vaccinated according to this rule.
The ICRs for this section would
require each HIT supplier to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at § 486.525
already require that HIT suppliers
provide their services in accordance
with nationally recognized standards of
practice. Thus, we believe most HIT
suppliers should already have infection
prevention and control policies and
procedures, including COVID–19
vaccination. However, we have no
reliable means to estimate how many
suppliers have done so. Thus, we will
base our burden estimate on all 337 HIT
suppliers.
All HIT suppliers would need to
review their current policies and
procedures and develop or modify them
to comply with all of the requirements
in § 486.525(c) as set forth in this IFC.
We believe these activities would be
performed by the RN and an
administrator working for the HIT
supplier. According to Table 3, an RN
working with for a HIT supplier would
have a total hourly cost of $73. Since
there are not any current requirements
that address COVID–19 vaccination, we
estimate it would require 8 hours for the
RN to research, draft, and work with an
administrator to finalize the policies
and procedures. Thus, for each HIT
supplier, the burden for the RN would
be 8 hours at a cost of $584 (8 hours ×
73). For all 337 HIT suppliers, the
burden would be 2,696 hours (8 hours
× 337) at an estimated cost of $24,601
(337 × 73).
The development and/or revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator
working for a HIT supplier is $97.
Hence, for each HIT supplier, the
burden would be 2 hours at an
estimated cost of $194 (2 × 97). For all
337 HIT suppliers, the total burden for
the administrator would be 674 hours (2
hours × 337) at an estimated cost of
$65,378 (337 × 194).
Therefore, for all 337 HIT suppliers,
the total burden for the requirements for
policies and procedures is 3,370 hours
(2,696 + 674) at an estimated cost of
$89,979 (24,601 + 65,378).
2. Documentation and Storage
Section 486.525(c) also requires HIT
suppliers to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the supplier’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require an
RN 5 minutes or 0.0833 hours to
perform the required documentation at
adjusted hourly wage of $73 for each
employee. According to Table 3, HIT
suppliers have 20,000 employees.
Hence, the burden for these
documentation requirements for all 337
HIT suppliers would be 1,666 (0.0833 ×
20,000) hours at an estimated cost of
$121,618 (1,666 × 73).
Therefore, the total burden for all 337
HIT suppliers for this rule would be
5,036 (3,370 + 1,666) hours at an
estimated cost of $211,597 (89,979 +
121,618).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–855B (expiration date
March 31, 2024).
N. ICRs Regarding the Development of
Policies and Procedures for RHCs and
FQHCs § 491.8(d), ‘‘COVID–19
Vaccination of Staff’’
1. Policies and Procedures
At § 491.8(d), we require RHCs/
FQHCs to develop and implement
policies and procedures to ensure their
staff are vaccinated for COVID–19 and
that appropriate documentation of those
vaccinations are tracked and
maintained. Each RHC/FQHC must also
have a contingency plan for all staff not
fully vaccinated according to this rule.
The ICRs for this section would
require each RHC/FQHC to develop the
policies and procedures needed to
satisfy all of the requirements in this
section. This IFC requires clinic or
center staff to receive the COVID–19
vaccine unless medically
contraindicated as determined by a
physician, advance practice registered
nurse, or physician assistant acting
within their respective scope of practice
as defined by and in accordance with all
applicable State and local laws. Based
upon experience with RHCs/FQHCs, we
believe some clinics or centers have
already developed policies and
procedures requiring COVID–19
vaccination for staff unless medically
contraindicated. However, since we do
not have a reliable means to estimate
how many facilities have already done
so, we will base the burden analysis for
this estimate on all 15,317 RHC/FQHCs
(4,933 RHCs and 10,384 FQHCs).
Each RHC/FQHC will need to review
their current policies and procedures
and modify them, if necessary, to ensure
compliance with the requirements in
this IFC, especially that their policies
and procedures cover all of the clinic or
center staff identified in this IFC.
Current regulations require a physician,
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222 42 CFR 491.7.
nurse practitioner, and physician
assistant to participate in the
development, execution, and periodic
review of the policies and
procedures.222 Moreover, the RHC/
FQHC operates under the medical
direction of a physician. Based on these
requirements and our experience with
RHCs/FQHCs, we believe activities
associated with this IFC would be
performed by the RHC administrator,
physician, nurse practitioner, physician
assistant, and medical director as
analyzed below.
The administrator would conduct
research to either modify or develop
policies and procedures. The
administrator would send any
recommendations for changes or
additional policies or procedures to the
physician, nurse practitioner, and
physician assistant. The administrator,
physician, nurse practitioner, and
physician assistant would need to make
the necessary revisions and draft any
necessary policies and procedures. The
administrator would need to work with
the medical director to obtain approval
for the policies and procedures to be
implemented. For the administrator, we
estimate this would require 8 hours
initially to perform research and revise
or develop the policies and procedures
to meet these requirements. According
to Table 3, the administrator’s total
hourly cost is $108. Thus, for each RHC/
FQHC, the burden for the administrator
would be 8 hours at a cost of $864 (8
× 108). For the administrators in all
15,317 RHCs/FQHCs, the burden would
be 122,536 hours (8 × 15,317) at an
estimated cost of $13,233,888 (864 ×
15,317).
As discussed above, the revision and
approval of these initial policies and
procedures would also require activities
by the physician, nurse practitioner,
physician assistant, and medical
director. The administrator would need
to have meetings with the physician,
nurse practitioner, and physician
assistant to discuss the revisions and
draft any necessary policies and
procedures. The administrator would
also need to have meetings with the
medical director to obtain approval for
the policies and procedures. We
estimate this would require 2 hours
each for the physician, nurse
practitioner, and physician assistant.
For the medical director, we estimate 1
hour would be required to perform this
function. According to Table 3, the total
hourly cost for the physician is $212.
The burden for the physician in each
RHC/FQHC would be 2 hours at an
estimated cost of $424 (2 × 212). For the
physicians in all 15,317 RHCs/FQHCs,
the burden would be 30,634 hours (2 ×
15,317) at an estimated cost of
$6,494,408 (424 × 15,317). The hourly
cost for the nurse practitioner is $107.
The burden for the nurse practitioner in
each RHC/FQHC would be 2 hours at an
estimated cost of $214 (2 × 107). For the
nurse practitioners in all 15,317 RHCs/
FQHCs, the burden would be 30,634
hours (2 × 15,317) at an estimated cost
of $3,277,838 ($214 × 15,317). The
hourly cost for the physician assistant is
$111. The burden for the physician
assistant in each RHC/FQHC would be
2 hours at an estimated cost of $222 (2
× 111). For the physician assistants in
all 15,317 RHCs/FQHCs, the burden
would be 30,634 hours (2 × 15,317) at
an estimated cost of $3,400,374 (15,317
× 222). The hourly cost for the medical
director is $212. The burden for the
medical director in each RHC/FQHC
would be 1 hour at an estimated cost of
$212. For the medical directors in all
15,317 RHCs/FQHCs, the burden would
be 15,317 hours (1 × 15,317) at an
estimated cost of $3,247,204 (15,317 ×
212).
Therefore, for all 15,317 RHCs/
FQHCs, the estimated burden associated
with the policies and procedures
requirement would be 229,755 hours
(122,536 + 30,634 + 30,634 + 30,634 +
15,317) at a cost of $29,653,712
(13,233,888 + 6,494,408 + 3,277,838 +
3,400,374 + 3,247,204).
2. Documentation and Storage
Section 491.8(d) also requires RHCs/
FQHCs to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the clinic’s or
center’s policies and procedures for
these activities is already accounted for
above. We believe that this would
require an administrator 5 minutes or
0.0833 hours to perform the required
documentation at an adjusted hourly
wage of $108 for each employee.
According to Table 3, RHCs have 40,000
employees and FQHCs have 110,000
employees for a total of 150,000
employees. Hence, the burden for these
documentation requirements for all
15,317 RHCs and FQHCs would be
12,495 (0.0833 × 150,000) hours at an
estimated cost of $1,349,460 (12,495 ×
108).
Therefore, the total burden for all
15,317 RHCs and FQHCs for this rule
would be 242,250 (229,755 + 12,495)
hours at an estimated cost of
$31,003,172 (29,653,712 + 1,349,460).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–0334 (expiration date
March 31, 2023).
O. ICRs Regarding the Development of
Policies and Procedures for ESRD
Facilities § 494.30(b), ‘‘COVID–19
Vaccination of Facility Staff’’
1. Policies and Procedures
Section 494.30(b) requires the ESRD
facilities to develop and implement
policies and procedures to ensure their
staff are vaccinated for COVID–19 and
that appropriate documentation of those
vaccinations are tracked and
maintained. The ESRD facility must also
have a contingency plan for all staff not
fully vaccinated according to this rule.
The ICRs for this section would
require each ESRD facility to develop
the policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at § 494.30
already require that ESRD facilities
follow standard infection control
precautions. Thus, all ESRD facilities
should have infection prevention and
control policies and procedures. We
believe that many ESRD facilities have
already addressed COVID–19
vaccination for their staff. However, we
have no reliable means to estimate how
many ESRD facilities have done so.
Thus, we will base our burden estimate
on all 7,893 ESRD facilities.
All ESRD facilities would need to
review their current policies and
procedures and develop or modify them
to comply with all of the requirements
in § 494.30(b) as set forth in this IFC. We
believe these activities would be
performed by the RN and an
administrator. According to Table 3, an
RN working with for an ESRD facility
would have a total hourly cost of $73.
Since there are not any current
requirements that address COVID–19
vaccination, we estimate it would
require 8 hours for the RN to research,
draft, and work with an administrator to
finalize the policies and procedures.
Thus, for each ESRD facility, the burden
for the RN would be 8 hours at a cost
of $584 (8 hours × $73). For all ESRD
facilities, the burden would be 63,144
hours (8 hours × 7,893) at an estimated
cost of $4,609,512 (7,893 × 584).
The development and/or revision and
approval of these policies and
procedures would also require activities
by an administrator. The administrator
would need to work with the RN to
develop the policies and procedures,
and then review and approve the
changes. We estimate this would require
2 hours. According to Table 3, the total
hourly cost for the administrator at an
ESRD facility is $97. Hence, for each
ESRD, the burden for the administrator
would be 2 hours at an estimated cost
of $194 (2 × 97). For all ESRD facilities,
the total burden would be 15,786 hours
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(2 × 7,893) at an estimated cost of
$1,531,242 (7,893 × 194). Thus, the total
burden for all ESRD facilities for the
policies and procedures requirement
would be 78,930 hours (63,144 +
15,786) at an estimated cost of
$6,140,754 ($4,609,512 + $1,531,242).
2. Documentation and Storage
Section 494.30(b) also requires ESRD
facilities to track and securely maintain
the required documentation of staff
COVID–19 vaccination status. Any
burden for modifying the facility’s
policies and procedures for these
activities is already accounted for above.
We believe that this would require an
RN 5 minutes or 0.0833 hours to
perform the required documentation at
an adjusted hourly wage of $73 for each
employee. According to Table 3, ESRD
facilities have 170,000 employees.
Hence, the burden for these
documentation requirements for all
7,893 ESRD facilities would be 14,161
(0.0833 × 170,000) hours at an estimated
cost of $1,033,753 (14,161 × 73).
Therefore, the total burden for all
7,893 ESRD facilities for this rule would
be 93,091 (78,930 + 14,161) hours at an
estimated cost of $ 7,174,507 (6,140,754
+ 1,033,753).
The requirements and burden will be
submitted to OMB under OMB control
number 0938–0386 (expiration date
March 31, 2024).
Based upon the above analysis, the
total burden for all of the ICRs in this
IFC is 1,555,487 hours at an estimated
cost of $136,088,221.
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223 For updated data, see CDC daily updates of
total deaths at https://www.cdc.gov/nchs/nvss/vsrr/
COVID19/index.htm, and the Kaiser Family
Foundation weekly updates on nursing home
deaths at https://www.kff.org/coronavirus-covid-19/
issue-brief/state-covid-19-data-and-policy-actions/,
among other sources.
224 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
225 https://www.va.gov/opa/pressrel/
pressrelease.cfm?id=5703.
226 For data on the massive differences in
healthcare usage by age, see the National Health
Expenditure Date at https://www.cms.gov/Research-
Statistics-Data-and-Systems/Statistics-Trends-and-
Reports/NationalHealthExpendData/NHE-Fact-
Sheet.
BILLING CODE 4120–01–C
If you comment on these information
collection requirements, that is,
reporting, recordkeeping or third-party
disclosure requirements, please submit
your comments electronically as
specified in the ADDRESSES section of
this IFC.
Comments must be received on/by
January 4, 2022.
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VI. Regulatory Impact Analysis
A. Statement of Need
The COVID–19 pandemic has
precipitated the greatest public health
crisis in the U.S. since the 1918
Influenza pandemic. The population of
older adults, and LTC facility residents
in particular, have been hard hit by the
impacts of the pandemic. Among those
infected, the death rate for older adults
age 65 or higher was hundreds of time
higher than for those in their 20s during
2020.223 Of the approximately 656,000
Americans estimated to have died from
COVID–19 through September 10,
2021,224 30 percent are estimated to
have died during or after an LTC facility
stay, although these numbers are
decreasing as vaccination rates increase
in residents and staff as shown in the
CDC Data Tracker. Despite the recent
nation-wide surge in infections from the
Delta variant of COVID–19, uptake of
vaccines and other measures (masking,
screening visitors, and social distancing
in particular) to prevent COVID–19, in
combination with available therapeutic
options to treat, has reduced COVID–19-
related patient deaths in all settings. But
reductions in COVID–19-related
morbidity and mortality depend
critically on continued success in
vaccination of all health care staff and
patients. The May 13, 2021 COVID–19
IFC (86 FR 26306) required offering
vaccination to residents and staff, but
did not mandate vaccination. Recently,
however the Departments of Defense
and Veterans Affairs staff, and civilian
Federal Government employees have
become subject to requirements similar
to those imposed in this rule.225 This
IFC will close a gap in current
regulations for all categories of health
care provider whose health and safety
practices are directly regulated by CMS.
Almost all CMS-regulated providers and
suppliers disproportionately serve
people who are older, disabled,
chronically ill, or who have complex
health care needs.226 Because the health
care sector has such widespread and
direct contact with hundreds of millions
of patients, clients, residents, and
program participants, the protective
scope of this rule is far broader than the
health care staff that it directly affects.
B. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
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Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). We
estimate that this rulemaking is
‘‘economically significant’’ as measured
by the $100 million threshold, and
hence also a major rule under the
Congressional Review Act. Accordingly,
we have prepared an RIA that, taken
together with COI section and other
sections of the preamble, presents to the
best of our ability the costs and benefits
of the rulemaking.
This RIA focuses on the overall costs
and benefits of the rule, taking into
account vaccination uptake to date or
anticipated over the next year that is not
due to this rule, and estimating the
likely additional effects of this rule on
both provider staff and the patients with
whom they come in contact. We analyze
both the costs of the required actions
and the payment of those costs. As
intended under these requirements, this
RIA’s estimates cover only those costs
and benefits that are likely to be the
effects of this rule. There are also
several unknowns that may affect
current progress or this rule or both.
These include the duration of strong
vaccine protection with or without a
booster shot and the possibility of new
virus variants that reduce the
effectiveness of currently authorized
and approved vaccines. We cannot
estimate the effects of each of the
possible interactions among them, but
throughout the analysis we point out
some of the most important assumptions
we have made and the possible effects
of alternatives to those assumptions.
The providers and suppliers regulated
under this rule are diverse in nature,
management structure, and size. That
said, we believe that the costs faced by
regulated entities will be very similar on
a ‘‘per person vaccinated’’ basis. Tables
5 and 6 show the full scope of provider
and supplier types, facility structures,
and staff sizes, taking into account part-
time staff (Table 5) and estimated staff
turnover (Table 6). As explained earlier
in the preamble, this rule includes
facility contractors and consulting
specialists as well as other persons
providing part-time or occasional
services to these providers and
suppliers and their patients.
In Table 5 we provide a rough
estimate of the likely number of full-
time employees and other employees
and contractors subject to this rule. The
‘‘total staff’’ number in the rightmost
column is the number of individual staff
directly affected at the time this rule
takes effect (adding the number of full-
time employees to the number of part-
time employees, contractors, and other
business persons who have recurring
patient or staff interactions).
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BILLING CODE 4120–01–C
This rule presents additional
difficulties in estimating both costs and
benefits due to the high degree to which
all current provider and supplier staff
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227 These data are taken from or calculated from
the CDC COVID Data Tracker. For example, in
recent weeks the number of new daily cases has
been gradually decreasing from about 150,000 to
about 90,000. Once the disease runs its course,
almost all these people will have recovered. Hence,
we use the rough estimate that about 100,000 a day
have recovered in recent weeks.
228 Among long term care residents, the
vaccinated percentage is now very close to 90
percent, but other categories of patients are
undoubtedly lower. That said, patients are heavily
age-skewed towards higher ages where vaccination
percentages are higher.
229 See ‘‘Valuing COVID–19 Mortality and
Morbidity Risk Reductions in U.S. Department of
Health and Human Services Regulatory Impact
Analyses, https://aspe.hhs.gov/reports/valuing-
covid-19-risk-reductions-hhs-rias.
230 For an NIH summary of the racial disparities,
see https://www.niddk.nih.gov/health-information/
kidney-disease/race-ethnicity.
231 At age 80, the average life expectancy of a
male is about 8 years and of females about 10 years,
or an overall average of about 9 years. Long term
care nursing home residents, however, have shorter
life expectancies because they have severe health
problems or would not have been admitted to a
facility. For those who remain in a facility until
death the average life expectancy is about 2 years.
But some recover and leave so we have used 5 years
as a reference point. See discussion at David B.
Reuben, ‘‘Medical Care for the Final Years of Life:
When you’re 83, It’s not going to be 20 years,’’
JAMA, Dec. 23, 2009, 2686–2694.
232 For patients in skilled nursing facilities,
average length of stay is less than a month. Hence,
turnover is far higher.
233 See Dvir Aran, Estimating real-world COVID–
19 vaccine effectiveness in Israel using aggregated
counts, medRxiv, February 28, 2021, at https://
www.medrxiv.org/content/10.1101/
2021.02.05.21251139v3.full.pdf and Noa Dagan et
al, ‘‘BNT162b2 mRNA Covid-19 Vaccine in a
Nationwide Mass Vaccination Setting,’’ The New
England Journal of Medicine, 2/24/2021, at https://
www.nejm.org/doi/full/10.1056/NEJMoa2101765.
234 Kaiser Family Foundation, COVID–19 and
Workers at Risk: Examining the Long-Term Care
Workforce, April 23, 2020, at https://www.kff.org/
coronavirus-covid-19/issue-brief/covid-19-and-
workers-at-risk-examining-the-long-term-care-
workforce/.
235 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC7267626/.
236 https://www.anderson.ucla.edu/faculty_
pages/keith.chen/papers/WP_Nursing_Home_
Networks_and_COVID19.pdf.
have already received information about
the benefits and safety of COVID–19
vaccination, and the rare serious risks
associated with it. Despite this progress,
the proportion of fully vaccinated health
care staff has approached but not hit the
70 percent with significant variation
among states. Moreover, among the
general population more than 600,000
persons a day are currently being
vaccinated with the first or second shot
and about 100,000 a day have recovered
from infection and are only in very rare
cases still infectious. These changes
reduce the risk to both health care staff
and patients substantially, likely by
about 20 million persons a month who
are no longer sources of future
infections.227 This in turn reduces the
number of newly infected cases
(currently about 100,000 a day and
decreasing rapidly). Yet another variable
of importance is the increasing number
of providers and suppliers that are
mandating employee vaccination, and
the increasing number of states that are
doing so as well. To characterize the
baseline scenario of no new regulatory
action, from which we estimate the
incremental impacts of the interim final
rule, we assume that when Phase 1 of
this IFC goes into effect, 75 percent of
provider staff, 90 percent of LTC facility
residents, and 80 percent of all other
patients and clients will have been
vaccinated, and that these rates will
improve over time as a result of both
this rule and the other factors
previously discussed.228
These numbers leave a large range for
the likely effects of this rule over time.
They do indicate, however, that many
cases of death or severe illness can be
prevented by increasing the number of
vaccinated persons, both for those
vaccinated and for others they might
otherwise infect. As estimated in Table
6, the number of unvaccinated health
care workers still remains in the
millions despite recent progress. As
discussed later in this analysis, we use
the concept of the value per statistical
life and per statistical case to capture
this major potential benefit, as
recommended by the Office of the
Assistant Secretary for Planning and
Evaluation based on standard practices
in cost-benefit analysis.229
One additional factor affecting our
estimates is remaining life expectancy.
Life expectancy varies by age, being
about 40 years across an entire
population, close to 80 years for a
younger population, and a relatively
fewer number of years for an older
population. These numbers, of course,
are overall averages and mask
substantial differences by race and sex
(among other factors), including access
to affordable health care and prevalence
of untreated or insufficiently controlled
disease. Individuals with diabetes, for
example, are disproportionately African
American and disproportionately older,
which leads to greater risks from kidney
failure and other adverse health effects,
including greater susceptibility to the
ravages of COVID–19.230 Health care
staff of most types of providers and
suppliers are of typical working ages.
But hospital patients, LTC facility
residents, ESRD patients treated for
kidney failure, and most other patients
are heavily weighted towards older ages
and are disproportionately members of
African American and Native American
minority groups. This means that the
morbidity and mortality reductions from
this rule when they are adjusted for the
age ranges affected disproportionally
benefit racial minorities.
In particular, LTC facility residents
are near the upper end of the age
spectrum. For a statistically average LTC
facility resident, the average pre-
COVID–19 life expectancy if death
occurs while in the facility is likely to
be on the order of 3 years or fewer but
taking into account residents who
recover and leave the facility and those
enrolled for skilled nursing services we
estimate overall life expectancies to be
about 5 years.231 We also estimate that
vaccination reduces the chance of
infection by about 95 percent, and the
risk of death from the virus to a fraction
of 1 percent.232 In Israel, of the first 2.9
million people vaccinated with two
doses there were only about 50
infections involving severe conditions
resulting from the virus after the 14th
day and of these so few deaths that they
were not reported in statistical
summaries. These data also show that
COVID–19 vaccines are effective for
both older and younger recipients. Of
those who have received a full primary
vaccine series, after the 14th day after
vaccination only 46 people over the age
of 60 became infected and had a severe
case, compared to 6 people under the
age of 60. Given that these numbers are
compared against 2.9 million recipients
of the second dose, both rates are near
zero.233
C. Anticipated Costs of the Interim Final
Rule With Comment Period
We note that our cost estimates
assume that all additional vaccination
costs for providers and suppliers
regulated by this rule are due to this
rule. We estimate on this basis because
we have no reliable way to estimate how
much of these costs might be equally
due to independent employer decisions,
to other Federal standards, to State and
local mandates, or even to individual
personal choices.
In our cost estimates we cover all
providers regulated by CMS for health
and safety standards, but we often use
LTC facilities for examples because they
pose some of the greatest risks for
COVID–19 morbidity and mortality. As
documented subsequently in this
analysis and in a research report on this
issue, about 1.5 million individuals
work in LTC facilities at any one
time.234 A number of these individuals
work in multiple LTC facilities which
may play additional roles in
transmission.235 236 These individuals
are at high risk both to become ill with
COVID–19 and to transmit the SARS-
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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
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.
CoV–2 virus to residents or visitors, or
among themselves. Far more than most
occupations, LTC facility work requires
sustained close contact with multiple
persons daily.
In Table 6 we present estimates of
total numbers of staff individuals
regulated under this rule, distinguishing
between numbers at the beginning of a
year and at any one time during the
year, versus the much higher numbers
when turnover is considered. In Table 6
we assume that the number departing
each year is the same as the number
entering each year, which is a
reasonable approximation to changes in
just a few years, but do not take account
of the aging of the population over time.
We note that our estimates do not
include a deduction for the overlap
among individuals who work in more
than one LTC facility. We know that this
number is substantial, but have no basis
for estimating its precise magnitude
and, more importantly, how it may
change after this rule goes into effect
and facilities change their staffing and
hiring patterns. One recent study found
about 17% of LTC nursing staff held
second jobs, and another recent study
found that about 5% held more than one
LTC job. The second study, moreover,
found that facilities with substantial
staff sharing were disproportionally
associated with as many as 49% of
nursing home COVID–19 cases.237
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These figures are approximations,
because none of the data that is
routinely collected and published on
resident populations or staff counts
focus on numbers of individuals
residing or working in the facility
during the course of a year or over time.
Depending on the average length of stay
(that is, turnover) in different facilities,
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238 Ashvin Gandhi et al, ‘‘High Nursing Staff
Turnover In Nursing Homes Offers Important
Quality Information,’’ Health Affairs, March 2021,
pages 384–391.
239 Ashvin Gandhi et al, ‘‘High Nursing Staff
Turnover In Nursing Homes Offers Important
Quality Information,’’ Health Affairs, March 2021,
pages 384–391. Published estimates vary widely.
For example, two recent sources said home health
care staff turnover is about 65 percent. See https://
www.hcaoa.org/newsletters/caregiver-turnover-rate-
is-652-2021-home-care-benchmarking-study and
https://www.leadingage.org/sites/default/files/
Direct%20Care%20Workers%20Report
%20%20FINAL%20%282%29.pdf.
240 At https://aspe.hhs.gov/sites/default/files/
private/pdf/242926/HHS_RIAGuidance.pdf, page
24.
241 See https://www.washingtonpost.com/local/
covid-vaccine-mandate-hospitals-virginia/2021/10/
01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_
story.html, and .
an average population at any one time
of, for example, 100 persons could be
consistent with radically different
numbers of individuals, such as 112
individuals in one facility if one person
left each month and was replaced by
another person, compared to 365 if one
person left each day and was replaced
that same day by another person.
As a specific example, we assume that
about 90 percent of existing LTC facility
residents and 75 percent of existing staff
will have been vaccinated by the date
Phase 1 of this IFC takes effect (we use
the same or similar assumptions for all
provider types). There will be many
new persons in each category during the
first full year of the regulation, and
likely almost all of these will have been
vaccinated elsewhere (for simplicity we
also assume a base rate 95 percent for
this group, almost all of whom will have
previously worked in a health care
facility requiring vaccination).
As presented in the third numeric
column of Table 6, the total number of
employees or otherwise compensated
individuals working in all these
different facilities over the course of a
year is about 13 million persons, which
is almost half again larger than the
annual average number of staff shown in
the first numeric column. A recent
study, using data from detailed payroll
records, found that median turnover
rates for all nurse staff in long term care
facilities is approximately 90 percent a
year, although other estimates are far
lower (see subsequent discussion).238
We have not seen figures this high for
other provider types but some may
approach this level—home health care
is well known for high turnover rates.239
Of course, most of these persons will
have been vaccinated through other
means when they enter the facilities
during the next year. That said, it is
likely that there will be approximately
2.4 million staff at the beginning or
during the first year after this rule is
published who will require vaccination
(rightmost column of Table 6), possibly
preceded in some cases by counseling
efforts or employer inducements.
While this IFC does not expressly
require COVID–19 vaccine counseling
or education, we anticipate that some
providers and suppliers will conduct
such activities as a part of their
procedures for ensuring compliance
with the provisions of this rule. Some
staff counseling can take place in group
settings and some will take place on a
one-to-one level. What works best will
depend on the circumstance of the
employee and the best method for
conveying the information and
answering questions. Staff education,
using CDC or FDA materials, can also
take place in various formats and ways.
Individualized counseling, staff
meetings, posters, bulletin boards, and
e-newsletters are all approaches that can
be used. Informal education may also
occur as staff go about their daily duties,
and some who have been vaccinated
may promote vaccination to others.
Facilities may find that reward
techniques, among other strategies, may
help. For example, monetary or other
benefits such as paid days off could be
given to staff who agree to vaccination.
Even simpler, the employer can bring
vaccination providers onsite to
vaccinate staff (or both staff and
unvaccinated patients). Of importance
in such efforts, the value of
immunization as a crucial component of
keeping patients healthy and well is
already conveyed to staff about
influenza and pneumococcal vaccines.
COVID–19 vaccine persuasion can build
upon that knowledge. The most
important inducement will be the fear of
job loss, coupled with the examples set
by fellow vaccine-hesitant workers who
are accepting vaccination more or less
simultaneously.
One hundred percent success is
unlikely. The HHS Guidelines for
Regulatory Impact Analysis note that
‘‘[i]n most cases, the analysis focuses on
estimating the incremental compliance
costs incurred by the regulated entities,
assuming full compliance with the
regulation, and government costs.’’
These guidelines further recommend
that ‘‘[a]nalysts should consider the
uncertainty associated with an
assumption of full compliance and
provide analysis of alternative
assumptions, as appropriate.’’ 240 In
preparing this analysis, we have
identified several significant sources of
uncertainty for these full-compliance
estimates, one of which stands out.
If only one health care provider in an
area required staff vaccination, then
those who refuse vaccination could quit
and obtain employment at another
location in the same field or type of
position.241 But with many employers
already mandating vaccination, and
with nearly all local (and distant) health
care employers requiring vaccination
under this rule, we expect that such
effects will be minimized (with
exceptions for medical or other
exemptions as required by law). That
said, currently there are endemic staff
shortages for almost all categories of
employees at almost all kinds of health
care providers and supplier and these
may be made worse if any substantial
number of unvaccinated employees
leave health care employment
altogether. In this regard, we note that
because CMS does not regulate health
and safety in physician and dental
offices, or in non-health care settings
such as assisted living facilities, those
entities may provide alternative places
of employment for some of the staff
currently working for providers and
suppliers subject to this IFC who refuse
vaccinations. On the other hand, staff
shortages might be offset by persons
returning to the labor market who were
unwilling to work at locations where
some other employees are unvaccinated
and hence provide some risk, to those
who have completed the primary
vaccination series for COVID–19.
Despite these uncertainties, we have
developed an estimate of staffing
disruption costs, primarily to provide a
complete cost picture even if this
element is particularly uncertain. We
note that these costs and benefits are
highly dependent on whether, for
example, staff vaccination refusals in
coming months are closer to 1 percent
than to 10 percent, and the extent to
which increased confidence in the
safety of working in a health care setting
leads to offsetting increases in the return
of former health care employees to the
workforce. Both variables, in turn, may
depend in significant ways on the
overall labor market and on the ability
of telehealth measures to replace in-
person staff to patient encounters. The
net outcomes of staff turnover over time
could easily exceed or offset the
administrative and vaccination costs we
have estimated. We welcome comments
and information on these issues.
The techniques for staff counseling,
education, and incentives are so
numerous and varied that there is no
simple way to estimate likely costs. Staff
hesitancy may and likely will change
over time as the benefits of vaccination
become clear to increasing numbers of
individuals working in health care
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242 Dorie Seavey, The Cost of Frontline Turnover
in Long-Term Care,’’ Better Jobs Better Care Report,
Washington, DC: Institute for the Future of Aging
Services, American Association of Homes and
Services for the Aging. 2004.
settings. For purposes of estimation, we
assume that, on average, one hour of
staff time or the equivalent will be
devoted to counseling or incentives for
each unvaccinated staff person, at the
same average hourly cost of about $75
estimated for RNs in the Information
Collection analysis. We assume that
these efforts occur during paid working
hours and that all costs will be borne by
the facility. Since we estimate that about
2.4 million employees will need to be
vaccinated (or replaced) in the first year
(rightmost column of Table 6), most in
the first two months after this rule is
published, total costs would be about
$180 million. This estimate assumes
that the 2.4 million will be some mix of
existing and replacement staff. For
example, if 95% of the existing
unvaccinated staff were vaccinated, and
5% of the unvaccinated staff terminated,
then in addition to the normal turnover
of 2.7 million new hires (second column
of Table 6) an additional 114 thousand
(.05 × 2,270) persons would need to be
hired, with 95% of them already fully
vaccinated and the remainder getting
vaccinated as a condition of hiring. For
purposes of this estimate we ignore the
existence of exemptions.
A third major cost component of
compliance with this IFC is the
vaccination, including both
administration and the vaccine itself.
We estimate that the average cost of a
vaccination is what the government
pays under Medicare: $20 × 2 = $40 for
two doses of a vaccine, and $20 × 2 for
vaccine administration of two doses, for
a total of $80 per employee. For
purposes of estimation (and not
reflecting any more knowledge than
recent press accounts), we further
assume that there will be a ‘‘booster’’
shot at the same cost, for a total
vaccination cost of $120 per employee.
While these vaccine costs are currently
incurred by the Federal Government, we
include them to provide an estimate of
total costs, regardless of who pays. In
addition, we expect that a significant
amount of time—one hour on average—
will be used per employee in vaccine
planning, arrangement, and
administration, and related activities for
three vaccinations per currently
unvaccinated employee. Together with
the additional assumption that there
will be an hour RN time or the
equivalent needed for arranging or
administering vaccination, at an average
cost for that hour of $75, the total cost
for vaccination compliance will be $195
per employee. We apply that cost to all
currently unvaccinated employees. Like
counseling and incentives, if 5% of the
existing unvaccinated staff leave and are
replaced by a slightly higher number of
new hires than would otherwise be
needed, a roughly equivalent fraction of
the new hires will need to be vaccinated
before they have patient contact. As a
result, we estimate the total costs of
vaccination to be approximately $466
million (2,390,000 unvaccinated
employees x $195). We note again that
these estimates do not reflect the factor
that multiple vaccine mandates already
do or will soon apply to many and
perhaps most providers covered by our
rule (employers’ own self-imposed
mandates, State and local mandates, and
OSHA ETS, among others). This means
the costs of this rule are overestimated
due to this factor, a conservative
assumption.
Our fourth and final major cost
category is staffing and service
disruptions. As discussed previously, it
is possible there may be disruptions in
cases where substantial numbers of
health care staff refuse vaccination and
are not granted exemptions and are
terminated, with consequences for
employers, employees, and patients. We
do not have a cost estimate for those,
since there are so many variables and
unknowns, and it is unclear how they
might be offset by reductions in current
staffing disruptions caused by staff
illness and quarantine once vaccination
is more widespread. We believe,
however, that the disruptive forces are
weaker than the return to normality. As
shown in Table 6, it is normal for there
to be roughly 2.66 million new hires
(column two) in the health care settings
we address in this rule, compared to a
baseline of roughly 10.4 million staff
(column one). These new hires replace
a roughly equal number of employees
leaving for one reason or another.
Health care providers are already in the
business of finding and hiring
replacement workers on a large scale.
The terminated or self-terminated
workers are not going to disappear.
They still need to earn a living. Many
of the non-clinical staff may will find
employment situations in settings that
are not subject to vaccination mandates.
Cooks, for example, may migrate to
restaurant jobs. But in those cases, a
cook who would otherwise have been
hired by a restaurant may find a newly
vacant health care position requiring
vaccination and accept (or more likely
already have) vaccination. Similarly,
nurses may find jobs in health care
settings that are not subject to
vaccination mandates, such as most
schools or physician offices. But that
means that nurses who would otherwise
have been hired in schools or physician
offices may find jobs in vacant jobs in
health care settings requiring
vaccination and accept (or more likely
already have) vaccination. In a dynamic
labor market such behaviors occur
continuously on a massive scale. If net
employment opportunities and job-
seeking behaviors do not change (and
there is no reason to believe they will),
these continuous adjustments will leave
health care providers and suppliers
subject to this rule with their desired
staff levels, and former employees who
refused vaccination in jobs that do not
require vaccination. Because job seeking
and worker seeking are already
operating on a massive scale in the
health care sector, there is no reason to
expect any massive new costs in such
routine functions as advertising jobs,
checking applicant employment history,
familiarizing new employees with the
nuances of the new employment setting,
training, and all the other steps and
costs involved in the normal workings
of the labor market.
As an example of the likely
magnitude of hiring costs, one analysis
of direct hiring costs for workers in the
long-term care sector (including LTC
facilities, home health care, and ICFs-
IID) found that the direct costs of hiring
new workers was on average about
$2,500 in 2004.242 Assuming that this
amount should be raised to $4,000
based on inflation since then, that a
comparable estimate for higher skills
health care professions would be
$6,000, and that health care workers
covered by this rule are half lower
skilled and half higher skilled, the
recruitment and hiring cost for
additional hires equal to 5 percent of the
normal annual hiring total of 2.4 million
workers would be $600 million (an
average of $5,000 × 120,000). (Costs
could actually be lower because this
study is almost a decade old and
internet services have in recent years
made recruitment and job application
procedures far easier.)
An additional cost category may
result from COVID–19-related staff
shortages, discussed extensively earlier
in this IFC. Although, as noted earlier,
COVID-related staff shortages are
occurring absent the rule due to
numerous factors, such as infection,
quarantine and staff illness. Shortages at
their most acute prevent facilities from
admitting as patients, clients, residents,
or participants persons they would
normally admit for treatment of diseases
or conditions that would in many cases
result in death or serious disability. We
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243 CDC Data Tracker, October 17, 2021 data, at
https://covid.cdc.gov/covid-data-tracker/#health-
care-personnel.
244 For a discussion of this issue, see Sumathi
Reddy, ‘‘How Long Do Covid-19 Vaccines Provide
Immunity?’’, The Wall Street Journal, April 13,
2021, at https://www.wsj.com/articles/how-long-do-
covid-19-vaccines-provide-immunity-11618258094.
245 See Rebecca Robbins, ‘‘Merck Says It Has the
First Antiviral Pill Found to Be Effective Against
Covid,’’ The New York Times, October 1, 2021.
246 As noted above, various populations are
directly or indirectly affected by this rule. Lessened
risk to patients due to staff vaccination, especially
in a setting such as a LTC facility, is arguably an
externality (a canonical market failure), and thus
use of a VSL or VSLY estimate per avoided fatality
or life extension does not represent a divergence
from the concept of revealed preference. On the
other hand, staff members’ own risk raises the
question of how to interpret their hesitation or
unwillingness, in the absence of regulation, to
accept an intervention that achieves extensive
health protection for themselves, with little or no
out-of-pocket cost, and ever-lessening time or
inconvenience cost; a simplistic revealed-
preference monetization of the rule’s effect would
be that it yields minimal or negative benefits for
such staff members, even the ones for whom it
prevents or reduces severity of COVID–19 infection.
However, given the dynamic nature of the
pandemic, it may be that long-run equilibrium for
COVID–19 vaccines has not been reached, in which
case the simplistic approach just mentioned may be
misleading—and the use of a standard VSL or VSLY
for staff-member risk evaluation may reflect
misunderstandings of either vaccine risks or
vaccine benefits.
are not aware of any data that would
enable a reasonably accurate estimate of
the total medical morbidity and
mortality involved, but it is certainly
massive. While it is true that
compliance with this rule may create
some short-term disruption of current
staffing levels for some providers or
suppliers in some places, there is no
reason to think that this will be a net
minus even in the short term, given the
magnitude of normal turnover and the
relatively small fraction of that turnover
that will be due to vaccination
mandates. Moreover, the benefits of
vaccination are not just the lives
directly saved, but the resources that
vaccination frees up because hospital,
LTC facility, and rehabilitation beds are
now available and because health care
staff themselves are not being
incapacitated or killed by COVID–19
infection. The data on cumulative
COVID–19 cases among health care
personnel show 677,000 cases (most of
which incapacitated workers at least
temporarily), and 2,200 deaths, all of
which permanently eliminated those
workers as sources of future care.243
Table 7 shows all of the costs that we
have estimated. As previously
explained, much and perhaps most of
these costs would be incurred under
other concurrent mandates, including
employer-specific decisions, other
Federal standards, and some State and
local government mandates. Since these
efforts overlap in scope, reach, and
timing, there is no basis for assigning
most of these costs to this rule or any
other similar rule.
There are major uncertainties in these
estimates. One obvious example is
whether vaccine efficacy will last more
than the approximately 1 year proven to
date and whether boosters are
needed.244 Some in the scientific
community believe that ‘‘booster’’
vaccinations after 6 or 8 months would
be desirable to maintain a high level of
protection against the predominant
Delta version of the virus. Delta may be
overtaken by other virus mutations,
which creates another uncertainty.
Booster vaccination or use of vaccines
whose licenses or EUAs have been
amended to address new variants would
likely maintain the effectiveness of
vaccination for residents and staff. At
this time, as to second (and succeeding)
year effects we assume no further major
changes in vaccine effectiveness. Yet
another uncertainty is treatment costs,
with a recently announced antiviral pill
that could potentially provide
substantial reductions in severity of
illness and subsequent treatment costs,
on a time schedule as yet unknown.245
D. Anticipated Benefits of the Interim
Final Rule With Comment Period
There will be more than 180 million
staff, patients, and residents employed
or treated each year in the facilities
covered by this rule. In our analysis of
first-year benefits of this rule we focus
first on prevention of death among staff
of facilities as well as on reduction in
disease severity. Second, we focus on
resulting benefits from avoiding
infection by unvaccinated staff among
patients served in these facilities, who
are likely to benefit more substantially
because patients receiving health care in
such facilities are disproportionately
older than working age adults and are
therefore more susceptible to severe
illness or death from COVID–19. A third
group of beneficiaries are staff family
members and caregivers and many other
persons outside the health care settings
who staff might subsequently infect if
not vaccinated. We focus initially on
LTC facilities because their residents
and patients have been among the most
severely affected by COVID–19 as well
as illustrating all the estimating issues
involved, but the same estimates,
uncertainties, and calculations apply to
all types of providers and suppliers in
varying degrees.
HHS’s Guidelines for Regulatory
Impact Analysis outline a standard
approach to valuing the health benefits
of regulatory actions. The approach for
valuing mortality risk reductions is
based on the value per statistical life
(VSL), which estimates individuals’
willingness to pay (WTP) to avoid fatal
risks. The approach to valuing
morbidity risk reductions is based on
measures of the WTP to avoid non-fatal
risks when specific estimates are
available, and based on measures of the
duration and severity of the illness,
including quality of life consequences,
when suitable WTP estimates are not
available.246 Based on this approach, the
Office of the Assistant Secretary for
Planning and Evaluation published a
report that develops an approach for
valuing COVID–19 mortality and
morbidity risk reductions.
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247 The risk of death from infection from an
unvaccinated 75- to 84-year-old person is 320 times
more likely than the risk for an 18- to 29-years old
person. CDC, ‘‘Risk for COVID–19 Infection,
Hospitalization, and Death by Age Group’’, at
https://www.cdc.gov/coronavirus/2019-ncov/covid-
data/investigations-discovery/hospitalization-
death-by-age.html.
248 We note that as long as most of the world’s
population remains unvaccinated, another variant
of the vaccine might arise and create new risks or
shifts in risks within the U.S. That said, the world-
wide shortage of vaccines is essentially over taking
into account both stocks and existing
manufacturing capacity and the biggest problem
abroad is getting the available vaccines rapidly into
the billions of people who need them.
249 https://aspe.hhs.gov/pdf-report/guidelines-
regulatory-impact-analysis.
250 We note that the VSL is based on a sample of
individuals whose average age is 40, This leads to
complexities in estimates for populations who are
much younger or older, including LTC residents.
See Lisa Robinson and James K. Hammit, ‘‘Valuing
Reductions in Fatal Illness Risks: Implications of
Recent Research,’’ Health Economics, August 2016,
pp. 1039–1052.
251 For the full likelihood distributions for all age
ranges, see the CDC age distribution table
previously referenced .
252 Hanmer, J. W.F. Lawrence, J.P. Anderson, R.M.
Kaplan, D.G. Fryback. 2006. ‘‘Report of Nationally
Representative Values for the Noninstitutionalized
US Adult Population for 7 Health-Related Quality-
of-Life Scores.’’ Medical Decision Making. 26(4):
391–400.
253 Deaths are from COVID–19 Nursing Home
Data, CMS, Week Ending 2/21/2021, at https://
data.cms.gov/stories/s/COVID-19-Nursing-Home-
Data/bkwz-xpvg/.
In addition to the avoided death and
human suffering, one of the major
benefits of vaccination is that it lowers
the cost of treating the disease among
those who would might otherwise be
infected and have serious morbidity
consequences. The largest part of those
costs is for hospitalization. As discussed
later in the analysis we provide data on
the average costs of hospitalization of
these patients (it is, however, unclear as
to how much that cost will change over
time due to improving treatment
options).
There is a potential offset to benefits
that we have not estimated because we
believe it is at this time not relevant in
the U.S. If vaccine supplies did not meet
all demands for vaccination, giving
priority to some persons over others
necessarily meant that some persons
would become infected who would not
have been infected had the priorities
been reversed. In this case, however, the
priority for older adults (virtually all of
whom have risk factors) who comprise
the majority of hospital inpatients and
the vast majority of LTC facility
residents has already been established
and is largely met. This rule provides a
priority for staff at a far lower risk of
mortality and severe disease that
benefits both groups.247 It achieves this
benefit because by preventing the
spread of COVID–19 from provider and
supplier staff, it actually provides a
higher mortality and morbidity
reduction for patients at far higher risk
than the staff who become
vaccinated.248
The HHS ‘‘Guidelines for Regulatory
Impact Analysis’’ explain in some detail
the concept of Quality Adjusted Life
Years (QALYs).249 QALYs, when
multiplied by a monetary estimate such
as the Value of a Statistical Life Year
(VSLY), are estimates of the value that
people are willing to pay for life-
prolonging and life-improving health
care interventions of any kind (see
sections 3.2 and 3.3 of the HHS
Guidelines for a detailed explanation).
The QALY and VSLY amounts used in
any estimate of overall benefits are not
meant to be precise, but instead are
rough statistical measures that allow an
overall estimate of benefits expressed in
dollars.
Under a common approach to benefit
calculation, we can use a Value of a
Statistical Life (VSL) to estimate the
dollar value of the life-saving benefits of
a policy intervention, for a person who
more broadly represent a mixture of
ages. We use the VSL of approximately
$11.5 million in 2021 as described in
the HHS Guidelines, adjusted for
changes in real income and inflated to
2020 dollars using the Consumer Price
Index.250 Using LTC facilities as an
example, and assuming that the average
rate of death from COVID–19 (following
SARS–CoV–2 infection) at typical LTC
facility resident ages and conditions is
5 percent, and the average rate of death
after vaccination is essentially zero, the
expected value of each resident who
would, in the absence of this rule,
otherwise be infected with SARS–CoV–
2 is about $575,000 ($11.5 million ×
.05). For staff, who are generally of
working ages in roughly the same
proportions as the population at large,
the typical rate of death for the full
course of two vaccines (or possibly three
with a booster) is roughly 1 percent of
the older adult rate, and the expected
value for each employee receiving the
same vaccinations is about $57,500
($11.5 million × .005).251 For
community residents who unvaccinated
staff might infect, the resulting
calculation is similar (actually
somewhat lower because the risk of
death from COVID–19 is even lower for
those below employment ages).
Under a second approach to benefit
calculation, we can estimate the
monetized value of extending the life of
LTC facility residents, which is based
on expectations of life expectancy and
the value per life-year. As explained in
the HHS Guidelines, the average
individual in studies underlying the
VSL estimates is approximately 40 years
of age, allowing us to calculate a value
per life-year of approximately $590,000
and $970,000 for 3 and 7 percent
discount rates respectively. This
estimate of a value per life-year
corresponds to 1 year at perfect health.
(These amounts might reasonably be
halved for average LTC facility
residents, since non-institutionalized
U.S. adults aged 80–89 years report
average health-related quality of life
(HRQL) scores of 0.753, and this figure
is likely to be lower for LTC facility
residents.252) Assuming that the average
life expectancy of long term care
residents is 5 years, the monetized
benefits of saving one statistical life
would be about $3.0 million ($590,000
x annually for 5 years) at a 3 percent
discount rate and about $4.8 million
($970,000 x annually for 5 years) at a 7
percent discount rate. Assuming that the
average rate of death from COVID–19
(SARS–CoV–2 infection) at LTC facility
resident ages and conditions is 5
percent, and the average rate of death
after vaccination is essentially zero, the
expected life-extending value of each
resident who would otherwise be
infected is $150 thousand at a 3 percent
discount rate and $240 thousand at a 7
percent discount rate. A similar
calculation can be made for staff and for
the community residents they might
infect, who will gain many more years
of life but whose risk of death is far
smaller since their age distribution is so
much younger. Deaths from COVID–19
in unvaccinated LTC facility residents
during 2020 were about 130,000, or
close to one tenth of the average LTC
facility resident census of 1.4 million, a
huge contrast to the handful of deaths
in the vaccination results from Israel.253
We do not have sufficient data so as to
accurately estimate annual resident
inflows and outflows over time, but it is
clear that over two million new
residents and over 700,000 new
employees make the total number of
individuals involved during the year far
higher than point in time or average
counts. Moreover, these counts do not
include family members and other
visitors, whose total visits certainly
number in the millions.
Most of the preceding calculations
address residential long-term care. Long
term care residents are a major group
within LTC facilities and are generally
in the LTC facility because their needs
are more substantial and they need
assistance with the activities of daily
living, such as cooking, bathing, and
dressing. These long-term stays are
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254 For a discussion on this problem, see
‘‘Medicare and You: at https://www.medicare.gov/
medicare-and-you
255 In fact, the average length of stay for skilled
nursing care is about 25 days. See MEDPAC, Report
to the Congress: Medicare Payment Policy, March
2019, ‘‘Skilled nursing facility services,’’ page 200.
256 See the previously cited CDC report on risks
by age group. In the age intervals used by CDC, the
40–49-year-old group is in the middle of typical
employment age ranges. The risk of death in this
age group is one tenth that of those aged 65–74. We
emphasize with round numbers that nothing about
these data is fixed and unlikely to change (for
example, as better future treatments are used to
treat severe cases).
257 The New York Times ‘‘Nearly One-Third of
U.S. Coronavirus Deaths Are Linked to Nursing
Homes, June 1, 2021.
258 This is not a robust estimate but is supported
by several sources. See for example Jiangzhuo Chen
et al, ‘‘Medical costs of keeping the US economy
open during COVID–19,’’ Scientific Reports,
Nature.com, July 19 2020, at https://
pubmed.ncbi.nlm.nih.gov/32743613/, and Michel
Kohli et al, ‘‘The potential public health and
economic value of a hypothetical COVID–19
vaccine in the United States: Use of cost-
effectiveness modeling to inform vaccination
prioritization,’’ Science Direct, February 12, 2021,
at https://pubmed.ncbi.nlm.nih.gov/33483216/.
primarily funded by the Medicaid
program (also, through long term care
insurance or self-financed), and the
custodial care services these residents
receive are not normally covered by
Medicare or any other health
insurance.254 A second major group
within the same facilities receives short-
term skilled nursing care services. These
services are rehabilitative and generally
last only days, weeks, or months. They
usually follow a hospital stay and are
primarily funded by the Medicare
program or other health insurance. The
importance of these distinctions is that
the numbers of residents and typical
ages in each category regulated under
this rule in each category are different.
The average number of persons in
facilities for long term care over the
course of a year is about 1.2 million
residents (as is the point-in-time
number), and the total number of
persons over the course of a year is
about 1.6 million. The average number
in skilled nursing care at any one time
is about 2 thousand persons, because
the average length of stay is weeks
rather than years and the median length
of stay is days rather than weeks.255 The
annual turnover in this group is such
that about 2.3 million residents are
served each year. There is some overlap
between these two populations and the
same person may be admitted on more
than one occasion. For purposes of this
analysis (these are rough estimates
because there are no data routinely
published on patient and resident
turnover or providing unduplicated
counts of persons served), we assume
that the expected longevity for each
group is identical on average, and that
a total of 3.9 million different persons
are served each year. The employee staff
are a third group and the direct target of
these rules. Since both long-term and
short-term residents are for the most
part served in the same facilities, their
care is managed and provided by the
same facility staff.
These nursing facilities have about
950,000 full-time equivalent employees
at any one time and another 100,000
visiting staff or the equivalent, all
covered by this rule. For these persons,
the average age is about 45, which
creates two offsetting effects: they have
more years of life expectancy than
residents, but their risk of death from
COVID–19 is far lower. For purposes of
this analysis, we assume that
vaccination against COVID–19 is
effective for at least 1 year and use a 1-
year period as our primary framework
for calculation of potential benefits, not
as a specific prediction but as a likely
scenario that avoids forecasting major
and unexpected changes that are either
strongly adverse or strongly beneficial.
If we were adding up totals for benefits
we would assume that the risk of death
after COVID–19 infection is likely only
one-half of one percent (one tenth of the
resident rate) or less for the
unvaccinated members of this group,
reflecting the far lower mortality rates
for persons who are almost all in the 18
to 65 year old age ranges compared to
the far older residents.256 We assume
that the total number of individual
employees is 50 percent higher than the
full-time equivalent but that only half
that number are primarily employed at
only one nursing facility, two offsetting
assumptions about the number of
employees working at each facility
(many employees are part-time
consultants or the equivalent who serve
multiple nursing facilities on a part-time
basis). We further assume that employee
turnover is 80 percent a year, lower than
the results for nurses previously cited.
Accordingly, we estimate that 80
percent of 950,000, or 760,000, are new
employees each year and must be
offered vaccination (again, most are
already vaccinated), for a total of
1,710,000 eligible employees over the
course of a year. (This number would
likely drop in future years as employers
decide to hire only persons previously
vaccinated and as vaccine uptake
increases due to Federal, State, local, or
employer requirements, as well as
individual choice.)
We have some data on the costs of
treating serious illness among the
unvaccinated who become infected, are
hospitalized, and survive. Among those
age 65 years or above, or with severe
risk factors, over 30 percent of those
known to be infected required
hospitalization in the first year of the
pandemic.257 That fraction is far lower
now as treatments have improved and
as vaccinations have greatly reduced
severity of the disease. Among adults
aged 21 years to 64 years, about 10
percent of those infected once required
hospitalization, but that fraction is now
far lower for the same reasons. For our
estimates, we assume a 10 percent
hospitalization rate among people aged
65 years or older in LTC facilities,
reflecting both that their conditions are
significantly worse than those of
similarly aged adults living
independently, and that pre-
hospitalization treatments have
improved. For staff we assume one fifth
of this rate, or 2 percent. Using LTC
facilities as our main example, the LTC
facility candidates for vaccination in the
first year covered by this rule, about
three-fourths are age 65 years or above.
Hence, the age-weighted hospitalization
rate that we project is about 8 percent.
Among those hospitalized at any age,
the average cost is about $20,000.258
To put these cost, benefit, and volume
numbers in perspective, vaccinating one
hundred previously unvaccinated LTC
facility residents who would otherwise
become infected with SARS–CoV–2 and
have a COVID–19 illness would cost
approximately $18,000 ($183 × 100) in
vaccination costs. Using the VSL
approach to estimation would produce
life-saving benefits of about $400,000 for
these 100 people ($20,000 × 100 × .05),
again assuming the death rate for those
ill from COVID–19 of this age and
condition is one in twenty. Reductions
in health care costs from hospitalization
would produce another $160,000
($20,000 × 100 × .08) in benefits for this
group assuming that 8 percent would
otherwise be hospitalized. However,
this comparison should be taken as
necessarily hypothetical and contingent
due to the analytic, data, and
uncertainty challenges discussed
throughout this regulatory impact
assessment. Patient benefits are simply
a consequence of fewer infections
among staff. Vaccinating one hundred
previously unvaccinated LTC facility
employees would be higher than for
staff. Life-saving benefits to employees
would be about $5,300,000 ($10,600,000
VSL × 100 × .005) for 100 people
assuming that the death rate for these far
younger 100 people is 1 in 500 hundred.
Reductions in health care costs from
hospitalizations of employees would
produce another $20,000 ($20,000 × 100
× .01).
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259 For a survey of the evidence on this issue, see
Gillian K. Steelfisher et al, ‘‘An Uncertain Public—
Encouraging Acceptance of Covid–19 Vaccines,’’
The New England Journal of Medicine, March 3,
2021.
260 CDC Data Tracker at https://covid.cdc.gov/
covid-data-tracker/#health-care-personnel_
healthcare-deaths.
There remain difficult questions of
estimating (1) likely numbers of
individuals in staff and patient
categories who are likely to be
unvaccinated when the rule goes into
effect and (2) numbers of staff likely to
be willing to accept vaccination in the
coming months and years.259 Both sets
of numbers vary substantially by
provider and supplier type. LTC facility
and home health care patients are on
average both the oldest and most health-
impaired of those in settings covered by
this rule. At the other extreme, rural and
other community-care oriented health
centers serve the full age spectrum and
a lower fraction of severely health-
impaired.
We do know that the life-saving
benefits for staff are probably small but
significant. During the entire period of
COVID–19 infections, since March 2020,
there have been over 2,000 health care
staff deaths recorded by the CDC
through October 3, 2021.260 Of these,
the great majority were in the year 2020.
Even during the recent Delta variant
surge, health care staff deaths decreased
to lower levels. Specifically, during the
last 6 months, April through September
2021, total staff deaths were 202, an
average of 34 per month and no clear
trend (the last 4 weeks, all in
September, 2021 produced fewer than
20 deaths). This is not surprising as the
most effective precautions other than
vaccination—masks, social distancing,
and ventilation—have been essentially
universal in the health care sector
during all of 2021. Even more
importantly, vaccination rates are
considerably higher than in the
population at large (although still well
below optimal levels). Yet, using the last
6 months of CDC Data Tracker
information, on an annual basis more
than 400 deaths could be expected.
These data, moreover, are almost all
among unvaccinated persons and are
probably undercounted in current data.
A major caution about these
estimates: None of the sources of
enrollment information for these
programs regularly collect and publish
information on client or staff turnover
during a year. These data have not
previously been found useful in
program management for individual
agencies or programs, or when needed
have been addressed through one-time
research projects. The estimates in this
analysis are based on inferences from
scattered data on average length of stay,
mortality, job vacancies, news accounts,
and other sources that by happenstance
are available for one type of facility or
type of resident or another. Nor do we
have data on the number of persons in
these settings who will be vaccinated
through other means during the
remainder of the year.
All these data and estimation
limitations apply to even the short-term
impacts of this rule, and major
uncertainties remain as to the future
course of the pandemic, including but
not limited to vaccine effectiveness in
preventing ‘‘breakthrough’’ disease
transmission from those vaccinated, the
long-term effectiveness of vaccination,
the emergence of treatment options, and
the potential for some new disease
variant even more dangerous than Delta.
Another unknown is what currently
unvaccinated employees would do
when the vaccination deadline is
reached, and how rapidly those quitting
rather than being vaccinated could be
replaced. Even a small fraction of
recalcitrant unvaccinated employees
could disrupt facility operations. On the
other hand, there have been significant
reductions in provider and supplier
staffing needs in some categories. For
example, LTC facility admissions have
declined in the last year, as families and
caregivers sought to avoid the risks of
exposing a care recipient to
unvaccinated residents and staff in LTC
facilities. The new vaccination
requirement may reduce such fears and
bring higher numbers of residents to
these facilities and the essential services
they provide. Again, we have no way to
estimate such behavioral changes.
Regardless, we believe it is clear that
reductions in patient/resident fatalities
through avoiding staff-generated
infections are both likely to be a
significantly larger benefit from staff
vaccination than direct benefits to staff.
Staff vaccination will also provide
significant community benefits when
staff are not at work. Hence, total lives
saved under this rule may well reach
several hundred a month or perhaps
several thousand a month for all three
groups in total. Patient and resident
benefits are especially likely to be many
times higher because the risks of death
and serious disease complications are so
many times higher among older persons
and people with multiple chronic
conditions.
As indicated by the preceding
analysis, predicting the full range of
benefits and costs in either the short run
or the next full year with any degree of
estimating precision is all but
impossible. As the minimum benefit
level needed for benefits to exceed
costs, however, we estimate that either
saving 120 lives, or preventing 600
hundred hospitalizations for serious
illness, or any combination of these two
magnitudes, would produce benefits
that exceed our estimate of costs over
the next year. There have been about
200 staff deaths in the last 6 months and
this is a likely undercount for this one
category of persons alone, and potential
life-saving benefits to more than 150
million mostly elderly patients and
residents (about 10 percent of whom are
likely to remain unvaccinated) who are
exposed to provider staff probably
would be many times higher. We note,
however, as discussed in the preceding
section on costs, much of these benefits
could be as well attributed to other
concurrent and parallel vaccination
mandates and campaigns.
E. Other Effects
1. Sources of Payment
The initial costs of this rule fall
almost entirely on health care providers
and suppliers and are extremely small
in comparison to the $4 trillion a year
spent on health care, mostly through
these same entities. In particular, the
costs of the vaccines are paid by the
Federal Government and vaccine costs
are about two-thirds of the total costs we
have estimated. Moreover, through the
treatment cost savings to the hospitals
and other care providers resulting from
the vaccinations that will be made due
to this rule, significant savings would
accrue to payers. It is likely that half or
more of these savings would primarily
accrue to Medicare given the age or
disability status of most clients and
Medicare’s role as primary payer, but
there would also be substantial savings
to Medicaid, private insurance paid by
employers and employees, and private
out-of-pocket payers including patients
and residents. In some rare cases funds
under the CARES Act and the American
Rescue Plan Act of 2021 might be
available at State or local discretion, but
it is hard to foresee any substantial
budgetary impact on any insurance plan
or service provider that would justify or
require such assistance.
2. Regulatory Flexibility Act
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. Under the RFA, ‘‘small
entities’’ include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Individuals
and states are not included in the
definition of a small entity. For
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purposes of the RFA, we estimate that
most health care facilities are small
entities as that term is used in the RFA
because they are either nonprofit
organizations or meet the SBA
definition of a small business (having
revenues of less than $8.0 million to
$41.5 million in any 1 year). HHS uses
an increase in costs or decrease in
revenues of more than 3 to 5 percent as
its measure of ‘‘significant economic
impact.’’ The HHS standard for
‘‘substantial number’’ is 5 percent or
more of those that will be significantly
impacted, but never fewer than 20.
As estimated previously, the total
costs of this rule for 1 year are about
$1.3 billion, most of which is directly
proportional to number of employees.
Spread over 10.4 million full-time
equivalent employees, this is about $125
per employee. Assuming a fully loaded
average wage per employee of $90,000,
the first-year cost does not approach the
3 percent threshold. Moreover, since
much of these costs (in particular, the
vaccine costs paid by the Federal
Government) will not fall on providers
or suppliers, the financial strain on
these facilities should be negligible.
Finally, as previously discussed, there
are other concurrent mandates and
much of these costs could as well be
attributed to those efforts. Therefore, the
Department has determined that this
IFC will not have a significant economic
impact on a substantial number of small
entities and that a final RIA is not
required. Finally, this IFC was not
preceded by a general notice of
proposed rulemaking and the RFA
requirement for a final regulatory
flexibility analysis does not apply to
final rules not preceded by a proposed
rule. Regardless, this RIA and the main
preamble, taken together, would meet
the requirements for either an Initial or
Final Regulatory Flexibility Analysis.
3. Small Rural Hospitals
Section 1102(b) of the Act requires us
to prepare an RIA if a proposed rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. For purposes of
this requirement, we define a small
rural hospital as a hospital that is
located outside of a metropolitan
statistical area and has fewer than 100
beds. Because this rule has only the
small impact per employee calculated
for RFA purposes, the Department has
determined that this IFC will not have
a significant impact on the operations of
a substantial number of small rural
hospitals. This IFC is also exempt
because that provision of law only
applies to final rules for which a
proposed rule was published. That said,
early indications are that rural hospitals
are having greater problems with
employee vaccination refusals than
urban hospitals, and we welcome
comments on ways to ameliorate this
problem.
4. Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates will impose
spending costs on State, local, or tribal
governments, or by the private sector,
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2021, that
threshold is approximately $158
million. This rule contains no State,
local, or tribal governmental mandates,
but does contain mandates on private
sector entities that exceed this amount.
However, this IFC was not preceded by
a notice of proposed rulemaking, and
therefore the requirements of UMRA do
not apply. The analysis in this RIA and
the preamble as a whole would,
however, meet the requirements of
UMRA.
5. Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This rule would pre-empt some State
laws that prohibit employers from
requiring their employees to be
vaccinated for COVID–19. Consistent
with the Executive Order, we find that
State and local laws that forbid
employers in the State or locality from
imposing vaccine requirements on
employees directly conflict with this
exercise of our statutory health and
safety authority to require vaccinations
for staff of the providers and suppliers
subject to this rule. Similarly, to the
extent that State-run facilities that
receive Medicare and Medicaid funding
are prohibited by State or local law from
imposing vaccine mandates on their
employees, there is direct conflict
between the provisions of this rule
(requiring such mandates) and the State
or local law (forbidding them). As is
relevant here, this IFC preempts the
applicability of any State or local law
providing for exemptions to the extent
such law provides broader grounds for
exemptions than provided for by
Federal law and are inconsistent with
this IFC. In these cases, consistent with
the Supremacy Clause of the
Constitution, the agency intends that
this rule preempts State and local laws
to the extent the State and local laws
conflict with this rule. The agency has
considered other alternatives (for
example, relying entirely on measures
such as voluntary vaccination, source
control alone, and social distancing) and
has concluded that the mandate
established by this rule is the minimum
regulatory action necessary to achieve
the objectives of the statute. Given the
contagion rates of the existing strains of
coronavirus and their disproportionate
impacts on Medicare and Medicaid
beneficiaries, we believe that
vaccination of almost all staff of covered
providers and suppliers is necessary to
promote and protect patient health and
safety. The agency has examined case
studies from other employers and
concludes that vaccine mandates are
vastly more effective than other
measures at achieving ideal vaccination
rates and the resulting patient
protections from morbidity and
mortality. Given the emergency
situation with respect to the Delta
variant detailed more fully above, time
did not permit usual consultation
procedures with the States, and such
consultation would therefore be
impracticable. We are, however, inviting
State and local comments on the
substance as well as legal issues
presented by this rule, and on how we
can fulfill the statutory requirements for
health and safety protections of patients
if we were to exempt any providers or
suppliers based on State or local
opposition to this rule.
F. Alternatives Considered
As discussed earlier in the preamble,
a major substantive alternative that we
considered was to limit COVID–19
vaccination requirements to full-time
employees rather than to all persons
who may provide paid or unpaid
services, such as visiting specialists or
volunteers, who are not on the regular
payroll on a weekly or more frequent
basis that is, individuals who work in
the facility and in some cases
infrequently or unpredictably, as well as
individuals who are not on the payroll
at all. We concluded that covering these
persons would be readily manageable
without creating major issues for
compliance, enforcement, and record-
keeping. We did not, however, include
some categories of visitors who do not
have a business relationship with the
provider, such as family member
visitors. There are also many issues
such as social isolation and loneliness
related to potential discouragement of
visiting volunteers or family members.
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261 See Medicare and Medicaid Programs: Organ
Procurement Organizations Conditions for
Coverage: Revisions to the Outcome Measure
Requirements for Organ Procurement
Organizations, 85 FR page 77898, December 2,
2020.
We also considered whether it would
be appropriate to limit COVID–19
vaccination requirements to staff who
have not previously been infected by
SARS–CoV–2. There remain many
uncertainties about as to the strength
and length of this immunity compared
to people who are vaccinated, and—in
recognizing that—the CDC recommends
that previously infected individuals get
vaccinated. Exempting previously
infected individuals would have
potentially reduced benefits while
reducing costs, both roughly in
proportion to the number affected. It
would have also, complicated
administration and likely require
standards that do not now exist for
reliably measuring the declining levels
of antibodies over time in relation to
risk of reinfection. Because of current
CDC guidance and understanding of
relevant scientific findings, we found
that it was not warranted to exempt
previously infected individuals.
Another option would be to devise a
standard with graduated compliance
expectations such as 90 percent and
then 95 percent and then 100 percent of
staff vaccinated and a time period in
which to reach each level. A variation
of this would be to put providers on a
probationary period if they failed to
reach 100 percent compliance by the
date set in the rule, and were allowed
additional time in which to cross that
last threshold. Yet another variation
would be to reduce payment to
providers and suppliers not meeting the
standard after the initial deadline. We
recently put a phased system in place
for Organ Procurement Organizations
(OPOs), so we are not reflexively
opposed to such options.261
Nonetheless, there are two major
arguments against such a system in the
context of this rule. First, to have any
usefulness the time periods would have
to have a reasonably extensive duration,
such as a month each. But that would
be almost the same as extending this
rule’s deadline for an extra several
months. We do not believe that
extending the deadline to extend the
employment of staff who will simply
delay vaccination or final refusal to the
last possible moment is in the interest
of other staff, patients, and patients who
would utilize the provider for needed
health care if they did not fear
unvaccinated staff. Second, it would not
only delay the achievement of both staff
and patient safety, but encourage
procrastination. For those few staff
absolutely unwilling to accept
vaccination, it would simply delay the
day of final action and the day of hiring
a vaccinated replacement. In the case of
the OPO rule, an entire organization had
to be slowly reformed to achieve
compliance. In the context of this rule,
and the lives at stake, there is no
obvious ethical or managerial reason to
give a relative handful of vaccination-
resisting individuals more time until
they leave the organization. It would
give management more time to find
replacements, but it is not at all clear
that this would be a fruitful grace
period.
As for a variation reducing payment
to non-performing providers, perhaps by
20 percent per patient over some
applicable time period, this would
arguably provide something better than
an ‘‘all of nothing’’ removal from
provider status. It would require
legislation but that is not a barrier to
meeting E.O. 12866 analysis standards
and in some rules may be essential to
a valid benefit-cost analysis. The
problem with this variation, however, is
that for most providers and suppliers is
it unlikely to be a realistic choice.
Rather than accept lower payment
levels, management can simply
terminate the unvaccinated employees,
a power they have with or without the
reduced payment alternative. Moreover,
it would be hard to devise a system that
treated equally and fairly providers of
all sizes—whether with 5 or 50
employees. We further note that CMS
already has and uses discretion in
enforcement when inspectors find a
violation. Termination of provider
status is not normally an immediate
consequence, as entities are typically
given the opportunity to correct
deficiencies. Regardless, we welcome
comments on this overall option and its
variations, and on the closely-related
option of simply adding a month to the
compliance deadline in this rule. We
considered what standards to apply
regarding proof of compliance with
exemptions requests base on medical
contraindications and religious
objections. We decided to establish
minimal compliance burdens for both
categories of exemptions. This decision
on the evidentiary standards could be
revisited should an abuse problem arise
on a significant scale. This may open
the door to forged documents or false
statements, and therefore validation of
such claims raises administrative costs.
Accordingly, we have allowed for
relatively relaxed standards for
verification in our administrative
provisions and cost estimates but may
reconsider in the future. We considered
alternative timelines for implementation
but decided that this would not only
delay badly needed live-saving
compliance, but also provide little real
management benefit to providers and
suppliers. Staff have had almost a year
to consider COVID–19 vaccinations that
are in their own interests as well as vital
to patient protections and the protection
of other workers. In this regard we note
that one of the claimed barriers to
vaccination has recently been removed,
now that one vaccine is now no longer
emergency-authorized, but fully
licensed. We believe our requirements
provide more than enough time for
reasonable counselling and other
management measures.
Finally, we considered requiring daily
or weekly testing of unvaccinated
individuals. We have reviewed
scientific evidence on testing and found
that vaccination is a more effective
infection control measure. As such, we
chose not to require such testing for
now but welcome comment. Of course,
nothing prevents a provider from
exercising testing precautions
voluntarily in addition to vaccination.
We note that nothing in this rule
removes the obligation on providers and
suppliers to meet existing requirements
to prevent the spread of infection,
which in practice means that these
entities may also conduct regular testing
alongside such actions as source control
and physical distancing. CMS will
continue to review the evidence and
stakeholder feedback on this issue.
These and some lesser options are
presented and discussed in the main
preamble. We do not have reliable
dollar estimates for either costs or
benefits of any alternatives, for the
reasons already discussed in the RIA
regarding the options we chose. We
welcome comments on these or other
options.
G. Accounting Statement and Table
The Accounting Table summarizes
the quantified impact of this rule. It
covers only 1 year because there will
likely be many developments regarding
treatments and vaccinations and their
effects in future years and we have no
way of knowing which will most likely
occur. A longer period would be even
more speculative than the current
estimates. Nonetheless, assuming no
major unforeseen events that would
impinge on our estimates, we would
expect lower costs in future years if for
no other reason than increases in the
fraction of new hires already vaccinated
as well as other positive results from the
President’s plan or individual
vaccination decisions. We further note
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that the vaccinations, and hence the
benefits and costs, estimated for this
rule are more or less simultaneously
being created voluntarily by some
employers (self-mandates), through the
OSHA vaccination rule applicable to
employers of 100 or more persons, and
by some State or local mandates. There
is no simple and non-arbitrary way to
disentangle which vaccination benefits
and which vaccination costs are due to
which source.
As explained in various places within
this RIA and the preamble as a whole,
there are major uncertainties as to the
effects of current variants of SARS–
CoV–2 on future infection rates, medical
costs, and prevention of major illness or
mortality. For example, the duration of
vaccine effectiveness in preventing
COVID–19, reducing disease severity,
reducing the risk of death, and the
effectiveness of the vaccine to prevent
disease transmission by those
vaccinated are not currently known.
These uncertainties also impinge on
benefits estimates. For those reasons we
have not quantified into annual totals
either the life-extending or medical cost-
reducing benefits of this rule and have
used only a 1-year projection for the
cost estimates in our Accounting
Statement (our first-year estimates are
for the last two months of 2021 and the
first ten months of 2022). We also show
a large range for the upper and lower
bounds of potential costs to emphasize
the uncertainty as to several major
variables, such as changes in voluntary
vaccination levels, longer term effects,
and others previously discussed. We
welcome comments on all of our
assumptions and welcome any
additional information that would
narrow the ranges of uncertainty or
guide us in any important revisions to
the requirements established in what is
an ‘‘interim’’ final rule.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
Chiquita Brooks-LaSure,
Administrator of the Centers for
Medicare & Medicaid Services,
approved this document on October 19,
2021.
List of Subjects
42 CFR Part 416
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 418
Health facilities, Hospice care,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 441
Aged, Family planning, Grant
programs—health, Infants and children,
Medicaid, Penalties, Reporting and
recordkeeping requirements.
42 CFR Part 460
Aged, Citizenship and naturalization,
Civil rights, Health, Health care, Health
records, Incorporation by reference,
Individuals with disabilities, Medicaid,
Medicare, Religious discrimination,
Reporting and recordkeeping
requirements.
42 CFR Part 482
Grant program—-health, Hospitals,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 483
Grant programs—health, Health
facilities, Health professions, Health
records, Medicaid, Medicare, Nursing
homes, Nutrition, Reporting and
recordkeeping requirements, Safety.
42 CFR Part 484
Administrative practice and
procedure, Grant programs—health,
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
42 CFR Part 485
Grant programs—health, Health
facilities, Medicaid, Privacy, Reporting
and recordkeeping requirements.
42 CFR Part 486
Administrative practice and
procedure, Grant programs—health,
Health facilities, Home infusion
therapy, Medicare, Reporting and
recordkeeping requirements, X-rays.
42 CFR Part 491
Grant programs—health, Health
facilities, Medicaid, Medicare,
Reporting and recordkeeping
requirements, Rural and urban areas.
42 CFR Part 494
Diseases, Health facilities,
Incorporation by reference, Medicare,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 416—AMBULATORY SURGICAL
SERVICES
■1. The authority citation for part 416
continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
■2. Amend § 416.51 by adding
paragraph (c) to read as follows:
§ 416.51
Conditions for coverage—
Infection control.
*
*
*
*
*
(c) Standard: COVID–19 vaccination
of staff. The ASC must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following center staff, who provide
any care, treatment, or other services for
the center and/or its patients:
(i) Center employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
center and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following center staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the center setting and who do
not have any direct contact with
patients and other staff specified in
paragraph (c)(1) of this section; and
(ii) Staff who provide support services
for the center that are performed
exclusively outside of the center setting
and who do not have any direct contact
with patients and other staff specified in
paragraph (c)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (c)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine,
prior to staff providing any care,
treatment, or other services for the
center and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (c)(1) of this
section are fully vaccinated, except for
those staff who have been granted
exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (c)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the center has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains:
(A) All information specifying which
of the authorized or licensed COVID–19
vaccines are clinically contraindicated
for the staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the center’s
COVID–19 vaccination requirements
based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 418—HOSPICE CARE
■3. The authority citation for part 418
continues to read as follow:
Authority: 42 U.S.C. 1302 and 1395hh.
■4. Amend § 418.60 by adding
paragraph (d) to read as follows:
§ 418.60
Condition of participation:
Infection control.
*
*
*
*
*
(d) Standard: COVID–19 Vaccination
of facility staff. The hospice must
develop and implement policies and
procedures to ensure that all staff are
fully vaccinated for COVID–19. For
purposes of this section, staff are
considered fully vaccinated if it has
been 2 weeks or more since they
completed a primary vaccination series
for COVID–19. The completion of a
primary vaccination series for COVID–
19 is defined here as the administration
of a single-dose vaccine, or the
administration of all required doses of a
multi-dose vaccine.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following hospice staff, who provide
any care, treatment, or other services for
the hospice and/or its patients:
(i) Hospice employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
hospice and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following hospice staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the settings where hospice
services are provided to patients and
who do not have any direct contact with
patients, patient families and caregivers,
and other staff specified in paragraph
(d)(1) of this section; and
(ii) Staff who provide support services
for the hospice that are performed
exclusively outside of the settings where
hospice services are provided to
patients and who do not have any direct
contact with patients, patient families
and caregivers, and other staff specified
in paragraph (d)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (d)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
hospice and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (d)(1) of this
section are fully vaccinated, except for
those staff who have been granted
exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (d)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the hospice
has granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains:
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the hospice’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 441—SERVICES:
REQUIREMENTS AND LIMITS
APPLICABLE TO SPECIFIC SERVICES
■5. The authority citation for part 441
continues to read as follows:
Authority: 42 U.S.C. 1302.
■6. Amend § 441.151 by adding
paragraph (c) to read as follows:
§ 441.151
General requirements.
*
*
*
*
*
(c) COVID–19 Vaccination of facility
staff. The facility must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or resident contact, the
policies and procedures must apply to
the following facility staff, who provide
any care, treatment, or other services for
the facility and/or its residents:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
facility and/or its residents, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following facility staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the facility setting and who
do not have any direct contact with
residents and other staff specified in
paragraph (c)(1) of this section; and
(ii) Staff who provide support services
for the facility that are performed
exclusively outside of the center setting
and who do not have any direct contact
with residents and other staff specified
in paragraph (c)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (c)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
facility and/or its residents;
(ii) A process for ensuring that all staff
specified in paragraph (c)(1) of this
section are fully vaccinated for COVID–
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
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring that the
facility follows nationally recognized
infection prevention and control
guidelines intended to mitigate the
transmission and spread of COVID–19,
and which must include the
implementation of additional
precautions for all staff who are not
fully vaccinated for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (c)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the facility has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains:
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the facility’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 460—PROGRAMS OF ALL-
INCLUSIVE CARE FOR THE ELDERLY
(PACE)
■7. The authority citation for part 460
continues to read as follow:
Authority: 42 U.S.C. 1302, 1395,
1395eee(f), and 1396u–4(f).
■8. Amend § 460.74 by adding
paragraph (d) to read as follows:
§ 460.74
Infection control.
*
*
*
*
*
(d) COVID–19 Vaccination of PACE
organization staff. The PACE
organization must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or participant contact, the
policies and procedures must apply to
the following PACE organization staff,
who provide any care, treatment, or
other services for the PACE organization
and/or its participants:
(i) PACE organization employees;
(ii) Licensed practitioners providing
services on behalf of the PACE
organization;
(iii) Students, trainees, and volunteers
providing services on behalf of the
PACE organization; and
(iv) Individuals who provide care,
treatment, or other services on behalf of
the PACE organization, under contract
or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following PACE organization staff:
(i) Staff who exclusively provide
telehealth or telemedicine services for
the PACE organization and/or its
participants and who do not have any
direct contact with participants and
other PACE organization staff specified
in paragraph (d)(1) of this section; and
(ii) Staff who provide support services
for the PACE organization and/or its
participants and who do not have any
direct contact with participants and
other PACE organization staff specified
in paragraph (d)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (d)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
PACE organization and/or its
participants;
(ii) A process for ensuring that all staff
specified in paragraph (d)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (d)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the PACE
organization has granted, an exemption
from the staff COVID–19 vaccination
requirements based on recognized
clinical contraindications or applicable
Federal laws;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains:
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the PACE
organization’s COVID–19 vaccination
requirements for staff based on the
recognized clinical contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 482—CONDITIONS OF
PARTICIPATION FOR HOSPITALS
■9. The authority citation for part 482
continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and
1395rr, unless otherwise noted.
■10. Amend § 482.42 by adding
paragraph (g) to read as follows:
§ 482.42
Condition of participation:
Infection prevention and control and
antibiotic stewardship programs.
*
*
*
*
*
(g) Standard: COVID–19 Vaccination
of hospital staff. The hospital must
develop and implement policies and
procedures to ensure that all staff are
fully vaccinated for COVID–19. For
purposes of this section, staff are
considered fully vaccinated if it has
been 2 weeks or more since they
completed a primary vaccination series
for COVID–19. The completion of a
primary vaccination series for COVID–
19 is defined here as the administration
of a single-dose vaccine, or the
administration of all required doses of a
multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following hospital staff, who
provide any care, treatment, or other
services for the hospital and/or its
patients:
(i) Hospital employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
hospital and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following hospital staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the hospital setting and who
do not have any direct contact with
patients and other staff specified in
paragraph (g)(1) of this section; and
(ii) Staff who provide support services
for the hospital that are performed
exclusively outside of the hospital
setting and who do not have any direct
contact with patients and other staff
specified in paragraph (g)(1) of this
section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (g)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
hospital and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (g)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (g)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the hospital
has granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains:
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the
hospital’s COVID–19 vaccination
requirements for staff based on the
recognized clinical contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–.
PART 483—REQUIREMENTS FOR
STATES AND LONG TERM CARE
FACILITIES
■11. The authority citation for part 483
continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a–7, 1395i,
1395hh and 1396r.
■12. Amend § 483.80 by revising
paragraph (d)(3)(v) and adding
paragraph (i) to read as follows:
§ 483.80
Infection control.
(d) * * *
(3) * * *
(v) The resident or resident
representative, has the opportunity to
accept or refuse a COVID–19 vaccine,
and change their decision; and
*
*
*
*
*
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(i) COVID–19 Vaccination of facility
staff. The facility must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or resident contact, the
policies and procedures must apply to
the following facility staff, who provide
any care, treatment, or other services for
the facility and/or its residents:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
facility and/or its residents, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following facility staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the facility setting and who
do not have any direct contact with
residents and other staff specified in
paragraph (i)(1) of this section; and
(ii) Staff who provide support services
for the facility that are performed
exclusively outside of the facility setting
and who do not have any direct contact
with residents and other staff specified
in paragraph (i)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (i)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
facility and/or its residents;
(ii) A process for ensuring that all staff
specified in paragraph (i)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (i)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the facility has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains:
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the facility’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
■13. Amend § 483.430 by revising
paragraph (f) to read as follows:
§ 483.430
Condition of participation:
Facility staffing.
*
*
*
*
*
(f) Standard: COVID–19 Vaccination
of facility staff. The facility must
develop and implement policies and
procedures to ensure that all staff are
fully vaccinated for COVID–19. For
purposes of this section, staff are
considered fully vaccinated if it has
been 2 weeks or more since they
completed a primary vaccination series
for COVID–19. The completion of a
primary vaccination series for COVID–
19 is defined here as the administration
of a single-dose vaccine, or the
administration of all required doses of a
multi-dose vaccine.
(1) Regardless of clinical
responsibility or client contact, the
policies and procedures must apply to
the following facility staff, who provide
any care, treatment, or other services for
the facility and/or its clients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
facility and/or its clients, under contract
or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following facility staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the facility setting and who
do not have any direct contact with
clients and other staff specified in
paragraph (f)(1) of this section; and
(ii) Staff who provide support services
for the facility that are performed
exclusively outside of the facility setting
and who do not have any direct contact
with clients and other staff specified in
paragraph (f)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (f)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
treatment, or other services for the
facility and/or its clients;
(ii) A process for ensuring that all staff
specified in paragraph (f)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (f)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the facility has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the facility’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
■14. Amend § 483.460 by revising
paragraph (a)(4)(v) to read as follows:
§ 483.460
Condition of participation:
Health care services.
*
*
*
*
*
(a) * * *
(4) * * *
(v) The client, or client’s
representative, has the opportunity to
accept or refuse a COVID–19 vaccine,
and change their decision;
*
*
*
*
*
PART 484—HOME HEALTH SERVICES
■15. The authority citation for part 484
continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
■16. Amend § 484.70 by adding
paragraph (d) to read as follows:
§ 484.70
Condition of participation:
Infection prevention and control.
*
*
*
*
*
(d) Standard: COVID–19 Vaccination
of Home Health Agency staff. The home
health agency (HHA) must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following HHA staff, who provide
any care, treatment, or other services for
the HHA and/or its patients:
(i) HHA employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the HHA
and/or its patients, under contract or by
other arrangement.
(2) The policies and procedures of
this section do not apply to the
following HHA staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the settings where home
health services are directly provided to
patients and who do not have any direct
contact with patients, families, and
caregivers, and other staff specified in
paragraph (d)(1) of this section; and
(ii) Staff who provide support services
for the HHA that are performed
exclusively outside of the settings where
home health services are directly
provided to patients and who do not
have any direct contact with patients,
families, and caregivers, and other staff
specified in paragraph (d)(1) of this
section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (d)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the HHA
and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (d)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (d)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the HHA has
granted, an exemption from the staff
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
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the HHA’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 485—CONDITIONS OF
PARTICIPATION: SPECIALIZED
PROVIDERS
■17. The authority citation for part 485
continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395(hh).
■18. Amend § 485.58 by revising
paragraph (d)(4) to read as follows:
§ 485.58
Condition of participation:
Comprehensive rehabilitation program.
*
*
*
*
*
(d) * * *
(4) The services must be furnished by
personnel that meet the qualifications of
§ 485.70 and the number of qualified
personnel must be adequate for the
volume and diversity of services offered.
Personnel that do not meet the
qualifications specified in § 485.70(a)
through (m) may be used by the facility
in assisting qualified staff. When a
qualified individual is assisted by these
personnel, the qualified individual must
be on the premises, and must instruct
these personnel in appropriate patient
care service techniques and retain
responsibility for their activities.
*
*
*
*
*
■19. Amend § 485.70 by adding
paragraph (n) to read as follows:
§ 485.70
Personnel qualifications.
*
*
*
*
*
(n) The CORF must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following facility staff, who provide
any care, treatment, or other services for
the facility and/or its patients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
facility and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following facility staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the facility setting and who
do not have any direct contact with
patients and other staff specified in
paragraph (n)(1) of this section; and
(ii) Staff who provide support services
for the facility that are performed
exclusively outside of the facility setting
and who do not have any direct contact
with patients and other staff specified in
paragraph (n)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (n)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
facility and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (n)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (n)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the facility has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the facility’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
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22:27 Nov 04, 2021
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and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
■20. Amend § 485.640 by adding
paragraph (f) to read as follows:
§ 485.640
Condition of participation:
Infection prevention and control and
antibiotic stewardship programs.
*
*
*
*
*
(f) Standard: COVID–19 Vaccination
of CAH staff. The CAH must develop
and implement policies and procedures
to ensure that all staff are fully
vaccinated for COVID–19. For purposes
of this section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following CAH staff, who provide
any care, treatment, or other services for
the CAH and/or its patients:
(i) CAH employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the CAH
and/or its patients, under contract or by
other arrangement.
(2) The policies and procedures of
this section do not apply to the
following CAH staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the CAH setting and who do
not have any direct contact with
patients and other staff specified in
paragraph (f)(1) of this section; and
(ii) Staff who provide support services
for the CAH that are performed
exclusively outside of the CAH setting
and who do not have any direct contact
with patients and other staff specified in
paragraph (f)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (f)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the CAH
and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (f)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status of all staff specified
in paragraph (f)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the CAH has
granted, an exemption from the staff
COVID–19 vaccination requirements
based on recognized clinical
contraindications or applicable Federal
laws;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the CAH’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
■21. Amend § 485.725 by adding
paragraph (f) to read as follows:
§ 485.725
Condition of participation:
Infection control.
*
*
*
*
*
(f) Standard: COVID–19 vaccination
of organization staff. The organization
that provides outpatient physical
therapy must develop and implement
policies and procedures to ensure that
all staff are fully vaccinated for COVID–
19. For purposes of this section, staff are
considered fully vaccinated if it has
been 2 weeks or more since they
completed a primary vaccination series
for COVID–19. The completion of a
primary vaccination series for COVID–
19 is defined here as the administration
of a single-dose vaccine, or the
administration of all required doses of a
multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following organization staff, who
provide any care, treatment, or other
services for the organization and/or its
patients:
(i) Organization employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
organization and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following organization staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the organization setting and
who do not have any direct contact with
patients and other staff specified in
paragraph (f)(1) of this section; and
(ii) Staff who provide support services
for the organization that are performed
exclusively outside of the organization
setting and who do not have any direct
contact with patients and other staff
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
specified in paragraph (f)(1) of this
section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (f)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
organization and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (f)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status for all staff specified
in paragraph (f)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the
organization has granted, an exemption
from the staff COVID–19 vaccination
requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the
organization’s COVID–19 vaccination
requirements for staff based on the
recognized clinical contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
■22. Amend § 485.904 by adding
paragraph (c) to read as follows:
§ 485.904
Condition of participation:
Personnel qualifications.
*
*
*
*
*
(c) Standard: COVID–19 vaccination
of center staff. The CMHC must develop
and implement policies and procedures
to ensure that all center staff are fully
vaccinated for COVID–19. For purposes
of this section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or client contact, the
policies and procedures must apply to
the following center staff, who provide
any care, treatment, or other services for
the center and/or its clients:
(i) Center employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
center and/or its clients, under contract
or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following center staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the center setting and who do
not have any direct contact with clients
and other staff specified in paragraph
(c)(1) of this section; and
(ii) Staff who provide support services
for the center that are performed
exclusively outside of the center setting
and who do not have any direct contact
with clients and other staff specified in
paragraph (c)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (c)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
CMHC and/or its clients;
(ii) A process for ensuring that all staff
specified in paragraph (c)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status for all staff specified
in paragraph (c)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the CMHC has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
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61625
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the CMHC’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 486—CONDITIONS FOR
COVERAGE OF SPECIALIZED
SERVICES FURNISHED BY
SUPPLIERS
■23. The authority citation for part 486
continues to read as follows:
Authority: 42 U.S.C. 273, 1302, 1320b–8,
and 1395hh.
■24. Amend § 486.525 by adding
paragraph (c) to read as follows:
§ 486.525
Required services.
*
*
*
*
*
(c) COVID–19 Vaccination of facility
staff. The qualified home infusion
therapy supplier must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following qualified home infusion
therapy supplier staff, who provide any
care, treatment, or other services for the
qualified home infusion therapy
supplier and/or its patients:
(i) Qualified home infusion therapy
supplier employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
qualified home infusion therapy
supplier and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following qualified home infusion
therapy supplier staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the settings where home
infusion therapy services are provided
to patients and who do not have any
direct contact with patients, families,
and caregivers, and other staff specified
in paragraph (c)(1) of this section; and
(ii) Staff who provide support services
for the qualified home infusion therapy
supplier that are performed exclusively
outside of the settings where home
infusion therapy services are provided
to patients and who do not have any
direct contact with patients, families,
and caregivers, and other staff specified
in paragraph (c)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (c)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
qualified home infusion therapy
supplier and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (c)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring that the
facility follows nationally recognized
infection prevention and control
guidelines intended to mitigate the
transmission and spread of COVID–19,
and which must include the
implementation of additional
precautions for all staff who are not
fully vaccinated for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status for all staff specified
in paragraph (c)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the qualified
home infusion therapy supplier has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains;
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the qualified
home infusion therapy supplier’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
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61626
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
PART 491—CERTIFICATION OF
CERTAIN HEALTH FACILITIES
■25. The authority citation for part 491
continues to read as follows:
Authority: 42 U.S.C. 263a and 1302.
■26. Amend § 491.8 by adding
paragraph (d) to read as follows:
§ 491.8
Staffing and staff responsibilities.
*
*
*
*
*
(d) COVID–19 vaccination of staff.
The RHC/FQHC must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following clinic or center staff, who
provide any care, treatment, or other
services for the clinic or center and/or
its patients:
(i) RHC/FQHC employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the clinic
or center and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following clinic or center staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the clinic or center setting
and who do not have any direct contact
with patients and other staff specified in
paragraph (d)(1) of this section; and
(ii) Staff who provide support services
for the clinic or center that are
performed exclusively outside of the
clinic or center setting and who do not
have any direct contact with patients
and other staff specified in paragraph
(d)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (d)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the clinic
or center and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (d)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring that the
clinic or center follows nationally
recognized infection prevention and
control guidelines intended to mitigate
the transmission and spread of COVID–
19, and which must include the
implementation of additional
precautions for all staff who are not
fully vaccinated for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status for all staff specified
in paragraph (d)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the facility has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains;
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the clinic’s
or center’s COVID–19 vaccination
requirements for staff based on the
recognized clinical contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
PART 494—CONDITIONS FOR
COVERAGE FOR END-STAGE RENAL
DISEASE FACILITIES
■27. The authority citation for part 494
continues to read as follows:
Authority: 42 U.S.C. l302 and l395hh.
■28. Amend § 494.30 by—
■a. Redesignating paragraphs (b) and
(c) as paragraphs (c) and (d)
respectively, and
■b. Adding a new paragraph (b).
The addition reads as follows:
§ 494.30
Condition: Infection control.
*
*
*
*
*
(b) COVID–19 Vaccination of facility
staff. The facility must develop and
implement policies and procedures to
ensure that all staff are fully vaccinated
for COVID–19. For purposes of this
section, staff are considered fully
vaccinated if it has been 2 weeks or
more since they completed a primary
vaccination series for COVID–19. The
completion of a primary vaccination
series for COVID–19 is defined here as
the administration of a single-dose
vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical
responsibility or patient contact, the
policies and procedures must apply to
the following facility staff, who provide
any care, treatment, or other services for
the facility and/or its patients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and
volunteers; and
(iv) Individuals who provide care,
treatment, or other services for the
facility and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of
this section do not apply to the
following facility staff:
(i) Staff who exclusively provide
telehealth or telemedicine services
outside of the facility setting and who
do not have any direct contact with
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61627
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
patients and other staff specified in
paragraph (b)(1) of this section; and
(ii) Staff who provide support services
for the facility that are performed
exclusively outside of the facility setting
and who do not have any direct contact
with patients and other staff specified in
paragraph (b)(1) of this section.
(3) The policies and procedures must
include, at a minimum, the following
components:
(i) A process for ensuring all staff
specified in paragraph (b)(1) of this
section (except for those staff who have
pending requests for, or who have been
granted, exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a single-
dose COVID–19 vaccine, or the first
dose of the primary vaccination series
for a multi-dose COVID–19 vaccine
prior to staff providing any care,
treatment, or other services for the
facility and/or its patients;
(ii) A process for ensuring that all staff
specified in paragraph (b)(1) of this
section are fully vaccinated for COVID–
19, except for those staff who have been
granted exemptions to the vaccination
requirements of this section, or those
staff for whom COVID–19 vaccination
must be temporarily delayed, as
recommended by the CDC, due to
clinical precautions and considerations;
(iii) A process for ensuring the
implementation of additional
precautions, intended to mitigate the
transmission and spread of COVID–19,
for all staff who are not fully vaccinated
for COVID–19;
(iv) A process for tracking and
securely documenting the COVID–19
vaccination status for all staff specified
in paragraph (b)(1) of this section;
(v) A process for tracking and securely
documenting the COVID–19 vaccination
status of any staff who have obtained
any booster doses as recommended by
the CDC;
(vi) A process by which staff may
request an exemption from the staff
COVID–19 vaccination requirements
based on an applicable Federal law;
(vii) A process for tracking and
securely documenting information
provided by those staff who have
requested, and for whom the facility has
granted, an exemption from the staff
COVID–19 vaccination requirements;
(viii) A process for ensuring that all
documentation, which confirms
recognized clinical contraindications to
COVID–19 vaccines and which supports
staff requests for medical exemptions
from vaccination, has been signed and
dated by a licensed practitioner, who is
not the individual requesting the
exemption, and who is acting within
their respective scope of practice as
defined by, and in accordance with, all
applicable State and local laws, and for
further ensuring that such
documentation contains
(A) All information specifying which
of the authorized COVID–19 vaccines
are clinically contraindicated for the
staff member to receive and the
recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating
practitioner recommending that the staff
member be exempted from the facility’s
COVID–19 vaccination requirements for
staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the
tracking and secure documentation of
the vaccination status of staff for whom
COVID–19 vaccination must be
temporarily delayed, as recommended
by the CDC, due to clinical precautions
and considerations, including, but not
limited to, individuals with acute
illness secondary to COVID–19, and
individuals who received monoclonal
antibodies or convalescent plasma for
COVID–19 treatment; and
(x) Contingency plans for staff who
are not fully vaccinated for COVID–19.
*
*
*
*
*
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–23831 Filed 11–4–21; 8:45 am]
BILLING CODE 4120–01–P
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109a

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.

110a

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)
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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
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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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File: 21A240_003_Dec_16_2021_Lower_Court_OrdersOpinions_20211216174132311_21A_Biden_v._Missouri_-CMS_Mandate_-_Appendix_to_Govt_Stay_App.pdf
Size: 2,924,270 bytes
SHA-256: 8a6dbd5032e740926be6ea1f59b1398b1a5ac264ee6b35221aeec9b855e7d716
Our copy: 21A240_003_Dec_16_2021_Lower_Court_OrdersOpinions_20211216174132311_21A_Biden_v._Missouri_-CMS_Mandate_-_Appendix_to_Govt_Stay_App.pdf
Original: www.supremecourt.gov

Appendix to Stay Application — Biden v. Missouri (CMS Vaccine Mandate) (U.S.)

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