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21A240 027 Jan 03 2022 Reply 20220103092323377 21A240 21A241 Government Combined Reply Fin - Scotus
Full text
Nos. 21A240 & 21A241
________________________________________________________________
________________________________________________________________
IN THE SUPREME COURT OF THE UNITED STATES
_______________
JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED STATES, ET AL.,
APPLICANTS
v.
STATE OF MISSOURI, ET AL.
_______________
XAVIER BECERRA, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH
AND HUMAN SERVICES, ET AL., APPLICANTS
v.
STATE OF LOUISIANA, ET AL.
_______________
REPLY IN SUPPORT OF APPLICATIONS FOR STAYS OF THE INJUNCTIONS
ISSUED BY THE UNITED STATES DISTRICT COURTS FOR THE EASTERN
DISTRICT OF MISSOURI AND WESTERN DISTRICT OF LOUISIANA PENDING
APPEALS TO THE UNITED STATES COURTS OF APPEALS FOR THE EIGHTH
AND FIFTH CIRCUITS AND FURTHER PROCEEDINGS IN THIS COURT
_______________
ELIZABETH B. PRELOGAR
Solicitor General
Counsel of Record
Department of Justice
Washington, D.C. 20530-0001
SupremeCtBriefs@usdoj.gov
(202) 514-2217
________________________________________________________________
________________________________________________________________
IN THE SUPREME COURT OF THE UNITED STATES
_______________
No. 21A240
JOSEPH R. BIDEN, JR., PRESIDENT OF THE UNITED STATES, ET AL.,
APPLICANTS
v.
STATE OF MISSOURI, ET AL.
_______________
No. 21A241
XAVIER BECERRA, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH
AND HUMAN SERVICES, ET AL., APPLICANTS
v.
STATE OF LOUISIANA, ET AL.
_______________
REPLY IN SUPPORT OF APPLICATIONS FOR STAYS OF THE INJUNCTIONS
ISSUED BY THE UNITED STATES DISTRICT COURTS FOR THE EASTERN
DISTRICT OF MISSOURI AND WESTERN DISTRICT OF LOUISIANA PENDING
APPEALS TO THE UNITED STATES COURTS OF APPEALS FOR THE EIGHTH
AND FIFTH CIRCUITS AND FURTHER PROCEEDINGS IN THIS COURT
_______________
Hospitals, nursing homes, and other healthcare providers that
choose to participate in Medicare and Medicaid have long been
subject to detailed conditions adopted by the Secretary of Health
and Human Services (HHS) -- including rules issued under the Sec-
retary’s express statutory authority to protect the health and
2
safety of Medicare and Medicaid patients. In response to an un-
precedented pandemic, the Secretary adopted an additional health
and safety condition requiring covered facilities to ensure that
their staff are vaccinated against COVID-19 (subject to medical
and religious exemptions). Such vaccine requirements had already
been adopted by many healthcare providers and public-health agen-
cies around the country and are overwhelmingly supported by the
medical community. And the Secretary determined that vaccination
of healthcare staff is the most effective way to prevent the
transmission of a highly communicable and dangerous virus to pa-
tients who are especially vulnerable to its deadly effects.
As the Eleventh Circuit concluded in a comprehensive pub-
lished opinion, respondents’ various challenges to the rule are
unlikely to succeed. Most importantly, the rule falls squarely
within the Secretary’s statutory authority. Respondents scarcely
dispute that requiring facilities to ensure that staff are vac-
cinated against COVID-19 qualifies as a measure to protect pa-
tients’ “health and safety” within the plain meaning of those
terms. 42 U.S.C. 1395x(e)(9); see pp. 5-6, infra (additional
statutes conferring authority). Instead, respondents ask this
Court to depart from ordinary principles of statutory interpreta-
tion by demanding a clear statement specifically authorizing a
vaccination requirement. That approach has no foundation in this
Court’s precedents. This is not a case where an agency is acting
outside its expertise or regulating in an area Congress has not
3
authorized. Nor do these cases involve any federal intrusion into
matters reserved to the States. Instead, a federal healthcare
agency adopted a familiar health and safety requirement to protect
patients in the federal healthcare programs the agency adminis-
ters, pursuant to express statutory authority to do just that.
The equities overwhelmingly support stays pending appeal.
The ongoing COVID-19 surge has driven case rates to new highs --
up more than fourfold since the Secretary issued the rule in early
November and nearly threefold since the government filed its
applications just over two weeks ago. See Centers for Disease
Control and Prevention (CDC), COVID Data Tracker,
https://go.usa.gov/xeFyx. The rule has never been more necessary
than it is now, as the virtually unanimous support of healthcare
organizations demonstrates. Absent stays, the preliminary injunc-
tions will likely result in hundreds or thousands of deaths and
serious illnesses from COVID-19 that could otherwise be prevented.
Respondents’ speculative assertions about the rule’s effect on
staffing pale in comparison to the overwhelming public interest in
saving lives and preventing serious illness. Stays pending appeal
are both wholly warranted and urgently needed.
I. This Court Would Likely Grant Review If Either Court Of Ap-
peals Affirmed One Of The Preliminary Injunctions
This Court would likely grant review if a court of appeals
upheld one of the preliminary injunctions. Respondents do not
seriously dispute that the validity of the rule is a question of
4
exceptional national importance. Cf. Missouri Opp. 9 & n.7; Lou-
isiana Opp. 39. Nor do they deny that the Fifth and Eighth Cir-
cuits’ orders denying stays directly conflict with a published
decision of the Eleventh Circuit holding that “the Secretary was
authorized to promulgate the interim rule.” Florida v. HHS, 19
F.4th 1271, 1287 (2021). And a rule to protect patients in the
nationwide Medicare and Medicaid programs in response to an ongoing
public health emergency is in effect in only half the States. That
is a paradigmatic basis for review.1
II. The Government Is Likely To Succeed On The Merits
The rule is squarely within the Secretary’s express statutory
authority, constitutionally sound, thoroughly explained, and pro-
cedurally valid.
A. The Rule Falls Within The Agency’s Statutory Authority
Respondents’ central argument (Missouri Opp. 10-24; Louisiana
Opp. 14-16, 22-26) is that requiring facilities that accept federal
Medicare and Medicaid funds to ensure their staff are vaccinated
against COVID-19 exceeds the Secretary’s statutory authority.
They are mistaken.
1 The Louisiana respondents note (Opp. 39) that Florida
has tried to renew its request for an injunction pending appeal
before the en banc Eleventh Circuit. But that court has neither
called for a response nor taken any other action on Florida’s
request in the more than two weeks since it was filed.
5
1. The rule is authorized by the plain text of the
relevant statutes
a. The rule invokes the Secretary’s statutory authority to
make “rules and regulations * * * as may be necessary to the
efficient administration of the functions with which [he] is
charged under” the Medicare and Medicaid programs. 42 U.S.C.
1302(a); see 42 U.S.C. 1395hh(a)(1). But respondents err in im-
plying (e.g., Louisiana Opp. 24) that the rule rests exclusively
-- or even primarily -- on that general authority. To the con-
trary, the Secretary also invoked additional authorities specifi-
cally applicable to each category of facility covered by the rule.
86 Fed. Reg. 61,555, 61,567 (Nov. 5, 2021); see ibid. (table set-
ting forth statutes); id. at 61,575-61,583 (detailed discussion).
And the statutory provisions applicable to the vast majority of
those facilities expressly authorize the Secretary to impose re-
quirements to protect the “health” and “safety” of patients.
The provision governing hospitals, for example, provides au-
thority to impose “requirements as the Secretary finds necessary
in the interest of the health and safety of individuals who are
furnished services in the institution.” 42 U.S.C. 1395x(e)(9)
(emphasis added); see 42 U.S.C. 1395i-3(d)(4)(B), 1396r(d)(4)(B)
(analogous authority for long-term care facilities); 42 U.S.C.
1395k(a)(2)(F)(i), 1395l(i)(1)(A) (ambulatory surgery centers); 42
U.S.C. 1395x(dd)(2)(G) (hospices); 42 U.S.C. 1395x(o)(6) (home
health agencies); 42 U.S.C. 1395x(ff)(3)(B) (community mental
6
health centers); 42 U.S.C. 1395eee(f)(4) (programs of all-inclu-
sive care for the elderly); 42 U.S.C. 1395x(cc)(2)(J) (comprehen-
sive outpatient rehabilitation facilities); 42 U.S.C.
1395x(p)(4)(A)(v) (providers of certain outpatient therapies); 42
U.S.C. 1395x(aa)(2)(k) (rural health clinics). For some of those
facilities, Congress conferred on the Secretary not only the au-
thority to impose health and safety requirements, but a “duty and
responsibility” to do so. 42 U.S.C. 1395i-3(f)(1) (long-term care
facilities); see 42 U.S.C. 1395bbb(b) (home health agencies).
The rule’s vaccination “requirement[]” protects “the health
and safety of” patients within the plain meaning of those statutes.
42 U.S.C. 1395x(e)(9). Most immediately -- and most importantly
-- requiring facilities to ensure that healthcare workers are vac-
cinated against COVID-19 substantially reduces the likelihood that
those workers will contract the virus and transmit it to patients.
86 Fed. Reg. at 61,558; see ibid. (citing study finding that vac-
cination was “80 percent effective in preventing * * * infection
among frontline workers”). That protection is especially im-
portant for Medicare and Medicaid beneficiaries, who are dispro-
portionately vulnerable to severe negative outcomes from COVID-
19. Id. at 61,566, 61,568. And it is particularly necessary in
healthcare facilities, where close contact is inevitable and phys-
ical distancing is often impossible, id. at 61,577 -- and where
patients typically have no practical ability to avoid exposure to
unvaccinated staff members. Requiring facilities to ensure staff
7
vaccination also protects patient health and safety by eliminating
a basis for patients to defer other medical care to avoid exposure
to unvaccinated staff. Id. at 61,558. And it reduces staff
infections and the resulting “absenteeism due to COVID-19-related
exposures or illness,” which can “create staffing shortages that
disrupt patient access to recommended care.” Id. at 61,559.
Those direct and vital protections for patient health and
safety explain the nearly universal support for the rule expressed
by medical and public-health organizations in the joint statement
relied upon by the Secretary, 86 Fed. Reg. at 61,565, and the
multiple amicus briefs filed in support of the government’s ap-
plications from a variety of perspectives, see American Medical
Ass’n (AMA) Amici Br. (more than a dozen associations representing
medical professionals and patients); American Public Health Ass’n
(APHA) Amici Br. (wide range of public-health scholars and deans);
Former Federal Health Officials Amici Br. (leaders of HHS and the
Centers for Medicare & Medicaid Services during the Clinton, George
W. Bush, and Obama Administrations); Service Employees Int’l Union
(SEIU) Amici Br. (labor representatives of hundreds of thousands
of healthcare workers).
b. Respondents offer no reason to doubt that requiring fa-
cilities to ensure that healthcare workers are vaccinated against
COVID-19 advances patient “health” and “safety” within the plain
meaning of the relevant statutes. The Missouri respondents contend
(Opp. 14-18) that the statutory requirement that a hospital comply
8
with “such other requirements as the Secretary finds necessary in
the interest of [patient] health and safety,” 42 U.S.C.
1395x(e)(9), must be construed in light of the other requirements
in Section 1395x(e). And they assert (Opp. 17) that the rule “is
materially unlike the requirements listed in the preceding eight
provisions” of that statute because those provisions “impose
structural requirements on hospitals themselves” not on “hospital
staff.” But the rule likewise operates on the hospital, not its
staff: “The hospital must develop and implement policies and
procedures to ensure that all staff are fully vaccinated for COVID-
19.” 42 C.F.R. 482.42(g) (emphasis added). And to the extent
respondents mean that the rule requires hospitals to ensure that
their staff meet a specified standard or take specified actions,
that does not distinguish it from many other requirements imposed
by and under the authority of Section 1395x(e).2
c. Respondents also observe (e.g., Missouri Opp. 13 & n.8)
that a few of the facility-specific statutes the Secretary invoked
-- which apply to less than three percent of all workers covered
2 See, e.g., 42 U.S.C. 1395x(e)(1) (requiring that care be
provided “by or under the supervision of physicians,” who are
defined in Section 1395x(r) as doctors meeting specified licensing
and other requirements); 42 U.S.C. 1395x(e)(5) (requiring hospi-
tals to have “a licensed practical nurse or registered professional
nurse on duty at all times”); 42 C.F.R. 482.15(d)(1)(i) (requiring
hospitals to provide “training in emergency preparedness policies
and procedures to all new and existing staff”); 42 C.F.R.
482.42(c)(2)(iv) (requiring training of “hospital personnel and
staff” on “infection prevention and control guidelines, policies,
and procedures”).
9
by the rule -- do not expressly refer to health and safety.3 But
the statutes respondents cite (ibid.) include broadly worded del-
egations of authority for the Secretary to set, e.g., “standards”
or “requirements” for the facilities’ participation in Medicare or
Medicaid. See 42 U.S.C. 1396d(h)(1) (authority to set “standards”
for psychiatric residential treatment facilities); 42 U.S.C.
1396d(d)(1) (authority to set “standards” for intermediate care
facilities for individuals with intellectual disabilities (ICFs-
IID)); 42 U.S.C. 1395rr(b)(1)(A) (authority to set “requirements”
for end-stage renal disease (ESRD) facilities); 42 U.S.C.
1395x(iii)(3)(D)(i)(IV) (authority to set “requirements” for home
infusion therapy suppliers).
Because, as shown above, the Secretary’s authority to set
health and safety requirements includes authority to require vac-
cination of staff at covered Medicare and Medicaid facilities, the
broadly worded authorities conferred by the statutes that respond-
ents cite do as well. Indeed, the Secretary has long exercised
the authorities in those statutes to impose health and safety
requirements for the covered facilities generally -- and, in some
3 Respondents point to four categories of facilities cov-
ered by statutes that do not include express health and safety
language: (1) psychiatric residential treatment facilities, which
have an estimated total of 30,000 staff; (2) intermediate care
facilities for individuals with intellectual disabilities, which
have an estimated total of 80,000 staff; (3) end-stage renal dis-
ease facilities, which have an estimated total of 170,000 staff;
and (4) home infusion therapy suppliers, which have an estimated
total of 20,000 staff. 86 Fed. Reg. at 61,603.
10
cases, infection-control requirements in particular. See, e.g.,
42 C.F.R. 483.470(l)(1) (infection-control requirements for ICFs-
IID); 42 C.F.R. 494.30 (same for ESRD facilities). The requirement
at issue here falls comfortably within those same authorities.4
2. Respondents offer no basis to depart from the plain
meaning of the statutory text
Because the requirement that Medicare and Medicaid facilities
ensure that their staff are vaccinated against a highly transmis-
sible and deadly virus is so readily understood as an exercise of
the “health and safety” and other statutory authorities conferred
on the Secretary, respondents repeatedly return to the assertion
that the Court should impose on Congress a heightened-specificity
requirement demanding an express reference to vaccination. There
is no basis for that departure from the text.
a. Respondents principally rely (Missouri Opp. 22-23; Lou-
isiana Opp. 22-23) on what they call the “major-questions doc-
trine.” But this case lacks the hallmarks of the decisions re-
spondents invoke, all of which grounded their analysis in the text,
structure, and context of the relevant statutes. Here, HHS is not
asserting regulatory power that is “markedly different” from the
type of authority that Congress expressly identified in the rele-
vant provision, Alabama Ass’n of Realtors v. HHS, 141 S. Ct. 2485,
4 Even if it did not, that would at most justify an in-
junction against enforcement of the few portions of the rule that
rest on statutes without express health and safety language. See
86 Fed. Reg. at 61,560 (“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.”).
11
2488 (2021) (per curiam); or trying to regulate in an area Congress
has affirmatively rendered off-limits in more specific legislation
directly addressing the issue, cf. FDA v. Brown & Williamson To-
bacco Corp., 529 U.S. 120, 143 (2000); or claiming authority that
would “render the statute ‘unrecognizable to the Congress that
designed’ it,” Utility Air Regulatory Grp. v. EPA, 573 U.S. 302,
324 (2014) (citation omitted); see id. at 321, 324 (observing that
under EPA’s interpretation, “annual permit applications would jump
from about 800 to nearly 82,000,” causing “construction projects
to grind to a halt nationwide”). Nor is this a case where an
agency responsible for public health has attempted to regulate
“the landlord-tenant relationship,” Alabama Ass’n, 141 S. Ct. at
2489, or a tax agency has made “health insurance policy,” King v.
Burwell, 576 U.S. 473, 486 (2015). Instead, the federal agency
primarily responsible for health care is setting health and safety
requirements for facilities participating in federally funded
healthcare programs, pursuant to an express statutory authoriza-
tion to do just that.
The Secretary’s exercise of that authority to require Medi-
care and Medicaid facilities to ensure their workers are vaccinated
in no way renders the relevant statutes “unrecognizable.” Utility
Air, 573 U.S. at 324 (citation omitted). To the contrary, Congress
authorized the Secretary to adopt health and safety requirements
he finds necessary precisely because it understood that it could
not foresee and “include in the legislation” all requirements that
12
might prove necessary to protect patients from hazards like “con-
tagion.” H.R. Rep. No. 213, 89th Cong., 1st Sess. 25-26 (1965).
Nor is there anything “breathtaking,” Alabama Ass’n, 141 S. Ct. at
2489, or “extravagant,” Utility Air, 573 U.S. at 324, about the
Secretary’s determination that requiring Medicare- and Medicaid-
funded facilities to adopt the measure most likely to prevent
transmission of a potentially deadly virus to vulnerable patients
is necessary for those patients’ health and safety.
Respondents rely heavily on the asserted “economic and po-
litical significance” of the rule. Louisiana Opp. 22 & n.6 (ci-
tations omitted); see Missouri Opp. 1, 20. But this Court regu-
larly decides challenges to agency actions of major economic and
political significance under the usual rules of statutory inter-
pretation, without imposing heightened-specificity requirements.
See, e.g., Collins v. Yellen, 141 S. Ct. 1761, 1776 (2021); Little
Sisters of the Poor Saints Peter & Paul Home v. Pennsylvania, 140
S. Ct. 2367, 2380-2381 (2020); Department of Commerce v. New York,
139 S. Ct. 2551, 2571-2572 (2019); cf. Trump v. Hawaii, 138 S. Ct.
2392, 2408 (2018). Likewise, although the scope of the Medicare
program inevitably means that the Secretary’s determinations may
involve billions of dollars, see Azar v. Allina Health Servs., 139
S. Ct. 1804, 1808 (2019), this Court has never treated that as a
reason to demand a specific authorization in a Medicare case.
Respondents thus err in presuming that the mere fact that a rule
13
could be called “economically and politically significant” re-
quires Congress to have specifically referred to the precise reg-
ulatory measures in the statute authorizing the agency action.
Respondents also emphasize (e.g., Missouri Opp. 21) that HHS
has not previously exercised the statutory authorities at issue
here to condition funding on policies requiring vaccination. But
HHS has never before faced a situation like this one: a pandemic
driven by an infectious disease that poses especially lethal
threats to patients at healthcare facilities, that can be prevented
through widely available and highly effective vaccines, and for
which near-universal vaccination has not already been achieved
through other means (such as the ubiquitous vaccination require-
ments imposed by schools). 86 Fed. Reg. at 61,567-61,569. In the
context of that unprecedented threat to patient health and safety,
a vaccination requirement is simply a specific, urgently needed
application of HHS’s longstanding requirements that facilities
take active measures to prevent the spread of “infections and
communicable diseases.” 51 Fed. Reg. 22,010, 22,027 (June 17,
1986); see, e.g., 42 C.F.R. 482.42 (current infection-control re-
quirements for hospitals); 42 C.F.R. 483.80 (long-term care fa-
cilities); 42 C.F.R. 484.70(b) (home health agencies); 42 C.F.R.
416.51 (outpatient surgery centers); 42 C.F.R. 418.60 (hospices);
42 C.F.R. 494.30 (ESRD facilities).
Vaccination requirements are, moreover, familiar measures
that have long been common in a variety of contexts. See Missouri
14
Appl. 22-23. “Healthcare facilities across the country” require
workers to be vaccinated for other infectious diseases, including
hepatitis B, influenza, and measles, mumps, and rubella. CDC,
State Healthcare Worker and Patient Vaccination Laws (Feb. 28,
2018), https://go.usa.gov/xtxxT; see 86 Fed. Reg. at 61,567-
61,568; Florida, 19 F.4th at 1288. Those common requirements to
prevent the spread of dangerous infectious disease in healthcare
settings reflect the “ethical duty” of healthcare workers “to pro-
tect those they encounter in their professional capacity,” 86 Fed.
Reg. at 61,569 -- a modern fulfillment of the ancient admonition
that a healer should first do no harm. The vaccination requirement
here rests on those deep foundations and thus is in no way “un-
precedented” as a health and safety measure. Alabama Ass’n, 141
S. Ct. at 2489.
It is instead respondents who seek an unprecedented result
here -- a holding that, even though the text of the relevant
statutory authorities clearly covers the health and safety re-
quirement at issue, some heightened measure of specificity is re-
quired simply because the rule has engendered some undefined meas-
ure of political disagreement. Agencies are not permitted “to act
unlawfully even in pursuit of desirable ends,” Alabama Ass’n, 141
S. Ct. at 2490, but neither are they disabled from acting lawfully
simply because some find the ends undesirable. To rely on such
“extratextual sources” would “risk amending statutes outside the
legislative process reserved for the people’s representatives,”
15
thereby undermining, not furthering, separation-of-powers princi-
ples. Bostock v. Clayton County, 140 S. Ct. 1731, 1738 (2020);
accord id. at 1824 (Kavanaugh, J., dissenting).
b. Respondents also rely on the proposition that extra
statutory clarity is required when an agency seeks to “signifi-
cantly alter the balance between federal and state power.” Loui-
siana Opp. 22 (citation omitted); see Missouri Opp. 20-21, 23-24.
That argument is misplaced. The rule is a condition on facilities
participating in federal spending programs, and States have no
power to set conditions on federal activities. See, e.g., McCul-
loch v. Maryland, 17 U.S. (4 Wheat.) 316, 436 (1819). The rule
accordingly does not alter or override the “constitutional balance
of federal and state powers.” Missouri Opp. 20 (citation omitted).
Respondents observe (e.g., Missouri Opp. 24) that this Court
has held that the federal government’s spending power does not
allow it to coerce States into adopting regulatory policies or to
impose conditions on States’ acceptance of federal funds without
clear notice. But those constitutional limitations (which, as
discussed below, are in no way exceeded here) do not imbue the
States with any power over federal spending programs. See, e.g.,
Sabri v. United States, 541 U.S. 600, 608 n.* (2004) (explaining
that the federal spending power applies with equal force when
Congress legislates “in an area historically of state concern”).
Because conditions on federal spending programs are in no sense
16
“the particular domain of state law,” Alabama Ass’n, 141 S. Ct. at
2489, respondents’ federalism-canon arguments fail.
c. For similar reasons, respondents’ argument that a
heightened-specificity requirement applies because the rule “in-
vokes the outer limits of Congress’ power,” Missouri Opp. 20 (ci-
tation omitted) -- and their related argument that the rule vio-
lates the Constitution, see Louisiana Opp. 26-28 -- are meritless.
As previously explained (see, e.g., Missouri Appl. 28-29),
the vaccination condition at issue here -– like countless other
conditions of participation in Medicare and Medicaid -- reflects
a straightforward exercise of Congress’s spending power. Respond-
ents do not seem to dispute that basic point. And respondents
cannot deny that protecting patients in federally funded
healthcare programs from a deadly virus furthers the “general Wel-
fare of the United States.” U.S. Const. Art. I, § 8, Cl. 1; see,
e.g., South Dakota v. Dole, 483 U.S. 203, 206–207 (1987).
The Louisiana respondents instead invoke the principle that
the conditions of federal grants to States must be clear. Opp.
26-27 (citing Pennhurst State Sch. & Hosp. v. Halderman, 451 U.S.
1, 17 (1981)). The conditions at issue here fully comply with
that principle. As an initial matter, the vast majority of the
facilities subject to the condition are private entities partici-
pating in Medicare and Medicaid -- not States. Those conditions
apply to state-run hospitals and other facilities only in the same
manner as they apply to federally funded facilities generally.
17
And in any event, the relevant statutes make perfectly clear that
participation in Medicare and Medicaid is conditioned on compli-
ance with, e.g., “requirements [that] the Secretary finds neces-
sary in the interest of the health and safety” of patients. 42
U.S.C. 1395x(e)(9) (hospitals).
Respondents seem to suggest that Congress was required not
only to clearly condition participation on compliance with health
and safety conditions adopted by the Secretary, but also to clearly
set forth all the detailed conditions in the statute itself. But
this Court has never imposed such a requirement, which would rad-
ically alter the administration of Medicare, Medicaid, and count-
less other spending programs. Medicare’s “Conditions of Partici-
pation” for hospitals alone span some 48 pages in the Code of
Federal Regulations. 42 C.F.R. Pt. 482. To take just a few
examples, those conditions address such matters as hospital gov-
ernance, hiring, staffing, and budgeting, 42 C.F.R. 482.12,
482.22; patients’ rights, including grievance procedures and lim-
its on the use of restraints, 42 C.F.R. 482.13; emergency prepar-
edness, 42 C.F.R. 482.15; recordkeeping, 42 C.F.R. 482.24; and the
hospital’s physical environment, down to the placement of hand
sanitizer, 42 C.F.R. 482.41(b)(8). On respondents’ view, all of
those conditions are invalid because they are not specifically set
forth in the statute.5
5 To the extent respondents suggest that the rule coerces
them in any way (cf. Louisiana Opp. 27), they are mistaken. Unlike
the Medicaid expansion the Court held to be impermissibly coercive
18
The Louisiana respondents’ cursory assertion (Opp. 27) that
any statutory provision authorizing the vaccination rule is “an
unconstitutional delegation of legislative authority” is similarly
baseless. As noted above, the rule is an exercise of the Secre-
tary’s statutory authorities to impose conditions -- including, in
most cases, “requirements * * * necessary in the interest of
[patient] health and safety,” 42 U.S.C. 1395x(e)(9) -- for entities
participating in Medicare and Medicaid. Those statutes readily
provide the “intelligible principle[s]” required by this Court’s
non-delegation decisions. Whitman v. American Trucking Ass’ns,
531 U.S. 457, 474 (2001) (citation omitted); see id. at 475 (find-
ing that direction to regulate “to protect the public health”
sufficiently guided the agency’s exercise of discretion); see also
Gundy v. United States, 139 S. Ct. 2116, 2129 (2019) (plurality
opinion) (collecting examples). Respondents do not attempt to
reconcile their claim with those precedents.
d. In one final effort to justify a departure from the
statutory text, respondents contend (Missouri Opp. 18-19, 23; Lou-
isiana Opp. 14-16) that the rule conflicts with 42 U.S.C. 1395.
in National Federation of Independent Business v. Sebelius, 567
U.S. 519, 541-542 (2012), the rule regulates Medicare and Medicaid
facilities, not States. And contrary to the Missouri respondents’
assertion (Opp. 6), HHS does not “force[] ‘State surveyors . . .
to assess compliance with’” the vaccination requirement. A State’s
decision to enter into a survey agreement with the Secretary is
voluntary. See 42 U.S.C. 1395aa(a) (“The Secretary shall make an
agreement with any State which is able and willing to do so[.]”)
(emphasis added).
19
But respondents misread Section 1395. That provision, titled
“Prohibition against any Federal interference,” provides that fed-
eral officials may not exercise “supervision or control over,”
inter alia, “the practice of medicine,” the “selection, tenure, or
compensation of” healthcare workers, or “the administration or
operation” of healthcare facilities. Ibid. The rule does none of
those things. It instead imposes a condition on the acceptance of
Medicare and Medicaid funds, thereby “regulating a federal pro-
gram.” Florida, 19 F.4th at 1287 (emphasis added; citation omit-
ted). The condition here no more violates Section 1395’s prohi-
bition on regulating the practice of medicine or the selection of
healthcare workers than do countless other conditions of Medicare
and Medicaid participation, such as detailed staff-qualification
and patient-treatment requirements. See, e.g., 42 C.F.R. 482.22-
482.27.6
B. The Rule Is Not Arbitrary And Capricious
Respondents alternatively contend that the vaccination rule
is arbitrary and capricious on various grounds. None has merit.
1. Both district courts focused on one of respondents’
challenges in particular, which respondents renew here: that the
6 The Louisiana respondents assert (Opp. 13-15) that the
government forfeited its right to contest the district court’s
contrary interpretation of Section 1395, as well as certain other
issues, by not raising them in its stay application. That is
mistaken. The Fifth Circuit did not endorse any of those alter-
native grounds for the preliminary injunction and instead rested
solely on circuit precedent addressing what the court called the
“major questions” doctrine. Louisiana Appl. App. 2a.
20
Secretary allegedly failed to consider whether the rule will cause
staffing shortages. Missouri Opp. 27-32; Louisiana Opp. 28-31.
But the Secretary extensively discussed the possible effects of
the rule on the labor market and ultimately found any risk of
short-term staffing shortages insufficient to outweigh the bene-
fits of the rule. See 86 Fed. Reg. at 61,607-61,609. Respondents
identify no sound basis to reject that judgment.
In particular, the Secretary recognized the possibility that
the rule may cause “staffing and service disruptions” in cases
where “substantial” numbers of staff members refuse vaccination
and are not granted an exemption. 86 Fed. Reg. at 61,608. But he
emphasized that such widespread departures had not actually come
to pass at healthcare facilities that had adopted vaccination re-
quirements. Id. at 61,566, 61,569. And he explained that any
such departures would be offset to some extent by reduced COVID-
related absenteeism and by the return to the labor force of indi-
viduals previously unwilling to work with unvaccinated colleagues.
Id. at 61,607, 61,609. He also explained that any short-term
disruptions must be viewed in the overall context of the healthcare
labor market, where “it is normal for there to be roughly 2.66
million new hires” each year out of a labor force of 10.4 million.
Id. at 61,608. He therefore concluded that “there is no reason to
think” that the rule will cause “a net minus” in staffing levels
“even in the short term.” Id. at 61,609. That conclusion was
amply supported by the evidence before the Secretary and accords
21
with the views of leading organizations of healthcare profession-
als, none of which have supported respondents’ efforts to enjoin
the rule. See Missouri Appl. 32-33; 86 Fed. Reg. at 61,565; see
also AMA Amici Br. 1-7; SEIU Amici Br. 1-2.
Respondents contend (Missouri Opp. 28-29; Louisiana Opp. 29
& n.9) that declarations they submitted in litigation show that
the Secretary overlooked a distinct risk of staffing shortages in
rural areas. But those declarations do not identify even a single
example of a vaccination requirement that triggered the sort of
widespread staff departure respondents predict. The declarations
instead consist largely of reports indicating that some facilities
estimate or have been told that a subset of their unvaccinated
staff members would rather quit than be vaccinated. See, e.g.,
Missouri Opp. App. 39a, 43a, 45a. As the Secretary explained,
however, real-world experience shows that employees generally “re-
spond[] to mandates by getting vaccinated” rather than leaving
their jobs. 86 Fed. Reg. at 61,569.
Respondents are mistaken in asserting that the evidence of
successful vaccination requirements involved only “urban areas.”
Missouri Opp. 29; see Louisiana Opp. 29. For example, the Secre-
tary discussed the Novant Health system in North Carolina, see 86
Fed. Reg. at 61,566 n.132, which includes the “primary location[s]
for emergency and specialized services for people in rural commu-
nities” in that State, see Gina DiPietro, Novant Health, 5 Things
To Know (Feb. 1, 2021), https://perma.cc/L399-5VXC. Similarly,
22
the Secretary relied in part on evidence that a nursing facility
in “rural Alabama” that imposed a vaccine mandate “lost only six
of its 260 employees.” Jack J. Barry et al., Half of Unvaccinated
Workers Say They’d Rather Quit Than Get a Shot -- But Real-World
Data Suggest Few Are Following Through (Sept. 24, 2021),
https://perma.cc/UDY2-F9ML; see 86 Fed. Reg. at 61,569 n.155.7
That said, the Secretary seriously considered the concerns
respondents raise, acknowledging some “early indications” that
“rural hospitals are having greater problems with employee vac-
cination refusals than urban hospitals,” and inviting “comments on
ways to ameliorate this problem.” 86 Fed. Reg. at 61,613. At the
same time, the Secretary noted that the need for the rule was
particularly strong in rural communities, where patients are es-
pecially at risk from COVID-19, id. at 61,566, and he ultimately
determined that the rule struck the appropriate balance based on
the evidence before him. That quintessential policy judgment was
one for the Secretary, not States or the courts. And the Secretary
was not required to wait for “perfect empirical or statistical
data” about the effects of the rule in rural areas before taking
steps to protect patients. FCC v. Prometheus Radio Project, 141
7 Public reports continue to confirm that concerns about
employees quitting en masse in response to COVID-19 vaccine man-
dates are generally overstated -- including in the respondent
States. See, e.g., Dave Muoio, Fierce Healthcare, How Many Em-
ployees Have Hospitals Lost to Vaccine Mandates? (Dec. 28, 2021),
https://perma.cc/E8LC-SQ4K (collecting reports of minimal staff
departures from healthcare facilities in Louisiana, Indiana, Kan-
sas, Kentucky, Ohio, South Carolina, and elsewhere).
23
S. Ct. 1150, 1160 (2021); see, e.g., FCC v. Fox Television Sta-
tions, Inc., 556 U.S. 502, 521 (2009) (explaining that an “agency’s
predictive judgment * * * merits deference”).
2. This Court is also likely to reject respondents’ other
arbitrary-and-capricious challenges.
First, respondents assert (Missouri Opp. 26; Louisiana Opp.
30) that the Secretary failed to adequately consider “testing” and
“natural immunity” (i.e., from a prior infection) as alternatives
to a vaccination requirement. The Secretary explicitly considered
both, and his decision to reject those alternatives was fully
explained and reasonable. For example, the Secretary found that
the “scientific evidence on testing” demonstrated that “vaccina-
tion is a more effective infection control measure,” 86 Fed. Reg.
at 61,614, and respondents have adduced no evidence to the con-
trary. Likewise, the evidence before the Secretary supported his
conclusion that experiencing a COVID-19 infection is not equiva-
lent to receiving vaccination for COVID-19, and that, among those
persons with prior infections, vaccination provides stronger pro-
tection against reinfection. Id. at 61,559-61,560 & n.69. That
conclusion is not undermined by the Secretary’s separate statement
that individuals who recover from COVID-19 are unlikely to be
“sources of future infections.” Id. at 61,604; see Missouri Opp.
26. The question before the Secretary was whether vaccination
provides superior protection. Substantial scientific evidence
24
supported his decision not to carve out from the vaccine require-
ment healthcare staff who previously contracted COVID-19. See 86
Fed. Reg. at 61,614 (noting that any such carve-out would be con-
trary to CDC recommendations and would require “standards that do
not now exist for reliably measuring the declining levels of an-
tibodies over time in relation to risk of reinfection”).
Second, the Secretary also acknowledged and fully explained
the agency’s change from its prior approach of merely encouraging
vaccination, which experience had shown to be “insufficient to
protect the health and safety of individuals receiving health care
services” from covered facilities. 86 Fed. Reg. at 61,583. The
fact that the Secretary issued the rule after the President an-
nounced multiple measures designed to combat the COVID-19 pandemic
in specific contexts within federal authority through requirements
encouraging or requiring vaccination hardly shows that the rule is
“pretextual.” Missouri Opp. 27; Louisiana Opp. 30. Respondents
provide no reason to doubt the Secretary’s conclusion that the
rule will protect vulnerable Medicare and Medicaid patients. The
fact that the rule will also protect the general public -- as the
Secretary forthrightly explained, see 86 Fed. Reg. at 61,612 -- is
an additional virtue, not impermissible pretext.
Finally, there is no merit to the Missouri respondents’ claim
(Opp. 25-26) that the Secretary relied only on evidence from long-
term-care facilities. Although the Secretary explained that such
25
facilities have produced the most extensive data on COVID-19 trans-
mission in healthcare settings, see 86 Fed. Reg. at 61,585, he
also relied on hospital data, see ibid.; see also id. at 61,557-
61,558. And he explained that those facilities illustrated the
danger of COVID-19 transmission in healthcare settings more
broadly because they “engage many, if not all, of the same health
care professionals and support services” as the other covered fa-
cilities. Id. at 51,585. The Secretary was entitled to draw such
inferences from the available data, particularly in the “absence
of any countervailing evidence.” Prometheus Radio Project, 141
S. Ct. at 1159.
C. The Secretary Validly Promulgated The Rule
This Court is also likely to reject respondents’ attacks on
the procedures the Secretary employed to issue the rule.
1. In light of the ongoing pandemic and urgent danger to
patients, the Secretary had good cause to issue the rule as an
interim final rule with a comment period, rather than delaying it
for advance notice and comment. Missouri Appl. 36-37. Respondents
do not identify any sound reason to reject the Secretary’s finding
that the rule is “the minimum regulatory action necessary” to
protect the health and safety of Medicare and Medicaid patients,
86 Fed. Reg. at 61,613, or that “further delay in imposing a
vaccine mandate would endanger the health and safety of additional
patients,” id. at 61,584. Indeed, even before the emergence of
the Omicron variant, the Secretary correctly anticipated that time
26
was of the essence because of the “potential for new variants” to
cause outbreaks of the kind that had devastated Medicare- and
Medicaid-participating facilities earlier in the pandemic. Id. at
61,583-61,584.
Respondents also do not dispute that Medicare and Medicaid
beneficiaries are especially at risk. Although “COVID-19 can af-
fect anyone,” “[a]ge remains a strong risk factor for severe COVID-
19 outcomes.” 86 Fed. Reg. at 61,566. The population aged 65 or
older accounts for more than 80% of U.S. COVID-19 related deaths.
See ibid. Social determinants of health such as poverty also
“increase risk of severe illness and death from COVID-19,” ibid.,
and Medicaid beneficiaries are by definition in low-income house-
holds. And “individuals seeking health care services are more
likely to fall into the high-risk category.” Id. at 61,568. Those
considerations all underscore the need for urgency.
Respondents nonetheless assert (Louisiana Opp. 31-33; Mis-
souri Opp. 33) that the two-month “delay” between the President’s
announcement in September and the issuance of the interim final
rule in November precludes any invocation of the good-cause ex-
ception. In that timeframe, the Secretary prepared and issued a
73-page rule -- including a detailed cost-benefit analysis, 86
Fed. Reg. at 61,586-61,615 -- while also continuing to manage the
agency’s other efforts to address the country’s worst pandemic in
a century. Respondents’ assertion (Louisiana Opp. 33) that the
27
agency could have prepared the rule, solicited comments, and re-
viewed and responded to those comments in two months seriously
misunderstands the demands of the rulemaking process. See, e.g.,
Anne Joseph O’Connell, Agency Rulemaking and Political Transi-
tions, 105 N.W. L. Rev. 471, 513-514 (2011) (finding that the
average notice-and-comment rulemaking takes more than a year).
Respondents also fail to demonstrate any prejudice from the
lack of a comment period because the Secretary already considered
the issues they raise. Compare Missouri Opp. 33-34 (arguing that
lack of comment period prejudiced the States by depriving them of
the opportunity to submit information on potential staffing short-
ages), with 86 Fed. Reg. at 61,608-61,609 (considering, at length,
the issue of “staffing and service disruptions”).
2. The Louisiana respondents’ reliance (Opp. 18-22) on 42
U.S.C. 1395z is equally unavailing. That provision instructs the
Secretary to “consult with appropriate State agencies and recog-
nized national listing or accrediting bodies” in determining con-
ditions of Medicare participation for some of the facilities cov-
ered by the rule, 42 U.S.C. 1395z, but it does not require that
such consultations occur in advance of any rulemaking. See Flor-
ida, 19 F.4th at 1290 n.3. To the contrary, the consultation
requirement should be construed in light of the Medicare statute’s
express authority for the Secretary to adopt “interim final regu-
lations,” which may be made effective immediately for good cause.
42 U.S.C. 1395hh(a)(3)(C); see 42 U.S.C. 1395hh(b)(2)(C). The
28
Secretary expressly found that delaying the vaccination rule --
including for advance consultations with States -- would jeopard-
ize the lives and health of patients. 86 Fed. Reg. at 61,567.
The Secretary therefore reasonably determined to engage in the
requisite consultations after issuing the rule. See ibid.
3. The Louisiana respondents also err in relying (Opp. 16-
18) on 42 U.S.C. 1302(b), which requires the preparation of a
regulatory impact statement for some rules that may affect a sub-
stantial number of small rural hospitals. By its terms, that
statute does not apply to interim final rules like the one at issue
here. Section 1302(b)(2) requires the preparation of a final
regulatory impact analysis “[w]henever the Secretary promulgates
a final version of a rule or regulation with respect to which an
initial regulatory impact analysis is required by paragraph (1),”
42 U.S.C. 1302(b)(2), which in turn applies only to the publication
of proposed rules. And in any event, the Secretary determined
that the rule “will not have a significant impact on the operations
of a substantial number of small rural hospitals.” 86 Fed. Reg.
at 61,613.
III. The Remaining Factors Overwhelmingly Favor A Stay
The remaining considerations overwhelmingly favor granting a
stay to allow the rule to protect Medicare and Medicaid patients
while the appeals are pending. The preliminary injunctions were
imposed right as the highly transmissible Omicron variant emerged
29
and at the beginning of the winter holiday season, with its pre-
dictable increases in travel and indoor social gatherings. The
explosion in COVID-19 cases that has resulted from those develop-
ments has severely strained the Nation’s healthcare system and
heightened the danger to vulnerable Medicare and Medicaid pa-
tients.
On the other side of the ledger, it bears repeating that the
rule has been challenged only by States, not any private facilities
impacted by the rule -- or their workers, who may seek medical or
religious exemptions. And the interests the States assert do not
support the sweeping relief granted by the district courts. Re-
spondents focus almost exclusively on an asserted risk of labor
shortages in “rural” areas (e.g., Missouri Opp. 1, 2, 6, 7, 29,
37). But that risk is, at best, highly speculative. See pp. 20-
23, supra. And it would be profoundly inequitable to deprive all
Medicare and Medicaid patients in the respondent States of the
rule’s protection based on speculative concerns about some rural
labor markets.
The Louisiana respondents also err in asserting (Opp. 35-37)
that a stay pending appeal would be tantamount to granting “ulti-
mate relief,” on the theory that employees who become vaccinated
during litigation cannot be unvaccinated afterwards if respondents
prevail. That assertion misapprehends the operation of the rule,
which specifies a condition of participation for facilities. A
facility that wishes to challenge the mandate may do so -- subject
30
to the statutory channeling provision, see Missouri Appl. 39 --
and the “ultimate relief” available to the facility if it were to
prevail would be the reversal of any sanctions imposed for non-
compliance. In short, granting a stay pending appeal may save
hundreds or thousands of lives and would not preclude granting
meaningful relief in the unlikely event that respondents ulti-
mately prevail.
* * * * *
For the foregoing reasons and those stated in the government’s
applications, the injunctions should be stayed pending appeal and,
if the Fifth or Eighth Circuit affirms the relevant injunction,
pending the filing and disposition of a petition for a writ of
certiorari and any further proceedings in this Court. At a mini-
mum, the injunctions should be stayed as to all facilities other
than those operated by respondents.
Respectfully submitted.
ELIZABETH B. PRELOGAR
Solicitor General
JANUARY 2022
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