21A240 019 Dec 30 2021 Main Document 20211230142923459 Respondents Appendix (U.S.)

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No. 21A240 
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., 
Respondents. 
RESPONDENTS’ APPENDIX 
ERIC S. SCHMITT 
Attorney General of Missouri 
D. JOHN SAUER
Solicitor General
  Counsel of Record 
JESUS A. OSETE 
Deputy Attorney General 
Maddie McMillian Green 
Assistant Attorney General 
Office of the Attorney General 
Supreme Court Building 
207 W. High St. 
P.O. Box 899 
Jefferson City, Missouri 65102 
Tel.: (573) 751-1800 
Fax: (573) 751-0774 
John.Sauer@ago.mo.gov 
Jesus.Osete@ago.mo.gov 
Counsel for Respondents 
DOUGLAS J. PETERSON 
Attorney General of Nebraska 
JAMES A. CAMPBELL 
Solicitor General 
Office of the Attorney General 
2115 State Capitol 
Lincoln, Nebraska 68509 
Tel.: (402) 471-2682 

Index 
Description 
Pages 
Sections of the Social Security Act Cited in the CMS 
Mandate 
1a-34a 
Declaration of Renee Gayhart 
35a-37a 
Declaration of Scott York 
38a-40a 
Declaration of Mark White 
41a-43a 
Declaration of Ed Smith 
44a-46a 
Declaration of Brittany Vanlandingham 
47a-49a 
Declaration of Nikki Strong 
50a-52a 
Declaration of Randall W. Tobler 
53a-55a 
Declaration of Steve Bollin 
56a-60a 
Declaration of Tim Schrage 
61a-64a 
Declaration of Valerie Huhn 
65a-69a 
Declaration of Abigail Cyboron 
70a-73a 
Declaration of Brett Eggleston 
74a-76a 
Declaration of Don Naiberk 
77a-79a 
Declaration of Eric Barber 
80a-82a 
Declaration of Jason Petik 
83a-85a 
Declaration of Kyle Kellum 
86a-91a 
Declaration of Larry Kahn 
92a-95a 
Declaration of Lori Mazanec 
96a-100a 
Declaration of Mel McNea 
101a-103a 
Declaration of Mark Sroczynski 
104a-106a 
Declaration of Nancy Glaubke 
107a-109a 
Declaration of Shannon Monheiser 
110a-113a 
Declaration of Troy Bruntz 
114a-117a 
Declaration of Tanya Sharp 
118a-120a 
Declaration of Tyler Toline 
121a-124a 
Declaration of Debra Shackett 
125a-127a 
Declaration of Christopher D. Jones 
128a-132a 
Declaration of Dr. Nizar Wehbi 
133a-134a 
Declaration of Laura Ringling 
135a-136a 
Declaration of Stefan Johansson 
137a-139a 
 

Sections of the Social Security Act Cited in the CMS Mandate 
General Rulemaking Statutes 
RULES AND REGULATIONS 
SEC. 1102. [42 U.S.C. 1302]  
(a) The Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health
and Human Services, respectively, shall make and publish such rules and regulations, 
not inconsistent with this Act, as may be necessary to the efficient administration of the 
functions with which each is charged under this Act. 
(b)(1) Whenever the Secretary publishes a general notice of proposed rulemaking for 
any rule or regulation proposed under title XVIII, title XIX, or part B of this title that may 
have a significant impact on the operations of a substantial number of small rural 
hospitals, the Secretary shall prepare and make available for public comment an initial 
regulatory impact analysis. Such analysis shall describe the impact of the proposed rule 
or regulation on such hospitals and shall set forth, with respect to small rural hospitals, 
the matters required under section 603 of title 5, United States Code, to be set forth with 
respect to small entities. The initial regulatory impact analysis (or a summary) shall be 
published in the Federal Register at the time of the publication of general notice of 
proposed rulemaking for the rule or regulation. 
(2) Whenever 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), the Secretary shall prepare a final regulatory impact analysis with respect to the 
final version of such rule or regulation. Such analysis shall set forth, with respect to 
small rural hospitals, the matters required under section 604 of title 5, United States 
Code, to be set forth with respect to small entities. The Secretary shall make copies 
of the final regulatory impact analysis available to the public and shall publish, in 
the Federal Register at the time of publication of the final version of the rule or 
regulation, a statement describing how a member of the public may obtain a copy 
of such analysis. 
(3) If a regulatory flexibility analysis is required by chapter 6 of title 5, United
States Code[7], for a rule or regulation to which this subsection applies, such 
analysis shall specifically address the impact of the rule or regulation on small rural 
hospitals. 
REGULATIONS 
SEC. 1871. [42 U.S.C. 1395hh] 
(a)(1) The Secretary shall prescribe such regulations as may be necessary to carry 
out the administration of the insurance programs under this title. When used in this title, 
the term “regulations” means, unless the context otherwise requires, regulations 
prescribed by the Secretary. 
(1a)

(2) No rule, requirement, or other statement of policy (other than a national 
coverage determination) that establishes or changes a substantive legal standard 
governing the scope of benefits, the payment for services, or the eligibility of 
individuals, entities, or organizations to furnish or receive services or benefits under 
this title shall take effect unless it is promulgated by the Secretary by regulation 
under paragraph (1). 
(3)(A) The Secretary, in consultation with the Director of the Office of 
Management and Budget, shall establish and publish a regular timeline for the 
publication of final regulations based on the previous publication of a proposed 
regulation or an interim final regulation. 
(B) Such timeline may vary among different regulations based on differences 
in the complexity of the regulation, the number and scope of comments 
received, and other relevant factors, but shall not be longer than 3 years except 
under exceptional circumstances. If the Secretary intends to vary such timeline 
with respect to the publication of a final regulation, the Secretary shall cause to 
have published in the Federal Register notice of the different timeline by not 
later than the timeline previously established with respect to such regulation. 
Such notice shall include a brief explanation of the justification for such 
variation. 
(C) In the case of interim final regulations, upon the expiration of the regular 
timeline established under this paragraph for the publication of a final 
regulation after opportunity for public comment, the interim final regulation 
shall not continue in effect unless the Secretary publishes (at the end of the 
regular timeline and, if applicable, at the end of each succeeding 1-year period) 
a notice of continuation of the regulation that includes an explanation of why 
the regular timeline (and any subsequent 1-year extension) was not complied 
with. If such a notice is published, the regular timeline (or such timeline as 
previously extended under this paragraph) for publication of the final 
regulation shall be treated as having been extended for 1 additional year. 
(D) The Secretary shall annually submit to Congress a report that describes 
the instances in which the Secretary failed to publish a final regulation within 
the applicable regular timeline under this paragraph and that provides an 
explanation for such failures. 
(4) If the Secretary publishes a final regulation that includes a provision that is 
not a logical outgrowth of a previously published notice of proposed rulemaking or 
interim final rule, such provision shall be treated as a proposed regulation and shall 
not take effect until there is the further opportunity for public comment and a 
publication of the provision again as a final regulation. 
 
* * * * * 
 
Ambulatory Surgical Centers (ASCs) 
SCOPE OF BENEFITS 
2a

SEC. 1832. [42 U.S.C. 1395k]  
(a) The benefits provided to an individual by the insurance program established by 
this part shall consist of— 
(1) entitlement to have payment made to him or on his behalf (subject to the 
provisions of this part) for medical and other health services, except those 
described in subparagraphs (B) and (D) of paragraph (2) and subparagraphs (E) 
and (F) of section 1842(b)(6); and 
(2) entitlement to have payment made on his behalf (subject to the provisions of 
this part) for— 
(A) home health services (other than items described in subparagraph (G) or 
subparagraph (I)); 
(B) medical and other health services (other than items described in 
subparagraph (G) or subparagraph (I)) furnished by a provider of services or by 
others under arrangement with them made by a provider of services, 
excluding— 
(i) physician services except where furnished by— 
(I) a resident or intern of a hospital, or 
(II) a physician to a patient in a hospital which has a teaching 
program approved as specified in paragraph (6) of section 1861(b) 
(including services in conjunction with the teaching programs of such 
hospital whether or not such patient is an inpatient of such hospital) 
where the conditions specified in paragraph (7) of such section are 
met, 
(ii) services for which payment may be made pursuant to section 
1835(b)(2), 
(iii) services described by section 1861(s)(2)(K)(i), certified nurse-
midwife services, qualified psychologist services, and services of a 
certified registered nurse anesthetist; 
(iv) services of a nurse practitioner or clinical nurse specialist but only if 
no facility or other provider charges or is paid any amounts with respect to 
the furnishing of such services; and 
(C) outpatient physical therapy services (other than services to which the 
second sentence of section 1861(p) applies), outpatient occupational therapy 
services (other than services to which such sentence applies through the 
operation of section 1861(g), and outpatient speech-language pathology 
services (other than services to which the second sentence of section 1861(p) 
applies through the application of section 1861(ll)(2)); 
(D)(i) rural health clinic services and (ii) Federally qualified health center 
services; 
(E) comprehensive outpatient rehabilitation facility services; 
(F) facility services furnished in connection with surgical procedures 
specified by the Secretary— 
3a

(i) pursuant to section 1833(i)(1)(A) and performed in an ambulatory 
surgical center (which meets health, safety, and other standards specified 
by the Secretary in regulations) if the center has an agreement in effect 
with the Secretary by which the center agrees to accept the standard 
overhead amount determined under section 1833(i)(2)(A) as full payment 
for such services (including intraocular lens in cases described in section 
1833(i)(2)(A)(iii)) and to accept an assignment described in section 
1842(b)(3)(B)(ii) with respect to payment for all such services (including 
intraocular lens in cases described in section 1833(i)(2)(A)(iii)) furnished 
by the center to individuals enrolled under this part, or 
(ii) pursuant to section 1833(i)(1)(B) and performed by a physician, 
described in paragraph (1), (2), or (3) of section 1861(r), in his office, if the 
Secretary has determined that— 
(I) a quality improvement organization (having a contract with the 
Secretary under part B of title XI of this Act) is willing, able, and has 
agreed to carry out a review (on a sample or other reasonable basis) 
of the physician’s performing such procedures in the physician’s 
office, 
(II) the particular physician involved has agreed to make available 
to such organization such records as the Secretary determines to be 
necessary to carry out the review, and 
(III) the physician is authorized to perform the procedure in a 
hospital located in the area in which the office is located, 
and if the physician agrees to accept the standard overhead amount 
determined under section 1833(i)(2)(B) as full payment for such services 
and to accept payment on an assignment-related basis with respect to 
payment for all services (including all pre-and post-operative services) 
described in paragraphs (1) and (2)(A) of section 1861(s) and furnished in 
connection with such surgical procedure to individuals enrolled under this 
part; 
(G) covered items (described in section 1834(a)(13)) furnished by a provider 
of services or by others under arrangements with them made by a provider of 
services; 
(H) outpatient critical access hospital services (as defined in section 
1861(mm)(3)); 
(I) prosthetic devices and orthotics and prosthetics (described in section 
1834(h)(4)) furnished by a provider of services or by others under 
arrangements with them made by a provider of services; and 
(J) partial hospitalization services provided by a community mental health 
center (as described in section 1861(ff)(2)(B)). 
(b) For definitions of “spell of illness”, “medical and other health services”, and other 
terms used in this part, see section 1861. 
 
4a

PAYMENT OF BENEFITS 
SEC. 1833. [42 U.S.C. 1395l]  
(a) Except as provided in section 1876, and subject to the succeeding provisions of 
this section, there shall be paid from the Federal Supplementary Medical Insurance 
Trust Fund, in the case of each individual who is covered under the insurance program 
established by this part and incurs expenses for services with respect to which benefits 
are payable under this part, amounts equal to— 
 
* * * * * 
 
(i)(1) The Secretary shall, in consultation with appropriate medical organizations— 
(A) specify those surgical procedures which are appropriately (when 
considered in terms of the proper utilization of hospital inpatient facilities) 
performed on an inpatient basis in a hospital but which also can be performed 
safely on an ambulatory basis in an ambulatory surgical center (meeting the 
standards specified under section 1832(a)(2)(F)(i)), critical access hospital, or 
hospital outpatient department, and 
(B) specify those surgical procedures which are appropriately (when 
considered in terms of the proper utilization of hospital inpatient facilities) 
performed on an inpatient basis in a hospital but which also can be performed 
safely on an ambulatory basis in a physician’s office. 
The lists of procedures established under subparagraphs (A) and (B) shall be reviewed 
and updated not less often than every 2 years. 
 
* * * * * 
 
Hospices 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
Hospice Care; Hospice Program 
(dd)(1) The term “hospice care” means the following items and services provided to a 
terminally ill individual by, or by others under arrangements made by, a hospice program 
under a written plan (for providing such care to such individual) established and 
periodically reviewed by the individual’s attending physician and by the medical director 
(and by the interdisciplinary group described in paragraph (2)(B)) of the program— 
5a

(A) nursing care provided by or under the supervision of a registered 
professional nurse, 
(B) physical or occupational therapy, or speech-language pathology services, 
(C) medical social services under the direction of a physician, 
(D)(i) services of a home health aide who has successfully completed a 
training program approved by the Secretary and 
(ii) homemaker services, 
(E) medical supplies (including drugs and biologicals) and the use of 
medical appliances, while under such a plan, 
(F) physicians’ services, 
(G) short-term inpatient care (including both respite care and procedures 
necessary for pain control and acute and chronic symptom management) in an 
inpatient facility meeting such conditions as the Secretary determines to be 
appropriate to provide such care, but such respite care may be provided only 
on an intermittent, nonroutine, and occasional basis and may not be provided 
consecutively over longer than five days, 
(H) counseling (including dietary counseling) with respect to care of the 
terminally ill individual and adjustment to his death, and 
(I) any other item or service which is specified in the plan and for which 
payment may otherwise be made under this title. 
The care and services described in subparagraphs (A) and (D) may be provided on a 24-
hour, continuous basis only during periods of crisis (meeting criteria established by the 
Secretary) and only as necessary to maintain the terminally ill individual at home. 
(2) The term “hospice program” means a public agency or private organization 
(or a subdivision thereof) which— 
(A)(i) is primarily engaged in providing the care and services described in 
paragraph (1) and makes such services available (as needed) on a 24-hour 
basis and which also provides bereavement counseling for the immediate 
family of terminally ill individuals and services described in section 1812(a)(5), 
(ii) provides for such care and services in individuals’ homes, on an 
outpatient basis, and on a short-term inpatient basis, directly or under 
arrangements made by the agency or organization, except that— 
(I) the agency or organization must routinely provide directly 
substantially all of each of the services described in subparagraphs 
(A), (C), and (H) of paragraph (1), except as otherwise provided in 
paragraph (5), and 
(II) in the case of other services described in paragraph (1) which 
are not provided directly by the agency or organization, the agency or 
organization must maintain professional management responsibility 
for all such services furnished to an individual, regardless of the 
location or facility in which such services are furnished; and 
(iii) provides assurances satisfactory to the Secretary that the 
aggregate number of days of inpatient care described in paragraph (1)(G) 
6a

provided in any 12-month period to individuals who have an election in 
effect under section 1812(d) with respect to that agency or organization 
does not exceed 20 percent of the aggregate number of days during that 
period on which such elections for such individuals are in effect; 
(B) has an interdisciplinary group of personnel which— 
(i) includes at least— 
(I) one physician (as defined in subsection (r)(1)), 
(II) one registered professional nurse, and 
(III) one social worker, 
employed by or, in the case of a physician described in subclause (I), under 
contract with the agency or organization, and also includes at least one 
pastoral or other counselor, 
(ii) provides (or supervises the provision of) the care and services 
described in paragraph (1), and 
(iii) establishes the policies governing the provision of such care and 
services; 
(C) maintains central clinical records on all patients; 
(D) does not discontinue the hospice care it provides with respect to a 
patient because of the inability of the patient to pay for such care; 
(E)(i) utilizes volunteers in its provision of care and services in accordance 
with standards set by the Secretary, which standards shall ensure a continuing 
level of effort to utilize such volunteers, and 
(ii) maintains records on the use of these volunteers and the cost 
savings and expansion of care and services achieved through the use of 
these volunteers; 
(F) in the case of an agency or organization in any State in which State or 
applicable local law provides for the licensing of agencies or organizations of 
this nature, is licensed pursuant to such law; and 
(G) meets such other 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. 
 
* * * * * 
 
Psychiatric Residential Treatment Facilities 
 
DEFINITIONS 
SEC. 1905. [42 U.S.C. 1396d]   
For purposes of this title— 
(a) The term “medical assistance” means payment of part or all of the cost of the 
following care and services or the care and services themselves, or both * * * *  
 
7a

* * * * * 
 
(h)(1) For purposes of paragraph (16) of subsection (a), the term “inpatient 
psychiatric hospital services for individuals under age 21” includes only— 
(A) inpatient services which are provided in an institution (or distinct part 
thereof) which is a psychiatric hospital as defined in section 1861(f) or in 
another inpatient setting that the Secretary has specified in regulations; 
(B) inpatient services which, in the case of any individual (i) involve active 
treatment which meets such standards as may be prescribed in regulations by 
the Secretary, and (ii) a team, consisting of physicians and other personnel 
qualified to make determinations with respect to mental health conditions and 
the treatment thereof, has determined are necessary on an inpatient basis and 
can reasonably be expected to improve the condition, by reason of which such 
services are necessary, to the extent that eventually such services will no 
longer be necessary; and 
(C) inpatient services which, in the case of any individual, are provided prior 
to (i) the date such individual attains age 21, or (ii) in the case of an individual 
who was receiving such services in the period immediately preceding the date 
on which he attained age 21, (I) the date such individual no longer requires 
such services, or (II) if earlier, the date such individual attains age 22; 
(2) Such term does not include services provided during any calendar quarter 
under the State plan of any State if the total amount of the funds expended, during 
such quarter, by the State (and the political subdivisions thereof) from non-Federal 
funds for inpatient services included under paragraph (1), and for active psychiatric 
care and treatment provided on an outpatient basis for eligible mentally ill children, 
is less than the average quarterly amount of the funds expended, during the 4-
quarter period ending December 31, 1971, by the State (and the political 
subdivisions thereof) from non-Federal funds for such services. 
 
* * * * * 
 
Programs of All-Inclusive Care for the Elderly (PACE) 
 
PAYMENTS TO, AND COVERAGE OF BENEFITS UNDER, PROGRAMS OF 
ALL–INCLUSIVE CARE FOR THE ELDERLY (PACE)  
SEC. 1894. [42 U.S.C. 1395eee]  
 
* * * * * 
 
(f) REGULATIONS.— 
(1) IN GENERAL.—The Secretary shall issue interim final or final regulations to carry 
out this section and section 1934. 
8a

(2) USE OF PACE PROTOCOL.— 
(A) IN GENERAL.—In issuing such regulations, the Secretary shall, to the extent 
consistent with the provisions of this section, incorporate the requirements 
applied to PACE demonstration waiver programs under the PACE protocol. 
(B) FLEXIBILITY.—In order to provide for reasonable flexibility in adapting the 
PACE service delivery model to the needs of particular organizations (such as 
those in rural areas or those that may determine it appropriate to use nonstaff 
physicians according to State licensing law requirements) under this section 
and section 1934, the Secretary (in close consultation with State administering 
agencies) may modify or waive provisions of the PACE protocol so long as any 
such modification or waiver is not inconsistent with and would not impair the 
essential elements, objectives, and requirements of this section, but may not 
modify or waive any of the following provisions: 
(i) The focus on frail elderly qualifying individuals who require the level 
of care provided in a nursing facility. 
(ii) The delivery of comprehensive, integrated acute and long-term care 
services. 
(iii) The interdisciplinary team approach to care management and 
service delivery. 
(iv) Capitated, integrated financing that allows the provider to pool 
payments received from public and private programs and individuals. 
(v) The assumption by the provider of full financial risk. 
(C) CONTINUATION OF MODIFICATIONS OR WAIVERS OF OPERATIONAL REQUIREMENTS 
UNDER DEMONSTRATION STATUS.—If a PACE program operating under 
demonstration authority has contractual or other operating arrangements 
which are not otherwise recognized in regulation and which were in effect on 
July 1, 2000, the Secretary (in close consultation with, and with the 
concurrence of, the State administering agency) shall permit any such program 
to continue such arrangements so long as such arrangements are found by the 
Secretary and the State to be reasonably consistent with the objectives of the 
PACE program. 
(3) APPLICATION OF CERTAIN ADDITIONAL BENEFICIARY AND PROGRAM PROTECTIONS.— 
(A) IN GENERAL.—In issuing such regulations and subject to subparagraph (B), 
the Secretary may apply with respect to PACE programs, providers, and 
agreements such requirements of part D (or, for periods before January 1, 
1999, section 1876) and sections 1903(m) and 1932 relating to protection of 
beneficiaries and program integrity as would apply to Medicare+Choice 
organizations under part D (or for such periods eligible organizations under 
risk-sharing contracts under section 1876) and to medicaid managed care 
organizations under prepaid capitation agreements under section 1903(m). 
(B) CONSIDERATIONS.—In issuing such regulations, the Secretary shall— 
9a

(i) take into account the differences between populations served and 
benefits provided under this section and under part D (or, for periods 
before January 1, 1999, section 1876) and section 1903(m); 
(ii) not include any requirement that conflicts with carrying out PACE 
programs under this section; and 
(iii) not include any requirement restricting the proportion of enrollees 
who are eligible for benefits under this title or title XIX. 
(4) CONSTRUCTION.—Nothing in this subsection shall be construed as preventing 
the Secretary from including in regulations provisions to ensure the health and 
safety of individuals enrolled in a PACE program under this section that are in 
addition to those otherwise provided under paragraphs (2) and (3). 
 
* * * * * 
 
PROGRAM OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) 
SEC. 1934. [42 U.S.C. 1396u–4]  
 
* * * * * 
 
(f) REGULATIONS.— 
(1) IN GENERAL.—The Secretary shall issue interim final or final regulations to carry 
out this section and section 1894. 
(2) USE OF PACE PROTOCOL.— 
(A) IN GENERAL.—In issuing such regulations, the Secretary shall, to the extent 
consistent with the provisions of this section, incorporate the requirements 
applied to PACE demonstration waiver programs under the PACE protocol. 
(B) FLEXIBILITY.—In order to provide for reasonable flexibility in adapting the 
PACE service delivery model to the needs of particular organizations (such as 
those in rural areas or those that may determine it appropriate to use nonstaff 
physicians according to State licensing law requirements) under this section 
and section 1894, the Secretary (in close consultation with State administering 
agencies) may modify or waive provisions of the PACE protocol so long as any 
such modification or waiver is not inconsistent with and would not impair the 
essential elements, objectives, and requirements of this section, but may not 
modify or waive any of the following provisions: 
(i) The focus on frail elderly qualifying individuals who require the level 
of care provided in a nursing facility. 
(ii) The delivery of comprehensive, integrated acute and long–term care 
services. 
(iii) The interdisciplinary team approach to care management and 
service delivery. 
10a

(iv) Capitated, integrated financing that allows the provider to pool 
payments received from public and private programs and individuals. 
(v) The assumption by the provider of full financial risk. 
(C) CONTINUATION OF MODIFICATIONS OR WAIVERS OF OPERATIONAL REQUIREMENTS 
UNDER DEMONSTRATION STATUS.—If a PACE program operating under 
demonstration authority has contractual or other operating arrangements 
which are not otherwise recognized in regulation and which were in effect on 
July 1, 2000, the Secretary (in close consultation with, and with the 
concurrence of, the State administering agency) shall permit any such program 
to continue such arrangements so long as such arrangements are found by the 
Secretary and the State to be reasonably consistent with the objectives of the 
PACE program. 
(3) APPLICATION OF CERTAIN ADDITIONAL BENEFICIARY AND PROGRAM PROTECTIONS.— 
(A) IN GENERAL.—In issuing such regulations and subject to subparagraph (B), 
the Secretary may apply with respect to PACE programs, providers, and 
agreements such requirements of part C of title XVIII (or, for periods before 
January 1, 1999, section 1876) and sections 1903(m) and 1932 relating to 
protection of beneficiaries and program integrity as would apply to 
Medicare+Choice organizations under such part C (or for such periods eligible 
organizations under risk–sharing contracts under section 1876) and to 
medicaid managed care organizations under prepaid capitation agreements 
under section 1903(m). 
(B) CONSIDERATIONS.—In issuing such regulations, the Secretary shall— 
(i) take into account the differences between populations served and 
benefits provided under this section and under part C of title XVIII (or, for 
periods before January 1, 1999, section 1876) and section 1903(m); 
(ii) not include any requirement that conflicts with carrying out PACE 
programs under this section; and 
(iii) not include any requirement restricting the proportion of enrollees 
who are eligible for benefits under this title or title XVIII. 
(4) CONSTRUCTION.—Nothing in this subsection shall be construed as preventing 
the Secretary from including in regulations provisions to ensure the health and 
safety of individuals enrolled in a PACE program under this section that are in 
addition to those otherwise provided under paragraphs (2) and (3). 
 
* * * * * 
 
Hospitals 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
11a

 
* * * * * 
 
Hospital 
(e) The term “hospital” (except for purposes of sections 1814(d), 1814(f), and 
1835(b), subsection (a)(2) of this section, paragraph (7) of this subsection, and 
subsection (i) of this section) means an institution which— 
(1) is primarily engaged in providing, by or under the supervision of physicians, to 
inpatients (A) diagnostic services and therapeutic services for medical diagnosis, 
treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation 
services for the rehabilitation of injured, disabled, or sick persons; 
(2) maintains clinical records on all patients; 
(3) has bylaws in effect with respect to its staff of physicians; 
(4) has a requirement that every patient with respect to whom payment may be 
made under this title must be under the care of a physician except that a patient 
receiving qualified psychologist services (as defined in subsection (ii)) may be 
under the care of a clinical psychologist with respect to such services to the extent 
permitted under State law; 
(5) provides 24-hour nursing service rendered or supervised by a registered 
professional nurse, and has a licensed practical nurse or registered professional 
nurse on duty at all times; except that until January 1, 1979, the Secretary is 
authorized to waive the requirement of this paragraph for any one-year period with 
respect to any institution, insofar as such requirement relates to the provision of 
twenty-four-hour nursing service rendered or supervised by a registered 
professional nurse (except that in any event a registered professional nurse must 
be present on the premises to render or supervise the nursing service provided, 
during at least the regular daytime shift), where immediately preceding such one-
year period he finds that— 
(A) such institution is located in a rural area and the supply of hospital 
services in such area is not sufficient to meet the needs of individuals residing 
therein, 
(B) the failure of such institution to qualify as a hospital would seriously 
reduce the availability of such services to such individuals, and 
(C) such institution has made and continues to make a good faith effort to 
comply with this paragraph, but such compliance is impeded by the lack of 
qualified nursing personnel in such area; 
(6)(A) has in effect a hospital utilization review plan which meets the 
requirements of subsection (k) and 
(B) has in place a discharge planning process that meets the requirements 
of subsection (ee); 
(7) in the case of an institution in any State in which State or applicable local law 
provides for the licensing of hospitals, (A) is licensed pursuant to such law or (B) is 
12a

approved, by the agency of such State or locality responsible for licensing 
hospitals, as meeting the standards established for such licensing; 
(8) has in effect an overall plan and budget that meets the requirements of 
subsection (z); and 
(9) meets such other requirements as the Secretary finds necessary in the 
interest of the health and safety of individuals who are furnished services in the 
institution. 
 
* * * * * 
 
Long Term Care Facilities (LTC Facilities) 
REQUIREMENTS FOR, AND ASSURING QUALITY OF CARE IN, SKILLED 
NURSING FACILITIES 
SEC. 1819. [42 U.S.C. 1395i–3]  
(a) SKILLED NURSING FACILITY DEFINED.—In this title, the term “skilled nursing facility” 
means an institution (or a distinct part of an institution) which— 
(1) is primarily engaged in providing to residents— 
(A) skilled nursing care and related services for residents who require 
medical or nursing care, or 
(B) rehabilitation services for the rehabilitation of injured, disabled, or sick 
persons, 
and is not primarily for the care and treatment of mental diseases; 
(2) has in effect a transfer agreement (meeting the requirements of section 
1861(l)) with one or more hospitals having agreements in effect under section 
1866; and 
(3) meets the requirements for a skilled nursing facility described in subsections 
(b), (c), and (d) of this section. 
 
* * * * * 
 
(d) REQUIREMENTS RELATING TO ADMINISTRATION AND OTHER MATTERS.— 
(1) ADMINISTRATION.— 
(A) IN GENERAL.—A skilled nursing facility must be administered in a manner 
that enables it to use its resources effectively and efficiently to attain or 
maintain the highest practicable physical, mental, and psychosocial well-being 
of each resident (consistent with requirements established under subsection 
(f)(5)). 
(B) REQUIRED NOTICES.—If a change occurs in— 
(i) the persons with an ownership or control interest (as defined in 
section 1124(a)(3)) in the facility 
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(ii) the persons who are officers, directors, agents, or managing 
employees (as defined in section 1126(b)) of the facility 
(iii) the corporation, association, or other company responsible for the 
management of the facility, or 
(iv) the individual who is the administrator or director of nursing of the 
facility, 
(C) SKILLED NURSING FACILITY ADMINISTRATOR.—The administrator of a skilled 
nursing facility must meet standards established by the Secretary under 
subsection (f)(4). 
(C) AVAILABILITY OF SURVEY, CERTIFICATION, AND COMPLAINT INVESTIGATION 
REPORTS.—A skilled nursing facility must— 
(i) have reports with respect to any surveys, certifications, and 
complaint investigations made respecting the facility during the 3 
preceding years available for any individual to review upon request; and 
(ii) post notice of the availability of such reports in areas of the facility 
that are prominent and accessible to the public. 
The facility shall not make available under clause (i) identifying information 
about complainants or residents. 
(2) LICENSING AND LIFE SAFETY CODE.— 
(A) LICENSING.—A skilled nursing facility must be licensed under applicable 
State and local law. 
(B) LIFE SAFETY CODE.—A skilled nursing facility must meet such provisions of 
such edition (as specified by the Secretary in regulation) of the Life Safety 
Code of the National Fire Protection Association as are applicable to nursing 
homes; except that— 
(i) the Secretary may waive, for such periods as he deems appropriate, 
specific provisions of such Code which if rigidly applied would result in 
unreasonable hardship upon a facility, but only if such waiver would not 
adversely affect the health and safety of residents or personnel, and 
(ii) the provisions of such Code shall not apply in any State if the 
Secretary finds that in such State there is in effect a fire and safety code, 
imposed by State law, which adequately protects residents of and 
personnel in skilled nursing facilities. 
(3) SANITARY AND INFECTION CONTROL AND PHYSICAL ENVIRONMENT.—A skilled nursing 
facility must— 
(A) 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, and 
(B) be designed, constructed, equipped, and maintained in a manner to 
protect the health and safety of residents, personnel, and the general public. 
(4) MISCELLANEOUS.— 
(A) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAWS AND PROFESSIONAL 
STANDARDS.—A skilled nursing facility must operate and provide services in 
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compliance with all applicable Federal, State, and local laws and regulations 
(including the requirements of section 1124) and with accepted professional 
standards and principles which apply to professionals providing services in 
such a facility. 
(B) OTHER.—A skilled nursing facility 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. 
 
* * * * * 
 
REQUIREMENTS FOR NURSING FACILITIES 
SEC. 1919. [42 U.S.C. 1396r]  
(a) NURSING FACILITY DEFINED.—In this title, the term “nursing facility” means an 
institution (or a distinct part of an institution) which— 
(1) is primarily engaged in providing to residents— 
(A) skilled nursing care and related services for residents who require 
medical or nursing care, 
(B) rehabilitation services for the rehabilitation of injured, disabled, or sick 
persons, or 
(C) on a regular basis, health-related care and services to individuals who 
because of their mental or physical condition require care and services (above 
the level of room and board) which can be made available to them only 
through institutional facilities, 
and is not primarily for the care and treatment of mental diseases; 
(2) has in effect a transfer agreement (meeting the requirements of section 
1861(l)) with one or more hospitals having agreements in effect under section 
1866; and 
(3) meets the requirements for a nursing facility described in subsections (b), (c), 
and (d) of this section. 
 
* * * * * 
 
(d) REQUIREMENTS RELATING TO ADMINISTRATION AND OTHER MATTERS.— 
(1) ADMINISTRATION.— 
(A) IN GENERAL.—A nursing facility must be administered in a manner that 
enables it to use its resources effectively and efficiently to attain or maintain 
the highest practicable physical, mental, and psychosocial well-being of each 
resident (consistent with requirements established under subsection (f)(5)). 
(B) REQUIRED NOTICES.—If a change occurs in— 
(i) the persons with an ownership or control interest (as defined in 
section 1124(a)(3)) in the facility 
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(ii) the persons who are officers, directors, agents, or managing 
employees (as defined in section 1126(b)) of the facility 
(iii) the corporation, association, or other company responsible for the 
management of the facility, or 
(iv) the individual who is the administrator or director of nursing of the 
facility, 
the skilled nursing facility must provide notice to the State agency responsible 
for the licensing of the facility, at the time of the change, of the change and of 
the identity of each new person, company, or individual described in the 
respective clause. 
(C) NURSING FACILITY ADMINISTRATOR.—The administrator of a nursing facility 
must meet standards established by the Secretary under subsection (f)(4). 
(V) AVAILABILITY OF SURVEY, CERTIFICATION, AND COMPLAINT INVESTIGATION 
REPORTS.—A nursing facility must— 
(i) have reports with respect to any surveys, certifications, and 
complaint investigations made respecting the facility during the 3 
preceding years available for any individual to review upon request; and 
(ii) post notice of the availability of such reports in areas of the facility 
that are prominent and accessible to the public. 
The facility shall not make available under clause (i) identifying information 
about complainants or residents. 
(2) LICENSING AND LIFE SAFETY CODE.— 
(A) LICENSING.—A nursing facility must be licensed under applicable State and 
local law. 
(B) LIFE SAFETY CODE.—A nursing facility must meet such provisions of such 
edition (as specified by the Secretary in regulation) of the Life Safety Code of 
the National Fire Protection Association as are applicable to nursing homes; 
except that— 
(i) the Secretary may waive, for such periods as he deems appropriate, 
specific provisions of such Code which if rigidly applied would result in 
unreasonable hardship upon a facility, but only if such waiver would not 
adversely affect the health and safety of residents or personnel, and 
(ii) the provisions of such Code shall not apply in any State if the 
Secretary finds that in such State there is in effect a fire and safety code, 
imposed by State law, which adequately protects residents of and 
personnel in nursing facilities. 
(3) SANITARY AND INFECTION CONTROL AND PHYSICAL ENVIRONMENT.—A nursing facility 
must— 
(A) 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, and 
(B) be designed, constructed, equipped, and maintained in a manner to 
protect the health and safety of residents, personnel, and the general public. 
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(4) MISCELLANEOUS.— 
(A) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAWS AND PROFESSIONAL 
STANDARDS.—A nursing facility must operate and provide services in compliance 
with all applicable Federal, State, and local laws and regulations (including the 
requirements of section 1124) and with accepted professional standards and 
principles which apply to professionals providing services in such a facility. 
(B) OTHER.—A nursing facility must meet such other requirements relating to 
the health and safety of residents or relating to the physical facilities thereof 
as the Secretary may find necessary. 
 
* * * * * 
 
Intermediate Care Facilities for Individuals with Intellectual 
Disabilities (ICFs-IID) 
DEFINITIONS 
SEC. 1905. [42 U.S.C. 1396d]   
For purposes of this title— 
 
* * * * * 
 
(d) The term “intermediate care facility for the mentally retarded” means an institution 
(or distinct part thereof) for the mentally retarded or persons with related conditions if— 
(1) the primary purpose of such institution (or distinct part thereof) is to provide 
health or rehabilitative services for mentally retarded individuals and the institution 
meets such standards as may be prescribed by the Secretary; 
(2) the mentally retarded individual with respect to whom a request for payment 
is made under a plan approved under this title is receiving active treatment under 
such a program; and 
(3) in the case of a public institution, the State or political subdivision responsible 
for the operation of such institution has agreed that the non-Federal expenditures in 
any calendar quarter prior to January 1, 1975, with respect to services furnished to 
patients in such institution (or distinct part thereof) in the State will not, because of 
payments made under this title, be reduced below the average amount expended 
for such services in such institution in the four quarters immediately preceding the 
quarter in which the State in which such institution is located elected to make such 
services available under its plan approved under this title. 
 
* * * * * 
 
Home Health Agencies (HHAs) 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
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SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
Home Health Services 
(m) The term “home health services” means the following items and services 
furnished to an individual, who is under the care of a physician, by a home health agency 
or by others under arrangements with them made by such agency, under a plan (for 
furnishing such items and services to such individual) established and periodically 
reviewed by a physician, which items and services are, except as provided in paragraph 
(7), provided on a visiting basis in a place of residence used as such individual’s home— 
(1) part-time or intermittent nursing care provided by or under the supervision of 
a registered professional nurse; 
(2) physical or occupational therapy or speech-language pathology services; 
(3) medical social services under the direction of a physician; 
(4) to the extent permitted in regulations, part-time or intermittent services of a 
home health aide who has successfully completed a training program approved by 
the Secretary; 
(5) medical supplies (including catheters, catheter supplies, ostomy bags, and 
supplies related to ostomy care, and a covered osteoporosis drug (as defined in 
subsection (kk)), but excluding other drugs and biologicals) and durable medical 
equipment and applicable disposable devices (as defined in section 1834(s)(2)) 
while under such a plan;  
(6) in the case of a home health agency which is affiliated or under common 
control with a hospital, medical services provided by an intern or resident-in-training 
of such hospital, under a teaching program of such hospital approved as provided 
in the last sentence of subsection (b); and 
(7) any of the foregoing items and services which are provided on an outpatient 
basis, under arrangements made by the home health agency, at a hospital or skilled 
nursing facility, or at a rehabilitation center which meets such standards as may be 
prescribed in regulations, and— 
(A) the furnishing of which involves the use of equipment of such a nature 
that the items and services cannot readily be made available to the individual 
in such place of residence, or 
(B) which are furnished at such facility while he is there to receive any such 
item or service described in clause (A), 
but not including transportation of the individual in connection with any such item 
or service; 
excluding, however, any item or service if it would not be included under subsection (b) 
if furnished to an inpatient of a hospital and home infusion therapy (as defined in 
subsection (iii)(i)). For purposes of paragraphs (1) and (4), the term “part–time or 
intermittent services” means skilled nursing and home health aide services furnished 
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any number of days per week as long as they are furnished (combined) less than 8 
hours each day and 28 or fewer hours each week (or, subject to review on a case-by-
case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per 
week). For purposes of sections 1814(a)(2)(C) and 1835(a)(2)(A), “intermittent” means 
skilled nursing care that is either provided or needed on fewer than 7 days each week, or 
less than 8 hours of each day for periods of 21 days or less (with extensions in 
exceptional circumstances when the need for additional care is finite and predictable).  
 
* * * * * 
 
Home Health Agency 
(o) The term “home health agency” means a public agency or private organization, or 
a subdivision of such an agency or organization, which— 
(1) is primarily engaged in providing skilled nursing services and other 
therapeutic services; 
(2) has policies, established by a group of professional personnel (associated 
with the agency or organization), including one or more physicians and one or more 
registered professional nurses, to govern the services (referred to in paragraph (1)) 
which it provides, and provides for supervision of such services by a physician or 
registered professional nurse; 
(3) maintains clinical records on all patients; 
(4) in the case of an agency or organization in any State in which State or 
applicable local law provides for the licensing of agencies or organizations of this 
nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of 
such State or locality responsible for licensing agencies or organizations of this 
nature, as meeting the standards established for such licensing; 
(5) has in effect an overall plan and budget that meets the requirements of 
subsection (z); 
(6) meets 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; 
(7) provides the Secretary with a surety bond— 
(A) in a form specified by the Secretary and in an amount that is not less 
than the minimum of $50,000; and 
(B) that the Secretary determines is commensurate with the volume of 
payments to the home health agency; and 
(8) meets such additional requirements (including conditions relating to bonding 
or establishing of escrow accounts as the Secretary finds necessary for the 
financial security of the program) as the Secretary finds necessary for the effective 
and efficient operation of the program; 
except that for purposes of part A such term shall not include any agency or 
organization which is primarily for the care and treatment of mental diseases. The 
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Secretary may waive the requirement of a surety bond under paragraph (7) in the case 
of an agency or organization that provides a comparable surety bond under State law. 
 
* * * * * 
 
CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES; HOME 
HEALTH QUALITY 
SEC. 1891. [42 U.S.C. 1395bbb]  
(a) The conditions of participation that a home health agency is required to meet 
under this subsection are as follows: 
(1) The agency protects and promotes the rights of each individual under its care, 
including each of the following rights: 
(A) The right to be fully informed in advance about the care and treatment to 
be provided by the agency, to be fully informed in advance of any changes in 
the care or treatment to be provided by the agency that may affect the 
individual’s well-being, and (except with respect to an individual adjudged 
incompetent) to participate in planning care and treatment or changes in care 
or treatment. 
(B) The right to voice grievances with respect to treatment or care that is (or 
fails to be) furnished without discrimination or reprisal for voicing grievances. 
(C) The right to confidentiality of the clinical records described in section 
1861(o)(3). 
(D) The right to have one’s property treated with respect. 
(E) The right to be fully informed orally and in writing (in advance of coming 
under the care of the agency) of— 
(i) all items and services furnished by (or under arrangements with) the 
agency for which payment may be made under this title, 
(ii) the coverage available for such items and services under this title, 
title XIX, and any other Federal program of which the agency is reasonably 
aware, 
(iii) any charges for items and services not covered under this title and 
any charges the individual may have to pay with respect to items and 
services furnished by (or under arrangements with) the agency, and 
(iv) any changes in the charges or items and services described in 
clause (i), (ii), or (iii). 
(F) The right to be fully informed in writing (in advance of coming under the 
care of the agency) of the individual’s rights and obligations under this title. 
(G) The right to be informed of the availability of the State home health 
agency hot-line established under section 1864(a). 
(2) The agency notifies the State entity responsible for the licensing or 
certification of the agency of a change in— 
20a

(A) the persons with an ownership or control interest (as defined in section 
1124(a)(3)) in the agency, 
(B) the persons who are officers, directors, agents, or managing employees 
(as defined in section 1126(b)) of the agency, and 
(C) the corporation, association, or other company responsible for the 
management of the agency. 
Such notice shall be given at the time of the change and shall include the identity of 
each new person or company described in the previous sentence. 
(3)(A) The agency must not use as a home health aide (on a full-time, temporary, 
per diem, or other basis), any individual to provide items or services described in 
section 1861(m) on or after January 1, 1990, unless the individual— 
(i) has completed a training and competency evaluation program, or a 
competency evaluation program, that meets the minimum standards 
established by the Secretary under subparagraph (D), and 
(ii) is competent to provide such items and services. 
For purposes of clause (i), an individual is not considered to have completed a 
training and competency evaluation program, or a competency evaluation program 
if, since the individual’s most recent completion of such a program, there has been 
a continuous period of 24 consecutive months during none of which the individual 
provided items and services described in section 1861(m) for compensation. 
(B)(i) The agency must provide, with respect to individuals used as a home 
health aide by the agency as of July 1, 1989, for a competency evaluation 
program (as described in subparagraph (A)(i)) and such preparation as may be 
necessary for the individual to complete such a program by January 1, 1990. 
(ii) The agency must provide such regular performance review and 
regular in-service education as assures that individuals used to provide 
items and services described in section 1861(m) are competent to provide 
those items and services. 
(C) The agency must not permit an individual, other than in a training and 
competency evaluation program that meets the minimum standards 
established by the Secretary under subparagraph (D), to provide items or 
services of a type for which the individual has not demonstrated competency. 
(D)(i) The Secretary shall establish minimum standards for the programs 
described in subparagraph (A) by not later than October 1, 1988. 
(ii) Such standards shall include the content of the curriculum, minimum 
hours of training, qualification of instructors, and procedures for 
determination of competency. 
(iii) Such standards may permit approval of programs offered by or in 
home health agencies, as well as outside agencies (including employee 
organizations), and of programs in effect on the date of the enactment of 
this section; except that they may not provide for the approval of a 
program offered by or in a home health agency which, within the previous 
2 years— 
21a

(I) has been determined to be out of compliance with subparagraph 
(A), (B), or (C); 
(II) has been subject to an extended (or partial extended) survey 
under subsection (c)(2)(D); 
(III) has been assessed a civil money penalty described in 
subsection (f)(2)(A)(i) of not less than $5,000; or 
(IV) has been subject to the remedies described in subsection 
(e)(1) or in clauses (ii) or (iii) of subsection (f)(2)(A). 
(iv) Such standards shall permit a determination that an individual who 
has completed (before July 1, 1989) a training and competency evaluation 
program or a competency evaluation program shall be deemed for 
purposes of subparagraph (A) to have completed a program that is 
approved by the Secretary under the standards established under this 
subparagraph if the Secretary determines that, at the time the program 
was offered, the program met such standards. 
(E) In this paragraph, the term “home health aide” means any individual who 
provides the items and services described in section 1861(m), but does not 
include an individual— 
(i) who is a licensed health professional (as defined in subparagraph 
(F)), or 
(ii) who volunteers to provide such services without monetary 
compensation. 
(F) In this paragraph, the term “licensed health professional” means a 
physician, physician assistant, nurse practitioner, physical, speech, or 
occupational therapist, physical or occupational therapy assistant, registered 
professional nurse, licensed practical nurse, or licensed or certified social 
worker. 
(4) The agency includes an individual’s plan of care required under section 
1861(m) as part of the clinical records described in section 1861(o)(3). 
(5) The agency operates and provides services in compliance with all applicable 
Federal, State, and local laws and regulations (including the requirements of 
section 1124) and with accepted professional standards and principles which apply 
to professionals providing items and services in such an agency. 
(6) The agency complies with the requirement of section 1866(f) (relating to 
maintaining written policies and procedures respecting advance directives). 
(b) It is the duty and responsibility of the Secretary to assure that the conditions of 
participation and requirements specified in or pursuant to section 1861(o) and 
subsection (a) of this section and the enforcement of such conditions and requirements 
are adequate to protect the health and safety of individuals under the care of a home 
health agency and to promote the effective and efficient use of public moneys. 
 
* * * * * 
 
22a

Comprehensive Outpatient Rehabilitation Facilities (CORFs) 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
Comprehensive Outpatient Rehabilitation Facility Services 
(cc)(1) The term “comprehensive outpatient rehabilitation facility services” means the 
following items and services furnished by a physician or other qualified professional 
personnel (as defined in regulations by the Secretary) to an individual who is an 
outpatient of a comprehensive outpatient rehabilitation facility under a plan (for 
furnishing such items and services to such individual) established and periodically 
reviewed by a physician— 
(A) physicians’ services; 
(B) physical therapy, occupational therapy, speech-language pathology 
services, and respiratory therapy; 
(C) prosthetic and orthotic devices, including testing, fitting, or training in the 
use of prosthetic and orthotic devices; 
(D) social and psychological services; 
(E) nursing care provided by or under the supervision of a registered 
professional nurse; 
(F) drugs and biologicals which cannot, as determined in accordance with 
regulations, be self-administered; 
(G) supplies and durable medical equipment; and 
(H) such other items and services as are medically necessary for the 
rehabilitation of the patient and are ordinarily furnished by comprehensive 
outpatient rehabilitation facilities, 
excluding, however, any item or service if it would not be included under subsection (b) 
if furnished to an inpatient of a hospital. In the case of physical therapy, occupational 
therapy, and speech pathology services, there shall be no requirement that the item or 
service be furnished at any single fixed location if the item or service is furnished 
pursuant to such plan and payments are not otherwise made for the item or service 
under this title. 
(2) The term “comprehensive outpatient rehabilitation facility” means a facility 
which— 
(A) is primarily engaged in providing (by or under the supervision of 
physicians) diagnostic, therapeutic, and restorative services to outpatients for 
the rehabilitation of injured, disabled, or sick persons; 
(B) provides at least the following comprehensive outpatient rehabilitation 
services: (i) physicians’ services (rendered by physicians, as defined in section 
23a

1861(r)(1), who are available at the facility on a full-or part-time basis); (ii) 
physical therapy; and (iii) social or psychological services; 
(C) maintains clinical records on all patients; 
(D) has policies established by a group of professional personnel 
(associated with the facility), including one or more physicians defined in 
subsection (r)(1) to govern the comprehensive outpatient rehabilitation 
services it furnishes, and provides for the carrying out of such policies by a full-
or part-time physician referred to in subparagraph (B)(i); 
(E) has a requirement that every patient must be under the care of a 
physician; 
(F) in the case of a facility in any State in which State or applicable local law 
provides for the licensing of facilities of this nature (i) is licensed pursuant to 
such law, or (ii) is approved by the agency of such State or locality, responsible 
for licensing facilities of this nature, as meeting the standards established for 
such licensing; 
(G) has in effect a utilization review plan in accordance with regulations 
prescribed by the Secretary; 
(H) has in effect an overall plan and budget that meets the requirements of 
subsection (z); 
(I) provides the Secretary on a continuing basis with a surety bond in a form 
specified by the Secretary and in an amount that is not less than $50,000; and 
(J) meets 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 facility, including conditions concerning 
qualifications of personnel in these facilities. 
 
* * * * * 
 
Critical Access Hospitals (CAHs) 
MEDICARE RURAL HOSPITAL FLEXIBILITY PROGRAM 
SEC. 1820. [42 U.S.C. 1395i–4]  
 
* * * * * 
 
(e) CERTIFICATION BY THE SECRETARY.—The Secretary shall certify a facility as a critical 
access hospital if the facility— 
(1) is located in a State that has established a medicare rural hospital flexibility 
program in accordance with subsection (c); 
(2) is designated as a critical access hospital by the State in which it is located; 
and 
(3) meets such other criteria as the Secretary may require. 
24a

 
* * * * * 
 
Clinics, Rehabilitation Agencies, and Public Health Agencies as 
Providers of Outpatient Physical Therapy and Speech-Language 
Pathology Services 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
Outpatient Physical Therapy Services 
(p) The term “outpatient physical therapy services” means 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— 
(1) who is under the care of a physician (as defined in paragraph (1), (3), or (4) of 
section 1861(r)), and 
(2) with respect to whom a plan prescribing the type, amount, and duration of 
physical therapy services that are to be furnished such individual has been 
established by a physician (as so defined) or by a qualified physical therapist and is 
periodically reviewed by a physician (as so defined); 
excluding, however— 
(3) any item or service if it would not be included under subsection (b) if 
furnished to an inpatient of a hospital; and 
(4) any such service— 
(A) if furnished by a clinic or rehabilitation agency, or by others under 
arrangements with such clinic or agency, unless such clinic or rehabilitation 
agency— 
(i) provides an adequate program of physical therapy services for 
outpatients and has the facilities and personnel required for such program 
or required for the supervision of such a program, in accordance with such 
requirements as the Secretary may specify, 
(ii) has policies, established by a group of professional personnel, 
including one or more physicians (associated with the clinic or 
rehabilitation agency) and one or more qualified physical therapists, to 
govern the services (referred to in clause (i)) it provides, 
(iii) maintains clinical records on all patients, 
25a

(iv) if such clinic or agency is situated in a State in which State or 
applicable local law provides for the licensing of institutions of this nature, 
(I) is licensed pursuant to such law, or (II) is approved by the agency of 
such State or locality responsible for licensing institutions of this nature, 
as meeting the standards established for such licensing; and 
(v) meets such other conditions relating to the health and safety of 
individuals who are furnished services by such clinic or agency on an 
outpatient basis, as the Secretary may find necessary, and provides the 
Secretary on a continuing basis with a surety bond in a form specified by 
the Secretary and in an amount that is not less than $50,000, or 
(B) if furnished by a public health agency, unless such agency meets such 
other conditions relating to health and safety of individuals who are furnished 
services by such agency on an outpatient basis, as the Secretary may find 
necessary. 
 
* * * * * 
 
Community Mental Health Centers (CMHCs) 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
Partial Hospitalization Services 
(ff)(1) The term “partial hospitalization services” means the items and services 
described in paragraph (2) prescribed by a physician and provided under a program 
described in paragraph (3) under the supervision of a physician pursuant to an 
individualized, written plan of treatment established and periodically reviewed by a 
physician (in consultation with appropriate staff participating in such program), which 
plan sets forth the physician’s diagnosis, the type, amount, frequency, and duration of 
the items and services provided under the plan, and the goals for treatment under the 
plan. 
(2) The items and services described in this paragraph are— 
(A) individual and group therapy with physicians or psychologists (or other 
mental health professionals to the extent authorized under State law), 
(B) occupational therapy requiring the skills of a qualified occupational 
therapist, 
(C) services of social workers, trained psychiatric nurses, and other staff 
trained to work with psychiatric patients, 
26a

(D) drugs and biologicals furnished for therapeutic purposes (which cannot, 
as determined in accordance with regulations, be self-administered), 
(E) individualized activity therapies that are not primarily recreational or 
diversionary, 
(F) family counseling (the primary purpose of which is treatment of the 
individual’s condition), 
(G) patient training and education (to the extent that training and educational 
activities are closely and clearly related to individual’s care and treatment), 
(H) diagnostic services, and 
(I) such other items and services as the Secretary may provide (but in no 
event to include meals and transportation); 
that are reasonable and necessary for the diagnosis or active treatment of the 
individual’s condition, reasonably expected to improve or maintain the individual’s 
condition and functional level and to prevent relapse or hospitalization, and 
furnished pursuant to such guidelines relating to frequency and duration of 
services as the Secretary shall by regulation establish (taking into account 
accepted norms of medical practice and the reasonable expectation of patient 
improvement). 
(3)(A) A program described in this paragraph is a program which is furnished by 
a hospital to its outpatients or by a community mental health center (as defined in 
subparagraph (B)), and which is a distinct and organized intensive ambulatory 
treatment service offering less than 24-hour-daily care other than in an individual’s 
home or in an inpatient or residential setting. 
(B) For purposes of subparagraph (A), the term “community mental health 
center” means an entity that— 
(i)(I) provides the mental health services described in section 1913(c)(1) 
of the Public Health Service Act; or 
(II) in the case of an entity operating in a State that by law 
precludes the entity from providing itself the service described in 
subparagraph (E) of such section, provides for such service by 
contract with an approved organization or entity (as determined by 
the Secretary); 
(ii) meets applicable licensing or certification requirements for 
community mental health centers in the State in which it is located; 
(iii) provides at least 40 per cent of its services to individuals who are 
not eligible for benefits under this title; and 
(iv) meets such additional conditions as the Secretary shall specify to 
ensure (I) the health and safety of individuals being furnished such 
services, (II) the effective and efficient furnishing of such services, and (III) 
the compliance of such entity with the criteria described in section 
1931(c)(1) of the Public Health Service Act. 
 
* * * * * 
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SCOPE OF BENEFITS 
SEC. 1832. [42 U.S.C. 1395k]  
(a) The benefits provided to an individual by the insurance program established by 
this part shall consist of— 
(1) entitlement to have payment made to him or on his behalf (subject to the 
provisions of this part) for medical and other health services, except those 
described in subparagraphs (B) and (D) of paragraph (2) and subparagraphs (E) 
and (F) of section 1842(b)(6); and 
(2) entitlement to have payment made on his behalf (subject to the provisions of 
this part) for— 
(A) home health services (other than items described in subparagraph (G) or 
subparagraph (I)); 
 
* * * * * 
 
(J) partial hospitalization services provided by a community mental health 
center (as described in section 1861(ff)(2)(B)). 
(b) For definitions of “spell of illness”, “medical and other health services”, and other 
terms used in this part, see section 1861. 
 
AGREEMENTS WITH PROVIDERS OF SERVICES; ENROLLMENT 
PROCESSES 
Sec. 1866. [42 U.S.C. 1395cc]  
(a)(1) Any provider of services (except a fund designated for purposes of section 
1814(g) and section 1835(e)) shall be qualified to participate under this title and shall 
be eligible for payments under this title if it files with the Secretary an agreement— 
 
* * * * * 
 
(e) For purposes of this section, the term “provider of services” shall include— 
(1) a clinic, rehabilitation agency, or public health agency if, in the case of a clinic 
or rehabilitation agency, such clinic or agency meets the requirements of section 
1861(p)(4)(A) (or meets the requirements of such section through the operation of 
subsection (g) or (ll)(2) of section 1861(g)), or if, in the case of a public health 
agency, such agency meets the requirements of section 1861(p)(4)(B) (or meets 
the requirements of such section through the operation of subsection (g) or (ll)(2) 
of section 1861(g)), but only with respect to the furnishing of outpatient physical 
therapy services (as therein defined) (through the operation of section 1861(g)) 
with respect to the furnishing of outpatient occupational therapy services, or 
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(through the operation of section 1861(ll)(2)) with respect to the furnishing of 
outpatient speech-language pathology; 
(2) a community mental health center (as defined in section 1861(ff)(3)(B)), but 
only with respect to the furnishing of partial hospitalization services (as described 
in section 1861(ff)(1)); and 
(3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), 
but only with respect to the furnishing of opioid use disorder treatment services (as 
defined in paragraph (1) of such section). 
 
* * * * * 
 
Home Infusion Therapy (HIT) Suppliers 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
(iii)HOME INFUSION THERAPY 
(1) The term “home infusion therapy” means the items and services described in 
paragraph (2) furnished by a qualified home infusion therapy supplier (as defined in 
paragraph (3)(D)) which are furnished in the individual's home (as defined in 
paragraph (3)(B)) to an individual— 
(A) who is under the care of an applicable provider (as defined in paragraph 
(3)(A)); and 
(B) with respect to whom a plan prescribing the type, amount, and duration 
of infusion therapy services that are to be furnished such individual has been 
established by a physician (as defined in subsection (r)(1)) and is periodically 
reviewed by a physician (as so defined) in coordination with the furnishing of 
home infusion drugs (as defined in paragraph (3)(C)) under part B. 
(2) The items and services described in this paragraph are the following: 
(A) Professional services, including nursing services, furnished in 
accordance with the plan. 
(B) Training and education (not otherwise paid for as durable medical 
equipment (as defined in subsection (n)), remote monitoring, and monitoring 
services for the provision of home infusion therapy and home infusion drugs 
furnished by a qualified home infusion therapy supplier. 
(3) For purposes of this subsection: 
(A) The term “applicable provider” means— 
(i) a physician; 
(ii) a nurse practitioner; and 
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(iii) a physician assistant. 
(B) The term “home” means a place of residence used as the home of an 
individual (as defined for purposes of subsection (n)). 
(C) The term “home infusion drug” means a parenteral drug or biological 
administered intravenously, or subcutaneously for an administration period of 
15 minutes or more, in the home of an individual through a pump that is an 
item of durable medical equipment (as defined in subsection (n)). Such term 
does not include the following: 
(i) Insulin pump systems. 
(ii) A self-administered drug or biological on a self- administered drug 
exclusion list. 
(D)(i) The term “qualified home infusion therapy supplier” means a 
pharmacy, physician, or other provider of services or supplier licensed by the 
State in which the pharmacy, physician, or provider or services or supplier 
furnishes items or services and that— 
(I) furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs; 
(II) ensures the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; 
(III) is accredited by an organization designated by the Secretary 
pursuant to section 1834(u)(5); and 
(IV) meets such other requirements as the Secretary determines 
appropriate, taking into account the standards of care for home 
infusion therapy established by Medicare Advantage plans under part 
C and in the private sector. 
(ii) A qualified home infusion therapy supplier may subcontract with a 
pharmacy, physician, provider of services, or supplier to meet the 
requirements of this subparagraph.  
 
* * * * * 
 
Rural Health Clinics (RHCs)/Federally Qualified Health Centers 
(FQHCs) 
DEFINITIONS OF SERVICES, INSTITUTIONS, ETC.  
SEC. 1861. [42 U.S.C. 1395x]   
For purposes of this title— 
 
* * * * * 
 
Rural Health Clinic Services And Federally Qualified Health Center Services 
(aa)(1) The term “rural health clinic services” means— 
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(A) physicians’ services and such services and supplies as are covered 
under section 1861(s)(2)(A) if furnished as an incident to a physician’s 
professional service and items and services described in section 1861(s)(10), 
(B) such services furnished by a physician assistant or a nurse practitioner 
(as defined in paragraph (5)), by a clinical psychologist (as defined by the 
Secretary) or by a clinical social worker (as defined in subsection (hh)(1)), and 
such services and supplies furnished as an incident to his service as would 
otherwise be covered if furnished by a physician or as an incident to a 
physician’s service, and 
(C) in the case of a rural health clinic located in an area in which there exists 
a shortage of home health agencies, part-time or intermittent nursing care and 
related medical supplies (other than drugs and biologicals) furnished by a 
registered professional nurse or licensed practical nurse to a homebound 
individual under a written plan of treatment (i) established and periodically 
reviewed by a physician described in paragraph (2)(B), or (ii) established by a 
nurse practitioner or physician assistant and periodically reviewed and 
approved by a physician described in paragraph (2)(B), 
when furnished to an individual as an outpatient of a rural health clinic. 
(2) The term “rural health clinic” means a facility which— 
(A) is primarily engaged in furnishing to outpatients services described in 
subparagraphs (A) and (B) of paragraph (1); 
(B) in the case of a facility which is not a physician-directed clinic, has an 
arrangement (consistent with the provisions of State and local law relative to 
the practice, performance, and delivery of health services) with one or more 
physicians (as defined in subsection (r)(1)) under which provision is made for 
the periodic review by such physicians of covered services furnished by 
physician assistants and nurse practitioners, the supervision and guidance by 
such physicians of physician assistants and nurse practitioners, the 
preparation by such physicians of such medical orders for care and treatment 
of clinic patients as may be necessary, and the availability of such physicians 
for such referral of and consultation for patients as is necessary and for advice 
and assistance in the management of medical emergencies; and, in the case 
of a physician-directed clinic, has one or more of its staff physicians perform 
the activities accomplished through such an arrangement; 
(C) maintains clinical records on all patients; 
(D) has arrangements with one or more hospitals, having agreements in 
effect under section 1866, for the referral and admission of patients requiring 
inpatient services or such diagnostic or other specialized services as are not 
available at the clinic; 
(E) has written policies, which are developed with the advice of (and with 
provision for review of such policies from time to time by) a group of 
professional personnel, including one or more physicians and one or more 
physician assistants or nurse practitioners, to govern those services described 
in paragraph (1) which it furnishes; 
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(F) has a physician, physician assistant, or nurse practitioner responsible for 
the execution of policies described in subparagraph (E) and relating to the 
provision of the clinic’s services; 
(G) directly provides routine diagnostic services, including clinical laboratory 
services, as prescribed in regulations by the Secretary, and has prompt access 
to additional diagnostic services from facilities meeting requirements under 
this title; 
(H) in compliance with State and Federal law, has available for administering 
to patients of the clinic at least such drugs and biologicals as are determined 
by the Secretary to be necessary for the treatment of emergency cases (as 
defined in regulations) and has appropriate procedures or arrangements for 
storing, administering, and dispensing any drugs and biologicals; 
(I) has a quality assessment and performance improvement program, and 
appropriate procedures for review of utilization of clinic services, as the 
Secretary may specify; 
(J) has a nurse practitioner, a physician assistant, or a certified nurse-
midwife (as defined in subsection (gg)) available to furnish patient care 
services not less than 50 percent of the time the clinic operates; and 
(K) meets 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. 
 
* * * * * 
 
DEFINITIONS 
SEC. 1905. [42 U.S.C. 1396d]   
For purposes of this title— 
(a) The term “medical assistance” means payment of part or all of the cost of the 
following care and services or the care and services themselves, or both * * * *  
 
* * * * * 
 
(l)(1) The terms “rural health clinic services” and “rural health clinic” have the 
meanings given such terms in section 1861(aa), except that (A) clause (ii) of section 
1861(aa)(2) shall not apply to such terms, and (B) the physician arrangement required 
under section 1861(aa)(2)(B) shall only apply with respect to rural health clinic services 
and, with respect to other ambulatory care services, the physician arrangement required 
shall be only such as may be required under the State plan for those services. 
(2)(A) The term “Federally-qualified health center services” means services of the 
type described in subparagraphs (A) through (C) of section 1861(aa)(1) when 
furnished to an individual as an patient of a Federally-qualified health center and, 
for this purpose, any reference to a rural health clinic or a physician described in 
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section 1861(aa)(2)(B) is deemed a reference to a Federally-qualified health center 
or a physician at the center, respectively. 
(B) The term “Federally-qualified health center” means a entity which— 
(i) is receiving a grant under section 330 of the Public Health Service 
Act, 
(ii)(I) is receiving funding from such a grant under a contract with the 
recipient of such a grant, and 
(II) meets the requirements to receive a grant under section 330 of 
such Act, 
(iii) based on the recommendation of the Health Resources and 
Services Administration within the Public Health Service, is determined by 
the Secretary to meet the requirements for receiving such a grant, 
including requirements of the Secretary that an entity may not be owned, 
controlled, or operated by another entity, or 
(iv) was treated by the Secretary, for purposes of part B of title XVIII, as 
a comprehensive Federally funded health center as of January 1, 1990; 
and includes an outpatient health program or facility operated by a tribe or 
tribal organization under the Indian Self-Determination Act (Public Law 93-638) 
or by an urban Indian organization receiving funds under title V of the Indian 
Health Care Improvement Act for the provision of primary health services. In 
applying clause (ii), the Secretary may waive any requirement referred to in 
such clause for up to 2 years for good cause shown. 
 
* * * * * 
 
End-Stage Renal Disease (ESRD) Facilities 
MEDICARE COVERAGE FOR END STAGE RENAL DISEASE PATIENTS 
SEC. 1881. [42 U.S.C. 1395rr] (a) The benefits provided by parts A and B of this title 
shall include benefits for individuals who have been determined to have end stage renal 
disease as provided in section 226A, and benefits for kidney donors as provided in 
subsection (d) of this section. Notwithstanding any other provision of this title, the type, 
duration, and scope of the benefit provided by parts A and B with respect to individuals 
who have been determined to have end stage renal disease and who are entitled to such 
benefits without regard to section 226A shall in no case be less than the type, duration, 
and scope of the benefits so provided for individuals entitled to such benefits solely by 
reason of that section. 
(b)(1) Payments under this title with respect to services, in addition to services for 
which payment would otherwise be made under this title, furnished to individuals who 
have been determined to have end stage renal disease shall include (A) payments on 
behalf of such individuals to providers of services and renal dialysis facilities which 
meet such requirements as the Secretary shall by regulation prescribe for institutional 
dialysis services and supplies (including self-dialysis services in a self-care dialysis unit 
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maintained by the provider or facility), transplantation services, self-care home dialysis 
support services which are furnished by the provider or facility, and routine professional 
services performed by a physician during a maintenance dialysis episode if payments 
for his other professional services furnished to an individual who has end stage renal 
disease are made on the basis specified in paragraph (3)(A)(i) of this subsection, (B) 
payments to or on behalf of such individuals for home dialysis supplies and equipment, 
and (C) payments to a supplier of home dialysis supplies and equipment that is not a 
provider of services, a renal dialysis facility, or a physician for self-administered 
erythropoietin as described in section 1861(s)(2)(P) if the Secretary finds that the 
patient receiving such drug from such a supplier can safely and effectively administer 
the drug (in accordance with the applicable methods and standards established by the 
Secretary pursuant to such section). The requirements prescribed by the Secretary 
under subparagraph (A) shall include requirements for a minimum utilization rate for 
transplantations. Beginning 180 days after the date of the enactment of this sentence, 
an initial survey of a provider of services or a renal dialysis facility to determine if the 
conditions and requirements under this paragraph are met shall be initiated not later 
than 90 days after such date on which both the provider enrollment form (without 
regard to whether such form is submitted prior to or after such date of enactment) has 
been determined by the Secretary to be complete and the provider’s enrollment status 
indicates approval is pending the results of such survey.  
 
* * * * * 
 
 
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IN THE UNITED STATES DISTRICT COURT 
FOR THE EASTERN DISTRICT OF MISSOURI   
 
STATE OF MISSOURI,  
STATE OF NEBRASKA, 
 
                         Plaintiffs,  
 
     v.  
 
JOSEPH R. BIDEN, JR., 
in his official capacity as the President of 
the United States of America;  
THE UNITED STATES OF AMERICA; 
UNITED STATES DEPARTMENT OF 
HEALTH AND HUMAN SERVICES;  
XAVIER BECERRA in his official 
capacity as Secretary of the United States 
Department of Health and Human Services; 
CENTERS FOR MEDICARE AND 
MEDICAID SERVICES;  
MEENA SESHAMANI in her official 
capacity as Deputy Administrator and 
Director of Center for Medicare; 
DANIEL TSAI in his official capacity as 
Deputy Administrator and Director of 
Center for Medicaid and CHIP Services; 
 
                         Defendants. 
 
 
 
 
 
 
 
No.  4:21-cv-01329 
DECLARATION OF SCOTT YORK 
 
1. 
My name is Scott York, and I am the Chief Executive Officer (CEO) of the 
Alaska Psychiatric Institute (“API”), a division of the Alaska Department of Health and Social 
Services. I am also a resident of Alaska and over the age of majority. API is located in 
Anchorage, Alaska. 
2. 
I have served as CEO of API since March 2020. I have worked in the healthcare 
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industry for approximately 37 years. I have personal knowledge of the facts in this declaration, 
and those facts are true and correct to the best of my knowledge. 
3. 
API is required by state law to admit individuals ordered to receive treatment by 
the Alaska Superior Court. As CEO of API, I am responsible for managing API such that it can 
admit all patients who are under a court order for involuntary commitment for mental health 
treatment.1 
4. 
Alaska Psychiatric Institute is licensed by the State of Alaska as a psychiatric 
hospital for the purpose of receiving reimbursement from the Center for Medicare and Medicaid 
Services (“CMS”).   
5. 
As a licensed hospital, API receives reimbursement from CMS to cover the cost 
of inpatient mental health treatment for individuals who are admitted to the hospital 
involuntarily. 
6. 
As a certified hospital, API must comply with CMS Conditions of Participation in 
order to be reimbursed for treatment costs. 
7. 
For the current fiscal year, API anticipates collecting approximately $7.5 in 
reimbursement from CMS, which comprises approximately 15.6 percent of the operating budget 
for the hospital. 
8. 
Presently, API has 248 employees. Approximately 31% of API’s employees are 
known to have not, or are reasonably believed to have not, received a COVID-19 vaccine.  
9. 
Despite the availability of medical and religious exemptions, API nevertheless 
believes it is likely to lose approximately 20 employees (8% of API’s workforce) as a result of 
the vaccine mandate.  
1 API also admits patients who are voluntarily receiving inpatient treatment, but the number of patients voluntarily 
admitted to API is relatively minimal. 
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10. 
Losing even 5% of its workforce would cause substantial harm to API because it 
would be extremely difficult to fill those positions with new workers.  
11. 
First, the positions could not be filled with other, unvaccinated workers.  Second, 
Alaska faces a shortage of qualified healthcare workers. Due to its remote geographic location, 
high cost of living, and potentially other factors, it is difficult to attract qualified, high-quality 
healthcare workers to the State of Alaska. 
12. 
API and its patients will be harmed by the negative consequences of the vaccine 
mandate. Even if a small percentage of API’s workforce is lost, hospital operations will be 
negatively impacted, which, in turn will affect availability of treatment. Capacity will be further 
limited, and enrollment at API will decline. As a result, patients will be forced to seek treatment 
elsewhere in a community where the availability of healthcare is already relatively limited. 
13. 
In the State of Alaska, there are a limited number of inpatient psychiatric services, 
with API being the only freestanding adult psychiatric facility. Thus, if API’s capacity is limited, 
that could potentially impact other services, such as emergency rooms and correctional facilities, 
since patients at those facilities could not receive immediate treatment at API. 
I declare under penalty of perjury that the foregoing is true and correct.  
Executed on November 11, 2021. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Scott York 
 
 
 
 
 
 
 
CEO, Alaska Psychiatric Institute 
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IN THE UNITED STATES DISTRICT COURT 
FOR THE EASTERN DISTRICT OF MISSOURI 
STATE OF MISSOURI et al., 
Case No. 4:21-CV-01329 
Plaintiffs, 
V. 
JOSEPH R. EIDEN, JR., et al., 
Defendants. 
DECLARATION OF 
ED SMITH 
I, Ed Smith, declare under penalty of perjury that I have personal knowledge 
of the following: 
1. 
I am a resident of Iowa and over the age of majority. 
2. 
I serve as the President and CEO of St. Anthony Regional Hospital. 
3. 
St. Anthony Regional Hospital is an independent, faith-based, rural 
hospital located in Carroll, Iowa. Carroll is in West Central Iowa equal distance 
(approximately 100 miles) between Omaha and Des Moines. St. Anthony provides a 
broad range of services to the citizens of west central Iowa. These services include: 
oncology, mental health, cardiology, orthopedics, obstetrics, and senior services. St. 
Anthony provides the public health function for Carroll County. As such, Carroll 
County Public Health has been a leader in the state in the response to the COVID-19 
pandemic and facilitating vaccinations throughout the county. 
4. 
St. Anthony employs over 7 50 staff. St. Anthony's current open positions 
are a reflection of the work force environment in healthcare generally, but also due 
to the extremely low unemployment rate in Carroll. 
44a

5. 
Currently, St. Anthony has 134 open positions, this includes 30 for our 
food and nutrition department and 30 on our med/surg/pediatric floor. 
6. 
St. Anthony employees have responded very well to voluntarily 
becoming vaccinated from COVID-19. Currently, St. Anthony's vaccination rate for 
its employees is 87%. 
7. 
St. Anthony has instituted a policy that requires employees declining 
the vaccine to wear an N95 mask and in some cases be tested prior to working each 
shift. This policy has been accepted by the unvaccinated and has resulted in no 
infections occurring within our workplace. 
8. 
St. Anthony conducted a survey of unvaccinated employees to 
understand the amount of risk St. Anthony is facing should a vaccine mandate be 
implemented. At the time of the survey, we had 115 unvaccinated employees. 20 
employees ultimately decided to be vaccinated. 55 employees indicated an intention 
to claim a religious or medical exemption. And 40 employees said that they would 
resign rather than comply with a vaccine mandate. 
9. 
St. Anthony is struggling with recruitment of all staff positions in the 
current environment with qualified applications being limited. The proposed CMS 
vaccine mandate would only exacerbate our work force challenges. 
10. 
As a rural health care provider, St. Anthony relies on Medicare and 
Medicaid as our dominant payor source. Medicare is 52% of revenues and Medicaid 
is 13% of revenues. 
- 2 -
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11. 
St. Anthony will be compliant with any CMS regulations. But that 
compliance will not be without cost. The loss of 40 employees coupled with the tight 
employment market will force us to evaluate the availability of needed healthcare 
services to the people in the region we serve. 
I declare under penalty of perjury that the foregoing is true and correct to the 
best of my knowledge. 
Executed on November 12, 2021. 
SMITH, Presiden 
St. Anthony Regional Hospital 
- 3 -
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-
DECLARATION OF TIM SCHRAGE, ADMINISTRATOR 
SCOTLAND COUNTY CARE CENTER 
I, TIM SCHRAGE, being first duly sworn upon my oath, do hereby state 
as follows: 
1. 
I am the Administrator of the Scotland County Care Center (SCCC) 
at 434 E. Sigler, Memphis, Missouri. I am also a resident of Missouri and over 
the age of majority. I have personal knowledge of the facts in this declaration, and 
those facts are true and correct to the best ofmy knowledge. 
2. 
SCCC is a 96 bed, not-for-profit nursing home in Memphis, Missouri 
and has been in operation since 1969. We are considered local government, a 
political subdivision of the state of Missourui governed by an elected board of 
directors and supported, in part, by a local county tax base. SCCC provides a wide 
variety of services including long term care for the disabled, post hospital 
rehabilitation through the 
Medicare Skilled Nursing Home benefit, and a 
Residential Care Facility holding an additional 28 beds. 
3. 
Like many of our rural nursing home districts, we are one of the 
largest employers in our county, second only to the school system. We have 
approximately 65 employees ranging from a licensed administrator, accountants, 
RN Director of Nurses, registered nurses, licensed practical nurses, certified 
nurses, dietary staff, med tees, and a host of other staff who are necessary and 
essential in caring for our residents. 
CMS provides reimbursement to SCCC for 
treatment of these patients through the federal Medicare and Medicaid programs, 
providing some of the funding needed to meet our expenses. 
61a

/ 
4. 
Approximately 50% of our total operational revenues come from the 
Centers for Medicare and Medicaid Services (CMS). This is a huge portion of our 
income. 
5. 
I have been an administrator for county nursing homes for the past 
21 years. I can tell you that rural county nursing homes have faced enormous 
challenges over the last few years, even before the advent of COVID-19. We have 
been watching our reserves diminish rapidly because our expenses have overrun 
our revenues. Sine~ January 2019, our reserves have decreased by 65%. We have 
had to dip into our re.serves in order to meet expenses. For example: over the past 
three years, miniµ,um wage has increased 33% while our state Medicaid 
reimbursement inc;reased 1.3%. We are facing a workforce shortage like never 
before, and not just m nursing. The shortage of nursing staff has caused us to 
lean heavily "Agency Staffing". Contracting with agency staffing means instead 
of paying $15 dollar~ an hour aide,we are charged $40-50 an hour for a Certified 
Nurses Aide. We are having to pay licensed nurses $65 an hour as compared to 
I 
about $22 an hour. In the recent 12 month period we have paid $385,000 to 
Agency Staffing because we had not been able hire enough of our own. If the 
vaccination mandate is imposed we will lose more staff, struggle to fill those 
vacancy spots with agency staffing, causing even more financial hardship. 
Furthermore agency staffing does not have enough staffing for the absence of 
nurses who are not willing to be vaccinated. We will be facing a huge problem! 
Without adequate staff we simply cannot take care of our residents. Another 
2 
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challenge is finding qualified workers. In our rural areas, the pool of qualified 
workers for specific skills and knowledge is much smaller than the lon-rural areas. 
We face immense difficulties filling "key'', "essential'' positions. 
6. 
On November 4, 2021 l received an emergency update notice from 
the Missouri Department of Health and Human Services. This notice informed 
us that the Eiden-Harris administration issued an emergency regulation 
mandating that all nursing home staff be fully vaccinated by January 4, 2022 . 
Furthermore, facilities who failed to ensure ALL staff were vaccinated could no 
longer be eligible for reimbursement under the Medicare and Medicare programs. 
The impact of this emergency regulation will have dramatic and devastating 
consequences. 
7. 
Out of about 65 employees, about 20 employees tell me they are 
vehemently opposed to taking the vaccine and if the CMS mandate is indeed 
imposed, they will quit working at SCCC. If that happens, I will lose about 30% 
of my workforce. If I lose 30% of my workforce, there is no way we can continue 
to operate. 
8. 
I stand to lose key people who are the foundation of our organization. 
My billing and accounting person will leave if they are required to get the vaccine. 
I would have substantial disruption in my billing and accounts receivable which 
would cause a level of financial distress that I fear we could not overcome. My 
building plant manager says he will not be forced into taking the vaccination, even 
if that means losing his job. That would leave me with no one competent enough 
3 
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to run my building and all the complicated systems and required inspections. You 
just can't fill these kinds of positions quickly, especially with today's workforce 
and being in a rural setting. 
9. 
While the intent of this emergency regulation may be to protect our 
elederly nursing home residents, I fear the result of this regulation may actually 
create more harm. We could not continue to operate our facility with 30% decrease 
in our workforce. We would be forced to close our doors and displace the residents 
who enjoy residing in the Scotland County Care Center and who desire to live in 
the community where they have lived their entire lives. 
Pursuant to 28 U.S.C. 1746, I declare under penalty of perjury that the foregoing 
is true and correct to the best of my knowledge. 
~J_Q_ =vember, 2021. 
T~~ 
Administrator, Scotland County Care Center 
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IN THE UNITED STATES DISTRICT COURT 
FOR THE EASTERN DISTRICT OF MISSOURI  
 
STATE OF MISSOURI, et al.,  
 
                         Plaintiffs,  
 
v. 
 
JOSEPH R. BIDEN, JR., et al., 
 
                         Defendants. 
 
 
 
 
No. 4:21-cv-01329 
 
 
 
DECLARATION OF VALERIE HUHN, ACTING DIRECTOR,  
MISSOURI DEPARTMENT OF MENTAL HEALTH 
 
1. 
My name is Valerie Huhn and I am the Acting Director of the 
Missouri Department of Mental Health (“DMH”).  I am also a resident of the State 
of Missouri and over the age of majority.  I have personal knowledge of the facts 
in this declaration, and those facts are true and correct to the best of my 
knowledge. 
2. 
DMH is a state agency that serves approximately 170,000 
Missourians annually through state-operated facilities and contracts with private 
organizations and individuals.  
3. 
DMH operates six psychiatric facilities, which provide inpatient 
psychiatric services for adults and children.  These facilities are certified by the 
Center for Medicare and Medicaid Services (“CMS”) as psychiatric treatment 
facilities for the purpose of receiving reimbursement from CMS.   
4. 
These six facilities receive reimbursement from CMS to cover the 
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cost of inpatient and residential psychiatric treatment for individuals who are 
Medicaid and/or Medicare eligible.   
5. 
As certified hospitals, these facilities must comply with CMS 
Conditions of Participation in order to be reimbursed for treatment costs and 
disproportionate share costs. 
6. 
The Center for Behavioral Medicine is a 65-bed facility in Kansas 
City, Missouri.  There are currently approximately 281 employees. Based on the 
most recently available information, only 34.6% of the staff at the Center for 
Behavioral Medicine are fully vaccinated. 
7. 
Fulton State Hospital is a 449-bed facility in Fulton, Missouri.  There 
are currently approximately 857 employees. Based on the most recently available 
information, 63% of the staff at the Fulton State Hospital are fully vaccinated. 
8. 
Northwest Missouri Psychiatric Rehabilitation Center is a 108-bed 
facility in St. Joseph, Missouri. There are currently approximately 250 employees.  
Based on the most recently available information, 52.6% of staff at Northwest 
Missouri Psychiatric Rehabilitation Center are fully vaccinated. 
9. 
Southeast Missouri Mental Health Center is a 323-bed facility in 
Farmington, Missouri.  There are currently approximately 878 employees. Based 
on the most recently available information, 60.3% of staff at Southeast Missouri 
Mental Health Center are fully vaccinated. 
10. 
St. Louis Forensic Treatment Center is a 230-bed facility in St. Louis, 
Missouri.  There are currently approximately 524 employees. Based on the most 
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recently available information, 67.6% of staff at St. Louis Forensic Treatment 
Center are fully vaccinated. 
11. 
Hawthorn Children’s Psychiatric Hospital is a 28-bed inpatient 
psychiatric hospital and a 16-bed psychiatric residential treatment facility that 
provides inpatient and residential services to children and youth.  There are 
currently approximately 170 employees.  Based on the most recently available 
information, 84.7% of staff at Hawthorn Children’s Psychiatric Hospital are fully 
vaccinated. 
12. 
Additionally, DMH operates six habilitation centers, which provide 
24-hour accommodation, board, personal care, active treatment, and basic health 
and nursing care services to individuals with developmental disabilities. These 
facilities are certified by CMS as Intermediate Care Facilities for Individuals with 
Intellectual Disabilities (“ICF/IID”) for the purpose of receiving reimbursement 
from CMS. 
13. 
These six facilities receive reimbursement from CMS to cover the 
cost of services for individuals with developmental disabilities and   intellectual 
disabilities. 
14. 
As certified ICF/IIDs, these facilities must comply with CMS 
Conditions of Participation in order to be reimbursed for treatment costs and 
disproportionate share costs. 
15. 
Bellefontaine Habilitation Center is a 133-bed facility in St. Louis, 
Missouri.  There are currently approximately 337 employees. Based on the most 
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recently available information, 63.8% of staff at Bellefontaine Habilitation Center 
are fully vaccinated. 
16. 
Higginsville Habilitation Center is a 40-bed facility in Higginsville, 
Missouri.  There are currently approximately 168 employees.  Based on the most 
recently available information, 65.4% of staff at Higginsville Habilitation Center 
are fully vaccinated.  
17. 
St. Charles Habilitation Center is a 72-bed facility in St. Charles, 
Missouri.  South County Habilitation Center is a 72-bed facility in St. Louis, 
Missouri.  Together, they are currently approximately 326 employees. Based on 
the most recently available information, 43.9% of staff at St. Charles Habilitation 
Center are fully vaccinated and 55.1% of staff at South County Habilitation 
Center are fully vaccinated.  
18. 
SEMO Residential Services has two locations – a 35-bed facility in 
Poplar Bluff, Missouri and a 25-bed facility in Sikeston, Missouri.  There are 
currently approximately 171 employees. Based on the most recently available 
information, only 29.6% of staff at the Poplar Bluff location are fully vaccinated 
and 41.4% of staff at the Sikeston location are fully vaccinated.  
19. 
All twelve DMH facilities and their patients will be directly affected 
by the interim rule with comment period (“IFC”) that Plaintiff States have 
challenged in this case.  
20. 
In Fiscal Year 2021, 89 % of DMH’s budget was funded with CMS 
federal funding from Medicaid/Medicare and Disproportionate Share payments.    
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21. 
As of September 2021, DMH’s Division of Behavioral Health 
hospitals had a registered nurse vacancy rate of 35% and a 54% vacancy rate for 
licensed practical nurses. The overall vacancy rate for paraprofessionals within 
the Division of Behavioral Health hospitals was 28%.  Within DMH’s Division of 
Developmental Disabilities, the direct care vacancy rate ranges from 11% at St. 
Louis Developmental Disabilities Treatment Center to 50% at Higginsville 
Habilitation Center.  
22. 
The loss of additional employees will cause significant difficulty in 
the continued operation of DMH facilities.  Even if a small percentage of DMH’s 
workforce is lost because of the vaccine mandate, operations will be negatively 
impacted.  
I declare under penalty of perjury that the foregoing is true and correct to 
the best of my knowledge.   
 
Executed on this 12th day of November, 2021. 
 
 
 
 
 
 
 
 
Valerie Huhn 
Acting Director, Missouri Department of Mental Health 
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UNITED STATES DISTRICT COURT 
FOR THE EASTERN DISTRICT OF MISSOURI 
STATE OF MISSOURI, 
STATE OF NEBRASKA, 
STATE OF ARKANSAS, 
STATE OF KANSAS, 
STATE OF IOWA, 
STATE OF WYOMING, 
STATE OF ALASKA, 
STATE OF SOUTH DAKOTA, 
STATE OF NORTH DAKOTA, and STATE 
OF NEW HAMPSHIRE, 
Plaintiffs, 
Case No. 4:21-cv-01329 
vs. 
JOSEPH R. BIDEN, JR., 
in his official capacity as the President of the 
United States of America; 
THE UNITED STATES OF AMERICA; 
UNITED STATES DEPARTMENT OF 
HEALTH AND HUMAN SERVICES; 
XAVIER BECERRA in his official capacity as 
Secretary of the United States Department of 
Health and Human Services; 
CENTERS FOR MEDICARE AND 
MEDICAID SERVICES; 
CHIQUITA BROOKS-LASURE in her 
official capacity as Administrator for the 
Centers for Medicare and Medicaid Services; 
MEENA SESHAMANI in her official capacity 
as Deputy Administrator and Director of 
Center for Medicare; 
DANIEL TSAI in his official capacity as 
Deputy Administrator and Director of Center 
for Medicaid and CHIP Services; 
Defendants. 
DECLARATION OF 
DR. NIZAR WEHBI 
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STATE OF NORTH DAKOTA 
) 
) ss. 
COUNTY OF BURLEIGH  
) 
Dr. Nizar Wehbi states as follows: 
1.
I am the North Dakota State Health Officer, which is the administrative officer of
the North Dakota State Department of Health (“Department”). I was appointed to such position by 
Governor Doug Burgum, effective May 1, 2021.  
2.
The Department reports thirty-three (33) surveyors to the Centers for Medicare &
Medicaid Services (“CMS”) as a part of our annual budget process.  
3.
Of these surveyors, twenty-nine (29) surveyors complete on-site surveys of
healthcare facilities to determine compliance with CMS standards. Two (2) surveyors complete 
on-site construction visits for compliance with North Dakota regulatory requirements. Two (2) 
surveyors are reported as temporary staff who can also be used for CMS survey purposes.  
4.
All thirty-three (33) surveyors are employees of the state of North Dakota.
5.
As a part of their job duties, surveyors determine healthcare facilities’ compliance
with federal and state regulations by conducting on-site surveys and evaluating the programs, 
services, staff, buildings, and equipment of inpatient care facilities and outpatient programs to 
ensure that they meet applicable standards and provide services consistent with generally accepted 
practices.  
6.
I declare, under penalty of perjury under the law of North Dakota, that the foregoing
is true and correct to the best of my knowledge and belief. 
Signed on this _____ day of November, 2021 at Bismarck, North Dakota, United States. 
_________________________________________ 
Dr. Nizar Wehbi 
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