Nondiscrimination in Health Programs and Activities

Federal RegisterAug 4, 2022

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 438, 440, 457, and 460

Office of the Secretary

45 CFR Parts 80, 84, 86, 91, 92, 147, 155, and 156

[Docket ID: HHS-OS-2022-0012]

RIN: 0945-AA17

Nondiscrimination in Health Programs and Activities

AGENCY:

Centers for Medicare and Medicaid Services; Office for Civil Rights (OCR), Office of the Secretary, HHS.

ACTION:

Notice of proposed rulemaking; notice of Tribal consultation.

SUMMARY:

The Department of Health and Human Services (HHS or the Department) is issuing this proposed rule on Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the ACA authorizes the Secretary of the Department to promulgate regulations to implement the nondiscrimination requirements of Section 1557. The Department is also proposing to revise its interpretation regarding whether Medicare Part B constitutes Federal financial assistance for purposes of civil rights enforcement and to revise nondiscrimination provisions to prohibit discrimination on the basis of sexual orientation and gender identity in regulations issued by the Centers for Medicare & Medicaid Services (CMS) governing Medicaid and the Children's Health Insurance Program (CHIP); Programs of All-Inclusive Care for the Elderly (PACE); health insurance issuers and their officials, employees, agents, and representatives; States and the Exchanges carrying out Exchange requirements; agents, brokers, or web-brokers that assist with or facilitate enrollment of qualified individuals, qualified employers, or qualified employees; issuers providing essential health benefits; and qualified health plan issuers.

DATES:

Comments:

Submit comments on or before October 3, 2022.

Meeting:

Pursuant to Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, the Department of Health and Human Services' Tribal Consultation Policy, and the Department's Plan for Implementing Executive Order 13175, the Office for Civil Rights solicits input by tribal officials as we develop the implementing regulations for Section 1557 of the Affordable Care Act at 45 CFR part 92. The Tribal consultation meeting will be held on August 31, 2022, from 2 p.m. to 4 p.m. Eastern Daylight Time.

ADDRESSES:

You may submit comments, identified by RIN Number 0945-AA17, by any of the following methods. Please do not submit duplicate comments.

To participate in the Tribal consultation meeting, you must register in advance at

https://www.zoomgov.com/meeting/register/vJIsfu-rqzksEl2T8gUp_lDrWBqkU0223CY.

Federal Rulemaking Portal:

You may submit electronic comments at

https://www.regulations.gov

by searching for the Docket ID number HHS-OS-2022-0012. Follow the instructions for submitting electronic comments. If you are submitting comments electronically, the Department strongly encourages you to submit any comments or attachments in Microsoft Word format. If you must submit a comment in Adobe Portable Document Format (PDF), the Department strongly encourages you to convert the PDF to “print-to-PDF” format, or to use some other commonly used searchable text format. Please do not submit the PDF in a scanned format. Using a print-to-PDF format allows the Department to electronically search and copy certain portions of your submissions to assist in the rulemaking process.

Regular, Express, or Overnight Mail:

You may mail written comments to the following address only: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: 1557 NPRM (RIN 0945-AA17), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue SW, Washington, DC 20201.

All comments received by the methods and due date specified above may be posted without change to content to

https://www.regulations.gov,

which may include personal information provided about the commenter, and such posting may occur after the closing of the comment period. However, the Department may redact certain non-substantive content from comments before posting, including threats, hate speech, profanity, graphic images, or individually identifiable information about a third-party individual other than the commenter. In addition, comments or material designated as confidential or not to be disclosed to the public will not be accepted. Comments may be redacted or rejected as described above without notice to the commenter, and the Department will not consider in rulemaking any redacted or rejected content that would not be made available to the public as part of the administrative record.

Because of the large number of public comments normally received on

Federal Register

documents, OCR is not able to provide individual acknowledgments of receipt.

Please allow sufficient time for mailed comments to be received timely in the event of delivery or security delays.

Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted.

Docket:

For complete access to background documents or posted comments, go to

https://www.regulations.gov

and search for Docket ID number HHS-OS-2022-0012.

FOR FURTHER INFORMATION CONTACT:

Office for Civil Rights

Dylan Nicole de Kervor, (202) 240-3110 or (800) 537-7697 (TDD), or via email at

1557@hhs.gov,

for matters related to Section 1557.

Centers for Medicare & Medicaid Services

John Giles, (410) 786-5545, for matters related to Medicaid.

Emily King, 410-786-8537, for matters related to CHIP.

Timothy Roe, (410) 786-2006 for matters related to Programs of All-Inclusive Care for the Elderly.

Becca Bucchieri, (301) 492-4341, Agata Pelka, (667) 290-9979, or Leigha Basini, (301) 492-4380, for matters related to 45 CFR 155.120, 155.220, 156.125, 156.200, and 156.1230.

Lindsey Murtagh, (301) 492-4106, for matters related to 45 CFR 147.104.

Hannah Katch, (202) 578-9581, for general questions related to CMS amendments.

Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record:

Upon request, the Department will provide an accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for the proposed regulations. To schedule an appointment for this type of accommodation or auxiliary aid, please

call (202) 240-3110 or (800) 537-7697 (TDD) for assistance or email

1557@hhs.gov

.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Nondiscrimination in Health Programs and Activities

A. Section 1557 Background and Rulemaking

B. Summary of the Proposed Rule

II. Reasons for the Proposed Rulemaking

A. The Scope of the 2020 Rule Is Not the Best Reading of the Affordable Care Act and Section 1557's Statutory Text

B. The 2020 Rule's Preamble Does Not Reflect Recent Developments in Sex Discrimination Law

C. The 2020 Rule Causes Unnecessary Confusion in Compliance

D. Proposed Changes Are Consistent With the Statute and Will Further the Intended Purpose of the Statute

III. Nondiscrimination in Health Programs and Activities

Subpart A—General Provisions

Purpose and Effective Date (§ 92.1)

Application (§ 92.2)

Relationship to Other Laws (§ 92.3)

Definitions (§ 92.4)

Assurances Required (§ 92.5)

Remedial Action and Voluntary Action (§ 92.6)

Designation and Responsibilities of a Section 1557 Coordinator (§ 92.7)

Policies and Procedures (§ 92.8)

Training (§ 92.9)

Notice of Nondiscrimination (§ 92.10)

Notice of Availability of Language Assistance Services and Auxiliary Aids and Services (§ 92.11)

Subpart B—Nondiscrimination Provisions

Discrimination Prohibited (§ 92.101)

Subpart C—Specific Applications to Health Programs and Activities

Meaningful Access for Limited English Proficient Individuals (§ 92.201)

Effective Communication for Individuals With Disabilities (§ 92.202)

Accessibility for Buildings and Facilities (§ 92.203)

Accessibility of Information and Communication Technology for Individuals With Disabilities (§ 92.204)

Requirement To Make Reasonable Modifications (§ 92.205)

Equal Program Access on the Basis of Sex (§ 92.206)

Nondiscrimination in Health Insurance Coverage and Other Health-Related Coverage (§ 92.207)

Prohibition on Sex Discrimination Related to Marital, Parental, or Family Status (§ 92.208)

Nondiscrimination on the Basis of Association (§ 92.209)

Use of Clinical Algorithms in Decision-Making (§ 92.210)

Nondiscrimination in the Delivery of Health Programs and Activities Through Telehealth Services (§ 92.211)

Subpart D—Procedures

Enforcement Mechanisms (§ 92.301)

Notification of Views Regarding Application of Federal Conscience and Religious Freedom Laws (§ 92.302)

Procedures for Health Programs and Activities Conducted by Recipients and State Exchanges (§ 92.303)

Procedures for Health Programs and Activities Administered by the Department (§ 92.304)

IV. Change in Interpretation—Medicare Part B Meets the Definition of Federal Financial Assistance

V. CMS Amendments

A. Medicaid and Children's Health Insurance Program (CHIP)

B. Programs of All-Inclusive Care for the Elderly (PACE)

C. Insurance Exchanges and Group and Individual Health Insurance Markets

VI. Executive Order 12866 and Related Executive Orders on Regulatory Review

A. Regulatory Impact Analysis

B. Regulatory Flexibility Act—Initial Small Entity Analysis

C. Executive Order 13132: Federalism

D. Executive Order 12250 on Leadership and Coordination of Nondiscrimination Laws

VII. Request for Comment

I. Background

A. Section 1557 Background and Rulemaking

In 2010, Congress passed and the President signed into law the Patient Protection and Affordable Care Act (ACA)

1

to reform the country's health insurance system, making health care more affordable and accessible for tens of millions of persons in the United States. Among other things, the ACA provided health care access to many individuals by increasing coverage options and prohibiting discrimination in health care. Section 1557 of the ACA (Section 1557) is one of the government's most powerful tools to ensure access to and coverage of health care in a nondiscriminatory manner. Except as otherwise provided in Title I of the ACA, Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in a health program or activity, any part of which is receiving Federal financial assistance, including credits, subsidies, or contracts of insurance. Section 1557 also prohibits discrimination on the basis of race, color, national origin, sex, age, or disability under any program or activity that is administered by an Executive Agency, or any entity established under Title I of the ACA or its amendments. The statute cites Title VI of the Civil Rights Act of 1964

2

(Title VI), Title IX of the Education Amendments of 1972

3

(Title IX), the Age Discrimination Act of 1975

4

(Age Act), and Section 504 of the Rehabilitation Act of 1973

5

(Section 504) to identify the grounds of discrimination prohibited by Section 1557. The statute further specifies that the enforcement mechanisms provided for and available under Title VI, Title IX, the Age Act, or Section 504 shall apply for purposes of violations of Section 1557.

6

The statute authorizes the Secretary of the U.S. Department of Health and Human Services (HHS or the Department) to promulgate implementing regulations for Section 1557.

7

1

The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010. The Healthcare and Education Reconciliation Act of 2010, Public Law 111-152, which amended and revised several provisions of the Patient Protection and Affordable Care Act, was enacted on March 30, 2010. In this rulemaking, the two statutes are referred to collectively as the “Patient Protection and Affordable Care Act,” “Affordable Care Act,” or “ACA.”

2

42 U.S.C. 2000d

et seq.

3

20 U.S.C. 1681

et seq.

4

42 U.S.C. 6101

et seq.

5

29 U.S.C. 794.

6

42 U.S.C. 18116(a).

7

Id.

18116(c).

Section 1557 was effective upon enactment, and the Department's Office for Civil Rights (OCR) began enforcing the law immediately thereafter while drafting implementing regulations.

8

8

See, e.g.,

Bulletin, U.S. Dep't of Health & Human Servs., The Brooklyn Hospital Center Implements Non-Discriminatory Practices to Ensure Equal Care for Transgender Patients (July 14, 2015),

https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf; OCR Enforcement under Section 1557 of the Affordable Care Act Sex Discrimination Cases,

U.S. Dep't of Health & Human Servs.,

https://www.hhs.gov/civil-rights/for-individuals/section-1557/ocr-enforcement-section-1557-aca-sex-discrimination/index.html

(last updated Aug. 1, 2016);

see also C.P.

v.

Blue Cross Blue Shield,

536 F. Supp. 3d 791, 796 (W.D. Wash. 2021) (citing

Tovar

v.

Essentia Health,

342 F. Supp. 3d 947, 957 (D. Minn. 2018) (stating “[a] claim of discrimination in violation of Section 1557 does not depend on an HHS rule” in denying a motion to dismiss a challenge to categorical exclusions for treatment for gender dysphoria in a health insurance plan);

Prescott

v.

Rady Children's Hosp. of San Diego,

265 F. Supp. 3d 1090, 1098 (S.D. Cal. 2017) (denying defendant hospital's motion to dismiss gender identity discrimination complaint under Section 1557 because Department regulations were not in effect at the time of the alleged discrimination, holding the claim of discrimination was grounded in the plain language of the statute).

1. 2016 Rulemaking

On August 1, 2013, the Department published a Request for Information in the

Federal Register

,

9

followed by issuance of a Notice of Proposed Rulemaking (NPRM) on September 8, 2015 (2015 NPRM).

10

The Department finalized the Section 1557 regulation on

May 18, 2016 (2016 Rule).

11

The 2016 Rule applied to all health programs and activities, any part of which received Federal financial assistance, and all health programs and activities administered by the Department or by an entity established under Title I of the ACA. The 2016 Rule included provisions intended to provide, for covered health programs and activities, consistent requirements across all prohibited forms of discrimination including grievance procedures, designated employees to coordinate compliance with the law, and notice requirements. The 2016 Rule included a detailed definition section. The 2016 Rule also required covered entities to provide, in “significant communications,” notice and information regarding the availability of language assistance services in the 15 most common languages spoken by limited English proficient

12

(LEP) persons in each state. Additionally, it required covered entities to take reasonable steps to provide meaningful access to each LEP individual eligible to be served in covered entities' health programs and activities. It further prohibited discrimination on the basis of sex, including gender identity; outlined requirements for equal program access on the basis of sex; and explicitly prohibited discrimination in health-related insurance and other health-related coverage, including a ban on categorical exclusions of gender-transition-related care in health insurance coverage and other health-related coverage. At the time, though the Department supported a prohibition on discrimination based on sexual orientation as a matter of policy, the 2016 Rule did not explicitly prohibit discrimination on the basis of sexual orientation because no Federal appellate court had yet concluded that sex-based discrimination included sexual orientation discrimination.

13

Instead, relying on the Supreme Court's opinion in

Price Waterhouse

v.

Hopkins,

14

the 2016 Rule explained that Section 1557's prohibition of discrimination on the basis of sex included sex discrimination related to an individual's sexual orientation where the evidence established that the discrimination was based on gender stereotypes.

15

The 2016 Rule explicitly exempted covered entities from complying with any requirements that would violate applicable Federal statutory protections for conscience and religious exercise.

16

9

78 FR 46558 (Aug. 1, 2013). Responses are available for public inspection at

https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments.

10

80 FR 54171 (Sept. 8, 2015). The 2015 NPRM received roughly 2,160 comments, which are available for public inspection at

https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments.

11

81 FR 31375 (May 18, 2016).

12

In the Proposed Rule at § 92.4,

infra,

a limited English proficient (LEP) individual means an individual whose primary language for communication is not English and who has a limited ability to read, write, speak, or understand English. An LEP individual may be competent in English for certain types of communication (

e.g.,

speaking or understanding), but still be LEP for other purposes (

e.g.,

reading or writing).

13

81 FR 31390 (“OCR has decided not to resolve in this rule whether discrimination on the basis of an individual's sexual orientation status alone is a form of sex discrimination.”).

14

490 U.S. 228, 250-51 (1989).

15

81 FR 31389, 31390.

16

See

former 45 CFR 92.2(b)(2). “Insofar as application of any requirement under this part would violate applicable Federal statutory protections for religious freedom and conscience, such application shall not be required.”

The 2016 Rule had an effective date of July 18, 2016, except to the extent that the rule required changes to health insurance or group health plan benefits or benefit design, in which case the 2016 Rule applied on the first day of the first plan year that began on or after January 1, 2017.

17

17

81 FR 313756, 31378, 31430, 31466.

The 2016 Rule was challenged under the Administrative Procedure Act

18

(APA) and the Religious Freedom Restoration Act

19

(RFRA). Before the rule went into effect, the United States (U.S.) District Court for the Northern District of Texas, in

Franciscan Alliance

v.

Burwell,

enjoined the Department from enforcing the 2016 Rule's prohibition against discrimination on the basis of gender identity or termination of pregnancy.

20

Subsequently, on October 15, 2019, the same district court vacated the 2016 Rule insofar as the 2016 Rule defined discrimination on the basis of sex to include gender identity and termination of pregnancy.

21

In 2021, the court in

Franciscan Alliance

issued an order enjoining the Department from interpreting or enforcing Section 1557 against the plaintiffs in that case in a manner that would require them to perform or provide insurance coverage for gender transition services or abortion.

22

In

Religious Sisters of Mercy et al.

v.

Becerra et al.,

the court enjoined the Department from enforcing Section 1557 against the plaintiffs in that case in a manner that would require them to perform or provide insurance coverage for gender transition services.

23

Both decisions have been appealed on standing and ripeness grounds, among other things. As of the publication of this NPRM, appeals are pending in the Fifth and Eighth Circuits. More recently, another district court in the District of North Dakota in

Christian Employers Alliance

v.

U.S. Equal Employment Opportunity Commission et al.

enjoined the Department from enforcing Section 1557 against the plaintiffs in that case in a manner that would require them to perform or provide insurance coverage for gender transition services or restrict or compel their speech on gender identity issues.

24

18

5 U.S.C. 551

et seq.

19

42 U.S.C. 2000bb

et seq.

20

Franciscan All., Inc.

v.

Burwell,

227 F. Supp. 3d 660 (N.D. Tex. 2016).

21

Franciscan All., Inc.

v.

Azar,

414 F. Supp. 3d 928 (N.D. Tex. 2019).

22

Franciscan All., Inc.

v.

Becerra,

553 F. Supp. 3d 361 (N.D. Tex. 2021),

amended,

No. 7:16-cv-00108-O, 2021 WL 6774686 (N.D. Tex. Oct. 1, 2021),

appeal pending,

No. 21-11174 (5th Cir. Nov. 21, 2021).

23

Religious Sisters of Mercy

v.

Azar,

513 F. Supp. 3d 1113 (D.N.D. 2021),

judgment entered sub nom. Religious Sisters of Mercy

v.

Cochran,

No. 3:16-cv-00386, 2021 WL 1574628 (D.N.D. Feb. 19, 2021),

appeal pending,

No. 21-1890 (8th Cir. April 20, 2021) (oral argument held Dec. 15, 2021).

24

Christian Emp'rs All.

v.

EEOC,

No. 21-cv-00195, 2022 WL 1573689 (D.N.D. May 16, 2022).

2. 2020 Rulemaking

On June 14, 2019, the Department published a new Section 1557 Notice of Proposed Rulemaking (2019 NPRM), proposing to rescind large portions of the 2016 Rule.

25

Citing the

Franciscan Alliance

litigation, the 2019 NPRM proposed to rescind the 2016 Rule's definition of “on the basis of sex,” and, given “the likelihood that the Supreme Court [would] be addressing the issue in the near future [in its

Bostock

v.

Clayton County

26

ruling],” the preamble to the 2019 NPRM proposed not to include a new definition for “on the basis of sex.” However, the preamble to the 2019 NPRM identified examples of other government entities that referred to “sex” in “binary and biological” terms and suggested that Section 1557's prohibition on sex discrimination may not extend to gender identity discrimination.

27

25

84 FR 27846 (June 14, 2019).

26

140 S. Ct. 1731 (2020).

27

84 FR 27853-55, 27856-57.

The 2019 NPRM also proposed to replace or rescind significant portions of the 2016 Rule in order to “relieve billions of dollars in undue regulatory burdens,” and “eliminate provisions [of the 2016 Rule] that are inconsistent or redundant with pre-existing civil rights statutes.”

28

The most common cost concern raised regarding the 2016 Rule was the notice requirements at former § 92.8, which required covered entities to include a notice of nondiscrimination and notice of the availability of language assistance services (“taglines”) in a range of communications.

29

28

84 FR 27848-49.

29

See e.g.,

84 FR 27857-58.

In addition, the 2019 NPRM proposed to eliminate the following provisions of the 2016 Rule: the definitions section, including the definition of “health program or activity” to include all of the

operations of an entity principally engaged in providing or administering health insurance or health-related coverage (former § 92.4); the requirement to designate a responsible employee to carry out a covered entity's responsibilities under Section 1557 (former § 92.7(a)); the requirement to adopt grievance procedures (former § 92.7(b)); notice and tagline requirements (former § 92.8); the approach to accepting disparate impact claims with respect to allegations of sex discrimination (former § 92.101(b)(3)(ii) and (iii)); the requirement for covered entities to justify sex-specific health programs or activities by demonstrating that the sex-specific health program or activity is substantially related to the achievement of an important health-related or scientific objective (former § 92.101(b)(3)(iv)); the requirement for a covered entity to take reasonable steps to provide meaningful access to

each

LEP individual (former § 92.201(a)) (emphasis added); the prohibition on discrimination in health-related insurance and other health-related coverage, including a prohibition of blanket exclusions of coverage for care related to gender transition (former § 92.207); the coverage of certain employee health benefit programs (former § 92.208); the prohibition of discrimination on the basis of association (former § 92.209); reference to compensatory damages for Section 1557 violations to the extent such damages are available under underlying Federal civil rights statutes (former § 92.301(b)); and the provision regarding the obligation to provide OCR access to review records and sources of information, and to otherwise comply with the Department's investigations (former § 92.303(c)).

On June 12, 2020, the Department publicly posted its second Section 1557 Final Rule (2020 Rule), making no substantive changes from the 2019 NPRM.

30

On June 15, 2020, the U.S. Supreme Court issued its ruling in

Bostock

v.

Clayton County,

holding that discrimination on the basis of sexual orientation and gender identity constitutes prohibited discrimination because of sex under Title VII of the Civil Rights Act of 1964 (Title VII).

31

The 2020 Rule was published in the

Federal Register

on June 19, 2020 with preamble language that was inconsistent with the Supreme Court's

Bostock

opinion.

32

30

85 FR 37160 (June 19, 2020) (“After considering public comments, in this final rule, the Department revises its Section 1557 regulations . . . as proposed, with minor and primarily technical corrections.”). The 2019 NPRM received roughly 155,960 comments, which are available for public inspection at

https://www.regulations.gov/docket/HHS-OCR-2019-0007.

31

140 S. Ct. 1731 (2020).

32

85 FR 37178-37180.

Following the issuance of the 2020 Rule, which included an effective date of August 18, 2020,

33

litigants in various U.S. District Courts sought to enjoin the rule on the basis that it was, among other allegations, arbitrary and capricious and contrary to law under the APA.

34

While these challenges addressed a range of changes made to the 2016 Rule, they primarily focused on the 2020 Rule's repeal of the definition of “on the basis of sex”; the incorporation of provisions governing the 2020 Rule's relationship to other laws related to various religious exemptions; the scope of coverage; and the elimination of language access provisions. As a result of these challenges, the Department is currently preliminarily enjoined from enforcing its repeal of certain portions of the 2016 Rule's definition of “on the basis of sex,” and of former 45 CFR 92.206, regarding equal program access on the basis of sex, as well as from enforcing the 2020 Rule's incorporation of Title IX's religious exemption.

35

The five pending lawsuits were stayed for the Department's review of the 2020 Rule.

33

Id.

at 37169.

34

Walker

v.

Azar,

No. 20-cv-2834 (E.D.N.Y. June 26, 2020);

Whitman-Walker Clinic

v.

U.S. Dep't of Health & Human Servs.,

No. 1:20-cv-01630 (D.D.C. June 22, 2020);

N.Y.

v.

U.S. Dep't of Health & Human Servs.,

No. 1:20-cv-05583 (S.D.N.Y. July 20, 2020);

BAGLY

v.

U.S. Dep't of Health & Human Servs.,

No. 20-cv11297 (D. Mass. July 9, 2021);

Chinatown Serv. Ctr.

v.

U.S. Dep't of Health & Human Servs.,

No. 1:21-cv-00331 (D.D.C. Oct. 13, 2021).

35

Walker

v.

Azar,

480 F. Supp. 3d 417, 430 (E.D.N.Y. 2020) (enjoining repeal of definition of “on the basis of sex,” including sex stereotyping);

Whitman-Walker Clinic

v.

U.S. Dep't of Health & Human Servs.,

485 F. Supp. 3d 1 (D.D.C. 2020) (enjoining repeal of definition of “on the basis of sex,” insofar as it includes “discrimination on the basis of . . . sex stereotyping” and enjoining incorporation of Title IX religious exemption);

Walker

v.

Azar,

No. 20-cv-2834, 2020 WL 6363970, at *4 (E.D.N.Y. Oct. 29, 2020) (enjoining repeal of former 45 CFR 92.206). The 2020 Rule provides that “[i]nosofar as the application of any requirement under this part would violate, depart from, or contradict definitions, exemptions, affirmative rights, or protections provided by” various statutes including Title IX's religious exemption, “such application shall not be imposed or required.” 45 CFR 92.6(b). Relying on language in the 2020 Rule's preamble, the

Whitman-Walker

court preliminarily construed § 92.6(b) to explicitly incorporate Title IX's religious exemption.

Whitman-Walker Clinic,

485 F. Supp. 3d at 14, 43. These orders did not affect the district court's vacatur of the 2016 Rule insofar as it defined sex discrimination to include gender identity discrimination in

Franciscan All., Inc.

v.

Azar,

414 F. Supp. 3d 928 (N.D. Tex. 2019).

3. May 10, 2021 Notification of Interpretation (“Bostock Notification”)

On May 10, 2021, the Department publicly announced, consistent with the Supreme Court's decision in

Bostock,

that the Department would interpret Section 1557's prohibition on sex discrimination to include (1) discrimination on the basis of sexual orientation and (2) discrimination on the basis of gender identity (“Bostock Notification”).

36

The Department explained that its interpretation will guide OCR's complaint processing and investigations; however, the interpretation did not “determine the outcome in any particular case or set of facts.” In addition, the Department explained that its Section 1557 enforcement will comply with RFRA and all other legal requirements, including applicable court orders that have been issued in litigation involving Section 1557 regulations.

36

86 FR 27984 (May 25, 2021) (U.S. Dep't of Health & Human Srvs.' Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972).

See also Hammons

v.

Univ. of Md. Med. Sys. Corp.,

551 F. Supp. 3d 567, 590 (D. Md. 2021) (stating that

Bostock

“made clear that the position stated in HHS' [Bostock Notification] was already binding law.”).

There are currently three court challenges to the Department's Bostock Notification, generally alleging violations of the APA and RFRA.

37

As of this writing, two opinions have been issued: (1) the district court in

Neese

v.

Becerra

denied the defendants' motion to dismiss, finding that the plaintiffs plausibly pled that neither Section 1557 nor

Bostock

prohibit health care providers from discriminating on the basis of sexual orientation and gender identity,

38

and (2) the district court in

Christian Employers Alliance

v.

EEOC

has preliminarily enjoined the Department from interpreting or enforcing Section 1557 and its implementing regulations against plaintiffs in a manner that would require them to provide, offer, perform, facilitate, or refer for gender transition services or that prevents, restricts or compels the plaintiffs' speech on gender identity issues.

39

All three cases remain pending.

37

Neese

v.

Becerra,

No. 2:21-cv-00163-Z (N.D. Tex. Aug. 25, 2021);

Am. Coll. of Pediatricians

v.

Becerra,

No. 1:21-cv-00195 (E.D. Tenn. Aug. 27, 2021);

Christian Emp'rs All.

v.

EEOC,

No. 21-cv-00195 (D.N.D. Oct. 18, 2021).

38

No. 2:21-cv-00163-Z, 2022 WL 1265925, at *14 (N.D. Tex. Apr. 26, 2022).

39

No. 21-cv-00195, 2022 WL 1573689, at *9 (D.N.D. May 16, 2022).

4. March 2, 2022 Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy

On March 2, 2022, the Department published guidance, consistent with the Bostock Notification, that Section 1557

prohibits discrimination on the basis of gender identity in access to covered health programs and activities.

40

Specifically, the Department stated that “[c]ategorically refusing to provide treatment to an individual based on their gender identity is prohibited discrimination. Similarly, federally funded covered entities restricting an individual's ability to receive medically necessary care, including gender-affirming care, from their health care provider solely on the basis of their sex assigned at birth or gender identity likely violates Section 1557.”

41

On March 31, 2022, the U.S. Department of Justice (DOJ) issued a letter to State Attorneys General addressing protections against unlawful discrimination based on gender identity, including protections afforded by Section 1557.

42

40

U.S. Dep't of Health & Human Servs., HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy (Mar. 2, 2022),

https://www.hhs.gov/sites/default/files/hhs-ocr-notice-and-guidance-gender-affirming-care.pdf.

41

Id.

at 2.

42

Letter from Kristen Clarke, Assistant Att'y Gen., Civil Rights Div., U.S. Dep't of Justice, to State Att'ys Gen. (Mar. 31, 2022),

https://www.justice.gov/opa/press-release/file/1489066/download.

There is currently one challenge to the Department's gender-affirming care notice alleging violations of the APA.

43

On May 26, 2022, the district court denied Defendants' supplemental motion to dismiss, finding that the March 2, 2022 Notice and Guidance was a final agency action and that Plaintiff had stated a credible threat of enforcement.

44

43

First Amended Compl.,

Tex.

v.

EEOC, et al,

No. 2:21-cv-00194-Z (N.D. Tex. Mar. 9, 2022).

44

Order,

Tex.

v.

EEOC, et al,

No. 2:21-cv-00194-Z (N.D. Tex. May 26, 2022).

B. Summary of the Proposed Rule

The Department proposes to revise the 2020 Rule to reinstate regulatory protections from discrimination on the basis of race, color, national origin, sex, age, or disability in covered health programs and activities, consistent with the statutory text of Section 1557 and Congressional intent.

This proposed rule would reflect Section 1557's application to health programs and activities of the Department, which holds the Department accountable to the same standards of compliance with civil rights laws to which it holds recipients of Federal financial assistance. The proposed rule would also reinstate the rule clarifying that Section 1557 generally applies to many health insurance issuers and also prohibits discrimination in health insurance and other health-related coverage,

45

furthering a central goal of the ACA—to increase access to health-related coverage—by ensuring that Section 1557's robust civil rights protections apply to health insurance and other health-related coverage.

45

The term “health coverage” generally refers to a “[l]egal entitlement to payment or reimbursement for your health care costs, generally under a contract with a health insurance company, a group health plan offered in connection with employment, or a government program like Medicare, Medicaid, or the Children's Health Insurance Program (CHIP).”

Glossary: Health coverage, HealthCare.gov, https://www.healthcare.gov/glossary/health-coverage/

(last visited June 15, 2022).

The proposed rule also seeks to create consistent procedural requirements for covered health programs and activities by requiring grievance procedures (for employers with 15 or more employees), the designation of a responsible employee (for employers with 15 or more employees), and the affirmative provision of civil rights notices. The absence of such consistency leaves individuals with different procedural protections in covered programs and activities depending on whether their complaint is based on race, color, national origin, sex, age, and/or disability. Further, the Department proposes to require covered entities to have in place a set of policies and procedures to support compliance with Section 1557, and to train relevant staff on their respective policies and procedures. The Department also proposes notice requirements, striking a balance between concerns raised by covered entities in response to the 2016 Rule and the importance of providing the public with information about their civil rights. The rule also proposes to implement robust protections for LEP individuals that ensure each LEP person has meaningful access to covered health programs and activities. The Department also proposes to address nondiscrimination on the basis of sex, including gender identity and sexual orientation, consistent with

Bostock

and related case law, as well as subsequent Federal agency interpretations.

46

Further, the rule proposes to ensure equal program access on the basis of sex and prohibit discrimination on the basis of sex related to marital, family, or parental status. The Department additionally proposes provisions related to nondiscrimination in the use of clinical algorithms in health care decision-making and in telehealth services.

46

E.g.,

Memorandum from Pamela S. Karlan, Principal Deputy Assistant Att'y Gen., to Fed. Agency Civil Rights Dirs. & Gen. Counsels (Mar. 26, 2021) [hereinafter Karlan Memo],

https://www.justice.gov/crt/page/file/1383026/download;

86 FR 32637 (June 22, 2021) (U.S. Dep't of Educ., notice of interpretation).

The Department further proposes to apply the provisions applicable to Title VI to administrative enforcement actions against recipients of Federal financial assistance (recipients) and State Exchanges concerning discrimination on the basis of race, color, national origin, sex, and disability, consistent with Section 504

47

and Title IX

48

regulations. For administrative enforcement actions against recipients and State Exchanges concerning discrimination on the basis of age, the Department proposes to employ the procedural provisions that apply under the Age Act. The Department proposes to apply the federally conducted Section 504 enforcement mechanisms with respect to administrative enforcement actions against the Department, including the Federally-facilitated Exchanges. Additionally, the Department proposes to adopt a process by which recipients may inform the Department of their views that the application of a specific provision or provisions of this part to them would violate Federal conscience or religious freedom laws, so that the Department may, as appropriate, make a determination that recipients are exempt from, or entitled to a modification of the application of, a provision or provisions of this part.

47

45 CFR 84.61 (adopting the procedural provision of Title VI).

48

Id.

§ 86.71 (adopting the procedural provision of Title VI).

The Department is proposing to revise its position regarding whether Medicare Part B payments constitute Federal financial assistance for purposes of Federal civil rights jurisdiction under Title VI, Section 504, Title IX, the Age Act, and Section 1557. The Department explains that payments made under the Medicare Part B program meet the longstanding definition of “Federal financial assistance,” and proposes necessary conforming amendments to the appendices of the implementing regulations for Title VI and Section 504.

Finally, the Department proposes to make limited amendments to the Centers for Medicare & Medicaid Services (CMS) Medicaid, Children's Health Insurance Program (CHIP), and Program of All-Inclusive Care for the Elderly (PACE) nondiscrimination regulatory provisions, as well as nondiscrimination provisions applicable to group and individual health insurance markets and Health Insurance Exchanges to clarify that discrimination on the basis of sex

includes discrimination on the basis of sexual orientation and gender identity.

II. Reasons for the Proposed Rulemaking

The Department is undertaking this rulemaking to better align the Section 1557 regulation with the statutory text of 42 U.S.C. 18116, to reflect recent developments in civil rights case law, to address unnecessary confusion in compliance and enforcement resulting from the 2020 Rule, and to better address issues of discrimination that contribute to negative health interactions and outcomes. Upon further consideration and informed by civil rights issues raised in the context of the coronavirus disease 2019 (COVID-19) pandemic, the Department believes that the 2020 Rule creates substantial obstacles to the Department's ability to address discrimination across the health programs and activities it financially supports or administers, thereby undermining the statutory purpose of Section 1557 and hindering the Department's mission of pursuing health equity and protecting public health.

In developing this NPRM, the Department undertook a significant review of previous rulemaking and developments in civil rights law since the publication of both the 2016 and 2020 Final Rules. The Department also engaged in a series of listening sessions with a diverse range of stakeholder groups.

49

49

A list of stakeholder groups and notes from these listening sessions and written materials provided during or after the listening sessions are attached to the docket of this proposed rule as a supplemental material at

federalregister.gov.

A. The Scope of the 2020 Rule Is Not the Best Reading of the Affordable Care Act and Section 1557's Statutory Text

In the Department's view, the scope of application in the 2020 Rule is not the best reading of the statutory text of Section 1557 in two significant respects. First, the 2020 Rule applies to “any program or activity administered by the Department under Title I of the [ACA].”

50

However, the statutory language provides that Section 1557's discrimination prohibitions apply to covered programs and activities that are “administered by an Executive Agency

or

any entity established under this title.”

51

The operative word, “or,” distinguishes programs and activities operated by an Executive Agency from those operated by a Title I entity. The 2020 Rule, however, construes this language to cover only programs and activities administered by the Department

under Title I of the ACA,

and programs and activities administered by any entity established under Title I of the ACA.

52

The reading of the statute in the 2020 Rule is strained, and the Department does not believe that the best way to resolve any ambiguity is to construe the phrase “established under this title” as modifying the phrase “administered by an Executive Agency.” The preamble to the 2020 Rule explained that its construction was “at least as reasonable” as the 2016 Rule's resolution of this issue.

53

However, upon further analysis the Department now believes that the reading proposed herein, which does not limit application to only programs and activities administered by the Department under Title I of the ACA, better reflects the statutory language as well as Congress' intent.

54

50

45 CFR 92.3(a)(2).

51

42 U.S.C. 18116(a) (emphasis added).

52

45 CFR 92.3(a)(2)-(3) (emphasis added).

53

85 FR 37160, 37170 (June 19, 2020).

54

See, e.g., Griffin

v.

Breckenridge,

403 U.S. 88, 97 (1971) (civil rights statutes should be construed broadly);

U.S.

v.

Price,

383 U.S. 787, 801 (1966) (same);

see also N. Haven Bd. of Educ.

v.

Bell,

456 U.S. 512, 521 (1982) (“[I]f we are to give Title IX the scope that its origins dictate, we must accord it a sweep as broad as its language.”); S. Rep. No. 64, 100th Cong., 2d Sess. 5-7 (1988), reprinted in 1988 U.S.C.C.A.N. 3, 7-9 (statement of Sen. Humphrey stating that Title VI should be interpreted as broadly as necessary to eradicate discriminatory practices in programs that Federal funds supported).

Second, the 2020 Rule limits Section 1557's application to health insurance by providing that “for purposes of this part, an entity principally or otherwise engaged in the business of providing health insurance shall not, by virtue of such provision, be considered to be principally engaged in the business of providing health care.”

55

The statutory text of Section 1557 demonstrates Congress' intent to apply Section 1557 to health insurance. In the description of Federal financial assistance subject to Section 1557, the statute identifies three examples of Federal financial assistance, all of which pertain to health insurance: “credits, subsidies, or contracts of insurance.” It is logical to conclude that the inclusion of credits and subsidies in Section 1557's statutory language refers to the tax credits and cost-sharing subsidies provided for under the same title of the ACA (Title I) to assist people in purchasing health insurance coverage. Additionally, as is discussed in detail in this preamble, in enacting the ACA, Congress demonstrated a clear intent to protect individuals from discrimination in health insurance and other health-related coverage. As a general matter, the fact that Section 1557 is contained within the ACA—a law that predominantly regulates health insurance—indicates that Congress intended Section 1557 to apply to health insurance. Thus, the Department, upon further evaluation, believes the 2020 Rule limits application to health insurance and other health-related coverage in a manner inconsistent with the statute and Congressional intent.

55

45 CFR 92.3(c).

B. The 2020 Rule's Preamble Does Not Reflect Recent Developments in Sex Discrimination Law

The 2020 Rule declined to adopt a definition of “on the basis of sex,” but the 2019 NPRM and the preamble to the 2020 Rule suggested that Section 1557's prohibition on sex discrimination may not extend to gender identity discrimination.

56

The Supreme Court has now held that Title VII's prohibition of employment discrimination on the basis of sex encompasses discrimination based on sexual orientation and gender identity.

57

The Court reasoned that, even if Congress understood that “the term `sex' in 1964 referred to `status as either male or female [as] determined by reproductive biology,' ” Title VII prohibits discrimination based on sexual orientation and gender identity.

58

Since

Bostock,

two Federal courts of appeals have held that the plain language of Title IX's prohibition on sex discrimination must be read similarly.

59

The DOJ has also taken this position in Title IX litigation.

60

56

84 FR 27846, 27853-55, 27856-57 (June 14, 2019); 85 FR 37178-79.

57

Bostock

v.

Clayton Cty.,

140 S. Ct. 1731 (2020).

58

Id.

at 1739-40, 1743.

59

See

Doe

v.

Snyder,

28 F.4th 103, 113-14 (9th Cir. 2022);

Grimm

v.

Gloucester Cty. Sch. Bd.,

972 F.3d 586, 616 (4th Cir. 2020),

as amended

(Aug. 28, 2020),

cert. denied,

141 S. Ct. 2878 (Mem) (2020).

60

See, e.g.,

U.S. Dep't of Justice, En Banc Brief as Amicus of the United States,

Adams

v.

Sch. Bd. of St. Johns Cty.,

No. 18-13592, 22 (11th Cir. Nov. 26, 2021); U.S. Dep't of Justice, Statement of Interest of the United States,

B.P.J.

v.

W. Va. Bd. of Educ.,

No. 2:21-cv-00316 (S.D.W. Va. June 17, 2021).

On January 20, 2021, President Biden, in Executive Order (E.O.) 13988, directed agencies to review all agency actions, including regulations, that prohibit discrimination on the basis of sex to determine if they were inconsistent with the Court's reasoning in

Bostock.

61

In response, the Department assessed its Section 1557 regulation and enforcement policies and issued its Bostock Notification. As discussed previously, the Bostock Notification stated that the Department would interpret and enforce Section 1557's sex discrimination prohibitions

consistent with

Bostock,

while recognizing that the interpretation did not “determine the outcome in any particular case or set of facts” and that the Department would comply with RFRA and all other legal requirements.

62

For these reasons and those described in this NPRM, the Department believes the understanding of sex discrimination described in the 2020 Rule's preamble

63

is an inaccurate reading of the statute.

61

86 FR 7023, 7023-24 (Jan. 25, 2021).

62

86 FR 27984;

see also

Karlan Memo,

supra

note 46.

63

85 FR 37160, 37178-79 (June 19, 2020).

The 2020 Rule's preamble relied heavily on the 2016 injunction and 2019 vacatur issued by the district court in the

Franciscan Alliance

case, which predated the

Bostock

decision, when removing the 2016 Rule's gender identity provisions.

64

The district court in that case found that Section 1557's prohibition of sex discrimination did not cover gender identity discrimination.

65

Even prior to

Bostock,

a number of courts had reached a contrary conclusion and held that Federal sex discrimination protections, including Section 1557, provided protection to transgender and gender-nonconforming individuals, although the exact rationales used by these courts varied.

66

Notably, the

Bostock

Court presumed for the sake of argument that “sex” referred only to “biological distinctions between male and female” and still found that Title VII's prohibition of sex discrimination prohibits discrimination on the basis of sexual orientation and gender identity.

67

Following

Bostock,

courts have continued to hold that Federal sex discrimination protections, including Section 1557 and Title IX, cover gender identity discrimination.

68

While some post-

Bostock

decisions have placed limits on Section 1557's application to discrimination against transgender people, these decisions have focused on whether RFRA exempts specific entities from potential future enforcement by HHS of Section 1557's requirements against them; for the most part they do not call into question

Bostock'

s application to Section 1557.

69

In its Bostock Notification, the Department affirmed its commitment to complying with RFRA and all other legal requirements supporting religious exercise and freedom of conscience while also affirming Section 1557's prohibition of discrimination on the basis of gender identity and sexual orientation.

70

64

85 FR 37163-65 (citing

Franciscan All., Inc.

v.

Burwell,

227 F. Supp. 3d 660 (N.D. Tex. 2016) and

Franciscan All., Inc.

v.

Azar,

414 F. Supp. 3d 928 (N.D. Tex. 2019)).

65

Franciscan All., Inc.

v.

Burwell,

227 F. Supp. 3d at 688.

66

See, e.g., Whitaker By Whitaker

v.

Kenosha Unified Sch. Dist. No. 1 Bd. of Educ.,

858 F.3d 1034 (7th Cir. 2017) (Title IX);

Smith

v.

City of Salem, Ohio,

378 F.3d 566 (6th Cir. 2004) (Title VII);

Rosa

v.

Park W. Bank & Trust Co.,

214 F.3d 213 (1st Cir. 2000) (Equal Credit Opportunity Act);

Schroer

v.

Billington,

577 F. Supp. 2d 293 (D.D.C. 2008) (Title VII);

Boyden

v.

Conlin,

341 F. Supp. 3d 979 (W.D. Wis. 2018) (Section 1557 and Title VII);

Flack

v.

Wis. Dep't. of Health Servs.,

395 F. Supp 3d 1001, 1014 (W.D. Wis. 2019) (Section 1557 and Equal Protection Clause);

Prescott

v.

Rady Children's Hosp. San Diego,

265 F. Supp. 3d 1090, 1098-100 (S.D. Cal. 2017) (Section 1557);

Tovar

v.

Essential Health,

342 F. Supp. 3d 947, 957 (D. Minn. 2018) (Section 1557).

67

Bostock

v.

Clayton Cty.,

140 S. Ct. 1731, 1739 (2020).

68

Doe

v.

Snyder,

28 F.4th 103, 113-14 (9th Cir. 2022);

Grimm

v.

Gloucester Cty. Sch. Bd.,

972 F.3d 586, 616 (4th Cir. 2020),

as amended

(Aug. 28, 2020),

cert. denied,

141 S. Ct. 2878 (Mem) (2020);

Kadel

v.

Folwell,

No. 1:19-cv-00272, 2022 WL 2106270, at *28-*29 (M.D.N.C. June 10, 2022);

Scott

v.

St. Louis Univ. Hosp.,

No. 4:21-cv-01270-AGF, 2022 WL 1211092, at *6 (E.D. Mo. Apr. 25, 2022);

C.P. by & through Pritchard

v.

Blue Cross Blue Shield of Ill.,

No. 3:20-cv-06145-RJB, 2021 WL 1758896, at *4 (W.D. Wash. May 4, 2021);

Koenke

v.

Saint Joseph's Univ.,

No. CV 19-4731, 2021 WL 75778, at *2 (E.D. Pa. Jan. 8, 2021);

Doe

v.

Univ. of Scranton,

No. 3:19-cv-01486, 2020 WL 5993766, at *11 n.61 (M.D. Pa. Oct. 9, 2020);

Maxon

v.

Seminary,

No. 2:19-cv-9969, 2020 WL 6305460 (C.D. Cal. Oct. 7, 2020);

B.P.J.

v.

W. Va. State Bd. of Educ.,

No. 2:21-cv-00316, 2021 WL 3081883, at *7 (S.D.W. Va. July 21, 2021);

Clark Cty. Sch. Dist.

v.

Bryan,

478 P.3d 344, 354 (Nev. 2020).

69

Franciscan All., Inc.

v.

Becerra,

No. 7:16-cv-00108-O, 2021 WL 3492338 (N.D. Tex. Aug. 9, 2021),

as amended

(Aug. 16, 2021),

appeal pending,

No. 21-11174 (5th Cir. Nov. 21, 2021);

Religious Sisters of Mercy

v.

Azar,

513 F. Supp. 3d 1113 (D.N.D. 2021),

judgment entered sub nom. Religious Sisters of Mercy

v.

Cochran,

No. 3:16-cv-00386, 2021 WL 1574628 (D.N.D. Feb. 19, 2021),

appeal pending,

No. 21-1890 (8th Cir. April 20, 2021) (oral argument held Dec. 15, 2021);

but see Neese

v.

Becerra,

No. 2:21-cv-00163-Z, 2022 WL 1265925, at *14 (N.D. Tex. Apr. 26, 2022) (denying motion to dismiss based on possibility that neither Section 1557 nor

Bostock

prohibit health care providers from discriminating on the basis of sexual orientation and gender identity).

70

86 FR 27984. Three Federal district courts have enjoined the Department from enforcing Section 1557 in certain respects against the plaintiffs in those cases and their members.

See Religious Sisters of Mercy,

513 F. Supp. at 1153-54;

Franciscan All., Inc.

v.

Becerra,

553 F. Supp. 3d 361, 378 (N.D. Tex. 2021),

amended,

No. 7:16-CV-00108-O, 2021 WL 6774686 (N.D. Tex. Oct. 1, 2021);

Christian Emp'rs All.

v.

EEOC,

No. 21-cv-00195, 2022 WL 1573689 (D.N.D. May 16, 2022). The Department has appealed the injunctions in

Religious Sisters of Mercy

and

Franciscan Alliance,

and those appeals remain pending. The Department is currently abiding by those injunctions and will continue to do so after this Rule takes effect, to the extent those injunctions remain in place.

C. The 2020 Rule Causes Unnecessary Confusion in Compliance

The 2020 Rule provides no guidance on how covered entities are to implement their compliance responsibilities under Section 1557 and, in particular, whether those responsibilities are the same as, or deviate from, their compliance responsibilities under Title VI, Title IX, Section 504, and the Age Act. Rather, it generally states the nondiscrimination requirements of Section 1557 by restating the statutory language of 42 U.S.C. 18116(a), followed by stating that the grounds prohibited are the grounds found in the Title VI, Title IX, Section 504, and Age Act statutes.

71

The resulting uncertainty is particularly stark for procedural requirements—including the designation of a responsible employee, the provision of notices of nondiscrimination, and adoption of grievance procedures—as the 2020 Rule removed the 2016 Rule provisions addressing these issues.

71

45 CFR 92.2.

The implementing regulations for the statutes referenced in Section 1557 require covered entities to have different policies and procedures depending on the alleged basis of discrimination. For example, only the regulations promulgated under Section 504

72

and Title IX

73

require recipients to implement grievance procedures; regulations to implement Title VI and the Age Act specify no such regulatory requirement. Given that the 2020 Rule does not reference grievance procedures, covered entities are unsure of their responsibility to have a grievance procedure for handling complaints of discrimination in their health programs and activities. As such, it would be reasonable for a covered entity to believe that the 2020 Rule does not require such a procedure. However, a covered entity could also reasonably believe that it must have a grievance procedure to address allegations of disability and sex discrimination, as this is what is independently required under Section 504 and Title IX regulations, but not for complaints of race, color, national origin, or age discrimination because neither the Title VI nor Age Act regulations have such a requirement. To further complicate the issues, the requirement to have a grievance procedure under Section 504 is limited to covered entities that employ 15 or more people, whereas the Title IX regulation requires grievance procedures for covered entities regardless of the number of employees.

72

Id.

§ 84.7(b).

73

Id.

§ 86.8(b).

As this discussion illustrates, the approach in the 2020 Rule has caused confusion in compliance by failing to provide clear procedural requirements. The 2020 Rule also significantly pared down regulatory language related to the specific discriminatory actions prohibited that one generally finds in an

implementing regulation for a civil rights statute.

74

The Department believes covered entities and protected individuals need additional clarity regarding the specific discriminatory actions prohibited under Section 1557, including clarification regarding whether and how those actions found in the implementing regulations of the statutes referenced in Section 1557 may also apply.

74

For example, the implementing regulations for each of Section 1557's referenced statutes include provisions describing specific actions that constitute prohibited discrimination.

See

45 CFR 80.3 (Title VI) § 84.4 (504); § 86.31 (Title IX); and § 91.11 (Age Act). Consistent with these implementing regulations, the 2016 Rule included a comparable provision at former 45 CFR 92.101, which the 2020 Rule repealed and purportedly replaced with § 92.2, which does not identify specific, prohibited discriminatory actions.

See

85 FR 37160, 37200 (June 19, 2020); 45 CFR 92.2.

D. Proposed Changes Are Consistent With the Statute and Will Further the Intended Purpose of the Statute

Despite the best efforts of many health care professionals, inequities in access to health care resulting in disparities in health status and outcomes persist. Such disparities pose a major public health challenge for the United States and hinder efforts by health care professionals who work to ensure that their patients receive quality care. As discussed throughout this preamble, discrimination in health care can contribute to these disparities, which negatively impacts communities of color, individuals with disabilities, women, lesbian, gay, bisexual, transgender,

75

queer, and intersex

76

(LGBTQI+)

77

individuals, LEP individuals, and older adults and children. Critically, access to health care that is free from discrimination benefits

all

communities and people, and is also vital to addressing public health emergencies, such as the COVID-19 pandemic. For example, ensuring nondiscriminatory access to health care, vaccines, and protective equipment during a public health emergency will more effectively and expeditiously end the emergency for everyone.

78

75

When used in this preamble, the term “transgender” refers to people who identify as a gender other than their sex assigned at birth. This may include people who identify as nonbinary, genderqueer, or gender nonconforming, regardless of whether those individuals explicitly use the term transgender to describe themselves.

76

When used in this preamble, the term “intersex” refers to people born with variations in physical sex characteristics—including genitals, gonads, chromosomes, and hormonal factors—that do not fit typical binary definitions of male or female bodies.

77

We use “+” in this acronym to indicate inclusion of individuals who may not identify with the listed terms but who have a different identity with regards to their sexual orientation, gender identity, or sex characteristics.

78

See, e.g.,

Ann Lee & Sheila David,

Ensuring Equitable Access to Vaccines,

Stan. Soc. Innovation Rev., Jun. 29, 2021,

https://ssir.org/articles/entry/ensuring_equitable_access_to_vaccines#.

Strong civil rights protections play a significant role in advancing an equitable society, and every part of government must contribute to ensuring that people in the United States enjoy the protections guaranteed to them. Since taking office, President Biden has issued more than a dozen directives aimed at promoting equity, including the robust enforcement of civil rights.

79

Discrimination in health programs and activities can lead to disparate health outcomes and adverse differences in access to care.

80

Accordingly, the Department is committed to doing its part to eliminate such discrimination, including through robust implementation and enforcement of Section 1557. Moreover, the Department is committed to addressing different, intersecting forms of discrimination experienced by individuals who may be entitled to protection from discrimination on more than one of the protected bases under Section 1557 and whose experience of discrimination may be both quantitatively and qualitatively different from that of individuals experiencing single-basis discrimination.

79

See, e.g.,

E.O. 13985, 86 FR 7009 (2021); E.O. 13988, 86 FR 7023 (2021); E.O. 13995, 86 FR 7193 (2021); Memorandum on Redressing Our Nation's and the Federal Government's History of Discriminatory Housing Practices and Policies (2021),

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/26/memorandum-on-redressing-our-nations-and-the-federal-governments-history-of-discriminatory-housing-practices-and-policies/;

Memorandum on Condemning and Combating Racism, Xenophobia, and Intolerance Against Asian Americans and Pacific Islanders in the United States (2021),

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/26/memorandum-condemning-and-combating-racism-xenophobia-and-intolerance-against-asian-americans-and-pacific-islanders-in-the-united-states/;

E.O. 14012, 86 FR 8722 (2021); E.O.14031, 86 FR 29675 (2021); E.O. 14035, 86 FR 34593 (2021); E.O. 14041, 86 FR 50443 (2021); E.O.14045, 86 FR 51581 (2021); and other Presidential Actions.

80

156 Cong. Rec. S1842 (daily ed. Mar. 23, 2010),

https://www.congress.gov/congressional-record/2010/03/23/senate-section/article/S1821-6.

1. Health Equity and Discrimination Related to Race, Color, and National Origin

Members of racial and ethnic groups that have historically faced discrimination and structural disadvantages in the United States experience disproportionately poor health status.

81

Though health indicators for aggregated racial and ethnic populations may suggest positive outcomes for some groups, broad demographic categories often conceal health disparities within and among racial and ethnic subgroups. For example, positive overall data on the health of persons of Asian descent often obscure disparities among subgroups.

82

One study revealed that while Asian persons in the aggregate appeared to be healthier than white persons in the United States, disaggregation of the data shows that persons of Filipino descent experience a higher prevalence of fair or poor health, obesity, high blood pressure, diabetes, or asthma when compared with white persons.

83

Similarly, while the rate of low birth weight infants is lower for the total Hispanic/Latino population in the United States in comparison to non-Hispanic white people, Puerto Ricans have a low birth weight rate that is almost twice that of non-Hispanic white people.

84

81

U.S. Dep't of Health & Human Servs., Office of Minority Health, Minority Population Profiles,

https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=26

(last visited Nov. 9, 2021).

82

Alexander Adia et al.,

Health Conditions, Outcomes, and Service Access Among Filipino, Vietnamese, Chinese, Japanese, and Korean Adults in California,

2011-2017, 110 a.m. J. of Pub. Health 520 (2020),

https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2019.305523.

83

Id.

84

U.S. Dep't of Health & Human Servs., Office of Minority Health, Profile: Hispanic/Latino Americans

https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=64

(last visited Nov. 19, 2021).

Beyond poor health outcomes, communities of color in the United States have long experienced disparities in health care—including in health insurance coverage, access to care, quality of care, maternal mortality rates, and inclusion in biomedical research. For example, American Indian/Alaska Native, Black, and Hispanic/Latino adults account for a disproportionately high share of the uninsured population. American Indian/Alaska Native individuals under 65 have an uninsured rate of 28 percent, higher than any other racial or ethnic group.

85

Hispanic/Latino people comprise 29 percent of the uninsured yet make up 19 percent of the U.S. population.

86

These

disparities are particularly salient in states that did not expand Medicaid; 37 percent of the total uninsured Black population in the United States reside in just three such states.

87

85

The U.S. Census does not classify the Indian Health Service as health coverage. U.S. Dep't of Health & Human Servs., Assistant Sec'y for Policy & Evaluation, Office of Health Policy, Issue Brief: Health Insurance Coverage and Access to Care for American Indians and Alaska Natives: Current Trends and Key Challenges, p. 1 (July 22, 2021),

aspe-aian-health-insurance-coverage-ib.pdf

(

hhs.gov

).

86

U.S. Dep't of Health & Human Servs., Assistant Sec'y for Policy & Evaluation, Office of Health Policy, Issue Brief: The Remaining Uninsured: Geographic and Demographic Variation, p. 1 (Mar. 23, 2021),

https://aspe.hhs.gov/sites/default/files/

private/pdf/265286/Uninsured-Population-Issue-Brief.pdf.

87

Id.

at p. 8.

In addition to experiencing disparities in coverage, people of color are also more likely than white people to experience a lower quality of care. For example, HHS' 2021 National Health Care Quality and Disparities Report evaluated whether different racial groups received worse care than white individuals in the areas of patient safety, person-centered care, care coordination, the effectiveness of care, healthy living, and affordable care. The study found that Black individuals received worse care than white individuals for 43 percent of 195 quality measures, American Indian/Alaska Native individuals received worse care than white individuals for 40 percent of 108 quality measures, Hispanic/Latino individuals received worse care than white individuals for 36 percent of 172 quality measures, Native Hawaiian/Pacific Islander individuals reported receiving a lower level of care than white people for 28 percent of 81 quality measures, and where Asian individuals received worse care than white individuals, it was for 28 percent of 173 quality measures.

88

While many factors may contribute to these disparities, the report highlights the role of social determinants of health,

89

which include racial and ethnic discrimination, limited English proficiency, and presence of health care laws.

90

88

U.S. Dep't of Health & Human Servs., Agency for Healthcare Research & Quality, 2021 National Healthcare Quality and Disparities Report Executive Summary, pp. ES-3, D-3-D-51 (Dec. 2020),

https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2021qdr.pdf.

89

Social determinants of health are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.

Social Determinants of Health,

Healthy People 2030, U.S. Dep't of Health & Human Servs., Office of Disease Prevention & Health Promotion,

https://health.gov/healthypeople/objectives-and-data/social-determinants-health

(last visited January 21, 2022).

90

U.S. Dep't of Health & Human Servs., Agency for Healthcare Research & Quality, 2019 National Healthcare Quality and Disparities Report Executive Summary, p. 7 (Dec. 2020),

https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2019qdr-final-es-cs061721.pdf.

Further, the disparities in maternal mortality rates are alarming. According to National Vital Statistics System data, in 2020, the maternal mortality rate for non-Hispanic/Latino Black women was 55.3 deaths per 100,000 live births, 2.9 times the rate for non-Hispanic/Latino white women (19.1).

91

This disparity is increasing, with maternal mortality rate increases between 2019 and 2020 for non-Hispanic/Latino Black and Hispanic/Latino people.

92

An analysis of vital statistics mortality data showing the cause of maternal deaths in the United States from 2016-2017 revealed maternal mortality for Black women largely resulted from conditions like preeclampsia and cardiomyopathy, and were believed to be preventable.

93

This study also found an increased risk of maternal mortality from multiple causes in Black women, which indicates negative impacts of structural racism on health and health care in the United States. The Biden-Harris Administration has taken initial steps to address these longstanding disparities, issuing the first-ever Presidential proclamation observing Black Maternal Health Week

94

and hosting the first-ever Federal “Maternal Health Day of Action,” which included a nationwide call to action to reduce mortality. The Administration has also announced several key policy actions, including CMS' intention to propose the first-ever hospital quality designation specifically focused on maternity care.

95

91

Donna L. Hoyert, U.S. Dep't of Health & Human Servs., Ctrs. for Disease Control & Prevention, Maternal Mortality Rates in the United States (Feb. 2022),

https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/E-stat-Maternal-Mortality-Rates-2022.pdf.

92

Id.

93

Marian F. MacDorman et al.,

Racial and Ethnic Disparities in Maternal Mortality in the United States Using Enhanced Vital Records, 2016-2017,

111 a.m. J. Pub. Health 1673, 1671 (2021),

https://ajph.aphapublications.org/doi/10.2105/AJPH.2021.306375.

94

The White House Briefing Room, A Proclamation on Black Maternal Health Week, 2021 (April 13, 2021),

www.whitehouse.gov/briefing-room/presidential-actions/2021/04/13/a-proclamation-on-black-maternal-health-week-2021/;see also,

The White House Briefing Room, A Proclamation on Black Maternal Health Week, 2022 (April 8, 2022),

https://www.whitehouse.gov/briefing-room/presidential-actions/2022/04/08/a-proclamation-on-black-maternal-health-week-2022/.

95

The White House Briefing Room, FACT SHEET: Biden-Harris Administration Announces Initial Actions to Address the Black Maternal Health Crisis (Apr. 13, 2021),

www.whitehouse.gov/briefing-room/statements-releases/2021/04/13/fact-sheet-biden-harris-administration-announces-initial-actions-to-address-the-black-maternal-health-crisis./

While research is beginning to reveal more information about the potential causes of Black maternal mortality, less research exists about the causes of maternal mortality among American Indian/Alaska Native women. A recent study documented the available literature on American Indian/Alaska Native women and found that the three leading causes of maternal mortality among such women are hemorrhage, cardiomyopathies, and hypertensive disorders of pregnancy.

96

The authors ultimately concluded that more research is needed to determine the root causes of maternal mortality among American Indian/Alaska Native women, but suggested that to reduce American Indian/Alaska Native maternal mortality and eliminate racial/ethnic disparities, provider-related factors including implicit bias must be addressed.

97

96

Jennifer L. Heck et al.,

Maternal Mortality Among American Indian/Alaska Native Women: A Scoping Review.

30 J. of Women's Health 220, 229 (2021),

https://www.liebertpub.com/doi/epdf/10.1089/jwh.2020.8890.

97

Id.

at 226.

Persistent bias and racism in the health care system, as well as across other social determinants of health, also contribute to health challenges for people of color. For example, one study showed that medical students and medical residents hold false beliefs about biological differences between Black people and white people, and these falsely held beliefs are associated with racial disparities in pain perception and treatment recommendation accuracy.

98

A recent study analyzing patients' electronic health records (EHR) found that Black patients had disproportionately higher odds of being described with one or more negative descriptors in the history and notes of the EHR than their white counterparts.

99

The authors note that this may indicate implicit racial bias against Black patients, potentially leading to stigmatizing Black patients and compromising the care they receive. A recent survey indicates that, shaped by these experiences and perceptions, most Black adults believe that racial discrimination is not uncommon in health care.

100

Black adults, and Black women in particular, are more likely than white people to report certain negative health care experiences.

101

Racism and discrimination experienced outside the health care setting may also affect the mental and physical well-being of individuals of color. For example, Black people who experience

racism were more likely to experience deteriorations in health that contribute to premature death, including increased risk of inflammation and chronic illness.

102

98

Kelly M. Hoffman et al.,

Racial Bias in Pain Assessment and Treatment Recommendations, and False Beliefs About Biological Differences Between Blacks and Whites,

113 Proc. of the Nat'l Acad. of Sci. 4296, 4301 (2016),

https://doi.org/10.1073/pnas.1516047113

.

99

Michael Sun et al.,

Negative Patient Descriptors: Documenting Racial Bias in the Electronic Health Record,

41 Health Affairs 203, 211 (2022),

https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2021.01423

.

100

Liz Hamel et al., The Kaiser Family Found., The Undefeated Survey on Race and Health, p. 4 (2020),

https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-of-Black-Americans.pdf

.

101

Id.

at 5.

102

Jamila Taylor, The Century Found., Racism, Inequality, and Health Care for African Americans, p. 6 (2019),

https://production-tcf.imgix.net/app/uploads/2019/12/19172443/AfAmHealth_Jamila_PDF.pdf

.

It is well-documented that LEP people experience obstacles to accessing health care in the United States.

103

Language barriers negatively affect LEP patients' ability to comprehend their diagnoses and understand medical instructions when they are delivered in English, and impact their comfort with post-discharge care regimens.

104

For example, Hispanic/Latino LEP people report worse access to care and report the receipt of fewer preventive services than Hispanic/Latino people who speak English proficiently.

105

For Asian Americans who are not proficient in English, language barriers are one of the most significant challenges to accessing health care, including making an appointment, communicating with health care professionals, and gaining knowledge about an illness.

106

This is even more pronounced among older Asian Americans, who are more likely to have limited English proficiency.

107

Studies show that LEP patients experience longer hospital stays—leading to a greater risk of line infections, surgical infections, falls, and pressure ulcers—when compared to English-speaking patients.

108

Because LEP patients have greater difficulty understanding medical instructions when those instructions are given in English, they are at higher risk of surgical delays and readmissions.

109

Although the use of qualified interpreters is effective in improving care for LEP patients, some clinicians choose not to use them, fail to use them effectively, or rely instead on ad hoc interpreters—such as family members or untrained bilingual staff.

110

However, in addition to posing legal and ethical concerns, ad hoc interpreters are more likely to make mistakes than professional interpreters.

111

Also, clinicians with basic or intermediate non-English spoken language skills often attempt to communicate with the patient on their own without using an interpreter, increasing patient risk.

112

These barriers contribute to disparities in health outcomes for LEP individuals, which have likely worsened during the COVID-19 pandemic.

113

103

Jason Espinoza et al.,

How Should Clinicians Respond to Language Barriers that Exacerbate Health Inequity?,

23 a.m. Med. Ass'n J. of Ethics E109 (2021) (LEP patients and families in the U.S. “face barriers to health service access, experience lower quality care, and suffer worse health outcomes”),

https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2021-02/cscm3-2102.pdf

.

104

Id.; see also

Leah S. Karliner et al.,

Convenient Access to Professional Interpreters in the Hospital Decreases Readmission Rates and Estimated Hospital Expenditures for Patients with Limited English Proficiency,

55 Med. Care 199 (2017),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5309198/

.

105

Espinoza,

supra

note 103.

106

Wooksoo Kim et al.,

Barriers to Healthcare Among Asian Americans,

25 Soc. Work in Pub. Health 286, 289 (2010),

https://www.tandfonline.com/doi/pdf/10.1080/19371910903240704?needAccess=true

.

107

Id.

108

U.S. Dep't of Health & Human Servs., Agency for Healthcare Research & Quality, Executive Summary: Improving Patient Safety Systems for Patients with Limited English Proficiency (Sept. 2020),

https://www.ahrq.gov/health-literacy/professional-training/lepguide/exec-summary.html#what

.

109

Id.

110

Espinoza,

supra

note 103, at 110.

111

See, e.g.,

Glenn Flores et al.,

Errors of Medical Interpretation and Their Potential Clinical Consequences: A Comparison of Professional Versus Ad Hoc Versus No Interpreters,

5 Annals of Emerg. Med. 545 (Nov. 1, 2012),

https://pubmed.ncbi.nlm.nih.gov/22424655/

; Ali Labaf et al.,

The Effect of Language Barrier and Non-Professional Interpreters on the Accuracy of Patient-Physician Communication in Emergency Department,

3 Adv. J. Emerg. Med., June 6, 2019, at p. 4,

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789075/pdf/AJEM-3-e38.pdf

.

112

U.S. Dep't of Health & Human Servs., Agency for Healthcare Research & Quality,

supra

note 108

.

113

See

Lala Tanmoy Das et al.,

Addressing Barriers to Care for Patients with Limited English Proficiency During the COVID-19 Pandemic,

Health Affairs Blog (July 29, 2020),

https://www.healthaffairs.org/do/10.1377/hblog20200724.76821/full/

.

2. Health Equity and Discrimination Related to Sex

Disparities in women's health are well-documented. For example, although heart disease is the leading cause of death for men and women in the United States, women are more likely to experience delays in emergency care and treatment to control their cholesterol levels.

114

Women are also more likely than men to die from a heart attack.

115

The delay in the diagnosis and treatment of heart disease is just one of many disparities women experience in health care settings. Some evidence suggests that women treated by male physicians for heart attacks experience higher rates of mortality compared to women treated by a female physician or by a male physician who has had more exposure to female patients and female physicians.

116

114

What Health Issues or Conditions Affect Women Differently than Men?,

U.S. Dep't of Health & Human Servs., Nat'l Inst. of Child Health & Human Dev.,

https://www.nichd.nih.gov/health/topics/womenshealth/conditioninfo/howconditionsaffect

(last visited Mar. 15, 2022).

115

Brad Greenwood et al.,

Patient-Physician Gender Concordance and Increased Mortality Among Female Heart Attack Patients,

115 Proc. Nat'l Acad. Sci. 8569, 8574 (2018),

https://www.pnas.org/doi/epdf/10.1073/pnas.1800097115

.

116

Id.

Studies regarding pain management have also indicated the risk of gender bias, based on the notion that men and women are “separate and different in manners and needs,” with a review of the literature revealing studies that show women receive less adequate pain medication, more antidepressants, and more mental health referrals compared to men.

117

Studies indicate this may have to do with erroneous gender stereotypes that men are “stoic, in control, and avoid[] seeking health care,” whereas women are presented as “more sensitive to pain and more willing to show and to report pain” compared to men.

118

117

Anke Samulowitz et al.,

“Brave Men” and “Emotional Women”: A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms Towards Patients with Chronic Pain,

Pain Res. & Mgmt., Feb. 25, 2018, at pp. 1, 9-10,

https://downloads.hindawi.com/journals/prm/2018/6358624.pdf

;

see also

Danielle M. Wesolowicz et al.,

The Roles of Gender and Profession on Gender Role Expectations of Pain in Health Care Professionals,

11 J. of Pain Res. 1121 (2018),

https://www.dovepress.com/getfile.php?fileID=42642

.

118

Samulowitz,

supra

note 117, at pp. 1, 9.

LGBTQI+ individuals in the United States also face pervasive health disparities and barriers in accessing needed health care. Throughout this preamble, we will use the full acronym of LGBTQI+ when talking broadly about individuals who are LGBTQI+ but will use a subset of the acronym (

e.g.,

“LGB,” “LGBT” or “LGBTQ”) when discussing studies, research, or concepts that apply only to a subset of this group.

Overall, LGBTQI+ individuals report being in poorer health than non-LGBTQI+ individuals. LGBTQ+ individuals, moreover, are at increased risk for or are particularly affected by certain health conditions, including sexually transmitted infections,

119

Human Immunodeficiency Virus (HIV),

120

obesity,

121

conditions associated with tobacco, alcohol, and other substance use,

122

and mental

health conditions,

123

including suicidality.

124

LGB people are more likely to acquire a disability at a younger age than heterosexual individuals.

125

119

Hilary Daniel et al., Annals of Internal Med. Position Papers, Lesbian, Gay, Bisexual, and Transgender Health Disparities: Executive Summary of a Policy Position Paper from the American College of Physicians (2015),

https://www.acpjournals.org/doi/full/10.7326/M14-2482?journalCode=aim

.

120

U.S. Dep't of Health & Human Servs., Ctrs. for Disease Control & Prevention, HIV Surveillance Report, 2019; Vol. 32, pp. 19, 24, 46 (2021),

https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf

.

121

Daniel,

supra

note 119.

122

Id.

123

Charlotte Patterson et al., Nat'l Acads. of Sci., Eng'g, & Med., Understanding the Well-Being of LGBTQI+ Populations, p. 298 (2020),

https://doi.org/10.17226/25877

.

124

Daniel,

supra

note 119.

125

Id.

Discrimination also poses a major challenge to the health of LGBTQI+ people. A 2018 literature review revealed that 82 percent of studies found “robust evidence that discrimination on the basis of sexual orientation or gender identity is associated with harms to the health of LGBT people.”

126

Anti-LGBT discrimination is associated with a higher risk of poor mental and physical health, including depression, anxiety, post-traumatic stress disorder, substance use, and cardiovascular disease.

127

These effects are exacerbated for youth and people of color who identify as LGBT.

128

Significant proportions of LGBTQ people report negative experiences with doctors and other health care providers.

129

According to a recent survey, negative experiences with providers occur at higher rates among transgender people, particularly transgender people of color, than among other LGBTQ subgroups.

130

126

What We Know Project, Cornell U., What Does the Scholarly Research Say About the Effects of Discrimination on the Health of LGBT People (2019),

https://whatweknow.inequality.cornell.edu/wp-content/uploads/2019/12/LGBT-Discrimination-Printable-Findings-121319.pdf

.

127

Lesbian, Gay, Bisexual, and Transgender Health, HealthyPeople.gov, https://healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health

(last visited June 8, 2022).

128

Id.; see also

Bianca D.M. Wilson et al., The Williams Inst., UCLA Sch. of Law, Racial Differences Among LGBT Adults in the US: LGBT Well-Being at the Intersection of Race (2022),

https://williamsinstitute.law.ucla.edu/wp-content/uploads/LGBT-Race-Comparison-Jan-2022.pdf

.

129

Sharita Gruberg et al., Ctr. for Am. Progress, The State of the LGBTQ Community in 2020 (2020),

https://www.americanprogress.org/issues/lgbtq-rights/reports/2020/10/06/491052/state-lgbtq-community-2020/

.

130

Sandy E. James et al., Nat'l Ctr. for Transgender Equality, The Report of the 2015 U.S. Transgender Survey, p. 97 (2016),

https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf

.

With respect to transgender individuals, the Department believes that it is particularly important to acknowledge that evidence demonstrates that some health care providers have discriminated against and continue to discriminate against transgender people based on their gender identities. Transgender people commonly report that their providers asked them unnecessarily invasive questions about their gender identity; were physically or verbally abusive; refused them gender-affirming care; or refused to see them at all due to their gender identity.

131

In some cases, transgender people and their providers face discriminatory obstacles at the hospitals or health systems where those providers work or have admitting privileges.

132

Fear of disrespect and discrimination leads many LGBTQI+ people to report delaying or forgoing needed health care, especially for those who identify as transgender.

133

While there is less published research addressing discrimination and disparate health outcomes in individuals with intersex conditions, preliminary studies suggest many of the same concerns and disparities apply.

134

131

Id.

at pp. 96-97.

132

See, e.g.,

Chico Harlan,

A Small-Town Doctor Wanted to Perform Surgeries for Transgender Women. He Faced an Uphill Battle,

Wash. Post (Nov. 11, 2017),

https://www.washingtonpost.com/national/a-small-town-doctor-wanted-to-perform-surgeries-for-transgender-women-he-faced-an-uphill-battle/2017/11/11/c6073a0a-c3d7-11e7-84bc-5e285c7f4512_story.html

.

133

Patterson,

supra

note 123, at p. 292.

134

Laetitia Zeeman & Kay Aranda,

A Systematic Review of the Health and Healthcare Inequalities for People with Intersex Variance,

17 Int'l J. of Envtl. Res. & Pub. Health 6533 (2020),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559554/

; Amy Rosenwohl-Mack et al.,

A National Study on the Physical and Mental Health of Intersex Adults in the U.S.,

15 PLoS ONE, Oct. 9, 2020,

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240088

.

LGBTQI+ people also face barriers to obtaining health insurance, which can impact their access to appropriate health care. Insured rates for LGB+ people have risen substantially since the implementation of the ACA coverage expansions, yet research indicates that some of these gains in coverage were lost between 2016 and 2019.

135

Although research suggests that transgender people have benefited from the ACA's coverage expansions and consumer protections,

136

significant disparities persist in the uninsured rate for transgender people when compared to cisgender

137

people. Nearly one in five transgender adults reported that they lacked insurance from 2017-2018.

138

Furthermore, transgender people who can access insurance may nonetheless be denied coverage for needed services, including gender-affirming care.

139

For example, more than 40 percent of transgender respondents in one survey said their health insurance company denied them coverage for a gender-affirming surgery; a similar proportion reported that they were denied coverage for hormone therapy.

140

135

U.S. Dep't of Health & Human Servs., Assistant Sec'y for Policy & Evaluation, Office of Health Policy, Issue Brief: Health Insurance Coverage and Access to Care for LGBTQ+ Individuals: Current Trends and Key Challenges, p. 4 (June 2021),

https://aspe.hhs.gov/sites/default/files/2021-07/lgbt-health-ib.pdf

.

136

Gruberg,

supra

note 129.

137

The term “cisgender” refers to a person whose gender identity is the same as the person's assigned sex at birth.

138

Wyatt Koma et al., The Kaiser Family Found., Demographics, Insurance Coverage, and Access to Care Among Transgender Adults (2020),

https://www.kff.org/health-reform/issue-brief/demographics-insurance-coverage-and-access-to-care-among-transgender-adults/

.

139

For purposes of this preamble, the term “gender-affirming care” refers to care for transgender individuals (including those who identify using other terms, for example, nonbinary or gender nonconforming) that may include, but is not necessarily limited to, counseling, hormone therapy, surgery, and other services designed to treat gender dysphoria or support gender affirmation or transition. Gender-affirming care may also be, but is not necessarily, referred to as “gender-affirming health services” or “transition-related care.” The terms “gender-affirming care” or “transition-related care” also include care sought by individuals with intersex conditions who seek treatment for gender dysphoria.

See

World Prof. Ass'n for Transgender Health, Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People, pp. 68-71 (7th Version 2012) [hereinafter WPATH Standards],

https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341

(last visited Feb. 7, 2022).

140

Gruberg,

supra

note 129.

Recent research confirms that the COVID-19 pandemic has also exacerbated the health disparities identified above for LGBTQI+ people. Specifically, LGBTQ+ people, who have a higher prevalence of underlying health conditions, are more susceptible to COVID-related illnesses and death.

141

Another study revealed that LGBT+ people, in general, have experienced increased negative mental health impacts during the COVID-19 pandemic compared with non-LGBT+ people.

142

LGBTQ+ youth, in particular, may have experienced increased negative mental health impacts during the pandemic based on increased feelings of isolation and the inability to access supportive community groups and LGBTQ+ friendly spaces resulting from stay-at-home orders and social distancing

recommendations.

143

These youth may also face familial rejection and related mental health and other consequences.

144

Compared to non-LGBT+ people, larger shares of LGBT+ people reported COVID-related employment disruptions.

145

Thus, accessing and affording mental health care

146

and health insurance generally

147

during the pandemic is disproportionally more difficult for LGBT+ people compared to their numbers in the general population.

141

Dustin Nowaskie & Anna Roesler,

The Impact of COVID-19 on the LGBTQ+ Community: Comparisons Between Cisgender, Heterosexual People, Cisgender Sexual Minority People, and Gender Minority People,

309 Elsevier Psychiatry Res., Jan. 10, 2022, at pp. 1, 3,

www.sciencedirect.com/science/article/pii/S0165178122000051

.

142

Lindsey Dawson et al., Kaiser Family Found., The Impact of the COVID-19 Pandemic on LGBT+ People's Mental Health (2021),

https://www.kff.org/other/issue-brief/the-impact-of-the-covid-19-pandemic-on-lgbt-peoples-mental-health/#:~:text=LGBT%20people%20reported%20the%20COVID,rates%20than%20non%2DLGBT%20people

.

143

Ishaan Sachdeva et al.,

Letter to the Editor: The Disparities Faced by the LGBTQ+ Community in Times of COVID-19,

297 Elsevier Psychiatry Res., Jan. 14, 2021,

https://www.sciencedirect.com/science/article/pii/S0165178121000226

; Laurie A. Drabble & Michael J. Eliason,

Introduction to Special Issue: Impacts of the COVID-19 Pandemic on LGBTQ+ Health and Well-Being,

68 J. Homosexuality 545, 549 (2021),

https://www.tandfonline.com/doi/pdf/10.1080/00918369.2020.1868182?needAccess=true

; Scott Emory Moore et al.,

Disproportionate Impact of the COVID-19 Pandemic on Perceived Social Support, Mental Health and Somatic Symptoms in Sexual and Gender Minority Populations,

68 J. Homosexuality 577, 587 (2021),

www.tandfonline.com/doi/full/10.1080/00918369.2020.1868184

.

144

Sachdeva,

supra

note 143.

145

Dawson,

supra

note 142.

146

Nowaskie,

supra

note 141, at p. 3;

see also

Brad Sears et al., Williams Inst., UCLA Sch. of L., The Impact of the Fall 2020 COVID-19 Surge on LGBT Adults in the U.S., p. 10 (2021),

https://williamsinstitute.law.ucla.edu/wp-content/uploads/COVID-LGBT-Fall-Surge-Feb-2021.pdf

.

147

Drabble,

supra

note 143, at 548.

3. Health Equity and Discrimination Related to Age

Although the health disparities discussed above exist in all age groups, older adults experience unique age-related discrimination that negatively impacts their health. There is evidence that age discrimination has negative effects on the physical and mental health of older adults,

148

including fatigue, pain, cognitive impairment, depression, and anxiety.

149

Older adults have reported discrimination including providers disregarding their knowledge of their own health care needs, having their pain ignored for prolonged periods of time, and providers assuming that as older adults they are cognitively compromised or unable to communicate their medical concerns.

150

Some older adults also report being disrespected, rushed, and ignored by their health care providers.

151

One study on age discrimination found that one in 17 adults over the age of 50 experience frequent age discrimination in health care settings, and this is associated with a new or worsened disability within four years.

152

148

David Burnes et al.,

Interventions to Reduce Ageism Against Older Adults: A Systematic Review and Meta-Analysis,

109 Am. J. of Pub. Health, e1, e9 (2019),

https://doi.org/10.2105/AJPH.2019.305123

.

149

Why Ageism in Health Care Is a Growing Concern,

RegisCollege.edu,

https://online.regiscollege.edu/blog/why-ageism-in-health-care-is-a-growing-concern/

(last visited Apr. 20, 2022).

150

Judith Graham, `

They Treat Me Like I'm Old and Stupid': Seniors Decry Health Providers' Age Bias,

Kaiser Health News (Oct. 20, 2021),

https://khn.org/news/article/ageism-health-care-seniors-decry-bias-inappropriate-treatment/

.

151

Id.

152

Stephanie E. Rogers et al.,

Discrimination in Healthcare Settings is Associated with Disability in Older Adults: Health and Retirement Study, 2008-2012,

30 J. Gen. Intern. Med., 1413, 1420 (2015),

https://doi.org/10.1007/s11606-015-3233-6

.

Health care disparities for older adults were tragically amplified by the impact of COVID-19. Recent data show that individuals 65 and older account for 74.3 percent of COVID-19 deaths in the United States.

153

Older adults in nursing homes in particular faced far worse outcomes. Older adults who require a nursing home level of care account for only about 2 percent of the Medicare population but represented about 22 percent of all COVID-19 cases from March 2020 through December 2020.

154

Across all demographic breakdowns, nursing home beneficiaries of Medicare had much higher rates of COVID-19 than beneficiaries in the community, with Hispanic/Latino, Black, and Asian American nursing home beneficiaries having the highest rates.

155

Similarly, nursing home residents were 12 times more likely to be hospitalized with COVID-19

156

and 43 percent died within 30 days of hospitalization as compared to 22 percent of the individuals admitted from the community.

157

Thus, older adults in nursing homes were dying at higher rates than the general population and disproportionate to their numbers in the general population. Studies suggest that longstanding concerns associated with institutionalization such as crowding, understaffing, and facilities with fewer resources and oversight contributed to the devastating COVID-19 health disparities for older adults in nursing homes.

158

153

U.S. Dep't of Health & Human Servs., Ctrs. for Disease Control & Prevention, COVID-19 Mortality Overview, Provisional Death Counts for Coronavirus Disease 2019,

https://www.cdc.gov/nchs/covid19/mortality-overview.htm

(last visited Feb. 16, 2022).

154

U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & Medicaid Servs., The Impact of COVID-19 on Medicare Beneficiaries in Nursing Homes,

https://www.cms.gov/medicare-covid-19-nursing-home-analysis

(last visited Mar. 15, 2022).

155

Id.

156

Id.

157

Id.

158

See, e.g.,

Fangli Geng et al.,

Daily Nursing Home Staffing Levels Highly Variable, Often Below CMS Expectations,

38 Health Affairs 1095, 1099 (2019),

https://doi.org/10.1377/hlthaff.2018.05322

.

Older adults of color sometimes experience discrimination in health care settings because of their age and their race. A recent study found that one in four Black and Hispanic/Latino adults in the U.S. age 60 and older reported that they have been treated unfairly or have felt that their health concerns were not taken seriously by health professionals because of their racial or ethnic background.

159

The findings from the report also stated that more than a quarter of U.S. older adults said they did not get the care or treatment they believed they needed,

160

and U.S. older adults who have experienced discrimination in a health care setting were more likely to have worse health status, face economic hardships, and be more dissatisfied with their care than those who did not experience discrimination.

161

159

Michelle M. Doty et al., Commonwealth Fund, How Discrimination in Health Care Affects Older Americans, and What Health Systems and Providers Can Do (2022),

https://doi.org/10.26099/yffm-2x15

.

160

Id.

161

Id.

Additionally, even though life expectancy and overall health have improved in recent years for most older Americans, with the exception of what we have seen during the COVID-19 pandemic where older Americans have been disproportionately negatively impacted, not all older adults are benefitting equally because of factors such as race, gender, and disability. For example, it is expected Hispanic/Latino and Black people will experience the largest increases in Alzheimer's disease and related dementias between 2015 and 2060.

162

Additionally, women are nearly two times more likely to be affected by Alzheimer's disease than men.

163

A recent survey commissioned by the Alzheimer's Association found that the ability to obtain a diagnosis, manage the disease, and access care and support services for dementia vary widely depending on race, ethnicity, geography, and socioeconomic status.

164

These disparities reach beyond clinical care to include uneven representation of Black, Hispanic/Latino, Asian American and American Indian/Alaska Native populations in Alzheimer's research and clinical trials as well.

165

162

Minorities and Women Are at Greater Risk for Alzheimer's Disease,

U.S. Dep't of Health & Human Servs., Ctrs. for Disease Control & Prevention,

https://www.cdc.gov/aging/publications/features/Alz-Greater-Risk.html

(last visited Mar. 15, 2022).

163

Id.

164

Alzheimer's Ass'n, Special Report: Race, Ethnicity and Alzheimer's in America, p. 72 (2021),

https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report.pdf

.

165

Id.

Another age group disadvantaged by health disparities is children. Social determinants of health such as racism and poverty have been shown to have profoundly negative effects on the health status of children and adolescents. Research on the relationship between the impact of racism and the biological effects of chronic exposure to stress hormones at the cellular level reveals links between birth disparities and mental health challenges in youth.

166

166

Maria Trent et al.,

The Impact of Racism on Child and Adolescent Health,

144 Am. Acad. of Pediatrics, Aug. 1, 2019,

https://publications.aap.org/pediatrics/article/144/2/e20191765/38466/The-Impact-of-Racism-on-Child-and-Adolescent

.

Additionally, the relationship between health disparities and the ability of low-income populations to access safe, healthy homes is well-documented. As early as 2005, the Office of the U.S. Surgeon General reported that 14 percent of low-income renters lived in homes with severe to moderate structural problems including water leaks and mold growth triggering allergic reactions and asthma attacks in residents.

167

Exposure to lead in water sources and paint, soil, and dust particles are known to cause neurological disorders and increased risks of learning and intellectual disabilities in children.

168

Data from national health surveys reveal that children of color, low-income families, and certain geographic regions are disproportionately impacted by lead poisoning.

169

Specifically, Black children are the most likely to have higher blood lead levels, children living in poverty are more likely to have lead in their bodies than other children (regardless of their race/ethnicity or age of the home), and the Southern region of the United States has the highest number of children with lead exposure.

170

167

U.S. Dep't of Health & Human Servs., Office of the Surgeon Gen., The Surgeon General's Call to Action to Promote Healthy Homes (2009),

https://www.ncbi.nlm.nih.gov/books/NBK44192/pdf/Bookshelf_NBK44192.pdf

.

168

Health Effects of Lead Exposure,

U.S. Dep't of Health & Human Servs., Ctrs. for Disease Control & Prevention,

https://www.cdc.gov/nceh/lead/prevention/health-effects.htm

(last visited Mar. 15, 2022).

169

See, e.g.,

Eric M. Roberts et al.,

Assessing Child Lead Poisoning Case Ascertainment in the US, 1999-2010,

139 Pediatrics, May 2017,

https://publications.aap.org/pediatrics/article/139/5/e20164266/38761/Assessing-Child-Lead-Poisoning-Case-Ascertainment

;

Who is Vulnerable to Childhood Lead Poisoning,

Tracking California,

https://www.trackingcalifornia.org/childhood-lead-poisoning/who-is-vulnerable-to-childhood-lead-poisoning

(last visited Mar. 15, 2022).

170

See, e.g.,

Roberts,

supra

note 169;

Who is Vulnerable to Childhood Lead Poisoning, supra

note 169.

4. Health Equity and Discrimination Related to Disability

Individuals with disabilities face barriers to accessing health care and fare worse on a broad range of health indicators than the general population.

171

In addition to experiencing disparate health outcomes and disparate social determinants of health, individuals with disabilities experience challenges in getting the health care they need. For example, standard medical diagnostic equipment is often inaccessible to individuals with mobility-related disabilities. As a result, as many as 20 million adults in the United States who have a disability that limits their functional mobility may experience challenges accessing preventive, primary, and specialty care due to the lack of accessible medical diagnostic equipment.

172

Lack of physical access may lead to poor quality of care, “delayed and incomplete care, missed diagnoses, exacerbation of the original disability, and increases in the likelihood of the development of secondary conditions.”

173

171

See, e.g.,

Valerie L. Forman-Hoffman et al.,

Disability Status, Mortality, and Leading Causes of Death in the United States Community Population,

53 Med Care 346 (2015),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5302214/

; Gloria L. Krahn et al.,

Persons with Disabilities as an Unrecognized Health Disparity Population,

205 Am. J. Pub. Health S198 (Apr. 2015),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355692/

;

2020 Topics and Objectives: Disability and Health, HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health

(last visited Nov. 10, 2021); Elham Mahmoudi & Michelle Meade,

Disparities in Access to Health Care Among Adults with Physical Disabilities: Analysis of a Representative National Sample for a Ten-Year Period,

8 Disability Health J. 182 (2015),

https://pubmed.ncbi.nlm.nih.gov/25263459/

.

172

Debra L. Brucker & Andrew J. Houtenville,

People with Disabilities in the United States,

96 Archives of Physical Medicine and Rehabilitation 771 (2015),

https://doi.org/10.1016/j.apmr.2015.02.024

.

173

Nat'l Council on Disability, Enforceable Accessible Medical Equipment Standards: A Necessary Means to Address the Health Care Needs of People with Mobility Disabilities, p. 7 (2021),

https://ncd.gov/sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf

.

Disability-based bias and discrimination in the health care setting likely contribute to access issues faced by individuals with disabilities. A recent survey of U.S. physicians' perceptions of individuals with disabilities shows the prevalence of potentially biased views. For example, 82.4 percent of respondents in a study published in 2021 reported that individuals with significant disabilities have worse quality of life than those without disabilities, and only 40.7 percent were very confident about their ability to provide the same quality of care to patients with disabilities.

174

Other studies confirm that some health care providers are likely to deny needed medical care to individuals with disabilities, substitute their own judgment for the preferences of patients with disabilities, and exhibit other forms of implicit and explicit bias.

175

174

Lisa I. Iezzoni et al.,

Physicians' Perceptions of People with Disability and Their Health Care,

40 Health Affairs 297 (2021),

https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01452

.

See also,

Lisa I. Iezzoni et al.,

US Physicians' Knowledge About the Americans with Disabilities Act and Accommodation of Patients with Disability,

41 Health Affairs 96 (2022),

https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.01136

.

175

Kenneth A. Gerhart et al.,

Quality of Life Following Spinal Cord Injury: Knowledge of Attitudes of Emergency Care Providers,

24 Annals of Emergency Med. 807 (1994),

https://www.annemergmed.com/article/S0196-0644(94)70318-3/fulltext

; David Carlson et al., Nat'l Disability Rights Network, Devaluing People with Disabilities: Medical Procedures that Violate Civil Rights, pp. 17, 23, 28, 42-43, 49, 54 (2012),

https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf

; Laura VanPuymbrouck et al.,

Explicit and Implicit Disability Attitudes of Healthcare Providers,

65 Rehab. Psychology 101 (2020),

https://pubmed.ncbi.nlm.nih.gov/32105109/

.

Compared to individuals without disabilities, people with disabilities are more likely to have unmet medical, dental, and prescription medication needs—especially women with disabilities and individuals with disabilities who have lower incomes.

176

Individuals with disabilities are also less likely to receive preventive health care services, such as routine teeth cleanings and cancer screenings.

177

One study of Medicare beneficiaries with disabilities found that they were significantly more likely to report difficulty accessing care and more likely to lack annual clinician evaluation and management visits for primary and specialty care than those without disabilities.

178

The same beneficiaries were also more likely to have general, nonemergent, and preventable emergency department visits.

179

Female Medicare beneficiaries with disabilities aged 65 and older were found less likely to receive mammography screening

compared to female beneficiaries of the same age reporting no disability.

180

176

Andrés J. Gallegos,

Misperceptions of People with Disabilities Lead to Low-Quality Care: How Policy Makers Can Counter that Harm and Injustice,

Health Affairs Blog (Apr. 1, 2021),

https://www.healthaffairs.org/do/10.1377/hblog20210325.480382/full/

.

177

2020 Topics and Objectives: Disability and Health, HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health

(last visited Nov. 10, 2021).

178

Kenton J. Johnson et al.,

Ambulatory Care Access and Emergency Department Use for Medicare Beneficiaries With and Without Disabilities,

40 Health Affairs 910 (2021),

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.01891

.

179

Id.

180

U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & Medicaid Servs., Medicare Current Beneficiary Survey (2013),

https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-ADA-2017.pdf

.

A recent study examined the intersectionality of disability and pregnancy and how this may impact risk for maternal morbidity and mortality, thereby underscoring the importance of ensuring nondiscrimination against women with disabilities.

181

181

Caroline Signore et al.,

The Intersection of Disability and Pregnancy: Risks for Maternal Morbidity and Mortality.

30 J. of Women's Health 147, 153 (2021),

https://doi.org/10.1089/jwh.2020.8864

.

The COVID-19 pandemic exacerbated existing health disparities and uniquely affected individuals with disabilities, who are more likely to have pre-existing health conditions and face barriers to accessing health care, placing them at increased risk of COVID-19 infection and death.

182

Further, some people who have been infected with COVID-19 continue to experience symptoms that can last months after first being infected, or may have new or recurring symptoms at a later time, a condition known as “long COVID” that itself can constitute a disability.

183

During the course of the COVID-19 pandemic, OCR has received a number of complaints from aging and disability rights advocates raising concerns that resource allocation decisions under state Crisis Standards of Care were being made in a manner that was discriminatory on the basis of age and disability. OCR provided technical assistance to a number of states to prevent resource allocation decisions from being made on the basis of discriminatory criteria.

184

182

Sabrina Epstein et al.,

New Obstacles and Widening Gaps: A Qualitative Study of the Effects of the COVID-19 Pandemic on U.S. Adults with Disabilities,

14 Disability & Health J. 101103 (2021),

https://doi.org/10.1016/j.dhjo.2021.101103

.

183

U.S. Dep't of Health & Human Servs. & U.S. Dep't of Justice, Guidance on “Long Covid” as a Disability Under the ADA, Section 504, and Section 1557 (July 26, 2022),

https://www.hhs.gov/about/news/2021/07/26/hhs-doj-issue-guidance-on-long-covid-and-disability-rights.html

.

184

Civil Rights and COVID-19,

U.S. Dep't of Health & Human Servs., Office for Civil Rights,

https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html

(last updated July 26, 2021); Bulletin, U.S. Dep't of Health & Human Servs., Office for Civil Rights,

Civil Rights, HIPAA, and the Coronavirus Disease 2019

(Mar. 28, 2020),

https://www.hhs.gov/sites/default/files/ocr-bulletin-3-28-20.pdf

.

5. Improving the Nation's Health Through Civil Rights Protections

The Department is committed to doing its part to address health disparities and to promote equity in health care access through a range of initiatives, including through implementation and enforcement of Section 1557's protections. As reviewed above, the 2016 Rule provided clarity regarding Section 1557's strong statutory protections from discrimination and equipped the Department with the means to enforce these protections. The 2020 Rule, by contrast, limited the Rule's scope, removed principal provisions from the Section 1557 regulation, and left ambiguity regarding the extent of various protections. The 2020 Rule removed specific provisions implementing nondiscrimination protections regarding gender identity. The 2020 Rule also eliminated specific provisions addressing discrimination in health insurance coverage benefit design and eliminated provisions designed to ensure access to language assistance services for LEP individuals. Furthermore, 2020 Rule also narrowed the regulation's application to some, but not all, operations of health insurance issuers and to only certain programs administered by the Department.

The 2020 Rule's removal of specific nondiscrimination provisions from the Section 1557 regulation—including the provision implementing protections based on gender identity discrimination, as well as other changes that could be read to limit the reach of Section 1557—has the potential to increase the incidence of discrimination for groups protected under the statute. As described above, discrimination leads to negative impacts on access to care and mental and physical health outcomes. An increase in discrimination will widen existing disparities and harm the well-being of underserved and historically marginalized individuals and communities. The Department acknowledges the potential interest that covered entities and other stakeholders may have in maintaining the 2020 Rule and recognizes that some of the proposed revisions reflect changes to certain positions articulated in that Rule. However, the Department is also cognizant of the fact that absent revisions to the 2020 Rule, protected groups likely will be relegated to inferior health care access without strong civil rights protections at a moment when health disparities have been magnified by the unequal burden of the COVID-19 pandemic.

III. Nondiscrimination in Health Programs and Activities

Subpart A—General Provisions

Purpose and effective date (§ 92.1)

Proposed § 92.1(a) states that the purpose of this part is to implement Section 1557, which prohibits discrimination in certain health programs and activities on the grounds prohibited under Title VI, Title IX, the Age Act, or Section 504. As discussed further in the Preamble's discussion of proposed § 92.2, HHS interprets Section 1557's prohibition of discrimination on the “ground[s] prohibited” under Title VI, Title IX, Age Act, or Section 504 to mean that Section 1557 prohibits discrimination based on race, color, national origin, sex, age, or disability.

185

In addition to incorporating the “ground[s] prohibited” by these other statutes, Section 1557 incorporates the “enforcement mechanisms” of the statutes.

186

Though the Section 1557 rule is informed by the Title VI, Title IX, Age Act, and Section 504 implementing regulations, Section 1557 provides an independent basis for regulation of discrimination in covered health programs and activities that is distinct from Title VI, Title IX, the Age Act, and Section 504. Section 1557's nondiscrimination requirements do not in any way limit or impact the interpretation of those statutes.

187

185

See Schmitt

v.

Kaiser Found. Health Plan of Wash.,

965 F.3d 945, 953 (9th Cir. 2020) (“Section 1557(a) incorporates only the prohibited `grounds' and `the mechanisms provided for and available under' the four civil rights statutes. A prohibited `ground' for discrimination . . . is simply the protected classification at issue.”).

186

42 U.S.C. 18116(a).

187

See id.

18116(b).

Section 92.1(b) proposes that the effective date of the Section 1557 implementing regulation shall be 60 days after the publication of a final rule in the

Federal Register

. This section provides an exception to the start date for provisions of this part that require changes to health insurance or group health plan benefit design. Such provisions will have a delayed implementation date of the first day of the first plan year (in the individual market, policy year) beginning on or after the year immediately following the effective date of the Final Rule in the

Federal Register

. This delayed implementation will allow covered entities to revise their health insurance coverage or other health-related coverage to comply with the regulation and to avoid administrative challenges associated with applying the Final Rule's requirements in the middle of a plan year or policy year. We seek

comments from issuers, employers, and other plan sponsors on how long they anticipate it would take to adjust their plan offerings, and from Exchanges on how long they would need to implement the proposed requirements.

Application (§ 92.2)

Proposed § 92.2 addresses the application of this regulation. The Department proposes in § 92.2(a) to apply the rule, except as otherwise provided in this part, to: (1) every health program or activity, any part of which receives Federal financial assistance, directly or indirectly, from the Department; (2) every health program or activity administered by the Department; and (3) every program or activity administered by a Title I entity.

Paragraph (a)(1) proposes to make the rule applicable to every health program or activity, any part of which receives Federal financial assistance, directly or indirectly, from the Department.

In paragraph (a)(2), we propose to apply the rule to all health programs and activities of the Department. This is consistent with the 2016 Rule, and in contrast to the 2020 Rule, which only applies to those programs and activities administered by the Department under Title I of the ACA. The statute prohibits discrimination on the enumerated bases in “any program or activity that is administered by an Executive Agency

or

any entity established under this title.”

188

The operative word, “or,” distinguishes programs and activities operated by an Executive Agency from those operated by a Title I entity. Although the 2020 Rule construes this language to cover only programs and activities administered by the Department under Title I of the ACA and programs and activities administered by any entity established under Title I of the ACA, upon further review the Department finds this reading of the statute unpersuasive. We do not believe that the best way to resolve any perceived ambiguity is to construe the phrase “established under this title” as modifying the phrase “administered by an Executive Agency.”

188

Id.

18116(a) (emphasis added).

We propose, consistent with the 2016 Rule, to reinstate the word “health” to modify “programs or activities” operated by the Department. The Department considered applying the rule to all programs and activities of the Department; however, we believe this is an appropriate limitation for this regulation given the specificity of the vast majority of the regulatory provisions to health programs and activities. We seek comment on the implications of this scope; the implications of applying a Section 1557 implementing regulation broadly to all programs and activities of the Department; and, if the Department were to do so, if that should be done through a separate regulation, similar to the Department's Section 504 implementing regulation that applies to programs and activities conducted by the Department at 45 CFR part 85.

Consistent with the 2016 Rule, the Department proposes to limit the application of this rulemaking to the health programs and activities of only the Department itself and not all Executive Agencies. The Department remains committed to working with other Departments that administer health programs and activities to support them in their efforts to ensure that their programs are nondiscriminatory, because Section 1557 applies to programs and activities that are administered by all Executive Agencies.

189

This proposed regulation, however, is limited to HHS.

189

Id.

Proposed paragraph (a)(3) states that the rule applies to every program or activity administered by a Title I entity. Title I entities include State Exchanges (including those on the Federal platform) and federally-facilitated Exchanges, both of which were created under Title I of the ACA.

190

We do not believe the modifier “health” is necessary when describing covered programs and activities of Title I entities because they are, as a whole, health programs or activities under the definition of “health program or activity” at proposed § 92.4.

190

Section 1311 of the ACA (codified at 42 U.S.C. 18031) (establishing grants and requiring those grants to be used by states to create “American Health Benefit Exchanges”).

Proposed paragraph (b) provides that provisions of this part do not apply to an employer with regard to its employment practices, including the provision of employee health benefits. This is distinct from both the 2016 and 2020 Rules, each of which applied to employment in very limited circumstances. The 2016 Rule did not apply to hiring, firing, promotions, or terms and conditions of employment but did address employee health benefit programs at former § 92.208. This provision was repealed by the 2020 Rule as “duplicative of, inconsistent with, or confusing in relation to the Department's preexisting regulations,” which instead reverted to enforcing the statutorily referenced nondiscrimination statutes through their existing regulations.

191

191

85 FR 37160, 37169 (June 19, 2020).

The Department has considered this issue, in consultation with Federal agencies primarily charged with enforcing existing employment discrimination laws, and is proposing that this part not apply to employment. OCR recognizes that over 55 percent of the U.S. population receives health care benefits through an employer.

192

However, based on enforcement experience under the 2016 and 2020 Rules, we believe that the proposed approach will minimize confusion among individuals seeking relief and will decrease the likelihood that individuals seeking relief under Federal Equal Employment Opportunity laws will miss strict time limits for filing complaints to challenge discrimination under those laws. The Department is proposing this language to promote clarity regarding the filing and processing of discrimination complaints. The Department proposes that employment discrimination complaints alleging violations of similar protections against discrimination to those that are covered under Section 1557 be handled by other Federal agencies under the statutes they enforce, and not by the Department. The Department would maintain jurisdiction over complaints alleging discrimination in covered health insurance or other health-related coverage; however, should the Department receive a complaint under Section 1557 alleging discrimination by an employer (such as a claim involving a Federal Employees Health Benefits plan), such a complaint will be referred to the appropriate Federal agency if it is determined that another agency (

e.g.,

Office of Personnel Management (OPM), Equal Employment Opportunity Commission (EEOC), or DOJ) may have jurisdiction under the statutes it enforces.

192

Katherine Keisler-Starkey & Lisa N. Bunch, U.S. Dep't of Commerce, U.S. Census Bureau, Health Insurance Coverage in the United States: 2019, p. 4 (2020),

https://www.census.gov/content/dam/Census/library/publications/2020/demo/p60-271.pdf

.

Proposed paragraph (c) provides that if any provision of this part is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, it shall be severable from this part and not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other, dissimilar circumstances.

We seek comment on the effects of the proposed scope of application of the regulation, including the application to

programs and activities of the Department and other Executive Agencies; application of this part to recipients of Federal financial assistance from Executive Agencies other than the Department; and the application to employment.

Treatment of Title IX Exceptions

Section 1557 provides that “an individual shall not, on the ground prohibited under” Title VI, Title IX, the Age Act, and Section 504, “be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance.”

193

The statute further provides that “[t]he enforcement mechanisms provided for and available under” Title VI, Title IX, the Age Act, and Section 504 “shall apply for purposes of violations of this subsection.”

194

Section 1557 thus explicitly incorporates from those four statutes the grounds of discrimination that are prohibited and the enforcement mechanisms of the referenced statutes (Title VI, Title IX, the Age Act, and Section 504). Under the most natural understanding of Section 1557's text, as well as the statute's structure and purpose, the statutory term “ground prohibited” is best understood as incorporating the bases of the discrimination prohibitions in the referenced statutes (race, color, national origin, sex, age, and disability).

193

42 U.S.C. 18116(a).

194

Id.

As discussed further below, the Department also believes that in order to construe particular terms in (or incorporated by) Section 1557, such as the meaning of “sex” or “disability”; what it means to be “subjected to discrimination” on one of the specified grounds; the scope of “program or activity”; and what counts as “Federal financial assistance,” it is reasonable and appropriate to look to how Congress, the agencies, and the courts have construed those terms under Title VI, Title IX, the Age Act, and Section 504. There is no similar basis, however, for concluding that Congress incorporated into Section 1557 any of the exceptions that Congress added to Title IX—the only one of the four statutes referenced by Section 1557 that contains such exceptions, and also the only statute with jurisdiction that is limited to a certain type of program or activity (

i.e.,

education programs or activities). At the very least, Section 1557 does not unambiguously require HHS to incorporate any of the Title IX exceptions into its regulatory scheme.

195

195

To the degree that there is any statutory ambiguity, the Department has discretion as to whether and how to incorporate other aspects of the referenced statutes.

See Chevron, U.S.A., Inc.

v.

Nat. Res. Def. Council, Inc.,

467 U.S. 837 (1984) (courts should give “considerable weight to an executive department's construction of a statutory scheme it is entrusted to administer, and the principle of deference to administrative interpretations, `has been consistently followed whenever a decision as to the meaning or reach of a statute has involved reconciling conflicting policies, and a full understanding of the force of the statutory policy in the given situation has depended upon more than ordinary knowledge respecting the matters subjected to agency regulations'”).

Section 1681(a) of Title IX states the statute's basic prohibition on discrimination on the basis of sex, and then enumerates several circumstances in which that prohibition does not apply, which it denominates as “exceptions” from the basic rule of section 1681(a). The prohibition on sex-based discrimination does “not apply” at all, for example, “to an educational institution whose primary purpose is the training of individuals for the military services of the United States, or the merchant marine”;

196

nor does it apply to any program or activity of the American Legion undertaken in connection with the organization or operation of any Boys State conference, Boys Nation conference, Girls State conference, or Girls Nation conference.

197

Title IX includes an exception for

admissions

decisions of educational institutions other than institutions of vocational education, professional education, graduate higher education, and public undergraduate institutions,

198

and yet another exception for the

membership

practices of certain tax-exempt social fraternities and sororities, the YMCA and YWCA, the Girl Scouts, the Boy Scouts, and voluntary youth service organizations whose membership has “traditionally been limited to persons of one sex and principally to persons of less than nineteen years of age.”

199

Title IX also contains exceptions that permit educational institutions to authorize father-son or mother-daughter activities,

200

and to award scholarships based upon the results of sex-specific beauty pageants.

201

Section 1681(a)(3) contains another exception for an educational institution controlled by a religious organization, which is permitted to engage in otherwise prohibited sex discrimination in particular circumstances—namely, where “the application of [Title IX's nondiscrimination mandate] would not be consistent with the religious tenets of such organization.”

202

196

20 U.S.C. 1681(a)(4).

197

Id.

1681(a)(7).

198

Id.

1681(a)(1).

199

Id.

1681(a).

200

Id.

1681(a)(8).

201

Id.

1681(a)(9).

202

The section 1681(a)(3) exception applies only to certain religiously affiliated

educational

institutions. The Civil Rights Restoration Act of 1987, however, contains a proviso that exempts application of Title IX to “any operation of an entity which is controlled by a religious organization if the application of section 1681 of this title to such operation would not be consistent with the religious tenets of such organization,” creating a parallel exception to that contained in section 1681(a)(3).

The 2016 Rule did not incorporate these Title IX exceptions for purposes of construing Section 1557. The treatment under the 2020 Rule is not as clear. Section 92.6(b) of the 2020 Rule states that “[i]nsofar as the application of any requirement under this part would violate, depart from, or contradict definitions,

exemptions,

affirmative rights, or protections provided by” the four referenced nondiscrimination statutes (and several others that are listed), “such application shall not be imposed or required.” (Emphasis added.) The preamble to the 2020 Rule asserted that because Section 1557 “incorporates the statutory

scope

of Title IX, . . . it is appropriate for this rule to incorporate the Title IX statutory language concerning religious institutions . . . ”

203

Indeed, the preamble went so far as to say that “this final rule amends the Department's Title IX regulation to explicitly incorporate relevant statutory exemptions from Title IX, including . . . the religious exemption.”

204

The regulatory text of the 2020 Rule itself, however, does not expressly call for incorporation of the religious exemption nor repeat the specific language of that Title IX provision.

205

203

85 FR 37160, 37207-08 (June 19, 2020) (emphasis added).

204

85 FR 37162.

205

Following issuance of the 2020 Rule, a consortium of plaintiffs filed a lawsuit against the Department in Federal district court, seeking to enjoin the Department from incorporating the Title IX religious exemption. Compl.,

Whitman-Walker Clinic

v.

U.S. Dep't of Health & Human Servs.,

No. 1:20-cv-01630 (D.D.C. June 22, 2020) [hereinafter

Whitman-Walker

Complaint];

see also

Compl.

BAGLY

v.

U.S. Dep't of Health & Human Servs.,

No. 20-11297, (D. Mass. July 9, 2020); Compl.

N.Y.

v.

U.S. Dep't of Health & Human Servs.,

No. 1:20-cv-05583 (S.D.N.Y. July 20, 2020). A little more than two weeks after the 2020 Rule went into effect, the court in

Whitman-Walker Clinic, Inc., et al.

v.

U.S. Dep't of Health & Human Servs.

preliminarily enjoined the Department “from enforcing its incorporation of the religious exemption contained in Title IX.”

Whitman-Walker Clinic

v.

U.S. Dep't of Health & Human Servs.,

485 F. Supp. 3d 1, 37 (D.D.C. 2020). The court held that the Department's apparent inclusion of Title IX's religious exemption in the 2020 Rule violated the APA because the Department failed to consider “the potential

negative consequences that importing a blanket religious exemption into Section 1557 might have for access to health care.”

Id.

(citing

Mfrs. Ass'n

v.

State Farm Mut. Auto Ins.,

463 U.S. 29, 42 (1983) (agency must examine relevant date and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made)). The preliminary injunction issued by the court in

Whitman-Walker

remains in effect.

This NPRM proposes not to import any of the Title IX exceptions into the Section 1557 regulation because the statutory language of Section 1557 is best interpreted to not authorize, and at the very least not command, the Secretary to promulgate such an extension of the Title IX exceptions.

The Department's analysis begins with the relevant statutory text. Section 1557 prohibits discrimination “on the ground[s] prohibited under” Title IX and the other referenced statutes.

206

The district court in

Franciscan Alliance

read the term “ground” to necessarily incorporate not only the prohibited basis for discrimination—

i.e.,

sex—but also any exceptions set forth in Title IX.

207

The Department believes that, as a textual matter, the more natural understanding of “ground prohibited” is that it refers simply to the basis on which discrimination is prohibited. Further, subsection (b) of Section 1557 refers to “discrimination on any

basis

described in subsection (a),” which suggests that “ground” in subsection (a) means the “basis” for discrimination,

i.e.,

race, color, national origin, sex, age, and disability.

208

206

42 U.S.C. 18116(a).

207

Franciscan All., Inc.

v.

Burwell,

227 F. Supp. 3d 660, 690-91 (N.D. Tex. 2016).

208

42 U.S.C. 18116(b) (emphasis added).

Recent Supreme Court opinions support the Department's reading. In an April 2022 decision, the Court used the term “grounds” when discussing prohibited bases for discrimination in several antidiscrimination statutes, including Section 1557.

209

Additionally, in the

Bostock

decision, the Court also used the term “grounds” in interpreting Title VII, while also referring separately to Title VII's “express statutory exception for religious organizations.”

210

209

Cummings

v.

Premier Rehab Keller, P.L.L.C.,

142 S. Ct. 1562, 1569 (2022) (“Congress has enacted four statutes prohibiting recipients of Federal financial assistance from discriminating based on certain protected grounds.”).

210

Bostock

v.

Clayton Cty.,

140 S. Ct. 1731, 1742, 1754 (2020).

As a matter of ordinary speech, it would be uncommon to refer to a provision “excepting” particular entities from a statutory prohibition on discrimination as part of the “ground prohibited” by the statute from which they are excepted. The preamble to the 2020 Rule assumed that Section 1557 “incorporates the statutory

scope

of Title IX”—which it understood to include Title IX's exceptions.

211

But nowhere does Section 1557 state that it incorporates the full “scope” of those statutes. The better reading of the text of Section 1557, then, is that it expressly incorporates the “grounds” and “enforcement mechanisms” of the four antidiscrimination statutes, but not their scope. Instead, the text of Section 1557 provides its own scope of application—to “any health program or activity, any part of which is receiving Federal financial assistance, including credits, subsidies, or contracts of insurance, or under any program or activity that is administered by an Executive Agency or any entity established under” Title I of the ACA.

212

Therefore, the best reading of Section 1557 is that it does not incorporate Title IX's religious exception or any of the other Title IX exceptions.

211

85 FR at 37208.

212

42 U.S.C. 18116(a).

Section 1557's structure confirms that textual understanding. The statute explicitly incorporates “[t]he enforcement mechanisms provided for and available under” the referenced statutes.

213

That provision demonstrates that when Congress wanted to incorporate aspects of the referenced statutes other than the “grounds” of prohibited discrimination, it did so expressly. There is, by contrast, no such express incorporation of the Title IX exceptions. To the contrary, the very first words of Section 1557 are that “

[e]xcept as otherwise provided for in this title (or an amendment made by this title),

an individual shall not, on the ground prohibited under [the four referenced statutes], be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance . . .”

214

Congress, in other words, specifically signaled that the only “except[ions]” to Section 1557's prohibition would be those “provided for” or “made by” Title I of the ACA, which does

not

encompass Title IX of the Education Amendments of 1972.

213

Id.

§ 18116.

214

Id.

18116(a) (emphasis added).

Furthermore, Section 1557's role as a health care statute further supports the Department's reading of the text and understanding of Congress' intent. The Title IX exceptions are specifically concerned with educational institutions and other recipients of Federal funds that operate an education program or activity. The apparent reasons for the exceptions in the education setting would, at least in many cases, be inappropriate or nonsensical in the context of health programs and activities. For example, Title IX exceptions related to the membership practices of social fraternities, sororities, YWCA, YMCA, Girls Scouts, Boys Scouts, and voluntary youth service organizations; father-son and mother-daughter activities; and beauty pageant-based scholarships are ill-suited for application to health programs and activities.

Moreover, the application of the Title IX exception for entities controlled by religious organizations, in particular, could raise distinctive concerns in the health care context that are not typically present in education programs and activities. Health care settings differ significantly from educational settings with respect to both the ability of affected parties to choose or avoid a certain religiously affiliated health care institution and the urgency of the need for services provided by the covered entities.

215

For example, access to health care settings raises considerations of choice and notice to affected parties that are largely absent in the educational context. Whereas students and families typically make a choice to attend religious educational institutions, patients seeking health care are much more likely to be driven by considerations of availability, convenience, urgency, geography, cost, insurance network restrictions, and other factors unrelated to the question of whether the health care provider is controlled by or affiliated with a religious organization. There are an increasing number of communities in the United States with limited options to access health care from non-religiously affiliated health care providers.

216

As a practical matter, then, many patients and their families may have little or no choice about where to seek care, particularly in exigent circumstances, or in cases where the quality or range of care may vary dramatically among providers. Moreover, health care consumers are not always aware that the health care entities from which they seek care may

be limited in the care they provide.

217

Incorporation of Title IX's religious exception would therefore seriously compromise Congress's principal objective in the ACA of increasing access to health care.

215

81 FR 31375, 31380 (May 18, 2016).

216

See, e.g.,

Maryam Guiahi et al.,

Patient Views on Religious Institutional Health Care,

2 JAMA Network Open, Dec. 27, 2019, at p. 2,

https://pubmed.ncbi.nlm.nih.gov/31880794/

(discussing growing religious ownership of health care entities in the context of whether U.S. adults consider religious affiliation when selecting health care facilities); Michael Booth,

SCL Health to Merge with Intermountain Health, Creating Not-For-Profit Hospital Giant in West,

The Colorado Sun (Sept. 16, 2021),

https://coloradosun.com/2021/09/16/hospital-merger-scl-health-colorado/

.

217

See, e.g.,

Coleman Drake et al.,

Market Share of US Catholic Hospitals and Associated Geographic Network Access to Reproductive Health Services,

Jama Network Open, Jan. 29, 2020,

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759762

(research study examining the impact and growth of Catholic health care entities on the provision of reproductive health care in the United States); Harris Meyer,

Most Catholic Hospitals Don't Disclose Religious Care Restrictions,

Modern Healthcare, Mar. 15, 2019,

https://www.modernhealthcare.com/operations/most-catholic-hospitals-dont-disclose-religious-care-restrictions

.

While not incorporating the Title IX religious exception, the Department is fully committed to respecting conscience and religious freedom laws when applying this rule, including an organization's assertion that the provisions of this rule conflict with their rights under Federal conscience and religious freedom laws as addressed in proposed § 92.302.

The application of these statutes, all of which Congress enacted

after

it enacted Title IX, protects important religious liberty interests and conflicts of conscience, even without the incorporation of the Title IX religious exception into Section 1557. Under RFRA, exemptions from any of the antidiscrimination requirements of Section 1557 would depend in part on the ramifications of applying such exemptions. For example, even if the rule substantially burdened religious practices, a religious exemption would not be required if that burden was the result of the government's advancement of a compelling interest by means that were least restrictive of religious exercise in particular contexts. The U.S. Supreme Court has made it clear that a fact-sensitive, case-by-case analysis of such burdens and interests is needed under RFRA, something the Title IX exception does not allow.

218

The Department will apply RFRA in this manner.

218

See, e.g., Gonzales

v.

O Centro Espírita Beneficente União do Vegetal,

546 U.S. 418, 430-31 (2006) (when applying RFRA, courts look “beyond broadly formulated interests justifying the general applicability of government mandates and scrutinized the asserted harm of granting specific exemptions to particular religious claimants”);

cf. Ramirez

v.

Collier,

142 S. Ct. 1264, 1281 (2022) (holding that the Religious Land Use and Institutionalized Persons Act, which applies RFRA's test for religious exemptions in the prison context, “requires that courts take cases one at a time, considering only `the particular claimant whose sincere exercise of religion is being substantially burdened'”) (quoting

Holt

v.

Hobbs,

574 U.S. 352, 363 (2015)).

Applying the existing Federal conscience and religious freedom laws will allow the Department to address the interests in providing nondiscriminatory health care and religious or conscience commitments by applying the legal standards applicable to those conscience and religious freedom laws. It was reasonable for Congress to rely upon existing conscience and religious freedom laws to protect religious exercise and respect conscience in appropriate cases, rather than to import the Title IX religious exception

219

into Section 1557.

219

A religiously controlled covered entity that operates an education program or activity that is entitled to a religious exemption under Title IX would follow the Department's Title IX regulation at 45 CFR 86.12.

We seek comment on the approach proposed in this NPRM and particularly invite comments from covered entities controlled by or affiliated with religious organizations; providers employed by such entities; and people who receive health care from religiously affiliated medical providers and entities.

Relationship to Other Laws (§ 92.3)

Proposed § 92.3 explains the relationship of the proposed regulation to existing laws. Paragraph (a) provides that Section 1557 is not intended to apply lesser standards for the protection of individuals from discrimination than the standards under Title VI, Title IX, Section 504, the Age Act, or the regulations issued pursuant to those laws.

Consistent with the statute, paragraph (b)(1) states that nothing in this part shall be interpreted to invalidate or limit the existing rights, remedies, procedures, or legal standards available to individuals aggrieved under the Federal civil rights laws cited in 42 U.S.C. 18116(b) (Title VI, Title VII, Title IX, Section 504, and the Age Act).

We note here that Title II of the Americans with Disabilities Act

220

(ADA) prohibits discrimination on the basis of disability by public entities (

i.e.,

State and local governments and their agencies) and is modeled on Section 504.

221

Title II of the ADA and Section 504 are generally understood to impose substantially the same requirements, given that Congress enacted the ADA to extend Section 504's existing protections beyond Executive Agencies and recipients of Federal funds,

222

and the Congressional directive that the ADA be construed to grant at least as much protection as provided by Section 504 and the regulation implementing Section 504.

223

Following the passage of the ADA, the Rehabilitation Act Amendments of 1992 revised the Rehabilitation Act's findings, purpose, and policy provisions to incorporate language acknowledging the discriminatory barriers faced by individuals with disabilities, and to recognize that individuals with disabilities have the right to “enjoy full inclusion and integration in the economic, political, social, cultural and educational mainstream of American society.”

224

The Senate Report concerning the Rehabilitation Act Amendments of 1992 states that the purpose and policy statement is “a reaffirmation of the precepts of the Americans with Disabilities Act” and that these principles are intended to guide the Rehabilitation Act's policies, practices, and procedures.

225

220

Public Law 101-336, 104 Stat. 327 (1990) (codified as amended at 42 U.S.C. 12101,

et seq.

).

221

42 U.S.C. 12132 (“[N]o qualified individual with a disability shall, by reason of such disability, be excluded from participation in or be denied the benefits of services, programs, or activities of a public entity, or be subjected to discrimination by any such entity.”).

222

See Berardelli

v.

Allied Servs. Inst. of Rehab. Med.,

900 F.3d 104, 115 (3d Cir. 2018).

223

See, e.g.,

42 U.S.C. 12201(a).

224

29 U.S.C. 701(a)(3), as amended.

225

S. Rep. 102-357, at 14 (Aug. 3, 1992); H.R. Rep. 102-822, at 81 (Aug. 10, 1992).

Accordingly, a number of the changes that the Department is proposing for specific disability-related provisions in the Section 1557 regulation, which encompasses Section 504's ground for discrimination, conform to DOJ's implementing regulation for Title II of the ADA, many of which were updated in 2010. Where the Department has made changes to its Section 1557 regulation to correspond to provisions in DOJ's Title II regulation, the Department encourages individuals to look to the corresponding Title II guidance and section-by-section analysis for guidance on how to interpret these provisions.

226

226

See

28 CFR pt. 35, app. A, B, C.

The Department also notes that there may be overlap among different Federal civil rights statutes, and that certain Section 504 requirements and terminology may be specific to the programs and activities that are funded or conducted by the relevant Federal agency. For example, if a covered entity is a recipient of Federal financial assistance from the Department of Housing and Urban Development (HUD), HUD's Section 504 regulation, which contains distinct requirements and terminology related to housing, would also apply.

Proposed paragraph (b)(2) provides that nothing in Section 1557 shall be interpreted to invalidate or limit the existing rights, remedies, procedures, or legal standards available to individuals

asserting rights under Federal conscience or religious freedom laws. These would include statutory protections under RFRA and the Coats-Snowe Amendment,

227

the Church Amendments,

228

section 1303 of the ACA,

229

section 1553 of the ACA,

230

and the Weldon Amendment.

231

227

42 U.S.C. 238n.

228

Id.

300a-7.

229

Id.

18023(b)(2)(A).

230

Id.

18113.

231

Consolidated Appropriations Act, 2022, Public Law 117-103, div. H, title V General Provisions, § 507(d)(1) (Mar. 15, 2022).

Under the 2016 Rule, former § 92.2(b)(2) provided that if an application of Section 1557 requirements violated applicable Federal statutory protections for conscience and religious exercise, application of Section 1557 was not required.

232

The 2020 Rule, at § 92.6(b), provides that Section 1557 will not apply if such application would “violate, depart from, or contradict definitions, exemptions, affirmative rights, or protections” of the Coats-Snowe Amendment, Church Amendments, RFRA, Section 1553 of the ACA, Section 1303 of the ACA, Weldon Amendment, or “any related, successor, or similar Federal laws or regulations.”

233

The Department has considered the current regulatory language and has determined that the 2020 Rule also fails to provide sufficient information to covered entities and beneficiaries regarding how OCR will approach any apparent interaction between Section 1557 requirements and the enumerated protections. Further, the 2020 Rule preamble and Regulatory Impact Analysis (RIA) failed to consider potential harms to third parties that may result from granting a religious exemption in the health care context—a consideration that can be relevant to the RFRA analysis in a particular case.

234

The Department acknowledges and respects laws protecting conscience and religious exercise. The Department believes the approach in this proposed rule will ensure that all constitutional and statutory rights are protected and seeks comment on this approach. We further address exemptions under Federal conscience and religious freedom laws at proposed § 92.302.

232

81 FR 31375, 31381 (May 18, 2016).

233

45 CFR 92.6(b).

234

See, e.g., Whitman-Walker Clinic

v.

U.S. Dep't of Health & Human Servs.,

845 F. Supp. 3d 1, 45-46 (D.D.C. 2020).

Definitions (§ 92.4)

Proposed § 92.4 contains proposed definitions, which is the same approach taken in the 2016 Rule at former § 92.4. The 2020 Rule does not include a specific definition section, an approach that contributes to uncertainty. We reintroduce definitions to help reinstate clarity. For ease of organization, definitions are discussed below by topic area, and definitions of particular note are set out in additional detail.

We propose to define a range of terms related to disability discrimination, including: auxiliary aids and services; disability; qualified individual with a disability; qualified interpreter for an individual with a disability; and qualified reader. These definitions appeared in the 2016 Rule and have not been changed substantively, with the exception of the addition of the term “qualified reader,” which incorporates the definition of “qualified reader” from the ADA Title II regulation

235

to provide clarity to both covered entities and protected individuals about the necessary qualifications of a reader when required under this regulation. Any other differences between the definitions proposed herein and the 2016 Rule were made to update appropriate citations.

235

28 CFR 35.104.

We also propose to define a range of terms related to language access, including limited English proficient individual; language assistance services; qualified bilingual/multilingual staff; qualified interpreter for a limited English proficient individual; and qualified translator. These definitions appeared in the 2016 Rule and have not been changed substantively. Terminology has been revised to read “limited English proficient individual,” rather than “individual with limited English proficiency,” as “limited English proficient individual” reflects widely used terminology. The Department also proposes to provide more detail in the definition of “limited English proficient individual” to explain that a limited English proficient individual may be competent in English for certain types of communication (

e.g.,

speaking or understanding), but still be LEP for other purposes (

e.g.,

reading or writing). This language will assist covered entities in understanding that a person who has proficiency in English in one context (

e.g.,

speaking) may still require assistance in another context (

e.g.,

receiving translated documents). The Department welcomes comment on this change in terminology.

We also propose to define terms related to covered entities and other entities addressed in the rule, including applicant; companion; covered entity; Department; Director; Exchange; Federally-facilitated Exchange; OCR; recipient; State Exchange; and Title I Entity. These definitions were included in the 2016 Rule and have not been changed substantively, though we have replaced the term “Marketplace” with “Exchange” to reflect the terminology used in Departmental regulations defining the term.

236

The terms “age” and “national origin” are also defined, with the same definitions as provided in the 2016 Rule.

236

45 CFR 155.20 (defining “Exchange” and “Federally-facilitated Exchange”); § 155.100 (providing for establishment of an Exchange by a State).

Particular definitions of note are included below.

Federal financial assistance.

We propose to include the definition of Federal financial assistance found in former § 92.4 of the 2016 Rule, with slight modifications. The 2020 Rule does not include a definition of this term.

We propose the definition of “Federal financial assistance” to include grants, loans, and other types of assistance from the Federal Government, in accordance with the definition of the term in the Section 504 and the Age Act implementing regulations at 45 CFR 84.3(h) and 91.4, respectively. We also propose to specifically include credits, subsidies, and contracts of insurance, in accordance with the statutory language of Section 1557. Examples of HHS programs that provide Federal financial assistance subject to this part include but are not limited to Medicaid and CHIP, Medicare Part A, Medicare Part B (as proposed in this rule), Medicare Part C (Medicare Advantage), Medicare Part D (drug coverage), and HHS grant programs.

As discussed previously, similar to the 2016 and 2020 Rules, this proposed rule applies only to Federal financial assistance from HHS and does not apply to health programs or activities receiving Federal financial assistance from other Federal agencies.

237

While the Section 1557 statute applies to all Executive Agencies, the Department continues to believe that it is appropriate to limit this proposed rule to health programs or activities that receive Federal funding from the Department, which is within the Department's area of expertise. We encourage other Federal agencies to use this proposed rule as a template for developing their own Section 1557 regulations and policies applicable to their federally assisted health programs or activities.

237

81 FR 31375, 31379 (May 18, 2016); 85 FR 37160, 37170 (June 19, 2020).

We propose to include a clause to clarify the Federal financial assistance

includes Federal financial assistance that the Department plays a role in providing or administering. This includes advance payments of the premium tax credit and cost-sharing reduction payments under Title I of the ACA, as well as payments, subsidies, or other funds extended by the Department. This is similar to, but differs slightly from, the 2016 Rule by clarifying that the Federal financial assistance that the Department plays a role in providing or administering includes the “advance payments of the premium tax credit and cost-sharing reduction payments,” which are the relevant credit and subsidy payments under Title I of the ACA that the Department plays a role in providing or administering. The language in this provision was informed by the definition of “Federal financial assistance” in the regulation implementing Title IX at 45 CFR 86.2(g). That Title IX regulatory provision clarifies that Federal financial assistance includes wages, loans, grants, scholarships, and other monies that are given to any entity for payment to or on behalf of students who are admitted to that entity or that are given directly to these students for payment to that entity.

238

238

45 CFR 86.2(g)(1)(ii).

In the health care context, Federal funds are provided on behalf of eligible individuals for advance payments of the premium tax credit and cost-sharing reductions (also referred to as cost-sharing subsidies) to ensure the affordability of health insurance coverage purchased through the Health Insurance Exchanges. As in the 2016 Rule, we have added language to this propo

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Nondiscrimination in Health Programs and Activities · 87 FR 47824 | Frix