Nondiscrimination in Health Programs and Activities, 54171-54221 [2015-22043]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary

[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Proposed Rules]
[Pages 54171-54221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22043]



[[Page 54171]]

Vol. 80

Tuesday,

No. 173

September 8, 2015

Part V





Department of Health and Human Services





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45 CFR Part 92





Nondiscrimination in Health Programs and Activities; Proposed Rule

Federal Register / Vol. 80 , No. 173 / Tuesday, September 8, 2015 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 92

RIN 0945-AA02


Nondiscrimination in Health Programs and Activities

AGENCY: Office for Civil Rights (OCR), Office of the Secretary, HHS.

ACTION: Notice of proposed rulemaking.

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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. In addition, the Secretary is authorized to prescribe 
regulations for the Department's governance, conduct, and performance 
of its business, including, here, how HHS will apply the standards of 
Section 1557 to HHS-administered health programs and activities.

DATES: Submit comments on or before November 9, 2015.

ADDRESSES: You may submit comments, identified by RIN Number 0945-AA02, 
by any of the following methods:
     Federal eRulemaking Portal: You may submit electronic 
comments at https://www.regulations.gov. Follow the instructions for 
submitting electronic comments. Attachments should be in Microsoft Word 
or Excel; however, we prefer Microsoft Word.
     Regular, Express, or Overnight Mail: You may mail written 
comments (one original and two copies) to the following address only: 
U.S. Department of Health and Human Services, Office for Civil Rights, 
Attention: 1557 NPRM (RIN 0945-AA02), Hubert H. Humphrey Building, Room 
509F, 200 Independence Avenue SW., Washington, DC 20201. Mailed 
comments may be subject to delivery delays due to security procedures. 
Please allow sufficient time for mailed comments to be timely received 
in the event of delivery delays.
     Hand Delivery or Courier: If you prefer, you may deliver 
(by hand or courier) your written comments (one original and two 
copies) to the following address only: Office for Civil Rights, 
Attention: 1557 NPRM (RIN 0945-AA02), Hubert H. Humphrey Building, Room 
509F, 200 Independence Avenue SW., Washington, DC 20201. (Because 
access to the interior of the Hubert H. Humphrey Building is not 
readily available to persons without Federal government identification, 
commenters are encouraged to leave their comments in the mail drop 
slots located in the main lobby of the building.)
     Inspection of Public Comments: All comments received 
before the close of the comment period will be available for public 
inspection, including any personally identifiable or confidential 
business information that is included in a comment. We will post all 
comments received before the close of the comment period at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Claudia Adams, at (800) 368-1019 or 
(800) 537-7697 (TDD).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1557 of the ACA provides that an individual shall not, on 
the grounds prohibited under Title VI of the Civil Rights Act of 1964 
(Title VI), 42 U.S.C. 2000d et seq. (race, color, national origin), 
Title IX of the Education Amendments of 1972 (Title IX), 20 U.S.C. 1681 
et seq. (sex), the Age Discrimination Act of 1975 (Age Act), 42 U.S.C. 
6101 et seq. (age), or Section 504 of the Rehabilitation Act of 1973 
(Section 504), 29 U.S.C. 794 (disability), 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, or under any program or 
activity that is administered by an Executive Agency or any entity 
established under Title I of the Act or its amendments. Section 1557 
states that the enforcement mechanisms provided for and available under 
Title VI, Title IX, Section 504, or the Age Act shall apply for 
purposes of addressing violations of Section 1557. The Department is 
responsible for developing regulations to implement Section 1557.
    On August 1, 2013, the Office for Civil Rights of the Department 
(OCR) published a Request for Information (RFI) in the Federal Register 
to obtain information that would assist OCR in drafting the proposed 
regulation.\1\ The RFI solicited information on issues arising under 
Section 1557. OCR received 402 comments. Of the total comments, one-
quarter (99) were from organizational commenters, with the remainder 
from individuals. Of the organizational comments, one-third (33) were 
from civil rights/advocacy groups with over half of these (17) coming 
from organizations serving lesbian, gay, bisexual, or transgender 
(LGBT) individuals. Six comments were received from health care 
providers (including two local government health agencies) and two were 
from health insurance providers or provider organizations. Of the 
comments from individuals, 239 were personal testimonies from 
transgender individuals describing their experiences of discrimination 
in the health care setting.
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    \1\ 78 FR 46558 (Aug. 1, 2013).
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    OCR has carefully reviewed all comments received, and has 
referenced them where appropriate and relevant in this preamble. The 
proposed rule both clarifies and codifies existing nondiscrimination 
requirements, and also sets forth new standards to implement Section 
1557, particularly with respect to the prohibition of discrimination on 
the basis of sex in health programs other than those provided by 
educational institutions and the prohibition of various forms of 
discrimination in health programs administered by the Department and 
entities established under Title I of the ACA. The Department invites 
comment on this proposed rule by all interested parties, including 
comment from Tribes on application of the rule to them.

Subpart A--General Provisions

Purpose and Effective Date (Sec.  92.1)
    Proposed Sec.  92.1 states that the purpose of this part is to 
implement Section 1557 of the ACA, which prohibits discrimination in 
certain health programs and activities on the grounds prohibited under 
Title VI, Title IX, the Age Act, and Section 504, which together 
prohibit discrimination on the basis of race, color, national origin, 
sex, age, or disability.
    Section 92.1 also establishes that the effective date of the 
Section 1557 implementing regulation shall be 60 days after the 
publication of the final rule in the Federal Register.
Application (Sec.  92.2)
    Section 1557 applies to all health programs and activities, any 
part of which receives Federal financial assistance from any Federal 
agency. In addition, Section 1557 applies to all programs and 
activities that are administered by an Executive Agency or any entity 
established under Title I of the ACA.

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    OCR proposes in Sec.  92.2(a) to apply the rule, except as 
otherwise provided in this part, to: (1) All health programs and 
activities, any part of which receives Federal financial assistance 
administered by HHS;\2\ (2) health programs and activities administered 
by the Department, including the Federally-facilitated Marketplaces; 
and (3) health programs and activities administered by entities 
established under Title I of the ACA, including the State-based 
Marketplaces.
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    \2\ Section 1557 applies to all health programs and activities, 
any part of which receives Federal financial assistance from any 
Federal Department. However, this proposed rule would apply only to 
health programs and activities any part of which receives Federal 
financial assistance from HHS. This narrowed application is 
consistent with HHS' enforcement authority over such health programs 
and activities, but other Federal agencies are encouraged to adopt 
the standards set forth in this proposed rule in their own 
enforcement of Section 1557.
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    Section 92.2(b) provides limitations to the application of the 
proposed rule. In this section, addressing limitations in the statutes 
referenced in Section 1557, and in Subpart B, which incorporates 
exceptions in the regulations implementing the statutes referenced in 
Section 1557, we have adopted the existing limitations and exceptions 
that already govern the health programs and activities subject to 
Section 1557. These limitations and exceptions are found in the Age Act 
and in the regulations implementing the Age Act, Section 504, and Title 
VI, which apply to all programs and activities that receive Federal 
financial assistance.
    Thus, Sec.  92.2(b)(1) incorporates the exclusions found in the Age 
Act, such that the provisions of this proposed rule do not apply to any 
age distinction contained in that part of a Federal, State, or local 
statute or ordinance adopted by an elected, general purpose legislative 
body which provides any benefits or assistance to persons based on age, 
establishes criteria for participation in age-related terms, or 
describes intended beneficiaries to target groups in age-related 
terms.\3\
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    \3\ See 42 U.S.C. 6103(b).
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    By contrast, we are requesting comment on whether the exemptions 
found in Title IX and its implementing regulation should be 
incorporated into this proposed rule. Unlike the Age Act, Section 504, 
and Title VI, which apply to all programs and activities that receive 
Federal financial assistance, Title IX applies only in the context of 
education programs and not to the health programs and activities 
subject to this proposed rule. In addition, many of Title IX's 
limitations and exceptions do not readily apply in a context that is 
grounded in health care, rather than education. For example, Title IX 
exempts from its prohibitions on sex discrimination certain 
institutions of undergraduate higher education, military and merchant 
marine educational institutions, and membership practices of social 
fraternities and sororities and voluntary youth service organizations.
    In the RFI, OCR specifically inquired as to what exceptions, if 
any, should apply in the context of sex discrimination in health 
programs and activities. Nearly all commenters who provided a response 
to this inquiry indicated that Section 1557 includes only one 
exception--that the statute applies except as otherwise provided in 
Title I of the ACA. To this end, commenters argued that nothing in the 
language or legislative history of Section 1557 allows for any other 
limitations or exceptions regarding its application, highlighting that 
exceptions to general rules like Section 1557's antidiscrimination 
provision must be read strictly and narrowly.
    We continue to seek comment on whether the regulation should 
include any specific exemptions for health providers, health plans, or 
other covered entities with respect to requirements of the proposed 
rule related to sex discrimination, including the particular 
requirements that are discussed in this proposed rule.\4\ For example, 
HHS wants to ensure that the rule has the proper scope and 
appropriately protects sincerely held religious beliefs to the extent 
that those beliefs conflict with provisions of the regulation. We note 
that certain protections already exist with respect to religious 
beliefs, particularly with respect to the provision of certain health-
related services; for example, this proposed rule would not displace 
the protections afforded by provider conscience laws,\5\ the Religious 
Freedom Restoration Act,\6\ provisions in the ACA related to abortion 
services,\7\ or regulations issued under the ACA related to preventive 
health services.\8\ We seek comment on the extent to which these 
existing protections would provide sufficient safeguards for religious 
concerns in the context of the proposed rule.
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    \4\ We are also seeking comment elsewhere in this Preamble on a 
number of possible exceptions to the proposed rule, including with 
regard to what sex-based distinctions, if any, should be permitted 
in the context of health programs and activities and the standards 
for permitting those distinctions. See Preamble discussion of Sec.  
92.101(c).
    \5\ See, e.g., 42 U.S.C. 300a-7; 42 U.S.C. 238n; Consolidated 
and Continuing Appropriations Act 2015, Pub. L. 113-235, 507(d) 
(Dec. 16, 2014).
    \6\ 42 U.S.C. 2000bb-1.
    \7\ See, e.g., 42 U.S.C. 18023.
    \8\ See 45 CFR 147.131.
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    At the same time, a fundamental purpose of the ACA is to ensure 
that vital health care services are broadly and nondiscriminatorily 
available to individuals throughout the country. As a result, we seek 
comment on any health care consequences that would ensue were the 
regulation to provide additional exemptions.
    Finally, we seek comment on the scope of additional exemptions, if 
any, that should be included and the processes for claiming them, 
including whether those processes should track those used under Title 
IX, at 45 CFR 86.12.
Relationship to Other Laws (Sec.  92.3)
    Proposed Sec.  92.3 explains the relationship of this part 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) 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 other Federal civil rights laws or to supersede State 
or local laws that provide greater or equal protection against 
discrimination on the basis of race, color, national origin, sex, age, 
or disability. This intent is derived from Section 1557(b) of the ACA. 
In addition to the statutory references cited directly in Section 
1557(b), the proposed rule includes the Architectural Barriers Act of 
1968, 42 U.S.C. 4151-4157 (2012), the Americans with Disabilities Act 
of 1990, 42 U.S.C. 12101 et seq. (codified as amended by the Americans 
with Disabilities Amendments Act of 2008, Pub. L. 110-325, 122 Stat. 
3553 (2008)) (ADA), and Section 508 of the Rehabilitation Act of 1973, 
29 U.S.C. 794d (Section 508). These laws establish additional Federal 
civil rights protections for individuals with disabilities, and covered 
entities must be mindful that the obligations imposed by those laws 
apply to them independent of the application of Section 1557.
Definitions (Sec.  92.4)
    Section 92.4 contains proposed definitions. Definitions of 
particular note are set out below.
    Auxiliary aids and services. The definition of ``auxiliary aids and 
services'' is the same as the definition of this term in the 
regulations

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implementing the ADA, at 28 CFR 35.104, 36.303(b).
    Covered entity. The term ``covered entity'' means: (1) An entity 
that operates a health program or activity, any part of which receives 
Federal financial assistance; \9\ (2) an entity established under Title 
I of the ACA that administers a health program or activity; and (3) the 
Department.
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    \9\ As noted supra at n.2, this proposed rule would apply to 
recipients of Federal financial assistance from HHS only. The term 
``covered entity'' is nonetheless defined broadly so that other 
Federal Departments can readily apply the standards of this rule to 
their own enforcement of Section 1557.
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    With regard to the Health Insurance Marketplaces, covered entities 
include, for example, Navigators that receive Federal financial 
assistance as defined in this rule. Navigators are entities that carry 
out the duties identified in the ACA and its implementing regulations, 
such as informing the public about the health coverage options 
available through the Health Insurance Marketplaces and facilitating 
enrollment in health coverage programs.\10\ State-based Marketplaces 
are covered as Title I entities. The Federally-facilitated Marketplaces 
are covered both as Title I entities and as health programs or 
activities of the Department.
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    \10\ See, e.g., 42 U.S.C. 18031(i) (authorizing the Navigator 
program); 45 CFR 155.210 (c), (e) (identifying eligibility 
requirements for, and responsibilities of, receiving a Navigator 
grant).
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    Director. Director means the Director of the Office for Civil 
Rights in the Department.
    Disability. The definition of ``disability'' is the same as the 
definition of this term in the Rehabilitation Act, at 29 U.S.C. 
705(9)(B), which incorporates the definition of disability in the ADA, 
as construed by the ADA Amendments Act of 2008 (Pub .L. 110-325; 42 
U.S.C. 12102), as amended. This part uses the term ``disability'' in 
place of the term ``handicap'' used in some previous civil rights 
statutes and regulations. Throughout this part, where we cross-
reference other regulatory provisions, regulatory language that uses 
the term ``handicap'' shall mean ``disability.'' This change in 
terminology does not reflect a change in the substance of the 
definition.
    Electronic and information technology. The definition of 
``electronic and information technology'' is consistent with 36 CFR 
1194.4, the regulation implementing Section 508.
    Employee health benefit program. The term ``employee health benefit 
program'' means (1) health benefits coverage or health insurance 
provided to employees and/or their dependents established, operated, 
sponsored or administered by, for, or on behalf of one or more 
employers, whether provided or administered by entities including but 
not limited to, a health insurance issuer, group health plan (as 
defined in the Employee Retirement Income Security Act of 1974 (ERISA, 
at 29 U.S.C. 1191(a)), a third party administrator, or an employer; (2) 
an employer-provided or -sponsored wellness program; (3) an employer-
provided health clinic; or (4) long term care coverage or insurance 
provided or administered by an employer, group health plan, third party 
administrator, or health insurance issuer.
    Federal financial assistance. The term ``Federal financial 
assistance'' includes the standard definition of grants, loans, and 
other types of assistance in accordance with the definition of 
``Federal financial assistance'' in the regulations implementing 
Section 504 and the Age Act at 45 CFR 84.3(h) and 91.4, respectively, 
and also specifically includes subsidies and contracts of insurance, in 
accordance with the statutory language of Section 1557.
    However, consistent with OCR's enforcement of other civil rights 
authorities, the definition of Federal financial assistance does not 
include Medicare Part B.
    An additional clause is added to the proposed regulatory provision, 
modeled on 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.\11\ This provision was included in the 
Title IX regulation to make clear that both funds paid to the 
educational entity on behalf of a student, and funds paid to the 
student and then remitted to the educational entity, are Federal 
financial assistance. In the health care context, Federal funds are 
provided to or on behalf of eligible individuals for premium tax 
credits and advance payments of premium tax credits and cost sharing 
reductions to ensure the affordability of health insurance coverage 
purchased through the Health Insurance Marketplaces. To clarify that 
these funds are Federal financial assistance, we have added language to 
this proposed definition stating that such funds are Federal financial 
assistance when extended to the entity providing the health insurance 
coverage or services, whether they are paid directly by the Federal 
government to that entity or to the individual for remittance to the 
entity providing health insurance coverage or services. Thus, an issuer 
participating in any Health Insurance Marketplace is receiving Federal 
financial assistance when advance payments of premium tax credits and/
or cost sharing reductions are provided to any of the issuer's 
enrollees. A health services provider that contracts with such an 
issuer does not become a recipient of Federal financial assistance by 
virtue of the contract, but would be a recipient if the provider 
otherwise receives Federal financial assistance.
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    \11\ See 45 CFR 86.2(g)(1)(ii).
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    Federally-facilitated Marketplace. The term Federally-facilitated 
Marketplace has the same meaning as ``Federally-facilitated Exchange'' 
defined in 45 CFR 155.20.
    Gender identity. The term ``gender identity'' means an individual's 
internal sense of gender, which may be different from an individual's 
sex assigned at birth. The way an individual expresses gender identity 
is frequently called ``gender expression,'' and may or may not conform 
to social stereotypes associated with a particular gender. Gender may 
be expressed through, for example, dress, grooming, mannerisms, speech 
patterns, and social interactions. For purposes of this part, an 
individual has a transgender identity when the individual's gender 
identity is different from the sex assigned to that person at birth; an 
individual with a transgender identity is referred to in this part as a 
transgender individual. The approach taken in this definition is 
consistent with the approach taken by the Federal government in similar 
matters.\12\
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    \12\ See, e.g., Memorandum from Office of Personnel Management, 
``Guidance Regarding the Employment of Transgender Individuals in 
the Federal Workplace'' (May 27, 2011); Resource Guide from Office 
of Personnel Management, the Equal Employment Opportunity 
Commission, the Office of Special Counsel, and the Merit Systems 
Protection Board, ``Addressing Sexual Orientation and Gender 
Identity Discrimination in Federal Civilian Employment'' (June 
2015).
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    Health Insurance Marketplace. The term ``Health Insurance 
Marketplace'' \13\ means the same as ``Exchange'' defined in 45 CFR 
155.20.
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    \13\ Health Insurance Marketplaces are also known as 
``Marketplaces.''
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    Health program or activity. The term ``health program or activity'' 
is defined to include the provision or administration of health-related 
services or health-related insurance coverage and the provision of 
assistance in obtaining health-related services or health-related 
insurance coverage. Similar to the

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approach of the Civil Rights Restoration Act \14\ and except as 
specifically set forth otherwise in this part,\15\ the term further 
includes all of the operations of an entity principally engaged in 
providing or administering health services or health insurance 
coverage, such as a hospital, health clinic, community health center, 
group health plan, health insurance issuer, physician's practice, 
nursing facility, or residential or community-based treatment 
facility.\16\ OCR intends to interpret ``principally engaged'' in a 
manner consistent with civil rights laws that use this term.
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    \14\ 102 Stat. 28, Pub. Law 100-259 (1988).
    \15\ Employee health benefits programs are discussed elsewhere 
in this proposed rule. See infra discussion of proposed Sec.  
92.208.
    \16\ A health program or activity also includes all of the 
operations of a State Medicaid program. Where a State Medicaid 
program resides in an agency that is principally engaged in 
providing health services or health insurance coverage, or is 
primarily engaged in providing assistance in obtaining health 
services or health coverage, all of the operations of the agency 
will be a health program or activity. Where a State Medicaid program 
is operated by a State agency that operates many other programs that 
provide services other than health-related services, health related 
insurance coverage, or assistance in obtaining health-related 
services or health-related coverage, the agency as a whole may not 
be principally engaged in providing health services, health 
insurance coverage, or assistance in obtaining health services or 
health coverage; in such cases, only the agency's Medicaid program 
and other health-related programs will meet the definition of health 
program and activity. The same is true for local Medicaid agencies.
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    OCR intends the plural ``health programs or activities'' used in 
this proposed part to have the same meaning as the term ``health 
program or activity'' in the singular. Similarly, this proposed part's 
use of ``health programs and activities,'' a variation of ``health 
program or activity,'' does not reflect a change in the substance of 
the definition of ``health program or activity.''
    Commenters responding to the request in the RFI for examples of 
programs and activities that should be considered ``health programs or 
activities'' generally supported a broad interpretation of the term. We 
propose to interpret ``health programs and activities'' to include 
programs such as health education and health research programs. 
However, OCR recognizes that health research is conducted to answer 
scientific questions and advance health through the advancement of 
knowledge; it is not designed to result in direct health benefits to 
participants, though individuals may in fact receive health benefits 
from participation. In addition, and consistent with basic 
nondiscrimination principles applied in other contexts, OCR notes that 
individuals have a right to nondiscriminatory consideration for 
inclusion in a research project but are not entitled to be selected to 
participate.
    Because Federal civil rights laws already prohibit discrimination 
on the basis of race, color, national origin, disability, or age in all 
health research programs and activities that receive Federal financial 
assistance and prohibit discrimination on the basis of sex in all 
health research programs conducted by colleges and universities, 
application of Section 1557 to health research should impose limited 
additional burden on covered entities. But including health research 
under Section 1557 would extend the prohibition against discrimination 
on the basis of sex to Federally assisted health research programs and 
activities in non-educational institutions, complementing existing 
initiatives to increase diversity and inclusion in health research. 
Moreover, applying the requirements of Section 1557 to Department-
conducted health programs and activities, including health research, 
would hold HHS components to the same standards as recipients of 
Federal financial assistance, prohibiting discrimination on all bases 
covered by Section 1557.
    OCR also recognizes that research projects are often limited in 
scope for many reasons, such as the principal investigator's scientific 
interest, funding limitations, recruitment requirements, and other 
nondiscriminatory considerations. Thus, criteria in research protocols 
that target or exclude certain populations are warranted where 
nondiscriminatory justifications establish that such criteria are 
appropriate with respect to the health or safety of the subjects, the 
scientific study design, or the purpose of the research. OCR does not 
intend for inclusion of health research within the definition of health 
program or activity to alter the fundamental manner in which research 
projects are designed, conducted, or funded; nor is OCR proposing to 
systematically review health research protocols. For example, a medical 
research institution that is a covered entity may exclude individuals 
who are a deaf from a clinical trial to investigate a new brain imaging 
technology for assessing cognitive functioning that relies on auditory 
stimulation as the test stimulus. This research design would not be 
discriminatory on the basis of disability because there is a 
nondiscriminatory justification for excluding individuals who are deaf.
    OCR continues to seek comment on programs and activities that 
should be considered health programs or activities.
    Individual with a disability. The proposed definition of 
``individual with a disability'' is the same as the definition of this 
term used for the purpose of Section 504 of the Rehabilitation Act, 
found at 29 U.S.C. 705(20)(B)-(F), as amended. The Rehabilitation Act, 
at 29 U.S.C. 705(20)(B)-(F), incorporates the definition of 
``individual with a disability'' from the ADA. This part uses the 
person-first term ``individual with a disability'' in place of the 
outdated terms ``handicapped person'' and ``individual with handicaps'' 
which are found in earlier civil rights laws and regulations. 
Throughout this part, where we cross-reference Section 504, regulatory 
language that uses ``handicapped person'' and ``individual with 
handicaps'' shall mean ``individual with a disability.'' This change in 
terminology does not reflect a change in the substance of the 
definition.
    Individual with limited English proficiency. The term ``individual 
with limited English proficiency'' codifies the Department's long-
standing definition reflected in guidance interpreting Title VI's 
prohibition of national origin discrimination, entitled Guidance to 
Federal Financial Assistance Recipients Regarding Title VI Prohibition 
Against National Origin Discrimination Affecting Limited English 
Proficient Persons \17\ (HHS LEP Guidance). Under this definition, an 
individual whose primary language for communication is not English is 
an individual with limited English proficiency under this part as long 
as the individual has a limited ability to communicate in one of the 
following ways: Reading, speaking, writing, or understanding. 
Consequently, an individual whose primary language for communication is 
not English and who has some ability to speak English is an individual 
with limited English proficiency under this part if the individual has 
a limited ability to read, write, or understand English.
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    \17\ Guidance to Federal Financial Assistance Recipients 
Regarding Title VI Prohibition Against National Origin 
Discrimination Affecting Limited English Proficient Persons, 68 FR 
47311, 47313 (Aug. 8, 2003) (hereinafter HHS LEP Guidance).
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    Language assistance services. The term ``language assistance 
services'' identifies types of well-established methods or services 
used to communicate with individuals with limited English proficiency, 
including oral language assistance, written translation, and taglines. 
A covered entity has flexibility to provide language assistance 
services in-house or through commercially available options. To 
maximize covered entities' flexibilities

[[Page 54176]]

and to account for the likelihood of future innovations, we decline to 
offer an exhaustive list of available methods. However, given the range 
of methods available specifically for oral language assistance, 
proposed paragraph (1) identifies the following as available methods to 
communicate orally with individuals with limited English proficiency: 
Oral interpretation (in-person or remotely) \18\ and direct 
communication through the use of bilingual and multilingual staff 
competent to communicate directly, in non-English languages using any 
necessary specialized vocabulary, with individuals with limited English 
proficiency.
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    \18\ We use the terms ``oral interpretation'' and ``written 
translation'' for clarity but we note that the term 
``interpretation'' used without the preceding descriptor of ``oral'' 
refers to the communication of information orally and the term 
``translation'' used without the preceding descriptor of ``written'' 
refers to the communication of information in writing. See, e.g., 
U.S Dep't of Justice, Commonly Asked Questions and Answers Regarding 
Limited English Proficient (LEP) Individuals and Translators, 
available at https://www.lep.gov/faqs/042511_Q&A_EO_13166.pdf 
(differentiating between interpreters and translators in FAQ 11); 
Interpreters and Translators, U.S. Department of Labor, Bureau of 
Labor Statistics, Occupational Outlook Handbook, 2014-15, available 
at https://www.bls.gov/ooh/media-and-communication/interpreters-and-translators.htm (explaining that interpreters convert information in 
a spoken language and translators convert information in written 
language).
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    On the basis of sex. The term ``on the basis of sex'' is defined to 
include, but is not limited to, discrimination on the basis of 
pregnancy, false pregnancy, termination of pregnancy, or recovery 
therefrom, childbirth or related medical conditions, sex stereotyping, 
or gender identity.
    Section 1557 extends the grounds for discrimination found in 
nondiscrimination laws (i.e., race, color, national origin, sex, age, 
or disability) to certain health programs and activities. The HHS Title 
IX regulation explicitly includes discrimination on the basis of 
pregnancy as a form of discrimination on the basis of sex, and the 
definition in this section mirrors that regulation. See 45 CFR 86.40(b) 
(prohibiting discrimination on the basis of ``pregnancy, childbirth, 
false pregnancy, termination of pregnancy or recovery therefrom'').
    The proposed inclusion of sex stereotyping reflects the Supreme 
Court's holding in Price Waterhouse v. Hopkins, 490 U.S. 228, 250-51 
(1989), that discrimination based on stereotypical notions of 
appropriate behavior, appearance or mannerisms for each gender 
constitutes sex discrimination.
    We propose that discrimination on the basis of sex further includes 
discrimination on the basis of gender identity. OCR has previously 
interpreted sex discrimination to include discrimination on the basis 
of gender identity.\19\ Other Federal agencies have similarly 
interpreted the meaning of sex discrimination.\20\ In addition, courts, 
including in the context of Section 1557, have recognized that sex 
discrimination includes discrimination based on gender identity.\21\ We 
thus propose to formally adopt this well-accepted interpretation of 
discrimination ``on the basis of sex.''
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    \19\ See Letter from Leon Rodriguez, Director, U.S. Department 
of Health & Human Services, Office for Civil Rights, to Maya Rupert, 
Federal Policy Director, National Center for Lesbian Rights (Jul. 
12, 2012).
    \20\ See regulations issued by the Office of Personnel 
Management, clarifying that the discrimination on the basis of sex 
includes discrimination on the basis of gender identity, 79 FR 43919 
(Jul. 29, 2014); Directive 2014-02, U.S. Department Of Labor, Office 
of Federal Contract Compliance Programs (Aug. 19, 2014), available 
at https://www.dol.gov/ofccp/regs/compliance/directives/dir2014_02.html; Statement of Interest of the United States, Jamal 
v. SAKS & Co., No. 4:14-CV-2782 (S.D. Tex. 2015); Statement of 
Interest of the United States, Tooley v. Van Buren Public Schools, 
No. 2:14-cv-13466-AC-DRG (E.D. Mich.) (Feb. 24, 2015), Mediated 
Settlement Order, United States v. Toone, No. 6:13-CV-744 (E.D. Tex. 
2014); Memo from Eric Holder, Att'y Gen., to U.S. Att'ys & Heads of 
Dep't Components (Dec. 15, 2014); U.S. Dep't of Educ., Questions and 
Answers on Title IX and Sexual Violence at B-2 (https://www2.ed.gov/about/offices/list/ocr/docs/qa-201404-title-ix.pdf) Resolution 
Agreement Between Arcadia Unified Sch. Dist., U.S. Dep't of Educ., 
Office for Civil Rights, & the U.S. Dep't of Justice, Civil Rights 
Div., OCR Case No. 09-12-1020, DOJ Case No. 169-12C-70, at 1 (Jul. 
24, 2013); Macy v. Holder, EEOC Appeal No. 0120120821, Agency No. 
ATF-2011-00751 (Apr. 20, 2012) 2012 WL 1435995, at *11.
    \21\ See, e.g., Rumble v. Fairview Heath Services, 2015 WL 
1197415 (D. Minn. 2015) (order denying motion to dismiss); Barnes v. 
City of Cincinnati, 401 F.3d 729 (6th Cir.), cert. denied, 546 U.S. 
1003 (2005); Smith v. City of Salem, Ohio, 378 F.3d 566 (6th Cir. 
2004); Schroer v. Billington, 577 F. Supp.2d 293 (D.D.C. 2008). But 
see Johnston v. University of Pittsburgh, Civ. Action No. 3:13-213 
(W.D.Pa. Mar. 31, 2015) (interpreting Title IX, among other 
authorities).
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    As a matter of policy, we support banning discrimination in health 
programs and activities not only on the bases identified previously, 
but also on the basis of sexual orientation. Current law is mixed on 
whether existing Federal nondiscrimination laws prohibit discrimination 
on the basis of sexual orientation as a part of their prohibitions of 
sex discrimination. To date, no Federal appellate court has concluded 
that Title IX's prohibition of discrimination ``on the basis of sex''--
or Federal laws prohibiting sex discrimination more generally--
prohibits sexual orientation discrimination, and some appellate courts 
previously reached the opposite conclusion.\22\
---------------------------------------------------------------------------

    \22\ See, e.g,, Kiley v. Am. Soc'y for Prevention of Cruelty to 
Animals, 296 Fed. App'x 107, 109 (2d Cir. 2008); Vickers v. 
Fairfield Med. Ctr., 453 F.3d 757, 759 (6th Cir. 2006); Bibby v. 
Philadelphia Coca Cola Bottling Co., 260 F.3d 257, 260 (3d Cir. 
2001); but cf. Latta v. Otter, 771 F.3d 456 (9th Cir. 2014) (Berzon, 
J., concurring) (in striking down State law prohibition on same sex 
marriage, observing that ``the same sex marriage laws treat the 
subgroup of men who wish to marry men less favorably than the 
otherwise similarly situated subgroup of women who want to marry 
men'' and therefore constitute sex discrimination); see also 
Muhammad v. Caterpillar, 767 F.3d 694 (7th Cir. 2014), 2014 WL 
4418649 (7th Cir. Sept. 9, 2014, as Amended on Denial of Rehearing, 
Oct. 16, 2014) (removing statements from previously issued panel 
decision that relied on outdated precedents about coverage of sexual 
orientation discrimination under Title VII as requested in EEOC 
Amicus Brief).
---------------------------------------------------------------------------

    However, a recent EEOC decision concluded that Title VII's 
prohibition of discrimination ``on the basis of sex'' precludes sexual 
orientation discrimination because discrimination on the basis of 
sexual orientation necessarily involves sex-based considerations. The 
EEOC relied on several theories to reach this conclusion: A plain 
interpretation of the term ``sex'' in the statutory language, an 
associational theory of discrimination based on ``sex,'' and the 
gender-stereotype theory announced in Price Waterhouse.\23\ The EEOC's 
decision cited several district court decisions that similarly 
concluded that sex discrimination included sexual orientation 
discrimination, using these theories.\24\ The EEOC also analyzed and 
called into question the appellate decisions that have concluded that 
sexual orientation discrimination is not covered under Title VII. The 
EEOC decision applies to workplace conditions, as well as hiring, 
firing, and promotion decisions, and is one of several recent 
developments in the law that have resulted in additional protections 
for lesbian and gay individuals against discrimination.\25\
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    \23\ Baldwin v. Foxx, EEOC Appeal No. 0120133080, Agency No. 
2012-24738-FAA-03, at 5-6 (July 15, 2015) (finding that sexual 
orientation is inseparable from and inescapably linked to sex and 
thus that an allegation of discrimination based on sexual 
orientation is necessarily an allegation of sex discrimination).
    \24\ See e.g. Centola v. Potter, 183 F. Supp. 2d 403, 410 (D. 
Mass. 2002); Heller v. Columbia Edgewater Country Club, 195 F. Supp. 
2d at 1212 (D. Or. 2002); Koren v. Ohio Bell, 894 F. Supp. 2d 1032, 
1038 (N.D. Ohio 2012); Terveer v. Billington, 34 F. Supp. 3d 100, 
116, 2014 WL 1280301 (D.D.C. 2014); Boutillier v. Hartford Public 
Schools, 2014 WL 4794527 (D. Conn. 2014); Deneffe v. SkyWest, Inc., 
2015 WL 2265373, at *6 (D. Colo. May 11, 2015).
    \25\ For example, in 1996, the Supreme Court struck down an 
amendment to the Colorado constitution that prohibited the State 
government from providing any legal protections to gay, lesbian, and 
bisexual individuals. Seven years later, in 2003, the Supreme Court 
invalidated a Texas law that criminalized same-sex sodomy. And just 
this year, the Supreme Court ruled that States may not prohibit 
same-sex couples from marrying and must recognize the validity of 
same-sex couples' marriages.

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[[Page 54177]]

    The final rule should reflect the current state of 
nondiscrimination law, including with respect to prohibited bases of 
discrimination. We seek comment on the best way of ensuring that this 
rule includes the most robust set of protections supported by the 
courts on an ongoing basis.
    Qualified individual with a disability. The definition of 
``qualified individual with a disability'' is the same as language in 
the ADA and the regulation implementing Title II of the ADA, at 42 
U.S.C. 12131(2) and 28 CFR 35.104, respectively, except that the 
definition has been modified to apply in the context of a health 
program or activity.
    Qualified interpreter. The term ``qualified interpreter'' means an 
individual who has the characteristics and skills necessary to 
interpret for an individual with a disability, for an individual with 
limited English proficiency, or for both. The language in paragraph (1) 
applicable for interpreting for an individual with a disability is the 
same as language in the regulations implementing the ADA, at 28 CFR 
35.104, 36.104. The language in paragraph (2) applicable for 
interpreting for an individual with limited English proficiency 
reflects a synthesis of the attributes, described in the Department's 
LEP Guidance, that are necessary for an individual to interpret 
competently and effectively under the circumstances and thus to provide 
the effective oral language assistance services required under the 
law.\26\ The fact that an individual has above average familiarity with 
speaking or understanding a language other than English does not 
suffice to make that individual a qualified interpreter for an 
individual with limited English proficiency.
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    \26\ See HHS LEP Guidance, supra n. 17, 68 FR at 47316 
(explaining that an individual's proficiency in another language, 
knowledge of specialized terminology, and adherence to interpreter 
ethics are considerations in determining competency to interpret); 
id. at 47317-18 and 47323 (discussing why family members, friends, 
and ad hoc interpreters may not be competent to interpret); see 
also, e.g., Voluntary Resolution Agreement between U.S. Dep't of 
Health & Human Servs., Office for Civil Rights and Mee Memorial 
Hosp., OCR Transaction Nos. 12-143846, 13-1551016, & 13-153378, pt. 
II.J. (2014), available at https://www.hhs.gov/ocr/civilrights/activities/agreements/mee.html (defining qualified interpreter); 
Voluntary Resolution Agreement between U.S. Dep't of Health & Human 
Servs., Office for Civil Rights and Montgomery County Dep't of Soc. 
Servs., OCR Transaction No. 08-79992, pts. II.E (defining 
qualifications of an ``interpreter'' under the agreement), IV.H 
(requiring timely, competent language assistance); & IV.L 
(identifying interpreter standards), available at https://www.hhs.gov/ocr/civilrights/activities/examples/LEP/mcdssra.html.
---------------------------------------------------------------------------

    The definition of ``qualified interpreter'' includes criteria 
regarding interpreter ethics, including client confidentiality. Because 
the definition of a qualified interpreter includes adherence to 
generally accepted interpreter ethics principles, bilingual or 
multilingual staff who are competent to communicate directly with 
individuals with limited English proficiency nonetheless may not 
satisfy a requirement to adhere to such principles. For instance, a 
bilingual nurse who is competent to communicate in Spanish directly 
with Spanish-speaking individuals with limited English proficiency may 
not be a ``qualified interpreter'' if serving as an interpreter would 
pose a conflict of interest with the nurse's treatment of the patient.
    Recipient. The term ``recipient'' is the same as language in the 
regulation implementing Title IX at 45 CFR 86.2(h), except that it has 
been modified to apply in the context of a health program or 
activity.\27\
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    \27\ See supra n. 2.
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    Sex stereotypes. The term ``sex stereotypes'' refers to 
stereotypical notions of masculinity or femininity, including 
expectations of how individuals represent or communicate their gender 
to others, such as behavior, clothing, hairstyles, activities, voice, 
mannerisms, or body characteristics. These stereotypes can include 
expectations that gender can only be constructed within two distinct 
opposite and disconnected forms (masculinity and femininity), and that 
gender cannot be constructed outside of this gender construct 
(individuals who identify as neither, both, or a combination of male 
and female). This definition is consistent with the approach taken by 
the Federal government in similar matters.\28\
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    \28\ See Brief of the U.S. Equal Employment Opportunity 
Commission as Amicus Curiae in Support of Rehearing, Muhammad v. 
Caterpillar Inc., No. 12-1723 at 4 (7th Cir. filed Oct. 9, 2014).
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    State-based Marketplace. The term ``State-based Marketplace'' means 
an Exchange operated by a State with the approval of the Department 
pursuant to 45 CFR 155.105.
    Taglines. Taglines are short statements written in non-English 
languages to alert individuals with limited English proficiency to the 
availability of language assistance services free of charge.\29\ For 
instance, a tagline in Tagalog appearing on an English language 
document serves to notify Tagalog-speaking individuals with limited 
English proficiency that language assistance services, such as oral 
interpretation services through a qualified interpreter, are available 
and how they can be obtained.
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    \29\ The HHS LEP Guidance, supra n. 17, describes the practice 
of tagging non-English statements in ``brochures, booklets, and in 
outreach and recruitment information'' informing individuals with 
limited English proficiency of the availability of language 
assistance services. See id. at 47,320 (explaining how statements in 
non-English languages ``could be `tagged' onto the front of common 
documents.'').
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    Title I Entity. Title I of the ACA established Health Insurance 
Marketplaces, including the State-based Marketplaces and Federally-
facilitated Marketplaces. The Federally-facilitated Marketplaces are 
also a health program or activity operated by the Department.
Assurances Required (Sec.  92.5)
    Section 92.5 proposes that each entity applying for Federal 
financial assistance, each issuer seeking certification to participate 
in a Health Insurance Marketplace, and each State seeking approval to 
operate a State-based Marketplace be required to submit an assurance 
that its health programs and activities will be operated in compliance 
with Section 1557 and this part. The regulations implementing Title VI, 
Title IX, Section 504, and the Age Act all require similar assurances. 
We modeled the assurance, duration of obligation, and covenants 
language on the Section 504 regulation, at 45 CFR 84.5. To reduce 
burden on covered entities, OCR is revising the Assurance of Compliance 
HHS-690 Form to include all civil rights laws, including Section 1557, 
with which covered entities must comply.
Remedial Action and Voluntary Action (Sec.  92.6)
    Section 92.6 proposes provisions addressing remedial action and 
voluntary action by covered entities. Paragraph (a) proposes that a 
recipient or State-based Marketplace that has been found to have 
discriminated on any of the bases prohibited by Section 1557 be 
required to take remedial action as required by the Director to 
overcome the effects of that discrimination. The Department, including 
the Federally-facilitated Marketplaces, like recipients and State-based 
Marketplaces, is also obligated to address discrimination, but is 
subject to a different remedial process than recipients and State-based 
Marketplaces. See proposed Sec.  92.303.
    Proposed paragraph (b) permits, but does not require, all covered 
entities to take voluntary action in the absence of a finding of 
discrimination to overcome the effects of conditions that result or

[[Page 54178]]

resulted in limited participation by persons based on race, color, 
national origin, sex, age, or disability. The provisions at Sec.  
92.6(a) and (b) are modeled after the Title VI, Title IX, Section 504, 
and Age Act regulations.
Designation of Responsible Employee and Adoption of Grievance 
Procedures (Sec.  92.7)
    Proposed Sec.  92.7 outlines the requirement for covered entities 
that employ 15 or more persons to designate a responsible employee and 
adopt grievance procedures. The implementing regulations for Section 
504 and Title IX contain such requirements. Moreover, through its case 
investigative experience, OCR has observed that the presence of a 
coordinator and a grievance procedure help to bring concerns to prompt 
resolution within the entity, leading to lower compliance costs and 
more efficient outcomes. We thus propose in this provision to apply 
these requirements to all bases of prohibited discrimination.
    Paragraph (a) proposes that covered entities that employ 15 or more 
persons designate at least one employee to coordinate compliance with 
the requirements of the rule. A covered entity that has already 
designated a responsible employee pursuant to the regulations 
implementing Section 504 or Title IX may use that individual to 
coordinate its efforts to comply with Section 1557 or this part, 
provided that the scope of the individual's responsibilities is 
modified to include all prohibited bases of discrimination included in 
Section 1557 and other duties as required by Section 1557 or this part. 
For the Department, including Federally-facilitated Marketplaces, OCR 
will be deemed the responsible employee.
    Paragraph (b) proposes that covered entities that employ 15 or more 
persons be required to adopt grievance procedures and appropriate due 
process standards that would allow for the prompt and equitable 
resolution of complaints concerning actions prohibited by Section 1557 
and this part. Covered entities that already have a grievance procedure 
in place pursuant to the regulation implementing Section 504 may use 
that procedure to address claims under Section 1557 or this part, 
provided that the existing procedure meets the standards established 
under the Section 504 regulation. In addition, covered entities may use 
that procedure to address all other Section 1557 claims, provided that 
that procedure meets the standards under the Section 504 regulation and 
that the procedure is modified to apply to race, color, national 
origin, sex, and age discrimination claims. For the Department, 
including Federally-facilitated Marketplaces, the procedures for 
addressing complaints of discrimination on the grounds covered under 
Section 1557 will be deemed grievance procedures.
    OCR is considering requiring that all covered entities, not just 
those that employ 15 or more persons, designate a responsible employee 
and establish grievance procedures. While Section 504 limits these 
requirements to recipients with 15 or more employees, Title IX applies 
them to all recipients that operate educational programs or activities, 
regardless of the size of the recipient. Following the approach of 
Title IX would lead to a broader application under Section 1557 that 
would benefit more individuals by reaching more covered entities and 
allowing covered entities to address any potential compliance issues at 
an earlier stage and in a less formal manner than an OCR investigation. 
We invite comment on this proposal, including any associated costs and 
benefits.
Notice Requirement (Sec.  92.8)
    Section 92.8 proposes that each covered entity take initial and 
continuing steps to notify beneficiaries, enrollees, applicants, or 
members of the public of certain important information. We modeled this 
section generally after the notice requirements found in regulations 
implementing Title VI, Title IX, Section 504, and the Age Act, which 
require covered entities to have a notice in place.
    Paragraphs (a)(1)-(7) of Sec.  92.8 propose the components of the 
notice that each covered entity is required by Sec.  92.8(b) and (f) to 
post.
    Paragraph (a)(1) proposes that the notice include that the covered 
entity does not discriminate on the basis of race, color, national 
origin, sex, age, or disability.
    Paragraphs (a)(2) and (a)(3) propose that the notice include a 
statement that the covered entity provides auxiliary aids and services, 
free of charge, in a timely manner, to individuals with disabilities, 
when such aids and services are necessary to provide an individual with 
a disability an equal opportunity to benefit from the entity's health 
programs or activities; and language assistance services, free of 
charge, in a timely manner, to individuals with limited English 
proficiency, when those services are necessary to provide an individual 
with limited English proficiency meaningful access to a covered 
entity's health programs or activities. These provisions are necessary 
to ensure that individuals are aware of their rights under the law, and 
are grounded in OCR's experience that failures of communication based 
on the absence of auxiliary aids and services and language assistance 
services raise particularly significant compliance concerns. In 
addition, such failures of communication often are a primary 
contributor to limitations in access to health programs and activities 
for individuals with disabilities and individuals with limited English 
proficiency. Apprising individuals of the availability of communication 
assistance under Section 1557 will promote both compliance with the law 
and better health outcomes.
    Paragraph (a)(4) proposes that the notice include information on 
how an individual can access the aids and services referenced in (a)(2) 
and (a)(3).
    Paragraph (a)(5) proposes that the notice provide contact 
information for the responsible employee, where such a responsible 
employee is required by Sec.  92.7(a).
    Paragraph (a)(6) proposes that the notice include the availability 
of the grievance procedure, where such a grievance procedure is 
required by Sec.  92.7(b), and information on how to file a grievance.
    Paragraph (a)(7) proposes that the notice provide information on 
how to file a complaint with OCR. Inclusion of this requirement ensures 
that covered entities inform individuals about the enforcement 
mechanisms outside of the covered entity's internal process.
    Paragraph (b) provides that within 90 days of the effective date of 
this part, each covered entity shall post the notice, consistent with 
paragraph (f) of this section, that conveys the information in English 
in paragraph (a)(1) through (7) of this section.
    Paragraph (c) provides that the Director shall make available an 
electronic sample notice in English that contains the content listed 
in, and meets the requirements of, paragraphs (a)(1) through (7). 
Covered entities may use this sample notice or may develop their own 
notices that meet the requirements of paragraphs (a)(1) through (7). We 
request comment on the sample notice included in Appendix A to this 
proposed rule.
    OCR also invites comment on whether this proposed rule should 
permit covered entities to combine the content of the notice required 
under the proposed rule with the content of other notices that covered 
entities may be required to disseminate or post under Federal laws and, 
if so, what steps covered entities may or should take to

[[Page 54179]]

ensure that the content of the notice required by the proposed rule is 
sufficiently conspicuous and visible to beneficiaries, enrollees, 
applicants, or members of the public that they are able to become aware 
of the content of the notice. In addition, OCR invites comment on 
whether this proposed rule should allow the notice to be modified to be 
appropriate for publications and other communication vehicles that may 
not have sufficient space to accommodate the full notice, e.g., 
postcards, trifold brochures, and social media platforms and, if so, 
what information such a modified notice should include.
    Paragraph (c) also proposes that the Director shall translate the 
sample notice into the top 15 languages \30\ spoken by individuals with 
limited English proficiency nationally and make the translated notices 
available to covered entities electronically and in any other manner 
the Director determines appropriate. Assigning to OCR the 
responsibility to translate the sample notice maximizes efficiency and 
economies of scale. This approach means covered entities will receive 
the benefits of having multi-language notices available without 
incurring the associated translation costs. We expect that making the 
sample notice available in non-English languages will substantially 
increase the value and utility of the notice required in paragraphs (a) 
and (b) of Sec.  92.8.
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    \30\ See U.S. Dep't of Commerce, U.S. Census Bureau, American 
FactFinder, Language Spoken at Home by Ability to Speak English for 
the Population 5 Years and Older, 3-Year American Community Survey 
(ACS), Estimates (2011-2013), https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ACS_13_3YR_B16001&prodType=table (last visited 
Mar. 27, 2015). The most recent ACS data available are the 2013 
estimates. OCR chose the three-year data set (as opposed to the one-
year or five-year data) because it best balances the currency and 
stability of the data. The top 15 languages in which OCR plans to 
translate the notice excludes bundled language groups, such as 
``other Indo-European languages'' and ``other Pacific Islander 
languages.'' The top 15 foreign languages, ordered from high to low 
estimates of number of individuals speaking English less than ``very 
well,'' are Spanish (or Spanish Creole), Chinese, Vietnamese, 
Korean, Tagalog, Russian, Arabic, French Creole, French (including 
Patois and Cajun), Portuguese (or Portuguese Creole), Polish, 
Japanese, Italian, German, and Persian (Farsi).
---------------------------------------------------------------------------

    Under our proposed approach, covered entities are encouraged, but 
not required, to post one or more of the translated notices, 
particularly in the most prevalent languages spoken by individuals with 
limited English proficiency in the covered entities' geographic service 
areas, as determined by the covered entities. Covered entities also may 
make the notice available in non-English languages other than the top 
15 languages for which translated notices are provided by the Director. 
We encourage covered entities to make the content of the notice 
available in additional non-English languages to inform national origin 
groups within covered entities' geographic service areas of their 
rights under Section 1557 and this proposed rule.
    In lieu of this approach, OCR considered requiring, rather than 
merely encouraging, covered entities to post one or more of the notices 
in the most prevalent non-English languages frequently encountered by 
covered entities in their geographic service areas, such as Spanish. 
This option would leverage the OCR-translated notices and improve, for 
certain national origin populations, access to the information in the 
notice in a language that those individuals with limited English 
proficiency could understand. The main disadvantage of this option is 
the burden of using physical wall space to post notices and using 
information technology staff/resources for web posting of notices and 
printing of notices. For the purposes of this proposed rule, we believe 
the availability of the taglines that Sec.  92.8(d) of this proposed 
rule requires covered entities to post strikes an appropriate balance. 
We seek comment on the alternate approach.
    With regard to the proposal that the Director provide translations 
of the sample notice, we selected the top 15 languages spoken by 
individuals with limited English proficiency nationally as a data 
driven policy. This scope reaches nearly 90 percent of individuals with 
limited English proficiency in the United States based on the U.S. 
Census Bureau's 2011 to 2013 data--the most recent three-year data 
available--that estimates the prevalence of foreign-language speakers 
who speak English less than ``very well.'' We will review U.S. Census 
Bureau data more recent than 2011 to 2013, as the data becomes 
available, to determine if and when the top 15 languages spoken 
nationally by individuals with limited English proficiency change, 
warranting the Director to make available notices translated in 
additional non-English languages.
    Paragraph (d) proposes that within 90 days of the effective date of 
this part, each covered entity shall post, consistent with paragraph 
(f) of this section, taglines in the top 15 languages spoken nationally 
by individuals with limited English proficiency.
    Paragraph (e) proposes that the Director shall make available 
taglines in the top 15 languages spoken nationally by individuals with 
limited English proficiency for use by covered entities. Taglines have 
a high utility as a gateway to language assistance services: They are 
written in non-English languages that individuals with limited English 
proficiency can understand, inform those individuals how to access 
language assistance services, and encourage those individuals to 
identify themselves and the languages in which they communicate.\31\ 
The Department's LEP Guidance describes the practice of tagging non-
English statements in publications and informational materials.\32\
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    \31\ See, e.g., HHS LEP Guidance, supra n. 17 at 68 FR at 47320 
(discussing ways to identify the primary languages in which 
individuals with limited English proficiency communicate and 
considerations for notifying individuals with limited English 
proficiency of language assistance services).
    \32\ See HHS LEP Guidance, id at 68 FR at 47320.
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    We request comment on the content of the sample tagline included in 
Appendix B to this proposed rule. As with our approach to making 
available translated notices, assigning to OCR the responsibility to 
provide translated taglines maximizes efficiency and economies of 
scale. This approach means that covered entities will receive the 
benefits of having multi-language taglines available without incurring 
the associated translation costs. For this reason, we anticipate 
covered entities will use the translated taglines that the Director 
makes available. Covered entities are not limited to posting taglines 
in the 15 languages made available by the Director; covered entities 
may provide taglines in as many other non-English languages as 
appropriate to alert national origin groups in the covered entity's 
geographic service area of language assistance services that may be 
available.
    Paragraph (f) of this section prescribes the location for posting 
both notices and taglines. Specifically, the proposed rule requires 
that covered entities post the English-language notice required by 
Sec.  92.8(a) and (b) and the taglines required by Sec.  92.8(d) in a 
conspicuously-visible font size in: Significant publications or 
significant communications targeted to beneficiaries, enrollees, 
applicants, or members of the public, which may include patient 
handbooks, outreach publications, or written notices pertaining to 
rights or benefits or requiring a response from an individual; in 
conspicuous physical locations; and in a conspicuous location on the 
home page of a covered entity's Web site. Section 92.8(f) specifically 
states that a

[[Page 54180]]

covered entity may post the notice and taglines in additional 
publications and communications beyond those listed in paragraphs 
(f)(1) through (3) of Sec.  92.8. We seek comments on additional ways 
to define the scope of the significant publications and significant 
communications.
    We propose to require the notice and taglines on a covered entity's 
Web site to be located conspicuously on the home page so that 
individuals, generally, are aware of their rights, and individuals with 
limited English proficiency do not have to navigate English-only text 
to find information in the individual's language. Covered entities may 
satisfy the requirement to post the notice on the covered entity's Web 
site by including a link in a conspicuous location on the covered 
entity's home page that immediately directs the individual to the 
content of the notice on the covered entity's Web site. Covered 
entities may satisfy the requirement to post taglines on the covered 
entity's Web site by including web links conspicuously on the home page 
that identify each of the 15 non-English languages, written ``in 
language,'' and that direct the individual to the full text of the 
tagline indicating how the individual may obtain language assistance 
services. For instance, a tagline web link directing a Spanish-speaking 
individual with LEP to a Spanish-language tagline should appear as 
``Espa[ntilde]ol'' rather than ``Spanish.'' Similarly, a tagline 
directing an individual to a Web site with the full text of a tagline 
written in Haitian Creole should appear as ``Krey[ograve]l Ayisien'' 
rather than ``Haitian Creole.'' Providing tagline web links and the 
text of taglines in their respective non-English languages is of 
particular importance for languages that do not use a Latin script.
    Covered entities that distribute general or major publications 
targeted to beneficiaries, enrollees, applicants, or members of the 
public will need to update these publications to include the new 
notice. However, we propose allowing entities to exhaust their current 
stock of hard copy publications, rather than requiring a special 
printing of the publications to include the new notice. When covered 
entities restock their printed materials, they will be expected to 
include in those printed materials the notice that we are promulgating 
with the final rule.
    Because the top 15 languages spoken by individuals with limited 
English proficiency nationally may be over-inclusive or under-inclusive 
of the languages spoken by individuals with limited English proficiency 
within the areas served by covered entities' health programs and 
activities, OCR considered a State-based methodology for identifying 
the languages in which covered entities would be required to post 
taglines. For instance, we considered proposing a requirement for 
entities to make available taglines in the top 15 languages spoken 
statewide, rather than nationwide, by individuals with limited English 
proficiency. Identifying a State-based threshold aligns with Federal 
regulations governing the Health Insurance Marketplaces and qualified 
health plan \33\ issuers.\34\ Under this approach, OCR would make 
available to covered entities translated taglines for the non-English 
languages constituting the top 15 languages spoken statewide by 
individuals with limited English proficiency. We seek comment on this 
alternate methodology, specifically regarding the geographic areas or 
service areas that should apply for determining a threshold number of 
languages in which the Director should translate and make available, or 
for which covered entities should post, taglines.
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    \33\ Qualified health plan means the same as ``Qualified health 
plan'' defined in 45 CFR 155.20.
    \34\ See 45 CFR 155.205(c)(2)(iii)(A) through (C).
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    To reduce the burden on covered entities, proposed subsection (g) 
of this section states that a covered entity's compliance with Sec.  
92.8 satisfies the notice requirements under HHS' Title VI, Section 
504, Title IX, and Age Act regulations. We request comment on OCR's 
proposal to treat compliance with Sec.  92.8 as satisfying the notice 
requirements under the regulations implementing Title VI, Section 504, 
Title IX, and the Age Act.

Subpart B--Nondiscrimination Provisions

    Subpart B of the proposed rule incorporates regulatory provisions 
implementing the civil rights statutes referenced in Section 1557(a): 
Title VI, Title IX, the Age Act, and Section 504.
Discrimination Prohibited (Sec.  92.101)
    Proposed Sec.  92.101 of subpart B prohibits discrimination on the 
basis of race, color, national origin, sex, age, or disability under 
any health program or activity to which Section 1557 or this part 
applies. Paragraphs (a) and (b) of Sec.  92.101 follow the structure of 
the implementing regulations for Title VI, Section 504, Title IX, and 
the Age Act by including a general nondiscrimination provision in 
paragraph (a) followed by a provision identifying specific 
discrimination prohibited in paragraph (b). Exceptions to 
discrimination prohibited under the Title VI, Section 504, and Age Act 
regulations are addressed in paragraph (c). Paragraph (d) effectuates 
technical changes in terminology to apply the provisions incorporated 
from other regulations to the covered entities obligated to comply with 
this proposed rule.
General Discriminatory Actions Prohibited Sec.  92.101(a)
    In paragraph (a)(1) of Sec.  92.101, we restate the core objective 
of Section 1557(a), which prohibits discrimination on the grounds 
prohibited under Title VI (race, color, or national origin), Title IX 
(sex), the Age Act (age), or Section 504 (disability) in any health 
program or activity to which this part applies.
    In paragraph (a)(2), we propose to limit the ways in which the 
proposed rule applies to employment. Except as provided in Sec.  
92.208, which addresses employee health benefit programs, this proposed 
rule does not apply to discrimination by a covered entity against its 
own employees. Thus, this proposed rule would not extend to hiring, 
firing, promotions, or terms and conditions of employment outside of 
those identified in Sec.  92.208; such claims would continue to be 
brought under other laws, including Title VII of the Civil Rights Act 
of 1964,\35\ Title IX, Section 504, the ADA and the Age Discrimination 
in Employment Act,\36\ as appropriate. We believe that this approach is 
consistent with the purpose of the ACA and with Section 1557's focus on 
discrimination in health programs and activities.\37\ We invite

[[Page 54181]]

comment on our proposal to exclude these forms of employment 
discrimination from the scope of this proposed rule.
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    \35\ 42 U.S.C. 2000e et seq.
    \36\ 29 U.S.C. 621 et seq.
    \37\ This approach is consistent with the coverage of the Age 
Act and Title VI, which explicitly exclude discrimination in 
employment, subject, in the case of Title VI, to certain exceptions 
not applicable here. See 45 CFR 91.3(b)(2) (excluding employment 
from application of the regulation implementing the Age Act); 
80.2(d) (excluding employment from application of the regulation 
implementing Title VI); 80.3(c), (d)(3) (exceptions to the exclusion 
of employment discrimination under the regulation implementing Title 
VI). Moreover, while Section 504 and Title IX, which are silent on 
the question, have been interpreted to bar discrimination in 
employment, those interpretations were based on analyses of the 
purposes underlying the Rehabilitation Act and on extensive 
discussion of employment in the legislative history of Title IX. 
Consolidated Rail Corp. v. Darrone, 465 U.S. 624, 626 (1984) 
(promoting and expanding employment opportunities for handicapped 
individuals is a stated purpose of the Rehabilitation Act, 29 U.S.C. 
701(8), and legislative history demonstrates that Congressional 
intent to bar employment discrimination was a focus of the Act); 
North Haven Bd. of Ed. V. Bell, 456 U.S. 512, 522-530 (1982) 
(statutory language favors inclusion of employment discrimination 
and legislative history corroborates Congressional intent to 
prohibit sex discrimination in employment in Title IX). Our approach 
in the proposed rule is not intended to alter the scope of either 
Section 504 or Title IX in this regard.
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Specific Discriminatory Actions Prohibited Sec.  92.101(b)
    Proposed paragraph (b) incorporates into this proposed regulation 
the specific discriminatory actions prohibited by each civil rights 
statute which Section 1557 references. We considered harmonizing each 
of the specific discriminatory actions prohibited across each civil 
rights law addressed by Section 1557. Although harmonization could 
reduce redundancy in the specific discriminatory actions incorporated 
that are similar to one another, harmonization would likely lead to 
confusion and unintended differences in interpretation that are subtle 
yet significant. For example, with respect to the separate or different 
treatment prohibited under the Title VI regulation, such as at 45 CFR 
80.3(b)(1)(iii) and (vi), the Section 504 regulation at 45 CFR 
84.4(b)(1)(iv), 85.21(b)(1)(iv) requires separate or different 
treatment in some instances where it is necessary to provide persons 
with disabilities with aids, benefits or services that are as effective 
as those provided to others. To avoid confusion and unintended 
differences in interpretation, therefore, paragraphs (b)(1)-(4) 
incorporate into this proposed regulation the specific discriminatory 
actions prohibited under each civil rights law on which Section 1557 is 
grounded. Thus, for example, the specific discriminatory actions listed 
under Title VI are incorporated here to govern the obligations of 
covered entities not to discriminate based on race, color, or national 
origin. We seek comments on this proposed approach.
    Proposed paragraph (b)(1) of Sec.  92.101 adopts the specific 
discriminatory actions prohibited by the Title VI implementing 
regulation, which appear in 45 CFR 80.3(b)(1) through (6).
    Proposed paragraph (b)(2)(i) of Sec.  92.101 addresses the specific 
prohibition of discrimination on the basis of disability with which 
recipients and State-based Marketplaces must comply. This paragraph 
adopts relevant provisions in the Section 504 implementing regulation 
for Federally assisted programs and activities at 45 CFR part 84. The 
provisions incorporated are the specific discriminatory actions 
prohibited at Sec.  84.4(b); the program accessibility provisions at 
Sec. Sec.  84.21 through 84.23(b); and the provisions governing 
education, health, welfare, and social services at Sec. Sec.  84.31, 
84.34, 84.37, 84.38, and 84.41-84.55. We do not propose adopting the 
program accessibility provision at Sec.  84.23(c), addressing 
conformance with the Uniform Federal Accessibility Standards for the 
construction and alteration of facilities, because these standards are 
outdated. Section 92.203 of this proposed rule requires compliance with 
more contemporary standards.
    Paragraph (b)(2)(ii) of Sec.  92.101 addresses the specific 
prohibitions of discrimination on the basis of disability with which 
the Department, including the Federally-facilitated Marketplaces, must 
comply. This paragraph adopts relevant provisions in the Section 504 
implementing regulation for Federally administered programs and 
activities at 45 CFR part 85. The provisions adopted are the specific 
discriminatory actions prohibited at Sec.  85.21(b) and the program 
accessibility provisions at Sec. Sec.  85.41 through 85.42 and 84.44 
through 84.51.
    Paragraph (b)(3) of Sec.  92.101 adopts the specific discriminatory 
actions prohibited by the Title IX implementing regulation, which 
appear at 45 CFR 86.3(b)(1) through (8).
    Paragraph (b)(4) of Sec.  92.101 adopts the specific discriminatory 
actions prohibited by the Age Act implementing regulation, which appear 
at 45 CFR 91.11(b).
    Paragraph (b)(5) of Sec.  92.101 states that the specific 
discriminatory actions prohibited in Sec.  92.101(b)(1) through (4) do 
not limit the general prohibition of discrimination in Sec.  92.101(a). 
This statement is consistent with regulatory provisions in the 
implementing regulations for Title VI at 45 CFR 80.3(b)(5) and the Age 
Act at 45 CFR 91.11(c).
    Paragraph (c) of Sec.  92.101 incorporates the exceptions to the 
general prohibition of discrimination that appear in the implementing 
regulations for Title VI, Section 504, and the Age Act, as these 
exceptions have applied to health programs and activities for nearly 40 
years. Generally, the exceptions in the Title VI, Section 504, and Age 
Act implementing regulations provide that it is not discriminatory to 
exclude a person from the benefits of a program that Federal law or 
executive order limits to a protected class. For instance, we 
incorporate the exceptions in the Age Act implementing regulation which 
address, among other things, age distinctions in Departmental 
regulations, and actions based on age where age is a factor necessary 
to the normal operation or achievement of a statutory objective of a 
program or activity. This would include allowable age rating under the 
ACA where issuers may vary premium rates based on age within a 3:1 
ratio.\38\
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    \38\ 45 CFR 147.102(a)(1)(iii). This is also consistent with 
language in the Section 1557 provision, which states that a person 
is protected from discrimination ``[e]xcept as otherwise provided 
for in this title.''
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    Paragraph (c) of Sec.  92.101 does not address the sex-based 
distinctions authorized in Title IX and its implementing regulation in 
the context of education programs or activities. As discussed 
previously, given Title IX's limitation to education programs and 
activities, these distinctions do not necessarily apply in the health 
care context.
    Title IX and its implementing regulation allow some single-sex 
education programs (e.g., separate toilet, locker room, and shower 
facilities in education programs and activities; contact sports in 
physical education classes; classes on human sexuality; and choruses) 
when certain requirements are met. Thirty organizations that filed 
comments in response to the RFI indicated that, to the extent single-
sex programs are permitted under Section 1557 or this part, they should 
be narrowly tailored and necessary to accomplish an essential health 
purpose. Some commenters also indicated that single-sex programs should 
be permissible when they are necessary to serve the disadvantaged sex 
or to comply with constitutionally protected rights to privacy. Nearly 
20 organizational commenters urged that, in the very narrow 
circumstances where single-sex programs or activities are permitted, 
Section 1557 should require equal access for all individuals in a 
manner consistent with their self-identified gender.
    HHS does not propose to prohibit separate toilet, locker room, and 
shower facilities where comparable facilities are provided to 
individuals, regardless of sex. However, we continue to seek comment on 
what other sex-based distinctions, if any, should be permitted in the 
context of health programs and activities and the standards for 
permitting the distinctions (see also the previous discussion of Sec.  
92.2 regarding the application of this proposed rule). Examples of sex-
based distinctions include a women's health clinic or a counseling 
program limited to male victims of domestic violence.

[[Page 54182]]

    Finally, paragraph (d) of Sec.  92.101 effectuates technical 
changes to apply the provisions incorporated in Sec.  92.101(b) and (c) 
to covered entities obligated to comply with this proposed rule by, 
among other things, replacing references to ``recipient'' in the 
incorporated provisions with ``covered entity.''

Subpart C--Specific Applications to Health Programs and Activities

    Section 1557 is unique among Federal civil rights laws in that it 
specifically addresses discrimination in health programs and 
activities. To provide additional specificity regarding 
nondiscrimination requirements in this setting, Subpart C builds upon 
pre-existing civil rights regulations referenced in Subpart B. Due to 
the nature and importance of health care, health-related insurance, and 
other health-related coverage to individuals and communities, OCR is 
proposing these additional specific requirements to ensure that covered 
entities have clear instruction in areas where OCR, through its 
enforcement work, has seen significant discrimination issues and 
complaints. We believe that these specific requirements will best 
assist covered entities in meeting their obligations and explain to 
individuals the scope of some of the protections afforded by Section 
1557. We seek comment on this approach.
Meaningful Access for Individuals With Limited English Proficiency 
(Sec.  92.201) Overview of Sec.  92.201
    Proposed Sec.  92.201 effectuates Section 1557's prohibition of 
national origin discrimination as it affects individuals with limited 
English proficiency in health programs and activities of covered 
entities. About 25 million individuals in the United States, or about 
8.5 percent, have limited proficiency in English.\39\ These individuals 
may have been born in other countries or in the United States, such as 
some Native Americans or children of immigrants.\40\ For purposes of 
this proposed part, an individual with limited English proficiency is a 
person whose primary language for communication is not English and who 
has a limited ability to read, write, speak, or understand English.
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    \39\ U.S. Dep't of Commerce, U.S. Census Bureau, American 
FactFinder, Language Spoken at Home by Ability to Speak English for 
the Population 5 Years and Older, supra n. 30 (serving as data 
source to calculate that 25 million of the 294 million individuals 
in the United States speak English less than ``very well''). OCR 
chose the three-year ACS, data (as opposed to the one-year or five-
year data) because it best balances the currency and stability of 
the data.
    \40\ Dep't of Justice, Enforcement of Title VI of the Civil 
Rights Act of 1964--National Origin Discrimination Against Persons 
with Limited English Proficiency; Policy Guidance, 65 FR 50123, 
50124 (Aug. 16, 2000) [hereinafter DOJ Policy Guidance, 2000].
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    For individuals with limited English proficiency, lack of 
proficiency in English--and the use of non-English languages--is a 
direct outgrowth of, and is integrally tied to, their national 
origins.\41\ As the Department of Justice explains, in its role 
coordinating Federal Departments' enforcement of Title VI, language 
serves as an identifier of one's national origin by `` `permit[ing] an 
individual to express both the personal identity and membership in a 
community. . . .' '' \42\ OCR's experience enforcing Title VI further 
demonstrates that disadvantaging an individual on the basis of his or 
her limited English proficiency is inextricably linked to 
discrimination on the basis of national origin.
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    \41\ See, e.g., 29 CFR 1606.1 (defining an individual's national 
origin in Equal Employment Opportunity Commission regulations as his 
or her ancestor's place of origin and an individual's ``physical, 
cultural or linguistic characteristics'').
    \42\ DOJ Policy Guidance 2000, 65 FR at 50124 & n.8 (citing 
Hernandez v. New York, 500 U.S. 352, 370 (1991) (plurality 
opinion)). See also 29 CFR 1606.1 (Equal Employment Opportunity 
Commission's definition of national origin, which includes an 
individual's linguistic characteristics); Garcia v. Gloor, 618 F.2d 
264, 269 (``To a person who speaks only one tongue or to a person 
who has difficulty using another language when spoken in his home, 
language might well be an immutable characteristic. . . .'').
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    It is thus well-established under Title VI and its implementing 
regulation that a prohibition on national origin discrimination 
requires covered entities to take reasonable steps to provide 
meaningful access to individuals with limited English proficiency.\43\ 
As the Supreme Court recognized 40 years ago, the provision of language 
assistance services is essential to ensure the equality of opportunity 
promised by nondiscrimination laws. As the Court stated in Lau v. 
Nichols, which arose in the context of education,
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    \43\ See, e.g., HHS LEP Guidance, supra n. 17 at 68 FR at 47313 
(``[T]he failure of a recipient of [F]ederal financial assistance 
from HHS to take reasonable steps to provide LEP persons with [a] 
meaningful opportunity to participate in HHS-funded programs may 
constitute a violation of Title VI and HHS's implementing 
regulations''); Policy Guidance, Title VI Prohibition against 
National Origin Discrimination As It Affects Persons with Limited 
English Proficiency, 65 FR 52762, 52765 (August 30, 2000) 
(explaining the requirement to take reasonable steps to provide 
meaningful access and to provide the ``language assistance services 
necessary to ensure such access. . . .''). See also E.O. 13166, 
Improving Access to Services for Persons with Limited English 
Proficiency, (Aug. 11, 2000) (requiring each Federal Department to 
improve access to Federally assisted programs and activities by 
persons with limited English proficiency and to implement a system 
by which individuals with limited English proficiency can 
meaningfully access the Departments' Federally conducted programs 
and activities).

    [T]here is no equality of treatment merely by providing [limited 
English proficient] students with the same facilities, textbooks, 
teachers, and curriculum [as their English speaking peers]; for 
students who do not understand English are effectively foreclosed 
from any meaningful education. . . . We know that those who do not 
understand English are certain to find their classroom experiences 
wholly incomprehensible and in no way meaningful.\44\
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    \44\ Lau v. Nichols, 414 U.S. 563, 566 (1974) (requiring a 
school district with students with limited English proficiency of 
Chinese origin to take reasonable steps to provide the students with 
a meaningful opportunity to participate in Federally funded 
educational programs).

    Based on these principles, OCR proposes Sec.  92.201 to require 
covered entities to take reasonable steps to provide meaningful access 
to health programs and activities for all persons regardless of 
national origin. Specifically, proposed paragraph (a) of Sec.  92.201 
incorporates the Title VI standard, and paragraph (b) identifies 
requirements for the Director's evaluation of a covered entity's 
compliance with paragraph (a). Proposed paragraph (c) contains 
requirements for language assistance services, and proposed paragraph 
(d) includes specific requirements for oral interpretation. Proposed 
paragraph (e) sets forth restrictions on covered entities' use of 
certain persons to interpret for, or facilitate communication with, 
individuals with limited English proficiency. Proposed paragraph (f) 
provides that no individual with limited English proficiency shall be 
required to accept language assistance services. Each paragraph is 
described further as follows.
General Requirements (Sec.  92.201(a), (b) and (c))
    Proposed Sec.  92.201(a) adopts the well-established principle that 
covered entities must take reasonable steps to provide meaningful 
access to health programs and activities for all individuals with 
limited English proficiency that they serve or encounter in their 
health programs or activities.\45\ Consistent with our longstanding 
enforcement of Title VI, we intend the general obligation in paragraph 
(a) to be a flexible standard that the Director

[[Page 54183]]

considers in light of the particular facts.\46\
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    \45\ The Department's LEP Guidance provides an in-depth 
explanation of Title VI's prohibition against national origin 
discrimination as it affects limited English proficient populations 
and how recipients can determine what steps are reasonable to 
provide all individuals with limited English proficiency meaningful 
access. HHS LEP Guidance, supra n. 17 at 68 FR 47311.
    \46\ Under Title VI, OCR investigates each complaint and 
conducts its compliance reviews on a case-by-case basis and tailors 
each case resolution to the particular facts of each case. For 
highlights of OCR's Title VI enforcement specific to the prohibition 
of national origin discrimination as it affects individuals with 
limited English proficiency, see Enforcement Success Stories 
Involving Individuals with Limited English Proficiency, Office for 
Civil Rights, U. S. Department Of Health And Human Services, https://www.hhs.gov/ocr/civilrights/activities/examples/LEP/ (last 
visited Jul. 20, 2015).
---------------------------------------------------------------------------

    Because it incorporates long-standing principles under Title VI, 
the standard we propose in paragraph (a) provides familiarity and 
consistency for covered entities about the scope of their obligations. 
As we stated in the Department's initial policy guidance released in 
2000 on the Title VI prohibition of national origin discrimination with 
respect to persons with limited English proficiency:

    The key to providing meaningful access for LEP persons is to 
ensure that the recipient/covered entity and LEP person can 
communicate effectively. The steps taken by a covered entity must 
ensure that the LEP person is given adequate information, is able to 
understand the services and benefits available, and is able to 
receive those for which he or she is eligible. The covered entity 
must also ensure that the LEP person can effectively communicate the 
relevant circumstances of his or her situation to the service 
provider.\47\
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    \47\ 65 FR at 52765.

    Further, the standard balances two core principles critical in 
effectuating Section 1557's prohibition of national origin 
discrimination.
    The first principle is that the Department must ``ensure that 
[health programs and activities] aimed at the American public do not 
leave some behind simply because they face challenges communicating in 
English.'' \48\ Safe and quality health care requires an exchange of 
information between health care provider and patient for the purposes 
of diagnoses, treatment options, the proper use of medications, 
obtaining informed consent, and insurance coverage of health-related 
services, among other myriad purposes.\49\ This exchange of information 
is jeopardized when the provider and the patient speak different 
languages and may result in adverse health consequences and even 
death.\50\ Indeed, the provision of health care services, by its ``very 
nature[,] requires the establishment of a close relationship with the 
client or patient that is based on sympathy, confidence and mutual 
trust.'' \51\ Provider-patient communication is essential to the 
concept of patient centeredness, which is a core component of quality 
health care and has been shown to improve patients' health and health 
care.\52\
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    \48\ 68 FR at 47312.
    \49\ See, e.g., 65 FR at 52763.
    \50\ See, e.g., id.
    \51\ Id.
    \52\ Dep't. of Health & Human Servs., Agency for Health Care 
Research & Quality, Chapter 6, Patient Centeredness, National 
Healthcare Quality Report, 2013, available at https://www.ahrq.gov/research/findings/nhqrdr/nhqr13/chap6.html.
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    The second principle is that the level, type and manner of language 
assistance services required under paragraph (a) should vary based on 
the relevant facts, which may include the operations and capacity of 
the covered entity.
    For these reasons, proposed Sec.  92.201(b) identifies how the 
Director will evaluate whether a covered entity has met the requirement 
in paragraph (a).\53\ Proposed Sec.  92.201(b)(1) requires the Director 
to consider, and give substantial weight to, the nature and importance 
of the health program or activity, including the particular 
communication at issue. Proposed Sec.  92.201(b)(2) requires the 
Director to take other relevant factors into account and lists some of 
the type of factors that the Director is required to consider, if 
relevant.
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    \53\ The Department's LEP Guidance takes a similar approach of 
identifying the factors that OCR will consider, in determining the 
extent of a recipient's obligations to individuals with limited 
English proficiency. See 68 FR 47314-16.
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    Section 92.201(b)(2)(i) and (ii) identify the length, complexity, 
and context of the communication as potentially relevant factors in a 
particular case. Where a communication is particularly long or complex, 
for example, a covered entity might be required to provide a means for 
an individual with limited English proficiency to be able to refer back 
to the information communicated through, for instance, a document 
written in the individual's primary language or an audio file of the 
information conveyed orally in the individual's primary language.
    The prevalence of the primary language, among those eligible to be 
served or likely to be encountered by the health program or activity, 
in which the individual with limited English proficiency communicates, 
identified in paragraph (b)(2)(iii) of Sec.  92.201, might also be 
relevant in a particular case. Where an individual with limited English 
proficiency speaks a language that has a low prevalence among those 
eligible to be served or likely to be encountered by the health program 
or activity, the covered entity might, for example and depending on 
other relevant factors, satisfy its obligations by providing, rather 
than a written document translated verbatim, a qualified interpreter 
who reads the brochure and provides an oral interpretation of the 
brochure into the non-English language.
    The resources available to the covered entity and the costs of 
language assistance services might also be relevant in a particular 
case. Where the Director considers an entity's resources, he or she 
will evaluate all available resources, including the entity's capacity 
to leverage resources among its partners or to use its negotiating 
power to lower the costs at which language assistance services could be 
obtained.
    Proposed Sec.  92.201(c) makes clear that language assistance 
services required under paragraph (a) must be provided free of charge, 
be accurate and timely, and protect the privacy and independence of the 
individual with limited English proficiency.\54\ Consistent with the 
observation in the Department's LEP Guidance that there is no one 
definition for ``timely'' that applies to every type of interaction 
with every type of recipient at all times, a determination of whether 
language assistance services are timely will depend on the specific 
circumstances of each case. However, the LEP Guidance makes clear that 
language assistance is timely when it is provided at a place and time 
that ensures equal access to persons of all national origins and avoids 
the delay or denial of the ``right, service, or benefit at issue.'' 
\55\
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    \54\ This principle is consistent with long-standing concepts 
reflected in the HHS LEP Guidance supra n. 17. See 68 FR at 47318, 
47323 (with respect to privacy), 47316-19, 47322 (with respect to 
timeliness), and 47317-20, 47322 (with respect to services free of 
charge).
    \55\ Id. at 47316. Additionally, the National Standards for 
Culturally and Linguistically Appropriate Services in Health and 
Health Care (the National CLAS Standards) also emphasize the 
importance of timely language assistance.
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Specific Requirements for Interpreter Services Sec.  92.201(d)
    Proposed Sec.  92.201(d) addresses standards applicable to oral 
interpretation. In particular, this paragraph provides that when a 
covered entity is required by proposed Sec.  92.201(a) to provide oral 
interpretation as a reasonable step to provide meaningful access to an 
individual with limited English proficiency, the covered entity must 
offer that individual a qualified interpreter. As defined in Sec.  
92.4, a qualified interpreter for an individual with limited English 
proficiency possesses certain characteristics and skills necessary for 
him or her to interpret competently and effectively under the 
circumstances and

[[Page 54184]]

adheres to generally accepted interpreter ethics principles, including 
client confidentiality.
Restricted Use of Certain Persons To Interpret or Facilitate 
Communication Sec.  92.201(e)
    Proposed Sec.  92.201(e) identifies restrictions on the use of 
certain persons to provide language assistance services for an 
individual with limited English proficiency. This paragraph applies in 
addition to, and regardless of, the appropriate level, type or manner 
of language assistance services a covered entity is required to 
provide. As some RFI commenters shared, the use of incompetent or ad 
hoc interpreters, such as family members, friends, and children, is not 
uncommon and can have negative implications. Thus, proposed paragraph 
(e)(1) of Sec.  92.201 prohibits a covered entity from requiring an 
individual with limited English proficiency to provide his or her own 
interpreter. Proposed paragraphs (e)(2)(i) and (ii), however, identify 
narrow and finite situations in which a covered entity may rely on an 
adult accompanying an individual with limited English proficiency to 
interpret. Proposed paragraph (e)(3) prohibits a covered entity from 
relying on a minor child to interpret or facilitate communication and 
identifies an exception to this prohibition that is narrower in scope 
than the exception identified in (e)(2)(i) and (ii).
    The provisions of Sec.  92.201(d) and (e) codify standards 
described in the Department's LEP Guidance regarding the use of family 
members or friends as interpreters or to facilitate communication.\56\ 
These standards account for the issues of competency, confidentiality, 
privacy, and conflict of interest that arise as a result of relying on 
an informal (or ad hoc) interpreter. The provisions of Sec.  92.201(d) 
and (e) are consistent with oral interpretation standards that OCR has 
advanced through its resolution of Title VI cases and compliance 
reviews.\57\
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    \56\ HHS LEP Guidance, supra n. 17 at 68 FR at 47317-18.
    \57\ See, e.g., Voluntary Resolution Agreement between U.S. 
Dep't of Health & Human Servs., Office for Civil Rights and Mee 
Memorial Hosp., OCR Transaction Nos. 12-143846, 13-1551016, & 13-
153378, pt. II.J. (2014), available at https://www.hhs.gov/ocr/civilrights/activities/agreements/mee.html (defining qualified 
interpreter); Voluntary Resolution Agreement between U.S. Dep't of 
Health & Human Servs., Office for Civil Rights and Montgomery County 
Dep't of Soc. Servs., OCR Transaction No. 08-79992, pts. II.E 
(defining qualifications of an ``interpreter'' under the agreement), 
IV.H (requiring timely, competent language assistance); & IV.L 
(identifying interpreter standards), available at https://www.hhs.gov/ocr/civilrights/activities/examples/LEP/mcdssra.html.
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    In lieu of the approach we propose in Sec.  92.201(d) and (e), OCR 
considered proposing that all covered entities have the capacity to 
provide, in their health programs or activities, qualified interpreters 
for individuals with limited English proficiency through telephonic 
oral interpretation services available in at least 150 non-English 
languages. We considered proposing this requirement to ensure that 
every covered entity could provide a base level of cost-effective 
language assistance services to the nation's increasingly 
linguistically diverse populations. This alternate approach, relative 
to the approach we propose in Sec.  92.201(d) and (e), likely would 
improve access to health programs and activities for individuals with 
limited English proficiency; would improve the clarity of covered 
entities' obligations when communicating orally with individuals; and 
would mirror the requirement for Health Insurance Marketplaces and 
qualified health plan issuers to provide telephonic oral interpretation 
services described further below.\58\
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    \58\ See 45 CFR 155.205(c)(2)(i)(A).
---------------------------------------------------------------------------

    Despite these benefits, we were concerned with proposing an overly 
prescriptive approach that regulated the manner in which covered 
entities take reasonable steps to provide meaningful access to 
individuals with limited English proficiency, given the range in the 
types, sizes, and service areas of covered entities' health programs 
and activities regulated by Section 1557 and this proposed rule. We 
seek comment on what oral interpretation services, if any, we should 
require and how such approaches appropriately balance the provision of 
meaningful access to individuals with limited English proficiency while 
preserving covered entities' flexibilities to identify the means of 
providing such access.
    Even without a requirement in this proposed rule to provide 
telephonic oral interpretation services, OCR expects that most entities 
will, at a minimum, have the capacity to provide individuals with 
limited English proficiency with qualified interpreters remotely, given 
the widespread commercial availability of relatively low-cost language 
assistance services such as remote oral interpretation via telephone, 
as well as the nature and importance of covered entities' health 
programs or activities.
Acceptance of Language Assistance Services Is Not Required Sec.  
92.201(f)
    Proposed paragraph (f) provides that no individual with limited 
English proficiency shall be required to accept language assistance 
services, consistent with an individual's right to self-determination. 
Paragraph (f) also demonstrates the corollary that a covered entity 
cannot coerce an individual to decline language assistance services. If 
an individual with LEP voluntarily declines an offer of language 
assistance services from the covered entity, a covered entity could 
denote, in the individual's file or records, the language assistance 
services offered and the declination.\59\
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    \59\ See HHS LEP Guidance, supra n. 17 at 68 FR at 47318 
(identifying recordkeeping of language assistance services offered 
in provided as a best practice).
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    Covered entities, including Health Insurance Marketplaces, Medicaid 
programs, and qualified health plan issuers, are reminded that 
independent of proposed Sec.  92.201, they must comply with any 
applicable language access requirements in other laws and 
regulations.\60\ For instance, Marketplaces and qualified health plan 
issuers must provide language assistance services for applicants and 
enrollees who are limited English proficient,\61\ free of charge, 
including telephonic oral interpretation services in at least 150 non-
English languages.\62\ Moreover, under Public Health Service Act 
Section 2719, as added by the ACA and incorporated by reference into 
ERISA and the Internal Revenue Code,

[[Page 54185]]

non-grandfathered group health plans and health insurance issuers 
offering non-grandfathered health coverage are required to provide 
relevant notices in a culturally and linguistically appropriate 
manner.\63\ We invite comment on whether and, if so, to what extent and 
how, the requirements under these different authorities should be 
harmonized.
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    \60\ See, e.g., 42 U.S.C. 18031(e)(3)(B) (requiring health plans 
seeking certification as qualified health plans to provide 
information on certain claims payment and rating practices, cost-
sharing, and enrollee and participant rights in plain language, 
which means language that the intended audience, including 
individuals with limited English proficiency, can readily use and 
understand); 42 U.S.C. 18031(i)(3)(E) (statutorily requiring 
Navigators to provide culturally and linguistically appropriate 
services); 45 CFR 155.210(e)(5) (requiring Navigators to provide 
culturally and linguistically appropriate services), 42 CFR 431.905 
(requiring State agencies providing Medicaid programs to provide 
language assistance services for applicants and beneficiaries who 
are limited English proficient).
    \61\ See, e.g., 45 CFR 155.205(c)(2) (requiring accessibility of 
information provided to individuals with limited English 
proficiency); 155.205(a) (requiring Marketplace toll-free call 
center to be accessible to individuals with limited English 
proficiency), 155.205(b) (requiring Marketplace Web site to be 
accessible to individuals with limited English proficiency), 
155.205(d) (requiring Marketplace consumer assistance functions, 
including the Navigator program in 45 CFR 155.210, to be accessible 
to individuals with limited English proficiency), 155.205(d) 
(requiring Marketplace outreach and education activities to be 
accessible to individuals with limited English proficiency), 
155.230(b) (requiring applications, forms, and notices to be 
accessible to individuals with limited English proficiency), 156.250 
(requiring meaningful access to qualified health plan information). 
Starting in benefit year 2017, 45 CFR 155.205(c)(2)(iii) requires 
Marketplaces and QHP issuers to provide taglines in 15 non-English 
languages into translate Web site content in certain languages.
    \62\ 45 CFR 155.205(c)(2)(i)-(iii).
    \63\ The Department of Labor, HHS and the Department of Treasury 
issued interim final rules implementing the Internal Claims and 
Appeals and External Review Processes under the Public Health 
Service Act Section 2719, as added by the ACA, which describes the 
``culturally and linguistically appropriate'' standard requirements. 
See 29 CFR 2590.715-2719(e); 45 CFR 147.135 (e). See also 80 FR 
34292, 34310 (June 16, 2015) (Summary of Benefits and Coverage and 
Uniform Glossary Final Rule), extending the culturally and 
linguistically appropriate standards set forth in the internal 
claims and appeals and external review to the requirements of the 
Summary of Benefits and Coverage and Uniform Glossary requirements. 
That standard requires language assistance services for individuals 
who speak primary languages other than English and reside in a 
county that meets the threshold under the rules. Specifically, the 
rules establish a threshold with respect to the percentage of people 
residing in a particular county who are literate only in the same 
non-English language (currently 10%) based on American Community 
Survey data published by the United States Census Bureau. See 29 CFR 
2590.715-2719(e)(3). For individuals residing in counties that meet 
this threshold, the plan or issuer must provide oral language 
assistance services (such as a telephone customer assistance 
hotline) that include answering questions in any applicable non-
English language and providing assistance with filing claims and 
appeals in any applicable non-English language. The plan or issuer 
must also provide, upon request, notices in any applicable non-
English language and taglines must be included in the English 
versions of all notices provided to such individuals.
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Alternative Approaches
    Although we believe that the approach of the proposed rule best 
serves the purposes of the law, we considered a regulatory scheme 
requiring covered entities to provide meaningful access to each 
individual with limited English proficiency by providing effective 
language assistance services, at no cost, unless such action would 
result in an undue burden or a fundamental alteration of the health 
program or activity. Under this approach, a covered entity would be 
able to raise an undue burden or fundamental alteration defense but 
would be required, if it made this showing successfully, to take 
another action to provide meaningful access if there was one that was 
less burdensome or that did not fundamentally alter the nature of the 
health program or activity.
    We also considered a regulatory scheme that would require a 
predetermined range of language assistance services in certain non-
English languages. The language assistance services required and the 
languages required would vary based on certain factors, such as whether 
the covered entity is of a certain type or size, has frequent contact 
with individuals with limited English proficiency, or operates 
particularly important health programs or activities, among other 
potential factors. Under this approach, instead of requiring the 
Director to evaluate each case on its particular facts, the Director 
would evaluate a covered entity's compliance based on whether the 
entity provided the range of language assistance services in the non-
English languages specified. Potential categories of covered entities 
that could have enhanced obligations to provide language assistance 
services under this alternative approach could include State agencies 
administering Medicaid or CHIP, Health Insurance Marketplaces, or the 
Department in its operation of its health programs or activities. Other 
potential categories could include the following types of covered 
entities that have a minimum number of beds, employees, or locations: 
Hospitals, nursing homes or skilled nursing facilities, home health 
agencies, and retail pharmacies (including mail-order pharmacies). We 
seek comment on whether certain categories of covered entities should 
have enhanced obligations to provide language assistance services and, 
if so, what characteristics of covered entities should define these 
categories.
    We also considered a regulatory scheme requiring covered entities 
to provide a range of language assistance services in the non-English 
languages spoken by State-wide populations with limited English 
proficiency that meet defined thresholds. Such thresholds would provide 
a minimum number of non-English languages covered entities would be 
required to provide in delivering oral interpretation services; 
requirements for written translation of vital documents and Web site 
content; and requirements for including taglines on vital documents and 
on Web sites. For instance, we considered thresholds triggering a 
requirement to translate standardized vital documents based on number 
of languages (e.g., top ten languages spoken by individuals with 
limited English proficiency); percentage of language speakers (e.g., 
languages spoken by at least 5% of individuals with limited English 
proficiency); the number of language speakers (e.g., languages spoken 
by at least 5,000 individuals with limited English proficiency); and 
composite thresholds mixing and matching these approaches. For example, 
we considered a composite threshold requiring the translation of 
standardized vital documents in the top ten languages spoken State-wide 
by individuals with limited English proficiency and the languages 
spoken by at least 10,000 individuals with limited English proficiency 
State-wide. We also considered a composite threshold that would require 
the translation of vital documents in the top five languages spoken 
State-wide by individuals with limited English proficiency and the 
languages spoken by at least 5,000 individuals with limited English 
proficiency State-wide.
    We seek comment on whether OCR should require thresholds, and if 
so, what thresholds should be required, and to what geographic areas or 
service areas the thresholds should apply. If thresholds should be 
required, we seek comment on the time that should be allowed for 
covered entities to come into compliance with the thresholds, including 
whether this proposed rule should permit covered entities to implement 
their obligations with a phased-in approach. We also seek comment on 
other methodologies for formulating language access thresholds that 
would result in meaningful access for individuals regardless of 
national origin, while being mindful of the potential burden on covered 
entities.
    We further considered adopting a requirement for covered entities 
to be systematically prepared to provide language assistance services 
in their health programs or activities, such as through the 
establishment of policies and procedures or through other advanced 
planning mechanisms. In OCR's experience, covered entities are in a 
better position to meet their obligations to provide language 
assistance services in a timely manner to individuals with limited 
English proficiency when those entities identify, in advance, the types 
and levels of services that will be provided in each of the contexts in 
which the covered entity encounters individuals with limited English 
proficiency. Thus, the Department's LEP guidance encourages covered 
entities to conduct advanced planning through the establishment and 
implementation of language access plans.\64\
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    \64\ See HHS LEP Guidance, supra n. 17 at 68 FR at 47319-21 
(encouraging recipients to develop a language access plan (called an 
``LEP plan'' in the guidance)).
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    An advanced planning requirement could require each covered entity 
to identify all resources for providing language assistance services; 
to annually assess the frequently-encountered or highly prevalent 
languages in the

[[Page 54186]]

service area of the health program or activity; to establish written 
procedures to which frontline staff could refer when encountering 
individuals with limited English proficiency; and to monitor and 
oversee the quality of language assistance services provided. An 
advanced planning requirement could also require each covered entity to 
build its inventory of translated materials and capacity to provide 
oral language assistance to meet the needs of the national origin 
populations that the entity frequently serves.
    OCR solicited information in its Request for Information about 
covered entities' experience with one mechanism for advanced planning--
developing and implementing language access plans. Nearly all of the 
commenters who responded to the question regarding language access 
plans had experience developing and implementing plans themselves or 
providing technical assistance to other organizations that were doing 
so. Commenters identified benefits, such as: Increasing the likelihood 
of ensuring nondiscrimination on the basis of national origin with 
respect to individuals with LEP; facilitating consistent and 
appropriate language assistance services; and defining clear staff 
obligations and roles. Most commenters who responded to this question 
described language access plans or the institution of organizational 
policies and procedures as simple and non-burdensome. We seek comment 
on whether Sec.  92.201 should include a requirement for covered 
entities to be systematically prepared to provide language assistance 
services in their health programs or activities, and if so what 
advanced planning mechanisms should be required and why.
    Covered entities that are already developing or implementing 
language access plans, or otherwise assessing their language assistance 
needs, are encouraged to continue such efforts. Covered entities should 
be aware, however, that engaging in such planning is not a defense for 
failing to provide language assistance services to any particular 
individual, at all or in an untimely manner, if such services are 
reasonable steps to provide meaningful access. Covered entities that 
are conducting advanced planning should consider how they can ensure 
that language assistance services are available in their health 
programs and activities as they simultaneously improve their 
operational capacities to provide effective language assistance 
services into the future.
Effective Communication for Individuals With Disabilities (Sec.  
92.202)
    Proposed Sec.  92.202 incorporates the provisions governing 
effective communication with individuals with disabilities found in the 
regulation implementing Title II of the ADA, which applies to State and 
local government entities.\65\ OCR typically looks to the ADA for 
guidance in interpreting Section 504 as the two laws contain very 
similar standards. The Title II implementing regulation and the 
regulation implementing Title III of the ADA, which applies to places 
of public accommodation and commercial facilities, were amended in 
2010. The updated regulations provide clear, specific, and current 
guidance in understanding rights and responsibilities respecting 
effective communication with individuals with disabilities.
---------------------------------------------------------------------------

    \65\ Comments received during the RFI period illustrate that, 
despite longstanding existing Federal civil rights laws, individuals 
with disabilities continue to face inequality and discrimination in 
health care.
---------------------------------------------------------------------------

    The amended regulations incorporate longstanding Department of 
Justice interpretations regarding effective communication with 
individuals with disabilities under the ADA, which are consistent with 
OCR's enforcement of Section 504 and are a sound set of standards for 
incorporation into the Section 1557 regulation.
    OCR considered whether to incorporate the standards in the 
regulation implementing Title II of the ADA or in the regulation 
implementing Title III of the ADA, or the standards in both 
regulations. As summarized by the Department of Justice,\66\ standards 
regarding effective communication under both regulations are very 
similar. There are, however, limited differences between the Title II 
and Title III regulations, regarding limitations on the duty to provide 
a particular aid or service and the obligation under the Title II 
regulation to give primary consideration to the choice of an aid or 
service requested by the individual with a disability.
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    \66\ https://www.ada.gov/effective-comm.htm.
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    OCR proposes to apply the Title II standards to entities covered 
under the proposed rule. First, State or local government entities that 
are covered under the proposed rule are already subject to the Title II 
standards. Second, the other entities covered under the proposed rule 
are health programs and activities that either receive Federal 
financial assistance from HHS or are conducted directly by HHS. 
Although OCR could apply Title II standards to States and local 
entities and Title III standards to private entities, we believe it is 
appropriate to hold all recipients of Federal financial assistance from 
HHS to the higher Title II standards as a condition of their receipt of 
that assistance. OCR also believes it appropriate to hold HHS itself to 
the same standards to which the Department subjects the recipients of 
its financial assistance.
    Where the regulatory provisions referenced in Sec.  92.202 use the 
term ``public entity,'' that term shall be replaced with ``covered 
entity.''
Accessibility Standards for Buildings and Facilities (Sec.  92.203)
    The Section 504 regulatory provisions incorporated into Subpart B 
in this proposed regulation contain program accessibility requirements 
that apply to existing facilities as well as new construction and 
alterations. This proposed provision establishes specific accessibility 
standards for new construction and alterations. OCR notes that these 
standards are consistent with existing standards under the ADA.
    Under Sec.  92.203(a) of the proposed rule, each facility or part 
of a facility in which health programs or activities are conducted that 
is constructed or altered by or on behalf of, or for the use of, a 
recipient or State-based marketplace shall comply with the 2010 ADA 
Standards for Accessible Design (2010 Standards), as defined in 28 CFR 
35.104, if construction or alteration was commenced on or after [18 
MONTHS FROM DATE OF PUBLICATION OF FINAL RULE]. All newly constructed 
or altered buildings or facilities subject to this section shall comply 
with the requirements for a ``public building or facility'' as defined 
in Section 106.5 of the 2010 Standards.
    Under Sec.  92.101(b)(2)(i) of the proposed rule, new construction 
and alterations of such facilities are also subject to the new 
construction standards found in the Section 504 implementing regulation 
at 45 CFR 84.23(a) and (b). OCR is not incorporating 45 CFR 84.23(c), 
which treats compliance with the Uniform Federal Accessibility 
Standards as compliance with 45 CFR 84.23(a) and (b) because the 2010 
Standards are more current than the Uniform Federal Accessibility 
Standards. Moreover, nearly all of the facilities covered under the 
proposed rule are already subject to the 2010 Standards. This provision 
will require facilities subject to the ADA and Section 1557 to comply 
with the same accessibility standards for new construction or 
alterations.

[[Page 54187]]

    However, under Sec.  92.203(b) of the proposed rule, each facility 
or part of a facility in which health programs or activities are 
conducted that is constructed or altered by or on behalf of, or for the 
use of, a recipient or State-based Marketplace before [18 MONTHS FROM 
DATE OF PUBLICATION OF FINAL RULE] in conformance with the Uniform 
Federal Accessibility Standards, the 1991 Standards, or the 2010 
Standards shall be deemed to comply with the requirements of this 
section and with 45 CFR 84.23 (a) and (b), cross referenced in Sec.  
92.101(b)(2)(i) with respect to those facilities. Thus, if the 
construction or alteration of facilities began prior to the effective 
date of paragraph (a) of this section, the facilities shall be deemed 
in compliance if they were constructed or altered in conformance with 
applicable standards at the time of their construction or alteration.
    Under Sec.  92.203(c) of the proposed rule, each building or part 
of a building that is constructed or altered by or on behalf of, or for 
the use of, the Department must be designed, constructed, or altered so 
as to be readily accessible to and usable by individuals with 
disabilities. The definitions, requirements, and standards of the 
Architectural Barriers Act, as established in Appendices C and D to 36 
CFR part 1191, apply to buildings and facilities covered by this 
section.
    OCR considered adding specific language regarding accessibility 
standards for medical diagnostic equipment. However, we are aware that 
the United States Access Board is currently developing standards for 
accessible medical diagnostic equipment and, therefore, are deferring 
on proposing specific accessibility standards for medical equipment at 
this time. Once the United States Access Board standards are 
promulgated, OCR intends to issue regulations or policies that require 
covered entities to conform to those standards. We request comment on 
this proposal. We note that a health program or activity's use of 
medical diagnostic equipment is covered by Section 1557 and this 
proposed rule under the general prohibition of discrimination on the 
basis of disability in Sec.  92.101.
Accessibility of Electronic and Information Technology (Sec.  92.204)
    Section 92.204(a) of the proposed rule requires covered entities to 
ensure that their health programs or activities provided through 
electronic and information technology are accessible to individuals 
with disabilities, unless doing so would impose undue financial and 
administrative burdens or would result in a fundamental alteration in 
the nature of an entity's health program or activity.\67\ For example, 
a Health Insurance Marketplace creating a Web site for application for 
health insurance coverage must ensure that individuals with 
disabilities have an equal opportunity to benefit from the Web site's 
tool that allows comparison of health insurance coverage options, quick 
determination of eligibility, and facilitation of timely access to 
health insurance coverage by making its new Web site accessible to 
individuals who are blind or who have low vision.
---------------------------------------------------------------------------

    \67\ The terms ``undue financial and administrative burdens'' 
and ``fundamental alteration'' as used in this part have the same 
meaning that they have under the ADA.
---------------------------------------------------------------------------

    This provision is consistent with existing standards applicable to 
covered entities. Specifically, Section 508 of the Rehabilitation Act 
requires that electronic and information technology developed, 
procured, maintained, or used by Federal agencies be accessible for 
individuals with disabilities. Section 508 applies to HHS administered 
health programs or activities, including the Federally-facilitated 
Marketplaces. Section 504 and the ADA, which apply to recipients of 
Federal financial assistance, and to State and local government 
entities and places of public accommodation, respectively, similarly 
have been interpreted to require that covered entities' programs, 
services, and benefits provided through electronic and information 
technology be accessible to individuals with disabilities.\68\
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    \68\ See, e.g., discussion in Dep't of Justice, Advanced Notice 
of Proposed Rulemaking: Accessibility of Web Information and 
Services of State and Local Government Entities and Public 
Accommodations, 75 FR 43460, 43462-67 (Jul. 26, 2010) discussing 
Section 504 and Title II of the ADA).
---------------------------------------------------------------------------

    Section 92.204(b) proposes to require State-based Marketplaces and 
recipients of Federal financial assistance to ensure that their health 
programs and activities provided through Web sites comply with the 
accessibility requirements of Title II of the ADA. OCR has decided to 
adopt Title II requirements for a number of reasons. First, State-based 
Marketplaces, as State entities, are already subject to the ADA Title 
II requirements. Second, even though recipients of Federal financial 
assistance from HHS include both entities covered by Title II of the 
ADA, as State and local government entities, and entities covered by 
Title III of the ADA, as places of public accommodation and commercial 
facilities, we believe it is appropriate to apply one uniform standard 
to all recipients of Federal financial assistance from HHS under the 
proposed rule. Further, it is reasonable to hold recipients of Federal 
financial assistance from HHS to the Title II ADA requirements (rather 
than those of Title III of the ADA), since Title II is modeled on 
Section 504, which applies to recipients of Federal financial 
assistance. Our proposed regulatory text cross-references the Title II 
regulations as a whole, which would therefore incorporate any future 
changes to the Title II regulations.
    These requirements are informed by this Department's extensive 
experience with web-based technology through Federal grant-making 
programs, including programs that provide funds for State 
infrastructure changes to allow electronic applications for 
participation in the Medicaid program and the Health Insurance 
Marketplaces, provider adoption of electronic health records, and the 
development of web-based curricula for health care professionals.
    Based on the Department's prior experience in this field, we 
believe that including an explicit requirement for electronic and 
information technology is necessary to clarify the obligations of 
covered entities to make this technology accessible. In addition, we 
are concerned that without an explicit requirement for accessible 
electronic and information technology, people with disabilities will 
not have opportunities to participate in services, programs, and 
activities that are equal to and as effective as those provided to 
others, further exacerbating existing health disparities for persons 
with disabilities. The RFI yielded numerous comments and concerns about 
the lack of accessibility of electronic and information technology and 
the incidents of and potential for discrimination, for example with 
respect to health information.
    OCR initially considered whether to limit the explicit 
accessibility requirements to a covered entity's Web site only, rather 
than all of a covered entity's electronic and information technology. 
However, given the existing requirements under Section 504, Section 
508, and the ADA applicable to information provided through electronic 
and information technology as a whole, and given the importance of such 
technologies, such as kiosks and applications, to access to health 
care, health-related insurance and other health-related coverage, we 
have decided to include an explicit accessibility requirement that 
applies to all of a covered entity's electronic and information 
technology. We seek comment on this proposal.

[[Page 54188]]

    In addition to proposing that Web sites of recipients of Federal 
financial assistance and State-based Marketplaces comply with the 
accessibility requirements of Title II of the ADA, OCR also considered 
requiring all covered entities to ensure that all their electronic and 
information technology comply with specific accessibility standards, 
such as standards developed pursuant to Section 508 by the Access Board 
at 36 CFR part 1194, the Worldwide Web Consortium's Web Accessibility 
Initiative's WCAG 2.0 AA, or other standards that provide equal or 
greater accessibility to individuals with disabilities. As part of this 
alternative, OCR considered whether a phased-in approach to 
accessibility similar to the one recently taken by the Department of 
Transportation might be appropriate.\69\ Most States already apply, to 
State agency Web sites, a standard based on Section 508 or WCAG, 
thereby reducing any regulatory burden from such a requirement.\70\ In 
addition, obligating covered entities to make their electronic 
information and technology comply with the accessibility requirements 
of Title II of the ADA should facilitate their compliance with any 
accessibility standards adopted in the future. Further, the Department 
of Justice is applying WCAG standards to municipal and public 
accommodations entities in publicly announced settlements.\71\ Finally, 
this alternative would provide more clarity for those covered entities 
and enhance access for individuals with disabilities.
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    \69\ See Nondiscrimination on the Basis of Disability in Air 
Travel: Accessibility of Web sites and Automated Kiosks at U.S. 
Airports, 76 FR 59307 (Sept. 26, 2011).
    \70\ The following states apply WCAG 2.0 (AA) to State agency 
Web sites: Alaska (https://doa.alaska.gov/ada/resources/web.html) 
(note that Alaska's standard for training, authoring, and 
procurement of accessible electronic and information technology is 
currently consistent with Level A Success Criteria and Conformance 
Requirements and Alaska is migrating toward WCAG 2.0 AA compliance 
as tools, training and resources permit; Georgia (https://georgia.gov/accessibility); Hawaii (https://portal.ehawaii.gov/page/accessibility/); Minnesota (mn.gov/mnit/images/Stnd_State_Accessibility.pdf). Virginia and Oklahoma have statutory 
requirements to apply Section 508 to State agencies (https://section508.gov/state-policy), and many others have adopted similar 
policies (https://www.ssbbartgroup.com/reference/laws-and-standards/state-and-local-laws/). In addition, States may utilize third party 
test software programs, which may utilize a Section 508/WCAG or a 
higher standard, to determine the accessibility of its Web sites.
    \71\ ADA Enforcement Activities--Settlements (Department of 
Justice) https://www.ada.gov/enforce_activities.htm#settlements.
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    However, this alternative could potentially place a greater burden 
on recipients of Federal financial assistance and Title I entities. In 
addition, we are aware that the Access Board is in the process of 
amending and updating the Section 508 standards applicable to 
electronic and information technology. Given these developments and 
circumstances, we are proposing a general accessibility performance 
standard for electronic and information technology, rather than a 
requirement for conformance to a specific set of accessibility 
standards. The application of this general accessibility performance 
standard will be informed by future rulemaking by the Access Board and 
the Department of Justice. We seek comment on whether the regulation 
should impose a general accessibility performance standard for 
electronic and information technology or require that electronic and 
information technology comply with a specific set of standards, such as 
the Section 508 or WCAG standards.
    As noted, under the proposed rule, covered entities must make their 
health programs and activities provided through electronic and 
information technology accessible, unless doing so would impose undue 
financial and administrative burdens or would result in a fundamental 
alteration in the nature of the health program or activity. In 
determining whether an action would be an undue burden, a covered 
entity must consider all resources available for use in the funding or 
operation of the health program or activity.
    When undue financial and administrative burdens or a fundamental 
alteration are determined to exist, the covered entity is still 
required to provide information in a format other than an accessible 
electronic format that would not result in such undue financial and 
administrative burdens or a fundamental alteration, but would ensure, 
to the maximum extent possible, that individuals with disabilities 
receive the benefits or services of the health program or activity that 
are provided through electronic and information technology.
Requirement To Make Reasonable Modifications (Sec.  92.205)
    Section 92.205 of the proposed rule provides that a covered entity 
shall make reasonable modifications in policies, practices, or 
procedures when necessary to avoid discrimination on the basis of 
disability, unless the covered entity can demonstrate that the 
modification would fundamentally alter the nature of the health program 
or activity. This provision is consistent with the U.S. Supreme Court's 
decision interpreting Section 504 in Alexander v. Choate, 469 U.S. 287 
(1985), Title II of the ADA, and OCR's longstanding interpretation of 
Section 504.
Equal Program Access on the Basis of Sex (Sec.  92.206)
    Section 92.206 proposes that covered entities be required to 
provide individuals equal access to their health programs or activities 
without discrimination on the basis of sex and proposes that covered 
entities treat individuals consistent with their gender identity. This 
provision applies to all health programs and activities, and prohibits, 
among other forms of adverse treatment, the denial of access to 
facilities administered by the covered entity. This proposed approach 
is consistent with the principle that discrimination on the basis of 
sex includes discrimination on the basis of gender identity and that 
failure to treat individuals in accordance with their gender identity 
may constitute prohibited discrimination. It is also consistent with 
recent guidance issued and enforcement actions taken by the U.S. 
Department of Education, the U.S. Department of Justice, and the Equal 
Employment Opportunity Commission.\72\
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    \72\ See, e.g., U.S. Dep't of Educ., Questions and Answers on 
Title IX and Single-Sex Elementary and Secondary Classes and 
Extracurricular Activities (2014); U.S. Dep't of Justice, Office of 
Justice Programs, Office for Civil Rights, Frequently Asked 
Questions, Nondiscrimination Grant Condition in the Violence Against 
Women Reauthorization Act of 2013 (2014); Resolution Agreement 
Between the Arcadia Unified School District, the U.S. Dep't of 
Educ., Office for Civil Rights, and the U.S. Dep't of Justice, Civil 
Rights Division, OCR Case Number 09-12-1020, DOJ Case Number 169-
12C-70 (July 24, 2013); Complainant v. McHugh, EEOC Appeal No. 
0120133395 (Apr. 1, 2015). See also U.S. Dep't of Educ., Questions 
and Answers on Title IX and Sexual Violence at B-2, available at 
https://www2.ed.gov/about/offices/list/ocr/docs/qa-201404-title-ix.pdf.
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    The limited exception to the requirement that covered entities 
treat individuals consistent with their gender identity is that a 
covered entity may not deny or limit health services that are 
ordinarily or exclusively available to individuals of one gender based 
on the fact that the individual's sex assigned at birth, gender 
identity, or gender otherwise recorded in a medical record or by a 
health insurance plan is different from the one to which such health 
services are ordinarily or exclusively available. The exception applies 
only in limited circumstances. For example, a covered entity may not 
deny an individual treatment for ovarian cancer where the individual 
could benefit medically from the treatment, based on the individual's 
identification as a transgender male.

[[Page 54189]]

Nondiscrimination in Health-Related Insurance and Other Health-Related 
Coverage (Sec.  92.207)
    Section 92.207 of the proposed rule emphasizes and provides 
specific details regarding the prohibition of discrimination on the 
basis of race, color, national origin, sex, age, or disability in the 
provision and administration of health-related insurance or other 
health-related coverage. This prohibition applies to all covered 
entities that provide or administer health-related insurance or other 
health-related coverage, including health insurance issuers and group 
health plans that are recipients of Federal financial assistance and 
the Department in the administration of its health-related coverage 
programs. This section is independent of, but complements, the 
nondiscrimination provisions at 45 CFR 155.120(c)(1) and (2) that apply 
to the Health Insurance Marketplaces and 45 CFR 156.200(e) that apply 
to issuers of qualified health plans through the Health Insurance 
Marketplaces with respect to their qualified health plans. These 
provisions prohibit discrimination on the basis of race, color, 
national origin, disability, age, sex, gender identity or sexual 
orientation, and entities covered under them and Section 1557 are 
obligated to comply with both sets of requirements.
    Based on the longstanding civil rights principles discussed in 
connection with the definition of ``health program or activity'' in 
Sec.  92.4 of this proposed rule, we propose to apply this part to all 
issuers that receive Federal financial assistance, whether those 
issuers' products are offered through the Marketplace, outside the 
Marketplace, in the individual or group health insurance markets, or as 
an employee health benefit program through an employer-sponsored group 
health plan. Thus, for example, an issuer that participates in the 
Marketplace and thereby receives Federal financial assistance, and that 
also offers plans outside the Marketplace, will be covered by the 
proposed regulation for all of its health plans, as well as when it 
acts as a third party administrator for an employer-sponsored group 
health plan.\73\
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    \73\ Where an entity that acts as a third party administrator 
for an employer's employee health benefit plan is legally separate 
from an issuer that receives Federal financial assistance for its 
insurance plans, we will engage in a case-by-case inquiry to 
evaluate whether that entity is appropriately subject to Section 
1557.
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    Paragraph (a) of the proposed rule provides a general 
nondiscrimination requirement, and paragraph (b) provides specific 
examples of prohibited actions. Paragraphs (b)(1) and (2) address the 
prohibition on denying, cancelling, limiting, or refusing to issue or 
renew a health-related insurance plan or policy or other health-related 
coverage on the basis of an enrollee's or prospective enrollee's race, 
color, national origin, sex, age, or disability, and the use of 
marketing practices or benefit designs that discriminate on these 
bases.
    The proposed rule does not require plans to cover any particular 
benefit or service, but a covered entity cannot have a coverage policy 
that operates in a discriminatory manner. For example, a plan that 
covers inpatient treatment for eating disorders in men but not women 
would not be in compliance with the prohibition of discrimination based 
on sex. Similarly, a plan that covers bariatric surgery in adults, but 
excludes such coverage for adults with particular developmental 
disabilities would not be in compliance with the prohibition on 
discrimination based on disability.
    Paragraphs (b)(3) through (5) of the proposed rule specifically 
address discrimination faced by transgender individuals in accessing 
coverage of health services. We propose in paragraph (b)(3) that to 
deny or limit coverage, deny a claim, or impose additional cost sharing 
or other limitations or restrictions, on any health service is 
impermissible discrimination when the denial or limitation is due to 
the fact that the individual's sex assigned at birth, gender identity, 
or gender otherwise recorded by the plan or issuer is different from 
the one to which such services are ordinarily or exclusively 
available.\74\ For example, although many sex-specific preventive care 
services (e.g. pelvic or prostate exams or mammograms) are routinely 
covered by covered entities, RFI commenters stated that individuals are 
routinely denied coverage for medically appropriate sex-specific health 
services due to their gender identity or because they are enrolled in 
their health plans as one sex, where the health service is generally 
associated with another sex. Under our proposed rule, coverage for 
medically appropriate health services must be made available on the 
same terms for all individuals, regardless of sex assigned at birth, 
gender identity, or recorded gender. Thus, for example, coverage cannot 
be denied for an individual for whom a pelvic exam is medically 
appropriate based on the fact that the individual either identifies as 
a transgender man or is enrolled in the health plan as a man.\75\
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    \74\ Under Section 207(a), a covered entity would be barred from 
denying coverage of any claim (not just for sex-specific services) 
on the basis that the enrollee is transgender.
    \75\ OCR recognizes that insurers may use computer systems, that 
at times, flag a gender mismatch for services requested; such 
flagging, by itself, would not be impermissible where it does not 
result in a denial of services or a claim for services.
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    In addition, many health-related insurance plans or other health-
related coverage, including Medicaid programs, currently have explicit 
exclusions of coverage for all care for beneficiaries related to gender 
dysphoria or associated with gender transition. Historically, covered 
entities have justified these blanket exclusions by categorizing 
transition-related treatment as cosmetic or experimental.\76\ However, 
such across-the-board categorization is now recognized as outdated and 
not based on current standards of care. For example, a May 2013 
decision of the HHS Departmental Appeals Board invalidated Medicare's 
National Coverage Determination 140.3, which disallowed coverage of 
``transsexual surgery'' because the record indicated that the blanket 
denial of coverage was not reasonably based on the state of current 
medical science.\77\
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    \76\ Liza Khan, Transgender Health at the Crossroads, 11 Yale J. 
Health Pol'y L. & Ethics 375,377 (2011).
    \77\ U.S. Dep't of Health and Human Serv. Departmental Appeals 
Board. Appellate Division NCD 140.3, Docket No. A-13-87, Decision 
No. 2576 (May 30, 2013). The board cited to the World Professional 
Association for Transgender Health (WPATH), an international 
multidisciplinary professional association that publishes Standards 
of Care for the Health of Transsexual, Transgender, and Gender 
Nonconforming People (7th ed. 2012), which provides clinical 
guidance for health professionals.
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    For similar reasons, an increasing number of states, including, 
California,\78\ Colorado,\79\ Connecticut,\80\ Illinois,\81\ 
Massachusetts,\82\ Nevada,\83\

[[Page 54190]]

New York,\84\ Oregon,\85\ Vermont,\86\ Washington State,\87\ and the 
District of Columbia,\88\ have laws and policies providing that 
exclusions and denials of coverage for treatment for gender identity 
disorder are or are likely to be discriminatory in at least some 
circumstances.\89\ Likewise, the Office of Personnel Management issued 
a letter on June 23, 2015, to health insurance carriers participating 
in the Federal Employees Health Benefits Program indicating that ``no 
[such] carrier may have a general exclusion of services, drugs or 
supplies related to gender transition or `sex transformations.' '' \90\ 
Additionally, a significant number of public and private employers are 
offering coverage to employees that includes coverage for transition-
related services.\91\
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    \78\ State of California Department of Managed Health Care. 
(2013). Gender Nondiscrimination Requirements, Letter No. 12-K, 
available at https://www.dmhc.ca.gov/Portals/0/LawsAndRegulations/DirectorsLettersAndOpinions/dl12k.pdf.
    \79\ Colorado Department of Regulatory Agencies. (2013). 
Division of Insurance Bulletin No. B-4.49, available at https://www.one-colorado.org/wp-content/uploads/2013/03/B-4.49.pdf.
    \80\ Connecticut Insurance Department. (2013). Bulletin IC-34, 
available at https://www.ct.gov/cid/lib/cid/Bulletin_IC-37_Gender_Identity_Nondiscrimination_Requirements.pdf.
    \81\ Illinois Department of Insurance. (2014). Company Bulletin 
2014-10, available at https://insurance.illinois.gov/cb/2014/CB2014-10.pdf.
    \82\ Massachusetts Office of Consumer Affairs and Business 
Regulation. (2014). Division of Insurance Bulletin 2014-03, 
available at https://www.mass.gov/ocabr/docs/doi/legal-hearings/bulletin-201403.pdf.
    \83\ Nevada Division of Insurance. (2015). 15-002--Prohibition 
of Denial, Exclusion, or Limitation of Medically Necessary Health 
Care Services on the Basis of Gender Identity or Expression, 
available at https://doi.nv.gov/uploadedFiles/doinvgov/_public-documents/News-Notices/Bulletins/Bulletin%2015-002.pdf.
    \84\ New York State Department of Financial Services. (2014). 
Insurance Circular Letter No. 7, available at https://www.dfs.ny.gov/insurance/circltr/2014/cl2014_07.pdf.
    \85\ Oregon Department of Consumer and Business Services. 
(2012). Insurance Division Bulletin INS 2012-1, available at https://www.oregon.gov/DCBS/insurance/legal/bulletins/Documents/bulletin2012-01.pdf.
    \86\ Vermont Department of Financial Regulation. (2014). 
Division of Insurance Bulletin No. 174, available at https://www.dfr.vermont.gov/sites/default/files/Bulletin_174.pdf.
    \87\ Washington Office of Insurance Commissioner. (2014). Letter 
to Health Insurance Carriers in Washington State, available at 
https://www.insurance.wa.gov/about-oic/newsroom/news/2014/documents/gender-identity-discrimination-letter.pdf.
    \88\ District of Columbia Department of Insurance, Securities, 
and Banking. (2014). Bulletin 13-IB-01-30/15 (Revised), available at 
https://www.insurance.wa.gov/about-oic/newsroom/news/2014/documents/gender-identity-discrimination-letter.pdf.
    \89\ https://www.transhealthcare.org/states-that-have-banned-anti-transgender-discrimination-in-health-insurance/.
    \90\ U.S. Office of Personnel Management. FEHB Program Carrier 
Letter, Letter No. 2015-12 (Jun. 23, 2015), available at https://transequality.org/sites/default/files/images/blog/FEHB%20CL%202015-12%20Covered%20Benefits%20for%20Gender%20Transition%20Services.pdf.
    \91\ Kellan Baker & Andrew Cray, Center for American Progress, 
FAQ: Health Insurance Needs for Transgender Americans (Oct. 12, 
2013), available at https://www.americanprogress.org/issues/lgbt/report/2012/10/03/40334/faq-health-insurance-needs-for-transgender-americans/.
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    OCR proposes to apply basic nondiscrimination principles in 
evaluating whether a covered entity's denial of a claim for coverage of 
treatment related to transition-related care is the product of 
discrimination. Based on these principles, an explicit, categorical (or 
automatic) exclusion of coverage for all health services related to 
gender transition is unlawful on its face under paragraph (b)(4); in 
singling out the entire category of services and treatments for 
transition-related care, such an exclusion systematically denies 
services and treatments for transgender individuals and is prohibited 
discrimination on the basis of sex.
    Moreover, we propose in Sec.  92.207(b)(5) to bar a covered entity 
from denying or limiting coverage, or denying a claim for coverage, for 
specific health services related to gender transition where such a 
denial or limitation results in discrimination against a transgender 
individual. In evaluating whether it is discriminatory to deny or limit 
a request for coverage of a particular service for an individual 
seeking the service as part of transition-related care, OCR will start 
by inquiring whether and to what extent coverage is available when the 
same service is not related to gender transition. If, for example, a 
health plan or State Medicaid agency denies a claim for coverage of a 
hysterectomy that a patient's provider says is medically necessary to 
treat gender dysphoria, OCR will evaluate the extent of the plan's 
coverage of hysterectomies under other circumstances. OCR will also 
carefully scrutinize whether the covered entity's explanation for the 
denial or limitation of coverage for transition-related care is 
legitimate and not a pretext for discrimination.
    These provisions do not, however, affirmatively require covered 
entities to cover any particular procedure or treatment for transition-
related care; nor do they preclude a covered entity from applying 
neutral standards that govern the circumstances in which it will offer 
coverage to all its enrollees in a nondiscriminatory manner.
    We invite comment as to whether the approach of Sec.  92.207(b)(1)-
(5) is over or under inclusive of the types of potentially 
discriminatory claim denials experienced by transgender individuals in 
their attempts to access coverage and care, as well as on how 
nondiscrimination principles apply in this context.
    Paragraph (c) of Sec.  92.207 provides that the enumeration of 
specific forms of discrimination in paragraph (b) does not limit the 
general applicability of the prohibition in paragraph (a) of this 
section. Paragraph (d) of the proposed rule provides that nothing in 
Sec.  92.207 is intended to determine, or restrict a covered entity 
from determining, whether a particular health care service is medically 
necessary or otherwise meets applicable coverage requirements in any 
individual case.
Employer Liability for Discrimination in Employee Health Benefit 
Programs (Sec.  92.208)
    Proposed Section 92.208 addresses the application of Section 1557 
to employers that offer health benefit programs to their employees. 
Under our proposed approach, where an entity that receives Federal 
financial assistance provides an employee health benefit program to its 
employees, it will be liable for discrimination in that employee health 
benefit program under this part only in the following circumstances:
    (a) The entity is principally engaged in providing or administering 
health services or health insurance coverage;
    (b) The entity receives Federal financial assistance the primary 
objective of which is to fund the entity's employee health benefit 
program; or
    (c) The entity is not principally engaged in providing or 
administering health services or health insurance coverage but operates 
a health program or activity (which is not an employee health benefit 
program) that receives Federal financial assistance; except that in 
such cases, the entity is accountable under this part with regard to 
the provision or administration of employee health benefits only to the 
employees in that health program or activity.
    Under Sec.  92.208(a) of the proposed rule, where an employer is 
principally engaged in providing or administering health services or 
health coverage and receives Federal financial assistance, the employer 
will be subject to Section 1557 in its provision or administration of 
employee health benefit programs to its employees. Thus, if a hospital 
provides health benefits to its employees, it will be covered by 
Section 1557 not only for the services it offers to its patients or 
other beneficiaries but also for the health benefits it provides to its 
employees.\92\
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    \92\ This approach is consistent with the basic principle 
underlying the proposed rule and derived from longstanding civil 
rights interpretations: where an entity that receives Federal 
financial assistance is principally engaged in providing or 
administering health services or health insurance coverage, all of 
its operations will be covered by Section 1557.
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    Under proposed Sec.  92.208(b), where an entity receives Federal 
financial assistance the primary objective of which is to fund an 
employee health benefit program, that entity's provision or 
administration of the health benefit program will be covered by Section 
1557 regardless of the business in which the entity is engaged. Where, 
for example, an entity receives Federal financial assistance that is 
specifically designated to support its employee wellness program, this 
part will apply to the entity's administration of that wellness 
program.
    Proposed Sec.  92.208(c) seeks to clarify that an employer that is 
not principally

[[Page 54191]]

engaged in providing or administering health services or health 
insurance coverage, but that operates a health program or activity 
(that is not an employee health benefit program) that receives Federal 
financial assistance will be covered by this part for its provision or 
administration of an employee health benefit program, but only with 
regard to employees in the health program or activity. Thus, when a 
State receives Federal financial assistance for its Medicaid program, 
the State is governed by Section 1557 in the provision of employee 
health benefits for its Medicaid employees, but not for its 
transportation department employees, assuming no part of the State 
transportation department operates a health program or activity.
    In summary, unless the primary purpose of the Federal financial 
assistance is to fund employee health benefits, we propose to not apply 
Section 1557 to an employer's provision of employee health benefits 
where the provision of those benefits is the only health program or 
activity operated by the employer. If, for example, a community 
organization that exclusively offers a legal clinic receives Federal 
financial assistance, and the organization uses grant funds to support 
personnel costs, including employee health benefits, Section 1557 would 
not apply to the organization's provision of employee health 
benefits.\93\
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    \93\ Health insurance issuers whose products are offered by an 
employer through its employee health benefit plans would continue to 
be covered under the standards set forth in Section 92.207: where an 
issuer receives Federal financial assistance, its operation of all 
of its health plans, whether offered through the Marketplace, the 
individual or group health insurance markets, or employee benefit 
plans, will be covered under this part. This analysis is independent 
of the analysis in proposed Section 92.208 of the employer's 
liability for discrimination in the employee benefit plans that it 
sponsors.
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    Absent the limitations this rule proposes in Sec.  92.208, 
employers that receive Federal financial assistance for any purpose 
could be held liable for discrimination in the employee health benefit 
programs they provide or administer, where those employers are not 
otherwise engaged in a health program or activity and where the use of 
Federal funds for employee health benefits is merely incidental to the 
purpose of the assistance. We believe that claims of discrimination in 
such benefits, brought against employers that do not operate other 
health programs or activities, are better addressed under other 
applicable laws.
    We propose to apply the same analysis of employer liability under 
Section 1557 whether the employee health benefit program is self-
insured or fully-insured by the employer. Where an employer that would 
otherwise be covered under this section creates a separate legal entity 
to administer its employee health benefit plan, the employer continues 
to be liable for the nondiscriminatory provision of employee health 
benefits to its employees; the employer, as a recipient, may not, 
through contractual or other arrangements, discriminate on a prohibited 
basis against its employees.\94\
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    \94\ With regard to the liability of the legal entity that an 
employer creates to administer its employee benefit plan, by 
contrast, we propose to analyze questions related to the application 
of Section 1557 to the issuer or group health plan on a case by case 
basis consistent with longstanding principles of nondiscrimination 
law. We will ask, for example, whether the plan itself receives 
Federal financial assistance, such as through receipt of Medicare 
Part D payments. If it does not, we will evaluate the plan's 
relationship with the employer in assessing whether Section 1557 
applies to the plan.
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Nondiscrimination on the Basis of Association (Sec.  92.209)
    Section 92.209 of the proposed rule specifically addresses 
discrimination faced by an individual or an entity on the basis of the 
race, color, national origin, age, disability, or sex of an individual 
with whom the individual or entity is known or is believed to have a 
relationship or association. The language of Section 1557 makes clear 
that individuals may not be subject to any form of discrimination ``on 
the grounds prohibited by'' Title VI and other civil rights laws; the 
statute does not restrict that prohibition to discrimination based on 
the individual's own race, color, national origin, age, disability or 
sex. Further, a prohibition on associational discrimination is 
consistent with longstanding interpretations of existing civil rights 
laws that prohibit discrimination on identified bases, whether the 
basis is a characteristic of the harmed individual or an individual who 
is associated with the harmed individual.\95\ A prohibition on 
associational discrimination is also consistent with the approach taken 
in the ADA, which includes a specific prohibition of discrimination 
based on association with an individual with a disability.\96\
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    \95\ See McGinest v. GTE Service Corp., 360 F. 3d 1103, 1118 
(9th Cir. 2004) (case involving indirect comments in the workplace 
that crossed racial lines, noting that ``Title VII has . . . been 
held to protect against adverse employment actions taken because of 
the employee's close association with black friends or coworkers'') 
(internal citations omitted); Tetro v. Elliot Popham Pontiac, 
Oldsmobile, Buick & GMC Trucks Inc., 173 F.3d 988, 994-95 (6th Cir. 
1999) (holding that white plaintiff with biracial child stated a 
claim under Title VII based on his own race ``even though the root 
animus for the discrimination is a prejudice against the biracial 
child''); Parr v. Woodmen of the World Life Ins., 791 F.2d 888, 892 
(11th Cir. 1986) (``Where a plaintiff claims discrimination based 
upon an interracial marriage or association, he alleges by 
definition that he has been discriminated against because of his 
race.''); Arceneaux v. Vanderbilt University, 25 Fed. Appx. 345 (6th 
Cir. 2001) (unpub'd) (treating sex discrimination as associational 
discrimination).
    \96\ 42 U.S.C. 12182(b)(1)(E). See also Loeffler v. Staten 
Island Univ. Hosp., 582 F.3d 268, 279 (2d Cir. 2009) (permitting 
associational discrimination claim under Section 504); Falls v. 
Prince George's Hosp. Ctr., No. 97-1545, 1999 U.S. Dist. LEXIS 22551 
(D. Md.1999) (holding that parent had an associational 
discrimination claim under Title III of the ADA because hospital 
directly discriminated against parent by requiring hearing parent to 
act as interpreter for child who was deaf). See generally https://www.eeoc.gov/facts/association_ada.html.
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    Associational discrimination prohibited by this rule can arise in 
multiple contexts. For example, a primary care physician could not 
refuse to accept a new patient because the physician disapproves of 
this individual's family relationships; i.e., because of the race, 
color, national origin, age, sex, or disability-status of one or more 
of the patient's family members. This refusal is impermissible 
associational discrimination because it is on grounds prohibited by 
Section 1557. That is, if the patient's family member(s) was not of a 
particular race, color, national origin, age, sex, or disability-
status, the individual would have been accepted as a new patient.
    Similarly, a physician could not deny a medical appointment to a 
patient who is an individual without a disability on the basis that the 
patient will be accompanied by a family member who is deaf and who will 
require a sign language interpreter; Sec.  92.202 of this proposed rule 
requires effective communication with individuals with disabilities, 
including companions with disabilities, and denying an appointment 
based on the patient's association with an individual with a disability 
who needs an interpreter thus would constitute associational 
discrimination based on disability.\97\
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    \97\ Thus, pursuant to Sec.  92.202, when a patient's companion, 
such as a family member or friend, is an appropriate person with 
whom the provider should communicate under the circumstances, the 
provider must provide auxiliary aids and services to a deaf or hard 
of hearing companion to ensure that communication with that 
individual is as effective as it would be with a companion who is 
not deaf or hard of hearing.
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Subpart D--Procedures

Enforcement Mechanisms (Sec.  92.301)
    This proposed section restates the language of Section 1557 
regarding enforcement, which provides that the enforcement mechanisms 
under Title VI, Title IX, the Age Act, or Section 504 apply for 
violations of Section 1557. These existing enforcement mechanisms 
include requiring covered entities to

[[Page 54192]]

keep records and submit compliance reports to OCR, conducting 
compliance reviews and complaint investigations, and providing 
technical assistance and guidance. Where noncompliance or threatened 
noncompliance cannot be corrected by informal means, the enforcement 
mechanisms provided for and available under the civil rights laws 
referenced in Section 1557 include suspension of, termination of, or 
refusal to grant or continue Federal financial assistance; referral to 
the Department of Justice with a recommendation to bring proceedings to 
enforce any rights of the United States; and any other means authorized 
by law.\98\ In addition, based on the statutory language, a private 
right of action and damages for violations of Section 1557 are 
available to the same extent that such enforcement mechanisms are 
provided for and available under Title VI, Title IX, Section 504, or 
the Age Act with respect to recipients of Federal financial assistance. 
A private right of action and damages are also available for violations 
of Section 1557 by Title I entities. We seek comment on these 
positions.
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    \98\ See 45 CFR 80.8(a).
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Procedures for Health Programs and Activities Conducted by Recipients 
and State-Based Marketplaces (Sec.  92.302)
    Proposed Sec.  92.302 specifies the regulatory procedures that will 
apply to claims under Section 1557 for health programs and activities 
conducted by recipients and State-based Marketplaces. The 
administrative procedures provided for and available under Title VI are 
found in the regulation implementing Title VI, at 45 CFR 80.6-80.11 and 
45 CFR part 81. These administrative procedures are incorporated into 
the regulation implementing Title IX at 45 CFR 86.71 and the regulation 
implementing Section 504 with respect to recipients at 45 CFR 84.61. 
Section 92.302(a) incorporates these procedures into the proposed rule 
with respect to race, color, national origin, sex, and disability 
discrimination. The administrative procedures provided for and 
available under the Age Act are found in the regulation implementing 
the Age Act at 45 CFR 91.41 through 91.50. Section 92.302(b) 
incorporates these procedures into the proposed rule with respect to 
age discrimination.
    Section 92.302(c) also provides that an individual may bring a 
civil action in a United States District Court in which a recipient or 
State-based Marketplace is located, as provided for and available under 
Section 1557.
Procedures for Health Programs and Activities Administered by the 
Department (Sec.  92.303)
    As noted, Section 1557 expressly states that the enforcement 
mechanisms provided for and available under Title VI, Title IX, Section 
504, or the Age Act shall apply for purposes of violations of Section 
1557. The administrative procedures provided for and available under 
Section 504--which is the only one of these statutes that applies to 
Federally conducted, as well as Federally assisted, programs--for 
programs and activities administered by the Department are found in the 
regulation implementing Section 504 at 45 CFR 85.61 and 85.62. These 
procedures shall apply with respect to complaints and compliance 
reviews of health programs or activities administered by the 
Department, including the Federally-facilitated Marketplaces, 
concerning discrimination on the basis of race, color, national origin, 
sex, age, or disability.
    The proposed rule adds two provisions that are not found in 45 CFR 
85.61 and 85.62. The first provision relates to OCR's access to 
information. This provision, which is in accordance with OCR's practice 
under Section 504, is designed to ensure that OCR has the ability to 
obtain all of the relevant information needed to investigate a 
complaint or determine compliance in a particular health program or 
activity administered by the Department, and mirrors similar 
requirements for recipients under the Title VI regulation.
    The second provision prohibits the Department, including the 
Federally-facilitated Marketplaces, from retaliating against any 
individual for the purpose of interfering with any right or privilege 
under Section 1557 or the proposed rule or because the individual has 
made a complaint, testified, assisted, or participated in any manner in 
an investigation, proceeding, or hearing under Section 1557 or this 
proposed rule. Section 504 of the Rehabilitation Act, to which the 
Department is already subject, provides that the procedures, rights, 
and remedies under Title VI are available to any individual aggrieved 
by an act or failure to act by any recipient of Federal financial 
assistance or Federal provider of such financial assistance under 
Section 504. Thus, the prohibition of retaliation under Title VI 
applies to the Department under Section 504. The retaliation provision 
in the proposed rule is simply an extension of this existing 
prohibition. This provision is also in accordance with a similar 
requirement for recipients under the Title VI regulation at 45 CFR 
80.7(e); the Department should hold itself to the same standards to 
which it holds recipients of Federal financial assistance.\99\
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    \99\ Further, as the U.S. Supreme Court observed in Jackson v. 
Birmingham Bd. of Educ., 544 U.S. 167, 181 (2005), ``providing 
individual citizens effective protection against discriminatory 
practices . . . would be difficult, if not impossible, to achieve if 
persons who complain about sex discrimination did not have effective 
protection against retaliation'' (internal citations omitted). The 
same principle is true for discrimination under Section 1557.
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Information Collection Requirements
    This notice of proposed rulemaking would call for new collections 
of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). As defined in 5 CFR 1320.3(c), ``collection of 
information'' comprises reporting, recordkeeping, monitoring, posting, 
labeling and other similar actions. The title and description of those 
entities that must collect the information and an estimate of the total 
annual burden follow. The estimate covers the time for reviewing and 
posting the collections required.
    Title: Notice on Nondiscrimination in Health Programs and 
Activities.
    OMB Control Number: XXXX-XXXX.
    Summary of the Collection of Information: Under the proposed rule, 
each entity applying for Federal financial assistance, each health 
insurance issuer seeking certification to participate in a Marketplace, 
and each entity seeking approval to operate a Title I entity would be 
required to submit an assurance that its health programs and activities 
will be operated in compliance with Section 1557 of the Affordable Care 
Act (ACA).
    In addition, each covered entity subject to the proposed rule would 
be required to post a notice of certain important information, 
including that the covered entity provides auxiliary aids and services, 
free of charge, in a timely manner, to individuals with disabilities, 
when such aids and services are necessary to provide an individual with 
a disability an equal opportunity to benefit from the entity's health 
programs or activities; and language assistance services, free of 
charge, in a timely manner, to individuals with limited English 
proficiency, when those services are necessary to provide an individual 
with limited English proficiency meaningful access to a covered 
entity's health programs or activities. Furthermore, each covered 
entity would be required to post taglines in the top 15 languages 
spoken by individuals with limited English proficiency nationally,

[[Page 54193]]

informing individuals with limited English proficiency that language 
assistance services may be available.
    Additionally, each covered entity that employs 15 or more persons 
would be required to adopt grievance procedures that incorporate 
appropriate due process standards and that provide for the prompt and 
equitable resolution of grievances alleging any action that would be 
prohibited by Section 1557. Each such entity would also be required to 
designate at least one individual to coordinate its efforts to comply 
with and carry out its responsibilities under Section 1557, including 
the investigation of any grievance communicated to it alleging 
noncompliance with Section 1557.
    Need for Information: The requirement that every entity applying 
for Federal financial assistance, seeking certification to participate 
in a Health Insurance Marketplace, or seeking approval to operate a 
Title I entity, submit an assurance of compliance, is similar to the 
current regulatory requirements under 45 CFR 80.4(a), 84.5 and 91.33. 
These requirements protect individuals by assuring that covered 
entities will comply with all applicable nondiscrimination statutes and 
their implementing regulations.
    The posting of a notice of certain important information and the 
posting of taglines in the top 15 languages spoken by individuals with 
limited English proficiency nationally are necessary to ensure that 
individuals are aware of their protections under the law, and are 
grounded in OCR's experience that failures of communication based on 
the absence of auxiliary aids and services and language assistance 
services raise particularly significant compliance concerns under 
Section 1557, as well as Section 504 and Title VI.
    The requirements that every covered entity that employs 15 or more 
persons adopt a grievance procedure and designate at least one 
individual to coordinate its efforts to comply with and carry out its 
responsibilities under Section 1557 are similar to requirements 
included in the Title IX and Section 504 implementing regulations. 
Through its case investigation experience, OCR has observed that the 
presence of a coordinator and grievance procedure helps to bring 
concerns to prompt resolution within an entity, leading to lower 
compliance costs and more efficient outcomes.
    Proposed Use of Information: OCR would use this information to 
ensure covered entities' adherence to the statutory requirements 
imposed under Section 1557 and this proposed rule. OCR would enforce 
the requirements by verifying during investigations of covered entities 
that an entity has submitted an assurance of compliance, posted the 
notice of important information and taglines and, for each covered 
entity that employs 15 or more persons, that an individual has been 
designated to coordinate its compliance efforts and that appropriate 
grievance procedures have been adopted, as required.
    Description of the Respondents: The respondents are each entity 
applying for Federal financial assistance, each issuer seeking 
certification to participate in a Marketplace, and each entity seeking 
approval to operate a Title I entity. These include such entities as 
hospitals, home health agencies, community mental health centers, 
skilled nursing facilities, and health insurance issuers.
    Number of Respondents: The number of respondents is estimated to 
include the 278,565 covered entities affected by the proposed rule.
    Burden of Response: Because the proposed rule would provide a model 
assurance of compliance, a model notice of important information, and 
model taglines in the top 15 languages, the burden on respondents is 
minimal. Additionally, because all recipients of Federal financial 
assistance with 15 or more employees are already expected to have in 
place a grievance procedure and a designated individual to coordinate 
their compliance responsibilities, the burden to comply with this 
requirement will be minimal for most respondents.
    While the requirement to submit an assurance of compliance is 
subject to the Paperwork Reduction Act (PRA), OCR believes the burden 
associated with this requirement is exempt from the PRA in accordance 
with 5 CFR 1320.3(b)(2). OCR believes that the time, effort, and 
financial resources necessary to comply with this requirement should be 
considered a usual and customary business practice and would be 
incurred by covered entities during their ordinary course of business.
    OCR estimates the burden for responding to the proposed notice 
requirement would be 17 minutes to download/print and post the notice 
of important information and that the burden to download/print and post 
taglines in the top 15 languages nationally would also be 17 minutes, 
for a burden total of 34 minutes. We estimate that administrative or 
clerical support personnel would perform these functions. Based on the 
wage rate for a Clerical Support Worker ($22.94) we estimate the annual 
burden cost for these two requirements to be approximately $4.8 
million.
    Regarding the requirement that every covered entity that employs 15 
or more persons adopt grievance procedures and designate at least one 
individual to coordinate its efforts to comply with and carry out its 
responsibilities under Section 1557, based on OCR's compliant workload 
increase since the passage of Section 1557, we anticipate that within 
the first five years following the rule's enactment, complaints will 
increase approximately 1%, but eventually will drop off as covered 
entities modify their policies and practices in response to the 
proposed rule. We estimate that medical and health service managers 
would handle the grievances. Taking 1% of the annual wage rate for 
medical and health service managers ($101,340) and increasing that 
amount by 100% to account for fringe benefits and overhead, we estimate 
the total annual burden cost for this requirement to be approximately 
$118.7 million.
    Thus, the total estimated annual burden cost for the proposed 
information collection requirements will be approximately $123.5 
million.
    We ask for public comment on the proposed information collection to 
help us determine:
    1. Whether the proposed collection of information is necessary for 
the proper performance of the functions of OCR, including whether the 
information will have practical utility;
    2. The accuracy of the estimated burden associated with the 
proposed collection of information;
    3. How the quality, utility, and clarity of the information to be 
collected may be enhanced; and
    4. How the burden of complying with the proposed collection of 
information may be minimized, including through the application of 
automated collection techniques or other forms of information 
technology.
    Comments regarding the collection of information proposed in this 
rule must refer to the proposed rule by name and docket number and must 
be submitted to both OMB and the Docket Management Facility where 
indicated under ADDRESSES, by the date specified under DATES.

Regulatory Impact Analysis

I. Introduction

A. Executive Orders 12866 and 13563

    Executive Order 12866 \100\ directs agencies to assess all costs 
and benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential

[[Page 54194]]

economic, environmental, public health and safety effects; distributive 
impacts; and equity). Executive Order 13563 \101\ is supplemental to 
and reaffirms the principles, structures, and definitions governing 
regulatory review as established in Executive Order 12866. The Office 
of Management and Budget (OMB) has determined that this proposed rule 
is a ``significant regulatory action'' under Executive Order 12866. 
Accordingly, OMB reviewed this proposed rule.
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    \100\ E.O. 12866, 58 FR 51735 (1993).
    \101\ E.O. 13563, 76 FR 3821 (2011).
---------------------------------------------------------------------------

B. The Need for a Regulation

    Section 1557 of the ACA prohibits an individual from being excluded 
from participation in, denied the benefits of, or otherwise subjected 
to discrimination on the basis of race, color, national origin, sex, 
age or disability in certain health programs and activities. It applies 
the protections available under Title VI, Title IX, the Age Act, and 
Section 504 to any health program or activity, any part of which is 
receiving Federal financial assistance, and to any program or activity 
that is administered by an Executive Agency or any entity established 
under Title I of the ACA.\102\ Under this section, the Secretary of the 
Department is authorized to promulgate regulations to implement Section 
1557. The purpose of this regulatory action is to implement Section 
1557 of the ACA.
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    \102\ Patient Protection and Affordable Care Act, Pub. L. 111-
148 (2010) (codified at 42 U.S.C. 18116).
---------------------------------------------------------------------------

    One of the central aims of the ACA is to expand access to health 
care and health coverage for all individuals. Equal access for all 
individuals without discrimination is essential to achieving this goal. 
Discrimination in the health care context can often lead to poor and 
inadequate health care or health insurance or other coverage for 
individuals and exacerbate existing health disparities in underserved 
communities. Individuals who have experienced discrimination in the 
health care context often postpone or do not seek needed health care; 
individuals who are subject to discrimination are denied opportunities 
to obtain health care services provided to others, with resulting 
adverse effects on their health status. Moreover, discrimination in 
health care can lead to poor and ineffective distribution of health 
care resources, as needed resources fail to reach many who need them. 
The result is a marketplace comprised of higher medical costs due to 
delayed treatment, lost wages, lost productivity, and the misuse of 
people's talent and energy.\103\
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    \103\ Kristen Suthers, American Public Health Association: Issue 
Brief: Evaluating the Economic Causes and Consequences of Racial and 
Health Disparities (2008), available at https://hospitals.unm.edu/dei/documents/eval_cause_conse_apha.pdf. Carol Rose DeLilly and 
Jacquelyn H. Flaskerud, Discrimination and Health Outcomes, 33(11), 
Issues Ment. Health Nurs., 801-804 (2012), available at https://informahealthcare.com/doi/abs/10.3109/01612840.2012.671442; Timothy 
Waldmann, Urban Institute, Estimating the Cost of Racial and Ethnic 
Health Disparities (2009), available at https://www.urban.org/research/publication/estimating-cost-racial-and-ethnic-health-disparities; LaVera M. Crawley, David K. Ahn, and Marilyn A. 
Winkleby, Perceived Medical Discrimination and Cancer Screening 
Behaviors of Racial and Ethnic Minority Adults, 17(8), Cancer 
Epidemiol Biomarkers Prev., 1937-1944 (2008), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2526181/.
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    To help address these issues, this regulation seeks to clarify the 
application of the nondiscrimination provision in the ACA to any health 
program or activity receiving Federal financial assistance or 
administered by HHS or any entity established under Title I. Such 
clarity will promote understanding of and compliance with Section 1557 
by covered entities and the ability of individuals to assert and 
protect their rights under the law.
    In addition, Executive Order 13563 directs Federal agencies to 
improve regulations and regulatory review by promoting the 
simplification and harmonization of regulations and to ensure that 
regulations are accessible, consistent and easy to understand. 
Regulations implementing the civil rights laws referenced in Section 
1557 contain certain inconsistencies across common areas and subject 
matters, reflecting, among other things, differences in time and 
experience when the regulations were issued. The approach taken in the 
proposed rule is to simplify and make uniform, consistent, and easy to 
understand the various nondiscrimination requirements and rights 
available under Section 1557, as appropriate.

C. Examples of Covered Entities and Health Programs or Activities Under 
the Proposed Regulation

    This proposed rule would apply to any entity that has a health 
program or activity, any part of which receives Federal financial 
assistance from the Department, any health program or activity 
administered by the Department, or any health program or activity 
administered by an entity created under Title I of the ACA. The 
following are examples of covered entities as well as health programs 
or activities under the proposed rule.
1. Examples of Covered Entities With a Health Program or Activity, Any 
Part of Which Receives Federal Financial Assistance From the Department
    This Department, through agencies such as the Health Resources and 
Services Administration (HRSA), the Substance Abuse and Mental Health 
Services Administration (SAMHSA), the Centers for Disease Control and 
Prevention (CDC), and the Centers for Medicare & Medicaid Services 
(CMS), provides Federal financial assistance through various mechanisms 
to health programs and activities of local governments, State 
governments, and the private sector. An entity may receive Federal 
financial assistance from more than one component in the Department. 
For instance, Federally qualified health centers receive Federal 
financial assistance from CMS by participating in the Medicare or 
Medicaid programs and also receive Federal financial assistance from 
HRSA through grant awards. Because more than one funding stream may 
provide Federal financial assistance to an entity, the examples we 
provide may not uniquely receive Federal financial assistance from only 
one HHS component.
    (1) Entities receiving Federal financial assistance through their 
participation in Medicare or Medicaid (about 133,343 facilities).\104\ 
Examples of these entities include:
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    \104\ CMS Provider of Service file for June 2014.

Hospitals (includes short-term, rehabilitation, psychiatric, and 
long-term)
Skilled nursing facilities/nursing facilities- facility-based
Skilled nursing facilities/nursing facilities--freestanding
Home health agencies
Physical therapy/speech pathology programs
End stage renal disease dialysis centers
Intermediate care facilities for individuals with intellectual 
disabilities
Rural health clinics
Physical therapy--independent practice
Comprehensive outpatient rehabilitation facilities
Ambulatory surgical centers
Hospices
Organ procurement organizations
Community mental health centers
Federally qualified health centers

    (2) Laboratories that are hospital-based, office-based, or 
freestanding that receive Federal financial assistance through Medicare 
or Medicaid payments for covered laboratory tests (about 445,657 
laboratories with Clinical Laboratory Improvement Act certification).
    (3) Community health centers receiving Federal financial assistance

[[Page 54195]]

through grant awards from HRSA (1,200 community health centers).\105\
---------------------------------------------------------------------------

    \105\ U.S. Department of Health and Hunan Services, HRSA: 
Justification of Estimates for Appropriation Committee, 42 (2014).
---------------------------------------------------------------------------

    (4) Health-related schools in the United States and other health 
education entities receiving Federal financial assistance through grant 
awards to support 40 health professional training programs that include 
oral health, behavioral health, medicine, geriatric, and physician's 
assistant programs (171 health-related schools and other health 
education entities).\106\
---------------------------------------------------------------------------

    \106\ Id. at .16.
---------------------------------------------------------------------------

    (5) State Medicaid agencies receiving Federal financial assistance 
from CMS to operate Medicaid and CHIP programs (includes every State, 
the District of Columbia, Puerto Rico, Guam, the Northern Marianas, 
U.S. Virgin Islands, and American Samoa).
    (6) State public health agencies receiving Federal financial 
assistance from CDC, SAMHSA, and other HHS components (includes each 
State, the District of Columbia, Puerto Rico, Guam, the Northern 
Marianas, U.S. Virgin Islands, and American Samoa).
    (7) Qualified health plan issuers receiving Federal financial 
assistance through premium tax credits or cost-sharing reductions 
(which include at least the 169 health insurance issuers receiving 
Federal financial assistance through premium tax credits and cost 
sharing reductions and at least 11 issuers operating in the State Based 
Marketplaces that we were able to identify).\107\ We seek comment on 
identifying additional issuers in the State-based Marketplaces.
---------------------------------------------------------------------------

    \107\ Qualified Health Plans Landscape Individual Market Medical 
(2015), available at https://data.healthcare.gov/dataset/2015-QHP-Landscape-Individual-Market-Medical/mp8z-jtg7.
---------------------------------------------------------------------------

    (8) Physicians receiving Federal financial assistance through 
Medicaid payments, ``meaningful use'' payments, and other sources, but 
not Medicare Part B payments, as the Department does not consider 
Medicare Part B payments to physicians to be Federal financial 
assistance.
    In regard to the eighth category of entities that may be covered by 
this proposed rule--physicians--we estimate that this proposed rule 
likely covers almost all licensed physicians because they accept 
Federal financial assistance from sources other than Medicare Part B. 
Most physicians participate in more than one Federal, State, and local 
health program that receives Federal financial assistance, and many 
practice in several different settings, e.g., they may practice in a 
hospital but also practice privately and develop nursing home plans of 
care at the local nursing home. We have data, by program, for the 
number of physicians receiving payment from each program, but there is 
no single, unduplicated count of physicians across programs. We can 
compare the various counts of physicians with the number of all 
licensed and practicing physicians in the United States as enumerated 
in the Area Health Resource File maintained by HRSA, but even this 
benchmark file may contain duplicate counts of licensed physicians as 
explained later in the analysis.
    In spite of the difficulty in obtaining an unduplicated physician 
count, we provide our best estimate of the number of physicians 
receiving Federal financial assistance by analyzing and comparing 
different data sources and drawing conclusions from this analysis. 
Based on 2010 Medicaid Statistical Information System data (the latest 
available), about 614,000 physicians accept Medicaid payments and are 
covered under Section 1557 as a result.\108\ This figure represents 
about 69% of licensed physicians in the United States when compared to 
the 890,000 licensed physicians reported in the Area Health Resource 
File. In addition, physicians receiving Federal payments from non-Part 
B Medicare sources will also come under Section 1557. For example, as 
of January 2014, 296,500 Medicare-eligible professionals had applied 
for funds to support their ``meaningful use'' technology efforts.\109\ 
Adding the 614,000 physicians who receive Medicaid payments to the 
296,500 physicians who receive meaningful use payments yields over 
900,000 physicians potentially reached by Section 1557 because they 
participate in Federal programs other than Part B of Medicare. Because 
physicians can receive both Medicaid and meaningful use payments, and 
these figures are not adjusted for duplication, the 900,000 result is 
probably best interpreted as an upper bound.
---------------------------------------------------------------------------

    \108\ John Holahan and Irene Headen, Kaiser Commission on 
Medicaid and the Uninsured, Medicaid Coverage and Spending in Health 
Reform: National and State-by-State Results for Adults at or Below 
133% FPL (2010), available at https://kff.org/health-reform/report/report-and-briefing-on-medicaid-coverage-and/. Estimates are based 
on data from FY 2010 MSIS.
    \109\ Mynti Hossain and Marsha Gold, Mathematical Policy 
Research Inc.: Prepared for The Office of the National Coordinator 
for Health Information Technology, U.S. Department of Health and 
Human Services, Monitoring National Implementation of HITECH: Status 
and Key Activity Quarterly Summary, (January to March 2014), 
available at https://www.healthit.gov/sites/default/files/globalevaluationquarterlyreport_january-march2014.pdf.
---------------------------------------------------------------------------

    Earlier, we identified several grant programs from various 
Department agencies that fund a variety of health care programs in 
which physicians participate and thus come under Section 1557, such as 
the National Health Service Corps, HRSA-funded community health 
centers, programs receiving NIH research grants, and SAMHSA-funded 
programs. Furthermore, physicians participating in a CMS gain-sharing 
demonstration project who receive gain-sharing payments would be 
covered under Section 1557 even if they did not participate in Medicare 
and Medicaid or any other health program or activity that receives 
Federal financial assistance. Again, there will be duplication and 
overlap with physicians who accept Medicaid or Medicare meaningful use 
payments, or other payments apart from Medicare Part B payments. 
Nevertheless, at least some of these physicians add to the total number 
of physicians reached under Section 1557 because some of them are not 
duplicates and do not accept Medicaid or Medicare meaningful use 
payments. We do not have an exact number, but adding these physicians 
may bring the total participating in Federal programs other than Part B 
to over 900,000.
    When we compare the upper bound estimated number of physicians 
participating in Federal programs other than Medicare Part B (over 
900,000) to the number of licensed physicians counted in HRSA's Area 
Health Resource File (approximately 890,000), we conclude that almost 
all practicing physicians in the United States are reached by Section 
1557 because they accept some form of Federal remuneration or 
reimbursement apart from Medicare Part B.\110\ We invite the public to 
submit information regarding physician participation in health programs 
and activities that receive Federal financial assistance.
---------------------------------------------------------------------------

    \110\ The Area Health Resource File itself double counts 
physicians who are licensed in more than one state. See infra 
discussion below at II.C.1.a.
---------------------------------------------------------------------------

2. Examples of Health Programs or Activities Conducted by the 
Department
    This proposed rule applies to the Department's health programs and 
activities, such as those administered by CMS, HRSA, CDC, IHS, and 
SAMHSA. Examples include the Indian Health Service tribal hospitals and 
clinics operated by the Department (about 876 hospitals and clinics) 
and the National Health Service Corps.\111\
---------------------------------------------------------------------------

    \111\ Id. at 66.

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[[Page 54196]]

3. Examples of Entities Established Under Title I of the ACA
    This proposed rule applies to entities established under Title I of 
the ACA. According to the CMS Center for Consumer Information and 
Insurance Oversight (CCIIO), there are Health Insurance Marketplaces 
covering 51 jurisdictions: (14 State-based-Marketplaces and 37 
Federally-facilitated Marketplaces).\112\ The proposed rule covers 
these Health Insurance Marketplaces.
---------------------------------------------------------------------------

    \112\ 45 CFR part 155 sets forth the Exchange Establishment 
Standards that a State-based Marketplace must satisfy. CCIIO's 
approval of a State-based Marketplace is based on the approval 
criteria established in 45 CFR 155.105. Using these criteria, CCIIO 
counts 14 State-based Marketplaces, including the District of 
Columbia.
---------------------------------------------------------------------------

II. Costs

    As discussed above, it is important to recognize that the NPRM--
except in the area of sex discrimination--applies pre-existing 
requirements in Federal civil rights laws to various entities, nearly 
all of which have been covered by these requirements for many years. 
Because the NPRM restates existing requirements, we do not anticipate 
that covered entities will undertake new actions or bear any additional 
costs in response to the issuance of the regulation with respect to the 
prohibition of race, color, national origin, age, or disability 
discrimination.
    However, the prohibition of sex discrimination is new for many of 
the covered entities, and we do anticipate that the enactment of the 
regulation will result in changes in action and behavior by covered 
entities to comply with this new prohibition. Some of these actions 
will impose costs and others will not.
    In addition, as noted above, Section 1557 applies to the Health 
Insurance Marketplaces, as entities newly created under Title I of the 
ACA. However, these entities, along with the qualified health plans 
issuers participating in the Health Insurance Marketplaces, are already 
covered by regulations issued by CMS that prohibit discrimination on 
the basis of race, color, national origin, sex, including sex 
stereotyping and gender identity, sexual orientation, age, or 
disability, and the Federally-facilitated Marketplaces are already 
covered by Section 504, which prohibits disability discrimination. Thus 
the impact of Section 1557 on these entities is limited.
    The following regulatory analysis examines the costs and benefits 
that are attributable to this regulation only. While we make 
assumptions about possible behavioral responses to the regulation, we 
acknowledge that more information may be available to inform these 
assumptions and we welcome comment.
    We first analyze the costs we expect the proposed rule to create 
for covered entities. Then we examine the potential benefits the rule 
is likely to produce. In the subsequent analyses of costs in this RIA 
and the Regulatory Flexibility Act (RFA), we use data sets from the 
Census Bureau and Bureau of Labor Statistics for estimating 
burdens.\113\
---------------------------------------------------------------------------

    \113\ The HHS data used in this section provides the best 
measure of the number and type of entities covered under the 
regulation. They do not, however, link to cost data needed to 
conduct a cost-benefit analysis. To obtain cost data linked with the 
covered entities, we must use Census and Bureau of Labor Statistics 
data sets. Because the data from these bureaus is organized along 
industrial and occupational categories, we lose some accuracy in the 
count of covered entities. We have done our best to minimize the 
loss of accuracy and have opted to overcount rather than undercount 
affected entities.
---------------------------------------------------------------------------

A. Assumptions

    The following cost assessment rests on certain key assumptions that 
include: (1) Voluntary activity on the part of covered entities that is 
triggered by the enactment of this regulation--and that would not have 
occurred absent the enactment of the regulation--which generates both 
costs and corresponding benefits; (2) to the extent that actions are 
required under the proposed rule where the same actions are already 
required by prior existing civil rights regulations, we assume that the 
actions are already taking place and thus that they are not a burden 
imposed by the proposed rule; (3) although the regulation does not 
require training at any time, we anticipate that covered entities may 
voluntarily provide one-time training to some employees on the 
requirements of the regulation at the time that the regulation is 
published; and (4) employers are most likely to train employees who 
interact with the public. Based on this assumption, we also assume 
employers likely will train between 40 and 60% of their employees, as 
the percentage of employees that interact with patients and the public 
varies by covered entity. For purposes of the analysis, we assume that 
50% of the covered entity's staff will receive one-time training on the 
requirements of the regulation. We use the 50% estimate as a proxy, 
given the lack of certain information as described below. For the 
purposes of the analysis, we do not distinguish between employees whom 
covered entities will train and those who obtain training independently 
of a covered entity.

B. Training

    We assume covered entities will provide some workers a one-time 
awareness or familiarization training regarding the requirements in the 
regulation at the time of its issuance. We are counting the cost of 
training on all aspects of the regulation, not only on the new 
responsibilities under the regulation, as we believe covered entities 
will want to offer comprehensive training to employees, recognizing 
that refresher training can provide value. We invite comment on whether 
we should count only the cost of training on new responsibilities under 
the regulation.
    We know that many employees work ``behind the scenes'' at large 
entities, and may not have contact with patients or the general public 
or otherwise have duties impacted by the requirements we are proposing 
and therefore may have little need for training. However, we are 
uncertain which employees those are. Furthermore, we do not know 
whether an entity rotates employees into different positions that may 
have patient contact or relevant duties, or whether, over time, an 
employee will switch to a position that places him or her in such a 
position, which may create a need for training.
    We also lack information on State and local regulations that may 
require employees to receive training on civil rights provisions and 
whether those provisions are more or less rigorous than the ones we 
propose. Thus, workers in covered entities in States and local 
jurisdictions with civil rights provisions more robust than the ones we 
propose may need only minimal training. In State and local 
jurisdictions where civil rights provisions are not more robust, 
workers may need more training. As stated above, because we lack data 
on covered entities' training practices we are assuming that covered 
entities will voluntarily provide training on the final rule for 
between 40% and 60% of their staffs.
    We welcome public comment and information that will help us focus 
our analyses on the specific entities and workers who likely will 
receive training.
    In the following section, we identify the pool of workers and staff 
that we anticipate may need knowledge of the proposed rule. Next, we 
identify the covered entities that may choose to train their staffs to 
provide this knowledge. Last, we estimate the costs of presenting the 
training materials and the worker time that will be spent in training.

[[Page 54197]]

1. Number of Individuals Who Will Receive Training
a. Health Care Staffs and Managers
    The Bureau of Labor Statistics \114\ Occupation Tables for codes 
29-0000 (Healthcare Practitioners (29-1000) and Technical Occupations 
(29-2000)) and 31-0000 (Healthcare Support Occupations) reports, for 
2013, that ``7.8 million health diagnosing and treating practitioners, 
2.9 million technicians and 3.9 million technical assistants'' were 
working in the health care sector in 2013.\115\
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    \114\ National Occupational Employment and Wage Estimates United 
States (May, 2013), available at https://www.bls.gov/oes/2013/may/oes_nat.htm.
    \115\ In choosing data from the Bureau of Labor Statistics 800 
occupation tables rather than Bureau of Labor Statistics 400 
industry tables, we are including health care workers employed in 
entities that may not receive Federal financial assistance. Thus, 
the count of employees included in the following analysis may be 
overstated. Using the alternative Bureau of Labor Statistics 
industry data is also problematic. The North American Industrial 
Code System (NAICS 623300-Continuing Care Retirement Communities and 
Assisted Living Facilities for the Elderly and NAICS 623900-Other 
Residential Care Facilities) may include both non-covered and 
covered entities. Were we to include these categories in the 
training analysis, the results would be similar to the results 
achieved using the occupational data presented above. Were we to 
exclude these categories, we might be undercounting staff needing 
training. Because the industry tables offered no advantage over the 
800 occupation tables and the occupations data were simpler and more 
direct, we chose to use them rather than the industry tables.
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    The first category of health care staff that may receive training 
is comprised of health diagnosing and treating practitioners. This 
category includes physicians, dentists, optometrists, physician 
assistants, occupational, physical, speech and other therapists, 
audiologists, pharmacists, registered nurses, and nurse practitioners. 
The Bureau of Labor Statistics occupational code for this grouping is 
29-1000 and the 2013 reported count is 4,833,840. We note that the 
Bureau of Labor Statistics reports the number of physicians as 623,380 
in contrast to the 888,947 physicians reported in the HRSA Area Health 
Resource File.\116\ Although the Area Health Resource File is the best 
national count of the number of licensed physicians, we need data that 
link to physician earnings in order to assess impact, which the Area 
Health Resource File lacks. Because we must use alternative sources for 
the physician earnings data, we also reconcile the differences between 
the two sources with regard to the number of physicians counted in the 
economic analysis.
---------------------------------------------------------------------------

    \116\ HRSA, Area Health Resource File National, State and County 
Health Resources Information Database, available at https://ahrf.hrsa.gov.
---------------------------------------------------------------------------

    Because the Area Health Resource File's count is based on 
licensure, it includes physicians who may hold licenses in more than 
one State. There are a number of metropolitan areas that cross State 
boundaries and physicians practicing in these areas may be licensed in 
the adjoining States and, thus, will be counted more than once in the 
Area Health Resource File. On the other hand, the Bureau of Labor 
Statistics data, which report physician employment and income, may be 
an inaccurate count of physicians because of sampling error. We note 
that the sampling error reported for one physician specialty category 
is 6.1% and five out of seven specialty categories reported have 
sampling errors of 3% or greater. To resolve the difference between the 
Bureau of Labor Statistics and Area Health Resource File sources, we 
propose to take the midpoint of the difference between the two files.
    The difference in the number of physicians in the Bureau of Labor 
Statistics and Area Health Resource File tables equals 265,567. Taking 
the midpoint yields 132,784 and adding this to the Bureau of Labor 
Statistics physician count gives us 756,164. Thus, the total count for 
Occupational code 29-1000--Healthcare Diagnostic and Treating 
Practitioners, after adjusting for the number of physicians, is 4.8 
million.
    The second category of health care staff that we assume will 
receive training is comprised of degreed technical staff (Occupation 
code 29-2000) and accounts for 2.8 million workers. Technicians work in 
almost every area of health care: From x-ray to physical, speech, 
psychiatric, dietetic, laboratory, nursing, and records technicians, to 
name but a few areas.
    The third category of health care staff that we assume will receive 
training is comprised of non-degreed medical assistants (Occupation 
code 31-0000), and includes psychiatric and home health aides, 
orderlies, dental assistants, and phlebotomists. Health care support 
staffs (technical assistants) operate in the same medical disciplines 
as technicians, but often lack professional degrees or certificates. We 
refer to this workforce as non-degreed compared to medical technicians 
who generally have degrees or certificates. There are 3.9 million 
individuals employed in these occupations.
    The fourth category of health care staff that we assume will 
receive training is health care managers (approximately 300,000 based 
on Bureau of Labor Statistics data for occupation code 11-9111).
    The fifth category of health care staff that we assume will receive 
training is office and administrative assistants--Office and 
Administrative Support Occupation (Occupation code 43-0000). These 
workers are often the first staff patients encounter in a health 
facility and, because of this, covered entities might find it important 
that staff, such as receptionists and assistants, receive training on 
the proposed regulatory requirements. Approximately 2.7 million 
individuals were employed in these occupations in health facilities in 
2013.\117\
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    \117\ Data from Bureau of Labor Statistics 400 industries table 
for the health care sector: North American Industry Classification 
System code 62. This code includes health care and social assistance 
(including private, State and local government hospitals).
---------------------------------------------------------------------------

    Below is a summary table of individuals employed in the health care 
sector.

          Table 1--Health Care Employees That May Need Training
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Health diagnosing and treating practitioners plus              4,833,840
 132,784 physicians not in the Bureau of Labor
 Statistics data........................................
Degreed technicians.....................................       2,849,330
Non-degreed technicians.................................       3,924,390
Medical and health services managers....................         300,180
Office and administrative support staff.................       2,739,640
                                                         ---------------
  Total.................................................      14,647,380
------------------------------------------------------------------------

b. Employees Working for the Federally-Facilitated Marketplaces and 
State-Based Marketplaces and Issuers in Those Marketplaces
    We have data from CMS/CCIIO on the number of issuers offering 
qualified health plans in the Federally-facilitated Marketplaces. We 
assume that many issuers that operate in the Federally-facilitated 
Marketplaces also operate in the State-based Marketplaces. However, to 
the extent there are issuers who operate in a State-based Marketplace 
only, an estimate of their employees will not be included in our count 
of issuers (derived from the CCIIO tables of issuers participating only 
in the 37 jurisdictions with Federally-facilitated Marketplaces). We 
propose to determine the number of employees working for those issuers 
participating in the Federally-facilitated Marketplaces and we assume, 
as noted above, that some of the same issuers and employees serve the 
State-based Marketplaces. Determining the number of employees working 
for issuers participating in the Health Insurance Marketplaces is 
problematic because we have no data directly linking the number of

[[Page 54198]]

employees to our data on participating issuers in the Federally-
facilitated Marketplaces. Consequently, we must impute the number of 
employees working for issuers participating in the Federally-
facilitated Marketplaces and, by extension, employees working for 
issuers in State-based Marketplaces.
    We perform this imputation by first identifying the number of 
issuers offering qualified health plans in the Federally-facilitated 
Marketplaces. To determine the number of issuers offering qualified 
health plans in the Federally-facilitated Marketplaces, we looked at 
the 2015 Qualified Health Plan Landscape Individual and Small Business 
Health Options Program Market Medical files.\118\ The Qualified Health 
Plan Landscape Individual Market Medical file contains over 100,000 
line items, and the Small Business Health Options Program Market 
Medical file contains over 50,000 line items listing each Federally-
facilitated Marketplace plan for each county by metal level (bronze, 
silver, gold, and platinum) and catastrophic plans provided by each 
issuer. To determine the number of issuers in the individual and Small 
Business Health Options Program Marketplaces, we removed all plan line 
items to reduce the count to an unduplicated count of the issuers in 
the Federally-facilitated Marketplaces. We identified 155 individual 
plan issuers and 14 issuers in the Small Business Health Options 
Program that only issued group plans to employees of employers 
participating in the Small Business Health Options Program. Our total 
count of 169 issuers differs from the CCIIO sources, which counted 
issuers in each State in which they operated. For example, a national 
issuer such as Aetna that offers coverage through Federally-facilitated 
Marketplaces operating in several States was counted separately by 
CCIIO for each State in which it was qualified, whereas we counted it 
only once.\119\
---------------------------------------------------------------------------

    \118\ Qualified Health Plans Landscape Individual Market Medical 
(2015), available at https://data.healthcare.gov/dataset/2015-QHP-Landscape-Individual-Market-Medical/mp8z-jtg7.
    \119\ We count the issuer only once because we assume the same 
enterprise will minimize training costs by preparing the same 
training materials for all its employees nationally.
---------------------------------------------------------------------------

    In addition to 169 issuers participating in Federally-facilitated 
Marketplace, we are aware of 11 issuers participating only in the 
State-based Marketplaces. Thus, we calculate that the total number of 
issuers included in the analysis of covered issuers equals 180.
    We next analyzed the number of employees working in the health 
insurance industry in the following way. Using Census Bureau 2011 
payroll and employment data (the latest data available) for North 
American Industry Classification System 524114--Direct Health Insurance 
\120\ we attempted to match the number of employees to the health 
insurance entities. The Census data permitted us to divide all health 
insurance issuers into ``large'' (500 or more employees) and ``small'' 
(fewer than 500 employees) issuers, and from that we were able to 
estimate the number of employees for large and small issuers.
---------------------------------------------------------------------------

    \120\ United States Census Bureau, Statistics of U.S. Businesses 
(SUSB) (2011), available at https://www.census.gov/econ/susb/.
---------------------------------------------------------------------------

    The Census data shows 805 small issuers and 180 large issuers. The 
ratio of small to large issuers is about 4.5 small issuers for every 
large issuer. We assumed the ratio of small to large issuers in the 
Health Insurance Marketplaces would be approximately the same as the 
ratio in the Census table. We ask for public comment on this 
assumption.
    Applying this ratio to the issuers in the Federally-facilitated 
Marketplaces, we get 131 small issuers and 38 large issuers. We assume 
that the 11 issuers (for which we have data and have thus identified) 
operating in the State-based Marketplaces are likely to be classified 
as small, based on Census workforce data. Therefore, we are adding them 
to the 131 small issuers identified above, bringing the total number of 
small issuers to 142. We ask for public comment on this assumption.
    Based on the Census data, the average number of employees in a 
small issuer is 34 and the average number of employees in a large 
issuer is 2,300. Multiplying the number of small issuers by the number 
of employees equals 4,828 employees in the 142 small issuers and 87,400 
employees in the 38 large issuers. The combined total number of 
employees for small and large issuers in the Federally-facilitated 
Marketplaces is estimated to be 92,228 employees.
    With respect to the majority of issuers operating in a State-based 
Marketplace that we have not been able to identify but would also be 
subject to the regulation, we do not have any direct data. However, the 
workforce data we have from the Census tables covers employees 
regardless of their work site. If any of the 169 issuers identified 
above operating in the Federally-facilitated Marketplaces also operate 
in the State-based Marketplaces, then some portion of the nearly 92,000 
employees imputed to be working for the issuers in the Federally-
facilitated Marketplaces may also be working for issuers operating in 
the State-based Marketplaces. Thus, in effect, we are including 
employees working for issuers that operate in both the State-based 
Marketplaces and the Federally-facilitated Marketplaces in our count of 
employees who likely will receive training on the regulation.
    At the same time that we include employees who work for issuers 
operating in both the Federally-facilitated Marketplaces and State-
based Marketplaces, we lack direct data on issuers participating only 
in State-based Marketplaces. We are not able to include employees that 
work for insurance issuers that operate only in State-based 
Marketplaces, such as New York or California, which would be subject to 
the proposed rule. We invite public comment on ways we can identify 
issuers that participate only in State-based Marketplaces and the 
number of employees they employ.
    A third category of workers who may need to be trained are 
Navigators receiving Federal financial assistance to support the 
functions they perform in assisting applicants to enroll in qualified 
health plans. CCIIO has awarded grant funding to 92 Navigator entities, 
and CCIIO estimates that 2,797 Navigators work for these 92 
entities.\121\
---------------------------------------------------------------------------

    \121\ HHS.gov/Health Care, By the Numbers: Open Enrollment for 
Health Insurance Fact Sheet, available at https://www.hhs.gov/healthcare/facts/factsheets/2015/02/open-enrollment-by-the-numbers.html (last visited June 12, 2015).
---------------------------------------------------------------------------

    We invite public comment on our approach to estimating the number 
of employees per issuer based on the Census data and seek any public 
information on issuers who operate only in State-based Marketplaces.
c. Medicaid and State and Local Health Department Employees
    The Census Bureau State government payroll and employment data for 
2013 shows the number of full-time employees working in State hospitals 
and departments of health as 531,251.\122\ The State Medicaid 
Operations Survey: Second Annual Survey of Medicaid Directors reports 
that the majority of State Medicaid agencies employed 750 or fewer 
full-time employees with a median workforce level of 421 
employees.\123\ Multiplying the median level of workers by 53 Medicaid 
agencies adds 22,313 workers to the number of State health

[[Page 54199]]

and hospital workers in health departments, bringing the total to 
553,564 employees. (Although a more appropriate method of calculating 
the total would be to use the mean as the multiplier, OCR used the 
median because the mean was unavailable.) However, this number double 
counts medical personnel that were previously counted as discussed in 
part C.1.a (regarding health care staffs and managers who will receive 
training) in this Regulatory Impact Analysis.
---------------------------------------------------------------------------

    \122\ United States Census Bureau, Government Employment and 
Payroll (2013), available at https://www.census.gov/govs/apes/.
    \123\ National Association of State Medicaid Directors, State 
Medicaid Operations Survey: Second Annual Survey of Medicaid 
Directors (February 2014).
---------------------------------------------------------------------------

    Using the Bureau of Labor Statistics industry data for North 
American Industry Classification System code 999201: State government, 
including schools and hospitals, we identified 446,210 medical 
personnel employed by State governments.\124\ Subtracting this number 
from the 553,564 employees we identified those employed in State 
government health services and Medicaid programs, which results in 
107,354 additional State employees who may obtain training on the 
provisions of the regulation.
---------------------------------------------------------------------------

    \124\ Bureau of Labor Statistics (BLS) 400 Industries tables 
available at: https://www.bls.gov/oes/current/999201.htm.
---------------------------------------------------------------------------

    The method for identifying and removing duplicate State medical 
personnel from the count of State employees in the health and Medicaid 
programs may remove too many covered State employees. We assume that 
most State medical personnel work in health departments and Medicaid 
agencies, but some medical personnel work in other units of State 
government such as environmental protection or schools that are not 
included in the State agencies subject to the rule. We invite public 
comment and data on this point.
d. Non-Health Care Personnel in Pharmacies
    The 2013 Census data for all US industries identifies 18,852 
pharmacy establishments. The number of employees presented in the 
Census data includes both pharmacists and non-pharmacist personnel. At 
this point, we must refer back to the Bureau of Labor Statistics data 
on the number of health care workers reported for 2013 because the 
Bureau of Labor Statistics data divides the pharmacy workforce by 
occupation. The number of employees that Bureau of Labor Statistics 
reports were employed in pharmacies for 2013 is 706,000. The number of 
health care workers discussed in subsection II.C.1.a. above includes 
348,381 pharmacists and other health care staff in occupation codes 29-
0000 and 31-0000 reported to be working in pharmacies.\125\ Because we 
already counted the costs of health care workers employed in pharmacies 
in the analysis of health care staff, to achieve a more accurate 
estimate of the number of non-health care pharmacy workers, we must 
subtract the 348,381 health care staff from the total workforce Bureau 
of Labor Statistics reports. Removing health care staff from the Bureau 
of Labor Statistics data yields a net of 357,620 non-health care 
pharmacy workers in pharmacies who may receive training on the proposed 
rule.
---------------------------------------------------------------------------

    \125\ The Area Health Resource File reports 272,022 pharmacists 
licensed in 2014.
---------------------------------------------------------------------------

    The following table shows the total number of employees who may 
receive training; that is, the table shows the 50% of total workers 
whom we expect will receive training. The table does not include HHS 
employees conducting HHS health programs or activities because there 
are roughly 65,000 HHS total employees and many of these employees do 
not work in health programs or activities administered by HHS. For 
those employees who do work in health programs or activities 
administered by HHS, many may not have direct beneficiary contact. 
Given these limitations, we estimate the number of employees added 
would be very small and have little impact on overall cost.

      Table 2--Workers That May Receive Training on the Regulation
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Medical health staffs and managers......................       7,323,690
Employees working for 180 issuers in the Health                   46,114
 Insurance Marketplaces.................................
State health employees..................................          53,677
Navigators..............................................           1,399
Pharmacy workers (excluding health care personnel)......         178,810
                                                         ---------------
  Total.................................................       7,633,717
------------------------------------------------------------------------

2. Number of Covered Entities That May Train Workers
    Just as there are a number of data sources for counting workforce, 
there are various sources for counting the number of health care 
entities. Many covered entities are controlled or owned by a single 
corporate entity and one can count each individual entity separately or 
count only the single corporate enterprise. For example, a multi-campus 
facility or vertically integrated entity that owns a hospital, a 
nursing home, and a home health agency and also operates an accountable 
care organization could count each of these entities separately--as 
does Medicare--or count them only once, with each entity treated as 
part of the corporate entity. At this point, we make two assumptions: 
(1) Albeit not required to do so by the regulation, each covered entity 
will provide some training to its staff on the requirements of the 
regulation; and (2) when entities are controlled or owned by a 
corporate entity, the corporate entity will supplement or make any 
desired modification to the OCR training materials and distribute the 
training materials. We believe this last point to be especially true 
because rather than have each entity prepare its own training 
materials, the corporate entity is more likely to prepare one set of 
training materials and distribute the materials to its individual 
entities. This is because the corporate entity saves money by preparing 
a limited set of training materials and assures uniform quality and 
consistency in its policies across all its entities. It is also 
possible that some local health centers in a State may be managed from 
a central location that handles logistics and training materials. 
Therefore, we propose using the 2012 Census table that presents the 
number of firms and establishments. In the Census data, a corporate 
entity is referred to as a ``firm'' and the corporation's facilities 
are ``establishments.'' When a firm has one establishment, the 
establishment is the firm. The difficulty we face in using these data 
sources is that the Census data captures all entity types that fit the 
definition of a health care service entity, including entities such as 
private retirement communities that are unlikely to receive Federal 
financial assistance and thus would not be covered by Section 1557. In 
our use of the Census data, we attempted to exclude types of entities 
that are not likely to receive Federal financial assistance by 
excluding retirement communities and other similar type entities in the 
file but have included entities that may receive Federal financial 
assistance, for example, community health centers and residential 
centers for individuals with intellectual disabilities.
    To test our success in producing a list of covered entities from 
the Census data, we compared the number of entities we selected from 
the Census data and the number of entities included in the CMS Provider 
of Service file. However, to make the lists comparable, we have to 
remove the count of Clinical Laboratory Improvement Act laboratories 
from the CMS Provider of Service data files. There are close to 450,000 
Clinical Laboratory Improvement Act laboratories located in hospitals, 
clinics, outpatient centers, and doctors' offices.

[[Page 54200]]

Only a few thousand of these laboratories serve the public. The 
majority of laboratories serve the facility in which they are housed--
including them in our comparison would grossly distort this comparison.
    If we add the entities in the Provider of Service file (excluding 
Clinical Laboratory Improvement Act laboratories) and the number of 
community health centers to our list of affected entities that are not 
included in the Provider of Service file, we get a total of 134,543 
entities. Using the Census data, minus the categories for medical 
laboratories, we obtain a total of 139,164 establishments. It is 
evident that these numbers are very similar. However, as discussed 
earlier, we propose using only the number of firms for the analysis of 
the number of entities possibly conducting training, that is, 70,384 
firms. As, noted, we believe firms and not establishments will modify 
or supplement materials and train employees.
    In addition to the firms we include from the Census file, we must 
add physicians' office firms and pharmacy firms because they may also 
need to train some workers. Physicians' office firms and pharmacy firms 
are generally referred to as physician group practices and pharmacy 
chains.
    Below we present the types and number of firms that we estimate 
will take part in the training for the regulation.

  Table 3--Number of Health Care Entity Firms Expected To Take Part in
                                Training
------------------------------------------------------------------------
                                                             Number of
              NAIC                     Entity type             firms
------------------------------------------------------------------------
62142..........................  Outpatient mental                 4,987
                                  health and substance
                                  abuse centers.
621491.........................  HMO medical centers....             104
621492.........................  Kidney dialysis centers             492
621493.........................  Freestanding ambulatory           4,121
                                  surgical and emergency
                                  centers.
621498.........................  All Other Outpatient              5,399
                                  Care Centers.
6215...........................  Medical and Diagnostic            7,958
                                  Laboratories.
6216...........................  Home health care                 21,668
                                  services.
6219...........................  All other ambulatory              6,956
                                  health care services.
62321..........................  Residential                       6,225
                                  intellectual and
                                  developmental
                                  disability facilities.
6221...........................  General medical and               3,067
                                  surgical hospitals.
621991.........................  Psychiatric and                     411
                                  substance abuse
                                  hospitals.
6221...........................  Specialty (except                   373
                                  psychiatric and
                                  substance abuse)
                                  hospitals.
6231...........................  Nursing Care Facilities           8,623
                                  (Skilled Nursing
                                  Facilities).
44611..........................  Pharmacies and drug              18,988
                                  stores.
6211...........................  Offices of physicians..         188,921
524114.........................  Insurance Issuers......             180
                                 Navigator Grantees.....              92
                                                         ---------------
                                 Total Entities.........         278,565
------------------------------------------------------------------------

3. Training Costs
a. Cost of Training Materials and Presentations
    There are two components to the cost of training the workers we 
identified in the previous section: (1) The cost of training materials 
that is based on the number of covered entities identified in the 
previous section; and (2) the cost of employee time spent in training.
    OCR estimates, based on its experience of training employees on 
other regulations it enforces, that training employees on this 
regulation will take about one hour of an employee's time. Based on 
discussions with firms that develop training materials, we estimate 
that developing or presenting materials for a one-hour course would 
cost about $500. However, OCR proposes to provide covered entities with 
training materials that will cover the key provisions of the regulation 
that can be used by entities in conjunction with their own training 
materials. We estimate that OCR preparing the training materials on the 
regulation will substantially reduce the material preparation burden to 
covered entities and reduce the cost by about three quarters or about 
$375 per entity. Therefore, the costs to entities will equal $125 
multiplied by the number of entities that will prepare and present 
training materials. Based on its experience in preparing training 
materials for Health Insurance Portability and Accountability Act 
regulations and other civil rights regulations, OCR expects to spend 
$10,000 to develop training materials that will prepare health care 
workers and managers to effectively implement the Section 1557 
regulation.
    Training materials can be presented in a number of ways. A common 
method for offering training materials is through e-courses that are 
distributed over an entity's computer network. Another method is to 
offer lectures to selected employees/staff and then have attendees 
present the materials to their co-workers as part of train-the-trainer 
programs. For small entities, one lecture session may be given to all 
employees. Regardless of presentation mode, we estimate that preparing 
the materials or having a lecturer will cost about the same amount.
    Applying the $125 per course materials to the number of firms (125 
x 278,565)--including the 169 health insurance issuers--equals $34.8 
million for the cost of developing training materials.
b. Cost of Employee Time
    The next step is to compute the cost of employee time for training. 
This involves taking the hourly wage rate times one hour, times the 
number of employees expected to take the training. The problem we face 
is only the Bureau of Labor Statistics data provides employee median 
wage rates.\126\ Census data presents only aggregate annual payroll 
data and we must calculate the cost of employee time indirectly. We are 
uncertain about how many employees identified in the workforce above 
will actually seek and obtain training and how many firms in the health 
sector will offer training. However, for the purposes of this analysis 
we assume that all firms may offer some training to their staffs, but 
because the training is voluntary, and because only a portion of

[[Page 54201]]

employees who have direct patient contact or otherwise have duties 
impacted by the regulation may require or take training, we assume that 
50% of employees may receive training.
---------------------------------------------------------------------------

    \126\ We chose to use the median rather than the mean wage 
because the wage variances are large, ranging from $22,400 to 
$246,320 for annual salaries with mean hourly wages of $10.77 to 
$118.42 for Occupation 29-1000.
---------------------------------------------------------------------------

    The occupation code 29-1000 (health care practitioners) applies to 
the 4.8 million professional staff and degreed technical staffs we 
discussed above. The Bureau of Labor Statistics reports the median 
hourly wage for this code as $35.76. We estimate one hour of a worker's 
time would be required for training. To this amount we must add 100% 
for fringe benefits and overhead, which yields an adjusted hourly wage 
per employee of $71.52. Assuming that half of the 4.8 million health 
care practitioners identified earlier receive or obtain training (2.4 
million workers), and multiplying this number by the hourly employee 
wage plus fringe benefits and overhead for one hour equals slightly 
more than $170 million in one-time training costs for practitioners.
    For the degreed health care work force in occupation 29-2000, the 
median hourly wage is $19.65. Adding 100% for fringe benefits and 
overhead equals $39.30. The total training cost for one hour of 
training for half of the 2.8 million degreed technical staff (1.42 
million workers) is about $56.0 million. In addition, we must add the 
cost of training non-degreed staff (reported in occupation 31-0000) who 
earn a median hourly wage of $12.54. Adding 100% for fringe benefits 
and overhead to the $12.54 median hourly wage rate yields an adjusted 
wage of $25.08. Multiplying this amount by half of the 3.9 million 
workforce yields a one-time cost of $49.2 million.
    To these amounts we must add the cost of training the medical and 
health service managerial staff in occupation 11-9111: 300,180 
individuals with a median hourly pay rate of $43.72. Adding 100% for 
fringe benefits and overhead gives us an adjusted hourly wage of 
$87.44, and assuming that half of the managers would seek or receive 
training results in a one-time cost of $13.1 million.
    The cost of training occupation code 43-0000, office and 
administrative support workers employed in covered health care 
entities, is the product of the median hourly rate of $15.26 adjusted 
for fringe benefits and overhead multiplied by the 2.7 million workers 
reported for North American Industry Classification System code 62: 
Health Care and Social Assistance (including private, State, and local 
government hospitals). Adding 100% for fringe benefits and overhead to 
the $15.26 equals $30.52. Multiplying the pay rate by half the number 
of support and administrative personnel equals $41.8 million.
    For the remaining entities for which we cannot use Bureau of Labor 
Statistics data, we must use the industry payroll and employment Census 
data. To arrive at an estimate of the cost of time for training 
employees of health insurance issuers and State health and Medicaid 
agencies, we must divide the total annual payroll reported for these 
entities by the total number of employees and divide that number by the 
annual hours paid (2,080 hours), adjusted for fringe benefits and 
overhead.
    For workers employed by the issuers participating in the Health 
Insurance Marketplaces, we must determine the hourly wage rate for 
workers employed in small and large issuers as we have described them 
above. The total number of workers in small entities (fewer than 500 
workers) is 27,269 and the annual payroll is $1.68 billion. The average 
wage per employee is $61,895. Using the 2,080 hours for the annual 
number of work hours, we obtain an hourly rate of $29.76. Assuming that 
the payroll amounts reported in the Census data do not include fringe 
benefits and overhead, we add 100% to the hourly rate to yield $59.51 
per hour. Multiplying this amount by half of the 4,454 employees in 
small issuers equals $132,540 in one-time training costs.
    The total number of employees employed by large issuers (500 or 
more) is 415,017 and the annual payroll is $30.8 billion. The average 
annual wage is $74,219. Dividing this figure by 2,080 hours yields an 
hourly wage rate of $35.68. Multiplying by 100% for fringe benefits and 
overhead yields $71.36. Multiplying this amount by 50% of the 87,400 
workers equals slightly more than $3.12 million in one-time training 
costs.
    For State government workers employed in welfare, health, and 
hospital services, we divided the total number of workers the 2013 
Annual Census Bureau reported (755,993 employees) into the annual 
payroll reported for the period ($3,275,595,529). On an annual basis, 
the average salary per employee equals $52,123. The hourly rate equals 
$25.06 and multiplied by 100% for fringe benefits and overhead yields 
$50.12 per worker for training costs.
    In the State Medicaid Operations Survey: Second Annual Survey of 
Medicaid Directors cited earlier, States reported the median number of 
full-time Medicaid employees is 421. Using this number multiplied by 
the 53 Medicaid agencies in the 50 States, the District of Columbia, 
Puerto Rico, Guam, and the other territories, we added 22,313 workers 
to the total of health and hospital workers reported in the Census 
data, bringing the total number of workers in covered State government 
entities to 553,564. We then subtracted the 446,210 medical personnel 
we accounted for in the training costs for all health care personnel 
and therefore were considered to be duplicative of the medical 
personnel previously counted in our analysis of medical staff workforce 
(occupations 29-1000, 29-2000 and 31-0000). This left a net of 107,354 
State employees receiving training. Taking half of this number and 
multiplying it by $50.12 equals a one-time training cost of slightly 
more than $2.69 million.
    Although we removed the cost of training the 446,210 medical 
personnel from the State training cost analysis to avoid double 
counting training costs, the cost of training half the medical staff 
may still fall to the States where they are employed. We estimate the 
cost to train State medical personnel to be approximately $10.5 
million.\127\
---------------------------------------------------------------------------

    \127\ We calculated the cost of training the medical personal 
using the weighted median hourly rate, $47.22, multiplied by the 
446,210 medical staff identified as employed in State governments.
---------------------------------------------------------------------------

    The 2013 Bureau of Labor Statistics data for North American 
Industry Classification System pharmacies and drugstores reports a 
total workforce of 706,000 workers. As with the analysis for State 
employees, we must remove health care workers that are already counted 
in our training costs analysis of the health care workforce. To avoid 
double counting training costs for these occupations, we removed them 
from the count of the pharmacy workforce. However, the entities that 
employ these workers will still bear the cost for training them. At a 
median weighted wage of $47.22, if employers trained half of the 
medical staff they employ, they would be responsible for $8.2 million 
in training costs for the employees we excluded from the analysis to 
avoid double counting.\128\
---------------------------------------------------------------------------

    \128\ Determining the cost to train employees other than 
pharmacists and medical staff who work in pharmacies requires use of 
the Bureau of Labor Statistics industry data for North American 
Industry Classification System code 446110. These data show that for 
2013, 348,380 medical practitioners, technologists and medical 
support staff (occupation code 29-1000 and 29-2000 and 31-000) were 
employed in pharmacies and drug stores.
---------------------------------------------------------------------------

    For the 357,620 non-medical pharmacy personnel, the cost of 
training half the employees equals the median hourly rate for pharmacy 
employees ($13.37), or $26.74 after adding 100% for fringe benefits and 
overhead. Total

[[Page 54202]]

costs for employee training time equals $7.78 million.
    The following table summarizes the training costs we estimate for 
the proposed rule.

                      Table 4--Total Training Costs
------------------------------------------------------------------------
                                        Number of
                                    entities/ workers         Cost
------------------------------------------------------------------------
Training preparation costs ($125/           * 278,565        $34,820,625
 entity)/entity...................
Health care staff and managers              7,323,690        335,137,611
 training.........................
Small Issuers in the Health                     2,414            143,669
 Insurance Marketplace training...
Large issuers in the Health                    43,700          3,118,618
 Insurance Marketplace training...
Navigators........................              1,399            120,551
State health, hospital and                     53,677          2,690,291
 Medicaid worker training.........
Pharmacy worker training..........            178,810          6,791,203
                                   -------------------------------------
    Total.........................          7,633,717        382,822,568
------------------------------------------------------------------------
* Not included in column total.

D. Notification and Other Procedural Requirements

1. Designation of Responsible Employee and Adoption of Grievance 
Procedures
    Pursuant to the regulations implementing Section 504, recipients of 
Federal financial assistance with 15 or more employees are required to 
designate a responsible employee to coordinate compliance with respect 
to nondiscrimination requirements and to have a grievance procedure to 
address complaints of discrimination under this law. Of the 279,000 
covered health care entities, approximately 15% employ more than 15 
employees, resulting in approximately only slightly more than 58,500 
covered health care entities being required to have a grievance 
procedure and designate a responsible official. Thus, all recipients of 
Federal financial assistance with 15 or more employees are already 
expected to have in place a grievance procedure and a designated 
employee to coordinate their compliance responsibilities. The proposed 
rule standardizes the requirement to designate a responsible employee 
and adopt grievance procedures across all bases of discrimination 
prohibited under Section 1557.
    To implement the proposed rule, a recipient of Federal financial 
assistance could increase the responsibilities of an already-designated 
employee to handle compliance with the proposed rule's 
nondiscrimination requirements. In addition, a recipient of Federal 
financial assistance could increase the scope of existing grievance 
procedures to accommodate complaints of discrimination under all bases 
prohibited under Section 1557. The costs associated with these 
requirements are the costs of training the designated employee on his 
or her increased responsibilities and the costs associated with 
modifying the existing grievance procedures to reflect the additional 
bases of race, color, national origin, sex, and age. Here we are 
referring to employee training to perform their specific enforcement 
responsibilities, not one-time training in the provisions of the rule 
described in the training section above. We also note that grievance 
officials will probably receive specific training on their new 
responsibilities and that covered entities will probably provide this 
additional training and absorb the costs, which are expected to be 
minimal. Many covered entities already may be using their existing 
grievance procedures to address the additional cases covered under 
Section 1557.
    State-based Marketplaces are required to designate an employee to 
handle compliance responsibilities and to adopt a grievance procedure 
under the ADA. The duties of the employee and the grievance procedure 
could be modified to reflect all the bases covered under Section 1557. 
We have not estimated the additional costs of training grievance 
officials on their individual enforcement responsibilities, but believe 
such cost would be absorbed in general training costs of all employees 
on their job responsibilities. Costs associated with modifying existing 
grievance procedures are covered in the section of the analysis on 
enforcement.
2. Notice Requirement
    The implementing regulations of Title VI, Section 504, Title IX, 
and the Age Act require recipients of Federal financial assistance and, 
in the case of Section 504, the Department, to notify individuals that 
recipients (and, under Section 504, the Department) do not 
discriminate. The content of the nondiscrimination notices varies based 
on the applicable civil rights law.
    The proposed rule harmonizes notification requirements under Title 
VI, Section 504, Title IX and the Age Act, and standardizes the minimum 
information for a notice. The proposed rule also requires initial and 
continuing notification of individuals. The proposed rule provides that 
OCR will draft a sample notice in English that meets the requirements 
and will translate that notice into 15 additional languages. Covered 
entities have discretion to use the OCR sample notice or their own 
notice, if preferred, and to post the notice in non-English languages.
    As all Section 1557 covered entities will need to create or update 
an existing notice of nondiscrimination, all covered entities can 
discharge their responsibilities under Sec.  92.8(a) by replacing their 
current notices with the sample notice OCR will make available to all 
covered entities pursuant to Sec.  92.8(c). Using the sample OCR notice 
means that covered entities will not have to compose their own notices; 
we expect nearly all covered entities will use the sample OCR notice.
    All covered entities will incur costs, however, to implement Sec.  
92.8(a) of the proposed rule, which requires ``initial and continuing'' 
notification. Such notification is expected to involve:
     Downloading the notice from the OCR Web site;
     Printing copies of the notice for posting;
     Posting hard copies of the notice in public spaces of the 
office or facility; and
     Posting the notice on the entity's Web site, if it has 
one.
    Approximately 278,500 covered entities would spend one minute 
downloading the notice from the OCR

[[Page 54203]]

Web site and then spend five minutes posting one copy of the notice in 
an average of two areas each. (Smaller entities may post the notice 
only in a reception area; larger entities may post the notice in 
emergency and reception areas.) Based on the fully loaded cost of 
$30.52 per hour for a clerical worker, the cost for the average covered 
entity is estimated to be:

     Downloading the OCR notice--1 minute at $30.52 per hour 
equals $0.51;
     Printing 2 hard copies of the notice--1 minute at 
$30.52 per hour equals $0.51;
     Posting the notice in an average of two areas--5 
minutes, at $30.52 per hour equals $2.54; and
     Preparing the OCR notice for posting on the facility's 
Web site and posting the notice on the Web site--ten minutes of a 
clerical worker's time adjusted for fringe benefits and overhead 
equaling $5.08.


    For each entity, the cost of downloading the notice, posting it in 
a public place and posting it to the entity's Web site is $8.64. The 
total cost for the 279,000 covered entities is $2,411,000.
    Covered entities that distribute general or major publications 
targeted to patients, consumers, or members of the public will need to 
update these publications to include the new notice. However, as noted 
above, we are allowing entities to exhaust their current publications, 
rather than do a special printing of the publications to include the 
new notice. When covered entities restock their printed materials, they 
will be expected to include in those printed materials the notice that 
OCR will provide with the final rule.
    Because we are permitting covered entities to exhaust their 
existing stock of publications with the current notices before using 
the new notice, we conclude that the notice requirement imposes no 
resource costs related to including updated notices in the 
publications. We invite public comment on our analysis. Section 92.8 
provides covered entities discretion to post the OCR sample notice of 
nondiscrimination in 15 non-English languages, which can include 
languages that differ from OCR's list. The 15 languages cover over 90 
percent of non-English language speakers. In addition, covered entities 
can draft and translate their own notice in however many languages they 
choose, if they prefer.
    We examined CMS contractual cost for translating a one page notice 
into 13 languages which was $1,000. Based on this figure, if we were 
providing notices to approximately 300,000 entities and used the same 
contractor, the costs to the Federal government would be a maximum of 
approximately $1.4 million dollars. However, because the Federal 
government would be posting the notice onto its Web site, rather than 
printing it, covered entities would have to bear the cost of 
downloading and printing the notice from OCR's Web site and then 
posting it.
    We expect total costs to the government to be limited to $1,000 to 
translate the notice into 15 languages and place the translated notices 
on OCR's Web site.
    Although not required, we expect that many covered entities would 
choose to post the OCR-provided notice in one or more non-English 
languages on their Web sites, in their physical office space, and in 
certain publications they may have. We do not know how many covered 
entities would take this action or how many non-English language 
versions of the notice they would choose to post, or where they would 
make the non-English versions of the notice available. We invite 
comment on these issues.
    Section 92.8 requires covered entities to publish taglines 
indicating the availability of language assistance services in the top 
15 languages nationally. OCR will make these taglines available 
electronically in the 15 languages; therefore, there will be no burden 
to the covered entity other than the cost of printing and posting these 
taglines, as described above with respect to the notice. We are 
uncertain of the exact volume of taglines that will be printed or 
posted, but we estimate that covered entities will print and post the 
same number of tag lines as notices and therefore the costs would be 
comparable to the cost for printing and disseminating the notice, or 
$2,411,000. The costs to the federal government for translating the 
taglines will approximately be the same as for printing the notices or 
$1,000. We estimate that the combined costs of printing and 
distributing notices and tag lines will be $4,822,000 for entities and 
$2,000 for the Federal government. We seek public comment on this 
estimate.

E. Meaningful Access for Individuals With Limited English Proficiency 
(LEP)

    Proposed Sec.  92.201, which effectuates Section 1557's prohibition 
of national origin discrimination as it affects individuals with 
limited English proficiency, does not pose any new burden on covered 
entities. With regard to recipients of Federal financial assistance, 
the proposed rule adopts recipients' existing obligations under Title 
VI to take reasonable steps to provide meaningful access to individuals 
with limited English proficiency and codifies standards consistent with 
long-standing principles from the HHS LEP Guidance regarding the 
provision of oral interpretation and written translation services. 
Because the proposed rule does not impose duties beyond recipients' 
legal obligations under Title VI, the proposed rule imposes no new 
burden.
    Although Title VI does not apply to the Department, Executive Order 
13166 ``Improving Access to Services for Persons with Limited English 
Proficiency,'' has applied to HHS for nearly 15 years.\129\ This 
Executive Order requires Federal departments to develop and implement a 
plan, consistent with the HHS LEP Guidance, to ensure that persons with 
limited English proficiency can meaningfully access the Department's 
programs and activities. HHS adopted a Language Access Plan in 2000, 
and updated it in 2014, to provide individuals with limited English 
proficiency meaningful access to HHS-conducted programs and 
activities.\130\ Because the proposed rule does not impose duties 
beyond the Department's existing obligation under the Executive Order, 
the proposed rule imposes no new burden on the Department.
---------------------------------------------------------------------------

    \129\ E.O. 13166, 65 FR 50121 (2000).
    \130\ U.S. Department of Health and Human Services, Language 
Access Plan (LAP) (2013).
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    Title VI applies to Title I entities that receive Federal financial 
assistance, including State-based Marketplaces. Executive Order 13166 
applies to the Federally-facilitated Marketplaces as an HHS-conducted 
health program. Additionally, both Federally-facilitated Marketplaces 
and State-based Marketplaces must already comply with language access 
provisions of the Federal regulations governing Health Insurance 
Marketplaces.\131\ For instance, 45 CFR 155.205(c) requires Health

[[Page 54204]]

Insurance Marketplaces to provide information to applicants and 
enrollees in a manner accessible to persons with limited English 
proficiency, including through the use of language assistance services, 
such as oral interpretation and written translation. We view covered 
entities' obligations under the proposed rule to ``take reasonable 
steps to provide meaningful access'' as imposing no greater burden than 
Sec.  155.205(c) already imposes.
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    \131\ Under Federal regulations governing the Health Insurance 
Marketplaces, the term ``Exchange'' includes a Marketplace that is 
``established and operated by a State. . . or by HHS.'' 45 CFR 
155.20. Health plans seeking certification as qualified health plans 
must provide information on certain claims payment and rating 
practices, cost-sharing, and enrollee and participant rights in 
information in plain language, which ``means language that the 
intended audience, including individuals with limited English 
proficiency, can readily understand and use . . . .'' 42 U.S.C. 
18031(e)(3)(B). Marketplaces must also provide language assistance 
services for applicants and enrollees who are limited English 
proficient for the following Marketplace functions, documents, and 
information: consumer assistance functions (including the Navigator 
Program), education and outreach activities; all applications, 
forms, and notices; a Marketplace's toll-free call center; and a 
Marketplace's Internet Web site, which includes comprehensive 
information on the costs, benefits, and quality of qualified health 
plans. 45 CFR 155.205(a), (d), (e), 155.230(b). These regulatory 
provisions incorporate by reference the language assistance services 
requirement in 45 CFR 155.205(c)(2).
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F. Nondiscrimination on the Basis of Sex

    Section 1557 prohibits discrimination on the basis of sex, 
including sex stereotyping and gender identity, in certain health 
programs and activities. When providing services, including access to 
facilities, covered entities must provide individuals with equal 
program access on the basis of sex, and are required to treat 
individuals in a manner consistent with their gender identity.
    Prior to the enactment of Section 1557, Title IX applied to 
educational institutions. Therefore, medical schools, nursing programs, 
and other health education programs were already prohibited from 
discriminating on the basis of sex. Under Section 1557 and this 
proposed regulation, health insurance issuers receiving Federal 
financial assistance, hospitals, clinics and other health facilities, 
HHS health programs and activities, and Title I entities, along with 
the staff and practitioners working in these health programs, are now 
similarly prohibited from discriminating on the basis of sex.\132\ This 
section discusses the costs associated with the prohibition of 
discrimination on the basis of sex in the proposed rule, taking into 
account the existing environment, including legal authorities that 
address equal access on the basis of sex.
---------------------------------------------------------------------------

    \132\ We note that consistent with OCR's enforcement of other 
civil rights authorities, the proposed definition of Federal 
financial assistance under the regulation does not include Medicare 
Part B, making physicians receiving only Medicare Part B payments, 
not covered under the regulation. However, because almost all 
physicians receive payments from other Department programs such as 
Medicaid or Medicare meaningful use payments, we believe that there 
would be very few physicians excluded from these provisions.
---------------------------------------------------------------------------

    Covered entities that provide or administer health services or 
health insurance coverage are covered by the prohibition of 
discrimination on the basis of sex, including sex stereotyping and 
gender identity. The costs that we anticipate that covered entities 
would incur relate to: (1) Training; (2) enforcement; (3) the posting 
of the notice; (4) the revision of policies and procedures; and (5) 
some costs associated with changes in discriminatory practices. The 
costs related to training, enforcement, and the posting of the notice 
have already been discussed in this analysis. This section discusses 
costs related to changes in policy and procedures and potential changes 
in discriminatory practices.
Costs for Entities Providing or Administering Health Services
    The NPRM would not invalidate specialties that focus on men or 
women, e.g., gynecology, urology, etc. Nor would providers have to 
fundamentally change the nature of their operations to comply with the 
regulation. For example, the NPRM would not require a provider that 
operates a gynecological practice to add to or change the types of 
services offered in the practice.
    Under the sex discrimination prohibition, however, providers of 
health services may no longer deny or limit services based on an 
individual's sex, without a legitimate nondiscriminatory reason. 
Although a large number of providers may already be subject to state 
laws or institutional policies that prohibit discrimination on the 
basis of sex in the provision of health services, the clarification of 
the prohibition of sex discrimination in this regulation, particularly 
as it relates to discrimination on the basis of sex stereotyping and 
gender identity, may be new. We anticipate that a large number of 
providers may need to develop or revise policies or procedures to 
incorporate this prohibition. For example, if a hospital or other 
provider has specific protocols in place for domestic violence victims, 
but only engages that protocol for women, the provider would have to 
revise its procedures to require that protocol for all individuals 
regardless of sex. A provider specializing in gynecological services 
that previously declined to provide a medically necessary hysterectomy 
for a transgender man would have to revise its policy to perform the 
procedure on transgender individuals in the same manner it provides the 
procedure for other individuals.
Developing or Revising Policies and Procedures
    We assume that it will take, on average, 3-5 hours for a provider 
to develop or modify policies and procedures concerning sex 
discrimination. We are selecting four hours, or the midpoint of this 
range, for our analysis. We further assume that three of the hours will 
be spent by a mid-level manager equivalent to a front-line supervisor 
(Occupation code 43-1011), at a salary, with fringe benefits and 
overhead of $48.52 per hour, and one hour will be spent by executive 
staff equivalent to a general and operations manager (Occupation code 
11-1021), at a salary, with fringe benefits and overhead of $81.84 per 
hour. We further assume that 75% of covered health providers will need 
to develop or modify policies and procedures, given that some 
proportion of health care providers already prohibit sex discrimination 
based on State law or institutional policies prohibiting discrimination 
generally. The total cost for the estimated 208,700 providers to make 
their policies and procedures consistent with the regulatory 
prohibition on discrimination on the basis of sex is estimated to be a 
one-time cost of approximately $47.5 million, which we assume is 
divided evenly between the first two years of compliance.
    The above estimates of time and number of entities that would have 
to revise their policies under the regulation is an approximate 
estimate based on general BLS data. Due to the wide range of types and 
sizes of covered entities, from complex multi-divisional hospitals to 
small neighborhood clinics and physician offices, the above estimates 
of time and number of entities that would have to revise their policies 
under the regulation is difficult to calculate. We invite the public to 
submit data and comments on our estimate.
Stopping Discrimination
    For providers that discriminate on the basis of sex in violation of 
the proposed rule, some changes in behavior or action would be 
necessary to come into compliance. We anticipate some change in the 
patient population for which a particular provider provides care or the 
extent of services provided. However, the infrastructure and protocols 
for providing services or treatment are already in place; providers 
would simply have to start providing those existing services in a 
nondiscriminatory manner to individuals regardless of sex. For example, 
a provider could not refuse to treat a patient for a cold or a broken 
arm based on the patient's gender identity. Similarly, if the provider 
is accepting new patients, it must accept a new patient request from a 
transgender individual and cannot decline to accept a transgender 
person in favor of a person who is not transgender.
    However, the proposed rule does not impose a burden on covered 
entities with respect to the number of patients treated. The proposed 
rule does not

[[Page 54205]]

require a covered entity to change the total number of patients it sees 
or to treat more patients than it currently accepts. Providers may 
continue to treat the same number of patients that were accepted prior 
to the issuance of this proposed rule, but they must do so in a 
nondiscriminatory manner. Thus, for example, if a provider is not 
accepting new patients, the provider does not have to accept a new 
patient request from a transgender person. We anticipate that the costs 
associated with these types of changes would be minimal.
    Moreover, costs associated with administering care or treating a 
new patient generally would be offset by the reimbursement received by 
the provider for providing the care, in the same way the provider gets 
paid for existing care or treatment of patients. Thus, for example, for 
the hospital or other provider that needs to revise its protocol for 
domestic violence to require that protocol for all individuals 
regardless of sex, rather than just women, there would be little to no 
net increase in costs for treating men because the hospital or provider 
would be paid for its services in the same way it would be paid to 
treat a woman for the same care. We welcome comments on this assumption 
and information about costs.
Costs for Entities Providing or Administering Health Insurance Coverage
    The ACA, including Section 1557, changed the health care landscape 
for millions of people by instituting protections against sex 
discrimination in the provision of health care and health insurance 
coverage. Prior to the ACA, it was standard health insurance practice 
to treat women differently in premium pricing and coverage of 
benefits,\133\ while transgender individuals frequently experienced 
discrimination when seeking treatment.\134\
---------------------------------------------------------------------------

    \133\ See Adelle Simmons, Katherine Warren, and Kellyann 
McClain, ASPE Issue Brief, The Affordable Care Act: Advancing the 
Health of Women and Children, (January 9, 2015), available at https://aspe.hhs.gov/health/reports/2015/MCH/ib_mch.pdf; HHS.gov/Health 
Care, The Affordable Care Act and Women Fact Sheet, https://www.hhs.gov/healthcare/facts/factsheets/2012/03/women03202012a.html 
(last visited June 12, 2015).
    \134\ See Lambda Legal, When Health Care Isn't Caring, Lambda 
Legal's Survey on Discrimination Against LGBT People and People 
Living with HIV, (2010), available at https://www.lambdalegal.org/publications/when-health-care-isnt-caring.
---------------------------------------------------------------------------

    The ACA addresses inequitable treatment by health plans based on 
sex in multiple ways. CMS regulations implementing the ACA prohibit 
Title I entities \135\ and most health insurance issuers \136\ from 
discriminating based on sex, including sex stereotyping and gender 
identity, in addition to other bases. These market-wide provisions are 
applicable to health insurance issuers both on and off the Health 
Insurance Marketplace, which includes qualified health plan issuers 
\137\ and health insurance issuers providing non-grandfathered coverage 
in the individual and group markets outside of the Health Insurance 
Marketplace.\138\
---------------------------------------------------------------------------

    \135\ 45 CFR 155.120(c)(1)(ii) prohibits a Health Insurance 
Marketplace from discriminating based on race, color, national 
origin, disability, age, sex, gender identity, or sexual 
orientation.
    \136\ 45 CFR 147.104(e) prohibits health insurance issuers in 
the non-grandfathered individual, small and large group markets from 
employing benefit designs that will have the effect of discouraging 
the enrollment of individuals with significant health needs in 
health insurance coverage or discriminate based on an individual's 
race, color, national origin, present or predicted disability, age, 
sex, gender identity, sexual orientation, expected length of life, 
degree of medical dependency, quality of life, or other health 
conditions. 45 CFR 156.200(e) prohibits a qualified health plan 
issuer from discriminating on the basis of race, color, national 
origin, disability, age, sex, gender identity, or sexual 
orientation. 45 CFR 156.125(a) prohibits issuers that provide 
essential health benefits from using benefit designs that 
discriminate based on an individual's age, expected length of life, 
present or predicted disability, degree of medical dependency, 
quality of life, or other health conditions. 45 CFR 156.125(b) 
requires issuers that provide essential health benefits to comply 
with 45 CFR 156.200(e).
    \137\ 45 CFR 147.104(e), 156.200(e) and 156.125(a)-(b) are 
applicable to qualified health plan issuers.
    \138\ 45 CFR 147.104(e) is applicable to non-grandfathered 
coverage in the individual, small and large group markets. 45 CFR 
147.150(a) incorporates essential health benefits requirements (and 
implementing regulations at 45 CFR 156.200(e) and 156.125(a)-(b)) 
for non-grandfathered coverage in the individual and small group 
markets.
---------------------------------------------------------------------------

    In addition, the Affordable Care Act prohibits many health 
insurance issuers from charging higher premiums based on sex;\139\ 
failing to provide essential health benefits that greatly impact women, 
such as maternity care; \140\ failing to cover preventive services that 
are necessary for women's health, such as mammograms; \141\ and denying 
benefits based on pre-existing conditions \142\ or health factors,\143\ 
many of which affect women's health, such as a history of a Caesarian 
section or a history of domestic violence.\144\ Thus, health insurance 
issuers and the Health Insurance Marketplaces have already had to 
expand access to women and lesbian, gay, bisexual and transgender 
(LGBT) individuals under these health insurance market reforms, 
independent of Section 1557. The existence of these other provisions 
circumscribes cost burdens on Health Insurance Marketplaces and issuers 
that are recipients of Federal financial assistance that are imposed by 
the prohibition of sex discrimination in the proposed rule. However, 
the proposed rule nonetheless would impose some costs.
---------------------------------------------------------------------------

    \139\ 45 CFR 147.102.
    \140\ 45 CFR 156.110.
    \141\ 45 CFR 147.130.
    \142\ 45 CFR 147.108.
    \143\ 45 CFR 147.110.
    \144\ ASPE Issue Brief, supra note 133.
---------------------------------------------------------------------------

    Section 92.207 (Nondiscrimination in health insurance and other 
health coverage) of the proposed rule prohibits discrimination on the 
basis of sex, including sex stereotyping and gender identity, by a 
covered entity providing or administering health insurance or other 
health coverage. As noted, many of the same covered entities subject to 
Section 1557, including Health Insurance Marketplaces and health 
insurance issuers that are recipients of Federal financial assistance, 
are also subject to existing nondiscrimination provisions in CMS 
regulations. While the CMS regulations complement and do not replace 
Section 1557, the existing nondiscrimination requirements applicable to 
health insurance issuers and Health Insurance Marketplaces mean that 
these entities are aware that they are not permitted to discriminate on 
the basis of sex, including sex stereotyping and gender identity, and 
thus they are familiar with their nondiscrimination obligations under 
the law. We assume that these covered entities have already taken steps 
to comply with CMS regulations and so instituted changes in their 
policies and actions. To the extent these existing obligations overlap 
with Section 1557 and covered entities have taken steps required under 
the CMS regulations, this proposed rule will impose little or no burden 
on health insurance issuers and Title I entities to comply with Section 
1557's prohibition on sex discrimination because these covered entities 
should already be in compliance with regulations that prohibit 
discrimination on the basis of sex, including sex stereotyping and 
gender identity.
Developing or Revising Policies and Procedures
    There may be some incremental burden on issuers and Title I 
entities in terms of the additional guidance that this proposed rule 
provides related to sex discrimination, since, in some circumstances, 
it provides more detail than CMS regulations or guidance. Therefore, 
covered entities may have an increased burden when incorporating this 
rule into their existing nondiscrimination policies and procedures. For 
example, this rule specifies that an explicit categorical exclusion of 
coverage for health care

[[Page 54206]]

services related to gender transition is discriminatory on its face. To 
the extent a covered entity did not interpret sex discrimination on the 
basis of gender identity in this way, the covered entity would have to 
revise its policies and procedures to provide coverage consistent with 
this rule's parameters, which might include revising policies to 
include gender transition-related care.
    However, we note that the number of major U.S. employers providing 
transgender-inclusive health care coverage has been increasing 
dramatically, from 0 in 2002, to 49 in 2009, 278 in 2013, 336 in 2014, 
and finally 418 in 2015.\145\ This indicates that plans that offer 
transgender-inclusive health care are becoming readily available as 
models for issuers that may not offer such care, limiting their costs 
in developing or revising compliant policies and procedures.
---------------------------------------------------------------------------

    \145\ Human Rights Campaign, Corporate Equality Index, Rating 
American Workplaces on Lesbian, Gay, Bisexual and Transgender 
Equality, 30, (2015), available at https://www.hrc.org/campaigns/corporate-equality-index.
---------------------------------------------------------------------------

    Similar to the estimate for providers of health services, we assume 
that it will take, on average, three to five hours for issuers of 
health insurance coverage to develop or modify policies and procedures 
concerning sex discrimination. We are selecting four hours, or the 
midpoint of this range, for our analysis. We further assume that three 
of the hours will be spent by a mid-level manager, at a salary, with 
fringe benefits and overhead of $57.60 per hour,\146\ and one hour will 
be spent by executive staff, at a salary, with fringe benefits and 
overhead of $122.15 per hour. Based on our best estimate of industry 
compliance with CMS regulations, we further assume that one-third or 
33% of health insurance issuers will need to develop or modify policies 
and procedures. Based on an unduplicated count of issuers, we 
previously identified 180 issuers in the Federally-facilitated 
Marketplaces. One third of this number equals 60 issuers that we 
estimate would need to revise policies to address the prohibition of 
sex discrimination in this regulation. The costs to issuers to revise 
policies and procedures to provide coverage consistent with this rule's 
parameters equal 60 issuers multiplied by $295 for a one-time cost of 
$17,700.
---------------------------------------------------------------------------

    \146\ Using BLS occupation code 43-1011 and occupation code 11-
1021 for the health insurance industry NAICS code 524114.
---------------------------------------------------------------------------

Stopping Discrimination
    In addition to the cost some covered health insurance providers may 
have for revising policies and procedures to comply with the proposed 
rule, such providers may also incur a minimal cost related to the cost 
of coverage. In this regard, we note that the April 2012 California 
Department of Insurance Economic Impact Assessment on Gender 
Nondiscrimination in Health Insurance found that covering transgender 
individuals under California's private and public health insurance 
plans would have an ``insignificant and immaterial economic impact'' on 
costs.\147\
---------------------------------------------------------------------------

    \147\ State of California, Department of Insurance, Economic 
Impact Assessment Gender Nondiscrimination in Health Insurance. 
(Apr. 13, 2012).
---------------------------------------------------------------------------

    This conclusion was based on evidence of low utilization and the 
estimated number of transgender individuals in California. The 
transgender population of California was estimated to range between 
0.0022% and 0.0173%.\148\ The study revealed that contrary to common 
assumptions, not all transgender individuals seek surgical 
intervention, and that gender-confirming health care differs according 
to the needs and pre-existing conditions of each individual.\149\ 
Additionally, issuers in California that established premium surcharges 
after enactment of California's Gender Nondiscrimination in Health 
Insurance Law subsequently eliminated them because they found they did 
not spend the extra funds generated.\150\
---------------------------------------------------------------------------

    \148\ Id.
    \149\ Id. at 8.
    \150\ Id. at 6-7.
---------------------------------------------------------------------------

    Based on the California study, we believe that providing 
transgender individuals non-discriminatory insurance coverage and 
treatment will impact a very small segment of the population due to the 
fact that the number of transgender individuals (and particularly those 
who seek surgical procedures in connection with their gender 
transition) in the general population is small, and will have minimal 
impact on the overall cost of care and on health insurance 
premiums.\151\
---------------------------------------------------------------------------

    \151\  Id. at 9. Insurers in California that established a 
premium surcharge to cover the City of San Francisco's expected 
claim costs eventually eliminated the additional premium because 
they found their cost assumptions were 15 times higher than actual 
claims generated.
---------------------------------------------------------------------------

G. Accessibility of Electronic and Information Technology

    Although Section 1557 requires covered entities to ensure that the 
health programs, services, and activities provided through electronic 
and information technology are accessible to individuals with 
disabilities, all covered entities affected by Section 1557 already 
have these obligations under Section 508, Section 504 or the ADA.
1. HHS Health Programs and Activities, Including the FFMs
    Section 508 requires that electronic and information technology 
developed, procured, maintained, or used by Federal agencies be 
accessible for individuals with disabilities (both members of the 
public and Federal employees). Section 504 also establishes general 
obligations for Federal agencies to make their programs that are 
provided through electronic and information technology accessible to 
individuals with disabilities. Both Section 504 and Section 508 were in 
place before the passage of the ACA. There is, therefore, no additional 
burden under Section 1557 for HHS health programs, including the 
Federally-facilitated Marketplaces, as the Section 1557 requirements 
are consistent with the obligations these programs already have under 
Section 504 and Section 508.
2. Recipients of Federal Financial Assistance From HHS and Title I 
Entities
    Section 504 also establishes general obligations for entities 
receiving Federal financial assistance to make their programs, 
services, and activities provided through electronic and information 
technology accessible to individuals with disabilities. The ADA imposes 
similar accessibility requirements on covered entities. The proposed 
regulation thus imposes no additional burden on recipients of Federal 
financial assistance from HHS because Section 1557 is consistent with 
existing standards these entities are already obligated to meet under 
the ADA and Section 504. Title I entities have no Section 1557 burden 
with respect to this proposed requirement, as the Title I entities must 
already be compliant with the ADA, which is consistent with the Section 
1557 accessibility standards.

H. Enforcing the Rule

    After grievances are filed with covered entities or complaints are 
filed with OCR, there are associated costs to investigate and resolve 
those grievances and complaints. We believe the following costs result 
from enforcement of the Section 1557 regulation:
     Costs to covered entities for modifying and implementing 
existing grievance procedures to cover grievances filed under Section 
1557.
     Costs to OCR for reviewing and investigating complaints, 
monitoring

[[Page 54207]]

corrective action plans or taking other enforcement actions against 
covered entities.
    We now proceed to estimate the aggregate costs of these enforcement 
procedures. In the analysis below, we analyze the costs to covered 
entities separately from the costs to OCR.
1. Costs to Covered Entities
    Federal civil rights laws that were in place before Section 1557 
became effective apply to entities that receive Federal financial 
assistance. Entities subject to those laws are already required to have 
in place an established grievance procedure to address disability 
discrimination complaints and complaints of sex discrimination in 
education programs. It is anticipated that any additional costs that 
may be imposed by this regulation would potentially arise because of 
the expansion of the grievance process to cover all bases covered under 
Section 1557, including race, color, national origin, and age, as well 
as sex discrimination in health care. It is expected that this may lead 
to a slight increase in additional grievances being filed, and require 
increased time to investigate and resolve these additional grievances.
    To compute the anticipated costs for covered entities to enforce 
the proposed regulation, we looked to OCR data. The current number of 
civil rights complaints filed annually with OCR is approximately 3,000. 
Since the passage of Section 1557, OCR's complaint workload has 
increased slightly; with somewhere in the range of 15-20 unique Section 
1557 cases filed each year. Stemming from the sentinel effects from the 
enactment of the regulation, if we include another ten cases per year, 
we calculate an increase of 30 cases per year or 1% of the annual 
caseload of 3,000. We assume the incremental workload will be similar 
for affected entities and thus will be approximately 1%. We anticipate 
that within the first five years following the rule's enactment, 
complaints will increase, but eventually will drop off as covered 
entities modify their policies and practices in response to the 
proposed rule. Although we have data on OCR's caseload, we have no data 
on the caseload of affected covered entities. We ask for public comment 
on the assumption regarding increased caseload.
    If we assume that as a result of promulgating the proposed 
regulation, a designated grievance official for the 58,550 covered 
entities with 15 or more employees had to devote an additional 1% of 
his or her time to investigating discrimination grievances, incremental 
costs (including fringe benefits and overhead) would be $118.7 million.
    To arrive at this number we used the annual mean wage of $101,340 
for medical and health service managers (occupation code 11-9111) and 
took 1%. We increased the amount by 100% to account for fringe benefits 
and overhead, and multiplied the value by the number of covered health 
entities that we estimate have 15 or more entities using 2012 US 
business census data.
    It is important to consider the assumptions we made in estimating 
the costs to covered entities. We assumed that all entities would 
experience the same proportional increase in complaints filed. This may 
not be accurate. We expect most covered entities will comply with the 
regulation and not see an increase in complaints. However, because we 
lack data to enable us to pinpoint which entities will experience an 
increase, we are required to make a general assumption about all 
covered entities. As such, we anticipate the resultant cost estimate to 
be an overestimation of the new costs for addressing grievances filed 
against covered health entities. We ask for public comment on these 
costs and estimates.
    The same incremental calculations apply to the workloads of State 
agencies and the officials working in these agencies. If we assume the 
same 1% increase in caseload and the average mid-level State official 
salary is $94,580 (including fringe benefits and overhead), we must 
multiply $94,580 by the number of State covered entities.\152\ To 
arrive at the number of State covered entities we make the following 
assumptions:
---------------------------------------------------------------------------

    \152\ Based on the annual salary of Executive Secretary and 
Executive Administrative Assistant (Occupation code 43-6011 for 
Sector 99).
---------------------------------------------------------------------------

     We assume that there are 53 Medicaid State agencies;
     We assume that there are 53 State health departments;
     We assume that each State and the District of Columbia has 
two State-run hospitals; and
     We assume that each of 3,143 counties has a county health 
department that provides direct health services (e.g., immunization 
clinics) and is accountable to the State Health Department. We assume 
that each of the county health departments has a designated official 
for handling grievances.
    The total number of State covered entities is 3,351. Multiplying 
$94,580 by 3,351 equals $316.9 million. One percent of this value 
equals $3.17 million.
2. Costs to OCR
    We considered the various OCR enforcement costs together, based on 
OCR average salary data presented in its annual budgets. According to 
the FY 2016 President's Budget, $28,400,000 and 137 Full Time 
Equivalents (FTEs) were requested for Enforcement and Regional 
Operations, at a cost of approximately $201,000 per FTE. Of the 137 
FTEs, approximately 40 FTEs spend 100% of their investigative time 
enforcing the civil rights laws.\153\ If we make the same assumption we 
did above and assume the same 1% increase in caseload from the issuance 
of Section 1557, the anticipated increase in number of staff necessary 
would be approximately 0.4 of an FTE (1% of 40) and would cost 
approximately $80,400.
---------------------------------------------------------------------------

    \153\ This is based on an informal staff estimate.
---------------------------------------------------------------------------

Summary of Cost and Phase-in
    The table below summarizes the costs attributable to the proposed 
regulation that covered entities may incur following enactment of the 
final regulation. We assume that half of the training costs and changes 
to policies and procedures on the prohibition of discrimination on the 
basis of sex will be incurred in the first year and the second half 
will be expended in the second year. For covered entities that will be 
printing and distributing notices to their patients and policy holders, 
we assume that all of the estimated printing and distribution costs 
will be expended in the first year after the effective date of the 
rule. Due to the likelihood that applicable changes will need to be 
phased in, we assume one half of the annual projected costs for 
investigating discrimination complaints will be incurred during the 
first year and three quarters of the annual projected enforcement costs 
will be spent in the second year and the full amounts in the third 
through fifth years. Information collection requirements and paperwork 
burden costs would be incurred within the first year after the 
effective date of the final regulation.

[[Page 54208]]



                                 Table 5--Cost Summary of the Proposed Regulation Following Enactment of the Final Rule
                                                           [discounted 3% and 7% in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Total/
                                                              Year 1          Year 2          Year 3          Year 4          Year 5       Annualized *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training (undiscounted).................................           191.4           191.4               0               0               0           382.8
Training (3%)...........................................           185.8           180.4               0               0               0            80.0
Training (7%)...........................................           173.7           157.6               0               0               0            80.8
Investigation (undiscounted)............................            59.3            89.0           118.7           118.7           118.7           504.3
Investigation (3%)......................................            57.6            83.9           108.6           105.4           102.4           100.0
Investigation (7%)......................................            53.8            73.3            88.6            80.4            73.0            90.0
Notice Publication (undiscounted).......................             4.8               0               0               0               0             4.8
Notice Publication (3%).................................             4.7               0               0               0               0             4.7
Notice Publication (7%).................................             4.4               0               0               0               0             4.4
Sex discrimination Policy and Procedure Changes                     23.7            23.7               0               0               0            47.5
 (undiscounted).........................................
Sex discrimination Policy and Procedure Changes (3%)....            23.0            22.4               0               0               0             9.9
Sex discrimination Policy and Procedure Changes (7%)....            21.5            19.5               0               0               0            10.0
    Total (undiscounted)................................           279.2           304.1           118.7           118.7           118.7           939.4
    Total (3%)..........................................           271.1           286.7           108.6           105.4           102.4           190.9
    Total (7%)..........................................           253.4           250.4            88.6            80.4            73.0          162.82
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Discounted and annualized values take into account the cost of borrowing and paying back funds at hypothetical interest rates to simulate opportunity
  costs.

    With this summary, we have completed our analysis the costs of the 
rule. Next, we examine the benefits that can be expected to accrue as a 
result of the proposed rule.

III. Benefits & Transfers

    In enacting Section 1557 of the ACA, Congress recognized the 
benefits of equal access to health services and health insurance that 
all individuals should have, regardless of their race, color, national 
origin, age, or disability. Section 1557 brought together the rights to 
equal access that had been guaranteed under Title VI, the Age Act and 
Section 504. At the same time, Congress extended these protections and 
rights to individuals seeking access to health services and health 
insurance without discrimination on the basis of sex.
    This proposed rule would implement the provisions of Section 1557. 
In most respects, the proposed rule clarifies existing obligations 
under existing authorities and we have noted in the cost analysis that 
we do not expect that covered entities would incur costs related to the 
clarification of those existing obligations in the proposed rule. 
However, we also noted that we expected that the prohibition of sex 
discrimination in the proposed rule would generate certain actions and 
other changes in behavior by covered entities and that these actions 
and changes would impose costs. These actions and other changes in 
behavior would also result in benefits.
    The provisions prohibiting sex discrimination in the ACA increase 
the affordability and accessibility of health care for women and 
transgender individuals. However, despite the ACA improving access to 
health services and health insurance, many women and transgender 
individuals continue to experience discrimination in the health care 
context. This continued discrimination demonstrates the need for 
further clarification regarding the prohibition of discrimination on 
the basis of sex.
    Prior to the enactment of the ACA, insurance companies were allowed 
to impose higher premiums on women or deny women coverage altogether. 
If issuers did cover women, they frequently did not cover many women's 
health services, including routine preventive and wellness services, 
such as pap smears or mammograms. Insurance premiums previously 
differed by sex, based on additional actuarial risk for females 
relative to males; with the ACA's requirement of equal premiums for 
both sexes, the payments associated with that risk are transferred from 
impacted females (who previously paid for that risk through higher 
premiums) to entities in society.
    In the transgender community, a major barrier to receiving care is 
a concern over being refused medical treatment based on bias against 
them.\154\ In a 2010 report, almost half of LGBT respondents reported 
suffering some form of discriminatory treatment by providers when 
receiving medical care, while 26.7% of transgender respondents reported 
that they were outright refused needed health care.\155\ A 2008 survey 
revealed that 28% of transgender individuals reported being subject to 
harassment in medical settings and 50% reported having to teach their 
medical providers about transgender care.\156\
---------------------------------------------------------------------------

    \154\ Lambda Legal, supra note 134 at 12-13.
    \155\ Id. at 9-10.
    \156\ National Center for Transgender Equality and National Gay 
and Lesbian Task Force, Injustice at Every Turn: A Report of the 
national Transgender Discrimination Survey (2008). available at 
https://www.thetaskforce.org/static_html/downloads/reports/reports/ntds_full.pdf.
---------------------------------------------------------------------------

    Covered entities' patient nondiscrimination policies often do not 
include gender identity. The 2014 Human Rights Campaign Healthcare 
Equality Index, which evaluates health care facilities' LGBT policies 
and practices, found that among the 640 hospitals it evaluated, 501 had 
patient nondiscrimination policies but of those only 257 had a patient 
nondiscrimination policy that included both the terms ``sexual 
orientation'' and ``gender identity.'' \157\
---------------------------------------------------------------------------

    \157\ The Human Rights Campaign, supra note 145, at 12.
---------------------------------------------------------------------------

    With respect to access to nondiscriminatory health insurance 
coverage, Durso, Baker and Cray cite interviews from their survey of 
the difficulties that LGBT individuals have experienced seeking 
insurance.\158\ The Out to Enroll Report: Key Lessons for LGBT Outreach 
and Enrollment under the Affordable Care Act focuses on the

[[Page 54209]]

lack of adequate training of Navigator staff when encountering LGBT 
individuals seeking access to the Health Insurance Marketplaces. A 
major complaint voiced was that Navigator staff were unaware of the 
multitude of discriminatory practices and policy restrictions in which 
issuers engage to deny or restrict coverage of transgender individuals, 
and that Navigator staff lacked basic knowledge of health issues that 
are unique to transgender individuals.\159\ Almost 24% of LGBT 
individuals, including transgender individuals, have stated that a 
major motivator for seeking out new insurance options would be learning 
that plans cannot discriminate against them.\160\
---------------------------------------------------------------------------

    \158\ Laura E. Durso, Kellan Baker, and Andrew Cray, Center for 
American Progress Issue Brief: LGBT Communities and the Affordable 
Care Act Findings from a National Survey, (October 10, 2013), 
available at https://www.preventionjustice.org/wp-content/uploads/2013/10/CAP-LGBT-Messaging-Research.pdf.
    \159\ Out2Enroll, Key Lessons for LGBT Outreach and Enrollment 
under the Affordable Care Act, 24, (July 24, 2014), available at 
https://out2enroll.org/key-lessons-for-lgbt-outreach-enrollment/.
    \160\ Center for American Progress, supra note 158.
---------------------------------------------------------------------------

    Discrimination in the health care context leads to denials of 
adequate health care for individuals and increases in existing health 
disparities in underserved communities.\161\ Individuals who have 
experienced discrimination in the health care context often postpone or 
do not seek much needed health care, which may lead to negative health 
consequences.\162\ For example, LGBT health disparities include higher 
rates of mental health issues, including depression and suicide 
attempts, higher risk of HIV/AIDS, higher use of tobacco and other 
drugs, and higher risk of certain cancers, such as breast cancer, with 
some portion of the differential potentially attributable to barriers 
to health care.\163\
---------------------------------------------------------------------------

    \161\ See Bruce G. Link and Jo C. Phelan, Conceptualizing 
Stigma, 27 Ann. Rev. Sociology 363, 371, 378-380 (2001) (discussing 
the consequences of stigmatization, including health disparities); 
Alexandra Brandes, The Negative Impact of Stigma, Discrimination, 
and the Health Care System on the Health of Gender and Sexual 
Minorities, 23 Tul. J. L. & Sexuality 155, 156, 160-161 (2014) 
(discussing how discrimination leads to health disparities); Kellan 
E. Baker, Center for American Progress, Open Doors for All, 1-2 
(2015) (discussing how discrimination exacerbates LGBT health 
disparities).
    \162\ Alexandra Brandes, The Negative Impact of Stigma, 
Discrimination, and the Health Care System on the Health of Gender 
and Sexual Minorities, 23 Tul. J. L. & Sexuality 155, 160 (2014) 
(stating ``Bias from health care professionals reduces the 
likelihood that LGBTQ individuals will seek and receive quality 
care.'').
    \163\ Center for American Progress, supra note 158 at 2.
---------------------------------------------------------------------------

    By prohibiting discrimination on the basis of sex, including sex 
stereotyping and gender identity, Section 1557 would result in more 
women and transgender individuals feeling secure in obtaining coverage 
and accessing health services. Since 2013, the uninsured rate for women 
has declined by 7.7 percentage points, resulting in nearly 7.7 million 
women gaining health insurance as of 2015.\164\ Similarly, uninsured 
rates for LGBT individuals have dropped 8% since 2013, to approximately 
20%.\165\ While these declines in the rates of the uninsured are 
attributable to many factors, among these factors may be provisions in 
the ACA prohibiting discriminatory practices in insurance. We expect 
that issuance of the Section 1557 regulation could contribute to a 
reduction in the number of individuals who are uninsured, though the 
reduction would be much more modest.
---------------------------------------------------------------------------

    \164\ ASPE Issue Brief, supra note 133 at 1-4.
    \165\ Kellan Baker, Laura E. Durso, and Andrew Cray, Center for 
American Progress, Moving the Needle, The Impact of the Affordable 
Care Act on LGBT Communities, 3 (November 2014), available at 
https://www.americanprogress.org/issues/lgbt/report/2014/11/17/101575/moving-the-needle/.
---------------------------------------------------------------------------

    The State of California, in an economic impact assessment of State 
practices prohibiting gender discrimination in health care, cites the 
following benefits: \166\
---------------------------------------------------------------------------

    \166\ California Department of Insurance, supra note 147, at 11.
---------------------------------------------------------------------------

    1. Reduced violence against affected individuals;
    2. Improved worker safety and improved productivity at work for 
affected individuals;
    3. Reduced depression and suicide attempts among the affected 
population; and
    4. Overall declines in substance abuse, smoking and alcohol abuse 
rates, and improvements in mental health among treated individuals in 
LGBT populations who receive appropriate medical treatment.
    Moreover, because discrimination contributes to health disparities, 
the prohibition of sex discrimination in health care under Section 1557 
can help reduce health disparities. While it is not possible to 
quantify the benefits of the reduction in health disparities, the 
benefits would include more people receiving adequate health care, 
regardless of their sex, including gender identity.
    The health and longevity benefits discussed above as potential 
effects of this rule can only occur if additional or higher-quality 
medical services are provided to affected individuals. These services 
would be associated with costs (which we lack data to estimate). As 
discussed in the earlier discussion of actuarial risk, to the extent 
that changes in insurance premiums do not alter how society uses its 
resources, then effects of the rule would be transfers between members 
of society, rather than social costs or benefits. In addition to women 
and transgender individuals, health service providers and the Federal 
government could also be recipients of these transfers. For example, in 
2013, hospitals provided over $50 billion in uncompensated care to the 
uninsured, and the Federal government pays approximately 62% of 
uncompensated care.\167\ HHS estimates that there was a $7.4 billion 
reduction in hospital uncompensated care costs attributed to ACA 
coverage expansions in 2014. Based on estimated coverage gains in 2014, 
uncompensated care costs are expected to continue to fall substantially 
following continued major insurance coverage expansions, including 
coverage expansions through the Health Insurance Marketplace.\168\ 
While issuance of the Section 1557 regulation is not a factor in this 
projection, we believe that issuance of the Section 1557 regulation 
will likewise contribute to a decrease in payments by the Federal 
government for uncompensated care by promoting an increase in the 
number of individuals who have insurance when they receive care.
---------------------------------------------------------------------------

    \167\ ASPE Issue Brief, supra note 133.
    \168\ ASPE Issue Brief: Insurance Expansion, Hospital 
Uncompensated Care, and the Affordable Care Act (March 23, 2015), 
available at: https://aspe.hhs.gov/sites/default/files/pdf/83961/ib_UncompensatedCare.pdf.
---------------------------------------------------------------------------

    Aside from the specific benefits and transfers that women, 
transgender individuals, and the health care community can be expected 
to gain from the enactment of the regulation, there are more general 
benefits that are intangible and unquantifiable. These benefits derive 
from having a society that provides equal access to health care for 
all.

IV. Alternatives Considered

    In the course of developing this regulation, the Department 
considered various alternatives. Some of those alternatives still under 
consideration are discussed in the preamble, and the Department invites 
public comment on those options. A discussion of alternatives 
considered cannot cover all alternatives considered by the Department. 
The following alternatives are meant to be a representative sample to 
show how burden reduction was a major consideration in constructing the 
standards in this regulation.
    OCR considered requiring covered entities to provide separate 
notices, covering separate content, e.g., separate notices on the 
requirements concerning providing meaningful access for individuals 
with limited English proficiency; requirements concerning effective 
communication for individuals with disabilities; and policies on

[[Page 54210]]

nondiscrimination. To reduce the burden on covered entities, the 
Department rejected this option in favor of a comprehensive single 
notice requirement.
    OCR decided to further reduce the burden imposed on covered 
entities by the notice requirement by providing that it would develop 
and provide covered entities with a sample notice. OCR allows covered 
entities flexibility in complying with the proposed notice requirement 
by giving covered entities the option of using the sample notice or 
developing their own notice. Although OCR considered requiring covered 
entities to post the notice in 15 languages (Spanish (or Spanish 
Creole), Chinese, Vietnamese, Korean, Tagalog, Russian, Arabic, French 
Creole, French (including Patois, Cajun), Portuguese (or Portuguese 
Creole), Polish, Japanese, Italian, German, and Persian (Farsi)), it 
rejected that option. Instead, it will translate the notice into 15 
languages and provide covered entities the discretion to post one or 
more of the translated notices, should they so choose. We believe that 
making translated notices readily available to covered entities 
maximizes efficiency and economies of scale, provides flexibility while 
minimizing burden, and helps provide greater access for beneficiaries 
and consumers. Additionally, although OCR considered requiring covered 
entities to create their own taglines in the top 15 national languages 
spoken by individuals with LEP, it rejected that option. Instead, OCR 
will provide covered entities the 15 translated taglines. As the 
tagline requirement for the covered entities only requires the cost of 
printing and posting, this burden is expected to be minimal.
    OCR considered not providing training materials to covered entities 
on the requirements of the regulation. However, in order to reduce 
costs and burden, OCR is providing these materials which will reduce 
covered entities' costs of developing training materials from $500 per 
entity to $125 per entity, saving an estimated $106 million. Entities 
are assumed to bear one quarter of the total costs. These costs result 
from paying the presenters who will run the training sessions, 
providing classroom space, and supplementing the OCR provided training 
materials (should they choose to do so).
    OCR considered remaining silent on covered entities' obligations to 
comply with Section 1557's prohibition of national origin 
discrimination as it affects individuals with LEP. We rejected this 
approach because we were concerned that the Department's silence would 
create ambiguity about covered entities' obligations to individuals 
with LEP and could jeopardize the access of individuals with LEP to 
covered entities' health programs and activities. Options for 
addressing the prohibition of national origin discrimination as it 
affects individuals with LEP are discussed in the preamble to the 
proposed rule.
    OCR considered a regulatory scheme requiring covered entities to 
provide meaningful access to each individual with LEP by providing 
effective language assistance services, at no cost, unless such action 
would result in an undue burden or fundamental alteration. OCR also 
considered requiring covered entities of a certain type or size to have 
enhanced obligations to provide language assistance services. Such 
enhanced obligations could include providing a predetermined range of 
language assistance services in certain non-English languages that met 
defined thresholds. A covered entity that was not of a certain type or 
size still would be required to provide meaningful access to each 
individual with LEP in its health programs and activities, but the 
covered entity would not have to provide a predetermined range of 
language assistance services in certain non-English languages. OCR also 
explored applying the threshold requirement to standardized vital 
documents on a national, State, or county level as well as specific to 
a covered entity's geographic service area.
    The strengths of these alternate regulatory schemes include limited 
obligations for small businesses providing health programs or 
activities and defined standards for larger entities. The costs of 
these approaches include the complexity of the regulatory scheme and 
the potential burden on the covered entities of a certain type or size 
that would have enhanced applications. OCR determined these costs 
outweighed the benefits at this time. As stated in the preamble, the 
Department invites public comment on these options.
    OCR considered drafting new provisions addressing effective 
communication (apart from communication through electronic and 
information technology) with individuals with disabilities, but instead 
is incorporating provisions of the regulation implementing Title II of 
the ADA to ensure consistency for covered entities and potentially 
reduce burden by limiting resources spent on training and modification 
of policies and procedures.
    Options regarding communication through electronic and information 
technology are discussed in the preamble to the regulation. Regarding 
the accessibility requirements under the proposed regulation, OCR 
considered two alternatives: (1) Clarifying the scope of the 
requirements by defining whether the standards adopted apply only to 
access to covered entities' Web sites or other means of electronic and 
information technology; and (2) updating the NPRM's current standards 
for determining accessibility to include newer functional standards 
such as the Web Content Accessibility Guidelines adopted by the World 
Wide Web Consortium or standards under Section 508. While these 
alternatives could potentially increase the burden on recipients of 
Federal financial assistance and State-based Marketplaces, they also 
would offer clarity to covered entities and would help enhance access 
for individuals with disabilities.
    In the area of compliance, OCR considered having one set of 
procedures for all compliance activities involving recipients of 
Federal financial assistance and State-based Marketplace entities. 
Instead, OCR decided to adopt the unique Age Act procedures \169\ for 
age-related compliance activities under Section 1557 because Age Act 
compliance activities and Section 1557 compliance activities regarding 
age discrimination are likely to substantially overlap.
---------------------------------------------------------------------------

    \169\ The Age Act procedures, for example, require mediation of 
all age discrimination complaints, and exhaustion of administrative 
remedies prior to the filing of a civil lawsuit.
---------------------------------------------------------------------------

    With regard to other areas of compliance, OCR considered developing 
a separate set of procedures for Section 1557 compliance activities 
involving HHS health programs and activities, but decided to largely 
adopt the existing procedures for disability compliance activities 
involving HHS health programs and activities (with some enhancement) to 
improve efficiencies for OCR and the HHS health programs and activities 
covered by Section 1557.

V. Unfunded Mandates Reform Act of 1995

    Section 202 of the Unfunded Mandates Reform Act of 1995 requires 
that agencies assess anticipated costs and benefits before issuing any 
rule that includes a Federal mandate that could result in expenditure 
in any one year by State, local, or tribal governments, in the 
aggregate, or by the private sector, of $100 million in 1995 dollars, 
updated annually for inflation. In 2015, that

[[Page 54211]]

threshold level is approximately $144 million.
    The Unfunded Mandates Reform Act does not address the total cost of 
a final rule. Rather, it focuses on certain categories of cost, mainly 
those ``Federal mandate'' costs resulting from: (1) Imposing 
enforceable duties on State, local, or tribal governments, or on the 
private sector; or (2) increasing the stringency of conditions in, or 
decreasing the funding of, State, local, or tribal governments under 
entitlement programs.
    Our impact analysis shows that burden associated with training 
staff working for covered entities will be spread widely across health 
care entities, State and local governmental entities and a substantial 
number of health insurance issuers. The analysis estimates the unfunded 
burden will be about $383 million in one-time training costs. We 
project that for the first few years following enactment of the final 
rule, private sector costs for investigating discrimination complaints 
may amount to $119 million per year. Within the first five years 
following the rule's enactment, we anticipate complaints to increase, 
but eventually to drop off as covered entities modify their policies 
and practices in response to the proposed rule.
    As we explain in the RIA, we believe there will be benefits gained 
from the enactment of this regulation in the form of reduction in 
discrimination based on race, color, national origin, sex, age, and 
disability, the improvement in the quality of care underserved 
communities will receive.

VI. Executive Order 13132: Federalism

    As required by Executive Order 13132 on Federalism, the Department 
has examined the effects of provisions in the proposed regulation on 
the relationship between the Federal government and the States. The 
Department has concluded that the proposed regulation does have 
Federalism implications but preempts State law only where the exercise 
of State authority directly conflicts with the exercise of Federal 
authority under the Federal statute.
    The proposed regulation attempts to balance State autonomy with the 
necessity to create a Federal benchmark that will provide a uniform 
level of nondiscrimination protection across the country. The proposed 
regulation restricts regulatory preemption of State law to the minimum 
level necessary to achieve the objectives of the underlying Federal 
statute, Section 1557 of the ACA.
    It is recognized that the States generally have laws that relate to 
nondiscrimination against individuals on a variety of bases. State laws 
continue to be enforceable, unless they prevent application of the 
proposed rule. The proposed rule explicitly provides that it is not to 
be construed to supersede State or local laws that provide additional 
protections against discrimination on any basis articulated under the 
regulation. Provisions of State law relating to nondiscrimination that 
are ``more stringent'' than the proposed Federal regulatory 
requirements or implementation specifications will continue to be 
enforceable.
    Section 3(b) of Executive Order 13132 recognizes that national 
action limiting the policymaking discretion of States will be imposed 
only where there is constitutional and statutory authority for the 
action and the national activity is appropriate in light of the 
presence of a problem of national significance. Discrimination issues 
in relation to health care are of national concern by virtue of the 
scope of interstate health commerce. The ACA's provisions reflect this 
position.
    Section 3(d)(2) of the Executive Order 13132 requires that where 
possible, the Federal Government defer to the States to establish 
standards. Title I of the ACA authorized the Secretary to promulgate 
regulations to implement Section 1557, and we have done so accordingly.
    Section 4(a) of Executive Order 13132 expressly contemplates 
preemption when there is a conflict between exercising State and 
Federal authority under a Federal statute. Section 4(b) of the 
Executive Order authorizes preemption of State law in the Federal rule 
making context when ``the exercise of State authority directly 
conflicts with the exercise of Federal authority under the Federal 
statute.'' The approach in this regulation is consistent with these 
standards in the Executive Order in superseding State authority only 
when such authority is inconsistent with standards established pursuant 
to the grant of Federal authority under the statute.
    Section 6(b) of Executive Order 13132 includes some qualitative 
discussion of substantial direct compliance costs that State and local 
governments would incur as a result of a proposed regulation. We have 
determined that the costs of the proposed rule would not impose 
substantial direct compliance costs on State or local governments. We 
have considered the cost burden that this proposed rule would impose on 
State and local health care and benefit programs, and estimate State 
and local government costs will be in the order of $18.5 million in the 
first two years of implementation. The $18.5 million represents the sum 
of the costs of training State workers and enforcement costs 
attributable to State agencies analyzed above.

VII. Regulatory Flexibility Act

    The RFA requires agencies that issue a regulation to analyze 
options for regulatory relief of small businesses if a rule has a 
significant impact on a substantial number of small entities. The RFA 
generally defines a ``small entity'' as:
    (1) A proprietary firm meeting the size standards of the Small 
Business Administration (SBA);
    (2) A nonprofit organization that is not dominant in its field; or
    (3) A small government jurisdiction with a population of less than 
50,000 (States and individuals are not included in the definition of 
``small entity'').
    HHS uses as its measure of significant economic impact on a 
substantial number of small entities a change in revenues of more than 
3% for 5% or more of affected small entities.
    If we judge that a rule would have a significant impact on a 
substantial number of small entities, we will consider alternatives to 
reduce the burden. To accomplish our task, we must first identify all 
the small entities that may be impacted, and then evaluate whether the 
economic burden we determined in the RIA represents a significant 
economic impact.

A. Entities That Will Be Affected

    HHS has traditionally classified most health care providers as 
small entities even though some nonprofit providers would not meet the 
definition of ``small entity'' were they proprietary firms. Nonprofit 
entities are small if they are independently owned and operated and are 
not dominant in their fields.
    The CMS Provider of Service file has indicators for profit and 
nonprofit entities, but these have proven to be unreliable. The Census 
data identifies firms' tax status by profit and non-profit status but 
only reports revenues and does not report them by the profit and non-
profit status of the entity.
1. Physicians
    One class of providers we do not automatically classify as small 
businesses is physician practices. Physician practices are businesses 
and therefore are ``small'' if they meet the SBA's definition. The 
current size standard for physicians (excluding mental health 
specialists)--North American Industry Classification System code 
62111--is annual receipts

[[Page 54212]]

of less than $11 million.\170\ Using the Census data showing the number 
of firms, employees and payroll, we selected physicians that reported 
fewer than 20 employees as the top end for small physician offices. 
This equaled 17,855 entities or 9.4% of all physician offices defined 
as ``large.'' This left 171,000 offices or 90% as ``small.'' \171\
---------------------------------------------------------------------------

    \170\ U.S. Small Business Administration (SBA), Table of Small 
Business Size Standards Matched to North American Industry 
Classification System Codes. Small Business Administration, (June, 
2014), available at https://www.sba.gov/sites/default/files/Size_Standards_Table.pdf.
    \171\ Physician practices may earn more than $11 million per 
year and that would reduce the number of ``large'' practices to be 
excluded from the analysis. But as we will later show, large 
practices will have proportionally larger workforce staff that must 
be excluded from the analysis.
---------------------------------------------------------------------------

2. Pharmacies
    Pharmacies also are businesses, and the size standard for them is 
annual receipts of less than $27.5 million. According to U.S. Census 
Statistics of U.S. Businesses, there are 18,852 pharmacy and drug store 
firms (North American Industry Classification System code 44611). 
Because of the lack of revenue or receipt data for pharmacies, we are 
unable to estimate the number of small pharmacies based on the SBA size 
standard. However, using the number of employees taken from the 
Statistics of U.S. Businesses as a proxy for revenues, the data is 
divided by number of employees per firm and shows the number of 
employers with fewer than 20 employees and those with more than 20 
employees.\172\ The number of firms with fewer than 20 employees is 
16,520 and represents 88% of the total number of pharmacy firms. It 
seemed reasonable to assume that firms with fewer than 20 employees 
satisfy the SBA size standard and thus we accepted that the number of 
small pharmacy firms equaled 16,520. As with the number of small 
physician offices, our method can only identify the minimum number of 
``small'' pharmacies that meet the SBA size standard. We cannot 
determine the actual number of ``small'' pharmacies.
---------------------------------------------------------------------------

    \172\ U.S. Census Bureau, Statistics of U.S. Businesses, supra 
note 120.
---------------------------------------------------------------------------

3. Health Insurance Issuers
    Another class of covered entities that are business enterprises is 
health insurance issuers. The SBA size standard for health insurance 
issuers is annual receipts of $38.5 million. Although the Blue Cross/
Blue Shield companies that operate in some markets are organized as 
nonprofit entities, they often are large enough so as to not meet the 
definition of ``small entity.''
    Unfortunately, we cannot use the Census revenue data for estimating 
the number of small health insurance issuers because the Census data 
combines life and health insurance. Substituting costs for revenues 
allows us to obtain a rough estimate of the number of large insurance 
issuers, realizing that cost will probably be less than revenues, thus 
giving us a lower count of large issuers. Using the National Health 
Expenditure for 2013, net cost of health insurance equaled $173.6 
billion. However, the 2012 Census data report a total of 815 health 
insurance issuers. Dividing the $174 billion in costs by the number of 
insurance issuers reported in the census tables yields average costs of 
over $213 million, which means that average annual revenues per issuer 
exceeds $213 million. We conclude, therefore, that there are almost no 
small insurance issuers. The above analysis comports with the 
conclusion CMS published in the Health Insurance Web Portal 
Requirements (75 FR 24481, May 5, 2010).
4. Local Government Entities
    We also exclude local governmental entities from our count of small 
entities because we lack the data to classify them by populations of 
fewer than 50,000. The following table shows the number of small 
covered entities we estimate may be affected by the proposed rule.

                     Table 6--Small Covered Entities
------------------------------------------------------------------------
                                                             Number of
            NAIC                     Entity type               firms
------------------------------------------------------------------------
62142......................  Outpatient mental health              4,987
                              and substance abuse
                              centers.
62141......................  HMO medical centers........             104
62142......................  Kidney dialysis centers....             492
62143......................  Freestanding ambulatory               4,121
                              surgical and emergency
                              centers.
621498.....................  All Other Outpatient Care             5,399
                              Centers.
6215.......................  Medical and Diagnostic                7,958
                              Laboratories.
6216.......................  Home health care services..          21,668
6219.......................  All other ambulatory health           6,956
                              care services.
62321......................  Residential mental                    6,225
                              retardation facilities.
62199......................  General medical and                   3,067
                              surgical hospitals.
621991.....................  Psychiatric and substance               411
                              abuse hospitals.
6221.......................  Specialty (except                       373
                              psychiatric and substance
                              abuse) hospitals.
6231.......................  Nursing Care Facilities               8,623
                              (Skilled Nursing
                              Facilities).
44611......................  Pharmacies and drug stores.          16,520
6211.......................  Offices of physicians......         171,000
                             Navigator grantees.........              92
                             TOTAL Small entities.......         258,176
------------------------------------------------------------------------

B. Whether the Proposed Rule Will Have a Significant Economic Impact on 
Covered Small Entities

    To determine the economic impact of the proposed rule, we divide 
the costs that small entities will bear by the number of small affected 
entities. We examine the costs we identified for training, enforcement, 
and complying with the notice requirement and adjust those costs to 
reflect only the costs that small entities will incur.
1. Training
    To remove the costs for training for large entities, we must remove 
both the large entities and their associated workforce. We removed 
17,855 physician firms with associated training costs of $60.8 million 
and 2,332 pharmacies with associated training costs of $11.4 million. 
Also, we removed costs borne by the 180 health insurance issuers we 
identified as

[[Page 54213]]

participating in the Federally-facilitated Marketplaces, with training 
costs of about $3.26 million. Also, removing State training costs from 
our computations reduces the costs allocated to small entities by $13.9 
million.
    The total cost burden of the ``large'' entities we can identify 
(including cost of preparing materials and employee time) amounts to 
$89.4 million.\173\ Thus the estimated burden we are proposing to place 
on small entities for training equals $293 million. Dividing this 
amount by the number of small entities in Table 6 gives an average 
burden of $1,135.
---------------------------------------------------------------------------

    \173\ We have removed the training and preparation costs for 
large and small issuers, equaling $3,251,158. The amount includes 
training of State medical staffs ($13,872,314), large physician 
offices ($38,860,424), and large pharmacy firms ($9,541,260). The 
amount of State medical staff training costs is 100%. Large 
physician office training costs are 68.3% of medical staff training 
costs based on the ratio of employees employed in large and small 
offices. The costs of medical staff training in large pharmacy firms 
is 85.7% and is similarly based on the ratio of employees employed 
in large and small firms.
---------------------------------------------------------------------------

2. Enforcement
    We also identified costs for investigating discrimination 
complaints that covered entities may incur following enactment of the 
final rule in the enforcement section in this analysis. The total 
amount ascribed to investigating discrimination complaints for covered 
health care entities with 15 or more employees is estimated to be 
$118.7 million per year over five years following final rule enactment. 
As we noted in the enforcement analysis, for purposes of the analysis, 
we assumed a uniform distribution of complaints across all covered 
entities.
    To determine costs for investigating discrimination complaints for 
small entities, we divided the cost attributed to health care covered 
entities. Dividing health care covered entity investigation costs of 
$118.7 million by the approximately 58,500 health care covered entities 
with 15 or more employees who are required to have grievance procedures 
under the proposed rule, yielding a cost per entity of $2,029.
3. Notice
    We also examined the cost for covered entities of printing, 
translating, and posting new notices as required under this proposed 
regulation. The estimated cost for printing and distributing notice and 
tag lines for health care providers is approximately $4.8 million. 
Dividing this amount by the 278,565 total health care providers equals 
$17 per entity.
4. Revising Policies and Procedures to Prohibit Discrimination on the 
Basis of Sex
    In the analysis of the cost for providers to revise their policies 
and procedures to conform to the prohibition of discrimination on the 
basis of sex, we estimate that 75% of total health care entities, or 
208,700, would incur a cost of approximately $47.5 million. To arrive 
at the cost per entity, we divide the cost by the 208,700 health care 
entities, which equals $227 per entity.
5. Overall Burden on Small Entities
    To estimate the overall burden cost on small entities, we must add 
training costs ($1,135), the cost to an entity to investigate a 
complaint of discrimination ($2,029), the costs for printing and 
distributing notices and tag lines ($17), and the cost for providers to 
revise their policy and procedures for prohibiting sex discrimination 
($227). The total estimated overall burden of the proposed rule on 
small entities is approximately $3,409.
    The definition of a small entity varies with its North American 
Industry Classification System code; for physicians, the SBA defines 
the threshold revenues as up to $11 million, for pharmacies up to $25 
million, and for health issuers up to $38.5 million. An average cost of 
$3,409 represents a de minimis percentage of their revenues and clearly 
less than the 3% standard that is set up under the RFA standards for 
significant impact. Furthermore we believe that fewer than 5% of all 
small entities will experience a burden of greater than 3% of their 
revenues. Ambulatory health care services facilities (North American 
Industry Classification System 621), for example, are small entities 
with an average of 13 employees and revenue of $1.7 million based on 
2012 reported data for employees of 6.4 million and total revenues of 
$825.7 million for 485,235 firms.\174\ In addition, the majority of the 
costs associated with this rule are proportional to the size of 
entities, meaning that even the smallest of the affected entities are 
unlikely to face a substantial impact. Thus, we would not consider this 
proposed regulation a significant burden on a substantial number of 
small entities, and, therefore, the Secretary proposes to certify that 
the proposed rule will not have a significant impact on a substantial 
number of small entities.
---------------------------------------------------------------------------

    \174\ U.S. Census Bureau, Statistics of U.S. Businesses. All 
sectors: Geographic Area Series: Economy-Wide Key Statistics: 2012: 
available at: https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2012_US_00A1&prodType=table.
---------------------------------------------------------------------------

VIII. Conclusion

    For the most part, because this regulation is consistent with 
existing standards applicable to the covered entities, the new burdens 
created by its issuance are minimal. The major impacts are in the areas 
of voluntary training and enforcement where increased caseloads pose 
incremental costs on covered entities. It is possible, if broader 
options that extend existing civil rights requirements beyond their 
current scope were adopted after public comment in a final rule, that 
the burdens estimated in this RIA would increase. However, the rule as 
currently written does not include such expansions and therefore 
minimizes the imposition of new burdens. Nevertheless, it is still a 
major rule with approximately $383 million in training costs over a 
two-year period and another $122 million in increased annual 
enforcement costs. We also account for printing notice and tagline 
costs of $5 million, and costs to revise policies and procedures of $48 
million, for a total of $558 million. This RIA was organized and 
designed to explain the origin of these cost impacts to allow for 
meaningful public comment.

[[Page 54214]]



                                          Table 7--Accounting Statement
----------------------------------------------------------------------------------------------------------------
                                              Accounting Statement
-----------------------------------------------------------------------------------------------------------------
                                               Primary
                Category                      Estimate        Low Estimate      High Estimate        Source
----------------------------------------------------------------------------------------------------------------
                                                    BENEFITS
----------------------------------------------------------------------------------------------------------------
Qualitative Benefits....................   Potential health improvements and longevity              RIA
                                              extensions as a result of reduced barriers to
                                                medical care for transgender individuals.
----------------------------------------------------------------------------------------------------------------
                                                COSTS (millions)
----------------------------------------------------------------------------------------------------------------
Annualized monetized....................  ................                 Covered entities  Cov................
                                                               train 40% of      train 60% of
                                                            their employees   their employees
                                                                 on the new        on the new
                                                                regulations       regulations
                                         ------------------------------------------------------
3%......................................            190.9             174.9             206.9               RIA
7%......................................            162.8             148.4             177.3               RIA
                                         ------------------------------------------------------
Non-quantified costs....................  Costs of increased provision of health care services              RIA
                                              as a result of reduced barriers to access for
                                                        transgender individuals.
----------------------------------------------------------------------------------------------------------------
Transfers...............................    Health insurance premium reductions for affected                RIA
                                           women, with offsetting increases for other premium
                                                        payers in affected plans.
----------------------------------------------------------------------------------------------------------------
Effects on State & Local Governments....  $18.5 million costs in the first 2 years (training +              RIA
                                                              enforcement)
----------------------------------------------------------------------------------------------------------------
Effects on Small Entities...............               Average $3,409/small entity                          RFA
----------------------------------------------------------------------------------------------------------------

List of Subjects in 45 CFR Part 92

    Administrative practice and procedure, Civil rights, 
Discrimination, Elderly, Health care, Health facilities, Health 
insurance, Health programs and activities, Individuals with 
disabilities, Nondiscrimination, Reporting and recordkeeping 
requirements, Sex discrimination.
    For the reasons set forth in the preamble, the Department of Health 
and Human Services proposes to add 45 CFR part 92 as follows:

PART 92--NONDISCRIMINATION ON THE BASIS OF RACE, COLOR, NATIONAL 
ORIGIN, SEX, AGE, OR DISABILITY IN HEALTH PROGRAMS OR ACTIVITIES 
RECEIVING FEDERAL FINANCIAL ASSISTANCE AND HEALTH PROGRAMS OR 
ACTIVITIES ADMINISTERED BY THE DEPARTMENT OF HEALTH AND HUMAN 
SERVICES OR ENTITIES ESTABLISHED UNDER TITLE I OF THE PATIENT 
PROTECTION AND AFFORDABLE CARE ACT

Subpart A--General Provisions
Sec.
92.1 Purpose and effective date.
92.2 Application.
92.3 Relationship to other laws.
92.4 Definitions.
92.5 Assurances required.
92.6 Remedial action and voluntary action.
92.7 Designation of responsible employee and adoption of grievance 
procedures.
92.8 Notice requirement.
Subpart B--Nondiscrimination Provisions
92.101 Discrimination prohibited.
Subpart C--Specific Applications to Health Programs and Activities
92.201 Meaningful access for individuals with limited English 
proficiency.
92.202 Effective communication for individuals with disabilities.
92.203 Accessibility standards for buildings and facilities.
92.204 Accessibility of electronic and information technology.
92.205 Requirement to make reasonable modifications.
92.206 Equal program access on the basis of sex.
92.207 Nondiscrimination in health-related insurance and other 
health-related coverage.
92.208 Employer liability for discrimination in employee health 
benefit programs.
92.209 Nondiscrimination on the basis of association.
Subpart D--Enforcement
92.301 Enforcement mechanisms.
92.302 Procedures for health programs and activities conducted by 
recipients and State-based Marketplaces.
92.303 Procedures for health programs and activities administered by 
the Department.
Appendix A to Part 92--Sample Notice Informing Individuals about 
Nondiscrimination and Accessibility Requirements
Appendix B to Part 92--Sample Tagline Informing Individuals with 
Limited English Proficiency of Language Assistance Services

    Authority:  42 U.S.C. 18116, 5 U.S.C. 301.

Subpart A--General Provisions


Sec.  92.1  Purpose and effective date.

    The purpose of this part is to implement Section 1557 of the 
Patient Protection and Affordable Care Act (42 U.S.C. 18116), which 
prohibits discrimination on the basis of race, color, national origin, 
sex, age, or disability in certain health programs and activities. 
Section 1557 provides that, except as provided in Title I of the 
Patient Protection and Affordable Care Act (ACA), an individual shall 
not, on the grounds prohibited under Title VI of the Civil Rights Act 
of 1964, Title IX of the Education Amendments of 1972, the Age 
Discrimination Act of 1975, or Section 504 of the Rehabilitation Act of 
1973, be excluded from participation in, be denied the benefits of, or 
be subjected to discrimination under any

[[Page 54215]]

health program or activity, any part of which is receiving Federal 
financial assistance or under any program or activity that is 
administered by an Executive Agency or any entity established under 
Title I of the ACA. This part applies to health programs or activities 
administered by recipients of Federal financial assistance from the 
Department, Title I entities that administer health programs or 
activities, and Department-administered health programs or activities. 
The effective date of this part shall be [60 DAYS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE].


Sec.  92.2  Application.

    (a) Except as provided otherwise in this part, this part applies to 
every health program or activity, any part of which receives Federal 
financial assistance administered by the Department; every health 
program or activity administered by the Department; and every health 
program or activity administered by a Title I entity.
    (b) Limitations:
    (1) Exclusions to the application of the Age Discrimination Act of 
1975, as set forth at 45 CFR 91.3(b)(1), apply to claims of 
discrimination based on age under Section 1557 or this part.
    (2) [Reserved]


Sec.  92.3  Relationship to other laws.

    (a) Rule of interpretation. This part shall not be construed to 
apply a lesser standard for the protection of individuals from 
discrimination than the standards applied under Title VI of the Civil 
Rights Act of 1964, Title IX of the Education Amendments of 1972, 
Section 504 of the Rehabilitation Act of 1973, the Age Discrimination 
Act of 1975, or the regulations issued pursuant to those laws.
    (b) Other laws. Nothing in this part shall be construed to 
invalidate or limit the rights, remedies, procedures, or legal 
standards available to individuals under Title VI of the Civil Rights 
Act of 1964, Title VII of the Civil Rights Act of 1964, the 
Architectural Barriers Act of 1968, Title IX of the Education 
Amendments of 1972, Sections 504 or 508 of the Rehabilitation Act of 
1973, the Age Discrimination Act of 1975, the Americans with 
Disabilities Act of 1990, as amended by the Americans with Disabilities 
Act Amendments Act of 2008, or other Federal laws or to supersede State 
or local laws that provide additional protections against 
discrimination on any basis described in Sec.  92.1.


Sec.  92.4  Definitions.

    As used in this part, the term--
    1991 Standards means the 1991 ADA Standards for Accessible Design, 
published at Appendix A to 28 CFR part 36 on July 26, 1991, and 
republished as Appendix D to 28 CFR part 36 on September 15, 2010.
    2010 Standards means the 2010 ADA Standards for Accessible Design, 
as defined at 28 CFR 35.104.
    ACA means the Patient Protection and Affordable Care Act (Pub. L. 
111-148, as amended by the Health Care and Education Reconciliation Act 
of 2010, Pub. L. 111-152; 42 U.S.C. 18001 et seq.).
    ADA means the Americans with Disabilities Act of 1990 (Pub. L. 101-
336; 42 U.S.C. 12101 et seq.), as amended.
    Age means how old an individual is, or the number of elapsed years 
from the date of an individual's birth.
    Age Act means the Age Discrimination Act of 1975 (Title III of Pub. 
L. 94-135; 42 U.S.C. 6101 et seq.), as amended.
    Applicant means an individual who applies to participate in a 
health program or activity.
    Auxiliary aids and services include:
    (1) Qualified interpreters on-site or through video remote 
interpreting (VRI) services, as defined in 28 CFR 35.104, 36.303(b); 
note takers; real-time computer-aided transcription services; written 
materials; exchange of written notes; telephone handset amplifiers; 
assistive listening devices; assistive listening systems; telephones 
compatible with hearing aids; closed caption decoders; open and closed 
captioning, including real-time captioning; voice, text, and video-
based telecommunication products and systems, text telephones (TTYs), 
videophones, and captioned telephones, or equally effective 
telecommunications devices; videotext displays; accessible electronic 
and information technology; or other effective methods of making 
aurally delivered information available to individuals who are deaf or 
hard of hearing;
    (2) Qualified readers; taped texts; audio recordings; Braille 
materials and displays; screen reader software; magnification software; 
optical readers; secondary auditory programs; large print materials; 
accessible electronic and information technology; or other effective 
methods of making visually delivered materials available to individuals 
who are blind or have low vision;
    (3) Acquisition or modification of equipment and devices; and
    (4) Other similar services and actions.
    Covered entity means:
    (1) An entity that operates a health program or activity, any part 
of which receives Federal financial assistance;
    (2) An entity established under Title I of the ACA that administers 
a health program or activity; and
    (3) The Department.
    Department means the U.S. Department of Health and Human Services.
    Director means the Director of the Office for Civil Rights (OCR) of 
the Department.
    Disability means, with respect to an individual, a physical or 
mental impairment that substantially limits one or more major life 
activities of such individual; a record of such an impairment; or being 
regarded as having such an impairment, as defined and construed in the 
Rehabilitation Act, at 29 U.S.C. 705(9)(B), which incorporates the 
definition of disability in the ADA Amendments Act of 2008 (P.L. 110-
325; 42 U.S.C. 12102.), as amended. Where this part cross-references 
regulatory provisions that use the term ``handicap,'' ``handicap'' 
means ``disability'' as defined in this section.
    Electronic and information technology includes information 
technology and any equipment or interconnected system or subsystem of 
equipment that is used in the creation, conversion, or duplication of 
data or information.
    (1) The term electronic and information technology includes, but is 
not limited to, telecommunications products (such as telephones), 
information kiosks and transaction machines, internet sites, 
multimedia, and office equipment such as copiers and fax machines.
    (2) The term does not include any equipment that contains embedded 
information technology that is used as an integral part of the product, 
but the principal function of which is not the acquisition, storage, 
manipulation, management, movement, control, display, switching, 
interchange, transmission, or reception of data or information. For 
example, HVAC (heating, ventilation, and air conditioning) equipment 
such as thermostats or temperature control devices, and medical 
equipment where information technology is integral to its operation, 
are not electronic and information technology as defined in this part.
    Employee health benefit program means:
    (1) Health benefits coverage or health insurance provided to 
employees and/or their dependents established, operated, sponsored or 
administered by, for, or on

[[Page 54216]]

behalf of one or more employers, whether provided or administered by 
entities including but not limited to an employer, group health plan 
(as defined in the Employee Retirement Income Security Act of 1974 
(ERISA, at 29 U.S.C. 1191(a)), third party administrator, or health 
insurance issuer.
    (2) An employer provided or sponsored wellness program;
    (3) An employer-provided health clinic; or
    (4) Long term care coverage or insurance provided or administered 
by an employer, group health plan, third party administrator, or health 
insurance issuer.
    Federal financial assistance. (1) Federal financial assistance 
means any grant, loan, credit, subsidy, contract (other than a 
procurement contract but including a contract of insurance), or any 
other arrangement by which the Federal government provides or otherwise 
makes available assistance in the form of:
    (i) Funds;
    (ii) Services of Federal personnel; or
    (iii) Real and personal property or any interest in or use of such 
property, including:
    (A) Transfers or leases of such property for less than fair market 
value or for reduced consideration; and
    (B) Proceeds from a subsequent transfer or lease of such property 
if the Federal share of its fair market value is not returned to the 
Federal government.
    (2) Federal financial assistance provided or administered by the 
Department includes all tax credits under Title I of the ACA, as well 
as payments, subsidies, or other funds extended by the Department to 
any entity providing health insurance coverage for payment to or on 
behalf of an individual obtaining health insurance coverage from that 
entity or extended by the Department directly to such individual for 
payment to any entity providing health insurance coverage.
    Federally-facilitated Marketplaces means the same as ``Federally-
facilitated Exchange'' defined in 45 CFR 155.20.
    Gender identity is an individual's internal sense of gender, which 
may be different from that individual's sex assigned at birth. The way 
an individual expresses gender identity is frequently called ``gender 
expression,'' and may or may not conform to social stereotypes 
associated with a particular gender. A transgender individual is an 
individual whose gender identity is different from the sex assigned to 
that person at birth; an individual with a transgender identity is 
referred to in this part as a transgender individual.
    Health Insurance Marketplace means the same as ``Exchange'' defined 
in 45 CFR 155.20.
    Health program or activity means the provision or administration of 
health-related services or health-related insurance coverage and the 
provision of assistance to individuals in obtaining health-related 
services or health-related insurance coverage. For an entity 
principally engaged in providing or administering health services or 
health insurance coverage, all of its operations are considered part of 
the health program or activity, except as specifically set forth 
otherwise in this part. Such entities include a hospital, health 
clinic, group health plan, health insurance issuer, physician's 
practice, community health center, nursing facility, residential or 
community-based treatment facility, or other similar entity. A health 
program or activity also includes all of the operations of a State 
Medicaid program.
    HHS means the U.S. Department of Health and Human Services.
    Individual with a disability means any individual who has a 
disability as defined, for the purpose of Section 504 of the 
Rehabilitation Act of 1973, at 29 U.S.C. 705(20)(B)-(F), as amended. 
Where this part cross-references regulatory provisions applicable to a 
``handicapped individual,'' ``handicapped individual'' means 
``individual with a disability'' as defined in this section.
    Individual with limited English proficiency means an individual 
whose primary language for communication is not English and who has a 
limited ability to read, write, speak, or understand English.
    Language assistance services may include, but are not limited to:
    (1) Oral language assistance, including interpretation in non-
English languages provided in-person or remotely by a qualified 
interpreter, and bilingual or multilingual staff competent to 
communicate, in non-English languages using any necessary specialized 
vocabulary, directly with individuals with limited English proficiency;
    (2) Written translation of documents and Web sites into languages 
other than English; and
    (3) Taglines.
    On the basis of sex includes, but is not limited to, on the basis 
of pregnancy, false pregnancy, termination of pregnancy, or recovery 
therefrom, childbirth or related medical conditions, sex stereotyping, 
or gender identity.
    Qualified individual with a disability means, with respect to a 
health program or activity, an individual with a disability who, with 
or without reasonable modifications to policies, practices, or 
procedures, the removal of architectural, communication, or 
transportation barriers, or the provision of auxiliary aids and 
services, meets the essential eligibility requirements for the receipt 
of aids, benefits, or services offered or provided by the health 
program or activity.
    Qualified interpreter. (1) Qualified interpreter means an 
interpreter who adheres to generally accepted interpreter ethics 
principles, including client confidentiality, and who, via a remote 
interpreting service or an on-site appearance, satisfies at least one 
of the following paragraphs:
    (i) Is able, for an individual with a disability, to interpret 
effectively, accurately, and impartially, both receptively and 
expressively, using any necessary specialized vocabulary, and/or;
    (ii) Has demonstrated proficiency in, and has above average 
familiarity with speaking or understanding, both spoken English and at 
least one other spoken language; and is able, for an individual with 
limited English proficiency, to interpret effectively, accurately, and 
impartially, both receptively and expressly, to and from such 
language(s) and English, using any necessary specialized vocabulary.
    (2) For an individual with a disability, qualified interpreters can 
include, for example, sign language interpreters, oral transliterators 
(individuals who represent or spell in the characters of another 
alphabet), and cued-language transliterators (individuals who represent 
or spell by using a small number of handshapes).
    Recipient means any State or its political subdivision, or any 
instrumentality of a State or its political subdivision, any public or 
private agency, institution, or organization, or other entity, or any 
individual, to whom Federal financial assistance is extended directly 
or through another recipient and which operates a health program or 
activity, including any subunit, successor, assignee, or transferee of 
a recipient.
    Section 504 means Section 504 of the Rehabilitation Act of 1973 
(Pub. L. 93-112; 29 U.S.C. 794), as amended.
    Section 1557 means Section 1557 of the ACA.
    Sex stereotypes refers to stereotypical notions of gender, 
including expectations of how an individual represents or communicates 
gender to others, such as behavior, clothing,

[[Page 54217]]

hairstyles, activities, voice, mannerisms, or body characteristics. 
These stereotypes can include expectations that gender can only be 
constructed within two distinct opposite and disconnected forms 
(masculinity and femininity), and that gender cannot be constructed 
outside of this gender construct (individuals who identify as neither, 
both, or as a combination of male and female genders).
    State-based Marketplace means a Health Insurance Marketplace 
identified in paragraphs (1) and/or (2) of this definition for which a 
State has received approval from the Department pursuant to the 
standards in 45 CFR 155.105:
    (1) A Health Insurance Marketplace that facilitates the purchase of 
health insurance coverage through qualified health plans in the 
individual market and that provides for the establishment of a Small 
Business Health Options Program; or
    (2) A Health Insurance Marketplace that provides only for the 
establishment of a Small Business Health Options Program.
    Taglines means short statements written in non-English languages 
that indicate the availability of language assistance services free of 
charge.
    Title I entity means any entity established under Title I of the 
ACA, including State-based Marketplaces and Federally-facilitated 
Marketplaces.
    Title VI means Title VI of the Civil Rights Act of 1964 (Pub. L. 
88-352; 42 U.S.C. 2000d et seq.), as amended.
    Title IX means Title IX of the Education Amendments of 1972 (Pub. 
L. 92-318; 20 U.S.C. 1681 et seq.), as amended.


Sec.  92.5  Assurances required.

    (a) Assurances. An entity applying for Federal financial assistance 
to which this part applies shall, as a condition of any application for 
Federal financial assistance, submit an assurance, on a form specified 
by the Director, that the entity's health programs and activities will 
be operated in compliance with Section 1557 and this part. An issuer 
seeking certification to participate in a Health Insurance Marketplace 
or a State seeking approval to operate a State-based Marketplace to 
which Section 1557 or this part applies shall, as a condition of 
certification or approval, submit an assurance, on a form specified by 
the Director, that the health program or activity will be operated in 
compliance with Section 1557 and this part. An applicant or entity may 
incorporate this assurance by reference in subsequent applications to 
the Department for Federal financial assistance or requests for 
certification to participate in a Health Insurance Marketplace or 
approval to operate a State-based Marketplace.
    (b) Duration of obligation. The duration of the assurances required 
by this subpart is the same as the duration of the assurances required 
in the Department's regulations implementing Section 504, at 45 CFR 
84.5(b).
    (c) Covenants. When Federal financial assistance is provided in the 
form of real property or interest, the same conditions apply as those 
contained in the Department's regulations implementing Section 504, at 
45 CFR 84.5(c), except that the nondiscrimination obligation applies to 
discrimination on all bases covered under Section 1557 and this part.


Sec.  92.6  Remedial action and voluntary action.

    (a) Remedial action. (1) If the Director finds that a recipient or 
State-based Marketplace has discriminated against an individual on the 
basis of race, color, national origin, sex, age, or disability, in 
violation of Section 1557 or this part, such recipient or State-based 
Marketplace shall take such remedial action as the Director may require 
to overcome the effects of the discrimination.
    (2) Where a recipient is found to have discriminated against an 
individual on the basis of race, color, national origin, sex, age, or 
disability, in violation of Section 1557 or this part, and where 
another recipient exercises control over the recipient that has 
discriminated, the Director, where appropriate, may require either or 
both entities to take remedial action.
    (3) The Director may, where necessary to overcome the effects of 
discrimination in violation of Section 1557 or this part, require a 
recipient or State-based Marketplace to take remedial action with 
respect to:
    (i) Individuals who are no longer participants in the recipient's 
or State-based Marketplace's health program or activity but who were 
participants in the health program or activity when such discrimination 
occurred; or
    (ii) Individuals who would have been participants in the health 
program or activity had the discrimination not occurred.
    (b) Voluntary action. A covered entity may take steps, in addition 
to any action that is required by Section 1557 or this part, to 
overcome effects of conditions that result or resulted in limited 
participation in the covered entity's health programs or activities by 
individuals on the basis of race, color, national origin, sex, age, or 
disability.


Sec.  92.7  Designation of responsible employee and adoption of 
grievance procedures.

    (a) Designation of responsible employee. Each covered entity that 
employs 15 or more persons shall designate at least one employee to 
coordinate its efforts to comply with and carry out its 
responsibilities under Section 1557 and this part, including the 
investigation of any grievance communicated to it alleging 
noncompliance with Section 1557 or this part or alleging any action 
that would be prohibited by Section 1557 or this part. For the 
Department, including the Federally-facilitated Marketplaces, the 
Office for Civil Rights (OCR) will be deemed the responsible employee 
under this section.
    (b) Adoption of grievance procedures. Each covered entity that 
employs 15 or more persons shall adopt grievance procedures that 
incorporate appropriate due process standards and that provide for the 
prompt and equitable resolution of grievances alleging any action that 
would be prohibited by Section 1557 or this part. For the Department, 
including the Federally-facilitated Marketplaces, the procedures for 
addressing complaints of discrimination on the grounds covered under 
Section 1557 or this part will be deemed grievance procedures under 
this section.


Sec.  92.8  Notice requirement.

    (a) Each covered entity shall take appropriate initial and 
continuing steps to notify beneficiaries, enrollees, applicants, or 
members of the public of the following:
    (1) The covered entity does not discriminate on the basis of race, 
color, national origin, sex, age, or disability;
    (2) The covered entity provides appropriate auxiliary aids and 
services, including qualified interpreters and information in alternate 
formats, free of charge and in a timely manner, when such aids and 
services are necessary to ensure an equal opportunity to participate to 
individuals with disabilities;
    (3) The covered entity provides language assistance services, free 
of charge and in a timely manner, when such services are necessary to 
provide meaningful access to individuals with limited English 
proficiency;
    (4) How to obtain the aids and services in paragraphs (a)(2) and 
(3) of this section;
    (5) An identification of and contact information for the 
responsible employee designated pursuant to Sec.  92.7(a), if 
applicable;

[[Page 54218]]

    (6) The availability of the grievance procedure and how to file a 
grievance, pursuant to Sec.  92.7(b), if applicable; and
    (7) How to file a discrimination complaint with OCR in the 
Department.
    (b) Within 90 days of the effective date of this part, each covered 
entity shall post, consistent with paragraph (f) of this section, an 
English-language notice that conveys the information in paragraphs 
(a)(1) through (7) of this section.
    (c) For use by covered entities, the Director shall make available, 
electronically and in any other manner that the Director determines 
appropriate, the content of a sample notice that conveys the 
information in paragraphs (a)(1) through (7) of this section in English 
and in the top 15 languages spoken by individuals with limited English 
proficiency nationally.
    (d) Within 90 days of the effective date of this part, each covered 
entity shall post taglines in the top 15 languages spoken by 
individuals with limited English proficiency nationally.
    (e) For use by covered entities, the Director shall make available, 
electronically and in any other manner that the Director determines 
appropriate, taglines in the top 15 languages spoken by individuals 
with limited English proficiency nationally.
    (f)(1) Each covered entity shall post the English-language notice 
required by paragraphs (a) and (b) of this section and the taglines 
required by paragraph (d) of this section in a conspicuously-visible 
font size:
    (i) In significant publications and significant communications 
targeted to beneficiaries, enrollees, applicants, or members of the 
public;
    (ii) In conspicuous physical locations where the entity interacts 
with the public; and
    (iii) In a conspicuous location accessible from the home page of 
the covered entity's Web site.
    (2) A covered entity may also post the notice and taglines in 
additional publications and communications.
    (g) A covered entity that complies with paragraphs (a), (b), (d), 
and (f) of this section meets the requirements of the regulation 
implementing Title VI, at Sec.  80.6(d) of this subchapter, the 
regulation implementing Section 504, at Sec. Sec.  84.8(a) and 85.12 of 
this subchapter, the regulation implementing Title IX, at Sec. Sec.  
86.8(b) and 86.9(a)(1) of this subchapter, and the regulation 
implementing the Age Act, at Sec.  91.32(b) of this subchapter, as 
applicable.

Subpart B--Nondiscrimination Provisions


Sec.  92.101  Discrimination prohibited.

    (a) General. (1) Except as provided in Title I of the ACA, an 
individual shall not, on the basis of race, color, national origin, 
sex, age, or disability, be excluded from participation in, be denied 
the benefits of, or otherwise be subjected to discrimination under any 
health program or activity to which this part applies.
    (2) Except as provided in Sec.  92.208, this part does not apply to 
discrimination by a covered entity against its own employees.
    (b) Specific discriminatory actions prohibited. Under any health 
program or activity to which this part applies:
    (1) Each covered entity must comply with the regulation 
implementing Title VI, at Sec.  80.3(b)(1) through (6) of this 
subchapter.
    (2)(i) Each recipient and State-based Marketplace must comply with 
the regulation implementing Section 504, at Sec. Sec.  84.4(b), 84.21 
through 84.23(b), 84.31, 84.34, 84.37, 84.38, and 84.41 through 84.55 
of this subchapter. Where this paragraph cross-references regulatory 
provisions that use the term ``recipient,'' the term ``recipient or 
State-based Marketplace'' shall apply in its place.
    (ii) The Department, including the Federally-facilitated 
Marketplaces, must comply with the regulation implementing Section 504, 
at Sec. Sec.  85.21(b), 85.41 through 85.42, and 85.44 through 85.51 of 
this subchapter.
    (3) Each covered entity must comply with the regulation 
implementing Title IX, at Sec.  86.31(b)(1) through (8) of this 
subchapter. Where this paragraph cross-references regulatory provisions 
that use the term ``student,'' ``employee,'' or ``applicant,'' the 
terms ``individual'' shall apply in its place.
    (4) Each covered entity must comply with the regulation 
implementing the Age Act, at Sec.  91.11(b) of this subchapter.
    (5) The enumeration of specific forms of discrimination in this 
paragraph does not limit the generality of the prohibition in paragraph 
(a) of this section.
    (c) The exceptions applicable to Title VI apply to discrimination 
on the basis of race, color, or national origin under this part. The 
exceptions applicable to Section 504 apply to discrimination on the 
basis of disability under this part. The exceptions applicable to the 
Age Act apply to discrimination on the basis of age under this part. 
These provisions are found at Sec. Sec.  80.3(d), 84.4(c), 85.21(c), 
91.12 through 91.15, and 91.17 through 91.18 of this subchapter.
    (d) Where the regulatory provisions referenced in paragraphs 
(b)(1), (b)(3), (b)(4), and (c) of this section use the term 
``recipient,'' the term ``covered entity'' shall apply in its place. 
Where the regulatory provisions referenced in paragraphs (b)(1), 
(b)(3), (b)(4), and (c) of this section use the terms ``program or 
activity'' or ``program'' or ``education program,'' the term ``health 
program or activity'' shall apply in its place.

Subpart C--Specific Applications to Health Programs and Activities


Sec.  92.201  Meaningful access for individuals with limited English 
proficiency.

    (a) General requirement. A covered entity shall take reasonable 
steps to provide meaningful access to each individual with limited 
English proficiency that it serves or encounters in its health programs 
and activities.
    (b) Evaluation of compliance. In evaluating whether a covered 
entity has met its obligation under paragraph (a) of this section, the 
Director shall:
    (1) Evaluate, and give substantial weight to, the nature and 
importance of the health program or activity, including the particular 
communication at issue, to the individual with limited English 
proficiency; and
    (2) Take other relevant factors into account. Such factors may 
include:
    (i) The length and complexity of the communication involved;
    (ii) The context in which the communication is taking place;
    (iii) The prevalence of the language in which the individual 
communicates among those eligible to be served or likely to be 
encountered by the health program or activity;
    (iv) All resources available to the covered entity; and
    (v) The cost of language assistance services.
    (c) Language assistance services requirements. Language assistance 
services required under paragraph (a) of this section must be provided 
free of charge, be accurate and timely, and protect the privacy and 
independence of the individual with limited English proficiency.
    (d) Specific requirements for interpreter services. Subject to 
paragraph (a) of this section, a covered entity shall offer a qualified 
interpreter for an individual with limited English proficiency when 
oral interpretation is a reasonable step to provide meaningful access 
for the individual with limited English proficiency.
    (e) Restricted use of certain persons to interpret or facilitate 
communication. A covered entity shall not:

[[Page 54219]]

    (1) Require an individual with limited English proficiency to 
provide his or her own interpreter;
    (2) Rely on an adult accompanying an individual with limited 
English proficiency to interpret or facilitate communication, except:
    (i) In an emergency involving an imminent threat to the safety or 
welfare of an individual or the public where there is no qualified 
interpreter immediately available; or
    (ii) Where the individual with limited English proficiency 
specifically requests that the accompanying adult interpret or 
facilitate communication, the accompanying adult agrees to provide such 
assistance, and reliance on that adult for such assistance is 
appropriate under the circumstances; or
    (3) Rely on a minor child to interpret or facilitate communication, 
except in an emergency involving an imminent threat to the safety or 
welfare of an individual or the public where there is no qualified 
interpreter immediately available.
    (f) Acceptance of language assistance services is not required. 
Nothing in this section shall be construed to require an individual 
with limited English proficiency to accept language assistance 
services.


Sec.  92.202  Effective communication for individuals with 
disabilities.

    A covered entity shall take appropriate steps to ensure that 
communications with individuals with disabilities are as effective as 
communications with others in health programs and activities, in 
accordance with the standards found at 28 CFR 35.160 through 35.164. 
Where the regulatory provisions referenced in this section use the term 
``public entity,'' the term ``covered entity'' shall apply in its 
place.


Sec.  92.203  Accessibility standards for buildings and facilities.

    (a) Each facility or part of a facility in which health programs or 
activities are conducted that is constructed or altered by or on behalf 
of, or for the use of, a recipient or State-based Marketplace shall 
comply with the 2010 Standards as defined in Sec.  92.4, if the 
construction or alteration was commenced on or after [18 MONTHS FROM 
DATE OF PUBLICATION OF FINAL RULE]. Departures from particular 
technical and scoping requirements by the use of other methods are 
permitted where substantially equivalent or greater access to and 
usability of the facility is provided. All newly constructed or altered 
buildings or facilities subject to this section shall comply with the 
requirements for a ``public building or facility'' as defined in 
Section 106.5 of the 2010 Standards.
    (b) Each facility or part of a facility in which health programs or 
activities are conducted that is constructed or altered by or on behalf 
of, or for the use of, a recipient or State-based Marketplace in 
conformance with the Uniform Federal Accessibility Standards, the 1991 
Standards, or the 2010 Standards as defined in Sec.  92.4 shall be 
deemed to comply with the requirements of this section and with 45 CFR 
84.23(a) and (b), cross-referenced in Sec.  92.101(b)(2)(i) with 
respect to those facilities, if the construction or alteration was 
commenced before [18 MONTHS FROM DATE OF PUBLICATION OF FINAL RULE] .
    (c) Each building or part of a building that is constructed or 
altered by or on behalf of, or for the use of, the Department must be 
designed, constructed, or altered so as to be readily accessible to and 
usable by individuals with disabilities. The definitions, requirements, 
and standards of the Architectural Barriers Act, as established in 
Appendices C and D to 36 CFR part 1191, apply to buildings and 
facilities covered by this section.


Sec.  92.204  Accessibility of electronic and information technology.

    (a) Covered entities shall ensure that their health programs or 
activities provided through electronic and information technology are 
accessible to individuals with disabilities, unless doing so would 
result in undue financial and administrative burdens or a fundamental 
alteration in the nature of the health programs or activities. When 
undue financial and administrative burdens or a fundamental alteration 
exist, the covered entity shall provide information in a format other 
than an electronic format that would not result in such undue financial 
and administrative burdens or a fundamental alteration but would 
ensure, to the maximum extent possible, that individuals with 
disabilities receive the benefits or services of the health program or 
activity that are provided through electronic and information 
technology.
    (b) State-based Marketplaces and recipients shall ensure that their 
health programs and activities provided through Web sites comply with 
the requirements of Title II of the ADA.


Sec.  92.205  Requirement to make reasonable modifications.

    A covered entity shall make reasonable modifications to policies, 
practices, or procedures when such modifications are necessary to avoid 
discrimination on the basis of disability, unless the covered entity 
can demonstrate that making the modifications would fundamentally alter 
the nature of the health program or activity. For the purposes of this 
section, the term ``reasonable modifications'' shall be interpreted in 
a manner consistent with the term as set forth in the ADA Title II 
regulation at 28 CFR 35.130(b)(7).


Sec.  92.206  Equal program access on the basis of sex.

    A covered entity shall provide individuals equal access to its 
health programs or activities without discrimination on the basis of 
sex, and shall treat individuals consistent with their gender identity, 
except that any health services that are ordinarily or exclusively 
available to individuals of one gender may not be denied or limited 
based on the fact that an individual's sex assigned at birth, gender 
identity, or gender otherwise recorded in a medical record is different 
from the one to which such health services are ordinarily or 
exclusively available.


Sec.  92.207  Nondiscrimination in health-related insurance and other 
health-related coverage.

    (a) General. A covered entity shall not, in providing or 
administering health-related insurance or other health-related 
coverage, discriminate on the basis of race, color, national origin, 
sex, age, or disability.
    (b) Discriminatory actions prohibited. A covered entity shall not, 
in providing or administering health-related insurance or other health-
related coverage:
    (1) Deny, cancel, limit, or refuse to issue or renew a health 
insurance plan or policy, or other health coverage, or deny or limit 
coverage of a claim, or impose additional cost sharing or other 
limitations or restrictions, on the basis of an enrollee's or 
prospective enrollee's race, color, national origin, sex, age, or 
disability;
    (2) Employ marketing practices or benefit designs that discriminate 
on the basis of race, color, national origin, sex, age, or disability 
in a health-related insurance plan or policy, or other health-related 
coverage;
    (3) Deny or limit coverage, deny a claim, or impose additional cost 
sharing or other limitations or restrictions, on any health services 
that are ordinarily or exclusively available to individuals of one sex, 
based on the fact that an individual's sex assigned at birth, gender 
identity, or gender otherwise recorded by the plan or issuer is

[[Page 54220]]

different from the one to which such health services are ordinarily or 
exclusively available;
    (4) Categorically or automatically exclude from coverage, or limit 
coverage for, all health services related to gender transition; or
    (5) Otherwise deny or limit coverage, or deny a claim, for specific 
health services related to gender transition if such denial or 
limitation results in discrimination against a transgender individual.
    (c) The enumeration of specific forms of discrimination in 
paragraph (b) does not limit the general applicability of the 
prohibition in paragraph (a) of this section.
    (d) Nothing in this section is intended to determine, or restrict a 
covered entity from determining, whether a particular health service is 
medically necessary or otherwise meets applicable coverage requirements 
in any individual case.


Sec.  92.208  Employer liability for discrimination in employee health 
benefit programs.

    A covered entity that provides an employee health benefit program 
to its employees and/or their dependents shall be liable for violations 
of this part in that employee health benefit program only when:
    (a) The entity is principally engaged in providing or administering 
health services or health insurance coverage;
    (b) The entity receives Federal financial assistance a primary 
objective of which is to fund the entity's employee health benefit 
program; or
    (c) The entity is not principally engaged in providing or 
administering health services or health insurance coverage but operates 
a health program or activity, which is not an employee health benefit 
program, that receives Federal financial assistance; except that the 
entity is liable under this part with regard to the provision or 
administration of employee health benefits only to the employees in 
that health program or activity.


Sec.  92.209  Nondiscrimination on the basis of association.

    A covered entity shall not exclude from participation in, deny the 
benefits of, or otherwise discriminate against an individual or entity 
in its health programs or activities on the basis of the race, color, 
national origin, age, disability, or sex of an individual with whom the 
individual or entity is known or believed to have a relationship or 
association.

Subpart D--Enforcement


Sec.  92.301  Enforcement mechanisms.

    The enforcement mechanisms available for and provided under Title 
VI, Title IX, Section 504, or the Age Act shall apply for purposes of 
Section 1557 and this part with respect to covered entities.


Sec.  92.302  Procedures for health programs and activities conducted 
by recipients and State-based Marketplaces.

    (a) The procedural provisions applicable to Title VI apply with 
respect to enforcement actions concerning discrimination on the basis 
of race, color, national, origin, sex, and disability discrimination 
under Section 1557 or this part. These procedures are found at 
Sec. Sec.  80.6 through 80.11 of this subchapter and part 81 of this 
subchapter.
    (b) The procedural provisions applicable to the Age Act apply with 
respect to enforcement actions concerning age discrimination under 
Section 1557 or this part. These procedures are found at Sec. Sec.  
91.41 through 91.50 of this subchapter.
    (c) An individual or entity may bring a civil action to challenge a 
violation of Section 1557 or this part in a United States District 
Court in which the recipient or State-based Marketplace is found or 
transacts business.


Sec.  92.303  Procedures for health programs and activities 
administered by the Department.

    (a) This section applies to discrimination on the basis of race, 
color, national origin, sex, age, or disability in health programs or 
activities administered by the Department, including the Federally-
facilitated Marketplaces.
    (b) The procedural provisions applicable to Section 504 at 
Sec. Sec.  85.61 through 85.62 of this subchapter shall apply with 
respect to enforcement actions against the Department concerning 
discrimination on the basis of race, color, national origin, sex, age, 
or disability under Section 1557 or this part. Where this section 
cross-references regulatory provisions that use the term ``handicap,'' 
this term shall be replaced with ``race, color, national origin, sex, 
age, or disability.''
    (c) Access to sources of information. The Department shall permit 
access by OCR to its books, records, accounts and other sources of 
information, and facilities as may be pertinent to ascertain compliance 
with Section 1557 or this part. Where any information required of the 
Department is in the exclusive possession of any other agency, 
institution or individual, and the other agency, institution or 
individual shall fail or refuse to furnish this information, the 
Department shall so certify and shall set forth what efforts it has 
made to obtain the information. Asserted considerations of privacy or 
confidentiality may not operate to bar OCR from evaluating or seeking 
to enforce compliance with Section 1557 or this part. Information of a 
confidential nature obtained in connection with compliance evaluation 
or enforcement shall not be disclosed except where necessary under the 
law.
    (d) Intimidatory or retaliatory acts prohibited. The Department 
shall not intimidate, threaten, coerce, or discriminate against any 
individual for the purpose of interfering with any right or privilege 
secured by Section 1557 or this part, or because such individual has 
made a complaint, testified, assisted, or participated in any manner in 
an investigation, proceeding or hearing under Section 1557 or this 
part. The identity of complainants shall be kept confidential by OCR, 
except to the extent necessary to carry out the purposes of Section 
1557 or this part.

Appendix A to Part 92 -- Sample Notice Informing Individuals About 
Nondiscrimination and Accessibility Requirements

Discrimination is Against the Law

    [Name of covered entity] complies with applicable federal civil 
rights laws and does not discriminate on the basis of race, color, 
national origin, age, disability, or sex, including sex stereotypes 
and gender identity[. [Name of covered entity] does not exclude 
people or treat them worse because of their race, color, national 
origin, age, disability, or sex.
    [Name of covered entity]:
     Provides free aids and services to people with 
disabilities to communicate effectively with us, such as:
    [cir] Qualified sign language interpreters
    [cir] written information in other formats (large print, audio, 
accessible electronic formats, other formats)
     Provides free language services to people whose first 
language is not English when needed to communicate effectively with 
us, such as:
    [cir] Interpreters
    [cir] information translated into other languages
If you need these services, contact------------------------------------
    If you believe that [Name of covered entity] has failed to 
provide these services or discriminated in another way on the basis 
of race, color, national origin, age, disability, or sex, you can 
file a grievance with: [Name of Civil Rights Coordinator], [Mailing 
Address], [Telephone number ], [TTY number--if covered entity has 
one], [Fax], [Email]. You can file a grievance in person, by mail, 
fax, or email. If you need help filing a grievance, [Name of Civil 
Rights Coordinator] is available to help you. You can also file a 
civil

[[Page 54221]]

rights complaint with the U.S. Department of Health and Human 
Services Office for Civil Rights electronically through the Office 
for Civil Rights Complaint Portal available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail, phone, or fax 
at: [Add address, phone and fax of OCR Headquarters Office]. 
Complaint forms are available at https://www.hhs.gov/ocr/office/file/.

Appendix B to Part 92--Sample Tagline Informing Individuals With 
Limited English Proficiency of Language Assistance Services

    ATTENTION: If you speak [insert language], language assistance 
services, free of charge, may be available to you. Contact 1-xxx-
xxx-xxxx (TTY: 1-xxx-xxx-xxxx).

    Dated: September 1, 2015.
Sylvia M. Burwell,
Secretary.

[FR Doc. 2015-22043 Filed 9-3-15; 11:15 am]
 BILLING CODE 4150-01-P