HHS Protection of Conscience Regulation (2008-2011)
U.S. Department of Health and Human Services
Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law

Comment by HHS on Final Rule (2008)

Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Rules and Regulations: Part VI, 78072-78101.

 

II.    Comments on the Proposed Rule

On August 26, 2008 (73 FR 50274), Department of Health and Human Services published the proposed rule.

The Department received a large volume of Comments on the proposed rule, both from Commenters supporting the proposed rule, as well as from those opposing the proposed rule.

Comments came from a wide variety of individuals and organizations, including private citizens, individual and institutional health care providers, religious organizations, patient advocacy groups, professional organizations, universities and research institutions, consumer organizations, and State and federal agencies and representatives.

Comments dealt with a range of issues surrounding the proposed rule, including the need for the rule; what kinds of workers would be protected by the proposed rule; what services are covered by the proposed rule; whether health care workers use the regulation to discriminate against patients; what significant implementation issues could be associated with the rule; legal arguments; and the cost impacts of the proposed rule. Many Comments from health care providers, members of the public, and others confirmed the need to promulgate this regulation to raise awareness of federal conscience protections and provide for their enforcement.

A summary of the substantive Comments, and the Department's Responses to those Comments, follows.

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A.    Comments on Proposed New § 88.1- Purpose

No Comments were received pertaining to this section.

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B.    Comments on Proposed New § 88.2- Definitions

Assist in the Performance

Comment: Many Comments suggested that the proposed definition of ''assist in the performance'' was too broad. These Comments focused primarily on the inclusion of referral, training, and other arrangements within the ambit of this statutory term, claiming that this would allow an individual or institution to refuse to provide information or counseling about an objectionable procedure to which he or it objected.

Commenters also expressed concern that the definition was too broad because, they asserted, a health care provider has an obligation to provide or assist patients with a referral or other information that allows the patient to receive health care services, regardless of the health care provider's conscientious objection.

Response: Commenters raising these concerns may lack understanding of the context in which the term ''assist in the performance'' is used in the statutes and in this regulation. The term is only used in the Church Amendments and in the provisions of this regulation that implement those statutory provisions.

As noted above (see section I), all provisions of the Church Amendment use the term ''assist in the performance'' to ensure that individuals are protected from being required to assist in the performance of certain health care services or research activities, and from being discriminated against on the basis that the individual

(1) assisted in the performance of a legal health service or research activity, or

(2) refused to assist in the performance of such a health service or research activity because it would be contrary to his religious beliefs or moral conviction.

Given that context, in interpreting the term ''assist in the performance,'' the Department has sought to provide broad protection for individuals, consistent with the plain language of the statutes. As a policy matter, the Department believes that limiting the definition of the statutory term ''assist in the performance'' only to those activities that constitute direct involvement with a procedure, health service, or research activity, falls short of implementing the protections Congress intended under federal law.

However, we recognized the potential for abuse if the term was unlimited. Accordingly, we proposed- and here finalize-a definition of ''assist in the performance'' that is limited to ''any activity with a reasonable connection to a procedure, health service or health service program, or research activity.'' We also finalize the limitation in the definition that required the individual involved to be ''a part of the workforce of a Department-funded entity.''

We wish to clarify here the scope of federal law respecting the protections afforded with respect to ''assist[ing] in the performance'' of a procedure, health service, or research activity.

Whether the relevant provision of the Church Amendments uses the term ''individual'' (42 U.S.C. 300a-7(b)(1), (d)), ''personnel'' (42 U.S.C. 300a- 7(b)(2)(B)), ''any physician or other health care personnel'' (42 U.S.C. 300a- 7(c)(1)-(2)), or applicant [ ] for training or study'' (42 U.S.C. 300a-7(e)), the term ''assist in the performance'' of a procedure, health service, or research activity applies to people. Thus, the protections of the Church Amendments with respect to ''assist[ing] in the performance'' of a procedure, health service, or research activity are afforded only with respect to people. To the extent such entities' or institutions' refusal to assist in the performance of such an activity would not be protected by PHS Act § 245, the Weldon Amendment, or the Church Amendments at section 300a-7(b)(2), such entities or institutions would have to arrange to provide any information or service otherwise required by law.

Individual and Workforce

Comment: Some Comments questioned whether the proposed definitions of the terms ''individual'' and ''workforce'' are too broad.

Comments suggested that the definitions of these two terms would require a health care facility to apply the protections to all of its employees and contractors, no matter how removed their involvement is from the delivery of abortion or sterilization services. Other Comments expressed concern that the proposed definition of ''workforce'' would extend the conscience protections to volunteers and trainees.

Commenters were also concerned that physicians, hospitals, and other health care institutions may find the definition burdensome in various areas of their operation (e.g., janitorial services, medical recordkeeping, security, reception services).

Lastly, Comments asserted that the definition of ''workforce'' needs to be changed to provide a complete list of the types of individuals who fall within it.

Response:The Department believes that its proposed definition of ''individual'' is consistent with the statutory language and the intent of Congress as gleaned from an examination of the provisions in context. We had proposed to define ''individual'' as ''a member of the workforce of an entity/health care entity.''

As noted above, the term ''individual'' is used in two provisions of the Church Amendments: 42 U.S.C. 300a-7(b)(1) 1 and 42 U.S.C. 300a-7(d).2 In other provisions of the Church Amendments, Congress chose to use more clearly limiting terms: ''personnel'' (42 U.S.C. 300a-7(b)(2)(B)), ''any physician or other health care personnel'' (42 U.S.C. 300a-7(c)(1)&(2)), or ''applicant [] for training or study'' (42 U.S.C. 300a-7(e)).

In addition, those other provisions are explicitly limited to discrimination in the employment/privileging or education/training contexts, while 42 U.S.C. 300a-7(d) is not so limited: It provides that ''[n]o individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or in part under a program administered by [HHS]'' if doing so ''would be contrary to his religious beliefs or moral convictions.'' Given this context, we believe that Congress did not intend that the term ''individual'' be limited to employees or health care personnel with privileges at a Department-funded entity, and that it is reasonable to include volunteers and trainees in the definition of ''workforce.''

These laws are intended to protect the conscience rights of all individuals participating in health care services, and research programs and activities receiving certain federal funds, or that are administered by the Department. The Department provides a definition of the term ''workforce'' to serve as a limiting criterion to ensure that individuals that are not under the control of an entity receiving Department funds do not claim the protection afforded by the statues. We further note that, where the individual is assisting in the performance of a sterilization procedure or abortion (or any other health service or research activity) in which the provisions of the Church Amendments are relevant, the definition of ''assist in the performance'' further limits the protection to ''any activity with a reasonable connection to a procedure, health service or health program, or research activity * * *.''

Thus, we disagree with the Comment that the definitions would require a health care facility to apply protections to all of its employees and contractors no matter how far removed from the performance of sterilization procedures or abortion. The Department acknowledges that these definitions would include volunteers and trainees.

It is clear that the statutes specifically envision that these protections apply to training programs, students, and applicants for training or study in the health professions. Regarding the Comment that physicians, hospitals or other providers may find it difficult or burdensome to comply with this requirement, the Department points to the fact that these requirements are not new, but are rather existing conditions on certain federal funds that recipients should be following already.

The Department agrees with the Comment that the term ''workforce'' should provide a complete identification of covered individuals, and will therefore replace the word ''includes'' with the word ''means'', to provide a clearer and more definitive definition.

As indicated in the proposed rule- and consistent with the scope of the Church Amendments, which include physicians and other health care providers that have privileges with an entity receiving funding from the Department-we intended the concept of ''workforce'' to include physicians and other health care providers who have privileges at the entity funded by the Department. After publication of the proposed rule, it came to the Department's attention that the language of the ''workforce'' definition may not be clear on this issue.

Accordingly, to ensure clarity on this point, we are revising the definition of ''workforce'' by adding at the end ''or health care providers holding privileges with the entity.'' The definition now reads:

'' 'workforce' means employees, volunteers, trainees, contractors, and other persons whose conduct, in the performance of work for a Department funded entity, is under the control or authority of such entity, whether or not they are paid by the Department-funded entity, or health care providers holding privileges with the entity.

Health Care Entity/Entity

Comment: A number of Comments suggested that the definitions of ''health care entity'' and ''entity'' are too broad and go beyond those in the Public Health Service Act and the Weldon Amendment. They assert that the Department exceeded its rule-making authority when it applied the legal standard enunciated in the Weldon Amendment and Public Health Service Act to ''health care entities'' that are not encompassed by the definitions set forth in those statutes.

Comments also requested that the Department clarify whether a health care entity includes pharmacists, nurses, occupational therapists, public-health workers, janitors working for health care entities, and technicians, as well as psychiatrists, psychologists, counselors, and other mental health workers, while others suggested that pharmacists should not be included.

Lastly, one Commenter expressed concern that the proposed rule did not specify what amount of Departmental funding would place an entity under the purview of these regulations.

Response: The Department believes the definitions proposed in the proposed rule and adopted herein are appropriate and within its authority.

In providing definitions of the term ''health care entity'' in their statutes, the Weldon Amendment and Public Health Services Act use the word ''include.'' As a matter of statutory drafting and construction, the use of that word indicates that the list following it is not exhaustive. In seeking to issue this regulation, the Department thought it would be beneficial to provide a clear and consistent definition that it would apply when implementing any of the three statutes.

In proposing the definition, the Department intended it to be appropriately broad, but did not attempt to specifically list every possible entity or health profession classification, to avoid the situation that new health care professional classifications-or current health care professions inadvertently not listed- were not protected. As such, the Department used the terms ''health care professional'' and ''health care personnel'' to cover other professions such as pharmacists, nurses, occupational therapists, public-health workers, and technicians, as well as psychiatrists, psychologists, counselors, and other mental health workers.

The Department rejects the suggestion that pharmacists or pharmacies be specifically excluded from the definition because that would seem inconsistent with both the text and the purpose of the statutes.

Lastly, the Department is concerned that some Commenters may incorrectly believe that there is a minimum financial threshold below which entities may receive a certain amount of Departmental funds without being subject to he statutory provisions and these implementing regulations. As in other cases, such as Title VI of the Civil Rights Act of 1964, when an entity elects to receive any amount of federal funds, that entity agrees to follow all conditions and rules that apply to the use of those funds or upon which receipt of the funds is conditioned.

Health Service/Health Service Program

Comment: Several Comments declared that the definitions of ''health service'' and ''health service program'' inappropriately expand the scope of the conscience provisions to all medical treatments or services, biomedical and behavioral research, activities related to providing medicine, health care, or other services related to health or wellness (including programs such as Medicare and Medicaid). Some observed that the definitions include certain public health programs, such as vaccinations and family planning.

Lastly, other Comments on these proposed definitions suggested that the definition of ''health service program'' be expanded to specifically include assisted suicide, transgender-related surgery and assisted reproductive technologies.

Response: Commenters' objections to this definition are fundamentally an objection to the Department's interpretation of the scope of the statutory protections themselves. We proposed to define ''health service program'' as including any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded, in whole or in part, by the Department, which may include components of programs operated by State or local governments.

There is nothing in the statute to suggest that the term ''health service program'' in 42 U.S.C. 300a-7(d) is to be read narrowly. Moreover, given the context of the provision in which it appears, while individuals and health care personnel are protected with respect to their participation in research activities, it would not be the result of a broad understanding of ''health service,'' but because such individuals and healthcare personnel are engaged in performing or assisting in the performance of research activities funded under programs administered by the Department, which are subject to statutory protection. See 42 U.S.C. 300a-7(d). The definition and the statutory protections apply to health services and research activities that are funded in whole or in part by the Department.

For the Department to adopt a definition that removes protection from entire programs that are appropriately included in the definition, given the statutory context, would be inconsistent with our understanding of the purpose of the statutory provisions. The observation that some of these programs may involve important public health issues that may be controversial or objectionable to some is not a justification to eliminate the statutory protections.

The Comment that seeks the inclusion of ''assisted suicide'' and other procedures in the definition of ''health service program'' is misinformed. This definition does not set out a list or description of the types of procedures to which a protected individual may or may not object, but the types of programs under which such protection exists.

While the Department had proposed to define the term ''health service,'' the Department has determined that the term is self-explanatory, and that a definition is not necessary, or may potentially confuse recipients. Accordingly, we do not finalize a definition of the term.

Recipient/Sub-Recipient

Comment: Several Comments expressed concern over extending the applicability of the proposed definitions of ''recipient'' and ''sub-recipient'' to foreign non-governmental organizations or international organizations (such as agencies of the United Nations) without reference to existing federal law governing U.S. foreign policy. These Comments claimed that it could create confusion among federal agencies about which laws to follow and could lead to unforeseen foreign policy complications. They added that it may also create confusion for entities that receive United States funding, but are located outside of the United States.

Response: The Department does not believe a conflict exists between these statutory requirements and U.S. foreign policy related to the use of federal funds abroad. To reduce any potential confusion among federal agencies, we proposed and here finalize a definitions of recipient and sub-recipient which permit the Department awarding agency to exercise discretion as to whether the terms include foreign or international organizations (such as agencies of the United Nations).

Other Definitions

[Abortion]

 Comment: Many Commenters asserted the term ''abortion'' should be defined in the regulation, some believing that, without such definition, the proposed rule does not provide sufficient information to direct health care providers to meet the obligations of the requirements. The main division among Commenters regarding the definition of abortion was whether certain contraceptive methods or services that have the potential to terminate a fertilized egg after conception but before implantation are considered abortion under the proposed rule. Several Commenters claimed that the proposed rule would seriously jeopardize Title X programs and Medicaid services if ''abortion'' is not clearly defined to exclude contraceptive services.

Response: After the full consideration of Comments on this issue, the Department declines to add a definition of abortion to the rule. As indicated by the Comments, such questions over the nature of abortion and the ending of a life are highly controversial and strongly debated. The Department believes it can enforce the federal health care conscience protection laws without an abortion definition just as the Department has enforced Hyde Amendment, Consolidated Appropriations Act, 2008, Public Law 110-161, Div. G, §§ 507, 508(a)-(c), 121 Stat. 1844, 2208 (Dec. 26, 2007), abortion funding restrictions without a formal definition. Additionally, nothing in this rule alters the obligation of federal Title X programs to deliver contraceptive services to clients in need as authorized by law and regulation.

[Discrimination]

Comment: Comments requested that the Department define many other terms or phrases that are used in the regulation. Some Comments suggested that the Department adopt a narrow definition of the term ''discrimination'' and make clear that the reassignment of an employee who states a religious or moral objection to a certain activity (such as abortion) does not constitute discrimination.

Response: The Department believes that these terms are sufficiently clear, and do not need further definition. The Department does not believe that a definition of the statutory term''discrimination'' is necessary. The term ''discrimination'' is widely understood, and significant federal case law exists to aid entities in knowing what types of actions do or do not constitute unlawful discrimination.

The Department expressly rejects the suggestion that the reassignment of an employee who states a religious or moral objection to a certain activity (such as abortion) may not constitute discrimination in all cases. Like most discrimination cases, the outcomes are dependent on the facts. It seems likely that there are situations where the reassignment of anemployee for the refusal to perform a specific procedure could constitute unlawful discrimination. Likewise, the Department recognizes that circumstances exist where thereassignment of such an employee would not constitute unlawful discrimination.

We encourage employers subject to the rule to have discussions with their employees thatlead to mutually agreeable resolutions.

[Religious belief/moral conviction]

Comment: Some Comments asked that the Department define the terms ''religious belief'' and ''moral conviction'' to ensure that they would not be interpreted broadly.

Response: The Department declines to adopt particular definitions of these terms because the common definitions are plainly understood, and the Department intends that common senseinterpretations apply. A well-defined body of federal law exists in this general topic, and the U.S. Supreme Court has repeatedly clarified that these terms are to be read broadly.

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C.    Comments: on Proposed New § 88.3-Applicability

No Comments were received specifically pertaining to this section.

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D.    Comments on Proposed New § 88.4- Requirements and Prohibitions

No Comments were received specifically pertaining to this section.

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E.    Comments on Proposed New § 88.5-Written Certification of Compliance

Comment: Several Comments stated that the requirement for written certification in proposed section 88.5 would be duplicative or unnecessary because current regulations alreadyrequire written certification of compliance with federal nondiscrimination and civil rights laws.Other Comments suggested that the certifications be modified in order to avoid confusion on the part of recipients and sub-recipients.

Response: We find that a specific written certification is necessary to protect institutions under these laws. Many recipients (and sub-recipients) of Department funds currently must certify compliance with certain listed federal nondiscrimination laws, yet federal health care conscience protection laws are separate laws not specifically mentioned in existing forms. As part of a broad effort to raise awareness in the public, in the health care community,among recipients of Department funds, and among protected individuals and institutions, of their rights and responsibilities under existing federal health care conscience protection laws,as well as to facilitate enforcement of these laws, the regulation requires certain recipients and sub-recipients of Department funds to certify their compliance in writing. Whereverpossible, Department programs will attempt to integrate certifications required under this regulation into existing forms.

The Department has modified the certifications in section 88.5. They have been made clear so that recipients and sub-recipients know, by means of the certifications themselves, with whichprovisions they must comply based on the type of entity the recipient is or the type of funding mechanism through which they receive funds.

Comment: Comments asserted that the Department is overstepping its authority by making compliance with the federal health care conscience protection statutes a condition of payment, stating Congress has not made compliance a condition of payment and would havesaid so if that were its intent.

Response: The Department disagrees that the proposed rule exceeds its authority. It is important to emphasize that the Department and recipients of Department funds, including State and local governments, are obligated to comply with the health care protection of conscience laws that have been in effect for many years, which prohibit federal funds from being used in a discriminatory or coercive manner against institutional and individual health care entities and workers for their participation or refusal to participate in abortions, other certain medical procedures, health services, or research activities that they find objectionable on religious or moral grounds. By employing existing regulatory enforcement measures to ensurecompliance with such statutory requirements under 45 CFR parts 74, 92, and 96, as well as other measures, the Department does not exceed its authority, but rather is carrying out itsobligation to enforce existing laws.

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F.    Comments Received in Response: Specific Requests for Comments in the Proposed Rule

Current Awareness of and Compliance With Provider Conscience Protections

Comment: This regulation implements existing federal health care conscience protection laws contained in the Church Amendments, the Public Health Service Act § 245 and the Weldon Amendment. Several Comments objected to the regulation on the grounds that these laws were sufficient in themselves and that their implementation by regulation was unnecessary or redundant. Generally, these Comments suggested that the health care field is sufficiently aware of the statutory protections available for provider conscience, and that no furtherregulatory effort was required in order to provide awareness of these laws or to assure compliance with them.

Several other Comments, however, reported widespread lack of knowledge regardingthese laws and inconsistent application of them. These Comments generally supported the regulation as a necessary and useful mechanism to support statutory protection. In addition,numerous Comments reported what they believed to be individual instances of violation of conscience, including health care providers suffering loss of employment, adverse actions during medical training, and discrimination in residency placement, among other consequences, due to their assertion of their conscience rights. Some Commenters also reported pressure toperform certain procedures from State authorities, professional organizations, or employers that appeared to the Commenters to be inconsistent with federal conscience protections.

Response: The Comments received in Response to the proposed rule support the Department position that the regulation is necessary to implement the statutes.

While many people in the health care field may have general knowledge that conscience protections exist for providers, the scope of these protections is not always widely understood. Because Congress has enacted several different protections, an individual or organization may be aware that, for instance, a physician may not be compelled to perform abortions, but may not be aware of other aspects of the statutes providing conscience protection. Others may become aware of these laws, at least in detail, only when a dispute arises and a provider or entity attempts to assert their conscience rights; there may be subsequent disagreement over the nature of the rights asserted.

The Department believes that coordinating the several related statutory protections, by incorporating their various requirements into this regulation, will allow for greater clarity and awareness of these protections within the health care field, in conjunction with other public education efforts connected with this regulation.

In addition, the issuance of a regulation will allow for greater ease of administration, provide a Departmental point of contact for complaints regarding violations of the statutes and this regulation, and provide a uniform mechanism for investigating complaints of noncompliance. The types of noncompliance reported by Commenters are expected to be reduced as a result of this regulation.

Methods To Address Compliance Problems and Increase Awareness

Comment: Commenters who supported and opposed the rule both noted that the Department must increase awareness of health care provider conscientious objection rights, and theobligations this rule may pose for employers, entities, and States.

Some Commenters also responded to the Department's request for Comments on methods which may be used by the Department and others to increase awareness among health care providers of their rights under laws protecting providers from discrimination for exercising their conscience rights.

Commenters who opposed the rule suggested that, as an alternative to further federal regulation, the Department should prepare and distribute informational materials to individual and institutional health care providers and State and local governments, and make these materials available on the HHS Web site. A Commenter also proposed that the Department develop continuing education courses for health care practitioners and attorneys, and that existing certifications that recipients of Departmental funds must currently sign could be modified to achieve the objectives of the rule.

Response: The Department agrees that the suggestions offered by Commenters of mechanisms for improving awareness of conscience rights among health care providers would increase the effectiveness of the rule. However, the rule seeks to achieve not only greaterawareness of provider conscience rights, but also a more consistent understanding of the scope of these rights (and the corresponding obligations), greater ease of administration, provision of a Departmental point of contact for complaints regarding violations of the statutes and this regulation, a uniform mechanism for investigating complaints of noncompliance, and, as a result, greater compliance with the laws protecting these rights.

Comment: Commenters who supported the rule also offered suggestions on how both theDepartment and covered entities could increase awareness of the legal protections for health care provider conscience. Among the suggested activities were posting notices in high trafficareas of buildings receiving Department funds, providing information within educationalprograms that receive Department funds, including information in applications for training, applications for residency programs, and private insurance plans benefit descriptions,posting information on the Department or provider Web sites, including of information in employee handbooks, and sending e-mail or postal communications directly to providers.Comments were made on how to best attract attention to such postings by making them distinct from other materials in which they might be included.

Response: The Department agrees that these suggestions would contribute to significantly greater public awareness of health care provider conscience protections. The Department encourages covered entities to undertake such public awareness activities. The Department also recognizes that it must undertake reasonable outreach efforts in order for the rule to be effective at increasing awareness of, and compliance with, provider conscience protections in the statutes and this implementing regulation. Thus, the Department will consider all avenuesavailable for increasing public awareness of health care conscience protection laws. Requiring certification of compliance by entities receiving Department funds provides an important vehicle for increasing awareness of health care conscience protection laws and ensuringcompliance with them.

Comment: Some Comments declared that the description of notice/posting of health care provider conscience protections in the proposed rule should be enhanced. One argued that posting of notices on bulletin boards, where they appear among multiple notices, is not avery effective way of communicating the protections afforded under the regulation and statutes. Other Comments requested that notices of federal health care conscience protection statutes should be conspicuous and posted in such locations as provider offices and pharmacies and in such public communications as advertising, health plan promotion materials, Medicaid literature, Web sites, as well as applications for training, residency, and educational programs, and in employee/volunteer handbooks.

Response: The Department agrees that informing health care entities of their rights and responsibilities under federal health care provider conscience provisions is important to ensuringinstitutional and individual conscience rights are protected. Consequently, the Department encourages covered entities to undertake such educational/public awareness activities. Within its statutory authorities, the Department is exploring a number of options, including many ofthose suggested by Comments as well as others, to provide further public education and notice of federal health care conscience protection laws and this regulation.

Exceptions to the Written Certification Requirement in Proposed New § 88.5

Comment: Several Comments expressed concern that the certification requirement would create an administrative burden, and one Commenter suggested that the Department should not impose the certification requirements of the regulation on every Department granteeregardless of the grant's purpose.

Response: In its Notice of Proposed Rule Making, the Department solicited Comments on whether further exceptions should be made from certification requirements for recipientsor sub-recipients of federal funds, where such recipients or sub-recipients receive Department funds for purposes unrelated to the provision of health care or medical research.

Because there is concern among Commenters over any burden of a certification, including that stemming from certifications required without regard to a grant's purpose, and because there appears to be little objection to limiting the certification requirement in the way put forth forComments in the proposed rule, the Department has determined to make further exceptions to the certification requirement for Departmental programs whose purpose is unrelated to healthcare provision, including certain programs currently administered by the Administration for Children and Families and the Administration on Aging.

These programs often involve the provision of grants to States and other governments, or cash assistance or vouchers rather than direct services, and they are not likely to involve medical research, the participation of health care providers, or referral to health care providers. These programs are unlikely to encounter the circumstances contemplated by this regulation, and therefore the assurance of compliance represented by a certification is not considered necessary by the Department for such programs.

The regulatory text has been changed by addition of sections 88.5(e)(4) and (e)(5), together with associated language and example programs in the preamble. Finally, in section 88.5(e)(6), we provide an exception from the written certification requirement for Indian tribes and tribal Organizations when contracting with the Indian Health Service under the Indian Self-Determination and Education Assistance Act. Of course, these entities must still comply with the relevant statutes, even if they are not under an obligation to make a certification.

Should Language Specify Written Certification Is a Material Prerequisite toPayment of Department Funds

Comment: The Department requested Comments on whether written certification of compliance with nondiscrimination provisions should contain language specifying that the certification is a material prerequisite to the payment of Department funds. The Department received a number of Comments in Response to this request, both in favor of and against including such language in the written certification of compliance.

Those in favor of including material prerequisite language felt that such language was important as part of the written certification process to protect individuals and institutions from discriminatory treatment. Others stated that certification should not be a prerequisite for Department funding, noting that explicitly tying payment to compliance with the certification requirement would subject the certification process to the federal False Claims Act.

One Commenter stated that, absent more explicit guidance on the policies and practices that will satisfy compliance, written certification should not be a material prerequisite to payment of Department funds.

Response: The Department does not consider the written certification of compliance to be a material prerequisite to the payment of Department funds any more than in any other similarly worded statute or regulation. As stated above, the Department intends to work with recipients and sub-recipients of Department funds to ensure compliance with the requirements or prohibitions promulgated in this regulation, and, if such assistance fails to achieve compliance, the Department will consider all legal options, including termination of funding and return offunds paid out in violation of health care conscience protection provisions under 45 CFR parts 74, 92, and 96, as applicable.