Comment: Many Comments stated concern that the proposed regulation could serve as a pretext for health care workers to claim religious beliefs or moral objections under the protections of the fourth provision of the Church Amendments, 42 U.S.C. 300a-7(d), in order to discriminate against certain classes of patients, including illegal immigrants, drug and alcohol users, patients with disabilities or patients with HIV, or on the basis of race or sexual preference.
Response: Comments offered a number of hypothetical situations where individual health care workers might attempt to discriminate against individuals on a variety of grounds, using provider conscience as a pretext, and have suggested that the proposed regulation would permit such activity. Many of the described hypothetical situations are vague or lack substantial detail, but to the extent that the Comments suggest that the regulation permits unlawful discrimination, we disagree.
It is important to emphasize that the health care provider conscience protection provisions have existed in law for many years, and that this regulation only implements these existing requirements. As a result, there is nothing in this regulation that newly permits the types of actions described in Comments.
It is also important to emphasize that the health care conscience protection laws exist as one part of a number of federal laws that address discrimination on a variety of grounds, and that the actions described in the hypothetical situations that violate federal civil rights laws, continue to violate federal civil rights laws.
We do not believe there is a conflict between the operation of health care conscience protection laws and other federal laws. Congress has enacted a network of laws that govern different activities, and we believe proper meaning can be given to all of them.
There are several federal civil rights laws intended to protect individuals from discrimination in programs receiving federal financial assistance or in public accommodations based on their individual characteristics (e.g., race, color, national origin, disability, age, sex and religion). In the former, the individuals protected by these laws typically are beneficiaries of, or applicants for, services and activities provided through federally funded programs. The health care conscience protection laws have a different purpose, protecting individual healthcare workers and entities from discrimination in connection with particular practices such as abortion, or from compulsion to perform health care activities that they find religiously or morally objectionable.
As such, these two sets of laws are intended to protect different populations and on different grounds. On their face, there is no inherent inconsistency or conflict between these laws. How various federal laws would apply to any particular situation depends largely on the facts of the situation. Thus, it is inappropriate to make definitive statements about legal outcomes in Response to the many scenarios raised in Comments.
Entities subject to these laws are responsible for ensuring against illegal discrimination in providing health care services to the public, while also protecting the conscience rights of the health care workers who are affiliated with these entities. Because these laws do not on their face conflict, we believe it is possible in most situations for entities to act without violating any applicable federal laws. In many cases, for example, entities may accommodate health care worker conscience rights- while ensuring that all eligible patients are served, including members of federally protected classes-by managing the workforce to ensure sufficient coverage.
Many of the scenarios raised in Comments involved health care workers hypothetically discriminating against particular individuals on legally impermissible grounds (e.g., race or disability). To the extent these scenarios implied that the health care conscience protection laws protect workers who object to providing services based on an individual's federally protected characteristics, we disagree.
We believe such actions are outside of the scope of the health care provider conscience protections. Those laws protect health care workers' conscience rights with respect to particular actions or activities, not with respect to an individual's characteristics that are protected by federal law. To the extent there are actual conflicts between any of the health care conscience protection laws and federal civil rights laws, an entity would be required to comply with federal civil rights requirements.
Where the federal health care conscience protection laws and the civil rights laws are both conditioned on the receipt of federal funding, application of rules of statutory construction require continued compliance with federal civil rights laws. The health care conscience protection laws would not be interpreted to impliedly repeal federal civil rights requirements. Moreover, given the strong national policies embodied in federal civil rights laws that protect individuals from unlawful discrimination based on their federally protected individual characteristics, and that ensure that federally supported programs are available to all without discrimination, we believe that federal civil rights protections prevail.
Comment: A number of Comments argued that the proposed regulation would limit patient access to basic reproductive health care services, including contraceptive services. Many Comments also asserted that the proposed regulation would disproportionately affect certain subpopulations, including low-income patients, minorities, the uninsured, patients in rural areas, the Medicaid population, or other medically underserved populations. Some Comments further warned of health consequences, such as an increase in unintended pregnancy, should the proposed rule be promulgated. Finally, several Comments expressed concern that the proposed rule would limit access to emergency procedures, such as emergency contraception for rape victims, surgery for ectopic pregnancies, and other services.
Response: The Department recognizes that access to health care services is a challenge facing the entire health care system, and that it is not a challenge restricted to the context of reproductive health services. In recent years, the Department has proposed or implemented several important initiatives aimed at increasing access to quality health care, including by providing health care services for the poor, elderly and disabled; increasing access to quality medical care through expansion of the federal Community Health Center program; proposing to support and encourage States' efforts to work with the private marketplace to help ensure affordable health insurance; and supporting the enactment of proven medical liability reforms that increase patient access to quality medical care. The Department supports continuing such efforts into the future in addressing barriers to affordable, quality health care.
We disagree that this regulation would create new limitations on health care access, including basic reproductive health care services, services provided by publicly funded clinics, and health care services provided in emergency situations.
First, this regulation does not expand the scope of existing federal laws, some of which have been in place for many years, protecting health care entities from discrimination on the basis of provider conscience with respect to abortion and certain other services to which a provider may have religious or moral objections. The Department has a duty to enforce these laws applying to recipients of Department funds. Even absent the issuance of this final rule, recipients of Department funds are still required to comply with these laws; this regulation is intended to raise awareness of the laws among the public, protected health care entities, and recipients of Department funds, as well as to provide for enforcement of federal conscience protections.
Second, the current shortage of health care providers in certain areas of the country provides additional justification for protecting conscience rights. Many Comments we received, including those of many health care providers, stated that forcing providers to perform or participate in procedures that violate their consciences discourages individuals from entering or remaining in careers in the health professions. One Commenter wrote, ''by insisting that those who are willing to violate their consciences in the delivery of health care are the only persons who should enter the health care field, one contributes to the creation of a health care delivery system of professionals who blindly follow directives rather than conscience, putting society at risk.''
Unlike some Commenters, we believe that problems of access to health care can be resolved without requiring health care providers to violate their conscience. By protecting conscience rights in accord with federal law, we wish to encourage more individuals and institutions to participate in Department-funded health service programs in accord with their consciences and, thereby, increase access to quality health care services.
Third, with regard to contraceptive services, the Department continues to support efforts to make safe and effective contraceptives and family planning services available to women-and men-who cannot otherwise afford them. This regulation will ensure that such programs are carried out in a way that is consistent with existing federal health care conscience protection laws. While Comments posed many hypothetical situations in which they claimed access to contraceptive services would be limited, we have found no evidence that issuing these regulations to better ensure compliance with existing federal health care conscience protection laws will create additional barriers to accessing contraceptive services.
Fourth, we note that many Commenters who believed that this rule will significantly restrict access to contraceptives or increase teen pregnancies also submitted Comments stating that the rule was unnecessary because health care provider conscience protection laws are being followed and no provider rights are currently being violated. These two statements are contradictory. If access to any service significantly declined with the implementation of this rule and all other factors remained unchanged, that fact could be evidence that health care providers in question had previously been compelled to deliver the service over their conscience objections.
Comment: Comments argued that any revised rule should include guidance discussing ways to balance the rights of providers and patients, and one Commenter stated that any final rule should contain ''a forceful statement of patients' rights to receive health care services in accordance with their religious beliefs or conscience.'' The Commenter also argued that any certification should require health care entities to certify that the rights of patients are respected to the extent required by law.
Response: Patients' ability to access health care services, including abortion and reproductive health services, is long-established and is not changed in this rule.
In issuing regulations implementing federal laws protecting health care entities' conscience rights, we recognize that many current or prospective recipients of Department funds must already certify or assure their compliance with certain federal nondiscrimination laws as a part of existing funding applications. We also encourage all participants in the health care system, including patients, health care providers, and those entities receiving Department funds, to review existing laws, regulations, and guidance, including the U.S. Constitution and federal laws enacted by Congress prohibiting discrimination by health care entities receiving certain federal funds. (For more information on these issues, visit the Web site of the Office for Civil Rights of the Department of Health and Human Services at http://www.hhs.gov/ocr.)
We also encourage full and open communication between patients and providers on sensitive issues surrounding the provision of health care services, including issues of morality and conscience. Patients are best served when their providers communicate clearly and early about any services they decline to provide or participate in.
We similarly encourage full and open communication between providers and their employers or the entities with which they have privileges on issues concerning the services the provider may be unwilling to perform. This would facilitate the appropriate accommodation of a provider's religious or moral objections to particular services, while at the same time enabling the employer/institution to meet the needs of its patients.
The Department seeks to strike a careful balance between the health care provider conscience protections provided in federal law, on the one hand, and patients' needs and the needs of the health care system on the other hand. A health care system that is intolerant of individual conscience, certain religious beliefs, ethnic and cultural traditions, or moral convictions serves to discourage individuals with diverse backgrounds and perspectives from entering the health care professions, further exacerbating health care access shortages and reducing quality of care. It is more likely to lead to situations in which a patient is receiving services or procedures from a provider who is not fully committed to the choice of care.
We seek a health care field in which patients can be more confident that their provider shares their views and concerns as identified through mutually open communication. The final regulation takes a cautioned and balanced approach to ensure compliance with federal health care conscience protection laws by defining key terms, stating requirements and prohibitions, and requiring certain recipients and sub-recipients of Department funds to provide written certification of compliance. In so doing, we wish to promote diversity in the health professions, increasing access to health care services.
Comment: Some Comments expressed concern that the proposed rule could restrict access to contraceptives which are being used for purposes other than preventing pregnancy or are being used in conjunction with other medical treatments.
Response: According to 42 U.S.C. 300a-7(d), which applies to any program funded in whole or in part under a program administered by the Department, no protected individual may be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or part under a program implemented by HHS contrary to that individual's religious beliefs or moral convictions; the motivation of the patient or intended use of the service is irrelevant under the statute.
We note that nothing in this rule changes the obligations of the federal Title X program or Medicaid to deliver contraceptives to eligible patients in need. However, we reiterate that we have found no evidence that these regulations will create new barriers in accessing contraception unless those contraceptives are currently delivered over the religious or moral objections of the provider in such programs or research activities.
Comment: Comments expressed concern that the proposed regulation will expand the ability of insurers to refuse to provide health care services, information, and referrals to patients. Other Comments expressed concern that the regulation could impact funding for programs that benefit immigrants or victims of domestic violence.
Response: As previously stated, this regulation does not expand the scope of existing federal conscience protections for health care entities, including health insurance plans. Rather, it provides for Departmental implementation and enforcement of existing federal health care conscience protection laws and educates the public and the health care community about laws protecting the consciences of health care entities that refuse to participate in abortions or other services in the case of Departmental grantees. We are unaware of any way in which the regulation could impact funding for programs that benefit immigrants or victims of domestic violence.
Comment: One Commenter thought the rule would increase spending and add a significant strain on Medicaid.
Response: We have not found evidence supporting the Commenter's assertion that the final rule would increase spending in Medicaid, in part because this final rule does not expand the scope of existing federal health care conscience protection laws, some of which have been in place for over thirty years.
Comment: Several Comments disagreed with the Department's assertion in the proposed rule that the regulation will not have an impact on family well being. Another Commenter stated that the Treasury and General Government Appropriations Act of 1999 requires the Department to determine if the proposed rule would affect family well-being. The Commenter stated that, if family well-being is affected, the Department must provide an impact assessment of these effects. The Commenter also stated that the proposed rule does not adequately address the impact on family wellbeing.
Response: As stated in the proposed rule, the Department has determined that the final rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (Pub. L. 105-277, 112 Stat. 2681). This final rule defines certain key terms, ensures that recipients of Department funds know about their legal obligations under existing federal health care provider conscience protection provisions, and requires written certification by certain recipients that they will comply with such provisions, as applicable.
Comment: Some Comments asserted that the proposed regulation follows from general laws restricting religious discrimination, such as Title VII of the Civil Rights Act of 1964, or the religious exercise clause of the First Amendment to the United States Constitution. Commenters on this topic disagreed over whether this suggested connection made the regulation necessary to implement core constitutional principles, or unnecessary because these rights are protected in other ways. Commenters pointed out current grantees, for instance, already certify to obey all nondiscrimination laws, and that a specific certification on conscience protection, as contemplated in the proposed regulation, would not be necessary.
Response: The Department agrees with Comments noting that federal health care conscience protections are consistent with constitutional and other statutory protections of religious belief and moral conviction.
However, Congress has enacted specific and detailed legislation in the area of health care provider conscience applicable to recipients of certain federal funds which is broader in scope than protections afforded under Title VII and the other examples cited by some Commenters. Because they implement health care specific statutory provisions applicable to recipients of certain federal funds, these regulations offer more administrable and directive guidance than do other existing laws prohibiting religious discrimination.
Many organizations and individuals may not be aware of the scope of the conscience protections or their relationship to other federal nondiscrimination laws when certifying compliance with the latter. The Department believes that the responsibilities of certifying entities will be made clearer by a certification that explains federal health care conscience protection laws explicitly.
Comment: A few Comments suggested that the Department should gather more evidence of noncompliance before regulating in this area, for example, by commissioning a national survey to determine the prevalence of civil rights violations of provider conscience, and that, in the absence of statistical evidence that a significant number of violations are occurring, refrain from issuing implementing regulations.
Response: The Department disagrees that such a survey is a necessary precondition to issuing this regulation.
The basis for the regulation is the existence of the several federal healthcare conscience protection laws. There are a number of purposes served by regulating in this area, including, but not limited to, making the health care community more aware of these rights and clarifying their scope through the exercise of agency expertise, as well as assuring compliance.
The Department has good reason to believe that there are risks of non-compliance. By their nature, civil rights protections create responsibilities for entities such as recipients of federal funds or employers to do things they otherwise may not do. It has been the Department's experience that, in the absence of a clear statement of responsibilities, civil rights are less effectively exercised.
Commenters did not indicate what they believed would be an ''acceptable'' level of civil rights violations preventable by this regulation. The Department's goal is compliance with federal law. In Response to the proposed rule, numerous Comments were received, including from those in the health care community, that indicated serious misunderstandings regarding statutory health care provider conscience protections, or which expressed a narrower view of the scope of these protections than is consistent with the Department's interpretation.
Especially in light of the additional Comments alleging violations of conscience protection, this Commentary reinforces the Department's view that, in the absence of a clear statement of responsibilities, there is a serious risk that, either from misunderstanding or from a groundless and overly narrow view of health care provider conscience rights, these conscience rights will not be fully protected.
How often these violations occur is not known, and it is unclear whether a valid survey could be conducted to determine this figure. Some health care providers may not at this time be aware their rights are being violated when they are compelled to act against their conscience, or they may not attempt to report such violations. As a result of this regulation, a procedure will be put in place to receive and compile complaints, extend protection to those who make them, and the complaints will be reviewed for validity. Consequently, a more reliable estimate of the prevalence of actual violations is likely to be obtained, which will enable the Department to track the extent of noncompliance overtime.
Comment: Several Comments were concerned about the absence of implementation guidance in the proposed rule for communication of a provider's individual conscience objections to entities and to patients. Commenters presented a variety of suggestions for additional guidance in the rule concerning communication of a health care provider with his or her employer and patients.
Several Comments recommended a requirement that employees submit a written statement of their conscience objection or objections. Some Comments suggested a requirement for posting or providing notice of limitations to healthcare services provided at a facility or office. One Commenter pointed out that the State of Illinois requires pharmacies that do not carry emergency contraception to post a sign directing patients to other pharmacies that do.
Response: We strongly encourage early, open, and mutually respectful communication of conscience concerns that may arise in the provision of medical services, including between employees and employers as well as between providers and patients.
However, we concluded that it was neither feasible nor prudent in this final rule to provide specific guidance on methods and means for such communication given the vast array of circumstances and settings in which communications regarding conscience are likely to take place.
Comment: Comments stated that the proposed rule did not clarify what safeguards health care facilities were required to have in place when a medical professional refused to provide a particular service.
Response: In general, the Department acknowledges that not every institutional or individual health care provider offers every legal health service, and requiring them to do so would be neither appropriate nor prudent.
At the same time, we encourage and expect health care facilities to take measures to protect conscience rights while ensuring access to health care services. The myriad number of circumstances occurring across different health care settings where the need to protect conscience rights may arise leads us to decline to prescribe particular measures in this final rule.
Because federal health care conscience protection laws have been in place for many years, we fully expect health care entities to take the necessary steps to protect conscience rights while meeting the needs of their patients.
Comment: Another Commenter stated that the proposed rule does not address whether refusal to perform a service must be a consistent, across-the-board refusal, or whether it can be a ''graded refusal.'' For example, the proposed rule does not clarify if an employee can refuse to schedule sterilizations for young or single women but not for married women.
Response: We reiterate here that, for abortion-related activities as covered by the Weldon Amendment and Public Health Service Act Â§ 245, a health care entity's refusal can be on any ground.
(42 U.S.C. 300a-7(d), which applies to any program funded in whole or in part under a program administered by the Department, requires that no individual may be required to perform or assist in the performance of any part of a health service program or research activity contrary to that individual's religious beliefs or moral convictions. For involvement in abortion and sterilization as covered by the rest of 42U.S.C. 300a-7, again, provisions require that no health care personnel be discriminated against for, among other reasons, his/her refusal to perform or assist in the performance of a sterilization procedure (or abortion) contrary to that professional's religious beliefs or moral convictions.
Thus, in the case of these statutes, it is the individual's religious beliefs or moral convictions that will control in a particular case, rather than the frequency of the objection. In addition, as we have previously noted, if the decision is being made based on an individual's characteristics that are federally protected, that is impermissible.
Comment: Comments argued that if a provider is unwilling to provide a certain service, it should give the patient a referral for that service. One Commenter asserted that providers should give patients a ''meaningful referral that will ensure that the patients receive continuity of care without facing an undue burden, such as traveling long distances or encountering additional barriers to obtaining the desired services.''
Response: Providers who object to participation in abortion or a particular health service may provide information on other options, if asked, but are under no obligation to do so.
First, with respect to abortion, both PHS Act Â§ 245and the Weldon Amendment (among other things) specifically prohibit discrimination by the federal government and State and local governments, and federal agencies and programs, and State and local governments, respectively, against health care entities who refuse to refer for abortion. The Department could not enforce such a referral requirement without violating these provisions.
With respect to entities imposing requirements on their employees or members of their workforces, the Church Amendments, while not identifying specific medical practices or services, uses very broad language to characterize the wide array of practices and services to be protected. For example, 42 U.S.C. 300a-7(d) states that individuals may not be required to perform or assist in the performance of' 'any part of'' an objectionable health service program or research activity.
For many health care providers, including many who Commented on the proposed rule, referral means assisting in the performance of objectionable procedures or services such as abortion and would violate their consciences. One health care practitioner Commenting on the proposed rule stated that referrals are a form of participation in objectionable acts, and forcing providers to provide referrals would effectively circumvent their moral objection.
Federal law recognizes and protects the conscience rights of individuals and entities when it comes to referral for certain objectionable services. Taking the Church Amendments, the Weldon Amendment, and Public Health Service Act Â§ 245 together, the regulation interprets these three federal laws in a way that is consistent with both the letter and the spirit of the law.
Comment: Some Comments argued that the proposed regulation seems to run counter to the Hippocratic Oath's admonition to ''do no harm'' to patients. Comments pointed out that health care providers must take this oath and agree to treat patients without judgment and provide patients with the care they need.
Response: According to the National Institutes of Health's National Library of Medicine (NLM), the Hippocratic Oath is an ancient medical text requiring new physicians to swear oaths by a number of deities to uphold several professional ethical imperatives, the most widely known of which is ''to do no harm.'' Notably, the NLM translation of the Hippocratic Oath also includes the prohibitions, ''I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan, and similarly I will not give a woman a pessary to cause an abortion.'' The NLM further states that most medical schools do not require graduates to take the Hippocratic Oath. For those physicians who take the Hippocratic Oath or other similar oaths, federal law protects health care providers whose consciences lead them to recognize that participation in certain activities, such as abortion, harms others. Conscience is consistent with and is a necessary part of quality care.
Comment: Commenters expressed concern about impacts on health care delivery, burdens and costs (particularly on small employers), and overlap with existing protections afforded to protect religious conscience of health care workers under Title VII of the Civil Rights Act of 1964, and suggested that the Department adopt elements of Title VII jurisprudence in enforcing these laws. Commenters also stated that health care providers must be able to address staffing issues and otherwise appropriately screen job applicants to determine if they are capable and willing to perform the core services required of the job.
Response: We do not believe that it is necessary or appropriate to incorporate elements of Title VII jurisprudence into this provider conscience regulation. Title VII was enacted nine years before the first of the health care conscience protection laws was passed; it includes specific language with respect to reasonable accommodation and undue hardship with respect to religion.
In contrast, the Church Amendment, the first of the health care conscience protection laws, is specific as to its prohibitions, and contains none of the reasonable accommodation or undue hardship language Congress elected to include in Title VII. This is also true of the additional health care conscience protection laws that Congress subsequently enacted.
Notwithstanding the existence of Title VII, Congress passed a series of laws to explicitly protect provider conscience without using Title VII's formulation. Moreover, where Title VII is restricted to the employment context, the provider conscience provisions are not so limited. As a result, we believe it is a reasonable interpretation of the statutes that Congress sought to ensure provider conscience protections that are distinct from, and extend beyond, those under Title VII.
The Department's enforcement of the provider conscience laws will be informed, for example, by comparison to Title VII religious discrimination jurisprudence. Congress enacted Title VII of the Civil Rights Act of 1964 to protect employees from discrimination by their employers with respect to certain individual characteristics, including religion. It applies to all employers of a certain size, regardless of whether the employer receives federal funding. In the context of the Title VII prohibition on employment discrimination on the basis of religion, Congress in 1972 limited the protection afforded to employees by defining ''religion'' as ''all aspects of religious observance and practice, as well as belief, unless an employer demonstrates that he is unable to reasonably accommodate an employee's or prospective employee's religious observance or practice without undue hardship on the conduct of the employer's business.'' Under the Title VII standard, an employer is, thus, only required to attempt to reasonably accommodate its current or prospective employee's religious objections if it would not place an undue burden on the employer.
In contrast, the healthcare conscience protection provisions apply only to recipients of federal funding, and primarily to recipients of funding from the Department, regardless of size. Congress was capable of incorporating an express balancing of interests in health care conscience protection provisions, but it chose not to, in spite of its general familiarity with the balancing test in the Civil Rights Act religious nondiscrimination provision. We believe that it is reasonable to interpret this action by Congress to impose higher standards for provider conscience on employers in the healthcare and medical research that receives Departmental funding than is imposed on employers in general.
Thus, we believe it is a reasonable interpretation that Congress in this context imposed a choice not between reasonable accommodations and undue burden, but between accommodation of religious belief or moral convictions and federal funding. Where an employer will not accommodate an employee's sincere religious belief or moral conviction, it may cease being eligible for federal funds and lose certain federal funding.
While it is a reasonable interpretation of the statutes that Congress did not intended to limit provider conscience protections to those provided to employees under the Title VII legal framework for religious accommodation requests, we also interpret nothing in the provider conscience statutes as preventing employers from accommodating employees' sincerely held religious beliefs, observances, and practices when requested as a means of accomplishing the same protections for provider conscience. As long as employees in the health care field are free from being discriminated against or required to participate in abortions or services they find religiously or morally objectionable, employers are free to balance employee rights with other interests in conducting their business operations.
We envision that, through open communication between employees and employers about each other's respective needs and requirements, and by employers providing accommodations of employees' religious beliefs and moral convictions, full compliance with the health care conscience protection laws and organizational objectives can best be achieved.
Similarly, we do not foresee that the health care conscience protection laws and this regulation would necessarily constrain employers in the health care field to hire individuals or accept volunteers who, due to their religious beliefs or moral convictions, refuse to perform job duties that comprise the significant majority or the entirety of duties required by the position. There are a number of reasons why these and other staffing concerns might not be constrained by protections afforded to health care workers on the basis of conscience.
First, employers have no obligation under the health care conscience protection laws to employ persons who are unqualified to perform the functions required of the jobs that they seek to fill. A job applicant must be qualified or, typically among a pool of qualified applicants, the best qualified, to perform the core services of a job for which he/she is applying. It is difficult to conceive of a circumstance in which an applicant who is fundamentally opposed on religious or moral grounds to a particular medical procedure, health service program, or research activity, would be among the best qualified to perform that procedure, service, or activity.
Additionally, a job applicant with a sincerely held religious belief or moral conviction against a lawful health service or activity would be unlikely to apply for a job in which that precise health service or activity constitutes a significant majority or the entirety of the job. That said, employers are to be expected to make rational hiring decisions based on due consideration of an applicant's knowledge, skills, ability, and desire to perform the essential functions of a job. To the extent a health care employer's adverse decision is based on an applicant's inability to perform the essential functions of a job, the decision would not typically constitute discrimination under the regulation even if the applicant had expressed an unwillingness to perform those functions on conscience grounds.
However, an adverse decision predicated on an applicant's alleged ''inability'' could constitute unlawful discrimination if the employer's stated reasons are pretextual; for example, if the employer is using the definition of essential functions as a pretext for excluding applicants with certain religious beliefs or moral convictions. In applying this standard, the Department will remain vigilant against discrimination and the potential for employers to use an applicant's qualifications as a pretext for unlawful discrimination.
Comment: Comments requested clarification regarding the application of the written certification requirement in the proposed rule to programs receiving federal funding under the President's Emergency Plan for AIDS Relief (PEPFAR).
Response: PEPFAR funding is distributed to several federal agencies, including the federal Centers for Disease Control and Prevention (CDC) within the Department. If the activities of CDC under PEPFAR are funded from the annual Labor, Health and Human Services appropriations act, the Weldon Amendment would apply, as would certain provisions of the Church Amendments.
To the extent that CDC's PEPFAR programs are funded solely from the Department of State appropriations, the Weldon Amendment would not apply because the funds for PEPFAR would come from the Department of State's appropriations act. The Weldon Amendment applies to funds appropriated under the Labor/HHSappropriations act to which the Weldon Amendment is a rider. PHS Act Â§ 245,42 U.S.C. 238n, would not apply because section 245 applies to the federal government and to State and local governments receiving federal financial assistance. The Church Amendments at 42 U.S.C. 300a-7(b),(c)(1) and (e) apply to activities funded and carried out under the PHS Act, the Community Mental Health Centers Act, and/or the Developmental Disabilities Assistance and Bill of Rights Act of2000, and, thus, would not be applicable.
There are two provisions of the Church Amendments that apply more broadly. The Church Amendments at 42U.S.C. 300a-7(c)(2) applies to grants or contracts for biomedical or behavioral research under any program administered by the Secretary of Health and Human Services. CDC's PEPFAR programs do not customarily involve such research. The Church Amendments at 42 U.S.C.300a-7(d) 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 part under a program administered by the Secretary of Health and Human Services if his performance or assistance in the performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions.'' 42 U.S.C. 300a-7(d)(emphasis added).
PEPFAR is a program administered, in part, by HHS. PEPFAR funds are appropriated under the State Department's authorities and then transferred to HHS and fund grant programs that are developed, administered and implemented by HHS/CDC which provide health services, including HIV prevention, treatment, and care. Accordingly, CDC's PEPFAR programs would be subject to the requirements/prohibitions in 42 U.S.C.300a-7(d), and foreign or international organizations (such as agencies of the United Nations) which are recipients or sub-recipients under CDC's PEPFAR programs may be recipients or subrecipients for the purposes of this rule at CDC's discretion. We note that these requirements are consistent with a conscience protection clause already existing in the PEPFAR authorizing statute.
Comment: One Commenter requested clarification on the Office for Civil Rights' (OCR) experience and knowledge of employment discrimination and how OCR would handle a potential increase in workload associated with its role in the proposed rule as the office designated to receive complaints of discrimination.
Response: With a Headquarters office in Washington, DC, ten regional and two field offices located throughout the United States, OCR promotes and ensures that individuals have equal access to, and opportunity to participate in, and receive services from, all relevant Department-funded programs without facing unlawful discrimination, and that the privacy of their health information is protected.
OCR is the sole agency within the Department charged with responsibility for enforcing these important federal protections. Through the enforcement work of its Headquarters policy staff and regional investigators, OCR annually resolves more than 12,000 citizen complaints alleging discrimination or a violation of the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA). OCR provides training and technical assistance annually to individuals and health care entities nationwide that receive certain funds from the Department through its public education and compliance activities to promote and ensure compliance with applicable federal laws requiring nondiscriminatory access to Department programs and services and protection of the privacy of individually identifiable health information under the HIPAA Privacy Rule. OCR is therefore well positioned within the Department to fulfill its designated role as the point of contact to receive, and coordinate with the Department-funding components the handling of, complaints from individual and institutional health care providers and entities seeking protection from discrimination in connection with particular practices, or from compulsion to perform health care activities, that they find religiously or morally objectionable.
The Department-funding components will bear the actual responsibility for enforcement of the health care conscience protection laws through their usual and ordinary program mechanisms, which include termination of funding and return of funds paid out in violation of the healthcare provider conscience protection provisions under 45 CFR parts 74, 92,and 96.OCR also has considerable experience working collaboratively with the Department-funding components to identify barriers and implement practices that can avoid potential discrimination in services, and also in supporting funding components' enforcement responsibilities.
For example, OCR conducts fully coordinated investigations with the Administration for Children and Families (ACF) in its enforcement of the Multiethnic Placement Act (MEPA) of1994, as amended by section 1808 of the Small Business Job Protection Act of1996, which provides that state agencies may not delay or deny the placement of a child for adoption or into foster care on the basis of the race, color, or national origin of the adoptive or foster parent, or the child involved.
OCR and ACF act collaboratively concerning the conduct of MEPA investigations and in resolution of MEPA complaints. Pursuant to a memorandum of understanding between OCR and ACF, OCR takes the lead in investigating violations; when OCR finds a violation of MEPA, ACF determines whether to require a monetary payment by the state as part of the resolution agreement and whether to require that the payment be an integral part of the resolution. In these ways, OCR routinely works with the staff of Departmental programs and brings its expertise to bear to ensure compliance with federal nondiscrimination requirements. With respect to OCR's experience and knowledge in the area of employment discrimination complaints, OCR has served as the designated entity within the Department to receive a variety of discrimination complaints for over 40 years, including employment discrimination complaints. OCR's authority covers discrimination base don race, color, national origin, age, disability, sex, and religion. OCR's designated responsibilities under the provider conscience regulation to receive and coordinate the handling of discrimination complaints under the statutes and this implementing regulation, with the Departmental programs funding the entities at issue in any complaint, therefore, fall clearly within OCR's area of expertise and responsibility within the Department.
Comment: One Commenter noted that designating OCR as the office to receive complaints appears to overlap with EEOC jurisdiction, and could confuse employees as to when and where to file complaints.
Response: OCR, EEOC, and other federal agencies have developed procedures over the years to ensure appropriate handling of federal nondiscrimination complaints where there is overlapping jurisdiction. The agencies responsible for federal nondiscrimination laws, including OCR and EEOC, coordinate to ensure these procedures are working and also confer on a case-by-case basis when needed to work out instances where there may be shared jurisdiction.
As part of this coordination, federal agencies, including OCR, use a variety of methods, including consumer brochures, fact sheets, grassroots meetings, and the Internet, to get information to the public about their federal civil rights and when, where, and how to file discrimination complaints depending upon the facts of the complaint. The Department will continue to use appropriate means to educate the public about their rights and how to file a complaint under the provider conscience regulation.
The Department agrees that it will be important to ensure that the regulated entities and their employees are aware that the EEOC retains its primary jurisdiction in the area of enforcing protections under Title VII prohibiting employment discrimination based on religion. The Department will explore all avenues available, in coordination with the EEOC, for increasing public awareness of both health care conscience protection laws and Title VII's protections against employment discrimination based on religion. Where there are overlapping interests between the EEOC and the Department with respect to enforcement of protections against religious discrimination in employment, the EEOC and OCR roles and responsibilities are set forth in a federal regulation which has been in effect for 25 years, 29 CFR part 1691, 48FR 3574 (January 25, 1983) (as amended) (Procedures for Complaints of Employment Discrimination filed against Recipients of Federal Financial Assistance). This regulation provides for coordination between EEOC and OCR for review, investigation, and resolution of certain overlapping employment discrimination complaints, including those based on religion.
Comment: Several Comments questioned the authority of the Secretary to issue this regulation. They pointed out that several of the statutory provisions such as the Church amendments lacked an explicit delegation of rulemaking authority to the Department. Several of these Commentators also stated the' 'housekeeping statute,'' 5 U.S.C. 301,does not authorize the Department to promulgate standards for entities outside the agency, and that this rule is, therefore, ultra vires.
Response: The Supreme Court has recognized the best, but not only, means by which an agency may promulgate binding legislative rules is through the issuance of regulations through notice and Comment rulemaking pursuant to delegated rulemaking authority. United States v. Mead, 533 U.S. 218 (2000). The Court has also found Chevron deference applicable where an agency has considerable expertise over a complex area and has given the issue careful consideration. Barnhart v. Walton, 535U.S. 212 (2002); Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). Lower courts have also recognized binding deference to the Department in determining whether recipients of federal funds are complying with myriad federal requirements. Pharmaceutical Manfs. v.Thompson, 362 F.3d 817 (DC Cir. 2004).All these deference factors are applicable here, and in addition to the notice and Comment the Secretary has conducted here.
Regardless of the Department's authority to promulgate legislative rules in this instance, it is well settled in case law that every agency has the inherent authority to issue interpretive rules and rules of agency practice and procedure. Pierce, Administrative Law at 306 (4thed. 2002). The compliance requirements set forth in this rule do not substantively alter or amend the obligations of the respective statutes. JEM Broadcasting v. FCC, 22 F3d 320 (DC Cir. 1994).
While specific certification of compliance for the health care conscience protection laws is new, recipients of federal funding have long certified compliance with other applicable federal laws, including civil rights laws. While this needed change in procedures may prompt a minor increase in the costs of compliance for some entities, that does not alter the procedural nature of the rule. Hurson v. Glickman, 229 F3d 277(DC Cir. 2000).Furthermore, provisions of the rule which do no more than define terms are reasonably drawn from the existing statutes. Hoctor v. Dept. of Agriculture,82 F3d 165 (7th Cir. 1996). Particularly as Congress intended the conscience protections to apply broadly across institutions and individuals, the Department has ample authority to issue these interpretive provisions.
Comment: Several Comments raised the question of how this regulation may conflict with rules governing other Department programs. Some expressed concerns that the rule was inconsistent with program requirements of the Medicaid, Community Health Center, and Title X Family Planning programs, as well as the treatment requirements under the Emergency Medical Training and Active Labor Act (EMTALA).
Specifically, Comments assert that this regulation is inconsistent with the requirement that institutions provide care in an emergency, a requirement that includes no exception for religious or moral objections to the needed service, and that the regulatory requirements for family planning clinics under Title X of the Public Health Service Act require Title X projects to offer pregnant women non-directive counseling, and referrals upon request for prenatal care and delivery, infant care, foster care or adoption, and abortion.
Response: The Department does not operate its programs in conflict with the existing federal protections being further implemented by this rule. The Department believes that many Commenters are confused as to the programmatic requirements of various Departmental programs, and suggests that concerned parties seek clarification from individual program offices as appropriate.
Similarly, the Department believes that Commenters mistakenly confuse certain legal requirements on institutions or health care entities as requirements on individual providers.
With respect to emergency treatment, the obligations of EMTALA are imposed on hospital under 1867 of the Social Security Act only if they elect to operate an emergency room and are also limited to the capabilities of the particular hospital. The requirement under EMTALA that such hospitals treat and stabilize patients who present in an emergency is not in conflict with the Church Amendments' requirement that certain recipients of Department funds not force any individual to participate in a health service program that they object to based on a religious belief or moral conviction. While this and other hypothetical situations were raised in the Comments, the Department is not aware of any instance where a facility required to provide emergency care under EMTALA was unable to do so because its entire staff objected to the service on religious or moral grounds.
With regards to the Title X program, Commenters are correct that the current regulatory requirement that grantees must provide counseling and referrals for abortion upon request (42 CFR59.5(a)(5)) is inconsistent with the health care provider conscience protection statutory provisions and this regulation. The Office of Population Affairs, which administers the Title X program, is aware of this conflict with the statutory requirements and, as such, would not enforce this Title X regulatory requirement on objecting grantees or applicants.
Comment: Multiple Comments questioned the balance between provisions in the Department's proposed rule and requested clarification on EMTALA requirements and how they will be upheld if the Department's proposed rule is promulgated.
Response: The Department notes that this Comment would only be relevant where a hospital, as opposed to an individual, has an objection to performing abortions that are necessary to stabilize the mother, as that term has been interpreted in the context of EMTALA. The Department is unaware of any hospital that has such a policy. Furthermore, the laws this regulations upports have existed alongside EMTALA for many years. Thus, we do not anticipate any actual conflict between EMTALA and this regulation.
Comment: Some Comments expressed concern that this rule could interfere with existing state laws that regulate contraceptive coverage mandates in insurance policies, access to emergency contraception, and access to birth control at pharmacies. Commenters were also concerned that this regulation would impact a State's ability to enforce these laws and upset the balance that state and local laws already strike between the religious freedom of healthcare providers and a patient's need to access health care services.
Response: As mentioned above, this rule was issued to help define the rights and responsibilities created by the existing federal health care provider conscience protection provisions, clarify the scope of the existing protections, require certain recipients of Department funds to certify compliance with these requirements, and define certain terms for the purposes of this rule.
This rule does not change federal policy regarding the conscience rights of health care providers, or create new rights, but simply seeks to ensure that recipients of Department funds are aware of the existing conditions that apply to the receipt of these funds. As such, States should already be aware of these existing protections, and should ensure that they do not take actions that would violate these established federal protections.
By accepting federal funds, States accept the conditions that the Congress has imposed on the receipt of those funds. In this case, Congress has seen fit to include broad conscience protections for health care entities that apply to a wide array of Department activities. As this rule implements existing law, if States wish to adopt or enforce policies that seek to ensure that patients have proper access to healthcare services, they would be expected to do so, but they should avoid policies that interfere with federally protected rights, or risk the loss of federal funds.
While the Department is aware that some States may have laws that, if enforced, depending on the factual circumstances, might violate these federally protected rights, the Department is not aware of any particular instance where a State has done so in an inappropriate fashion. The Department's objective is to protect the conscience rights established in federal law, not to penalize States that adopt laws that, if enforced against an objecting individual or entity, could violate federal law. The Department is committed to working cooperatively with States to help ensure that they do not violate the federal protections.
Comment: Several Comments claimed that the proposed rule is covered under existing federal laws, which makes the new proposed rule unnecessary.
Response: The Department agrees that the provider conscience regulation's purpose is to implement existing federal laws by providing definitions to clarify the scope of those laws and to adopt certification mechanisms that will be used to increase awareness of, and compliance with, those laws. For reasons stated above, the Department disagrees that the rule is unnecessary.
Comment: Several Comments noted that the rule supports the First Amendment right of freedom of religion.
Response: The Department agrees. It is clear that Congress intended these statutes-the Church Amendment in particular-to further protect, in part, the First Amendment right to free exercise of one's religion in the context of healthcare provided by recipients of Departmental funds.
Comment: Commenters claimed that the rule, if promulgated, would violate the ''constitutionally protected right to choose.''
Response: We disagree. The Supreme Court has read the Constitution to include rights to privacy and bodily integrity broad enough to protect a woman's choice to procure an abortion. The case law enshrining this interpretation of the Constitution does not create or identify a corresponding duty on the part of any provider to be involved in the procedure in any way.
In contrast, many protections, including principles established in court cases4 and ethical principles found in State and federal laws,5 are in place to ensure that no such duty is imposed on providers. The regulations implementing the Church Amendments, PHS Act Â§ 245, and the Weldon Amendment merely interpret these federal health care conscience protection provisions and encourage compliance.
Comment: Comments stated that Congress upheld the access-to-care rights of pregnant women in the Education Appropriations Act beginning in 1997. The Comments declared that the proposed rule would contradict 42 CFR 59.5(a)(5), which states women are to receive ''neutral,factual information and nondirective counseling, and referral upon request,'' regarding prenatal care and delivery, as well as adoption and termination options.
Response: The Department is unsure which provision in the Education Appropriations Act the Commenter was referencing, and cannot respond except to say that we are unaware of any federal law that imposes a positive duty on doctors to provide services to which the provider objects.
This rule is consistent with 42 CFR59.5 with respect to an individual provider's right to refuse to counsel or refer for abortion, as explained in the preamble to the final rule that promulgated that requirement: The corollary suggestion, that the requirement to provide options counseling should not apply to employees of a grantee who object to providing such counseling on moral or religious grounds, is likewise rejected.
In addition to the foregoing considerations, such a requirement is not necessary: Under 42 U.S.C. 300a-7(d),grantees may not require individual employees who have such objections to provide such counseling. However, in such cases the grantees must make other arrangements to ensure that the service is available to Title X clients who desire it. 65FR 41270, 41274 (2000).
As is always the case, requirements and prohibitions contained in a regulation cannot be enforced in derogation of conflicting statutes. Thus, under section 245 of the Public Health Service Act and the Weldon Amendment, the Department cannot and does not enforce 42 CFR 59.5(a)(5) against an otherwise eligible grantee or applicant who objects to the requirement to counsel on or refer for, abortion. See Nat'l Family Planning & Reprod. Health Ass'n v. Gonzales, 468F.3d 826, 828 (DC Cir. 2006) (''* * * the government notes, and plaintiff doesn't contest, that in the event of conflict the regulation must yield to a valid statute.'').
Comment: A number of Comments stated that the proposed rule is unnecessary in part because of the National Research Act, which created protection within biomedical and behavioral research organizations and formed a commission to ensure these rights are protected.
Response: The Department disagrees. The Department has identified several instances that suggest that providers, employers, and employees are unaware of the protections found in federal law. Hundreds of Comments have confirmed this lack of awareness. This rule is an important step in ensuring knowledge of, and compliance with, the provider conscience provisions found in these statutes.
Comment: One Commenter argued that the regulation was needed and there are no court rulings, including Roe v. Wade and Planned Parenthood v. Casey, 505 U.S. 833 (1992), that compel an individual or institutional health care provider to participate in the provision of abortions, so the regulation does not contradict the cases.
Response: The Department agrees. Although these cases interpret the Constitution to include a right to abortion, they do not create an affirmative duty on the part of any provider to perform or participate in the provision of such an abortion.
Comment: A Commenter cited the Supreme Court case of Griswold v. Connecticut, 381 U.S. 479 (1965), that addressed the privacy of a married couple to engage in the use of birth control versus the State's law which declared contraception illegal.
Response: The Department notes that the Supreme Court in Griswold affirmed a married couple's right to use contraception as against a State law that prohibited such access. It did not impose upon any provider an affirmative duty to prescribe or dispense contraception.
Comment: One Commenter stated thatShelton v. University of Medicine and Dentistry of New Jersey, 223 F.3d 220(3d Cir. 2000), clearly shows that in times of emergency professional ethical obligations to care for the sick and injured outweigh their conscience.
The sole issue in that case was ''whether a state hospital reasonably accommodated the religious beliefs and practices of a staff nurse who refused to participate in what she believed to be abortions.'' Shelton v. University of Med. & Dentistry, 223 F.3d220, 222 (3d Cir. 2000).
Her employer offered her a lateral transfer, which she refused. The court held that this offer of a lateral transfer was a reasonable accommodation under the Civil Rights Act of 1964. The court said nothing of ethical obligations to care for the sick and injured outweighing conscience.
Comment: One Commenter argued that the rule does not make clear that the providers' religious objection has to be to the activity or procedure, not to the patient and stated that in a recent decision (North Coast Women's Care Medical Group v. BenÄ±Â´tez, 44 Cal. 4th1145 (2008)), the California Supreme Court ruled that doctors are barred from refusing medical care to homosexuals based on the doctors' religious beliefs about homosexuals.
Response: In BenÄ±Â´tez, the California Supreme Court was interpreting State, not federal, law. The Court's analysis is inapplicable to this situation. Further, the Department believes the statutes and this rule are sufficiently clear as to applicability.
Comment: One Commenter suggested that the proposed rule violates a White House directive that executive departments and agencies submit all proposed rules by June 1, 2008, except in ''extraordinary circumstances.'' The Commenter stated the Department should explain those extraordinary circumstances or withdraw its proposal.
Response: The memorandum issued by the Chief of Staff to the President was solely for purposes of management and coordination of the Executive Branch, conferred no rights on anyone outside the Executive Branch, did not create any legal requirements, and by its own terms authorized the exercise of discretion and exceptions to timing guidelines where appropriate. The Department has solicited and carefully evaluated public Comment as required by the Administrative Procedure Act. Nothing in applicable law precluded issuance of the proposed rule, just as nothing in applicable law precludes the issuance of this final rule.
The purpose of extending the Comment period would be to provide additional opportunity to Comment on the proposed rule. We note that, as demonstrated by the volume of Comments received by the Department, Commenters had ample opportunity to submit Comments and did so. The Department received Comments discussing a wide range of issues, including potential impact of the proposed rule, from stakeholders including hospitals, health care providers, professional associations, trade groups, advocacy organizations, private citizens, and others.
The Department has had sufficient opportunity to weigh the issues posed by public Comments, including the impact of the proposed rule and its interaction with State and federal laws, and has taken such Comments into account in issuing this final rule.
Comment: One Commenter stated that the interests protected in the regulation are only specific concerns of providers in particular situations or locations, and the only thing needed to remedy the conflict is to change the situation or location to accommodate the employee.
Response: The Department agrees that employers should strive for accommodation of religious beliefs, moral convictions, or convictions against involvement in abortions or sterilizations. However, the Department believes that regulations are necessary to ensure that employers opt to accommodate their employees' objections rather than to engage intimidation or discrimination.
Comment: One Comment asserted that HHS's concern about the development of an environment in which individuals from diverse backgrounds are discouraged from entering health care professions contrasts with the accreditation requirements of The Liaison Committee on Medical Education (LCME) and The Accreditation Council for Graduate Medical Education (ACGME).
That is, these organizations have standards that are ''designed to ensure that the education of physicians provides an environment that embraces a diversity of views and values for both health care providers and patients.''
Response: The Department disagrees. Although the requirements are certainly useful as future physicians are educated, the Department thinks it would be uncontroversial to suggest that over time, as physicians and other professionals are trained and begin practicing medicine, their attitudes and demeanor may change. Thus, these regulations are needed to protect against coercion and discrimination across the span of a professional's education and career.
Comment: One Commenter claimed that the regulation would require the American Medical Association to rewrite its code of ethics.
Response: As noted before, this regulation simply enforces federal law. The American Medical Association code of ethics-which, in any event, does not appear to conflict with federal law-is not binding law, so it may not matter if there is a conflict. Insofar as problems may arise as a result of conflict between any code of ethics and federal law, the proper solution is to rewrite the relevant code of ethics.
Comment: One Commenter recommended that the Department set up a process by which providers ensure patients receive care from another provider when they have objections to the requested procedure.
Response: While the Department suspects that such referrals may be how many providers will handle these types of situations, it declines to impose such a requirement in the rule, since such a requirement would constitute ''making arrangements for'', ''referring for'', or ''assisting in the performance'' of an abortion or other objectionable procedure in violation of the health care provider conscience protection statutes.