News

By  Lynda M. Johnson, Timothy C. Ezell and Amie K. Alexander
Published in Arkansas Medical News (May/June)

The U.S. Department of Health and Human Services (HHS) recently announced its Final Conscience Regulation which broadens protections for individuals and healthcare entities that refuse to perform, assist in the performance of, or undergo certain healthcare services or research activities to which they may object for religious, moral, ethical or other reasons.

This final rule, which was issued on May 2, 2019, clarifies conscience rights that broadly protect individuals, healthcare entities, and providers from discrimination in healthcare by government-related entities “because of the exercise of religious belief or moral convictions.” A similar expansive rule was announced in 2008, but was replaced by a more limited interpretation of existing Federal laws in 2011. This new Rule effectively replaces the 2011 regulations with broader protections for conscience objections. 

Its purpose is to protect the conscience and associated anti-discrimination rights of individuals, and healthcare entities, as well as protect patients from being subjected to certain healthcare or services over their conscientious objection. Examples of the types of objections contemplated by the final rule are procedures such as abortion or sterilization services, and situations related to assisted suicide or euthanasia.

What does the final rule do?

The final rule implements existing Federal laws and regulations to strengthen the enforcement of Federal conscience and anti-discrimination laws related to the HHS, its programs and recipients of Department funds. Perhaps most notably, the final rule delegates authority to the Office for Civil Rights (OCR) to engage in compliance reviews, conduct investigations, supervise and coordinate compliance by the department, and use enforcement tools otherwise available to address violations and resolve complaints. OCR will now have enforcement authority to protect conscience protections created under the following Federal statutes and existing regulations:

• The Church Amendments, which protect entities and individuals who hold religious beliefs or moral convictions related to abortion or sterilization services from discrimination by entities that receive certain Federal funds, and in health service programs and research activities funded by HHS.
• The Coats-Snowe Amendment, which provides conscience protections for health care entities related to providing abortions, or training, referrals for abortions or training, or accreditation standards related to abortion.
• The Weldon Amendment, which protects health care entities from discrimination that do not provide, pay for, provide coverage of, or refer for abortions under programs funded by the Department’s appropriations acts.
• Affordable Care Act conscience protections regarding abortion coverage, assisted suicide, and provisions prohibiting the discriminatory denial of a religious exemption from the individual mandate.
• Certain conscience protections under Medicare Advantage and Medicaid, such that the status of patients as beneficiaries with certain self-determinable rights does affect provider’s conscience rights regarding assisted suicide, euthanasia, or mercy killing.
• Conscience protections concerning advance directives with respect to certain HHS funded programs.
• Conscience protections for Global Health programs administered by HHS or funded by HHS appropriations.
• Conscience exemptions for patients from certain specified health care services, such as compulsory medical screening, examination, diagnosis or treatment.
• Conscience protections for religious nonmedical health are institutions and patients who seek religious nonmedical care.

What steps should providers take to ensure compliance?

Providers should seek counsel in taking steps to come into compliance with the final rule. To begin, providers should talk with counsel about taking the following steps:

1. Implement a non-discrimination policy.
2. Implement policies and procedures for providing accommodations for individuals who request an accommodation.
3. Maintain records evidencing compliance, including any complaints, statements, policies, notices, procedures for accommodating protected individuals’ religious beliefs or moral convictions, and records of requests for such accommodations and the response to such requests.
4. Provide certifications and assurances of compliance requirements which are now required as a condition of receiving federal funding.
5. Develop and post compliant notices which inform employees, contractors, and others of their rights under Federal conscience and anti-discrimination laws.
6. Be prepared to respond appropriately to any inquiries from the OCR, which is delegated broad enforcement authority by the final rule.

The new regulations go into effect on July 1, 2019.

Written by the attorneys in the Health Law Practice Group at Friday, Eldredge & Clark, LLP, this information is not a substitute for legal advice and should be considered for general guidance only. For more information or if you have further questions, please contact one of our Health Law Attorneys.

Lynda M. Johnson has practiced in the health law area since 1986, representing a wide variety of healthcare providers including hospitals, physicians, physician groups, nursing homes, and home health agencies. Recently, her practice has focused on the representation of hospitals and physicians in HIPAA compliance efforts and other areas of regulatory compliance. Her practice also includes issues involving Stark I and II and Anti-Kickback compliance, Medicare/Medicaid reimbursement, corporate compliance issues, physician and hospital organization issues, managed care, healthcare and hospital law, long-term care and home health.

Timothy Ezell practices primarily in the area of healthcare law, representing hospitals, physician groups and other medical service providers in various corporate and compliance matters. His experience covers matters relating to HIPAA, Stark, fraud and abuse, anti-kickback, EMTALA, Medicare reimbursement, compliance, joint ventures, provider sales and acquisitions, medical staff bylaws and credentialing issues.

Amie K. Alexander joined the firm after earning her law degree from the University of Arkansas at Little Rock William H. Bowen School of Law. Her practice is focused in the area of healthcare where she works primarily on various corporate and compliance matters. She drafts and reviews policies to ensure compliance with federal healthcare regulations such as HIPAA, Stark I and Stark II, Anti-Kickback and Medicare/Medicaid reimbursement.