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Court Issues Nationwide Injunction Prohibiting Enforcement of Section 1557 Provisions Relating to Gender Identity and Termination of Pregnancy – But Other Provisions Still Can Be Enforced

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and eight states in which the plaintiffs allege, among other allegations, that the Section 1557 regulations force them to provide gender transition services and abortion services against their religious beliefs and medical judgment in violation of the Religious Freedom Restoration Act (“RFRA”).

By way of background, the Section 1557 regulations prohibit discrimination on the basis of gender identify, which regulations define to mean “an internal sense of gender, which may be male, female, neither, or a combination of male and female, and which may be different from an individual’s sex assigned at birth.”[i] The regulations prohibit a categorical insurance coverage exclusion or limitation for all health services related to gender transition and requires providers to provide transition-related procedures if the provider performs an analogous service in a different context. The plaintiffs also alleged that because they perform certain procedures for miscarriages, the Section 1557 regulations will require them to perform such procedures for abortions to avoid discriminating on the basis of termination of pregnancy.

The court held that the Section 1557 regulations failed to incorporate the exceptions for religious institutions and abortions services that Congress provided in Title IX. The court also found that Title IX, which is incorporated by Section 1557 statute, only prohibits discrimination on the basis of biological sex. The court further noted that “the government’s own health insurance programs, Medicare and Medicaid, do not mandate coverage for transition surgeries; the military’s health insurance program, TRICARE, specifically excludes coverage for transition surgeries. . .”[ii]

Specifically, the court concluded that “the regulation violates the Administrative Procedure Act (“APA”) by contradicting existing law and exceeding statutory authority, and the regulation likely violates the [RFRA] as applied to Private Plaintiffs.” The court also agreed that the plaintiffs would likely suffer irreparable harm without the injunction as “one of the State Plaintiffs is already undergoing investigation by the HHS’s OCR, and entities similarly situated to Private Plaintiffs have already been sued under the Rule since it took partial effect on May 18, 2016″ (emphasis added). Conversely, the court found that HHS will not suffer any harm by delaying implementation of this portion of the Section 1557 regulations. It should be noted that this is a ruling granting a preliminary injunction and a final ruling on the merits of a permanent injunction is still to come.

While an HHS appeal of this order would normally be expected, the impending change of Administration—including new leadership at HHS and an expected early Congressional push to repeal and replace the Affordable Care Act—makes it very uncertain whether an appeal will be filed, or ruled upon, prior to any possible changes in the regulatory scheme or underlying statute.

Health care entities should take note, however, that the remaining provisions of the Section 1557 regulations, including those that prohibit discrimination on the basis of disability, race, color, age, national origin, or sex (other than gender identity), are not impacted by the nationwide injunction and HHS can still enforce such provisions. Indeed, HHS has issued a broadcast email specifically stating that:

“[OCR] will continue to enforce the law—including its important protections against discrimination on the basis of race, color, national origin, age, or disability and its provisions aimed at enhancing language assistance for people with limited English proficiency, as well as other sex discrimination provisions—to the full extent consistent with the Court’s order.”

Health care entities should closely monitor this area of law for further developments and ensure that their operations are compliant with the remaining provisions of the Section 1557 regulations.


[i] 45 C.F.R. § 92.4

[ii] The court cited Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2780 (2014). The Supreme Court will consider whether Title IX covers gender identity in Gloucester Cty. School Bd. V. G.G., Sup. Ct. No. 16-273, during the current term.

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About this Author

George Breen, Health Care Attorney, Epstein Becker Law Firm
Board of Directors/Member of the Firm

GEORGE B. BREEN is a Member of the Firm in the Health Care and Life Sciences and Litigation practices. He is Chair of the firm's National Health Care and Life Sciences Practice Steering Committee and a member of the firm's Board of Directors.

Mr. Breen:

  • Defends clients undergoing investigation for health care fraud by the Department of Justice, the Department of Health and Human Services Office of the Inspector General, and other state and federal governmental authorities
  • ...
202-861-1823
Jonathan K. Hoerner, Epstein Becker law firm Life Sciences Attorney Washington D.C.,
Associate

JONATHAN K. HOERNER is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green.

Mr. Hoerner:

  • Defends health care and life sciences companies in litigation as well as in connection with federal and state government investigations, qui tam actions, and internal investigations related to health care fraud
  • Advises clients regarding fraud and abuse issues arising under anti-kickback laws, the Stark Law, and the False Claims Act
  • Assists clients in evaluating, developing, and implementing health care corporate compliance programs and compliance training programs
  • Advises a variety of health care providers—including hospitals, physician groups, nursing homes, ambulance providers, and various other health care facilities and businesses—in transactional and regulatory compliance matters arising under Medicare, Medicaid, and other third-party reimbursement programs
  • Advises Medicare Part C and Exchange plans on matters concerning risk adjustment payment including retraction and self-disclosures to CMS, enforcement counseling, and defense

At Saint Louis University School of Law, Mr. Hoerner completed concentrations in Health Law and Civil Litigation and achieved Academic Excellence Awards in Healthcare Fraud and Abuse, Healthcare Finance and Business Planning, Electronic Discovery, Legal Profession/Ethics, and Civil Litigation Practice. He also served as the Lead Editor of the Saint Louis University Law Journal.

Mr. Hoerner served as a Legal Extern at one of the nation’s largest nonprofit health care systems and as a Judicial Extern for the Honorable David D. Noce of the U.S. District Court for the Eastern District of Missouri.

202-861-1826