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Materia Medica

Post-Dobbs Fallout: Federal Guidance Abounds

Beth anne jaCksOn

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The release of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization dated June 23, 2002, was followed swiftly by actions by the U.S. Department of Health and Human Services (“HHS”) and an executive order. HHS had launched the HHS Reproductive Access Task Force (the “Task Force”) to plan for the previously leaked Dobbs decision. So, it is not surprising that HHS issued guidance regarding two federal statutes within weeks of Dobbs: EMTALA and HIPAA.

The Emergency Medical Transfer and Active Labor Act (“EMTALA”) requires that hospitals with emergency rooms provide all patients with an appropriate medical screening examination, stabilizing treatment for any emergency medical conditions, and transfer to another facility, if necessary. Prompted by President Biden’s July 8, 2022, executive order titled Protecting Access to Reproductive Healthcare Services, which required Secretary of HHS Xavier Becerra to submit a report to the President “identifying steps to ensure that all patients – including pregnant women and those experiencing pregnancy loss, such as miscarriages and ectopic pregnancies – receive the full protections for emergency medical care afforded under the law,” HHS released guidance on EMTALA. This came in the form of a letter from Secretary Becerra, as well as a CMS memorandum to State Survey Agency Directors, both of which were published on July 11, 2022 (the “EMTALA Guidance”). The EMTALA Guidance states that EMTALA and the duties imposed on hospitals and medical personnel thereunder, “preempts any directly conflicting state law or mandate that might otherwise prohibit such treatment.”

In accordance with the executive order, the EMTALA Guidance specifically addresses emergency medical conditions including, but not limited to, ectopic pregnancy, complications of pregnancy loss, and preeclampsia with severe features. While, of course, the treatment necessary to stabilize these emergency medical conditions is determined by the treating physician or other qualified medical personnel, the EMTALA Guidance states that such treatment could include “medical and/or surgical interventions (e.g., abortion, removal of one or both fallopian tubes, antihypertensive therapy, methotrexate therapy, etc.) irrespective of any state laws or mandates that apply to specific procedures.” (Emphasis added)

The EMTALA Guidance proceeds to advise physicians that their obligation under EMTALA, specifically to provide an “abortion” when necessary to stabilize the pregnant patient’s emergency, is both mandatory and protected under federal law when state law does not include an exception for the life and health of the pregnant patient. The EMTALA Guidance reminds physicians that not only are they potentially subject to civil monetary penalties that may be imposed against a physician for failing to provide necessary stabilizing treatment or appropriate transfer, but also suggests that they can use EMTALA as a defense against state enforcement action or to assert a retaliation claim if disciplined for refusing to transfer a patient who had not received the recommended stabilizing care. The EMTALA Guidance from CMS goes into further detail regarding hospitals’ obligations under EMTALA, particularly with respect to transfers of pregnant patients: transfers may only occur based on the patient’s request after informed consent or a physician’s determination that the benefits of transfer to the woman and/or the unborn child outweigh its risks. State law cannot be cited as the basis for the transfer. Although EMTALA does not apply once a patient is admitted, the EMTALA Guidance also cites the

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From Page 31 Medicare Conditions of Participation (“CoPs”) requirements to provide appropriate care to inpatients, including: medical staff accountability; quality assessment and performance improvement programs; and discharge planning. Failure to follow these CoPs, and thereby protect patient health and safety, “could result in a finding of noncompliance at the condition level for the hospital and lead to termination of the hospital’s Medicare provider agreement.”

Within days of issuance of the EMTALA Guidance, the State of Texas sued Secretary Becerra in federal court to challenge the validity of the Guidance as exceeding statutory authority and violating Texas’s “sovereign right to enforce its criminal laws,” as well as the federal Administrative Procedure Act by imposing an “Abortion Mandate” on Texas hospitals and physicians. That litigation is pending in the U.S. District Court in Lubbock, Texas.

HHS issued guidance on HIPAA, titled “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care” (the “Privacy Guidance”), on June 29, 2022. The Privacy Guidance discusses potential provider disclosures of the PHI of pregnant patients under three exceptions under the Privacy Rule: disclosures “required by law;” disclosures for law enforcement purposes; and disclosures to avert a serious threat to health or safety, all in the context of state laws on abortion.

With respect to disclosures “required by law,” the first example describes an individual who goes to the hospital emergency department during a miscarriage in the tenth week of pregnancy when applicable state law prohibits abortion after six weeks. In such a case, the Privacy Guidance states that if a hospital workforce member suspects the individual of having taken medication to cause the miscarriage, the Privacy Rule would not permit a disclosure to law enforcement unless the state statute expressly requires such reporting. Reporting when not required by law constitutes a breach of protected health information (“PHI”).

Disclosures for law enforcement purposes are similarly limited. For example, if a law enforcement official asked a reproductive health care clinic for records of abortions performed there, the clinic could not disclose any such records in the absence of a court order. Even if the official had a court order, the Privacy Rule would permit but not require the clinic to disclose the PHI, but only the specific PHI identified in the court order. (Note, however, that a court of competent jurisdiction can compel the clinic to disclose such information and, if the information is not disclosed, hold the clinic in contempt of court.)

Similarly, the Privacy Guidance clarifies that a health care provider in a state that bans abortion cannot use the “disclosure to avert a serious threat to health or safety” exception to report to law enforcement a pregnant patient’s intent to get a legal abortion. HHS asserts two bases for this conclusion. First, a statement regarding the “individual’s intent to get a legal abortion [presumably in another state] or any other care tied to pregnancy loss, ectopic pregnancy or other complications related to or involving a pregnancy does not qualify as a ‘serious and imminent threat to the health or safety of a person or the public.’” Further, such a disclosure would be inconsistent with professional ethical standards because it compromises the physicianpatient relationship and may actually increase the risk of harm to the patient. Accordingly, such a disclosure would constitute a breach of PHI under HIPAA.

Any physician who interacts with patients who may be or become pregnant and who practices in a state that limits or prohibits abortion (or may do so in the future) should be aware of this guidance. Hospital-based physicians might look to the facilities in which they work for assistance in navigating EMTALA and HIPAA privacy issues, while office-based physicians will need to develop and enforce appropriate policies to ensure that they and their staff understand limits on disclosure that are set forth in the Privacy Guidance. It should be noted, however, that the EMTALA Guidance and the Privacy Guidance are subregulatory guidance that reflect the Biden administration’s interpretation of existing law and rules: they do not have the force and effect of law. Nevertheless, they can be used to prioritize enforcement actions by HHS. DISCLAIMER: This article is for information purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem. Ms. Jackson is a shareholder in the Health Care Practice Group of Brown & Fortunato, P.C., which is headquartered in Amarillo, Texas, and serves healthcare providers nationally. She is licensed in both Pennsylvania and Texas and maintains an office in the greater Pittsburgh area. She may be reached locally at (724) 413-5414 or bjackson@ bf-law.com. Her firm’s website is www.bf-law.com. www.acms.org

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