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Amy Dilcher is special counsel in the Corporate Practice Group in the firm's Washington D.C. office.

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court’s stay implemented earlier this year.

Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. 

Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

On May 1, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced two investigations of hospitals that failed to offer necessary stabilizing care to a pregnant individual experiencing an emergency medical condition (“EMC”), in violation of the Emergency Medical Treatment and Labor Act (“EMTALA”). The U.S. Department of Health and Human Services (“HHS”) released a public statement and a letter to hospitals and provider associations, emphasizing the obligations of Medicare-participating hospitals’ under EMTALA, including stabilizing treatment, like abortion care, or an appropriate transfer. These investigations represent the first EMTALA enforcement action related to abortion emergency care since the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (“Dobbs”).

Continue Reading EMTALA and Pregnancy Care Remains a Federal Enforcement Priority

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has authority to enforce the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty law (“CMPL”). One of the ways that the OIG utilizes its enforcement authority is through the issuance of advisory opinions. 

Continue Reading OIG 2022 Advisory Opinions: Year in Review

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail. 

Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

According to the White House, the end of the COVID-19 national emergency and public health emergency (PHE) declarations is now barely two months away, as they are scheduled to end on May 11, 2023. These declarations provided the federal government with flexibility to waive or modify certain regulatory requirements applicable to the healthcare industry. Once the declarations end, so will the vast majority of these flexibilities and waivers. Accordingly, a relatively short and closing window remains for the healthcare industry – including but not limited to health plans, hospitals, home health agencies, clinics, and entities that offer telehealth services – to prepare their operational, administrative, and clinical teams for the reinstatement of previously waived requirements.

Continue Reading Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

The Centers for Medicare & Medicaid Services (“CMS”), on behalf of the U.S. Department of Health and Human Services (“HHS”), recently issued a proposed rule to adopt standards under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) for “health care attachment” transactions (the “Proposed Rule”). The Proposed Rule would implement requirements of HIPAA’s administrative simplification regulations, which are intended to support healthcare claims and prior authorization transactions while also introducing a standard format for electronic signatures to be used in conjunction with health care attachments.

Continue Reading CMS’s Administrative Simplification Rule Aims to Increase Efficiency and Standardization for Health Care Attachments

Social media’s interplay with healthcare privacy presents a constantly evolving challenge. ICYMI (“in case you missed it”), there is an uptick in enforcement and scrutiny IRL (“in real life”) related to communications through social media and other public platforms by entities subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

Continue Reading ICYMI: HIPAA and Social Media IRL

During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth services and were made possible by the COVID-19 emergency blanket waivers, which went into effect when the U.S. Department of Health & Human Services (“HHS”) declared a Public Health Emergency (the “PHE”). Some of these tools:

Continue Reading Finding Our Way Out of the Pandemic Haze: What Telehealth Tools Are Medicare Providers Allowed to Keep, and Which Must They Leave Behind?

The abortion debate continues in America after the Supreme Court decision in Dobbs v. Jackson and the midterm elections on November 8th. Following our first post in this series, there have been a number of noteworthy developments* that occurred over the past month including several significant events at both federal and state levels as well as recent activity by registered voters during the midterms to protect access to reproductive care.

Continue Reading Part 2: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights