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FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more

Health Care Providers Navigate Fallout of Major Cyberattack on Change Healthcare

Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more

Conducting a Post-Dobbs Risk Assessment: A Guide for Hospitals and AMCs

Since the US Supreme Court ruled in Dobbs v. Jackson Women’s Health Organization (Dobbs) in June 2022, the impact of the Court’s decision continues to ripple across the health care delivery system. In this multi-part series,...more

Which Law Should Emergency Departments Follow? DOJ Sues Idaho Over Conflict Between EMTALA and State Abortion Restrictions

In a newly filed lawsuit against the State of Idaho, the federal government argues that Idaho’s “near-total ban on abortion,” scheduled to take effect on August 25, 2022, overreaches by prohibiting abortion even where federal...more

CMS Guidance on EMTALA and Abortion Raises New Issues for Hospital Emergency Services

According to guidance published by the Centers for Medicare and Medicaid Services (CMS) on July 11, 2022, EMTALA, the Emergency Medical Treatment and Labor Act of 1986, requires hospitals to provide abortion services when...more

HHS COVID-19 Public Health Emergency Persists as California COVID-19 Policies Are Set To Expire

The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more

Providing Remuneration to Address Physician Burnout: Stark Law Considerations

Hospitals and Other Providers Should Make Sure Any Items or Services of Value That They Provide to Their Referring Physicians To Alleviate Burnout Comply With the Stark Law - Amidst the ongoing labor market shortages and...more

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