The Supreme Court’s decision last week in the companion cases of Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce overturned the Court’s prior precedent in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., and, in
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OIG Issues Favorable Opinion on Drug Assistance Programs
The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion that relates to whether two drug assistance programs would run afoul of the Federal anti-kickback statute (“AKS”).
In good news for the
Supreme Court Decision Leaves FDA Approval of Mifepristone Untouched, But For How Long?
This post was co-authored by Megan E. McWaters, a Reed Smith summer associate.
In a unanimous decision, the U.S. Supreme Court overturned a ruling by the U.S. Court of Appeals for the Fifth Circuit which had placed doubt on the
OIG Approves Travel and Lodging Assistance for Patients Receiving Gene Therapy
On June 17, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion, approving a plan to provide assistance with travel, lodging, meals, and other associated expenses for qualifying patients receiving a
The end of Chevron? Webinar to follow highly anticipated Supreme Court decision
As Reed Smith has previously covered, an issue before the Supreme Court that could be decided this week could bring a seismic shift in the balance of power between agencies and courts, upend regulatory certainty, and open new opportunities
HHS Pledges $50 million to Empower Hospitals in the Battle Against Cyberattacks
Hospitals and large healthcare organizations have increasingly become prime targets for cybercriminals. In response, the Department of Health and Human Services (HHS) has established a new initiative within the National Institutes of Health (NIH) aimed at enhancing cybersecurity measures for
Colorado sets baseline for AI regulation in high-risk applications, including health care
Colorado recently passed a law creating consumer protections for interactions with artificial intelligence systems. The law specifically identifies high-risk systems, including in those that impact health care. The law requires risk mitigation, documentation and robust governance.
FDA LDT Rule Begins Enforcement Discretion Phaseout, But Some Discretion Remains
On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as FDA’s phaseout of its general enforcement discretion approach to laboratory developed tests (LDTs).
The October
What to know about the new CMS Minimum Staffing Rule for LTC Facilities
The Centers for Medicare & Medicaid Services (CMS) has finally published the minimum staffing rule for Long Term Care facilities in the Federal Register, which starts the clock for compliance with some provisions of the rule.
But what does the
OIG Exercises Discretion in Independent Charity Patient Assistance Program
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 24-02, involving independent charity patient assistance programs (PAPs) associated with 12 specific diseases (the Disease Funds) operated by the