Health Law Advisor

When a provider or supplier of services bills the Medicare program and receives payment, but at a later date the program audits the claim and denies it, can the provider or supplier be relieved of any financial liability if it had a good faith belief that the service met all relevant coverage requirements, even when that belief is incorrect? In a recent decision, the U.S. Court of Appeals for the Sixth Circuit ruled that this relief is possible, and that administrative adjudicators must conduct an analysis under the “hold harmless” provision of the Social Security Act (the “Act”).[1]

[1] In Home Health, LLC v. Kennedy, 2026 WL 2147418 (6^th Cir., July 27, 2026); also available at: https://www.opn.ca6.uscourts.gov/opinions.pdf/26a0205p-06.pdf.

On August 13, 2026, Senior U.S. District Judge B. Lynn Winmill of the District of Idaho issued a ruling in Seyb v. Members of the Idaho Board of Medicine, holding that Idaho’s near-total abortion ban is unconstitutional to the extent it prohibits abortions necessary to protect the health—not just the life—of the pregnant patient. Along with that holding, the court entered an injunction barring enforcement of the ban in those circumstances. The ruling is the first federal district court decision since Dobbs v. Jackson Women’s Health Organization to hold that the U.S. Constitution affirmatively protects a right to health-preserving abortion.

On July 31, 2026, the Health Resources and Services Administration (“HRSA”) announced a revised 340B Rebate Model Pilot Program (“2026 Pilot”) to provide a rebate mechanism through which qualifying manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities—as opposed to an upfront discount, which has been the longstanding model. The 2026 Pilot, which is limited to the drugs selected for negotiation under Medicare, is open to qualifying manufacturers that submit plans meeting specific criteria.

On August 13, 2026, the Assistant Attorney General for the U.S. Department of Justice (“DOJ”) National Fraud Enforcement Division (the “NFED”), Colin M. McDonald, released a memorandum outlining NFED’s enforcement priorities. The memorandum is the first memo of this kind from NFED.  The establishment of NFED earlier this year represented a watershed moment for federal fraud prosecution, as it established DOJ’s first-ever division dedicated exclusively to combating fraud against taxpayer dollars and taxpayer-funded programs.  With a stated goal of having 500 prosecutors and staff by August 24, NFED seeks to deploy “cutting-edge data analysis” across a “whole-of-government” effort.  The establishment of NFED signals a fundamental shift in federal fraud enforcement, one that seeks to compress investigation timelines and narrow the window for voluntary disclosures.  Breaking down data barriers, eliminating silos, and establishing partnerships with U.S. Attorneys’ Offices, federal agencies, and state and local partners, the NFED’s priorities are a warning call to companies to expect more efficient detection, investigation, and prosecution than in the past.  The creation of the NFED signals a desire on the part of the Trump administration (“Administration”) to meaningfully escalate federal fraud enforcement sophistication and resources.

On August 7, 2026, Epstein Becker Green attorneys Thomas J. Jaworski and Caitlin Carlton joined podiatrists from across the country at the American Podiatric Medical Association’s (APMA) 2026 Annual Scientific Meeting for a discussion on a subject that has become increasingly difficult for providers to ignore: federal health care fraud enforcement.

Less than a month remains for physicians, health systems, technology companies, and other stakeholders to comment on several questions buried deep in a Request for Information (“RFI”) within the Centers for Medicare & Medicaid Services’ (“CMS”) Calendar Year 2027 Physician Fee Schedule Proposed Rule. Among them is a deceptively simple question: “What are the payment implications of including technology in primary care?”

The federal government is pursuing restrictions on gender-affirming care through a coordinated, multifaceted enforcement strategy.

For health care providers, understanding both the tools being deployed and the methods providers are using to respond is essential to compliance planning.

Jennifer Nelson Carney, Member of the Firm, examines the federal enforcement mechanisms and discusses how health care organizations are responding to coordinated federal challenges.

President Trump’s Executive Order 14321, Ending Crime and Disorder on America’s Streets (“EO 14321”), signed on July 24, 2025, directs federal agencies to expand the use of civil commitment for people experiencing homelessness who have a serious mental illness or substance use disorder. A year later, EO 14321 has sharpened a long-running national debate over when the government may compel treatment; the tension is often described as one between care and coercion. For hospitals and behavioral health organizations—and the lawyers who advise them—EO 14321’s practical effect runs less through new legal standards, which remain a matter of state law, than through federal funding conditions.

The first half of 2026 has seen active U.S. Food and Drug Administration (FDA) enforcement across multiple regulatory domains. For regulated companies, monitoring the FDA’s enforcement priorities is critical to compliance and audit readiness.

Megan Robertson, Member of the Firm, examines the FDA’s recent enforcement actions, identifies six trends in the agency’s regulatory approach, and offers practical guidance for in-house counsel.

Key Takeaways

• The FDA is monitoring websites, social media, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status.
• The most prominent trend is continued enforcement against online telehealth platforms offering compounded GLP-1s. Companies must clearly distinguish health care services from drugs being compounded and sold by pharmacies.
• The Center for Drug Evaluation and Research is actively enforcing current Good Manufacturing Practice compliance. Recalls alone do not satisfy the FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.
• Food facilities face enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including produce, rice, matcha powder, and green tea.
• Form 483 responses are receiving heightened FDA scrutiny. Medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.
• These warning letters were issued under the former FDA commissioner. In-house counsel should monitor for potential shifts in enforcement priorities under new leadership as the year progresses.

In recent weeks, two competing visions have emerged to legislatively modernize the federal 340B drug discount program (“340B Program”). On July 6, 2026, Representatives Scott Peters (D-CA) and Dr. John Joyce (R-PA) introduced the bipartisan House bill H.R. 9599, called the SECURE 340B Act (or “the 340B House Bill”), hailed as “the first-ever comprehensive, bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992.” This follows on the heels of the Senate bill “340B Drug Pricing Integrity and Affordability for Patients Act” that was issued as a discussion draft (“340B Senate Discussion Draft”), released by Sen. Bill Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, on June 25, 2026. Cassidy’s 340B Senate Discussion Draft was touted as the first statutory update to the 340B Program in fifteen years.