Health Care

DOJ denied ACLA’s EKRA rulemaking petition, signaling scrutiny of referral-based sales commissions and prompting labs to reassess compensation plans.

On October 5, 2026, the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) announced changes to the Transparency in Coverage (TIC) final rules, overhauling the 2020 regulatory framework for group health plans and health insurance issuers.  The changes aim to standardize the TIC machine-readable files (MRFs) for greater accuracy and accessibility.  The rules take effect December 7, 2026, with requirements phased in through July 2028.

HRSA’s 340B rebate pilot starts Jan. 1, 2027. Learn the approved plans, litigation risks, and readiness steps for health systems.

Senators Warren, Wyden, and Merkley, along with Representatives Hoyle, Ocasio-Cortez, and Subramanyam, have introduced the Stop Corporate Takeovers of Physicians Act. The bill would establish the corporate practice of medicine doctrine, rooted in more than a century of law in about half of the states, as a federal baseline. The bill would require that licensed physicians be majority owners and controlers of medical practices and place limitations upon management services organizations. Its rationale is straightforward: a prior Senate bill titled the Break Up Big Medicine Act asserted that more than 75% of U.S. physicians now work for corporate employers and the sponsors want clinical decisions made by doctors rather than shareholders.

Most of the 340B debate centers on rural hospitals and community health centers. The biggest dollars, however, sit with academic medical centers (AMCs) and large health systems, and that is where Washington’s next three moves converge.

On August 26, 2026, the Seventh Circuit Court affirmed in Central States SE & SW Areas Health & Welfare Fund v. McClain that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas insurance regulation designed to regulate how pharmacy benefit managers (PBMs) compensate pharmacies. 

On September 18, 2026, the Department of Justice (DOJ) announced revisions to the Justice Manual formalizing two significant changes to False Claims Act (FCA) enforcement policy. First, DOJ reestablished and enhanced a prior policy providing that alleged noncompliance with nonbinding agency guidance documents cannot establish civil FCA liability. Second, when making a declination decision, DOJ attorneys “will in each case” assess whether to seek dismissal.

While it has been a busy summer in the pharmaceutical and PBM industries, the Trump administration’s most-favored-nation (MFN) pricing agenda is moving into a second phase targeting mid-sized pharmaceutical manufacturers. Following the MFN pricing deal announcement with Regeneron, the last of President Trump’s original list of 17 manufacturers that received MFN demands, President Trump announced on Monday, August 31, 2026, deals with nine additional mid-sized manufacturers to lower prescription drug costs for Americans. The nine manufacturers are Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB. Together, the 26 drugmakers cover 89% of the brand drug market.

Key FDA updates on generative AI, medical product user fees, SEC coordination, GLP-1 drug shortages, and the future of diagnostic testing.

Can FemTech help solve rural America’s maternal health crisis? Explore innovations, policy barriers, reimbursement, telehealth and access gaps.

On September 1, 2026, the Eleventh Circuit issued its long-awaited decision in United States ex rel. Zafirov v. Florida Medical Associates, vacating the district court’s ruling that the False Claims Act’s (FCA) qui tam provisions violate the Appointments Clause of Article II. The court found that FCA relators are not “Officers of the United States” because they do not occupy a “continuing position established by law,” and therefore are not subject to the Appointments Clause’s requirements. The Eleventh Circuit’s decision is in line with decisions from other circuits rejecting similar Appointments Clause challenges, but it is the first to do so since Justice Thomas’s dissent in United States ex rel. Polansky v. Executive Health Resources.

The Department of Justice’s recent resolution with Veloxis Pharmaceuticals sends a clear signal: pharmaceutical companies’ relationships with health care professionals remain under close scrutiny. Veloxis Pharmaceuticals Inc., a North Carolina-based drug manufacturer, agreed to pay more than $46 million to resolve criminal and civil allegations arising from a purported years-long kickback scheme involving its kidney transplant drug, Envarsus. The resolution included a deferred prosecution agreement (DPA), a civil False Claims Act (FCA) settlement, and the largest recovery on record under the federal Open Payments Program (Sunshine Act), which underscores the government’s continuing focus on pharmaceutical manufacturers’ relationships with health care professionals (HCPs) and its willingness to pursue both criminal and civil remedies when it considers those relationships to have crossed the line.

Learn how OPTN modernization, CMS OPO reforms, and new transplant policies will impact donor hospitals, transplant centers, compliance, and planning.

The August 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for the medical, life sciences, and consumer product sectors.

For decades women's health has too often been treated as a narrow policy category, despite affecting roughly half the population. That is changing. There is now an emerging category of medicine built around regulated software, biomarker-based decision-making, and new regulatory and reimbursement pathways. FemTech now spans menstrual health, fertility, pregnancy and postpartum care, pelvic and sexual health, menopause, contraception, and conditions that affect women differently or disproportionately. 

Watch Mintz's on-demand webinar on DOJ health care fraud and False Claims Act enforcement priorities, emerging risk areas, whistleblower trends, and compliance strategies for 2026.

A hastily reassembled Pharmacy Compounding Advisory Committee (PCAC) held meetings on July 23 and 24, 2026 to consider whether seven unapproved peptides should be included on an affirmative list of bulk ingredients that can be used by compounding pharmacies operating under the Food, Drug, & Cosmetic Act’s (FD&C Act) Section 503A (503A compounders). A second PCAC meeting to discuss an additional five peptides is expected to be scheduled in February 2027. In close votes over the course of July’s two-day meeting, the PCAC members recommended that BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax be added to the 503A affirmative list. They voted against the addition of emideltide. 

On July 14, 2026, the Federal Trade Commission (FTC) announced its settlement with Caremark Rx, LLC and Zinc Health Services, LLC (Caremark) to resolve claims from the FTC’s 2024 Complaint alleging Caremark, OptumRx, Inc. (OptumRx), and Express Scripts, Inc (ESI) used anticompetitive rebate schemes to artificially inflate insulin prices.

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (Proposed Rule) on July 6 that would expand its authority over Medicare enrollment denials and revocations applicable to all providers and suppliers (Providers). CMS’s proposed expansion of Medicare enrollment denial and revocation authorities is consistent with the Trump administration's broader strategy of preventing improper payments before they occur.