Health Care

The August 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors. Responding to President Trump’s executive order on reducing regulatory burdens, FDA announced the PreCheck program, with the goal of accelerating onshoring of drug manufacturing. FDA, HHS, and USDA have issued a joint request for data and information to develop a uniform definition of ultra-processed foods (UPF). FDA held a public meeting on August 4 to start negotiation for reauthorizing the Medical Device User Fee Amendments (MDUFA), providing a look at what stakeholders hope to achieve in terms of FDA commitments and performance goals. In July, FDA announced that it is revoking 52 individual “obsolete and unnecessary” food product standard-of-identity (SOI) regulations.

In follow-up to the May 12^th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for manufacturers to provide the United States with most-favored-nation pricing for drugs. 

As we previously reported, the Executive Order gave manufacturers 180 days to negotiate most-favored-nation drug pricing terms with the Department of Health and Human Services (HHS) before the Attorney General and the Chairman of the Federal Trade Commission (FTC) can bring enforcement action against manufacturers for anti-competitive practices. The Executive Order also warned manufacturers that the HHS Secretary and heads of other agencies would consider alternative measures to compel manufacturers to modify drug prices if “significant progress toward most-favored-nation pricing for American patients [was] not delivered.” These measures include, but are not limited to, issuing rulemaking to impose most-favored-nation pricing, certifying to Congress that importation is a viable drug cost-reduction strategy, and modifying or revoking existing drug approvals. 

In a significant legal development, a federal judge has temporarily blocked Arkansas from enforcing Act 624. Act 624 prohibits pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state, effectively forcing vertically integrated companies to divest or shut down their Arkansas pharmacy operations. However, on July 28, 2025, U.S. District Judge Brian Miller granted a preliminary injunction to several major PBMs and affiliated entities, halting the law’s implementation pending final resolution of the case.

On July 31, 2025, the United States Department of Justice (DOJ) announced a pair of settlements with companies accused of having violated the False Claims Act (FCA) by falsely representing their compliance with certain cybersecurity requirements applicable to federal contractors. These two settlements highlight key aspects of DOJ’s enforcement priorities: (1) DOJ’s strong focus on enforcing the FCA in the cybersecurity space, and (2) DOJ’s willingness to reward companies that self-disclose violations. All government contractors certifying compliance with regulatory and contractual requirements must stay vigilant and take the steps needed to comply. 

In the CY 2026 Medicare Physician Fee Schedule proposed rule (PFS Proposed Rule), released on July 14, 2025, the Center for Medicare and Medicaid Innovation (CMMI) introduced the Ambulatory Specialty Model (ASM), a new payment model focused on specialists who treat heart failure and low back pain in ambulatory settings. If implemented as proposed, participation in ASM will be mandatory for specialists, including cardiologists, orthopedic surgeons, pain management specialists, anesthesiologists, and neurosurgeons, who are located in designated regions and treat Medicare Fee-for-Service (FFS) beneficiaries for heart failure or low back pain. Participating providers will continue to bill Medicare FFS but will receive payment adjustments – positive, neutral, or negative – based on their performance across four domains: cost, quality, care improvement, and interoperability. 

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare Part B drugs. While the rule is directed at manufacturers, it has important implications for plans, pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), and other entities that receive BFSFs, particularly if the Centers for Medicare & Medicaid (CMS) proposes similar changes to Part D. 

The Rhode Island Medical Spas Safety Act (RI MSSA) was signed into law by Governor Daniel McKee on June 30, 2025, and is the latest example of the increasing regulation of medical spas.

U.S. District Court for the Southern District of Iowa issued a comprehensive preliminary injunction blocking enforcement of key provisions of Iowa Senate File 383.

The Center for Medicare and Medicaid Innovation (CMMI) recently announced a six-year payment model for 2026-2031 called the Wasteful and Inappropriate Service Reduction (WISeR) Model. This blog post outlines key considerations for health care providers and suppliers to prepare for WISeR, which becomes effective January 1, 2026. 

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because a company advertises the product for wellness and lifestyle purposes. The advisory action also indicates that FDA’s Center for Devices and Radiological Health (CDRH) remains steadfast in its enforcement of device regulations despite ongoing changes in other centers and throughout the agency.

Within the first six months of President Trump’s second term, his Administration and the GOP have already implemented significant policies that are reshaping health care in the United States. Through his Administration’s restructuring of the Department of Health and Human Services (HHS), promulgation of Marketplace Integrity and Affordability rules, sweeping RADV audit changes, and now the passage of the One Big Beautiful Bill Act (OBBA), entities throughout the health care industry—particularly managed care plans and sub-capitated providers—will need to readjust to the new paradigm. 

On July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on compensation paid to marketers who sold testing on behalf of Schena’s laboratory. 

A few elements of this decision are particularly significant, including the court’s finding that percentage-based compensation arrangements are not per se illegal under EKRA and that evidence of undue influence over providers’ decision-making must be presented to demonstrate that the compensation was paid to “induce a referral” in violation of the statute.  The decision is also notable for its reliance on case law interpreting the Anti-Kickback Statute to reach this conclusion.

Since April 2024, the California Department of Health Care Access and Information (HCAI), Office of Health Care Affordability (OHCA) has received twenty-six Material Change Transaction Notices (Notices) as part of its authority to review certain proposed California health care transactions. (See our prior posts here and here.) In twenty-three of the proposed transactions, OHCA has reviewed the Notices and waived a full Cost and Market Impact Review (CMIR), with two transactions still under review. 

In a brief press release published on July 9, 2025, the Department of Justice (DOJ) announced the issuance of more than 20 subpoenas to doctors and clinics as part of investigations into health care fraud, false statements, and related federal violations. The actions specifically target health care providers involved in transgender medical procedures for minors, representing a significant enforcement response that warrants careful analysis.

The July 2025 edition of FDA in Flux highlights five significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

Of Counsel Bridgette Keller is joined by Joanne Hawana, Ben Zegarelli, and John Daley, as they offer advice for navigating communications with the FDA.

On June 11, 2025, Iowa enacted Senate File 383 (the “Act”), a comprehensive bill aimed at regulating pharmacy benefit managers (PBMs) with the stated goals of increasing transparency, supporting independent pharmacies, and reducing prescription drug costs. However, on June 30, 2025, just one day before the Act’s effective date, the U.S. District Court for the Southern District of Iowa issued a temporary restraining order (TRO), enjoining enforcement of the Act against the lawsuit’s named plaintiffs. The court found that the plaintiffs, a coalition of Iowa employers and ERISA-governed health plans, demonstrated a likelihood of success on the merits of their claims that the Act is preempted by the Employee Retirement Income Security Act of 1974 (ERISA) and violates the First Amendment. The lawsuit aligns with other recent challenges against similar comprehensive legislation and further demonstrates the long-lasting conflict between PBM reform legislation and preemption by federal law.

This year’s National Health Care Fraud Takedown (Takedown) announced recently by the Department of Justice (DOJ) was touted by the Department of Justice as the largest to date, involving over $14.6 billion in “intended loss” and 324 defendants charged. The Takedown reinforces the Trump administration’s commitment to prioritizing health care fraud enforcement, highlights the “significant return on investment” these efforts yield, and repeatedly emphasizes the imperative to prevent fraud before it starts.

On June 9, 2025, Oregon Governor Tina Kotek signed into law Oregon Senate Bill 951 (Oregon CPOM Law), further expanding Oregon’s prohibition on the corporate practice of medicine (CPOM) doctrine. The stated purpose of the Oregon CPOM Law is to build upon Oregon’s established corporate practice of medicine prohibition, originally established by the Oregon Supreme Court in the 1947 decision in State ex rel. Sisemore v. Standard Optical Co, which banned corporations from holding a majority ownership in medical practices, practicing medicine, or employing physicians.

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services organization (MSO) would engage telehealth-based practices and platforms (collectively, Telehealth Companies) to provide telehealth services, including leasing health care professionals and maintaining the telehealth platform. The physician practice would submit claims for the telehealth services under its own private and government payor contracts. This advisory opinion addresses an increasingly common telehealth delivery model aimed at increasing the availability of health plan coverage for telehealth services, particularly in recent years with the rise in popularity of GLP-1 drugs for managing obesity.