Insights

FAQs: What OPOs Need to Know About the Proposed Rule

On February 3, 2026, President Trump signed a $1.2 trillion spending deal that, among other points, introduced significant regulatory changes for Medicare Part D plans and PBMs providing services to PDP sponsors in the Medicare Advantage and Medicare Part D programs, and imposed significant new restrictions and transparency requirements on PBMs contracting with private group health plans.

On January 27, 2026, the Centers for Medicare and Medicaid Services (CMS) released a Health Plan Management System (HPMS) memo that provided a long-awaited update on how the agency plans to approach previously announced Risk Adjustment Data Validation (RADV) audits for Payment Years (PY) 2020-2024. The memo is the agency’s most comprehensive statement on the subject since September 25, 2025, when the Northern District of Texas vacated the 2023 RADV Final Rule. The memo makes clear that, while CMS has made certain operational adjustments in response to concerns expressed by Medicare Advantage Organizations (MAOs), the agency is largely pressing forward with the accelerated audit strategy announced in May 2025.

On January 26, 2026, the Centers for Medicare and Medicaid Services (CMS) circulated the Calendar Year (CY) 2027 Advance Notice to communicate proposed changes to Medicare Advantage (MA) capitation rates and Parts C and D payment policies.  The changes are expected to be finalized in April 2026 but may be delayed. The following is a summary of the most significant proposals, with further details below:

The U.S. Court of Appeals for the 6th Circuit may no longer be as favorable a venue for health plans engaged in legal disputes with members who allege that insufficiently detailed claim denials violate the Employee Retirement Income Security Act’s (ERISA) protections against “arbitrary and capricious” decision making.

On January 13, 2026, Miami-based pharmaceutical wholesaler Atlantic Biologicals Corporation entered into a two-year DPA, admitting to conspiracy to distribute and dispense controlled substances, including more than 14 million opioid doses to “pill mill” pharmacies in Texas at a markup. The DOJ and DEA underscored the company’s deliberate evasion of compliance checks and disregard for red flags signaling diversion.

On January 5, 2026, District of Colorado Magistrate Judge Cyrus Chung issued a recommendation that the district court grant a motion to quash a Department of Justice (DOJ) administrative subpoena that sought records about the provision of gender-related care by Children’s Hospital Colorado (Children’s) in In re: Department of Justice Administrative Subpoena No. 25-1431-030, U.S. District Court for the District of Colorado, No. 1:25-mc-00063. The court concluded that the DOJ had failed to carry its “light” burden, noting that no other courts that had considered the more than 20 similar subpoenas issued by DOJ had ruled in the DOJ’s favor.  

Since the signing of Executive Order 14187 (“Protecting Children from Chemical & Surgical Mutilation”) in late January 2025, the Trump Administration has made its skeptical stance on gender-affirming care—especially regarding services provided to minors—clear.

The regulatory environment for skilled nursing facilities (SNFs) is shifting rapidly, creating challenges and uncertainties for providers across the country—and especially those in New York. While the Trump administration has rolled back federal nurse staffing mandates, state-level requirements remain in full force, and new federal ownership disclosure rules are set to take effect in January 2026. Even as federal enforcement slows, state regulators appear primed to intensify oversight of nursing home operators by enhancing Certificate of Need (CON) review processes.

On November 26, 2025, the Centers for Medicare & Medicaid Services (CMS) published its Proposed Rule for the Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program (the “CY 2027 NPRM” or “proposed rule”) for public comment. In addition to outlining prospective policy and technical changes to Medicare Advantage (Part C), the Medicare Prescription Drug Benefit (Part D), and Medicare Cost Plan regulations, the proposals showcase the government’s plans to make comprehensive updates in response to statutory changes—notably the Inflation Reduction Act of 2022 (IRA)—as well as feedback from interested parties, and current federal deregulatory priorities.

The facts before the Third Circuit in the recently decided case of Patel v. United States illustrate how parties can put themselves in a bind if they make factual admissions when resolving a criminal case involving fraud on the government while not simultaneously resolving the government’s civil claims under the False Claims Act (FCA) for the same underlying conduct.

Ransomware attacks continue to evolve in frequency, sophistication, and impact. Threat actors are now leveraging artificial intelligence to enhance phishing campaigns, automate data exfiltration, and execute double extortion schemes—where data is both encrypted and stolen for leverage.

The deadline for Department of Health and Human Services (“HHS”) to notify approved manufacturers of acceptance into the 340B Rebate Model Pilot Program has passed, and stakeholders across the healthcare industry should start planning for compliance and operational changes. The Model Pilot Program may also face legal challenges that could delay or disrupt implementation.

On September 30, 2025, the Food and Drug Administration (FDA) issued a Request for Public Comment (“Request”) inviting stakeholders to share practical experience and recommendations for measuring and evaluating the real-world performance of AI-enabled medical devices, including those powered by GenAI. According to FDA, the Request is not intended to communicate new guidance or regulatory expectations but aims to advance the conversation on how best to assure the safety, effectiveness, and reliability of AI-driven technologies in clinical practice.

On September 25, 2025, the Northern District of Texas granted plaintiffs’ motion for summary judgment in Humana v. Becerra, vacating CMS’s 2023 Final Rule regarding risk adjustment data validation (RADV) audits. In the litigation, Humana challenged CMS’s decision in the Final Rule to not continue applying a Fee-for-Service (FFS) adjuster to its RADV audit methodology.

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising.  This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”

CMS is well underway in initiating and conducting its Risk Adjustment Data Validation (RADV) audits of Medicare Advantage (MA) organizations for PY 2019, and PY 2020 audit notices are likely to arrive by the end of September. The timing for subsequent PY audits is less clear, but notices will likely be coming soon given CMS’s announced plans to complete all remaining audits by early 2026, including all contracts for PY 2020 and beyond. This approach marks a significant deviation from the agency’s prior policy of reviewing only a fraction of contracts and at a much slower pace.

On August 19, 2025, the Office of Personnel Management (OPM) informed insurers participating in the Federal Employees Health Benefits or Postal Service Health Benefits programs that gender-affirming care would no longer be covered for federal workers starting in 2026. This coverage decision is the Trump Administration’s latest action stemming from Executive Order 14187 which aims to prevent certain treatments, such as gender-affirming hormone therapy, surgeries, and puberty blockers for those under the age of 19. As previously discussed, the Administration has also signaled its intent to use various law enforcement tools against gender-affirming care, including  Section 5 of the Federal Trade Commission Act to police false or unsupported claims by medical professionals about gender-affirming treatments.

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials” from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is currently in Step 2 of the ICH process and open for public comment until September 19, 2025.

On July 23, 2025, the Trump Administration issued an artificial intelligence (AI) action plan titled “Winning the Race: America’s AI Action Plan” (the Plan) to guide AI innovation in the U.S. The Plan includes 90 policy recommendations that will shape future AI guidance and policies impacting a range of entities and industry sectors, including health care/life sciences and entities involved in clinical research.