Insights

2026 will prove to be a pivotal year for organ procurement organizations (OPOs). For the first time, the impact of the Center for Medicare and Medicaid Services’ (CMS) 2020 outcome measures will be fully felt, as the year marks the end of the first certification cycle governed by the new benchmarks. In the meantime, OPOs are challenging the 2020 rule in several federal lawsuits and, as that litigation progresses, CMS is accepting comments on a new proposed rule, which we discussed in a prior alert. 

On February 26, 2026, the Senate Health, Education, Labor, and Pensions (HELP) Committee voted 22-1 to advance the Health Care Cybersecurity and Resiliency Act of 2026. Sponsored by a bipartisan group — led by HELP Committee Chair Senator Bill Cassidy (R-LA); and Senators Mark Warner (D-VA), Maggie Hassan (D-NH), and John Cornyn (R-TX) — the bill represents perhaps the most significant federal legislative effort to overhaul health care cybersecurity since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, and would compel health care companies to make major investments in cybersecurity.

On March 3, 2026, the Department of Labor (DOL), Department of Health and Human Services (HHS), and Department of the Treasury (TREAS) — collectively, the “Tri-Agencies” — published their fourth annual report to Congress on enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA). The 2025 Report demonstrates a shift in approach by the Tri-Agencies in its tone and content and suggests that federal regulators, and the DOL in particular, are not as active as they previously were in MHPAEA enforcement. However, federal enforcement remains ongoing, and state enforcement of mental health parity laws continues to grow. Plans and issuers must continue to maintain comprehensive compliance processes and documentation for MHPAEA compliance.

A recent decision by the United States Court of Appeals for the Fifth Circuit, Farmers Texas County Mutual Insurance Co. v. 1st Choice Accident & Injury, LLC, No. 24-20275 (5th Cir. Feb. 24, 2026), offers important lessons for health care payors and other potential plaintiffs considering civil claims under the federal Racketeer Influenced and Corrupt Organizations Act (RICO). Although the Fifth Circuit’s decision focused on a procedural issue, the underlying case turned on a fundamental pleading failure: the plaintiff insurers did not adequately describe the fraudulent network they were suing as a RICO “enterprise.” The result was dismissal of a $14 million fraud case.

On February 20, 2026, the Department of Justice’s Antitrust Division (DOJ) and Ohio Attorney General (Ohio AG) sued OhioHealth Corporation (OhioHealth), alleging that OhioHealth had unlawfully restrained trade in the market for general acute care inpatient hospital services in the Columbus metropolitan statistical area and the narrower Central Columbus area, respectively. The DOJ and Ohio AG allege violations of Section 1 of the Sherman Act, as well as the Valentine Act (Ohio’s antitrust statute), claiming that OhioHealth leveraged its market power to impose contractual restrictions that blocked payors from working with competing health systems to design “budget-conscious” lower-cost health plans.

By the end of 2025, 16 drug manufacturers had voluntarily negotiated and executed agreements to adopt Most Favored Nation (MFN) pricing for certain high-cost drugs. The Trump Administration highlighted the agreements in its “Great Healthcare Plan,” published on January 15, 2026, and communicated the government’s plans to “codify” such deals as a means of “get[ting] Americans the same low prices that people in other countries pay.” The Administration recently leveraged MFN pricing to establish the TrumpRx website, which helps uninsured or cash-paying consumers find drugs at a discounted price. The website reflects the Administration’s stated commitment to provide more lower-cost drugs directly to consumers. Currently, 40 branded medications are available at reduced prices.

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.

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.

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.

On Friday, November 21, the Centers for Medicare & Medicaid Services (CMS) noticed its appeal of the Northern District of Texas’ decision in Humana Inc. et al. v. Becerra et al.

On January 4, in its most recent effort to expand federal support for addressing health-related social needs (HRSNs), the Centers for Medicare & Medicaid Services (CMS) issued guidance to clarify an existing option for states to address HRSNs through the use of “in lieu of” services and settings policies in Medicaid managed care. This option is designed to help states offer alternative benefits that take aim at a range of unmet HRSNs, such as housing instability and food insecurity, and to help enrollees maintain their coverage and improve health outcomes. 

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.

In Health Republic Insurance Co. v. U.S. (Jan. 10, 2017), the Court of Federal Claims (Court) rejected the Government’s motion to dismiss a lawsuit filed under the Tucker Act seeking to recover “risk corridors” payments pursuant to §1342 of the Affordable Care Act, holding that “HHS is required to make annual risk corridors payments to eligible qualified health plans” under the ACA, and that the “plaintiff’s claim for unpaid risk corridors payments is ripe for adjudication.” The Court’s decision was based on several factors, including the risk corridors program’s purpose of stabilizing insurance premiums in the ACA’s new and untested health insurance marketplace; notably, the Court held that even if the ACA were ambiguous and the court were to apply a Chevron deference analysis, HHS has interpreted the program to require annual payments, and the agency’s own actions (i.e., making partial annual payments) indicate it believes the program is annual in nature.

The Affordable Care Act (ACA) was enacted in 2010 and most of its provisions became effective by 2014. President Obama’s signature law ushered in nation-wide health insurance reforms and new pathways for coverage, but also created controversy over some of its key provisions—like the mandate to purchase insurance.

On Friday, October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the pre-publication version of the final rule with comment period (Final Rule) that, beginning January 1, 2017, will implement the provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) relating to the new Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). MIPS and APMs are collectively referred to as the “Quality Payment Program” or “QPP”. Physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists (collectively, “MIPS-eligible clinicians”) are part of the QPP if they bill Medicare more than $30,000 a year or provide care for more than 100 Medicare patients a year (both higher thresholds than initially proposed by CMS in the notice of proposed rulemaking).