The Administrator for the Centers for Medicare & Medicaid Services (CMS), Dr. Mehmet Oz, spoke to non-profit health system executives, investors, and industry observers this week at the 25th Annual Not-for-Profit Healthcare Investors Conference sponsored by Barclays, HFMA and the American Hospital Association. Dr. Oz outlined his vision for CMS – after joking that the difference between a “vision” and a “hallucination” is whether a person can bring others along with them – and addressed some of the critical policy issues related to Medicaid currently under debate in the United States Congress. Continue Reading CMS Administrator Outlines His Vision for CMS at NFP Healthcare Investors Conference

On May 15, 2025, the U.S. Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (“Departments”) issued a Statement announcing that they will not enforce portions of a final rule relating to the Mental Health Parity and Addiction Equity Act (“MHPAEA”), which was adopted in 2024. This non-enforcement policy will likely be well received by plan sponsors, employers and health plans, many of whom have been critical of additional reporting obligations and unclear guidance from the Departments. Perhaps more significantly, the statement provides that the Departments will reconsider broader issues related to mental health parity, including the Departments’ approach to enforcement of MHPAEA as amended by legislation passed in 2021. The history below provides more context on this recent development.Continue Reading Enforcement of Mental Health Parity Rules Paused with Further Changes Anticipated

In a recent decision with important implications for artificial intelligence (AI) driven innovation, the Patent Trial and Appeal Board (PTAB) denied a patent for an AI-based medical tool.[1] The refusal was not because the invention was not new or inventive. Rather, the refusal was because the invention did not meet a fundamental rule of U.S. patent law. In Ex parte Michalek, the PTAB specifically acknowledged that the patent claims at issue recited new information about the nexus between certain biomarkers and the development of lung cancer as facilitated by machine learning. In fact, prior to appeal, the applicant had successfully refuted all arguments raised by the patent examiner that the invention was not new or nonobvious. That said, based on U.S. Patent Office guidance and a related example from that guidance, the PTAB still determined the claims were flawed based on the legal principle of subject matter eligibility. Although the facts in this decision concern medical health innovation, the decision is helpful to inform patent strategy for AI-enabled inventions across various disciplines and industries.Continue Reading PTAB Rejects AI-Driven Medical Patent – Not for Novelty, But Eligibility

Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act[i] (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with generative AI with heightened requirements on regulated professions, including licensed healthcare professionals.Continue Reading Utah Enacts AI Amendments Targeted at Mental Health Chatbots and Generative AI

The Centers for Medicare & Medicaid Services (CMS) recently published the fiscal year (“FY”) 2026 proposed rule for Hospital Inpatient Prospective Payment Systems (IPPS) (the “Proposed Rule”). Comments to the Proposed Rule must be submitted by 5 p.m. EDT on June 10, 2025.Continue Reading CMS Proposes Medicare Payment Policies for Hospital Inpatient Services for Federal Fiscal Year 2026

Earlier this month, the Eleventh Circuit (the “Court”) issued a decision in a False Claims Act (“FCA”) case against a medical supplier that offers welcome clarity for companies facing whistleblower allegations. In Vargas ex rel. Alvarez v. Lincare, Inc., 2025 U.S. App. LEXIS 9084 (11th Cir.), the Court emphasized high pleading requirements FCA plaintiffs must satisfy to survive a motion to dismiss. Specifically, the court held that it is not enough to allege a general scheme; the FCA plaintiff must also plead, with detail, how the scheme caused the actual submission of false claims to the government. The decision is especially significant in the healthcare context with respect to Anti-Kickback Statute (“AKS”) based FCA cases. The court made clear that the plaintiff must do more than include conclusory allegations that one purpose of the payment was to induce referrals—it must include details as to the defendant’s intent.Continue Reading Inferential Leaps and Conclusory Kickback Allegations Remain Verboten in False Claims Act Complaints

On January 28, 2025, President Trump signed Executive Order 14187 (the “EO”), which directed the federal government to take steps to ensure that the federal government does not “sponsor, promote, assist, or support” the “‘transition’ of a child from one sex to another,” including the provision of gender-affirming care to individuals under the age of nineteen. Specific provisions of the EO directed, among other things, that: (1) all federal agencies rescind or amend all policies relying on guidance issued by the World Professional Association for Transgender Health; (2) federal agencies that provide research or education grants to hospitals and medical schools take “appropriate steps” to ensure that institutions receiving federal research or education grants end gender-affirming care to individuals under the age of nineteen; (3) the Secretary of the Department of Health and Human Services (“HHS”) take all appropriate regulatory and legal action to end gender-affirming care for individuals under the age of nineteen—such as through Medicare or Medicaid conditions of participation or conditions for coverage, clinical-abuse or inappropriate-use assessments relevant to State Medicaid programs; (4) the U.S. Attorney General to enforce an existing federal law against “genital mutilation” (18 U.S.C. § 116), and coordinate with state attorneys general to enforce state laws against gender-affirming care; and (5) the Director of the Office of Personnel Management include provisions in the Federal Employee Health Benefits and Postal Service Health Benefits programs call letter for the 2026 plan year specifying that eligible carriers exclude coverage for pediatric transgender surgeries or hormone treatments.Continue Reading Recent Legal and Regulatory Developments Involving Gender-Affirming Care

As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is being transformed before our eyes. The journey ahead is anything but straightforward, with solutions ranging from bold, large-scale changes to more nuanced, focused innovations. Let’s delve into the high-level, dynamic trends shaping the pharmacy world today.Continue Reading Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

The number of U.S. states implementing or considering new antitrust laws (or supplementing existing laws) targeting proposed transactions continues to grow. As detailed in our healthcare merger matrix, many states have focused their attention on the healthcare industry, and that continues to be the case, for example, in New York, where a broad range of proposed transactions involving health care entities could be subject to filing requirements and suspensory rules before they can close.Continue Reading State Antitrust Enforcement Roundup: New Laws; New Potential Legislation; and New (and Broader) Areas of Focus

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”), Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (the “Final Rule”). While CMS finalized several proposals of its Proposed Rule, it did not finalize many of its key proposals, including on anti-obesity medication (“AOM”) coverage, enhanced guardrails for artificial intelligence (“AI”), and various health equity related initiatives in MA and Part D.Continue Reading CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

In a move signaling a major shift in federal priorities, the Centers for Medicare & Medicaid Services (“CMS”) recently announced it will limit federal funding for state Medicaid initiatives that support services beyond direct medical care. New policy guidance indicates that CMS intends to narrow the scope of the federal-state Medicaid partnership, refocusing matching funds on core healthcare services delivered to Medicaid beneficiaries. The timing is notable, as Congress and state Medicaid leaders brace for the potential of more significant cuts to federal funding for Medicaid in the upcoming federal budget reconciliation process.Continue Reading CMS to Withdraw Federal Medicaid Match for Workforce, Social Needs, and Infrastructure: What States, Health Care Providers and Community Organizations Need to Know