Health Care Watch: August 31, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 23 – August 29. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
The House is scheduled to return from its summer recess on August 31.
On September 1, the House is expected to consider the Senate-passed government funding bill under suspension of the rules. Government funding is set to expire on October 1, absent Congressional action.
Senate
On August 27, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) released a report examining mifepristone manufacturers Danco Laboratories, GenBioPro, and Evita Solutions following a months-long committee investigation into the companies’ business practices and compliance with the Food & Drug Administration’s (FDA’s) Risk Evaluation and Mitigation Strategy (REMS) requirements. The report raised concerns about manufacturer oversight of certified prescribers and pharmacies, online prescribing practices, and the availability of adverse-event data following FDA’s 2016 removal of the requirement that prescribers report non-fatal adverse events to mifepristone sponsors. A press release can be found here.
The Senate is scheduled to return from its summer recess on September 14.
REGULATORY UPDATE
On August 24, the Centers for Medicare & Medicaid Services (CMS) announced $144 million in Rural Health Transformation Program (RHTP) funding for 138 grants in Alabama to expand access to care, modernize health care technology and infrastructure, and strengthen the rural health care workforce. The funding will support projects focused on mental health and substance use disorder services, emergency and maternal care, telehealth and mobile health services, electronic health records and cybersecurity, and workforce training and recruitment.
On August 24, Roche announced that FDA cleared the Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, developed in collaboration with Lilly, to aid in assessing amyloid pathology associated with Alzheimer’s disease in people ages 55 and older with signs, symptoms, or complaints of cognitive decline. The test provides positive, intermediate, or negative results to support rule-in and rule-out assessment of amyloid pathology and is intended to be interpreted alongside clinical information and other diagnostic findings. The test is not intended for stand-alone use or routine screening.
On August 25, CMS announced $160 million in RHTP funding for 142 projects across Alaska focused on health care technology, access, workforce development, and infrastructure. Projects include $250,000 to develop a framework for drone-based prescription drug delivery to remote villages, as well as funding for surgical robotics, behavioral health services, health data infrastructure, primary care workforce development, and an artificial intelligence imaging network across 21 hospitals.
On August 26, FDA approved Revolution Medicines’ Rasonque (daraxonrasib), a RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations and Priority Review, and reviewed the application under the Commissioner’s National Priority Voucher pilot program.
On August 26, CMS announced $3.15 million in RHTP funding to improve pharmacy connectivity and care coordination across rural Ohio. The funding includes $2 million to improve pharmacists’ access to patient medical records and medication management and $1.15 million to increase rural providers’ integration with the Ohio Automated Rx Reporting System.
On August 27, CMS announced $93.3 million in RHTP funding for Georgia to support 87 rural hospitals, including investments in value-based care preparation, workforce training and recruitment, telehealth, maternal and behavioral health services, and health care technology such as surgical robotics. CMS stated that the funding completes Georgia’s initial Year 1 RHTP award cycle, with the state committing its full approximately $218 million first-year award.
On August 27, FDA approved Priovant Therapeutics’ Lisraya (brepocitinib) for the treatment of dermatomyositis in adults, making it the first FDA-approved oral treatment for the rare autoimmune disease. The once-daily JAK/TYK2 inhibitor was evaluated in a Phase 3 trial of 241 adults, in which patients receiving the approved 30 mg dose demonstrated greater clinical improvement compared with placebo at 52 weeks. FDA granted Lisraya Orphan Drug and Priority Review designations.
On August 28, CMS announced that enforcement actions have prevented or recovered more than $1.6 billion in potentially improper Medicare laboratory payments since the beginning of the Trump Administration. CMS attributed the total to actions including revoking 157 laboratory providers, suspending payments, recovering overpayments, and referring cases to law enforcement, and said it has used artificial intelligence and machine-learning tools to identify potentially fraudulent billing patterns.
On August 28, CMS announced $122 million in RHTP funding for Virginia to expand rural health care access, workforce capacity, and health care innovation. The funding will support initiatives including remote patient monitoring, virtual and mobile care, maternal health services, community paramedicine, health care workforce training, health technology, and care coordination for individuals dually enrolled in Medicare and Medicaid.
On August 28, Lilly announced that FDA approved Mounjaro to reduce the risk of major adverse cardiovascular events, including cardiovascular death, nonfatal heart attack, and nonfatal stroke, in adults with type 2 diabetes who are at high risk for these events. Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with type 2 diabetes.
WHITE HOUSE
On August 26, Bloomberg reported that the Trump Administration plans to announce additional Most Favored Nation (MFN) drug pricing agreements with several midsize biotechnology companies on August 31. According to the report, participating companies would provide state Medicaid programs with discounts intended to align prices for outpatient drugs with prices charged in foreign countries, while the companies would receive exemptions from planned Medicare drug pricing pilots and potentially receive tariff relief.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Exchange Pre-Enrollment Eligibility Verification (CMS-9873); Proposed Rule; 04/22/2026
Strengthening the Integrity of Medicaid and CHIP Managed Care, Financing, and Access to Care (CMS-2450); Proposed Rule; 05/12/2026
Short-Term, Limited-Duration Insurance (CMS-9881); Proposed Rule; 05/30/2026
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546); Final Rule; 06/15/2026
Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545); Final Rule; 06/26/2026
Cutting Administrative Requirements for Excellence in Patient Care (CMS-3484); Proposed Rule; 07/02/2026
Patient Protection and Affordable Care Act; State Innovation Waivers and Health Care Choice Compacts (CMS-9877); Proposed Rule; 07/13/2026
Contract Year 2028 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and PACE (CMS-4214); Proposed Rule; 07/20/2026
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualification Requirements, and Other Changes (CMS-3478); Proposed Rule; 07/20/2026
Transparency in Coverage (CMS-9882); Final Rule; 07/27/2026
Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) (CMS-6098); Proposed Rule; 08/07/2026
Request for Information: Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards (CMS-4217); Notice; 08/19/2026
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Final Rule; 08/20/2026
FDA
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Notice; 05/22/2026
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Notice; 06/01/2026
New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Notice; 06/02/2026
Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension; Final Rule; 06/03/2026
Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition; Proposed Rule; 06/05/2026
Administrative Detention of Tobacco Products; Proposed Rule; 07/09/2026
U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Notice; 07/10/2026
Nonclinical Testing Terminology; Final Rule; 07/28/2026
White Paper: Proposed Definition of Ultra-Processed Food; Notice; 08/03/2026
Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products; Proposed Rule; 08/06/2026
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Notice; 08/11/2026
HEARINGS
House
Ways & Means Committee
Potential Markup
September 16
Bills to be considered: TBA; health care price transparency legislation is expected
REPORTS
Office of Inspector General (OIG)
On August 24, the HHS OIG released an audit finding that Arizona did not adequately ensure that selected Medicaid managed care organizations (MCOs) complied with federal mental health and substance use disorder parity requirements when applying prior authorization. OIG found that two of the three MCOs reviewed did not perform required annual parity analyses and recommended that Arizona clarify its requirements, require supporting documentation, and review MCOs’ annual analyses. Arizona concurred with two of the three recommendations.
ADDITIONAL POLICY NEWS
On August 21, the Federal Trade Commission (FTC) issued a press release announcing that it had filed, on August 17, an amicus brief in the U.S. Court of Appeals for the Fourth Circuit in litigation brought by CareFirst of Maryland alleging that Amgen’s acquisition of exclusive rights to pending patent applications related to Enbrel violated federal antitrust law. The FTC argued that private acquisitions of patent application rights are subject to antitrust scrutiny and that subsequent patent prosecution or enforcement does not shield the underlying transaction from antitrust liability. A press release can be found here.
On August 24, the U.S. District Court for the District of Columbia rejected Merck’s constitutional challenge to the Medicare Drug Price Negotiation Program (MDPNP). The court rejected Merck’s claims that the program violates the First Amendment by compelling speech and the Fifth Amendment by taking private property without just compensation, concluding in part that participation in the Medicare Part D Manufacturer Discount Program and the Medicaid Drug Rebate Program is voluntary.
On August 26, the U.S. Court of Appeals for the Fifth Circuit upheld a lower court ruling rejecting a challenge by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other groups to the MDPNP. The court rejected claims that the program violates the Constitution’s nondelegation doctrine and Fifth Amendment Due Process Clause and affirmed dismissal of the Eighth Amendment Excessive Fines Clause challenge concluding that the IRA’s excise tax is not a “fine” subject to that clause. The court concluded that manufacturers do not have a protected interest in selling drugs to the federal government at their preferred price because participation in Medicare and Medicaid is voluntary.
On August 26, Health Affairs published an analysis estimating that the No Surprises Act’s independent dispute resolution (IDR) process generated $22.4 billion in costs from 2022 through 2025, including payment awards above in-network rates, administrative costs, and IDR fees. The analysis found that IDR costs reached $16.6 billion in 2025 as dispute volume increased 77% and total payment awards increased 264% from 2024. The authors recommended that policymakers consider changes to the IDR process to address rising costs while maintaining the law’s consumer protections.
On August 27, the U.S. Court of Appeals for the Fifth Circuit upheld FDA determinations that Lilly’s Mounjaro and Zepbound and Novo Nordisk’s Ozempic and Wegovy are no longer in shortage. The court rejected challenges brought by the Outsourcing Facilities Association, concluding that FDA engaged in reasoned decision-making and that its determinations were not arbitrary or capricious. The FDA determinations limited outsourcing facilities’ ability to rely on the drug-shortage exception to broadly compound versions of the products.
On August 28, the Medicare Payment Advisory Commission (MedPAC) announced the agenda for its September public meetings, scheduled for September 3-4.