Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Trump Administration Negotiates Cheaper GLP-1 Weight Loss Drugs Through Medicare Coverage Expansion
The Trump administration is finalizing negotiations with Eli Lilly and Novo Nordisk to reduce pricing for weight loss medications Wegovy and Zepbound by leveraging expanded Medicare and Medicaid coverage as part of a new CMS policy strategy. This “most favored nation” approach would significantly improve patient access to GLP-1 treatments, as Medicare currently restricts coverage to diabetes indications only, leaving millions without affordable access. The policy shift establishes a new precedent for federal drug pricing negotiations through coverage leverage, potentially impacting pharmaceutical manufacturers, healthcare stakeholders, and patients seeking weight management therapies.
Source(s):
Novo and Lilly Near Agreement for Cheaper Weight Loss Drugs (Stat)
Trump Administration Leverages Medicare Coverage for GLP-1 Drug Pricing (InsideHealthPolicy Daily News)
Tags: #DRUG, #PAYER, #PATIENT
Medicare Officials Push Prior Authorization Reform as Current Peer Review System Faces Mounting Criticism
CMS Director Chris Klomp is pressing private Medicare plans to implement their summer agreement to streamline prior authorization processes, calling current reforms “underwhelming” amid growing concerns over systemic delays in the peer-to-peer review system. The reform initiative aims to reduce administrative burdens on hospitals and healthcare providers while improving patient access to pharmaceutical treatments and medical devices, as critics highlight how the current CMS-regulated authorization system creates barriers to essential medication renewals and negatively impacts Medicare patient outcomes.
Source(s):
Medicare Chief Presses Plans To Implement Prior Auth Deal (InsideHealthPolicy Daily News)
The Dangerous Illusion of ‘Peer-to-Peer’ Review for Prior Authorization (Stat)
Tags: #ALL
CMS Finalizes Controversial 2.5% Medicare Physician Fee Schedule Adjustment for 2026 Despite Widespread Provider Opposition
The Centers for Medicare & Medicaid Services (CMS) has finalized the 2026 Medicare Physician Fee Schedule featuring a contentious 2.5% efficiency adjustment that will reduce payments for surgeries and specialist procedures while increasing overall payments by 2.5% as part of a shift toward preventive care models. The policy has drawn sharp criticism from physician groups, medical associations, and specialty societies who argue the cuts threaten practice sustainability, provider participation in Medicare programs, and patient access to specialized cardiovascular and surgical care. Healthcare stakeholders are calling for Congressional intervention to address what they view as inadequate Medicare reimbursement structures that fail to account for care complexity while potentially forcing practice consolidations and reduced service availability for Medicare beneficiaries.
Source(s):
Final Medicare Physician Fee Schedule Rule Displeases Doc Groups (MedPageToday.com – medical news for physicians)
2026 Medicare Physician Fee Schedule: Payment up 2.5% as CMS shifts from ‘sick-care’ to health care (Medical Economics – “healthcare and CMS” – Google News)
Medicare Physician Fee Schedule cuts cardiologist pay because CMS says doctors should be more efficient (Cardiovascular Business)
Physicians criticize CMS’ efficiency adjustment (Becker’s Hospital Review)
Medicare to Cut Pay for Specialist Physicians (Stat)
Tags: #PROVIDER, #PAYER
Trump Administration’s Medicaid Policy Shifts Create Mixed Results for States and Vulnerable Populations
The Trump administration’s Medicaid initiatives through CMS have produced conflicting outcomes, with new eligibility verification targeting suspected undocumented individuals while drug pricing programs like the most-favored nation pilot show limited cost savings potential for states. Despite proven successes like North Carolina’s Healthy Opportunities Pilot saving $1,020 per participant annually and reducing emergency visits, innovative programs face termination due to funding challenges, highlighting systemic barriers to scaling effective healthcare delivery models. These policy changes collectively impact hospital systems, Medicare-Medicaid dual eligibles, and vulnerable patient populations while creating administrative burdens for state agencies managing enrollment and reimbursement processes.
Source(s):
Report: CMS sent states lists of names for impromptu Medicaid eligibility check (Health Exec)
Medicaid’s ‘GENEROUS’ Pricing May Not Save States Money (Stat)
States might not get cheaper drugs in Trump’s most-favored nation Medicaid pilot program (Stat)
The Medicaid Program That Saved Money, Turned People’s Health Around — and Got Killed (POLITICO)
Tags: #ALL
PhRMA Says 340B Rebate Pilot Helps With PFS Data Repository; CMS Advances ASP Changes
Starting January 1, 2026, CMS will establish a voluntary Medicare Part D claims data repository for 340B drug discount program participants, enhancing pharmaceutical pricing transparency. This CMS initiative coincides with a pilot allowing drug companies to offer rebate payments instead of upfront discounts to hospitals, potentially improving program efficiency and stakeholder compliance with federal pricing requirements.
Source(s):
PhRMA Says 340B Rebate Pilot Helps With PFS Data Repository; CMS Advances ASP Changes (InsideHealthPolicy Daily News)
Tags: #DRUG, #HOSPITAL, #PAYER
Medicare Contractors Weigh Coverage Cuts to Chronic Pain Procedures
Medicare administrative contractors are proposing significant coverage restrictions for chronic pain management procedures, specifically limiting the use of peripheral nerve blocks. The American Society of Regional Anesthesia and Pain Medicine has criticized these proposals, warning they could severely restrict access to effective pain management for patients across 24 states.
Source(s):
Medicare Contractors Weigh Coverage Cuts to Chronic Pain Procedures (Becker’s Hospital Review)
Tags: #PROVIDER, #PATIENT, #PAYER
UnitedHealthcare drops remote monitoring coverage in defiance of Medicare policies
Starting January 2026, UnitedHealthcare will cease Medicare Advantage coverage for remote patient monitoring devices for chronic conditions, citing insufficient evidence, impacting millions of beneficiaries. Coverage limited to heart failure and pregnancy hypertension monitoring only. Policy contradicts CMS guidance supporting remote monitoring access, potentially restricting necessary care and creating coverage gaps for device manufacturers and healthcare providers serving Medicare populations.
Source(s):
UnitedHealthcare drops remote monitoring coverage in defiance of Medicare policies (Stat)
Tags: #ALL
Food and Drug Administration (FDA)
FDA Faces Credibility Crisis as Top Drug Regulator Resigns Amid Defamation Lawsuit and Regulatory Challenges Mount
The FDA is confronting a significant credibility crisis following the resignation of George Tidmarsh, head of the Center for Drug Evaluation and Research, amid a defamation lawsuit filed by Aurinia Pharmaceuticals alleging misconduct and personal vendettas in regulatory decisions. This controversy compounds existing challenges highlighted by the agency’s recent rejection of Biohaven Pharmaceuticals’ spinocerebellar ataxia treatment, underscoring broader tensions between pharmaceutical companies and FDA oversight regarding approval standards and real-world evidence requirements. The developments raise critical concerns about regulatory integrity and its potential impact on drug approval processes, industry stakeholder confidence, and ultimately patient access to medications.
Source(s):
The FDA is a mess, but don’t blame it for everything (Stat)
Scandal and Controversy Take Toll on FDA Credibility (Stat)
Lawsuit Against Top FDA Drug Regulator is Packed with Incendiary Texts, Emails (Stat)
FDA’s Top Drug Regulator Sued by Drug Company, Resigns Amid Conduct Probe (The Hill)
Tags: #DRUG, #PATIENT
FDA Commissioner Makary Faces Mounting Pressure as CDER Director Search Stalls Following Ethics Scandal
FDA Commissioner Marty Makary is struggling to fill the critical Center for Drug Evaluation and Research director position after George Tidmarsh’s departure over ethical violations, with multiple candidates declining the role and creating regulatory uncertainty. The leadership vacuum at CDER threatens to impact drug approval timelines and pharmaceutical oversight, raising concerns among industry stakeholders and Medicare beneficiaries who depend on timely access to FDA-approved medications. The Wall Street Journal’s ongoing criticism of FDA governance highlights broader organizational challenges facing the agency’s pharmaceutical regulatory operations.
Source(s):
Makary Struggles To Fill CDER Slot, WSJ Again Slams FDA (InsideHealthPolicy Daily News)
FDA broadens search for new top drug regulator after early setbacks (Stat)
Tags: #DRUG, #DEVICE, #PATIENT
FDA Launching New Medical Device RWE Program Amid Staff Losses
The FDA is partnering with the Medical Device Innovation Consortium to launch a new NEST program enhancing real-world evidence quality for medical device regulatory decisions. This initiative aims to expedite device approvals and foster innovation despite agency staffing challenges from private sector departures, potentially impacting hospital adoption timelines and Medicare coverage determinations for new medical technologies.
Source(s):
FDA Launching New Medical Device RWE Program Amid Staff Losses (insidehealthpolicy.com)
Tags: #DEVICE
FDA Halts Severance Pay For RIF’d Employees Amid Shutdown
The FDA has suspended severance pay for employees laid off during a reduction in force, citing the ongoing government shutdown as the reason.
Source(s):
FDA Halts Severance Pay For RIF’d Employees Amid Shutdown (InsideHealthPolicy Daily News)
Tags: #ALL
How Medtech Can Navigate Changes in FDA – Medical Device and Diagnostic industry
Strategies for medical device and diagnostic companies to adapt to evolving FDA regulatory changes affecting hospital procurement and Medicare reimbursement. Emphasizes compliance frameworks and innovation pathways for device manufacturers navigating CMS coverage decisions and pharmaceutical-device convergence in the changing regulatory landscape.
Source(s):
How Medtech Can Navigate Changes in FDA – Medical Device and Diagnostic industry (Medical Device and Diagnostic industry)
Tags: #DEVICE, #DRUG, #HOSPITAL
Health and Human Services
Depoliticize Public Health to Rebuild Trust, Former HHS Officials Say
Former HHS officials call for depoliticizing public health to restore trust in health systems and federal agencies like FDA and CMS. They recommend state-level policy wins and education initiatives to improve public cooperation with health policies affecting hospitals, Medicare programs, and pharmaceutical oversight.
Source(s):
Depoliticize Public Health to Rebuild Trust, Former HHS Officials Say (MedPageToday.com)
Tags: #ALL
‘Faster is better’ for AI, HHS’ Jim O’Neill says as agency looks to bulk up tech talent
Jim O’Neill from HHS emphasized rapid AI advancement as the agency strengthens its tech workforce to enhance healthcare efficiency. This initiative could impact Medicare administration through CMS, FDA device approvals, and pharmaceutical oversight, potentially accelerating regulatory processes and improving hospital system integration with federal health programs.
Source(s):
‘Faster is better’ for AI, HHS’ Jim O’Neill says as agency looks to bulk up tech talent (Fierce Healthcare)
Tags: #ALL
Heard on the Hill
Government Shutdown May End Without ACA Subsidy Extension Despite Democratic Push
The Senate voted 60-40 on November 9, 2025, to advance a deal ending the historic 36-day government shutdown, but the agreement excludes the extension of enhanced ACA premium tax credits set to expire at year-end 2025. The shutdown disrupted FDA device approvals, CMS Medicare processing, and hospital compliance oversight, while the continuing resolution would retroactively extend Medicare telehealth flexibilities through January 31 and ensures federal worker backpay. Eight Senate Democrats voted with Republicans to advance the deal despite lacking ACA subsidy guarantees, drawing criticism from party members concerned about rising premiums for millions of Americans and potential impacts on Medicare beneficiaries, hospital reimbursements, and pharmaceutical access.
Source(s):
Fresh from election wins, Dems demand Trump meeting over shutdown (Government Executive – All Content)
House members release bipartisan ‘principles’ for extending Obamacare subsidies (POLITICO – TOP Stories)
Democrats split over shutdown endgame (POLITICO – TOP Stories)
House lawmakers pitch ACA enhanced subsidy extension amid shutdown (Becker’s Hospital Review)
Eight Senate Democrats Vote to End Government Shutdown (POLITICO – TOP Stories)
Democrats Concede Shutdown Fight Without ACA Subsidies Extension (modernhealthcare.com)
Senate Moves Shutdown-Ending Deal That Ensures Backpay and Unwinds Federal Layoffs (Government Executive – All Content)
Senate CR Would Retroactively Extend Telehealth Flexibilities, Other Medicare Programs To Jan. 31 (InsideHealthPolicy Daily News)
Six Takeaways From the Senate Deal to End the Shutdown (The New York Times)
Senate Inches Closer To Ending Shutdown, But Deal Faces Uncertainty In House (InsideHealthPolicy Daily News)
Senate Takes First Step Toward Ending the Government Shutdown (Stat)
Democrats Outraged Over Shutdown Deal (POLITICO – TOP Stories)
Democrats Scale Back Shutdown Demands, but G.O.P. Digs In (The New York Times)
Tags: #PAYER, #PATIENT
Trump renews a Republican battle cry: Repeal Obamacare
Amid the longest federal government shutdown, President Trump and Republican leaders have reignited calls to repeal the Affordable Care Act, citing rising healthcare costs and access issues. This reflects ongoing partisan debates over healthcare policy, particularly regarding the implications of tax cuts on Medicaid and the ACA’s expansion.
Source(s):
Trump renews a Republican battle cry: Repeal Obamacare (Stat)
Tags: #ALL
Notable Notes
Pfizer Wins $10 Billion Bidding War for Obesity Startup Metsera After FTC Raises Antitrust Concerns Over Novo Nordisk’s Competing Bid
Pfizer successfully acquired obesity-drug startup Metsera for $10 billion, defeating Novo Nordisk in a competitive bidding war that prompted Federal Trade Commission antitrust scrutiny over potential Hart-Scott-Rodino Act violations and pharmaceutical market consolidation concerns. The acquisition reflects intensified industry investment in obesity treatments amid FDA approval pathways and potential Medicare coverage expansion, while Pfizer’s legal action against both companies over alleged contract breaches highlights the complex regulatory and competitive dynamics affecting drug pricing and patient access to innovative obesity therapies. The deal’s outcome could influence future pharmaceutical consolidation patterns and healthcare costs for Medicare beneficiaries and hospital systems.
Source(s):
Novo CEO Defends Acquisition Bid for Metsera Amidst Competitive Bidding War (Stat)
FTC raises concern about Novo Nordisk attempt to acquire obesity startup Metsera (Stat)
Bidding war between Pfizer, Novo Nordisk for obesity startup Metsera escalates (Stat)
Pfizer sues Metsera, Novo Nordisk over failed merger (Becker’s Hospital Review)
Pfizer beats out Novo in bidding war for obesity-drug startup Metsera (Stat)
Tags: #DRUG, #PAYER, #PATIENT
UnitedHealth’s Dual Policy Shifts Signal Broader Healthcare Market Consolidation Strategy
UnitedHealth Group is implementing contrasting reimbursement policies that favor its own operations while restricting coverage elsewhere, with a new study showing the insurer pays its Optum-owned physician practices 17% more than independent providers, raising CMS antitrust concerns about vertical integration. Simultaneously, UnitedHealthcare will end Medicare Advantage and commercial reimbursement for most remote patient monitoring services starting in 2026, diverging from expanded CMS Medicare RPM coverage and potentially limiting access to monitoring technologies. These coordinated moves affect hospital systems, independent practices, device manufacturers, and healthcare providers, prompting potential federal oversight of insurer strategies that may distort healthcare delivery and market competition.
Source(s):
UnitedHealth Pays Its Own Physician Groups 17% More Than Outside Ones, Study Shows (Stat)
UnitedHealthcare Ends Reimbursement for Most Remote Patient Monitoring (Health Exec)
Tags: #PAYER, #PROVIDER, #HOSPITAL
Sponsor, Advocates Hopeful VA PDAB Bill Passes With New Governor
With Virginia’s new Democratic governor, advocates expect passage of a state prescription drug affordability board (PDAB) bill previously vetoed by the Republican predecessor. The PDAB would regulate pharmaceutical pricing, potentially affecting Medicare beneficiaries and healthcare stakeholders, as Virginia joins other states implementing drug cost control mechanisms amid rising prescription expenses. However, many stakeholders have expressed concerns that PDABs only serve to limit access to costly medications.
Source(s):
Sponsor, Advocates Hopeful VA PDAB Bill Passes With New Governor (InsideHealthPolicy Daily News)
Tags: #DRUG, #PAYER, #PATIENT
All 50 States Apply For Rural Health Fund As Applications Close
As the application window closes for the rural health fund established by a recent GOP megabill, CMS Administrator Mehmet Oz announced that all 50 states intend to apply. States are proposing initiatives to enhance nutrition, bolster the rural workforce, and utilize telehealth to improve healthcare coordination in rural areas, reflecting a concerted effort to address health disparities and improve access in underserved communities.
Source(s):
All 50 States Apply For Rural Health Fund As Applications Close (InsideHealthPolicy Daily News)
Tags: #ALL
U.S. Lung Cancer Survival Improves to Nearly 30%, but Funding Cuts Threaten Progress
The American Lung Association reports lung cancer five-year survival rates improved to nearly 30% from 18% eight years ago, driven by FDA-approved pharmaceutical advances and device innovations. However, potential Medicare and CMS funding cuts threaten to undermine hospital-based cancer programs and ongoing research, jeopardizing patient access to life-saving treatments and putting healthcare stakeholders at risk of reduced reimbursements for critical oncology services.
Source(s):
U.S. Lung Cancer Survival Improves to Nearly 30%, but Funding Cuts Threaten Progress (Managed Healthcare Executive articles)
Tags: #ALL
Why delayed care is taking on new urgency for health systems
Hospitals face mounting financial pressures as 36% of adults delay necessary care due to costs, rising to 75% among uninsured patients. This trend threatens Medicare reimbursements and hospital stability, prompting health systems to implement proactive screening outreach programs. CMS and policymakers must address access barriers to prevent escalating healthcare costs and worsening patient outcomes across vulnerable populations.
Source(s):
Why delayed care is taking on new urgency for health systems (Becker’s Hospital Review)
Tags: #HOSPITAL, #PAYER, #PATIENT
Are We Ready for the Onslaught of Health Data?
The increasing use of artificial intelligence in patient care raises concerns about healthcare systems’ capacity to manage the influx of health data. As AI technology advances, hospitals and healthcare providers must prepare for data management complexities while navigating FDA regulatory requirements and potential Medicare reimbursement implications for AI-integrated clinical practice.
Source(s):
Are We Ready for the Onslaught of Health Data? (MedPageToday.com)
Tags: #ALL
Gilead’s Twice-Yearly HIV Prevention Shot Beats Coverage Goals
Gilead’s twice-yearly HIV prevention injection achieved 75% U.S. payor coverage, exceeding targets by three months. The FDA-approved pharmaceutical breakthrough demonstrates improved Medicare and commercial insurance access to innovative prevention methods, potentially reducing HIV transmission rates and healthcare costs while advancing CMS prevention priorities for vulnerable populations.
Source(s):
Gilead’s Twice-Yearly HIV Prevention Shot Beats Coverage Goals (InsideHealthPolicy Daily News)
Tags: #DRUG, #PAYER, #PATIENT
Opinion: It’s Time to Fundamentally Rethink How America Pays for Health Care
The current U.S. healthcare reimbursement system prioritizes high-cost hospital procedures and device interventions over patient-centered care, affecting Medicare spending and CMS policies. Healthcare reform advocates call for shifting from volume-based to relationship-driven care models to improve patient outcomes, reduce pharmaceutical costs, and enhance satisfaction across healthcare stakeholders.
Source(s):
Opinion: It’s Time to Fundamentally Rethink How America Pays for Health Care (Stat)
Tags: #ALL
Is the White House’s Deal with Pharma on GLP-1 Drugs a Game Changer?
President Trump’s pharmaceutical agreement with drug manufacturers will reduce GLP-1 weight loss medication costs for Medicare beneficiaries from $1,000 to $250 monthly through CMS negotiations. This FDA-approved drug pricing policy shift significantly expands access for high-risk patients while impacting pharmaceutical company revenues and Medicare spending.
Source(s):
Is the White House’s Deal with Pharma on GLP-1 Drugs a Game Changer? (Stat)
Tags: #ALL
Microsoft to develop healthcare AI ‘superintelligence’
Microsoft has initiated the formation of an AI “superintelligence” team aimed at revolutionizing healthcare, with predictions of achieving expert-level diagnostic capabilities in the coming years. The Microsoft AI Diagnostic Orchestrator has demonstrated an 85% accuracy rate in diagnoses, significantly outperforming human doctors, who typically achieve around 20%. This advancement could enhance clinical knowledge and treatment accessibility across various healthcare settings.
Source(s):
Microsoft to develop healthcare AI ‘superintelligence’ (Becker’s Hospital Review)
Tags: #ALL
How much competition does healthcare need?
Healthcare executives debate optimal competition levels in the industry, emphasizing that balanced market dynamics drive innovation and improve patient outcomes while preventing care fragmentation. Hospital leaders stress maintaining mission-driven approaches under Medicare and CMS pressures, ensuring pharmaceutical and device innovations serve patient needs over market forces, with FDA oversight supporting quality standards.
Source(s):
How much competition does healthcare need? (Becker’s Hospital Review)
Tags: #ALL