EPA’s Draft CCL6 Adds Microplastics, Drugs In MAHA Alignment
The Environmental Protection Agency released a draft of its sixth Contaminant Candidate List (CCL6) that formally includes microplastics and pharmaceutical residues as chemical groups for possible future drinking‑water regulation. The move mirrors demands from the Make America Healthy Again (MAHA) coalition, which has urged the agency to address emerging contaminants in public water supplies. While the EPA acknowledges these substances, the draft stops short of requiring immediate monitoring or setting enforceable limits. The proposal opens a regulatory pathway that could reshape testing and compliance for utilities nationwide.
Lilly Weight-Loss Pill First Novel Drug Approved Under CNPRV
Eli Lilly’s anti‑obesity pill Foundayo (orforglipron) became the first new molecular entity approved under the FDA Commissioner’s National Priority Voucher (CNPRV) pilot. The FDA granted approval just 50 days after Lilly filed the NDA, well ahead of its 294‑day target deadline. Foundayo’s...
CDC Not Testing For Pox Viruses Amid Mpox Outbreaks, Treatment Concerns
The Centers for Disease Control and Prevention has removed smallpox, mpox and rabies from its routine testing portfolio, even as mpox outbreaks flare in several nations. The agency’s website update confirms the suspension, raising alarms among clinicians who rely on...
Digital Rights Advocates Sue CMS Over WISeR, Dems Urge House Approps To Repeal Model
Digital rights group Electronic Frontier Foundation has filed a lawsuit against the Centers for Medicare & Medicaid Services demanding transparency for the Wasteful and Inappropriate Service Reduction (WISeR) model, which automates Medicare prior‑authorization decisions. The suit argues the model violates...
CMS LEAD Model Incorporates Telehealth, AI, Wearables, Interoperability
The Centers for Medicare & Medicaid Services (CMS) unveiled its Long‑term Enhanced ACO Design (LEAD) model, expanding accountable care organization (ACO) benefits to a larger share of Medicare beneficiaries. The model embeds new interoperability mandates and makes technology adoption—such as...
FDA Open To More Data On Rare Disease Drug Ersodetug Despite Missed Phase 3 Endpoint
Rezolute announced that the FDA remains open to reviewing additional data from its Phase 3 trial of the rare‑disease hypoglycemia drug ersodetug, despite the study missing its primary efficacy endpoint. The agency’s willingness suggests the experimental therapy could still move toward...
Bipartisan Bill Would Set Up Permanent Full-Risk ACO Program In Traditional Medicare
Lawmakers introduced a bipartisan bill on March 26 to establish a permanent, full‑risk accountable care organization (ACO) program within traditional Medicare. The legislation seeks to transition successful CMS Innovation Center pilots into a lasting model that places financial risk on...
Proposed FTC, CVS Agreement Underway To Settle Inflated Insulin Costs Allegations
The Federal Trade Commission and CVS Caremark have reached a settlement that resolves all claims alleging the pharmacy‑benefit manager inflated insulin prices through anticompetitive rebate practices. Court filings on March 23 indicate the agreement ends the FTC’s lawsuit in its...
Hawley Seeks Internal Data From Danco As Telehealth Abortions Rise
Sen. Josh Hawley (R-MO) has demanded that Danco Labs, the maker of mifepristone and misoprostol, turn over any internal communications it has had with the FDA, telehealth providers, pharmacists, patients, state medical boards, and attorneys general concerning the safety of...
CMMI AI Lead Bullish On Future Of ACCESS Model, Downplays Tech Focus
CMS Innovation Center’s AI and technology chief expressed strong confidence that the upcoming ACCESS payment model, built around outcome‑aligned payments (OAPs), will quickly gain traction in Medicare, Medicaid, and private insurers. He emphasized that the model’s focus on aligning payments...
Doctors for America Raises PDUFA, CNPV, Bayesian, Supply Chain Concerns With Lawmakers
Doctors for America met with bipartisan lawmakers to flag several regulatory concerns at the FDA. The group warned that “America First” provisions in the upcoming PDUFA negotiations could increase user fees and hinder drug access, while the agency’s reliance on...
Confusion Swirls Over ACIP, Vaccine Policy Future After Court Ruling
A federal court has halted the CDC’s Advisory Committee on Immunization Practices (ACIP) recommendations, throwing the Trump administration’s vaccine policy into uncertainty. Officials are weighing whether to appeal the decision or dissolve the current panel and appoint new members. The...
TrumpRx List Grows To 54 Drugs, Many Nearing End Of Exclusivity
The TrumpRx website now lists 54 prescription drugs after adding seven products from GlaxoSmithKline and Amgen. The expansion pushes the total from 47 to 54, but health‑policy analysts note that the majority are older medicines nearing the end of their...
Advocates Press Agencies For Guidance On New Medicare Eligibility Restrictions For Certain Immigrants
Advocates have warned that the Centers for Medicare & Medicaid Services (CMS) and the Social Security Administration (SSA) have not yet issued public guidance on new Medicare eligibility restrictions targeting certain immigrant groups. The restrictions, embedded in the Republican‑led reconciliation...
ACO Leaders Say Mandatory Models Could Expand Value-Based Care, But Incentives Must Be Right
CMS Innovation Center Director Abe Sutton signaled a push to enroll more providers in mandatory ACO payment models. In interviews, ACO executives said mandatory models could significantly expand the reach of value‑based care, but their success hinges on how CMS...
FDA Leucovorin Approval Raises Concerns About Reliance On Case Reports
The FDA granted approval for leucovorin calcium tablets to treat a rare genetic disorder that impairs folate transport to the brain. Unlike typical approvals, the agency relied primarily on a handful of patient case reports rather than a sponsor‑run clinical...
FDA Advisor Touts Approach Tailoring Regulation To Specific AI Use
The FDA’s artificial‑intelligence advisor announced a shift toward evaluating AI‑driven health technologies on a case‑by‑case basis, focusing on each tool’s specific function rather than applying a one‑size‑fits‑all rule set. This risk‑based approach will tailor regulatory requirements to the actual clinical...
Public Citizen To Push Compulsory Licensing If Pfizer Withholds Drugs From France
Public Citizen announced it will encourage compulsory licensing of generic drugs if Pfizer follows through on its January threat to withhold medicines from France unless the country raises drug prices. The consumer group’s stance turns a pricing dispute into a...
Senate Dems Ask How Trump’s MFN Deals Mesh With GENEROUS Model
Senate Democrats have pressed major pharmaceutical companies to clarify the secretive most‑favored‑nation (MFN) pricing agreements they struck with the Trump administration in December. Lawmakers are questioning how those deals align with the Centers for Medicare & Medicaid Services’ new GENEROUS...
ACOs Meet With Hill Staff On MACRA Reform
Accountable Care Organizations met with congressional staff last week to discuss reforms to the Medicare Access and CHIP Reauthorization Act (MACRA) after a bipartisan request for information was issued. The meeting aimed to explore long‑term solutions for physician payment that...
Prasad Out At FDA, Turning Critics’ Focus Back To Makary
Vinay Prasad, the FDA’s controversial biologics chief, has announced his departure, marking his second exit within a year. His resignation follows a public dispute over the agency’s handling of rare disease drug approvals, intensifying scrutiny of FDA decision‑making. Critics are...
CMS Gives States Two Options To Transition To Six-Month Medicaid Eligibility Checks
The Centers for Medicare & Medicaid Services (CMS) announced that beginning in 2027 states must move Medicaid eligibility checks from annual to six‑month intervals for the expansion population. States have two pathways: an immediate transition for all eligible beneficiaries or...
New Eli Lilly Platform To Expand Obesity Drug Options For Employers
Eli Lilly launched an Employer Connect platform on March 5, linking more than 15 independent program administrators with a nationwide pharmacy and telehealth network to broaden discounted access to its obesity drugs, notably the GLP‑1 Zepbound (tirzepatide) pen. The service targets employer‑sponsored...
Poll: Career Scientists, Outside Experts Trusted More Than HHS Leaders
A recent Annenberg Public Policy Center poll reveals that career scientists and independent experts enjoy higher public trust than leaders of the U.S. Department of Health and Human Services (HHS). Trust in federal public‑health agencies has declined steadily since the...
HHS Says About 50 Medical Schools Will Add Nutrition Training To Curricula
The U.S. Department of Health and Human Services announced that about 50 medical schools across 31 states will add at least 40 hours of nutrition training to their four‑year undergraduate curricula starting this fall. The initiative, driven by HHS Secretary...
CMS Eyes AI To Tackle Coding Under ‘CRUSH’ Anti-Fraud Plan
The Centers for Medicare & Medicaid Services (CMS) is evaluating artificial‑intelligence tools to improve the precision of Medicare Advantage coding and hospital billing. The initiative is part of the Trump administration’s proposed CRUSH (Combatting and Reducing Unnecessary Spending and Healthcare...
Johnson Floats ‘Right To Try 2.0’ As Makary Defends FDA’s Approval Standards
Senator Ron Johnson (R‑WI) is urging Congress to draft a “Right to Try 2.0” bill that would force the FDA to grant broader, faster access to experimental therapies for rare diseases. FDA Commissioner Martin Makary pushed back, defending the agency’s...
AHA Unveils ‘We Care, We Vote’ Campaign To Engage Candidates Ahead Of Midterms
The American Hospital Association (AHA) has launched the “We Care, We Vote” campaign to mobilize its member hospitals ahead of the 2026 midterm elections. The initiative offers a dedicated website featuring voter‑registration tools, turnout guides, and a questionnaire that helps...
Top HHS Officials Tout TEFCA Data-Sharing Framework As Central To MAHA
Top officials at the Department of Health and Human Services highlighted the Trusted Exchange Framework and Common Agreement (TEFCA) as a cornerstone of the "Make America Healthy Again" (MAHA) initiative. TEFCA, mandated by the 2016 bipartisan law, seeks to create...
CBO: Part D Contributed To Higher Medicare Spending Than Expected
The Congressional Budget Office’s latest 10‑year budget outlook reveals that Medicare spending will be higher than previously projected, largely due to the Part D prescription‑drug benefit. CBO estimates the drug benefit adds several hundred billion dollars to federal outlays over the...
Cassidy, GOP Colleagues File Brief In LA Case On Comstock Act
Senate health committee chair Bill Cassidy and 59 Republican lawmakers filed an amicus brief supporting Louisiana’s lawsuit that the FDA violated the 1870 Comstock Act by permitting telehealth prescribing of mifepristone. The brief argues the agency overstepped its authority, seeking...
Oz: Codifying MFN Deals Could Avert ‘Draconian’ Pricing Measures
Pfizer CEO Albert Bourla met with CMS Administrator Mehmet Oz to negotiate a "most‑favored‑nation" (MFN) drug pricing agreement, though the specific terms were not disclosed. Oz indicated that the Trump administration plans to codify such voluntary MFN deals into law...
Oz: Codifying MFN Deals Could Avert ‘Draconian’ Pricing Measures
Pfizer CEO Albert Bourla disclosed a direct collaboration with CMS Administrator Mehmet Oz on a "most favored nation" (MFN) drug pricing arrangement, though the specific terms remain undisclosed. Oz indicated that the Trump administration intends to codify such voluntary MFN...
Pediatric Myopia Drug Is Latest In String Of Unexpected FDA Rejections
The FDA has rejected a pediatric myopia drug, citing a lack of substantial evidence for its efficacy. Pediatric ophthalmologists argue the drug, already used in compounded form, effectively slows myopia progression in children. The decision follows a series of recent,...
FDA Backtracks On Moderna mRNA Flu Vaccine Refusal, Sets Aug. 5 Review Deadline
The U.S. Food and Drug Administration has reversed its earlier decision to decline a review of Moderna's mRNA influenza vaccine candidate. Following a Type A meeting with the company, the agency set an August 5, 2026 deadline for completing its evaluation. The...
Judge’s Ruling Expected On Whether To Block ACIP Meeting
A federal judge is set to rule this week on a lawsuit seeking to prevent the CDC’s Advisory Committee on Immunization Practices (ACIP) from convening. The plaintiffs argue the committee, whose members were appointed by HHS Secretary Robert F. Kennedy...
Doctors Tell Senators CMS Red Tape Is Driving Workforce Exodus, Threatening Access
Physicians, medical educators and health system leaders testified before the Senate Special Committee on Aging that escalating CMS regulations—particularly prior authorizations and Medicare quality reporting—are intensifying burnout and prompting many to leave clinical practice. The testimony highlighted that these administrative...
RFK Jr. Taps FDA Policy And Food Chiefs As Senior Counselors To Also Serve On His Immediate Staff, Raising Expectations...
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has appointed FDA policy chief Grace Graham and senior FDA food official Kyle Diamantas as senior counselors who will also serve on his immediate staff. The move follows a broader senior‑level...
Oklahoma Plans Decentralized State-Based Exchange
Oklahoma’s insurance commissioner announced that the state will abandon the federal health‑insurance marketplace and launch a decentralized, state‑run exchange beginning in the 2028 plan year. The new platform will rely on web‑based brokers to handle enrollment, giving the state greater...
Hims Jumps Into Cancer Detection Market, Awaits Medicare Coverage
Telehealth and wellness brand Hims & Hers Health announced it will enter the multi‑cancer early‑detection market. The move comes as the company’s GLP‑1 weight‑loss segment slows and it seeks new growth avenues. Hims is leveraging the current regulatory gap for...
FDA Staff Dropoff Continues In First Quarter Of FY 2026
FDA’s drug and biologic product centers reported a continued decline in staff during the first quarter of fiscal 2026, extending a year‑long downward trend. The reduction persists even as Commissioner Marty Makary publicly pledged to accelerate hiring. The agency has...
CBO: CMS Skin Substitute Policy To Save $245B By 2035
CMS announced a comprehensive overhaul of its reimbursement rules for skin substitutes, high‑cost dressings used in chronic wound care. The policy tightens medical‑necessity criteria, promotes evidence‑based alternatives, and leverages negotiated pricing. The Congressional Budget Office incorporated these changes into its...
Payers Pledge To Launch Digital Health Payment Models Like CMS’ ACCESS
On Feb 12, HHS announced that health insurers covering roughly 165 million Americans have pledged to implement digital‑health reimbursement models modeled on CMS’s ACCESS program by Jan 1 2028. The ACCESS model adjusts payments based on measurable patient‑outcome impact, shifting from volume‑based to value‑based...
CDC, NIH Performance Review Change May Rate More Workers ‘Unacceptable’
The Centers for Disease Control and Prevention and the National Institutes of Health announced a new performance‑review framework that links lower ratings to easier termination. The policy reclassifies a swath of federal staff into a category with reduced civil‑service protections,...
CDC Facing Another Lawsuit Over Grant Cuts In Blue States
The Centers for Disease Control and Prevention abruptly cancelled multi‑year public‑health grants that had already been awarded to jurisdictions in Democratic‑led states. The rescinded funding includes Public Health Infrastructure Grants and programs targeting HIV and other sexually transmitted infections. The...
NIH Will Not Renew Criswell’s Term As NIAMS Director, Adding To Leadership Vacancies
The National Institutes of Health announced it will not renew Linsey Criswell's term as director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Criswell's departure creates another open director position amid a growing list of leadership...
CBO: Medicaid Spending Increases Will Slow Due To OBBBA But Expected To Continue
The Congressional Budget Office (CBO) projects that the 2025 reconciliation bill’s Omnibus Budget Reconciliation Act (OBBBA) will trim roughly $1.2 trillion from Medicaid spending over the next decade. Despite this sizable reduction, overall Medicaid outlays are expected to keep rising because...
E&C Health Panel Determined To Rein In Remaining PBM Business Tactics
On February 11, the House Energy & Commerce health subcommittee signaled it will keep pressuring pharmacy benefit managers (PBMs) after a recent FTC settlement involving Cigna’s Express Scripts. Chair Rep. Buddy Carter asked the new head of the traditional PBM...
