Weekly Spotlight
FDA Leadership in Freefall: Five Departures, One Week, and the Structural Forces That Drove Them
On May 5, the FDA authorized new electronic nicotine delivery system products, and by May 11 STAT reported that new guidance would allow some flavored vapes to stay on the market — what one expert called a “get-out-of-jail-free card” for the industry. The New York Times framed it plainly: with a friend in the Trump administration, the tobacco industry had secured a lucrative regulatory win.
FDA Commissioner Marty Makary, who had reportedly resisted the authorization, resigned on Tuesday, May 12. The next day, HHS communications director Rich Danker submitted a written resignation to President Trump, invoking child health in his protest. Kyle Diamantas — the Human Foods Program chief, not a scientist — was named acting commissioner. By Friday, STAT confirmed that Tracy Beth Høeg, acting director of CDER, was also departing — leaving both the commissioner role and the top drug-review position simultaneously in transition.
Diamantas did not settle in quietly. Inside Health Policy reported that anti-abortion groups were already pressuring the new acting commissioner over his past legal work adjacent to a Planned Parenthood case. Stakeholders across industry and public health feared more instability, not less, regardless of who held the title.
The search for a permanent commissioner is underway. STAT reported the administration wants a leader who can rebuild trust with agency staff, focus on food policy, and continue drug-approval reforms — a wish list that does not resolve the structural tensions that drove Makary out. Political interference from the White House, organized pressure from industry and advocacy coalitions on opposite ends of every contested issue, and an agency workforce depleted by mass layoffs will face any successor. The departures this week were not about one person’s management style. They were about whether the FDA can continue to function as an independent regulatory body when every decision has become a political signal.
Source(s):
STAT+: Makary departs FDA amid turmoil
NYT: With a Friend in Trump, Tobacco Industry Secures a Win
STAT+: Høeg leaves FDA
STAT+: What the administration wants in its next FDA leader
Tags: #DEVICE #DRUG #HOSPITAL #PROVIDER
Centers for Medicare and Medicaid Services (CMS)
CMS Finalizes Major ACA Marketplace Overhaul for 2027
CMS published its final rule for the 2027 ACA marketplace on May 15, removing standardized plan requirements, allowing non-network plans to participate in exchanges, and expanding access to catastrophic coverage options. The rule arrives as total marketplace enrollment has already fallen 5 percent to 23.1 million in 2026 following expiration of enhanced subsidies, and payers warn that the combination of loosened plan design rules and tightened program integrity provisions will accelerate adverse selection and payer-mix pressures for hospitals.
Source(s):
CMS finalizes ACA marketplace overhaul for 2027: 6 notes
ACA marketplace final rule: payer-mix concerns
CMS Finalizes Removal Of Standardized Plan Options
Tags: #HOSPITAL #PAYER #PATIENT
CMS Launches Multi-Front Medicaid Enforcement Blitz
The Trump administration executed a sequenced Medicaid enforcement campaign: CMS withheld $1.3 billion from California citing fraud; imposed a six-month nationwide freeze on new Medicare enrollments for hospices and home health agencies; then threatened all 50 states with Medicaid Fraud Control Unit compliance audits. The White House expanded from a California-specific action to a national framework in a single week. KFF provided the legal analysis of CMS’s Social Security Act authority to withhold payments; Georgetown CCF had tracked a similar playbook deployed against Minnesota weeks earlier.
Source(s):
NYT: Trump Administration Will Withhold $1.3 Billion from California
The Hill: White House threatens Medicaid withholding from all 50 states
Federal Register: Six-Month Enrollment Moratorium
KFF: CMS’ New Approach to Federal Medicaid Spending in Fraud Cases
Georgetown CCF: CMS Weaponizes Fraud Against Minnesota
Tags: #HOSPITAL #PAYER #PATIENT
Medicaid Work Requirements: State Readiness Uneven as January 2027 Looms
Nebraska went first on May 1., but KFF and Georgetown CCF are tracking mounting evidence that most states are not operationally ready. Staff shortages at state Medicaid offices are creating administrative backlogs. Patient advocacy groups for people with HIV and sickle cell disease are lobbying for exemptions, reflecting a broader scramble to carve out protected populations. KFF released five separate trackers this week covering state-by-state implementation, 1115 waivers, and implementation questions.
Source(s):
Georgetown CCF: The New Medicaid Work Reporting Requirements Are Here
STAT+: Patients jockey for exemptions
KFF Health News: States Face Staff Shortage Challenge
KFF: Work Requirements Tracker Overview
Tags: #PATIENT #PAYER #HOSPITAL
Trump Demands Medicaid Deportation Data; Some States Go Further
The Trump administration is requiring states to share Medicaid enrollment data with immigration enforcement agencies, and several states including North Carolina are directing public health agencies to go further than the federal mandate. The policy creates enrollment and care-access risks for families who may disenroll or avoid seeking care to prevent data exposure.
Source(s): KFF Health News: Trump Demands Medicaid Data for Deportation
Tags: #PATIENT #PAYER #HOSPITAL
Prior Authorization: CMS Launches Digital Pledge; MACPAC Adds AI Oversight Mandate
CMS named 29 early-adopter companies — including Epic, Oracle, Cleveland Clinic, and major health plans — for a new electronic prior authorization initiative. Separately, MACPAC voted May 7 on four recommendations for AI-based prior authorization in Medicaid: requiring a qualified human reviewer for all automated adverse determinations, prohibiting AI from making denials independently, amending fee-for-service Medicaid regulations, and requiring managed care plans to disclose their use of automation. The recommendations will be included in MACPAC’s June 2026 report to Congress. An AMA survey found only 33 percent of physicians believe voluntary insurer pledges will produce meaningful change; a New York Times investigation confirmed insurer delays persist despite years of promises.
Source(s):
CMS Unveils New Prior Auth Pledge
MACPAC calls for transparency in Medicaid AI prior authorization
Physicians skeptical of insurer pledges
NYT: Insurers’ Delays in Approving Care Persist
Prior auth may reduce access to heart failure drugs
Tags: #PAYER #PROVIDER #PATIENT
Drug Pricing: Supreme Court Clears Medicare Negotiation; PBM Disruption Accelerates
The Supreme Court declined Monday to take up the pharmaceutical industry’s challenge to the IRA’s Medicare drug price negotiation program — clearing a major legal obstacle to implementation. Optum Rx’s launch of a fee-based, rebate-free PBM model on May 11 signaled accelerating structural pressure on the traditional PBM model. Bipartisan lawmakers reintroduced legislation barring PBMs from owning pharmacies. The Trump administration is requiring EHR vendors to display cash-pay drug prices to physicians at the point of prescribing. CMS Administrator Oz is defending the WISeR AI model for Medicare prior authorization against bipartisan criticism, with the GAO having given Congress a green light to use the Congressional Review Act to block it.
Source(s):
STAT+: Supreme Court rejects challenge to Medicare drug price negotiation
Policy Changes May Be Disrupting Rebate-Driven PBM Market Dynamics
Bipartisan bill barring PBMs from owning pharmacies reintroduced
Oz Defends WISeR Model, GAO Gives Congress Green Light
Tags: #DRUG #PAYER #PATIENT
Department of Health and Human Services (HHS)
RFK Jr. and Vaccines: Background Inquiries Continue Amid Public Pivot
HHS Secretary Kennedy is publicly pivoting toward food policy and chronic disease messaging while the New York Times reported this week that vaccine safety inquiries continue in the background. The Supreme Court on May 18 declined to revisit the longstanding precedent allowing state entities to mandate vaccines. The U.S. measles case count reached nearly 1,900 — the largest domestic resurgence in decades. Congress has largely resisted MAHA’s food policy push, with industry lobbyists blunting most legislative action.
Source(s):
NYT: Kennedy Is Driving a Vast Inquiry Into Vaccines
Supreme Court Declines To Revisit Precedent On Vaccine Mandates
US Measles Total Nears 1,900
POLITICO: Why MAHA Isn’t Breaking Through on Capitol Hill
Tags: #DRUG #PATIENT #PROVIDER
Trump and Kennedy Move to Relax EHR AI Safeguards
The Trump administration is rolling back HHS standards for EHR interoperability and AI healthcare tool oversight. Physicians and hospital IT leaders are raising alarms about data fragmentation and care coordination risks.
Source(s): KFF Health News: Trump and Kennedy Seek to Relax Safeguards for AI Healthcare Tools
Tags: #HOSPITAL #PROVIDER
340B: Hospitals Press Eli Lilly to Replace Claims Data Requirement
Hospital systems are pressing Eli Lilly to abandon its requirement that 340B-covered entities submit claims data every time one of the company’s drugs is dispensed at the 340B discount price, asking for a clearinghouse model instead.
Source(s): Hospitals Ask Eli Lilly To Replace Claim Data Policy With Clearinghouse
Tags: #HOSPITAL #DRUG
Heard on the Hill
Cassidy Loses Primary — MAHA Wins HELP Committee
Sen. Bill Cassidy lost his Louisiana Republican primary Saturday, with Trump-endorsed Rep. Julia Letlow heading to a runoff. His departure creates a vacancy at the chair of the Senate HELP Committee — the Senate body with jurisdiction over federal health policy legislation, user fee reauthorizations, and FDA oversight. POLITICO framed the loss as a major win for Kennedy and the MAHA movement, with the likely successor expected to push Kennedy’s priorities rather than check them. Cassidy’s final act as chair was launching an investigation into federally funded centers providing pediatric gender-affirming care, with a hearing scheduled for May 21.
Source(s):
STAT+: Sen. Bill Cassidy loses primary
POLITICO Pulse: Cassidy’s loss is a MAHA win
Cassidy Launches Pediatric Gender-Affirming Care Investigation
Tags: #ALL
Reconciliation Update: New Text Released, Senate Timeline Uncertain
Senate Republicans provided revised reconciliation text to Democrats with housing provisions removed. Health-related Medicaid and CHIP spending provisions remain in flux. Senate Republicans have also signaled cool reception to House plans for a second reconciliation bill this summer.
Source(s):
New reconciliation text
Senators Give House GOP’s Summer Reconciliation Plan a Cool Reception
Tags: #ALL
House E&C Schedules FDA Modernization Markup
House Energy & Commerce chairs Guthrie and Griffith announced a Health Subcommittee markup of FDA modernization and drug import bills. Rep. Auchincloss is targeting the next PDUFA reauthorization as a vehicle for bipartisan clinical trial reform.
Source(s):
Chairmen Guthrie and Griffith Announce Health Subcommittee Markup
Auchincloss: Clinical Trial Reform Could ‘Catch A Ride’ On Next PDUFA
Tags: #DEVICE #DRUG #PROVIDER
No Surprises Act: IDR Standoff Continues
CMS announced an additional federal IDR entity as provider and insurer groups continue to press for a final No Surprises Act arbitration rule, which has been pending for more than a year.
Source(s):
Additional Federal IDR Entity Available
STAT+: Provider, insurer groups rush to shape No Surprises Act rules
Tags: #HOSPITAL #PAYER #PROVIDER
Notable Notes
TAVR: Boston Scientific’s $1.5B MiRus Stake Anchors a Busy Structural Heart Week
Boston Scientific secured a 34 percent equity stake in MiRus, a TAVR platform developer, for $1.5 billion, with an option to acquire the full platform for an additional $3 billion. New real-world data prompted a “call to action” from structural heart specialists over increasing TAVR use in patients younger than 65. A first-in-world report described cardiologists using transcatheter aortic root tricuspidization to convert a bicuspid valve to tricuspid anatomy before TAVR. Cedars-Sinai and PCORI registered a new TAVR vs. SAVR comparative effectiveness trial in bicuspid aortic stenosis (NCT07413965). The CAPTURE-2 trial is evaluating EmStop’s embolic protection system for TAVR stroke prevention.
- Boston Scientific buys $1.5B stake in TAVR developer MiRus
- Is TAVR too common among younger patients? New data prompt a ‘call to action’
- Cardiologists are first in world to use new leaflet-splitting technique before TAVR
- How expert guidelines have influenced TAVR vs. SAVR decisions
- TAVR vs SAVR in Severe Bicuspid Aortic Stenosis (NCT07413965)
- Medtronic TAVR Low Risk Bicuspid Study (NCT03635424)
- CAPTURE-2 Trial Tests EmStop’s TAVR Embolic Protection System
Tags: #DEVICE
Cardiac Devices: IVL, LAAO, Aortic Arch, Lymphatic Drainage
Boston Scientific’s Seismiq IVL platform showed early promise in a first-in-human study for calcified coronary lesions. New data support LAAO as a safe alternative to long-term anticoagulation in atrial fibrillation on a case-by-case basis. Artivion completed its $175M acquisition of Endospan following FDA approval of the Nexus aortic arch stent graft. A catheter-based lymphatic drainage device showed early efficacy in reducing heart failure rehospitalizations.
- New coronary IVL tech from Boston Scientific impresses in first-in-human study
- New data point to LAAO as a safe alternative to long-term drug therapy
- Artivion closes Endospan purchase after FDA approves Nexus system
- First-of-its-kind drainage device helps limit heart failure rehospitalizations
Tags: #DEVICE #PROVIDER
GLP-1s: Medicare Coverage, Cardiac Outcomes, and Growing Pipeline
CMS launched the BALANCE model offering $50/month GLP-1 prescriptions for Medicare patients. NIH released new research showing GLP-1 drugs penetrate the brain to suppress hunger and that adding GLP-1 to cognitive behavioral therapy further reduces binge eating. Cardiovascular Business reported data linking Eli Lilly’s oral weight loss pill to reduced heart attack and stroke risk in established cardiovascular disease patients.
- CMS unveils $50 GLP-1 prescriptions for Medicare patients
- NYT: Medicare Coverage for GLP-1 Weight Loss Drugs
- Weight loss pill linked to reduced risk of heart attack or stroke
- NIH: Oral GLP-1 drugs penetrate deep into the brain to suppress hunger
Tags: #DRUG #PATIENT #PAYER
Drugmakers Must Reveal U.S. Production Plans for Tariff Exemptions
To secure exemptions from 100% tariffs on imported pharmaceuticals, companies must provide the administration with detailed information on U.S. investment and production plans — using trade policy as leverage for manufacturing commitments.
Source(s): To gain tariff exemptions, drugmakers must reveal US production plans
Tags: #DRUG
Trump Exempts Physicians from H-1B Work Visa Freeze
The Department of Homeland Security resumed visa processing for foreign-born physicians following alarm from medical societies. The ACC, SCAI, and others welcomed the update but noted the new $100,000 H-1B petition fee for new applicants remains in place. SCAI President Dawn Abbott noted that nearly one in four U.S. physicians is foreign-born and that interventional cardiology faces acute rural staffing strain.
Source(s): Trump administration exempts doctors from work visa freeze
Tags: #HOSPITAL #PROVIDER
World Heart Federation 2026 Report: Congenital Heart Disease
The World Heart Federation released its 2026 World Heart Report on CHD, documenting 16 million people living with CHD globally, CHD as the leading NCD cause of neonatal and infant mortality, and U.S. lifetime costs averaging $2.1 million per patient with a $74 billion annual economic burden. The report supports a campaign for a 2027 World Health Assembly Resolution on Childhood-Onset Heart Disease and is supported by the Linda and Mike Mussallem Foundation.
Source(s): World Heart Report 2026: Congenital Heart Disease
Tags: #PATIENT #DEVICE #ADVOCATE