Policy Digest—April 20, 2026

Introduction
This week delivered a marathon of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.'s first major congressional testimony, during which he confirmed an overhaul of the U.S. Preventive Services Task Force (USPSTF), an expansion of prior authorization into traditional Medicare, and plans to hire 12,000 new HHS employees. President Trump separately nominated former deputy surgeon general Erica Schwartz to lead the Centers for Disease Control and Prevention (CDC), a pick seen as a departure from earlier vaccine-skeptic signaling. Nebraska prepares to become the first state to enforce Medicaid work requirements on May 1, just as a Senate minority report documented that drugmakers raised prices on hundreds of medications despite signing voluntary most-favored-nation deals with the administration.

Weekly Spotlight

CMS Takes Aim at Device Payment: IPPS FY27 Rule Proposes First Mandatory Nationwide CMMI Model and Repeal of Breakthrough Device Add-On Pathway

The Centers for Medicare and Medicaid Services (CMS) released its fiscal year 2027 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital proposed rule on April 10, 2026, projecting a 2.4% net payment increase for acute care hospitals worth approximately $1.4 billion annually. Hospital groups immediately pushed back on the bump as inadequate given continued inflation, rising uncompensated care, and a growing uninsured population. The more consequential news is embedded in the rule’s policy provisions, which collectively signal that CMS intends to reshape how innovative device reimbursement works in Medicare.

The rule proposes the Comprehensive Care for Joint Replacement Expanded (CJR-X) Model, which would become the first mandatory, nationwide episode-based payment model in traditional Medicare. Beginning October 1, 2027, most hospitals paid under IPPS would be held accountable for total Medicare spending across a 90-day episode covering hip, knee, and ankle replacements in both inpatient and outpatient settings. The original CJR Model, which ran from 2016 through 2024 in 34 metropolitan areas, generated an estimated $112.7 million in net Medicare savings during performance years 6 and 7 while maintaining quality. CJR-X would expand the risk adjustment methodology from 3 adjusters to 29 and apply a 5% stop loss to rural and safety-net participants. Hospitals in the Transforming Episode Accountability Model (TEAM), critical access hospitals, and Maryland hospitals would be excluded.

More directly relevant to device manufacturers, CMS is proposing to repeal the alternative New Technology Add-On Payment (NTAP) pathway that since 2021 has let Food and Drug Administration (FDA)-designated Breakthrough Devices qualify for NTAP supplemental payments without demonstrating substantial clinical improvement over existing alternatives. Under the current pathway, a breakthrough-designated technology only had to prove it was sufficiently expensive to qualify. CMS says the waiver was created with limited evaluation and proposes that all NTAP applicants beginning with FY2028 meet the full substantial-clinical-improvement standard. Technologies already approved and those under FY2027 review would be grandfathered, and applications submitted on or before September 30, 2026 would remain eligible under the existing pathway. The rule also proposes a parallel repeal of the outpatient device pass-through alternative pathway.

Separately, HHS Secretary Kennedy told lawmakers this week that HHS will “soon” announce changes to the Transitional Coverage for Emerging Technologies (TCET) pathway, the mechanism by which FDA-designated breakthrough devices receive expedited Medicare coverage. Taken together, the NTAP repeal and signaled TCET changes represent the most significant restructuring of federal payment policy for novel medical devices since the alternative pathway was established.

Industry response to the CJR-X expansion has been guarded. The American Hospital Association said mandatory participation presents significant challenges particularly for hospitals without the scale or capital to make care redesign investments, and raised concerns that smaller hospitals lack the infrastructure to manage 90-day episodes. The comment period on the IPPS proposed rule closes June 9, 2026, and CMS has explicitly invited public comment on how to “more effectively align payment with value for innovative technologies”—an open door for device manufacturers to press the case that clinical-improvement evidence standards should not be applied uniformly to devices addressing unmet need in small populations.

#HOSPITAL #DEVICE #PAYER

Centers for Medicare and Medicaid Services (CMS)

CMS Proposes Prior Authorization Deadlines for Prescription Drugs as Appeal Data Show High Denial-Overturn Rates

CMS issued a proposed rule that would, for the first time, set federal time limits on prior authorization decisions for prescription drugs in Medicare Advantage and Affordable Care Act (ACA) marketplace plans. Plans would be required to respond to urgent requests within 24 hours and standard requests within 72 hours, and to publicly disclose claims denial rates, appeal outcomes, and decision timeframes. The proposal extends electronic prior authorization requirements already finalized for medical services to cover drugs—a gap left by the 2024 CMS streamlining rule. Separately, new research found patients who appeal denied insurance claims through independent external review win between 30% and 78% of the time depending on the insurer, raising questions about the validity of initial denial practices across commercial and government payers.

Source: Proposed CMS Rule Would Set Prior Auth Deadlines for Drugs

#DRUG #PAYER #PATIENT

Insurer Trade Group Reports 11% Prior Auth Reduction but Declines to Disclose Methodology

America’s Health Insurance Plans (AHIP) reported that prior authorization requirements among its members declined 11% following the industry’s 2025 voluntary reform pledge. The trade group has not disclosed baseline figures, methodology, or which specific requirements were reduced. The announcement landed as CMS separately moves to impose mandatory prior authorization deadlines through rulemaking, underscoring the regulatory pressure behind the voluntary industry posture.

Source: Insurers Fail to Get Specific on Prior Authorization Reforms

#PAYER #PROVIDER

WISeR Model Brings AI-Powered Prior Authorization to Traditional Medicare, Drawing Lawsuits and Provider Alarm

The Wasteful and Inappropriate Service Reduction (WISeR) model, which launched January 1, 2026 in Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington, marks the first time traditional Medicare has required prior authorization for specific Part B services at scale. Private technology vendors conduct AI-powered review and are paid a percentage of savings from averted care—a structure critics say creates a pay-for-denial incentive mirroring the most contested Medicare Advantage practices. The Electronic Frontier Foundation has filed suit seeking algorithm transparency from CMS. Early real-world reports document authorization delays well beyond the stated 3-day turnaround, denied claims without clear appeal pathways, and practices spending 100+ hours per week navigating the system. The model currently covers 17 Part B services including skin substitutes, nerve stimulators, and knee arthroscopy; CMS has flagged potential expansion to additional states and services if the pilot demonstrates savings.

Source: Medicare’s WISeR Prior Authorization Model: AI-Powered Gatekeeping

#PROVIDER #PATIENT #PAYER

Medicaid Work Requirements: Nebraska Goes First, Federal Rules Take Effect 2027, States Seek Stricter Terms

Nebraska will become the first state to enforce Medicaid work requirements on May 1, 2026 under a state plan amendment, serving as the test case ahead of the federal January 1, 2027 deadline under the Working Families Tax Cut Act. About 18.5 million adults across 42 states and the District of Columbia will be subject to the new rules, which require applicants to show at least one month of work before receiving benefits—though several Republican-controlled states are seeking CMS approval to triple that work period. State Medicaid agencies are simultaneously grappling with staffing shortages that could impair their ability to process compliance determinations alongside routine enrollment workloads. Federal implementation regulations have advanced to final review.

#PATIENT #PAYER #PROVIDER

Medicare Advantage Policy Roundup: Quality Reporting, LEAD Framework, Broker Incentives, and Spending Data

Multiple Medicare Advantage developments surfaced this week. CMS proposed including MA enrollees in inpatient hospital quality reporting measures currently applied only to traditional Medicare. Agency officials separately began publicly positioning MA as a model for the new Long-term Enhanced Accountable Care Organization Design (LEAD) framework. New reporting showed brokers receive higher compensation for steering seniors into MA than into traditional Medicare, reviving longstanding concerns about enrollment incentives. Industry-sponsored Elevance research found higher MA enrollment correlates with lower total Medicare spending, though the finding’s sponsorship warrants caveats. STAT reported that despite Trump’s early rhetoric against health insurers, administration policies have broadly favored MA plans, including significantly higher 2027 payments and an indefinite pause on updating the program’s risk adjustment system.

#PAYER #HOSPITAL

CMS ACCESS Model Accepts 150+ Organizations, Extends Application Deadline to May 15

The CMS Innovation Center announced on April 13 that more than 150 digital health companies and healthcare providers have been accepted into the first cohort of the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model—an outcome-aligned payment program that reimburses participants a set fee for managing Medicare beneficiaries with chronic conditions including diabetes, chronic kidney disease, and hypertension through technology-enabled care coordination. The model launches July 5, 2026, with the application deadline for the first cohort extended to May 15. CMS has described ACCESS as a potential template for scaling tech-enabled chronic care management across Medicare and as one of the Innovation Center’s largest cohort launches to date.

Sources: CMS Taps 150 Digital Health Companies for ACCESS Model, ACCESS Model Accepted Applicants, CMS ACCESS Medicare Chronic Care Pilot Program Participants, CMS Accepts More Than 150 Organizations for ACCESS Model

#PAYER #HOSPITAL #DEVICE

CMS LEAD Model: Next Phase for Accountable Care with Implementation Considerations

Health Management Associates and the Healthcare Financial Management Association (HFMA) separately published analyses of the CMS Long-term Enhanced Accountable Care Organization Design (LEAD) Model, the Innovation Center’s successor to ACO REACH. The voluntary, nationwide 10-year model will operate from 2027 to 2036 and introduces targeted design changes intended to improve predictability and payment alignment accuracy. HFMA’s analysis also flagged hospital capital-planning implications of the FY27 IPPS proposed rule, which is moving through its comment period in parallel.

Source: CMS’s LEAD Model: A New Phase for Accountable Care

#HOSPITAL #PROVIDER #PAYER

Hospitals Urge CMS to Protect Medicaid State-Directed Payments in Coming Fraud Initiative

Hospital associations are pressing CMS to clarify that its forthcoming anti-fraud initiative will not target legitimate Medicaid state-directed payment (SDP) arrangements alongside actual fraud. SDPs are supplemental Medicaid mechanisms that states use to direct additional federal matching funds to children’s hospitals, safety-net providers, and rural facilities to offset Medicaid’s below-cost base rates. The concern follows CMS signals tied to the Working Families Tax Cut Act that the agency plans to scrutinize SDP structures as part of a broader enforcement push.

Source: Medicaid State-Directed Payments: CMS Fraud Scrutiny

#HOSPITAL

ACA Exchange Enrollment Continues to Shrink as 14% of Enrollees Fail to Pay January Premiums

A Wakely Consulting Group analysis found that approximately 14% of Affordable Care Act marketplace plan enrollees failed to pay their January premiums following the expiration of enhanced premium subsidies, forfeiting coverage at a rate substantially higher than usual. The report projects continued enrollment declines as more enrollees face higher out-of-pocket costs, with implications for risk pool composition, insurer pricing decisions, and the ongoing congressional debate over extending the American Rescue Plan-era subsidies that drove record exchange enrollment.

Sources: Around 14% of ACA Enrollees Failed to Make Premium Payments, ACA Exchanges Will Continue to Shrink as Fewer Enrollees Pay Premiums

#PAYER #PATIENT

Food and Drug Administration (FDA)

FDA Seeks Congressional Authority on Misleading Direct-to-Consumer Drug Advertising

The FDA is asking Congress for new enforcement powers to hold pharmaceutical companies accountable for misleading direct-to-consumer (DTC) advertising. The agency’s current authority over prescription drug marketing has limited enforcement mechanisms, and the legislative request would add penalties for deceptive drug advertising practices.

Source: FDA Seeks Legislative Teeth on Misleading DTC Drug Ads

#DRUG #PATIENT

FDA Presses 2,200+ Sponsors and Researchers to Report Missing Clinical Trial Results

The FDA sent notices on March 30 to more than 2,200 medical product companies and researchers linked to over 3,000 registered clinical trials that have not submitted required results to ClinicalTrials.gov. An internal FDA analysis found 29.6% of studies likely subject to mandatory reporting had no results posted, creating what the agency called a “distorted” evidence base affecting clinical decision-making and drug development. FDA Commissioner Marty Makary said companies have an ethical obligation to publish results regardless of the effect on share price, and the agency warned it may issue formal Notices of Noncompliance and pursue civil fines of up to $10,000 per day.

Source: FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

#DRUG #DEVICE #PROVIDER

GLP-1 Landscape: Oral Foundayo Launches, Safety Signals, Self-Pay Programs, and Muscle-Loss Concerns

A busy week for glucagon-like peptide-1 (GLP-1) drug policy and market developments. Eli Lilly’s newly approved oral GLP-1 pill Foundayo drew 1,390 U.S. prescriptions in its launch week, distributed through LillyDirect, Amazon Pharmacy, GoodRx, Ro, and Weight Watchers, even as the FDA requested additional safety information citing “unexpected serious” cardiovascular risks. GoodRx launched a 7.2 mg Wegovy dose at $399 per month for self-pay patients. Walmart added GLP-1 prescribing to its digital health platform. The United Kingdom is slashing clinical trial times for obesity drugs. A new study found weight-loss drugs reduce muscle mass more than previously expected, and researchers behind the GLP-1 obesity mechanism suggest pathways other than GLP-1 may drive the observed weight loss.

#DRUG #PATIENT

United States Pharmacopeia Warns of Vulnerable Drug Starting Materials, Bolstering Reshoring Push

The United States Pharmacopeia (USP) issued a warning about U.S. pharmaceutical supply chain vulnerabilities, focusing on key starting materials used in drug manufacturing. The report adds to mounting pressure for domestic pharmaceutical production as geopolitical tensions and tariff threats intensify the reshoring debate.

Source: USP Flags Hamstrung Starting Material Sourcing

#DRUG

FDA and Medical Device Industry Near Agreement on MDUFA VI User Fee Package

The FDA and medical device industry reached an agreement in principle on most provisions for the sixth Medical Device User Fee Agreement (MDUFA VI) as of the March 18 meeting, with both sides proceeding to draft commitment letter language. Under the current agreement (MDUFA V), industry paid higher user fees in exchange for the FDA’s device center hiring more than 500 additional employees. MDUFA VI will govern device review performance goals and user fee levels for the next five-year authorization cycle and requires congressional reauthorization.

Source: FDA, Medtech Industry Near MDUFA VI Agreement

#DEVICE

FDA Launches READI-Home Innovation Challenge to Accelerate Home-Based Medical Devices

The FDA’s Center for Devices and Radiological Health on April 7 launched the READI-Home Innovation Challenge, inviting device developers to submit proposals for home-use medical technologies that reduce hospital readmissions. Up to nine devices from distinct manufacturers will advance to a December 2026 interaction phase, during which companies receive early FDA engagement through sprint discussions and can demonstrate technology at FDA facilities. Devices must be designed for use by patients or lay caregivers rather than trained clinicians. Proposal submissions are due September 30, 2026, and selected devices may be eligible for Breakthrough Device or Safer Technologies Program designation.

Source: CDRH Targets Hospital Readmissions with Home Device Innovation Challenge

#DEVICE #HOSPITAL #PROVIDER

House Energy and Commerce Weighs Bill Codifying FDA Digital Health Guidances

The House Energy and Commerce Health Subcommittee held a hearing on April 15 on the Digital Health Screeners Act, a draft bill from Rep. Troy Balderson (R-OH) that would codify two January 2026 FDA guidance updates: a clarification allowing clinical decision support software offering a single recommendation to remain outside FDA oversight, and updated general wellness product definitions covering devices that display physiological parameters in contexts such as sleep, activity, or stress. The bill does not yet incorporate Oura’s push to further expand the wellness product exemption. FDA Commissioner Marty Makary has separately committed to slashing digital health regulations and issuing a new artificial intelligence risk framework. Electronic health record vendors have welcomed the clinical decision support clarification.

Source: E&C to Weigh Draft Bill Codifying FDA Digital Health Guidances

#DEVICE #PROVIDER

Institute for Clinical and Economic Review Urges FDA to Strengthen Accelerated Approval Evidence Standards

The Institute for Clinical and Economic Review (ICER) recommended that the FDA strengthen evidence requirements and transparency surrounding accelerated approval decisions. ICER’s recommendations call for clearer standards for confirmatory trials and for public disclosure of the evidence supporting agency decisions on drugs that reach patients through the accelerated approval pathway.

Source: FDA Should Increase Transparency and Bolster Evidence for Accelerated Drug Approvals, ICER Says

#DRUG

FDA Urges Congress to Pass Patent, Biosimilar, and Combination Product Reforms

The FDA has formally asked Congress to amend federal drug law to clarify when brand drug manufacturers can block biosimilar competition using patent and citizen petition processes. The request is part of a broader FDA push to reduce regulatory barriers to biosimilar access and runs parallel to Senate Finance Committee hearings this week on legislation to accelerate biosimilar market entry.

Source: FDA to Congress: Pass Patent, Biosimilar, Combo Product Reforms

#DRUG #PAYER

Department of Health and Human Services (HHS)

Kennedy’s Congressional Testimony Marathon: USPSTF Overhaul, Prior Auth Expansion, AI at FDA, and 12,000 New HHS Hires

HHS Secretary Robert F. Kennedy Jr. appeared before the House Energy and Commerce Health Subcommittee, the House Ways and Means Committee, the House Appropriations Labor-HHS Subcommittee, and the House Education and Workforce Committee across April 15-17 to defend the Trump fiscal year 2027 budget proposal and HHS restructuring. Kennedy confirmed plans to appoint new members to the U.S. Preventive Services Task Force (USPSTF), describing the panel as “lackadaisical,” and indicated broader changes to how the body operates. USPSTF recommendations drive insurance coverage mandates for preventive services under the Affordable Care Act. Kennedy stated the measles, mumps, and rubella (MMR) vaccine is “safe for most people”—a measured departure from his longstanding vaccine-skeptic record—and said 90% of FDA reviewers are now using artificial intelligence (AI) to speed drug approvals. He also confirmed expansion of prior authorization into traditional Medicare and told lawmakers HHS plans to hire 12,000 new employees. Democrats used the hearings to challenge Kennedy on HHS restructuring, proposed budget cuts, and MAHA political dynamics in competitive districts ahead of the midterms.

Sources: Kennedy’s Marathon of Congressional Hearings on HHS Budget, RFK Jr. Begins His Congressional Testimony Marathon, RFK Jr.’s Hill Marathon Begins, Kennedy Says MMR Safe for Most in Heated House Hearing, RFK Jr.: HHS Making Plans to Hire 12,000 New Employees, Kennedy: 90% of FDA Reviewers Using AI for Faster Drug Approvals, RFK Jr. Heads to Congress for First Round of Budget Testimony, RFK Jr. Says He’s Overhauling ‘Lackadaisical’ USPSTF

#ALL

Trump Nominates Erica Schwartz as CDC Director, Signaling Shift from Vaccine-Skeptic Tone

President Trump on April 16 nominated former deputy surgeon general Erica Schwartz as director of the Centers for Disease Control and Prevention (CDC). Schwartz served as deputy surgeon general during Trump’s first term and is viewed across the public health community as a traditional, highly qualified public health leader who has expressed support for vaccines—a departure from the vaccine-critical tone that has characterized Kennedy’s HHS tenure. MAHA-aligned voices have expressed skepticism about the pick, viewing Schwartz as insufficiently aligned with the movement’s priorities. If confirmed, she would become the CDC’s fourth leader in roughly a year. CDC staff reportedly described the internal reaction as “guarded but hopeful.”

Sources: Erica Schwartz Nominated as CDC Director, Schwartz CDC Nominee Reaction: Cautious Optimism, MAHA Leaders Skeptical of Trump’s CDC Pick, Trump CDC Nomination, Former Deputy Surgeon General Erica Schwartz Nominated as CDC Director, CDC Leadership Shift on Vaccines, Trump Nominates New CDC Director Amid Push for MAHA Image Makeover, Erica Schwartz CDC Director Trump

#ALL

HHS Reshapes ACIP Charter as Maryland and Other States Decouple from Federal Vaccine Guidance

Following a legal setback, HHS Secretary Kennedy updated the CDC’s Advisory Committee on Immunization Practices (ACIP) charter retroactively to April 1, 2026 to place heightened emphasis on vaccine safety in committee deliberations. HHS separately added several organizations with documented histories of opposing mainstream vaccine guidance as official ACIP liaison groups, which public health experts say will skew the committee’s evidence base. Georgetown University’s Center for Children and Families published an analysis of the new charter, flagging language changes that could shift committee deliberative priorities. ACIP recommendations directly shape vaccination coverage under Medicaid, the Children’s Health Insurance Program (CHIP), and the Vaccines for Children program. In response, Maryland Governor Wes Moore signed the Vax Act, directing the state health secretary to issue independent recommendations for immunizations, screening, and preventive services rather than relying on CDC’s ACIP. Several other states have taken similar steps to insulate their coverage mandates from federal policy shifts.

Sources: HHS After Legal Setback Updates ACIP Charter, New ACIP Charter Signals Possible Change in Priorities for Committee, Maryland Decouples from RFK Jr. Vaccine Guidance, POLITICO Poll: More Americans Doubt Vaccine Safety Than Trust It

#PATIENT #PAYER #PROVIDER

Federal Judge Allows 19 States’ Lawsuit Over HHS Restructuring to Proceed

A federal judge rejected the Trump administration’s motion to dismiss a lawsuit filed by 19 states and the District of Columbia challenging the mass terminations and restructuring of the Department of Health and Human Services under Secretary Kennedy. The court’s ruling allows the states to proceed on claims that the reorganization was conducted without congressional authorization and in violation of federal administrative procedure requirements. The case is the most significant legal challenge to the HHS overhaul to date and could result in reinstatement orders or injunctions affecting agency operations.

Sources: Judge Rules HHS Must Face States’ Lawsuit Over RFK Jr.’s Agency Overhaul, Judge Rules HHS Must Face States’ Lawsuit

#ALL

Other HHS Developments: NIH Funds Human-Based Research, Mulligan Named Chief Economist, PBM Transparency Push, AHRQ Operating at Minimal Capacity, Mental Health Parity Gaps Persist

Several additional HHS and agency-level developments shaped the landscape this week. The National Institutes of Health (NIH) announced a $150 million investment in human-based research tools to reduce reliance on animal disease models. HHS named economist Casey Mulligan as chief economist and regulatory officer focused on healthcare affordability. A coalition of 45 state attorneys general joined employers and lawmakers in urging the Department of Labor to finalize a proposed rule requiring pharmacy benefit manager fee and revenue disclosure to Employee Retirement Income Security Act (ERISA)-governed plans; PBMs and health insurer lobbyists are pushing back. The Agency for Healthcare Research and Quality (AHRQ) is reportedly operating at minimal capacity under the current administration, described by STAT’s Bob Herman as “basically a ghost town.” STAT separately covered persistent mental health parity enforcement gaps affecting coverage for pediatric and adult behavioral health services.

#PROVIDER #PAYER #PATIENT

Heard on the Hill

Congress Returns from Recess to a Packed Health Care Agenda

Congress returned from recess with a full health care docket including drug pricing reform, reconciliation negotiations, and HHS oversight hearings. Issues in active play include most-favored-nation (MFN) pricing transparency, direct-to-consumer drug pricing legislation, Medicaid work requirements implementation, and multiple scheduled committee hearings on agency operations. Competing legislative vehicles—the farm bill, immigration funding packages, and reconciliation—are in motion simultaneously and could affect health program spending timelines.

Source: Congress Returns to Packed Health Care Agenda

#ALL

April 22 Budget Hearings: Senate HELP, Senate Finance, and House Energy and Commerce to Examine FY27 HHS Budget

The Senate Health, Education, Labor, and Pensions (HELP) Committee, the Senate Finance Committee, and the House Energy and Commerce Committee each announced hearings on April 22 to examine the President’s fiscal year 2027 budget request for HHS. The Senate HELP hearing begins at 2:00 PM EDT; Senate Finance begins at 10:00 AM EDT. House Energy and Commerce announced two separate hearings on April 22—one on Nuclear Regulatory Commission oversight and a second specifically examining the impact of proposed FY27 funding changes on the health care system. The hearings follow Kennedy’s appearances before House committees earlier this week.

Source: Chairmen Guthrie and Griffith Announce Hearing on HHS FY 2027 Budget

#ALL

Drug Pricing on the Hill: MFN Terms, Tariff Pressure on Biotech, Senate Report on Price Increases, and Murphy’s DTC Deductible Fix

Drug pricing dominated congressional activity this week. A Senate HELP Committee minority report led by Sen. Bernie Sanders (I-VT) found that several pharmaceutical companies raised prices on hundreds of medications despite entering confidential most-favored-nation (MFN) pricing agreements with the administration—findings that undercut administration claims of meaningful drug cost savings. Congressional Democrats escalated pressure on participating drugmakers to disclose MFN deal terms and confirm whether tariff exemptions were traded for price commitments. Meanwhile, Axios reports the threat of 100% pharma tariffs is forcing small and midsize biotech companies—which develop more than half of all FDA-approved medicines—to weigh voluntary pricing deals they cannot afford; the Biotechnology Innovation Organization (BIO) is cautioning members against the deals. Rep. Greg Murphy (R-NC) introduced the Every Dollar Counts Act, which would require insurers to apply out-of-pocket drug spending—including from direct-to-consumer platforms like TrumpRx, LillyDirect, and NovoCare—toward patients’ deductibles and out-of-pocket maximums, addressing a gap that has blunted patient-visible savings from the administration’s DTC strategy.

#DRUG #PAYER #PATIENT

Senate Finance Hearing: Multiple Bills Seek Faster Biosimilar Market Entry

The Senate Finance Committee held a hearing on legislation to speed biosimilar access, addressing patent litigation delays and pharmacy benefit manager practices that advocates say keep higher-cost brand drugs on formularies. Senate HELP Chair Bill Cassidy (R-LA) touted two bipartisan bills: one eliminating certain study requirements for biosimilar approval, and another bolstering the FDA’s ability to reject citizen petitions intended to slow generic and biosimilar entry. Sen. Cassidy simultaneously outlined a broader affordability plan to expand TrumpRx and rein in PBMs, while a conservative think tank with Trump administration ties pressed senators to remove biosimilar access obstacles.

Source: Bills to Speed Biosimilars Take Center Stage at Senate Hearing

#DRUG #PAYER

Bipartisan Bill Would Eliminate Medicare Cost-Sharing for Chronic Care Management

Provider organizations praised bipartisan legislation that would waive patient cost-sharing for Medicare chronic care management (CCM) services—care coordination and planning services for patients with two or more chronic conditions. Sponsors argue the small monthly fee is deterring millions of eligible Medicare beneficiaries from using services shown to reduce expensive hospitalizations and downstream complications from poorly managed chronic disease.

Sources: Providers Applaud Bipartisan Bill Waiving Cost Sharing for CCM, Providers Back Bipartisan Bill Eliminating Medicare CCM Cost-Sharing

#PROVIDER #PATIENT

Budget, Workforce, and Midterms: Vought Defends FY27 Request, H-1B Fee Pressures Healthcare, MAHA Targets Cassidy

Office of Management and Budget Director Russell Vought defended the Trump administration’s FY27 budget request and proposed 10% reduction to non-defense agency spending before congressional committees, as Democrats criticized OMB for impoundment-related withholding of appropriated funds. Sen. Chuck Grassley (R-IA) told Vought, “you don’t have the authority to impound.” Separately, one year after the Trump administration’s $100,000 H-1B visa fee, the healthcare sector is grappling with the implications for the legal immigration pipeline for skilled workers, particularly in physician and nursing workforce areas. On the political front, MAHA movement leaders’ efforts to sway the 2026 midterms—starting with attempts to defeat Sen. Bill Cassidy (R-LA)—will help determine whether the movement outlasts Trump’s second term.

#PROVIDER #HOSPITAL

Notable Notes

AbbVie Sues Over 340B Guidance as DOJ Enters State-Law 340B Cases

AbbVie filed a new lawsuit challenging federal Health Resources and Services Administration (HRSA) guidance governing the 340B drug discount program, which requires pharmaceutical manufacturers to offer steep discounts to qualifying safety-net hospitals, children’s hospitals, and federally qualified health centers. AbbVie characterized the existing guidance as “outdated” and is seeking to narrow the program’s scope, continuing an industry legal campaign that accelerated following the Supreme Court’s 2022 decision in AstraZeneca v. Becerra. Separately, the Department of Justice has begun intervening in 340B cases involving state laws, raising questions about federal preemption that will shape 340B contracting and data-sharing expectations for manufacturers and covered entities.

Sources: AbbVie Challenges Outdated 340B Drug Discount Program Guidance, AbbVie Challenges Outdated 340B Drug Discount Program Guidance in New Suit, Industry Voices: DOJ Jumps into 340B Cases Over State Law

#DRUG #HOSPITAL

Virginia Governor Strips Price-Setting Authority from State Drug Affordability Board

Virginia Gov. Abigail Spanberger amended out the price-setting authority from the state’s prescription drug affordability board (PDAB) legislation, removing the enforcement mechanism that advocates said made the board meaningful. Patient advocates are pursuing a legislative override of the governor’s change. Virginia’s PDAB had been closely watched as a potential model for state-level drug cost containment, and the governor’s action is a significant setback for state affordability board efforts nationally.

Source: Advocates Hope for Override of Virginia PDAB Changes

#DRUG

HeartFlow Sues Cardiac Artificial Intelligence Rival Cleerly Over Six Patent Claims

HeartFlow filed a patent infringement lawsuit against cardiac artificial intelligence rival Cleerly in the U.S. District Court for the Eastern District of Texas, alleging that Cleerly’s Ischemia, Plaque Analysis, and Compare products infringe six HeartFlow patents with priority dates from 2012 to 2018. The complaint characterizes Cleerly’s alleged infringement as “one of the most egregious examples of piracy in the medical technology industry” and notes that Cleerly founder and CEO Dr. James K. Min served as a HeartFlow consultant from 2012 to 2017. Cleerly has refuted the allegations. HeartFlow’s fractional flow reserve computed tomography platform and Cleerly’s coronary plaque quantification tools compete directly in the market for noninvasive AI-assisted cardiac imaging used to guide treatment decisions in coronary artery disease.

Source: HeartFlow Sues Cardiac AI Rival Cleerly Over Alleged IP Theft

#DEVICE

Structural Heart and Interventional Cardiology Update: Bleeding, Paravalvular Leak, and Pipeline Signals

A cluster of structural and interventional cardiology developments landed this week, spanning real-world safety data and pipeline activity across the transcatheter valve and cardiac imaging ecosystem. A real-world analysis of more than 4,000 transcatheter aortic valve replacement (TAVR) patients with atrial fibrillation found apixaban was associated with a 14% relative reduction in major bleeding events compared to rivaroxaban over a median two-year follow-up, with no significant differences in intracranial hemorrhage, all-cause mortality, ischemic stroke, or cardiovascular hospitalization; authors attributed the bleeding gap to rivaroxaban’s once-daily dosing producing higher peak anticoagulant levels (American Journal of Cardiology, April 2026). Separately, a TRIPLACE registry analysis of nearly 400 transcatheter tricuspid valve replacement (TTVR) patients—predominantly treated with the Edwards Lifesciences Evoque system—found that moderate or greater paravalvular leak (PVL) was associated with a one-year all-cause mortality of 39.7%, versus 12.6% for mild PVL and 10.5% for no or trace PVL, identifying moderate-or-greater PVL as an independent predictor of one-year mortality (JACC: Cardiovascular Interventions, March 2026). Authors concluded that continued development of improved TTVR devices will be essential to reduce PVL risk.

#DEVICE #PROVIDER

Industry and Market Shifts: PhRMA CEO Departs, PBM-ERISA Preemption Limits State Laws, Employers Shop for Vendors, KFF Documents Affordability Crisis, MAHA Polling, MGMA on Prior Auth Burden

Notable cross-cutting industry and market developments this week. Steve Ubl will step down as CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of 2026 after more than a decade leading the industry’s most influential trade group. State efforts to regulate pharmacy benefit managers have run into a significant legal obstacle, with courts finding key state PBM oversight provisions preempted by the Employee Retirement Income Security Act (ERISA); the rulings limit states’ ability to enforce spread-pricing bans, network adequacy requirements, and transparency rules against PBMs serving employer plans. A Purchaser Business Group on Health survey found affordability pressures driving more employers to shop for new healthcare vendors. KFF polling documented widespread affordability struggles with disproportionate impact on uninsured, Black, and Hispanic adults and lower-income households. Multiple polls found MAHA maintains broad public recognition but low political identification, with new data suggesting MAHA positions could create vulnerabilities for Republican incumbents in competitive districts. A new Medical Group Management Association (MGMA) survey documented that prior authorization, Medicare Advantage administrative demands, and quality reporting burdens are driving physician burnout and forcing practices to hire additional administrative staff.

#PROVIDER #PAYER #PATIENT

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