In this issue: Combo drugs proposed for Medicare DPNP inclusion, PBM reform legislation reintroduced, 340B rebate guidance meetings, and more.

Welcome to NPC This Week! We hope you'll join us each week for a look-ahead at the policy, research, and industry conversations that matter to the future of biopharmaceutical innovation. The DMs are open if you have suggestions — and please share with your network. - Michael Pratt, Devon Bortz, and Haley McKeefer

New From NPC

Trump Administration Proposes Combo Drug Inclusion in Medicare DPNP: A new proposal from the Trump administration would allow CMS to select fixed-dose drug combinations for Medicare drug price negotiation if the drugs lack a "clinically meaningful" improvement over previous versions, according to Bloomberg Law.

• NPC Perspective: Manufacturers and health policy experts including NPC President and CEO John O'Brien are raising red flags over the change, citing important differences in administration routes: "It’s literally the difference between a minutes-long injection and a much longer, sometimes hours-long, infusion. That matters to patients."
• Go Deeper: Read NPC’s Comment Letter to CMS responding to this proposal.

Addressing Health Inequities in the Workforce: In BenefitsPRO, Bruce Sherman , Brian Sils , and NPC Chief Strategy Officer Kimberly Westrich examine how employers can identify and incorporate workforce equity considerations into health benefit design. The commentary builds on an article published in the February issue of the Journal of Managed Care & Specialty Pharmacy.

• From the Commentary: "Everyone — including employees and their family members — should be able to receive affordable and accessible, high-quality care for their health concerns. And given that workforce health equity can enhance organizational outcomes, incorporating it as a component in strategic benefits planning simply makes good business sense as well."

Industry News

"High Stakes" Meetings on 340B Rebate Guidance: More than a dozen biopharma companies, healthcare providers, and trade groups have met with the Office of Management and Budget in recent weeks to provide input on HHS’ highly anticipated guidance for rebate models in the 340B program.

• Go Deeper: Recent research has found that 340B program growth:

1. Costs self-insured employers more than $5 billion in lost rebates (IQVIA)
2. Increases health insurance premiums for employers and their employees (Health Capital Group)
3. Costs state and local governments more than $1 billion (IQVIA)
4. Is mainly driven by utilization increases — not price (Health Affairs Scholar)
5. Isn't translating into financial assistance for the patient filling a prescription at a contract pharmacy (IQVIA)

FDA Updates:

• Makary Teases FDA Priority Review for Pricing Promises: During interviews with Bloomberg and CNBC, FDA Commissioner Marty Makary suggested that the agency would issue priority review vouchers to companies that pledge to "equalize the price between OECD countries and the United States, even with other products that they currently have."
• CRLs Published for "Radical Transparency": Last week, the FDA published more than 200 past complete response letters (CRLs) — each from 2020–2024 and related to since-approved applications. Makary wrote in The Washington Post that the move to make these letters public is part of "a broader agenda toward radical transparency" and "predictability."
• PDUFA Reauthorization Proposed Changes: During the FDA’s kickoff meeting yesterday for the renewal of the Prescription Drug User Fee Act (PDUFA) program, Commissioner Makary told stakeholders that he would "like to see lower user fees" to make it easier for "small companies and individual investors and people in academics" to participate in the program.
• FDA Moves Forward With Reduction-in-Force Plans: As part of HHS-wide layoffs, Endpoints News reports that as many as 3,500 FDA employees received final termination notices Monday night after layoffs were first announced in April. Makary has defended the reduction-in-force moves, telling Congress that "the terminations won’t delay user fee goal reviews."

HHS Postpones USPSTF Meeting: First reported by Axios, HHS postponed a scheduled meeting of the U.S. Preventive Services Task Force — an independent panel of national experts responsible for recommendations that drive cost-free insurance coverage for preventive services and products. In response, AcademyHealth circulated a letter co-signed by 104 public health groups urging Congress to protect the committee’s "transparent, rigorous, and scientifically independent process."

ICYMI

Trump Promises Pharmaceutical Tariffs, After a Grace Period: President Trump floated new tariff rates for several industries during a recent cabinet meeting, including a 200% rate on imported pharmaceuticals after a grace period of "a year, year and a half." Coverage by The Wall Street Journal emphasizes, though, that investors feel "the size of the tariff matters less than the timing."

Fiscal Impact of 340B on Medicaid: A new brief from the BRG (Berkeley Research Group) found that reductions in drug rebate revenue for managed care Medicaid beneficiaries due to 340B program use have created a "substantial federal and state budgetary impact." The model finds that, without the 340B drug pricing program, Medicaid rebates for managed care beneficiaries would have been $6.5 billion higher in 2024.

Pharmacists Ask Insurers to Continue Vaccine Coverage: A coalition of pharmacy organizations, including the American Society of Health-System Pharmacists and the National Alliance of State Pharmacy Associations, sent letters urging major insurers to maintain existing vaccine coverage without increasing patient cost-sharing — emphasizing that "the science underpinning the role of vaccines in disease prevention remains unchanged."

PBM Reform Legislation Reintroduced: Rep. Earl L. "Buddy" Carter (R-Ga.) introduced the PBM Reform Act last week. The bill contains four PBM reforms from last December’s Continuing Resolution package: the Drug Price Transparency and Medicaid Act, the PBM Accountability Act, the Protecting Patients Against PBM Abuses Act, and the NO PBMs Act. Rep. Carter shared more insights with Drug Topics at the 2025 McKesson ideaShare conference.

"Health, Like Disease, Is Contagious": In light of observed "network effects" for medicines like GLP-1s that appear to improve the health of adjacent family members, value assessments are "systematically undervaluing innovation" unless such effects are factored into decision making, writes health economist Richard Z. Xie .

• Value-Based GLP-1 Coverage: Instead of "[chasing] a silver bullet" that accounts for all aspects of GLP-1 coverage, Soumi Saha and Somaieh McMullan, PhD write in STAT that Medicare administrators should pilot a value-based care payment model that targets the populations most likely to medically and financially benefit.

Value Viewpoint: In her latest "Value Viewpoint," Ms. Westrich reviews two new Value in Health pre-proof articles which use Delphi groups to elicit key value factors for inclusion in HTA and health systems more broadly.

Mark Your Calendar

July 29: Join NPC President and CEO John O’Brien on July 29 from 3:00 - 4:00 PM ET as he moderates an NPC webinar discussion on “340B: Hidden Costs and Patient Impact” with Anna Hyde of the Arthritis Foundation , Rory Martin of IQVIA , and William Sarraille of the University of Maryland Francis King Carey School of Law . The panel will discuss what the program's growth means for the healthcare system, patients, and employers — and how to course correct. Register to attend the free webinar here.