August 6, 2025
Health Policy Report – August 6, 2025
Maryland Oncology Hematology Hosts Congresswoman Sarah Elfreth (D-MD)
On Friday, August 1, Maryland Oncology Hematology (MOH) hosted Congresswoman Sarah Elfreth (D-MD) at their Annapolis practice location for a tour. The visit provided a meaningful opportunity to showcase the value of community oncology and the personalized, high-quality care our teams deliver close to home.
Dr. Kashif Firozvi, Dr. Carol Tweed, and the entire MOH team guided Congresswoman Elfreth (D-MD) through an engaging tour of the practice, complemented by insightful policy discussions. Key topics included the importance of allowing patients to receive their oncolytics via mail or through a trusted caregiver (H.R. 2484, the Seniors’ Access to Critical Medications Act), as well as concerns surrounding the Inflation Reduction Act—particularly the potential for providers to be caught in the middle of the drug pricing negotiation process (H.R. 4299, the Protecting Patient Access to Cancer and Complex Therapies Act).
The conversation also addressed the increasing pressures of healthcare consolidation and underscored the vital role that independent practices like MOH play in preserving patient choice, access, and affordability within the healthcare system.
We’re grateful to Congresswoman Elfreth (D-MD) and her team for their time and genuine interest in learning more about MOH and The US Oncology Network. As a member of the House Natural Resources Committee and the House Armed Services Committee, her willingness to engage directly with providers is the kind of leadership that helps ensure policy decisions reflect the realities of patient care.
If your practice is interested in hosting a site visit, please contact Angela Storseth at angela.storseth@usoncology.com.
To read more, CLICK HERE.
Dr. Debra Patt, Jeff Hunnicutt Pen Op-Ed on PBM Reform
Dr. Debra Patt, Texas Oncology, and Jeff Hunnicutt, Highlands Oncology, recently penned an op-ed in Pharmacy Times on how states are leading the way on PBM reform efforts.
In their op-ed, Dr. Patt and Jeff Hunnicutt highlight how states like Arkansas and Texas have used the Supreme Court case Rutledge v. PCMA (2020) to regulate unfair PBM practices. This year, Arkansas passed HB 1150, a first-in-the-nation law to ban PBMs operating in the state from owning retail or mail-order pharmacies. Similarly, in 2023, the Texas Legislature passed legislation that prohibits PBMs from steering patients toward PBM-owned pharmacies, charging retroactive fees, or unfairly reimbursing their own pharmacies at higher rates than what are paid to independent pharmacies.
“Lawmakers across the country can learn from these examples. Texas and Arkansas have created a solid blueprint for meaningful PBM reform by taking on the industry’s abusive practices head-on and restoring balance and fairness to the system. Until Congress finds the will to act, more states should follow in their footsteps and enact similar PBM reforms that help patients access the care they need when they need it,” they concluded.
To read the op-ed, CLICK HERE.
President Trump Urges Drug Companies to Lower Prices, Extends Most Favored Nation Policy
On July 31, President Trump issued formal letters to 17 major pharmaceutical manufacturers as part of his administration’s push to implement the Most-Favored-Nation (MFN) pricing model for prescription drugs. This action follows his May 12 Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.”
The letters were sent to the CEOs of AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead Sciences, GlaxoSmithKline (GSK), Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi.
President Trump outlined four primary actions that manufacturers are expected to take within 60 days:
- Extend MFN Pricing to Medicaid: Drugmakers must offer U.S. Medicaid programs the lowest prices they offer in any other developed nation.
- Guarantee MFN Pricing for New Drugs: Companies must commit not to offer lower prices for newly launched drugs to other countries than what is offered in the U.S.
- Enable Direct-to-Consumer Sales at MFN Prices: Manufacturers are encouraged to bypass pharmacy benefit managers (PBMs) and sell directly to patients, provided the price does not exceed the lowest available internationally.
- Repatriate International Revenues to Lower U.S. Prices: The administration will support companies in raising prices abroad, with the expectation that increased revenues be reinvested to reduce costs for American patients and taxpayers.
While still voluntary at this point, the letters emphasize that failure to comply will prompt the federal government to “deploy every tool in our arsenal” to address what the administration describes as “abusive drug pricing practices.”
This increasingly aggressive stance on pricing underscores broader concerns about the long-term impact of such policies. On July 25, the Pacific Research Institute released a new report about the chilling impact that price control provisions in the Inflation Reduction Act, as well as any Most Favored Nation policy, could have on biopharmaceutical innovation in the United States. Examining Europe as an example as to what could happen to the U.S. if pharmaceutical price controls remain in place or are expanded, the researchers suggest that there could be fewer drugs coming to market, fewer clinical trials, and longer wait times for patients to access the medicines they need.
The researchers warned policymakers against moving forward with a Most Favored Nation drug pricing policy that could extend price controls, which could further discourage investment and harm innovation of new pharmaceuticals. In addition to the PRI report, several news outlets also recently published op-eds opposing tying American drug costs to the prices set by foreign governments.
Moreover, the Drug Channels Institute (DCI) released a report on July 15, which found that there is a growing gap between the gross-to-net reductions for all brand-name drugs. In 2024, the gap, which DCI terms “the gross-to-net bubble,” rose 7% year-on-year to $356 billion. Overall, this finding suggests that the total value of discounts, rebates, and other price concessions that pharmaceutical manufacturers provide for brand-name drugs continues to expand, albeit at the slowest rate in more than a decade.
To read more about the letters President Trump sent to pharmaceutical manufacturers, CLICK HERE and HERE.
To read the PRI report, CLICK HERE.
To read the DCI report, CLICK HERE.
To read recent op-eds in the news against the Most Favored Nation policy, CLICK HERE and HERE.
Regulatory & Legislative Proposals Impact 340B Program
On July 31, the Department for Health and Human Services (HHS) Health Resources and Services Administration (HRSA) unveiled a new demonstration program to increase transparency in the 340B Drug Pricing Program.
Specifically, the 340B Rebate Model Pilot Program would replace the discounts that are typically paid upfront to qualified providers for an equivalent post-purchase payment coordinated by the pharmaceutical manufacturer after the covered entity submits a report about the drugs dispensed. The pilot program, which is slated to begin on January 1, 2026, would only cover the 10 drug products included on the Centers for Medicare and Medicaid Services (CMS) Medicare Drug Price Negotiation Selected Drug List.
Meanwhile, in Medicare’s new Hospital Outpatient Payment System Proposed Rule for 2026, the Trump Administration proposed accelerating the recovery of $7.8 billion in improper cuts to 340B program discounts already given to facilities, meaning CMS plans to recoup these funds from 340B covered entities.
This proposal stems from a 2022 Supreme Court decision, which overturned a nearly 30% cut made under the first Trump Administration after some facilities were shown to have inappropriately profited from the program. Last year alone, Medicare reimbursed 340B hospitals an estimated $9 billion.
While the Biden Administration created a plan to recoup the $7.8 billion in increased reimbursements over 16 years, the Trump Administration now wants to ramp up the process by a decade, putting greater pressure on hospitals which have to pay back CMS for the previous discounts.
On Capitol Hill, Congresswoman Doris Matsui (D-CA) and Senator Peter Welch (D-VT) recently introduced the 340B PATIENTS Act, legislation that would codify 340B providers’ ability to use contract pharmacies to dispense 340B discounted drugs. The bill is meant to enable patients to pick up their prescriptions at any local pharmacy while receiving 340B discount savings.
According to the lawmaker press release, the legislation would:
- Require manufacturers to offer 340B discount prices to covered entities regardless of the manner or location in which a drug is dispensed, including if a covered entity uses a contract pharmacy to dispense 340B drugs to the entity’s patients.
- Prevent manufacturers from placing conditions on the ability of a covered entity to purchase and use 340B drugs, including drugs dispensed at contract pharmacies.
- Impose civil monetary penalties on manufacturers that violate statutory requirements and prohibitions.
To read more about the pilot program, CLICK HERE.
To read more on this issue, CLICK HERE.
To read the full text of the bill, CLICK HERE.
To read the lawmaker press statement, CLICK HERE.
Republicans Plan Bipartisan Health Package
With reconciliation in the rearview mirror, there is growing talk on Capitol Hill about the potential for a bipartisan health policy package to come together in the months ahead. However, Democrats are still largely upset about being shut out of the reconciliation process and it is still unclear if they would work across party lines to support such a package.
Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, has signaled that he would like to work across the aisle to pass legislation that could include health policy elements that were ultimately left out of the lame duck legislation passed in December 2024. The Senate HELP Committee will also likely take up several pharmacy benefit manager (PBM) reform bills that have already passed the Senate Finance Committee.
Senator Cassidy, M.D. (R-LA) also suggested the committee will consider the No UPCODE Act, which would eliminate incentives for Medicare Advantage plans to engage in costly and wasteful upcoding practices. If passed, the No UPCODE Act would save an estimated $200 billion to $270 billion over 10 years – savings which would be used to cover the costs of Congress’ other healthcare priorities. Moreover, some Congressional Republicans are indicating they could support a limited extension of enhanced Affordable Care Act subsidies, which expire at the end of the year. If Congress were to make those tax credits permanent, it could cost $335 billion over the next decade, according to projections from the Congressional Budget Office and the Joint Committee on Taxation.
It’s important to note that Congress is currently in its annual August recess and will not return to session until September. As always, the legislative landscape can shift quickly, and much may change between now and when lawmakers reconvene.
To read more, CLICK HERE, HERE and HERE.
House Ways & Means Committee Holds Hearing on Prior Authorization
On July 22, the House Ways & Means Joint Health and Oversight Subcommittee held a hearing to discuss Medicare Advantage (MA), including the challenges that prior authorization presents for older Americans and the physicians who care for them. Prior authorization is a significant barrier to care, and a growing number of Medicare beneficiaries are forced to wait for their physician to get approval from their health insurance plan before they can receive particular medical services or medications.
During the hearing, Chairman Jason Smith (R-MO) said, “When 54 percent of Medicare beneficiaries are choosing a Medicare Advantage plan, there is clearly a strong and growing interest by seniors to have access to MA and the benefits that come with it – like lower out-of-pocket cost, access to supplemental benefits such as prescription drug coverage and transportation services, as well as specialized plans tailored to patients with chronic conditions.”
The hearing highlighted that seniors in rural areas are disproportionately impacted by prior authorization delays and denials, often leading to longer hospital stays and higher healthcare costs. Moreover, delays in care risk the health and well-being of seniors in this country while also increasing administrative burdens for physicians. To ensure seniors receive the care they need when they need it, Congress is considering streamlining prior authorization under MA through legislation like the bipartisan Improving Seniors’ Timely Access to Care Act. Other potential solutions discussed during the hearing were the responsible use of AI to accelerate approvals, finding a balance in pre-approval requirements, and increasing transparency.
To read more about the House W&M hearing, CLICK HERE.
To watch the House W&M hearing, CLICK HERE.
Senate Advances NIH Funding, Holds Hearing on Making Health Care Affordable
On July 31, the Senate Appropriations Committee overwhelmingly approved a $446 million increase in funding for the Department of Health and Human Services (HHS) over the current fiscal year. Significantly, this included a $400 million increase in the budget for the National Institutes of Health (NIH), a notable rejection of the Trump Administration’s proposal to slash the NIH budget by 40% next year. The appropriations vote came a day after the White House reportedly barred NIH from disbursing funds for research and training, leading to bipartisan backlash. That funding was quickly reinstated.
The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing that examined policy solutions to counter the consolidation of large health systems, particularly focusing on 340B and pharmacy benefit manager (PBM) reform.
Senator Roger Marshall, M.D (R-KS) highlighted legislation to delink PBMs from the cost of drugs so as not to incentivize artificially inflated prices. Witnesses also attested that the 340B Drug Pricing Program is unintentionally forcing smaller practices to consolidate with larger ones and, that while the program is intended to help increase access to affordable drugs, it needs to be adjusted. One witness suggested that these subsidies should be tied to the number of patients being served, while another suggested a flat allotment to hospitals, allowing pharmaceutical companies to know how much they will need to spend and giving hospitals the opportunity to allocate accordingly.
Senators Marshall, M.D. (R-KS), Maggie Hassan (D-NH), and John Hickenlooper (D-CO) also highlighted their bipartisan Patients Deserve Price Tags Act, which would require healthcare providers to publish the costs of the services they offer.
To read more about NIH funding, CLICK HERE and HERE.
To watch the hearing, CLICK HERE.
To read more about the Patients Deserve Price Tags Act, CLICK HERE.
Federal Judge Blocks Arkansas Law for PBM Reform
Recently, a federal judge temporarily blocked a law that would prohibit companies from owning both pharmacy benefit managers (PBMs) and either retail or mail-order pharmacies in Arkansas, the first law of its kind in the U.S. The purpose of this state law is to prevent PBMs from favoring their own pharmacy operations. With amplified control in healthcare and insufficient transparency requirements, PBMs often serve to increase drug prices and limit patient access to affordable medications.
Since Congress has failed to pass legislation that would restrict concerning PBM practices, many states have taken action to regulate PBMs. The Arkansas law, which was set to go into effect in January 2026, was intended to force PBM owners to relinquish their right to run a pharmacy in the state and reduce drug costs for Arkansans.
In response to the law, The Pharmaceutical Care Management Association joined four PBMs, including the “Big Three” – CVS Caremark, Cigna’s Express Scripts, and UnitedHealth’s Optum Rx – in filing lawsuits on the grounds that the law is unconstitutional since it discriminates against out-of-state entities. Agreeing, U.S. District Court Judge Brian Miller granted a preliminary injunction, temporarily preventing the law from going into effect.
To learn more, CLICK HERE.
FDA CBER Director, Chief Medical, and Scientific Officer Departs FDA
On July 29, Dr. Vinay Prasad abruptly stepped down as director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) – less than three months after his appointment to the position.
The departure comes amid mounting criticism from conservative commentators and biotech stakeholders over his regulatory approach and past political statements. In a statement, HHS stated he was stepping down to “avoid being a distraction” during the work of the FDA under the Trump Administration.
The controversy came amid Dr. Prasad’s handling of Sarepta Therapeutics’ Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD). After reports of multiple patient deaths, the FDA demanded Sarepta halt its production. Shortly after, the agency reversed its decision, allowing treatments to continue. Dr. Prasad was often critical of accelerated approval pathways and his regulatory style led to the rejection or delay of several gene therapy applications, which often frustrated “right-to-try” industry groups who advocate for broader access.
To read more, CLICK HERE.
NBER Study Shows Number of Independent Physician Practices Declining
A new working paper published by the National Bureau of Economic Research (NBER), titled “Are Hospital Acquisitions of Physician Practices Anticompetitive?,” studied the consequences of hospital systems acquiring physician practices. Through data and insurance claims, the researchers analyzed the impact of non-horizontal mergers on pricing and the market for practices. Data showed that physician prices rose by 15.1% while hospital prices rose by 3.3% after integration, with no measurable gains in quality of care.
NBER found that physician-hospital mergers often increase prices and, when they do, they do so in ways consistent with three main factors: greater foreclosure of rivals, improving negotiating parties’ outside options through recapture, and increasing concentration in physician markets.
To read the full paper, CLICK HERE.