The Academy of Managed Care Pharmcy's (AMCP’s) Government Affairs team led a discussion on key federal legislation and regulations affecting managed care pharmacy, focusing on top-priority issues. The session also covered potential congressional and administrative actions related to pharmacy benefit managers (PBMs), Medicare, Medicaid, and other emerging federal policy developments. 

Adam Colborn, JD, AVP, Congressional Affairs, AMCP, and Editorial Advisory Board Member for First Report Managed Care, opened the presentation with a review of federal legislation updates. 

“Feedback from our [AMCP] Nexus session on the same subject [said] that it was helpful to see all this stuff in the pipeline in Congress, but it would be great if we spent more time talking about what has passed,” said Colborn. “I spend all my time thinking about Congress, and maybe I’ve taken for granted that people knew—Congress hasn’t really passed anything.” 

Colborn explained that due to narrow margins in Congress, legislation moves very slowly and necessitates a focus on developing legislation. Congress is currently in its 119th session, and members were sworn in on January 3, 2025. The republican party (GOP) maintains House control with a mix of 218 republicans and 213 democrats; 4 seats are currently vacant, which Colborn noted is the slimmest majority in the House for any party since 1931. The GOP regained Senate control at a mix of 53 republicans and 47 democrats. Last year, the House passed 5 of the 12 annual appropriations bills, and the Senate passed none. 

“Congress has not passed all 12 funding bills very often. And so, what happens is they will pass a continuing resolution to fund the government at existing levels for a set amount of time,” said Colborn. 

Continuing resolutions (CRs) extend government funding either as a standalone “clean” bill or an omnibus bill that includes additional “policy rider” amendments. On December 17, 2025, the House reached an agreement on a CR to fund the government through March 2025. Two days later, President-elect Donald Trump, Elon Musk, and other GOP figures expressed support for a “clean” CR, which passed and extended government funding until March. On March 11, the House passed H.R. 1968 to extend funding for most programs at fiscal year 2024 levels until September 30, including several health care extenders. The Senate subsequently passed H.R. 1968, sending the bill to the President’s desk, and the CR has an expiration date of September 30. H.R. 1968 retains funding for public health programs, Medicare, and Medicaid. However, pharmaceutical drug patenting reform and PBM reform were not included. 

Budget reconciliation is an optional legislative process often used under unified government control to bypass the Senate’s 60-vote filibuster threshold for legislation directly impacting federal spending or revenue. Each year’s budget resolution may include “reconciliation instructions” directing specific committees to meet fiscal targets over a 10-year period. Reconciliation bills must contain provisions with a nonincidental impact on the budget, and they cannot be used to alter Social Security.

“Prior to drafting reconciliation legislation, both chambers must agree on a concurrent budget resolution,” said Colborn. “Right now, they are negotiating that resolution. But the sticking point currently is that the Senate and the House have proposed different approaches that need to be reconciled.” 

The Senate’s “Skinny” Budget Resolution proposes increasing annual spending on border security, energy, and defense by $85.5 billion over 4 years, while offsetting it with an equal amount in annual cuts. It does not extend tax cuts from the first Trump administration or raise the debt limit. In contrast, the House’s “Big Beautiful” Budget Resolution would raise the debt limit by $4 trillion, extend the Trump-era tax cuts, increase spending by up to $4.5 trillion, and implement between $1.5 trillion and $2 trillion in cuts.

“For our purposes in the health sector, the House Energy and Commerce Committee has been tasked with identifying at least $880 billion in cuts. There is no possible way to get that number,” said Colborn. “We will see cuts, I’m sure, but what that exact number will be remains to be seen.” 

Medicare, the Affordable Care Act, Medicaid could all experience potential health care offsets because of this push for reduced spending, Colborn noted. 

AMCP has thrown its priority legislation into the mix through the Access to Prescription Digital Therapeutics Act and the Medicaid VBPs for Patients Act. Currently, neither of these bills has been reintroduced in Congress. The Equitable Community Access to Pharmacist Services (ECAPS) Act would primarily authorize pharmacists to receive reimbursement under Medicare Part B for certain COVID-19 care beyond the end of the Public Health Emergency (PHE). This act also has yet to be reintroduced. 

Congress has already started to move forward with PBM reform. On February 26, 2025, the House Energy and Commerce Health Subcommittee held a hearing on PBMs titled, “An Examination of How Reining in PBMs Will Drive Competition and Lower Costs for Patients.” There was an overwhelming sense of bipartisan support for reform during the hearing. 

Significant PBM reform provisions include a spread pricing ban, Medicare Part D delinking, and commercial market transparency. Potential vehicles for PBM reform include budget reconciliation and standalone bills, and packages. Additional PBM legislation to keep an eye on are the Protecting Pharmacies in Medicaid Act, the Saving Seniors Money on Prescriptions Act, and the Bipartisan Health Care Act. 

“There is a growing consensus among policymakers that something needs to be done about 340B. No two people agree on what that something is,” said Colborn. 

Suggested reform revolves around transparency, patient savings, and reducing duplicate discounts. Key examples of this movement include the Protect 340B Act, Sustain 340B Act, and the 340B Access Act. 

Geni Tunstall, JD, AVP, Regulatory Affairs, AMCP, presented on federal regulation, including important agency nominations, ongoing executive orders, regulatory process changes, Inflation Reduction Act (IRA) negotiations, and final and proposed rules. 

Robert F. Kennedy, Jr was recently confirmed as the Secretary of Health and Human Services (HHS). Dr Marty Makary was confirmed by the Senate on March 25, 2025, for the position of US Food and Drug Administration (FDA) Commissioner. Dr Mehmet Oz is awaiting a confirmation vote about his nomination for Centers for Medicare & Medicaid Services (CMS) Administrator. On an agency level, Dr Susan Monarez is nominated for the position of director of the Centers for Disease Control and Prevention (CDC) after the abrupt withdrawal of nomination for Dave Weldon. Dr Jay Bhattacharya is nominated to be the director of the National Institutes of Health (NIH), and Dr Janette Nesheiwat is awaiting a confirmation hearing for the position of Surgeon General. 

“In just a couple of months that we’ve had this administration, President Trump has already signed more than 100 executive orders,” said Tunstall. “It’s a record number; no other president in history has signed that many in such a short period of time.” 

Executive orders are directives issued by the president to guide the operations of the federal government, but they typically don’t have broad national impact until federal agencies implement them. Many of the recent executive orders are already facing lawsuits and are expected to undergo lengthy legal challenges. Among the active orders are those related to tariffs, which currently exclude pharmaceuticals—but that could change.

“The regulatory process is dependent on the administration. Since the Trump administration has made it a point that deregulation and reform are important, we’re likely to see a lot of actions by the administration,” said Tunstall. 

Actions already taken by the administration through the Department of Government Efficiency, (DOGE) include cuts to many federal programs and restructuring departments, including HHS. 

“HHS workforce cuts are supposed to reach about 20 000 employees,” said Tunstall. “That’s going to make a big difference for the FDA, CDC, NIH, and NCMS.” 

Tunstall also noted that a new initiative, “A Healthy America” (AHA), is intended to better coordinate chronic care and disease prevention efforts. She added that the FDA may be moving away from its traditional evidence-based approach to vaccines—a shift underscored by the recent resignation of Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research.

The Anti-Competitive Regulations Task Force, created by the Department of Justice to identify and cut regulations that may be seen as anticompetitive, has put out a request for public comment on any regulations that reduce competition between businesses. 

“This includes laws and regulations in health care markets that discourage doctors and hospitals from providing low-cost, high-quality health care,” said Tunstall. 

Tunstall also noted that for the first time since 1971, HHS is limiting public comment on proposed regulations, ending the long-standing Richardson waiver tradition. 

CMS recently announced 15 drugs selected for the second round of price negotiations under the IRA and is inviting public input through engagement events. Additional updates to the Medicare Drug Price Negotiation Program are expected in 2025 and beyond, including continued validation of selected Part D drugs, the addition of more Part B and D drugs in 2026, and up to 20 new drugs added annually starting in 2027.

Regarding recent final rules and guidance, CMS recently announced the early termination of several payment model files, including the Maryland Total Cost of Care Model, the Primary Care First Model, End-Stage Renal Disease Treatment Model, the Vermont All-Payer Accountable Care Organization Model, the Maternal Opioid Misuse Model, and potentially downsizing the Integrated Care for Kid’s Model. The 2022 HHS guidance on gender affirming care was also rescinded in February, and a strategic plan for the use of artificial intelligence in health and human services and public health was put forward. 

For proposed rules, the Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability Rule is being advanced. Subsequent provisions would remove enrollment eligibility for Deferred Action for Childhood Arrivals (DACA) recipients, allow adjustment for premiums, alter enrollment periods, and limit sex trait modification as an essential health benefit. 

“2025 so far is a year of uncertainty and significant change for health care policy. The Trump administration has issued a barrage of different actions, and there are important questions being raised. I think there is an opportunity for stakeholders to shape the future of health care by being as involved in advocacy as possible,” said Turnstall. “AMCP’s website has a lot of resources that can help you stay on top of where things are.” 

Reference 
Colborn A, Tunstall G. Federal legislative and regulatory update. Presented at: AMCP 2025; March 31-April 3; Houston, TX.