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GLP-1 regulation policy continues to be a hot topic in Washington. In May 2025, we wrote about the benefits and costs of expanding patient access to GLP-1 medications. Now a year later, the Trump administration continues its balancing act between increasing individual access to GLP-1 medications while simultaneously providing strong oversight for the popular medications. This blog will explore ways that the administration is managing these priorities.
Expanding Patient Access
President Trump has sought to expand patient access through GLP-1 regulation policy in a couple of key ways. First, his administration entered into Most-Favored-Nation pricing agreements for Ozempic, Wegovy, and Zepbound, the most common brands for US patients to address concerns about the costs of these drugs. These deals can be found on the TrumpRx website, along with over 50 other medications, and are accessed through printable drug manufacturer coupons that can be redeemed at pharmacies at the time of purchase or directly from the drug manufacturer’s website.
The Trump administration has also acted through the Centers for Medicare and Medicaid Services (CMS) to increase access for Medicare and Medicaid beneficiaries through the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model. State Medicaid agencies have the option to opt-into the program, which allows CMS to negotiate pricing and coverage terms of GLP-1 medications, as early as May 2026. Medicare beneficiaries will have access through Part D benefits beginning in January 2027.
Medicare is also offering a GLP-1 payment demonstration beginning in July 2026 that will operate outside of Part D coverage to allow earlier access until the BALANCE Model is implemented.
Addressing Safety Concerns
The Trump administration has also pursued GLP-1 regulation policy to address possible safety concerns through the Food and Drug Administration (FDA). In February 2026, Commissioner Martin Makary issued a statement announcing that the FDA intends to restrict the use of GLP-1 active pharmaceutical ingredients (APIs) that are being used in non-FDA approved formulations by compounding pharmacies. In March 2026, the FDA issued an import alert for GLP-1 APIs due to concerns that drugs made with these products may be adulterated, and therefore unsafe for patients to take.
The FDA is also examining how companies are marketing their GLP-1 medications. In March 2026, warning letters were sent to telehealth companies for alleged misleading claims that their compounded formulas are equivalent to FDA-approved formulas.
There was also a spotlight shone on Novo Nordisk, the maker of Ozempic, for failure to follow Adverse Drug Events (ADEs) reporting guidelines. The investigation revealed Novo Nordisk did not have proper written procedures and did not report ADEs to the FDA in an appropriate amount of time. ADE tracking is one way the FDA evaluates the safety of drugs currently on the market.
What is the end goal?
So, over the past 6 months, GLP-1 regulation policy has created more access to GLP-1 medications, either through self-pay options, or through Medicare and Medicaid. At the same time, the FDA has tightened oversight, especially for compounding pharmacies. While increasing access and ensuring safety are not inherently in conflict with each other, the ongoing balancing act creates questions about how patients will be impacted.
For example, the US experienced a GLP-1 medication shortage when more patients began taking the medications. It was during the shortage that compounding pharmacies began to make and distribute GLP-1 medications. However, now that the shortage was resolved, the FDA is once again restricting compounding of GLP-1s, and voices within the compounding industry have claimed that the policy will cause yet another shortage.
Conclusion
We expect President Trump to tout actions taken to increase low-cost access to GLP-1 medications as part of his strategy to highlight his actions to bring down health care costs. At the same time, the administration will need to ensure efforts to address patient access and efforts to ensure patient safety are seen as striking just the right balance.
The Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) plays a central role in identifying health care waste, fraud, and abuse. They provide oversight and recommendations to improve HHS programs, including Medicare and Medicaid.
As part of the effort, OIG has developed its Top Unimplemented Recommendations list to highlight the efforts that could produce the most substantial savings. This list of ready-made proposals would be a good place for the Trump administration to start if they are looking for more wins ahead of the November midterms.
Cracking down on Medicaid fraud has emerged as a key priority for the Trump administration in 2026, and OIG has already made several recommendations to strengthen the program. So, what moves could the Trump administration make in the future?
This blog outlines specific recommendations aligned with the Trump administration’s priorities for Medicaid, as well as the barriers to implementing these recommendations.
Recovering Medicaid Overpayments
Currently, OIG estimates that the Centers for Medicare and Medicaid Services (CMS) has not recovered over $1 billion in Medicaid overpayments. These overpayments have been found through audits conducted over the past 25 years and include multiple reporting periods. The overpayments have yet to be recovered as CMS does not have set time frame for resolving overpayment issues, does not have a verification process to ensure that states follow guidance, and does not retain documentation to support recovered overpayments.
Kimberly Brandt, CMS’s Deputy Administrator and COO, told the Energy and Commerce Oversight Subcommittee at a March 17 hearing that CMS is looking to move towards a “stop and cop” enforcement strategy as opposed to a “pay and chase” strategy, which would prevent money from being lost to fraud, rather than trying to recover it after the fact. While this change in strategy could be helpful in reducing future overpayments, CMS would still need to take additional actions to recover previous overpayments.
Reviews of Prior Authorization Denials
Prior authorization reform has been gaining traction on both sides of the aisle over the past few years. In 2023, HHS-OIG flagged the high rate of prior authorization denials for Medicaid Managed Care Organizations (MCOs), raising concerns that enrollees are not receiving all medically necessary health care services.
To address these concerns, OIG has recommended that CMS:
- Require states to review the appropriateness of prior authorizations
- Require states to collect data on MCO prior authorization decisions
- Issue guidance to states on use of MCO data for oversight
- Require external medical reviews of upheld MCO prior authorization denials
- Work to identify MCOs that may be issuing inappropriate denials
The Medicaid and CHIP Payment and Access Commission (MACPAC) has also made similar recommendations in the past. In their March 2024 Report to Congress, the Commission recommended that states establish an independent, external medical review process and for CMS to update regulations to require states to collect and report data on denials and appeal outcomes.
These actions could be enticing for the administration because they are reforms the president could point to as examples of action to address concerns about health care access and increase transparency.
Barriers to Implementation
Despite these seemingly straightforward recommendations to address health care waste, fraud, and abuse, implementation is not without challenges.
Pushback could come from stakeholders. For example, states could be unsupportive of new federal mandates that impact Medicaid administration, especially if they come with increased costs and administrative burden. States are also required to balance their budgets, which could make it more difficult to recover overpayments in the wake of Medicaid funding changes from the One Big Beautiful Bill Act or proposed increased program oversight. Additionally, MCOs are unlikely to be supportive of additional oversight over their decision-making processes, with the push back that it will increase administrative burden and delay care. Patient groups may also worry that increased enforcement will lead to improper denials or delays in getting care for enrollees.
The administration would also likely face opposition from Democratic lawmakers and potentially from more moderate Republicans. During consideration of the One Big Beautiful Bill Act, we saw moderate Republicans looking to demonstrate concerns about the impact of certain policies on access to care for Medicaid enrollees. More recently, Democratic members have raised concerns that the Trump administration is unfairly targeting Democratic states in its search to uproot health care waste, fraud, and abuse.
So, what happens now?
HHS-OIG’s recommendations are a starting point to address health care waste, fraud, and abuse. The Trump administration is reviewing some of the recommendations from the list, with an update expected in August. However, a key question is can the administration persuading sell the anti-fraud efforts as also effective in addressing health care affordability concerns. The answer to that question could have implications for who controls Congress next year.
On March 18, 2026, the House Ways and Means Health Subcommittee held a hearing focused on improving kidney health. Both Republicans and Democrats recognized the need to increase funding for and awareness of kidney disease in order to better address the needs of the community. Democrats also took the opportunity to argue that provisions within the One Big Beautiful Bill Act will reduce health care coverage and therefore harm this community.
OPENING STATEMENTS
WITNESSES
- Ms. Ashli Littleton, Home Dialysis Patient – Testimony
- Dr. Suzanne Watnick, MD, Health Policy Scholar, American Society of Nephrology – Testimony
- Dr. Robert Taylor, MD, Chief Medical Officer, DCI – Testimony
- Mr. John P. Butler, President and CEO, Akebia Therapeutics – Testimony
MEMBER DISCUSSION
Innovation and Education
Both Republicans and Democrats highlighted the lack of innovation in kidney care compared with other chronic illnesses and the need for education. Ranking Member Lloyd Doggett (D-TX-37) and Rep. Suzan DelBene (D-WA-1) both asked how to help incentivize kidney care research and how to encourage providers to use the new practices. Dr. Watnick explained that the National Institutes of Health (NIH) is devoting only $19 per patient with end-stage kidney disease, despite reports that investments can save money in the long run. She described the importance of KidneyX, a new program that incentivizes people to develop innovative solutions for kidney disease, in encouraging people to think more about prevention, treatments, and cures. In response from a question from Rep. Brian Fitzpatrick (R-PA-1) about why kidney innovation hasn’t kept pace with that of other chronic illnesses, Mr. Butler explained that the dollars currently don’t follow the patient, so a small provider risks the survival of a dialysis center if they administer new practices.
Subcommittee Chair Vern Buchanan (R-FL-16) and Rep. Judy Chu (D-CA-28) asked about preventing kidney disease and ensuring patients were well educated on their care options. Dr. Watnick expressed the importance of starting upstream in primary care offices to ensure providers are screening their patients for kidney disease and educating them on the possible signs. She also explained the importance of providers detailing all of the care options for a patient once diagnosed with kidney disease, so they can make the best choice for them.
At-Home Dialysis vs In-Center Dialysis
The Committee spent time working to better understand the differences between at-home and in-center dialysis treatment. Rep. Adrian Smith (R-NE-3) and Rep Carol Miller (R-WV-1) asked Ms. Littleton about her personal experience on home dialysis and how it has impacted her life. She explained that it is much more flexible and allows her to continue working while receiving her treatments on her own schedule. She also highlighted the importance of the staff-assisted program, which gives her more confidence in her own abilities and in the support she would receive should anything go wrong at home.
Rep. Greg Murphy (R-NC-3) and Rep. Rudy Yakym (R-IN-2) asked about the requirements and hurdles patients face in accessing home dialysis. Dr. Watnick identified the main barrier as education for not only patients, but also providers who do not know to mention it to their patients as an option. She explained that a lot of patients are very interested in the opportunity to receive dialysis at home once the treatment is explained to them. Dr. Taylor also explained that providers are incentivized to offer only in-center dialysis because they receive higher reimbursement rates for that care than for at-home dialysis.
Coverage of Care
Both Republicans and Democrats brought up the costs associated with accessing care. Ranking Member Doggett (D-TX-37) expressed concerns regarding changes to Medicare and Medicaid made by the One Big Beautiful Bill Act and how it would impact patients. He also brought up other concerns about access to care for Medicare beneficiaries, including those enrolled in Medicare Advantage. Dr. Watnick raised concerns about needing prior authorization in Medicare Advantage to receive life-saving dialysis and the lack of data-sharing within Medicare fee-for-service payments, which makes it difficult to provide correct care. Full Committee Chair Jason Smith (R-MO-8) asked about coverage of the Medicare payment policies in terms of innovation. Mr. Butler discussed the shortcomings of the Medicare payment policy, which are below what is typically spent caring for the patient, leading to care centers drowning in costs. He also discussed the lack of reimbursements for innovative care, which he said discourages providers, despite the two-year Transitional Drug Add-on Payment Adjustment (TDAPA) program. Rep. Claudia Tenney (R-NY-24) also asked if TDAPA would function better if it was patient driven rather than facility driven. Mr. Butler explained this would help spread the money across all types of care and give providers more stability as the money would follow the patient.
Kidney Transplants
While most of the focus was on dialysis, some Committee members emphasized the importance of ensuring access to transplants and improving that process. Rep. Murphy (R-NC-3) asked about the barriers to transplant. Dr. Taylor explained that the current regulatory controls restrict the ability to get kidneys to every patient until they are in kidney failure, which means a long dialysis process prior to the transplant. Rep. Danny Davis (D-IL-7) asked how to best help patients who need a transplant. Ms. Littleton voiced that there needs to be more accessible information on why kidneys are needed and what the donor process looks like. Rep. DelBene (D-WA-1) raised concerns about living donor costs and how best to address them. Dr. Watnick explained that living donations have remained stagnant while deceased donations have increased over the past 2 decades. She described the need for wage reimbursement and child-care expenses to allow people to donate their kidneys.
Care in Rural Communities
Multiple members focused on rural communities and the unique challenges they face when getting kidney care. Full Committee Chair Smith (R-MO-8) asked what the specific challenges are in delivering care in rural areas. Dr. Taylor explained that yearly adjustments to Medicare are not meeting needs, and clinics need higher reimbursement rates to keep their doors open. He further explained that there is typically only one clinic in a rural county, which is already difficult for patients to access, so it is vital that they remain open. Rep. Steven Horsford (D-NV-4) asked which policies Congress could pursue to strengthen the rural health infrastructure to address kidney care. Dr. Watnick described the need to ensure affordable healthcare, education for providers and patients, and the availability of providers whom people in rural communities can relate to.
On March 18, 2026, the House Energy and Commerce Health Subcommittee held a hearing to examine the US health provider landscape. Subcommittee members raised concerns about hospital consolidation, price transparency, the health care workforce, and the impact of the One Big Beautiful Bill Act, among others. While there was bipartisan concern about the high cost of health care, members did not agree on paths forward.
OPENING STATEMENT
WITNESS TESTIMONY
- Mr. Richard Pollack, President and CEO, American Hospital Association – Testimony
- Dr. David H. Aizuss, MD, Chair, Board of Trustees, American Medical Association – Testimony
- Mr. R. Shawn Martin, Executive Vice President and CEO, American Academy of Family Physicians – Testimony
- Ms. Elizabeth Mitchell, President and CEO, Purchaser Business Group on Health – Testimony
- Dr. Anthony DiGiorgio, DO, MHA, Neurosurgeon, University of California, San Francisco Health – Testimony
- Ms. Barbara Merrill, CEO, American Network of Community Options and Resources – Testimony
MEMBER DISCUSSION
Hospital Consolidation
Subcommittee Republicans were very concerned about the loss of independent medical practices and increasing consolidation. Rep. Neal Dunn (R-FL-2) asked Mr. Pollack to explain how hospitals are consolidating, but Mr. Pollack shared that hospitals themselves are not the major driver of consolidation. Instead, Mr. Pollack emphasized the role of private equity and shared that many private practices seek to be part of a hospital system due to the burden of compliance and administrative costs. Additionally, he stated that hospital systems are often a lifeline for rural hospitals. Rep. Kat Cammack (R-FL-3) asked if the consolidation lowers prices for patients. Mr. Pollack explained that it reduces operating costs and often improves quality of care, but the reductions in cost are not seen by patients, as hospitals still maintain the contracted rates with insurers. Rep. John Joyce (R-PA-13) was curious about how larger hospital systems react to referrals to providers outside the system. Mr. Martin shared that, in his experience, it is not looked favorably upon, and Dr. DiGiorgio agreed, sharing that providers that he knows have been reprimanded. Rep. Nanette Diaz Barragan (D-CA-44) asked about how to prevent consolidation, and Dr. Aizuss responded that greater reimbursements under the Medicare Fee Schedule will prevent private practices from seeking to sell to larger systems.
Price Transparency
There were many suggestions for pricing transparency reforms during the Subcommittee hearing. Rep. John James (R-MI-10) highlighted H.R.5582, the Patients Deserve Price Tags Act. Ms. Mitchell expressed support for this bill, sharing that pricing information is helpful in increasing competition and accountability. Rep. Nick Langworthy (R-NY-23) suggested an advanced explanation of benefits would help patients understand the cost of care before they receive it. Mr. Pollack shared that the idea has promise, and he said that hospitals have been working with stakeholders to provide cost information to patients. Mr. Pollack continued to explain that many hospitals are committed to helping their patients but are confused by the many different laws and regulations that have been passed in the past decade regarding price transparency procedures.
Impact of Reconciliation Bill
Many Democrats were focused on the impacts of the One Big Beautiful Bull Act, specifically the changes to Medicaid. Full Committee Ranking Member Pallone (D-NJ-6) and Health Subcommittee Ranking Member DeGette (D-CO-1) were interested in how the bill’s changes will impact the delivery of health care services and which ones will be most affected. Ms. Merril shared her view that providers will see a reduction in reimbursement rates across the board, but home and community-based care will be greatly impacted as they are not required services. Rep. Raul Ruiz (D-CA-25) and Rep. Lori Trahan (D-MA-3) questioned what the effect will be on hospital systems. Mr. Pollack explained that, in his view, emergency departments will see higher patient volumes, and services for obstetrics, behavioral health, and pediatrics will be greatly reduced or eliminated. Mr. Pollack also said that in severe cases, hospitals will close.
Workforce
Rep. Marc Veasey (D-TX-33) highlighted the current physician shortage and asked for Dr. Aizuss to elaborate on the future impacts of this shortage. Dr. Aizuss shared that it will be more difficult for patients to receive care and that this problem will only get worse as less students attend medical schools in the future due to the high cost of tuition. Rep. Cliff Bentz (R-OR-2) wanted to know what strategies could be helpful in addressing this issue. Dr. DiGiorgio emphasized the need for more residency spots and suggested Congress find ways to increase physician autonomy, like private practices, to keep physicians in the workforce for longer.
Other Topics
- Rep. Buddy Carter (R-GA-1) highlighted H.R.5256, the 340B ACCESS Act, and asked if Mr. Pollack would be supportive of the bill. Mr. Pollack shared that the 340B program benefits patients by providing additional services and that he could be interested in a conversation with Rep. Carter about his proposals.
- Rep. Erin Houchin (R-IN-9) highlighted the reimbursement differences between Medicare, Medicaid, and private payers. Dr. Aizuss agreed and emphasized the need for Medicare and Medicaid payment reform, including updates for inflation.
- Health Subcommittee Chairman Griffith expressed support for physician owned hospitals and questioned Mr. Pollack about his concerns. Mr. Pollack explained that while he is not opposed to physician-owned hospitals, they often do not provide all services, such as emergency departments and obstetric care, and many do not accept Medicaid. Dr. DiGiorgio responded that all hospitals expand access to care.
