Analysts suggest that Medicare’s drug price regulations might limit Americans’ access to healthcare and potentially increase expenses over time. The Inflation Reduction Act (IRA), enacted by former President Joe Biden in August 2022, allows the U.S. federal government to negotiate prices for specific high-cost prescription medications included in Medicare, through the Medicare Drug Price Negotiation Program. While Democratic lawmakers previously asserted that the IRA would lower healthcare costs, some analysts expressed concerns to the Daily Caller News Foundation, arguing that these price controls could restrict access to certain medications for patients and burden Americans financially.
Isabelle Marchese, the Health Policy Director at Americans for Tax Reform, pointed out to the DCNF that despite being promoted as a benefit for consumers, these price controls don’t actually address the key health policy issues people care about most. “They don’t eliminate costs or risks; they merely shift them around in less efficient, more opaque ways,” she noted. There’s a possibility that, to safeguard their revenue, insurers and Pharmacy Benefit Managers (PBMs) will tighten utilization management practices—such as prior authorization, quantity limits, and formulary exclusions—affecting the drugs whose prices have been artificially lowered.
Marchese further mentioned that these price controls are likely to constrain access to certain prescription drugs in the future. “Not only may they lead to increased drug prices and limit access soon, but the long-term impacts could be even worse,” she stated. She explained that companies might boost initial launch prices for new medications, hasten price hikes on non-selected drugs, and shift more costs onto commercial markets, affecting under-65 Americans. The innovative research projects that established the U.S. as a leader in biomedical innovation may not even be initiated due to these changes.
The Centers for Medicare and Medicaid Services (CMS) introduced its first proposed rule in June to lay down guidelines for the IRA’s Drug Price Negotiation Program, targeting the Initial Price Applicability Year (IPAY) 2029 and subsequent years. Following the implementation of the coverage requirement for selected drugs in IPAY 2026 during the first quarter, 24% of initial requests for these medications were rejected, indicating minimal improvement in patient access, according to IQVIA analysis.
CMS plans to publish the final rule for the Medicare Drug Price Negotiation Program in the fall of 2026. They also aim to provide revised information requests on data the federal government will need for drug selection and negotiation purposes, seeking the Office of Management and Budget’s final approval.
Former President Trump has criticized price controls in the past, linking them to leftist policies. In August 2024, he referred to then-Vice President Kamala Harris’ proposal for a ban on food price gouging as an expression of “communist” price controls. Interestingly, some experts have drawn parallels between Trump’s May 2025 executive order aimed at allowing broader access to favored prices for prescription drugs and the introduction of similar controls.
A CMS spokesperson stated their commitment to reducing prescription drug costs for seniors while ensuring that taxpayers are protected and innovative treatments remain accessible. They emphasized an ongoing examination of cost trends and utilizing all available means to enhance affordability and transparency within the system.
In March, a survey conducted by No Patient Left Behind revealed that 92% of Medicare beneficiaries anticipate facing higher out-of-pocket expenses under the IRA. Additionally, 30% reported initial denial of access to prescribed drugs from their Medicare Part D plans.
According to Pacific Research Institute President Sally Pipes, the IRA has not achieved the promised results. She pointed out that about 25% of patients trying to access one of the first ten price-controlled drugs were initially denied, with much higher rates for some severe conditions. She contended that this reinforces the belief that government price controls hinder patient access to medications.
Despite these concerns, a KFF poll conducted in September 2024 still found that 85% of voters support allowing the federal government to negotiate prices for certain prescription drugs for Medicare recipients.
Republican North Carolina Rep. Greg Murphy has claimed that Americans’ access to necessary medications will significantly decline because of the IRA’s price negotiation program. Pipes added that the IRA might deter companies from investing in medical research and development across the country, raising doubts over whether rejection rates and utilization management practices will continue to escalate as more medicines fall under IRA controls.
