The Inflation Reduction Act’s Medicare Drug Price Negotiation Program

The Inflation Reduction Act's Medicare Drug Price Negotiation Program

The Centers for Medicare & Medicaid Services (CMS) recently unveiled transcripts from a series of patient-focused listening sessions, a pivotal element of the Inflation Reduction Act’s Medicare Drug Price Negotiation Program.

These sessions, conducted between Oct. 30 and Nov. 15, 2023, marked a significant step forward in the Program’s mission to make prescription drugs more affordable for Medicare Part D enrollees. Specifically, these sessions focused on the inaugural set of 10 drugs selected for negotiation, which treat a range of medical conditions, including diabetes, blood clots, heart failure, psoriasis, rheumatoid arthritis, Crohn’s disease, and blood cancers.

The drugs in question – Farxiga, Fiasp/NovoLog, Januvia, Jardiance, Eliquis, Xarelto, Entresto, Stelara, Enbrel, and Imbruvica – were chosen for their clinical importance and the financial burden they impose on patients. These sessions provided a platform for patients, caregivers, and representatives from consumer and patient organizations to voice their experiences, concerns, and hopes regarding access to these critical medications under the new negotiation framework.

While much of the public discourse surrounding the Medicare Drug Price Negotiation Program has revolved around the technicalities of the negotiation process, potential impacts on drug development, and legal challenges from pharmaceutical companies, less attention has been paid to the Program’s implications for Medicare Part D enrollees’ access to and utilization of these medications.

Key provisions of the law are designed to ensure broad access to these medications once negotiated prices come into effect in 2026. All Medicare Part D plans will be required to cover each of the negotiated drugs in all available dosages and forms. Furthermore, CMS will closely monitor and regulate the placement of these drugs on formulary tiers, ensuring that any decision to place these drugs on non-preferred tiers, which typically involve higher cost-sharing for patients, is well-justified.

Additionally, CMS aims to curtail the use of utilization management tools like prior authorization requirements for these drugs, potentially easing administrative hurdles and facilitating easier access to these medications for enrollees. Despite the currently high coverage rates for most of these drugs across Part D plans, variations do exist, particularly in the coverage of different dosages and forms. For example, while nearly all enrollees have access to Xarelto tablets, coverage for its oral suspension drops to 78 percent. Similarly, coverage varies for different forms of Imbruvica, with a slight decrease in coverage for higher-dosage forms. As the Medicare Drug Price Negotiation Program moves forward, these measures reflect a comprehensive approach to not only lowering drug prices, but also ensuring that enrollees have the access they need to critical medications. This balanced focus on affordability and accessibility highlights the Program’s potential to significantly impact the lives of millions of Americans reliant on Medicare Part D for their prescription drug coverage.

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Timothy Powell, CPA, CHCP

Timothy Powell is a nationally recognized expert on regulatory matters, including the False Claims Act, Zone Program Integrity Contractor (ZPIC) audits, and U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) compliance. He is a member of the RACmonitor editorial board and a national correspondent for Monitor Mondays.

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