The Trump administration recently released “American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.” In a complementary request for information (RFI), the administration is soliciting input from stakeholders across a wide range of topics related to drug pricing. Specifically, the administration is exploring options to introduce additional management and competition under the Part B benefit by transitioning some products from the Part B program into Part D.

Few details are available on the parameters for the proposed shift, but such a policy modification would likely present a significant change for providers in terms of revenues and their role in purchasing, storing, and billing for physician-administered drugs. This transition could also result in unintended patient access barriers caused by differences in payment, cost-sharing, reimbursement, and settings of care in Part B and Part D.

Similar to physician-administered specialty drugs, vaccines are also biologics that are generally not self-administered by patients and require complex storage and handling to ensure safety. Due to a long history of incremental statutory changes by the United States Congress, coverage of vaccinations routinely recommended for adults age 65 and older is now divided between Part B and Part D. As such, the experience of Medicare coverage of vaccines offers an informative example of how covering provider-administered products under what is largely an outpatient retail drug program can affect patient access and create administrative, financial, and operational burdens for patients and providers.

The administration’s RFI is seeking feedback on a host of operational and policy design questions, as well as on the potential impact on providers and beneficiaries. Understanding the vaccines experience is instructive for policymakers and the public to anticipate the potential risks of shifting drugs from Part B to Part D. This issue brief reviews some of the operational and access challenges that patients and providers have faced with Part D vaccines to illustrate the key considerations that should be examined by policymakers evaluating a policy to transition certain Part B drugs into the Part D program.

Access the issue brief here.

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Funding for this research was provided by The Pharmaceutical Research and Manufacturers of America (PhRMA). Avalere maintained full editorial control.