On May 14, 2018, HHS issued a request for information (RFI) on the administration's "American Patients First" drug pricing policy blueprint. The RFI seeks input from stakeholders on a wide range of policy proposals included in the blueprint released late last week. HHS Secretary Alex Azar, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma held a press conference alongside the release of the RFI to provide additional detail on the administration's potential next steps. Comments on the RFI are due on or before July 16, 2018.
Overall, the RFI echoes the set of questions and priorities included in the administration's blueprint document, reflecting key themes of enhanced competition, transparency and value-driven incentives. The RFI sets forth the same four "challenges" in the U.S. drug market and proposes nearly identical "immediate actions" and "further opportunities" for each challenge discussed in the blueprint. However, the RFI also includes a new section not included in the blueprint, titled "Additional Feedback." There, HHS solicits any other suggestions to "improve the affordability and accessibility of prescription drugs" as well as comments regarding regulatory burdens posed by current and/or proposed drug pricing rules.
HHS is looking for feedback on topics such as whether the Medicaid drug rebate program may pose a barrier to price negotiations in other markets and how changes to the rebates in the Affordable Care Act (ACA) have impacted list prices of drugs. The RFI also seeks feedback on proposed changes to Medicare Parts B and D, the 340B Drug Discount Program, and FDA-centric issues such as which resources or development tools from FDA would most reduce the development costs of biosimilars.
Given the blueprint's broad scope, there is potential for significant market implications in the longer term. Although many of the proposals may leverage existing executive authority, including potentially Center for Medicare & Medicaid Innovation (CMMI) demonstration authority, it is likely that the administration may call on Congress to remove statutory roadblocks to lower drug prices.
The blueprint and other administration statements are a mixture of general principles and specific actions, but they are a long way from actual implementation. The blueprint mostly lists potential steps the administration may take. Some of the ideas can be put into effect through regulations or guidance documents. Some will require legislation, provided the administration is beginning to move forward on select priority items in the near term. For example, CMS released updated drug dashboard data, reflecting the administration's focus on transparency in drug prices.
Additional proposals are in the works, and given the request for comment on an extensive list of topics, stakeholders should closely review the blueprint and RFI to consider topics that merit submission to HHS.