Today, PhRMA submitted its comments in response to the Centers for Medicare & Medicaid Services (CMS) request for information on the future of the Center for Medicare and Medicaid Innovation (CMMI). While well intentioned, CMMI’s current flexibility to make far-reaching changes has raised a number of concerns about large-scale mandatory demonstrations developed without stakeholder input, such as the proposed Part B drug payment model that was recently withdrawn. We welcome the Administration’s call for feedback and look forward to working with them on the evolution of CMMI. Here are some of our suggestions for the new direction of CMMI:
- Formalize Guiding Principles: “We encourage CMMI to build on the strong initial set of principles included in the RFI by formalizing these principles in rulemaking and clarifying how CMMI will engage Congress in any model expansions before proceeding with new demonstrations.”
- Considerations for New Demonstrations: “With appropriate guardrails in place, we believe there are several concepts that CMS could test across the proposed focus areas to improve quality and reduce costs. These demonstrations could look to better align incentives for Part D plans, promote shared decision making between providers and patients, further integrate care for beneficiaries with mental health and substance abuse disorders or improve the Oncology Care Model.”
- Address Barriers to Value-Based Arrangements: “PhRMA appreciates CMMI’s interest in innovative value-based purchasing arrangements for pharmaceuticals, and we believe that broader participation in voluntary, market-based arrangements can benefit patients in Medicare and Medicaid. However, CMMI is limited in its ability to address the regulatory barriers that biopharmaceutical manufacturers and payers are facing. We encourage CMMI to work across agencies to address barriers such as price reporting rules, the anti-kickback statute, and FDA rules for manufacturer communications in order to facilitate broader use of value-based arrangements.”
- Preserve the Structure of Medicare and Medicaid: “There are structural elements of Medicare and Medicaid that are working well, like the robust negotiation that occurs in Part D, the market-based average sales price system for Medicare Part B drugs and the Medicaid rebate statute [covenant]. CMMI should avoid policies that would undermine the success of these programs or reduce patient access to needed treatments.”
CMMI programs could negatively impact millions of Medicare beneficiaries without appropriate safeguards. That’s why we encourage the Administration to review all of the feedback provided by stakeholders as part of this RFI process before issuing any new demos.
Read our full comments here, and learn more at PhRMA.org/CMMI.