Alexandria, VA – May 5, 2023 – The Innovation and Value Initiative (IVI), a non-profit research organization committed to advancing the science, practice, and use of health technology assessment (HTA) in health care, submitted comments on the Centers for Medicare & Medicaid Services (CMS) initial guidance on the implementation of the Medicare Drug Price Negotiation Program (Medicare DPNP).

We commend CMS for its efforts to develop thoughtful and thorough guidance on the implementation of the DPNP, however, upon examining the initial guidance through the lens of equity, transparency, and patient-centricity, we have some concerns.

IVI’s recommendations include the following:

  • Focus of DPNP should be on maximizing value, not simply minimizing prices. To the extent allowed by existing legislation, the DPNP should emphasize understanding and maximization of value—as opposed to simply minimizing product prices—as a primary objective of the program and orient program guidelines around this objective.
  • Health equity must clearly inform all aspects of DPNP guidelines. Equity implications of all aspects of the program should be systematically considered as part of DPNP activities, and strategies to support equity (by including members of underrepresented or “specific” populations as formal partners in the process, for example) should be incorporated wherever possible.
  • Systematic approaches to elevating. Affected beneficiaries (e.g., current patients), their families and caregivers, and organizations that represent them must be actively involved in DPNP processes with a meaningful voice in decision making, and specific measures to ensure patient experience and other inputs are elevated in CMS’s evaluation of candidate drugs must be explicitly outlined in the guidance.
  • Clarity and specificity in methods and overall approach are needed. A “qualitative approach” is needed when evaluating evidence on a given drug provides CMS.
  • DNP guidance must be informed by forward-thinking strategic considerations. In an environment where availability of evidence and methodologies lags behind the needs of comprehensive value assessments, CMS must endeavor to spur innovations that advance the field, for example, by calling for data on relative treatment affects across patient subpopulations and encouraging exploration of novel methods to capture quality-of-life outcomes as an alternative to QALYs.

IVI looks forward to working with CMS and others as they proceed with implementation of the Inflation Reduction Act (IRA).

Read IVI’s full comments here.


About IVI
The Innovation and Value Initiative (IVI) is a 501(c)(3) tax-exempt, non-profit research organization dedicated to advancing the science and improving the practice of health technology assessment through development of novel methods and the creation and application of enhanced health technology assessment models to support local decision-making needs in healthcare.

Contact: Smita Sanwardeker
Phone: 267.909.7661