PIPC has provided the Medicare Drug Negotiation Program with recommendations for a process centered on patients and people with disabilities. These recommendations may be useful references for consideration in response to the agency’s initial guidance, particularly related to the factors outlined for consideration in statute.
- CMS should establish a negotiation process that allows for continuous, robust engagement of patients and people with disabilities at multiple levels.
- When developing its offer for MFPs, CMS should ensure it is prioritizing assessing therapeutic benefit and considering value through the lens of how patients and people with disabilities experience and value their health care.
- CMS should set standards for high-quality, patient-centered evidence that will drive investment in the development and testing of innovative methodologies that are inclusive and advance health equity.
- CMS should follow the NCD’s recommendation not to rely on QALYs or similar metrics as a factor for determining therapeutic benefit or “value.”