Nearly 60 organizations and advocates representing the patient and disability communities joined PIPC's comment letter on the Centers for Medicare and Medicaid Services' (CMS) guidance implementing the Medicare Drug Price Negotiation Program.
Our comments focus on the agency’s process for engaging patients in its decisions, including determinations related to a treatment’s clinical effectiveness, unmet need and therapeutic alternatives, as well as the agency’s use of value assessments.
While we appreciate that CMS is considering certain recommendations from patients and people with disabilities for improving its engagement, we are concerned that the new guidance does not put forward a concrete plan or process for developing predictable, targeted, and specific tactics for engaging patients and people with disabilities. We are also concerned that the guidance does not capture the limitations on use of quality-adjusted life years (QALYs) and similar measures explicitly described in the Affordable Care Act. Therefore, the letter shares the following recommendations:
While we appreciate that CMS is considering certain recommendations from patients and people with disabilities for improving its engagement, we are concerned that the new guidance does not put forward a concrete plan or process for developing predictable, targeted, and specific tactics for engaging patients and people with disabilities. We are also concerned that the guidance does not capture the limitations on use of quality-adjusted life years (QALYs) and similar measures explicitly described in the Affordable Care Act. Therefore, the letter shares the following recommendations:
- CMS should avoid one-size fits all value metrics.
- CMS should develop a formalized process to ensure continuous, robust engagement of patients and people with disabilities at multiple levels.
- Using patient insights, CMS should clearly communicate how it intends to use the input it receives, and how that input is reflected in the final negotiated prices.
- CMS should solicit input from diverse communities to ensure representation of the diversity of the patients and communities affected by the topic.
- CMS should ensure that opportunities for patient engagement are accessible.
- To gauge both successes and challenges, CMS should establish a structured process for continuous review and assessment of its engagement strategy.
| final_cms_letter_july_2024.pdf |
