On April 14, 2023, 56 organizations representing patients and people with disabilities sent a letter to CMS related to its guidance for implementation of the Medicare Drug Negotiation Program. The letter to CMS provides the following recommendations and comments:
- We Urge Meaningful Engagement of Patients and People with Disabilities
- We urge CMS to Explicitly Recognize, Without Exception, the Existing Statute Barring Use of QALYs and Similar Measures
- Recommendations for Consideration of Non-QALY Evidence in Reports Using QALYs
- Recommendations for Consideration of Comparative Clinical Effectiveness Research and Appropriate Comparators
- Recommendations for Therapeutic Advance and Unmet Need
- We Urge CMS to Set a High Bar for the Quality of Evidence to be Considered.
The letter states, "For CMS to meet its obligations to beneficiaries, it will be critically important for CMS to be thoughtful in how it assesses therapeutic benefit to affected patients. CMS must ensure that patients and people with disabilities are granted a seat at the table and a clear and robust path to engagement throughout the process."
| joint_comment_to_cms_on_negotiation.pdf |
