April 16, 2021
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
200 Independence Ave S.W.
Washington, DC 20201
Submitted via https://www.regulations.gov
RE: Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period [CMS-3372-IFC]
Dear Acting Administrator Richter,
Thank you for the opportunity to comment on the interim final rule Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period, which addresses the recent final rule establishing a Medicare coverage pathway for medical devices designated as breakthrough by the Food and Drug Administration (FDA) and regulatory standards for making reasonable and necessary determinations. The National Pharmaceutical Council previously submitted comments in response to the initial proposed rule.
The National Pharmaceutical Council (NPC) is a health policy research organization dedicated to the advancement of good evidence and science and to fostering an environment in the United States that supports sustainable medical innovation. NPC is supported by the major U.S. research-based biopharmaceutical companies. We focus on research development, information dissemination, education and communication of the critical issues of evidence, innovation and the value of medicines for patients. Our research helps inform important health care policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.
Codification of Reasonable and Necessary Should Rely on More Deliberate Stakeholder Input
In response to the final rule, CMS adopted regulatory standards for making reasonable and necessary determinations for items and services furnished under Medicare Part A and Part B. NPC and other commenters encouraged CMS to take a cautious approach to finalizing such a provision, allowing time for dialogue with stakeholders and careful consideration of any impacts of finalizing the policy.
In the initial proposed rule, CMS outlined a modification to “reasonable and necessary” in response to the medical device industry request for greater clarity. It is unclear whether the scope of the definition for “reasonable and necessary” would include both devices and pharmaceutical products. Coverage policies for drugs and devices may have different challenges. Further, any changes to the definition of reasonable and necessary could have important implications for patient access to needed treatments. For these reasons, we suggest CMS allow for separate stakeholder dialogue and input to ensure that any changes will not lead to unintended consequences for patients.
Pharmaceutical products continue to represent significant innovations in the health care market, offering patients, caregivers, and providers effective treatments that produce significant clinical outcomes. Payment structures and incentives designed to promote patient access are crucial as new and innovative curative therapies come to market. We appreciate CMS’ acknowledgment of the role of innovation represented by new technologies coming to market and encourage the agency to continue supporting further innovation across the health care landscape.
Robert W. Dubois, MD, PhD
Interim President and Chief Executive Officer,
Chief Science Officer and Executive Vice President