34 Organizations to CMS: Access Must be at the Forefront of the National Coverage Analysis Process

On August 21, the Alliance for Aging Research was joined by 33 other organizations in submitting a letter to the Centers for Medicare and Medicaid Services (CMS), regarding the “National Coverage Analysis Evidence Review Proposed Guidance” that was released earlier this summer. The letter advocates for several critical changes to enhance the transparency and equity of the National Coverage Analysis (NCA) and National Coverage Determination (NCD) process, as conducted by CMS.

The letter’s key points and recommendations included:

1. Public Notice and Comment:The organizations urged CMS to commit to public notice and comment in the Federal Register for all future NCAs, noting that the lack of public notice limits stakeholder engagement to those who are already informed or subscribed to CMS email alerts. This shift towards Federal Register notifications and longer comment periods of at least 45 days, will foster more equitable participation in the NCA process.
2. Transparency in Evidence Review: There is currently no transparency about the rationale for how each NCA process is assessed, and the letter emphasized the need for CMS to clarify its reasoning behind evidence review and questions in each NCA, ensuring that the standards for evidence are well-defined and consistently applied. Additionally, we advocate against the use of Coverage with Evidence Criteria, noting the that those criteria can significantly reduce access to care.
3. Coverage Guidance: The letter highlights the significant waiting times that patients and clinicians often endure during the NCA/NCD process, noting that the current NCA process takes 9-12 months on average, and implementation can take even longer. Medicare beneficiaries and clinicians should not have to wait months for coverage and access to FDA-approved products.

The signatories of the letter listed below represented a broad coalition of organizations, including patient advocacy groups, health foundations, and professional associations. Read the full letter here.

• Alliance for Aging Research
• Alliance for Health Innovation
• Alzheimer’s Los Angeles
• Alzheimer’s New Jersey
• Alzheimer’s San Diego
• Arthritis Foundation
• Association of Black Cardiologists
• Asthma and Allergy Foundation of America
• Caregiver Action Network
• Chronic Care Policy Alliance
• EveryLife Foundation for Rare Diseases
• Family Caregiver Alliance
• Global Alzheimer’s Platform Foundation
• Global Coalition on Aging Alliance for Health Innovation
• Healthy Men Inc.
• HealthyWomen
• Infusion Providers Alliance
• LuMind
• LUNGevity
• Lupus and Allied Diseases Association, Inc.
• Melanoma Research Alliance
• National Consumers League
• National Minority Quality Forum
• National Task Group on Intellectual Disabilities and Dementia Practices
• Nevada Chronic Care Collaborative
• NTM Info & Research
• Parent Project Muscular Dystrophy
• Partnership to Fight Chronic Disease
• Society for Women’s Health Research
• The Gerontological Society of America
• The Global CEO Initiative on Alzheimer’s Disease
• The Mended Hearts, Inc.
• UsAgainstAlzheimer’s
• Voices of Alzheimer’s