Twenty Organizations Submit Comments on Proposed Requirements for Medicare Coverage with Evidence Development Parameters

On September 7, 2022, the Agency for Healthcare Research and Quality (AHRQ) released proposed updated study requirements for Medicare’s coverage with evidence development (CED) program. CED is utilized by the Centers for Medicare and Medicaid Services (CMS) when the agency believes additional clinical information is necessary before providing broad access to a procedure, medical device, diagnostic, or prescription drug in the Medicare program.

During CMS’s CED data collection process, Medicare beneficiary access is limited. CED coverage requirements are currently in place for therapeutics for a number of conditions including: sickle cell, lung diseases, heart disease, chronic pain, depression, and dementia. In many cases, an item can remain under CED review for a prolonged period of time.

The Alliance for Aging Research supports a review of the CED process to ensure there are defined, condition-specific endpoints that can result in the end of CED restrictions. However, AHRQ’s recommendations are overly broad and may result in prolonged reviews.  (More coverage of this topic is available via the Pink Sheet.)

The comment letter, supported by 20 organizations, raises several concerns stemming from the AHRQ recommendations, including:

• Current challenges with CED, including lack of therapy-specific criteria for ending coverage restrictions
• Concerns that AHRQ’s proposed criteria are undefined and would permit CMS to potentially indefinitely extend CED
• Lack of transparency in the recommendation process, and in regards to AHRQ’s recommendation to require posting CED trials on CMS website only, rather than also on ClinicalTrials.gov
• Improper reliance on cost-effectiveness studies
• A request that AHRQ address the above concerns, issue a second comment period, and postpone relevant MEDCAC pertaining to the guidance

The full letter can be read here. The letter was was supported by the following organizations:

Alliance for Aging Research
Alliance for Patient Access
ALS Association
The American Society of Consultant Pharmacists
The Balm In Gilead, Inc – Brain Health Center for African Americans
BrightFocus Foundation
Caregiver Action Network
Global Alzheimer’s Platform Foundation
The Global CEO Initiative on Alzheimer’s Disease
Global Coalition on Aging’s Alliance for Health Innovation
HealthyWomen
Heart Valve Voice US
Infusion Providers Alliance
Men’s Health Network
National Minority Quality Forum
Partnership to Fight Chronic Disease
RetireSafe
Society for Women’s Health Research
UsAgainstAlzheimer’s
Voices of Alzheimer’s

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The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org.

For more information about the Alliance for Aging Research or to interview an expert on this topic, please contact Katie Riley, Vice President of Communications, at [email protected].