Alliance for Aging Research Statement on Restrictive Medicare Coverage Policies that Mandate Clinical Study Participation for FDA-Approved Medical Treatments

WASHINGTON, Aug. 13, 2024 /PRNewswire/ -- On August 8, the Centers for Medicare and Medicaid Services (CMS) released final guidance documents on Coverage with Evidence Development (CED), the National Coverage Analysis (NCA) Evidence Review process, and the final notice of process and procedures for the Transitional Coverage for Emerging Technologies (TCET). Alliance for Aging Research President and CEO Sue Peschin, MHS, released the following statement in response:

"The coverage policies released by the Centers for Medicare and Medicaid Services (CMS) will further decrease Medicare beneficiaries' ability to access FDA-approved drugs, devices, and procedures covered under Medicare Part B,¹ and would severely impact beneficiaries with life-threatening conditions. The final policies allow CMS to indiscriminately mandate that Medicare beneficiaries enroll in clinical studies for coverage of selected treatments, or else coverage will be denied.

Equally troubling, CMS arbitrarily reiterates that FDA-accepted clinical trials are no longer sufficient to determine Medicare coverage of drugs and devices and takes direct aim at the FDA's Accelerated Approval and Breakthrough Devices programs. The agency's refusal to accept the FDA's clinical judgments will result in tens of millions of Medicare beneficiaries having only second-class access to new Part B treatments. 

In the policies, CMS expresses support for use of randomized, controlled trial (RCTs) models for CED and TCET clinical studies—meaning enrolled beneficiaries would not know whether they are assigned to the previous standard of care, a placebo, or the new, FDA-approved intervention their doctor recommended. A separate CMS OPPS proposed rule would further cement this model by creating a coding and payment policy for RCT CED studies.

It is no secret that the Medicare program's existing CED policies have had the opposite impact on access from what CMS publicly claims they would do. CMS originally created CED in 2005 and, since then, has applied it to dozens of procedures—including those for severe hearing loss (cochlear implants), less-invasive heart valve replacement, and stem cell transplant for certain cancers and sickle cell disease. As the Alliance documented in our February 2023 report, Façade of Evidence: How Medicare's Coverage with Evidence Development Paradigm Rations Care and Exacerbates Inequity, once CMS places a treatment in CED, it's extraordinarily difficult to reverse the decision. Between 2005 and 2023, CMS issued a total of 27 CED policies—in that time, the agency retired just five of them. CMS's April 7, 2022, Alzheimer's coverage decision was the first time CMS applied CED to an on-label use of an FDA-approved drug.

The CED final guidance states that, in the future, Medicare will only cover medical products for which there is CED study participation by the 'intended population' in their 'expected sites of care.' However, it is well documented that Medicare beneficiaries in rural communities and communities of color are more likely to be denied access under CEDs because the conditions of coverage primarily direct care to urban medical centers in wealthier areas. Worse, CMS has exploited inequitable participation in existing CED clinical studies as justification to keep CED going—for example, the TAVR CED has lasted for over a decade. Years into the CED decision, and despite the development of additional compelling evidence, CMS confirmed its commitment to continuing the CED on the grounds that the study – which was approved by CMS – did not include sufficient representation from communities of color. Unfortunately, CED policies restrict access and collection of additional data for these very communities.

The 'Transitional Coverage for Emerging Technologies' (TCET) coverage policy is a form of CED that specifically applies to medical devices approved through the FDA's Breakthrough Device pathway. Breakthrough devices show clinical improvement over standard of care or otherwise address unmet medical needs. Yet, CMS has announced it will only consider up to 5 such products for TCET coverage, and then only cover the beneficiaries in the TCET clinical studies, which can last for years. The CMS policy undermines Congress' intent that access to breakthrough devices should be expedited to improve patient care. Now, while FDA will accelerate consideration, CMS will block access to these new and innovative treatments.

CMS's comments on its new policies reject Section 1801 of the Medicare law, which explicitly bars CMS from supervising or controlling clinical care. Yet, CMS is directly violating the law by presuming FDA-approved treatments are not relevant for Medicare beneficiaries and by restricting coverage to entire classes of treatments, irrespective of the level of evidence for an individual product.

Moreover, Congress has not authorized CED or TCET coverage policies. While CMS includes interpretation of its legal authority for these policies in its guidance documents, the Agency's legal justification has been rejected by its own legal counsel and would clearly fail review under the Supreme Court's recent Loper Bright decision. CMS has also made clear that it will ignore the FDA's determinations going forward and reach its own 'scientific' conclusions, even though CMS – unlike the FDA – does not have the staff or resources to be able to make such decisions.

These policies afford the Medicare program unchecked power to not only lock up access to future Part B treatments and services, but to throw away the keys. The agency is clearly overstepping its authority and—absent a pullback—Congress or the President needs to step in to safeguard beneficiary care.

About the Alliance for Aging Research
The Alliance is dedicated to changing the narrative to achieve healthy aging and equitable access to care. We strive for a culture that embraces healthy aging as a greater good and values science and investments to advance dignity, independence, and equity. Learn more about the Alliance at www.agingresearch.org.

To interview Sue Peschin, email Katie Riley, Vice President of Communications, at [email protected].

¹ Among other benefits, Medicare Part B covers treatments administered by doctors and other health care providers.

SOURCE Alliance for Aging Research