WASHINGTON, D.C. — In a new letter, top lawmakers are urging Biden administration health officials to provide transparency to patients for how Medicare coverage is determined. Following the Centers for Medicare and Medicaid Services’s (CMS) recent proposal of its Transitional Coverage of Emerging Technologies (TCET) notice and its blanket coverage policy of Alzheimer’s treatments, House Ways and Means Committee Chair Jason Smith (R-MO) and House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) led members of their committees in sending a letter calling for more transparency in how CMS makes National Coverage Determinations (NCDs). The letter was sent to the Department of Health and Human Services (HHS) Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.
“Providing access to innovative technologies is critical to ensuring our federal health care programs are best serving patients. […] As we review the CMS coverage policies in the [TCET] rule, we urge you to encourage transparency in the agency’s consideration of Medicare National Coverage Determination (NCD) requests overall.
“[T]here are an unknown number of review requests pending before the agency, with unknown time intervals for each review, and an unknown methodology for how these requests are prioritized. Consequently, patients are waiting for access to items and services without any visibility into the government’s decision-making process or a means to anticipate when such products may be available to them, even after clearance, approval, or licensure by the Food and Drug Administration (FDA).
“This uncertainty could prove harmful to Medicare patients. Beneficiaries may not be able to afford a product without Medicare coverage and will resort to less effective alternative treatments for their unique needs, or wait to receive necessary care until a coverage decision is granted by CMS. Some may choose to delay necessary care altogether until a coverage decision is granted by CMS. Additionally, patients outside of the Medicare program may also face barriers to getting an FDA-approved medical product their doctor may think is best while a CMS coverage decision is pending.”
“We also implore you to reconsider the unprecedented decision to restrict Medicare coverage for an entire class of Alzheimer’s treatments through a blanket NCD, a decision that illustrates the fundamental problems with the vast agency discretion and political uncertainty within the review and determination process. Families struggling with Alzheimer’s or other health conditions deserve a more transparent and predictable process for medical products already approved by the FDA.”
In order to serve patients, providers, and medical innovators with greater transparency in the NCD process, the members requested the following information no later than July 25:
1. A comprehensive list of up-to-date items awaiting a formal NCD, which shall include, but not be limited to, all NCD requests which are under review, on the wait list, open, or that have been finalized within the past 12 months. Each request should include the date the request was initially made;
2. A plan for updating the NCD dashboard, which will detail how this information will be made available to the public and include specific timelines for how frequently CMS will publicly update the NCD dashboard.
CLICK HERE to read the full letter.
The following members joined Chairs Smith and Rodgers in sending the letter: Reps. Vern Buchanan, Brett Guthrie, Mike Kelly, Michael. C. Burgess, M.D., Adrian Smith, Robert E. Latta, Darin LaHood, H. Morgan Griffith, Brad R. Wenstrup, D.P.M, A. Drew Ferguson, IV, Bill Johnson, Gus M. Bilirakis, Lloyd Smucker, Larry Bucshon, M.D., Kevin Hern, Richard Hudson, David Kustoff, Earl L. “Buddy” Carter, Brian Fitzpatrick, Jeff Duncan, W. Gregory Steube, Gary Palmer, Claudia Tenney, Neal P. Dunn, M.D., Michelle Fischbach, Greg Pence, Blake Moore, Daniel Crenshaw, Michelle Steel, John Joyce, M.D., Beth Van Duyne, Troy Balderson, Randy Feenstra, Diana Harshbarger, Nicole Malliotakis, Mariannette J. Miller-Meeks, M.D., Mike Carey, and Kat Cammack.