Capitol Hill Report: Working with CMS on monoclonal antibodies coverage
March 20, 2023
Latest advocacy news
- On March 15, the Medicare Payment Advisory Commission (MedPAC) calling for an annual physician payment update tied to the Medicare Economic Index. The Â鶹´«Ã½Ó³» is highly supportive of MedPAC’s acknowledgment of the inadequacy of the current Medicare physician payment system and the need for a positive update. As part of Neurology on the Hill, the Â鶹´«Ã½Ó³» recently urged Congress to consider the need for broad payment reform and a positive update tied to inflation.
- On March 1, the Drug Enforcement Administration (DEA) impacting prescribing of controlled substances via telemedicine following the termination of the public health emergency. The proposed rules impact telemedicine consultations by a medical practitioner who has never conducted an in-person evaluation of a patient, and who has not received a referral from a medical practitioner who conducted an in-person examination. The proposed rule’s primary impact is that it would allow impacted telehealth practitioners to prescribe a 30-day supply of Schedule III-V non-narcotic controlled medications without an in-person examination or a referral from a practitioner who conducted an in-person examination. The Â鶹´«Ã½Ó³» is currently reviewing the proposed rule and plans to submit comments.
- Earlier this month, the Senate Committee on Health, Â鶹´«Ã½Ó³», Labor and Pensions released a on the health care workforce shortage. The Â鶹´«Ã½Ó³» is reviewing the request and working on a response. Visit the Â鶹´«Ã½Ó³» Advocacy Action Center to share how workforce shortages have affected you, your patients, and your practice.
- The Conrad State 30 and Physician Access Reauthorization Act was by Senators Amy Klobuchar (D-MN), Susan Collins (R-ME), Jackie Rosen (D-NV), and Thom Tillis (R-NC). This legislation supports international medical graduates by extending the Conrad 30 program, which provides 30 waivers per state to allow these physicians to remain in the US without having to return home for two years if they agree to practice in a medically underserved area for three years. The legislation would reauthorize the Conrad 30 program for an additional three years, as well as make several key improvements to the program, including creating a process to gradually increase the number of waivers while requiring additional employment protections.
Issue in focus
The Â鶹´«Ã½Ó³» is continuing to work with the Centers for Medicare & Medicaid Services (CMS) to refine coverage requirements impacting monoclonal antibody products for the treatment of Alzheimer’s Disease. The Â鶹´«Ã½Ó³» is providing CMS with critically needed thought leadership in advance of a decision on traditional approval that is expected by July 6, 2023. The Â鶹´«Ã½Ó³» is committed to continuing to have an open dialogue with CMS on how coverage policy should be designed for this and other monoclonal antibodies.
On February 2, the Â鶹´«Ã½Ó³» sent a letter to the Coverage and Analysis Group at CMS requesting that the agency reconsider the National Coverage Determination (NCD) that restricts coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease. The Â鶹´«Ã½Ó³» noted in our letter that we believe that the phase III data from the CLARITY AD trial published in the New England Journal of Medicine indicating a direct clinical benefit warrants a focused, expedited reconsideration of the existing coverage policy as it applies specifically to lecanemab, as it would have been impossible for CMS to consider this highly relevant data at the time that the NCD was published.
On February 27, the Â鶹´«Ã½Ó³» met with CMS to discuss this letter. The Â鶹´«Ã½Ó³» is highly encouraged by CMS’s indicated interest in the Â鶹´«Ã½Ó³»'s expertise and in continued dialogue regarding potential modifications to the NCD, especially in light of CMS’s recent rejection of the Alzheimer’s Association’s request. CMS is eager to continue to work with the Â鶹´«Ã½Ó³» on this issue and CMS’s interest in the Â鶹´«Ã½Ó³»’s perspective is a testament to the strong relationship the Â鶹´«Ã½Ó³» has developed with the agency over a number of years as well as the high esteem that the agency has for the Â鶹´«Ã½Ó³» and its members.
The Â鶹´«Ã½Ó³» is currently working to refine and build upon its recommendations on potential modifications to the existing coverage policy. The Â鶹´«Ã½Ó³» will also work to educate CMS on the limitations of the existing NCD and the impact that it will have on patient access if lecanemab receives traditional approval. The Â鶹´«Ã½Ó³» plans to meet with CMS on several more occasions to make sure that the concerns of neurologists and neurology patients are fully accounted for in ongoing discussions. Read more about lecanemab and the work the Â鶹´«Ã½Ó³» has been doing.
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