capitol Hill report: ADVISORY COMMITTEE SUPPORTS MEDICARE REIMBURSEMENT INCREASES
January 23, 2023
Latest Advocacy News
- On January 12, the Medicare Payment Advisory Committee (MedPAC) voted in support of a set of recommendations to Congress to increase reimbursement for physicians providing services to Medicare beneficiaries. The first recommendation was in support of a positive annual inflation adjustment that would update Medicare payments by 50 percent of the Medicare Economic Index. The second recommendation supported the establishment of add-on payments for both specialty and primary care providers. The AAN has repeatedly urged both the Biden administration and Congress to implement positive annual payment updates to counterbalance the detrimental impacts of inflation on patient access to care and the stability of neurology practices serving all communities.
- On January 12, the AAN submitted comments to the Sequoia Project in response to a proposal impacting implementation of the Trusted Exchange Framework and Common Agreement that would require all workstations that house Protected Health Information to require two-factor authentication for access.
- As the 118th Congress organizes, there are new members of Congress we need to build relationships with so we can educate them about the issues facing neurology and our patients. As an AAN member, you play an important part in that relationship building, through supporting BrainPAC or letting us know any relationships you may have with your member of Congress. You can learn more about BrainPAC at BrainPAC.org and share any relationships you have with your legislators here.
- On January 19, the Food and Drug Administration announced that Eli Lilly's monoclonal antibody for the treatment of Alzheimer's disease, donanemab, would not be receiving accelerated approval due to issues with the phase 2 trial design. Eli Lilly has announced that a full readout of phase 3 trial results as well as application for traditional approval are still expected in the coming months.
Issue in Focus
On January 6, 2023, the Food and Drug Administration granted Accelerated Approval to a new monoclonal antibody—lecanemab (brand name Leqembi)—directed against amyloid for the treatment of mild Alzheimer’s disease (AD) and mild cognitive impairment (MCI). According to the FDA label, treatment with lecanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. The initial sale price for lecanemab has been set at $26,500 per year, above the Institute for Clinical and Economic Review recommended price range of $8,500 to $20,600 based on their review of the efficacy data. Analysis of the results from lecanemab’s phase three CLARITY AD trial published in the New England Journal of Medicine found that lecanemab was able to demonstrate a modest slowing in decline on measures of cognition and daily functioning in patients with early AD and MCI relative to placebo at 18 months. This demonstration of clinical benefit sets lecanemab apart from the previously approved, yet controversial, drug aducanumab, a monoclonal antibody which also targets beta amyloid.
In the wake of aducanumab’s approval in June 2021, the Centers for Medicare & Medicaid Services (CMS) published a National Coverage Determination (NCD) that stipulated that aducanumab, and other monoclonal antibodies for the treatment of AD, would only receive coverage in the context of an approved clinical trial unless or until it was able to satisfy a variety of criteria as part of Coverage with Evidence Development. The AAN was heavily involved in the NCD process with CMS and other key stakeholders, and while we were supportive of certain limitations on the coverage of aducanumab, the Academy advocated vociferously for any coverage decision to be limited to aducanumab so that future products, like lecanemab, could be judged on their own merits.
While the AAN was cited extensively throughout the NCD, the recommendation against a class-wide determination was not followed, meaning that as soon as lecanemab was approved it fell under the existing NCD and so enters the market with very limited coverage. The AAN already has been in discussions with CMS and other key stakeholders regarding a potential expedited reconsideration of the NCD for lecanemab. This is in line with our comments on the original NCD where the AAN highlighted the need for an “off ramp” should a new product be granted approval that is able to demonstrate meaningful clinical benefit for the AD population.
The AAN will continue its advocacy on this issue and is providing resources and education to help its members understand this new therapy. Please visit Monoclonal Antibodies for Alzheimer’s Resources to stay up to date on the Academy’s activity in this space.