On January 11, the Centers for Medicare & Medicaid Services (CMS) issued a draft national coverage determination (NCD) decision memo that outlines how Medicare may cover aducanumab (Aduhelm™) and future Food & Drug Administration-approved monoclonal antibodies (mAbs) directed against amyloid plaque for the treatment of Alzheimer’s Disease (AD). The CMS proposes to implement a coverage with evidence development (CED) component to the NCD, which would allow Medicare to cover this class of drugs only within the context of CMS-approved or National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) in the hospital outpatient department (HOPD) setting. The draft NCD with CED also requires that participation in approved RCTs be representative of the national population with AD.

During the draft memo comment period, a variety of stakeholders lauded the CMS’s focus on closing disparities gaps in AD, but also flagged concerns that prior Medicare NCDs with CED have not been successful in including robust numbers of underrepresented populations. Patient groups have expressed concerns that in the past when Medicare placed a CED requirement, coverage was largely restricted to Medicare beneficiaries who live close to or can travel to participating medical centers, which are typically large academic centers or major healthcare systems.

Ahead of the upcoming April 11, 2022, release of a final NCD, a bipartisan group of 44 House members sent a letter to the CMS expressing concerns that the coverage policy should not reinforce barriers to equitable access, including for communities of color. To examine the potential impact of the draft NCD on Medicare Fee-for-Service (FFS) beneficiaries, Avalere has been conducting analyses of potential access barriers for underserved populations. Prior analysis uncovered challenges for rural beneficiaries if the CMS finalizes the draft NCD decision memo as written. In this current study, Avalere conducted an analysis of expected beneficiary access to AD mAbs potential clinical trial sites by race, given that underrepresented populations more often receive healthcare services from essential community providers (e.g., federally qualified health centers and Indian health providers) and experience disparities in AD diagnosis rates.

Access to AD Academic and Research Centers by Race

With qualified trials limited to the HOPD setting, it remains unclear how many hospitals—especially those that serve underrepresented populations—will be willing and able to conduct the clinical trials required by the CMS. Research centers that will conduct RCTs for the CED requirement will likely include Alzheimer’s Disease Research Centers (ADRCs), which are NIH centers of excellence at major medical institutions across the US that conduct AD clinical trials and provide infrastructure to facilitate the Alzheimer’s Clinical Trials Consortium.

ADRCs already host trials sponsored by the manufacturers of mAbs directed against amyloid plaque for the treatment of AD. But ADRCs also tend to be highly concentrated in certain parts of the country, especially in coastal and more densely populated regions. Currently there are 33 ADRCs and 4 Exploratory ADRCs nationwide.

Given the CMS’s draft CED requirements and diversity benchmarks, Avalere analyzed the potential impact on Medicare beneficiaries with AD by race and ethnicity. Avalere’s analysis found that across all non-White beneficiaries with early onset Alzheimer’s diagnosis, almost 8% have no access to a HOPD of any kind in their county of residence. Moreover, even though diverse populations more often reside in more urban areas than in rural areas, 75% of Black, 61% of Hispanic, 88% of North American Native, and 51% of Asian beneficiaries with early onset AD or mild dementia do not live in counties with an ADRC.

Analysis of AD Diagnosis by Race and Ethnicity

Another requirement in the draft coverage memo is that Medicare beneficiaries would have access to anti-amyloid mABs if they have a clinical diagnosis of mild cognitive impairment due to AD or mild AD dementia. Given stakeholder concerns about underdiagnosis of early onset AD among minority populations, Avalere explored the proportion of beneficiaries by race within different AD diagnosis codes. The analysis found that Black and Hispanic beneficiaries make up 9.2% of beneficiaries with early onset AD and mild dementia, but they constitute 14% of beneficiaries with a more advanced Alzheimer’s diagnosis. This finding suggests potential disparities in early diagnosis of AD are an additional barrier to anti-amyloid treatment for minority population.

Conclusion

The results showing proximity to potential trial sites and disparities in diagnosis rates raise questions about the expected ability to recruit trial populations that are that representative of the national population with AD. These results also challenge whether the CMS will be able to undertake an adequate number of trials that meet its trial requirements in a timely fashion to allow appropriate access to beneficiaries who may be candidates for anti-amyloid mAbs treatment.

Furthermore, the Avalere analysis reflects the FFS population, but stakeholders should also consider the potential impact of the NCD with CED on Medicare Advantage, given the increasingly higher share of beneficiaries from racial/ethnic minority groups enrolling in Medicare Advantage.

What’s Next

The CMS collected stakeholder comments through February 10 and aims to issue the final NCD decision memo by April 11. Until the final memo is released, coverage decisions for mAbs directed against amyloid for the treatment of AD will continue to be determined by local Medicare administrative contractors on a case-by-case basis.

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Methodology

Under a research-focused data use agreement with the CMS, Avalere examined data from CMS’s Medicare Part B FFS claims to identify beneficiaries with an AD or dementia diagnosis code in 2020. Avalere identified beneficiaries with at least one of the following AD or mild cognitive impairment diagnosis codes: G30.0, G30.1, G30.8, G30.9, G31.84.

Avalere used beneficiary race/ethnicity codes available in the Master Beneficiary Summary File to identify the racial/ethnic status of beneficiaries with AD or dementia. The locations of HOPDs were identified using the CMS list of Medicare Outpatient Hospital Providers, and the locations of ADRCs were identified using the NIH list of center locations. HOPD and ADRC locations were then mapped to counties. The proportion of beneficiaries by racial/ethnic status who have a HOPD or ADRC in their county was then determined dividing the number of beneficiaries in a county with an HOPD or ADRC within the county by the total number of beneficiaries by racial/ethnic status.