AHIP Comments on Alzheimer’s Drug National Coverage Determination

AHIP supported CMS on its national coverage determination for monoclonal antibodies (mAbs) directed against amyloid for treating Alzheimer’s Disease and offered recommendations for clarification in its comments letter to CMS.

“The proposed NCD is the right approach for patients. It would provide Medicare patients consistent and national access to this class of products and related services. And it would appropriately emphasize the need for sufficient clinical evidence to support future determinations of whether these drugs are both reasonable and necessary for the right populations within the program,” AHIP’s letter explained.

AHIP supported the agency’s decision to offer the treatment under a coverage with evidence development. This approach requires trials to be conducted in hospital-based outpatient settings to continue to observe the long-term effects of the treatment and assess whether the benefits outweigh the risks.

The payer organization also noted that CMS could return to this determination later when more evidence is available and adjust Medicare coverage policies.

CMS raised concerns about the diversity of participants in the initial trials and required that future trials incorporate a diverse, representative population to obtain CMS approval. AHIP affirmed this and noted that Medicare Advantage plans could play a key role in providing a diverse set of participants.

“Given that nearly half of all racial and ethnic minorities eligible for Medicare choose a Medicare Advantage (MA) plan, we look forward to discussions with CMS regarding how MA plans may assist CMS in reaching diverse groups and achieving its goal of representative populations participating in approved clinical trials,” the letter noted.

The proposed national coverage determination would require Medicare to cover one beta amyloid PET scan for participants if needed, a procedure that identifies the presence of the beta amyloid plaque which the therapy seeks to treat.

AHIP observed that CMS neglected to address whether Medicare would cover alternative forms of identifying the plaque, such as cerebral spinal fluid, or coverage for tests that would isolate the causes of adverse events, such as an MRI to assess brain swelling or bleeding. The payer organization asked for more clarification on relevant Medicare coverage policies.

AHIP made some recommendations regarding patient eligibility, namely that patients be excluded if they have already participated in the clinical trials for a drug of the same class.

CMS laid out specific research questions that the clinical trials should address. AHIP affirmed these, but the payer organization noted that national coverage determination trials allow sponsors to set their own metrics. AHIP recommended that, instead, all metrics be standardized.

Apart from responding to the national coverage determination content, AHIP included seven requests for more information, mainly related to Medicare Advantage, Medicaid, and supplemental Medicare coverage policies for this treatment.

AHIP asked CMS to clarify whether this treatment would fall under a particular section of the Social Security Act which requires fee-for-service Medicare to cover the Medicare Advantage members’ treatment costs under certain conditions. 

This is necessary when a national coverage determination would drastically impact spending. CMS would need to evaluate the fiscal impacts of the determination. The agency would repeat the evaluation in the future as circumstances change.

The payer organization requested greater clarification on Medicare Advantage plans’ and supplemental Medicare plans’ obligations to cover the treatment’s clinical trial costs. The organization suggested that CMS make clinical trial data available to Medicare Advantage plans. CMS should also address medical necessity criteria for Medicaid programs.

The agency should also clarify how this national coverage determination will impact patients are already receiving the treatment. CMS should ensure that patients and stakeholders are well-informed about any changes in coverage and reimbursement.

Finally, AHIP stated that the drug should be covered under Medicare Part B, not Part D.

“Such clarification is necessary to make clear CMS’ determination that Part D does not cover monoclonal antibodies directed against amyloid for the treatment of AD, regardless of whether such treatments are provided to a Part D enrollee through a clinical trial described in the final NCD,” the letter explained.

The determination process for the Alzheimer’s treatment started in July 2021. At the time, many Medicaid programs called on CMS to allow Medicare coverage of the drug.

The agency released its national coverage determination in mid-January 2022, requested comments, and planned to finalize its decision by April 11, 2022.

Since the national coverage determination’s release, industry stakeholders have voiced a wide range of opinions on the treatment and the agency’s proposal regarding how to cover it.