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Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer Disease
MA08.151

Policy


In accordance with Medicare, monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease is considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

Monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease is eligible for coverage consideration for individuals who (1) meet all the requirements of Original Medicare's Coverage with Evidence Development (CED) provisions for this topicincluding but not limited to the CED as it applies to aducanumab (Aduhelm), and (2) are enrolled in a Medicare-approved clinical study.

Claims for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.​


Guidelines

This policy is consistent with Medicare’s coverage determination for monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease​ is covered under the applicable medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development listed in this medical policy are met.

Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

Description

The Centers for Medicare & Medicaid Services (CMS) covers Food and Drug Administration (FDA)--approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease (AD), including but not limited to Original Medicare's Coverage with Evidence Development (CED)​, when furnished in accordance with Coverage Criteria under the CED for individuals who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD. More information and details, including coverage criteria, for the Decision Memo by CMS and related requirements on this topic can be located at: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305​. 


References

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N). [CMS Web site]. 04/07/2022. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305. Accessed June 16, 2022.

Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
N/A

HCPCS Level II Code Number(s)
J0172 Injection, aducanumab-avwa, 2 mg​

Revenue Code Number(s)


Coding and Billing Requirements


Policy History

7/1/2022
7/1/2022
MA08.151
Medical Policy Bulletin
Medicare Advantage
No