| Today, the Centers for Medicare & Medicaid Services (CMS) released a national policy for coverage of aducanumab (brand name Aduhelm™) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer's disease. From the onset, CMS ran a transparent, evidence-based process that incorporated more than 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination. As finalized in this two-part National Coverage Determination (NCD), Medicare will cover monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer's disease that receive traditional approval from the Food and Drug Administration (FDA) under coverage with evidence development (CED). CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries. Registry data may be used to assess whether outcomes seen in carefully controlled clinical trials (e.g., FDA trials) are reproduced in the real-world and in a broader range of patients. Any new drugs in this class that receive FDA traditional approval may be available in additional care settings that people with Medicare can use, such as an outpatient department or an infusion center. Secondly, for drugs that FDA has not determined to have shown a clinical benefit (or that receive an accelerated FDA approval), Medicare will cover in the case of FDA or National Institutes of Health (NIH) approved trials. Under this NCD, CMS will support the FDA by covering the drug and any related services (including, in some cases, PET scans if required by trial protocol) for people with Medicare who are participating in these trials. For purposes of this NCD, when Aduhelm or other drugs included in the NCD are not covered by Medicare Part B under the terms of the NCD, CMS considers them Part D drugs. Medicaid does not pay for Part D drugs for full-benefit dually eligible individuals, regardless of whether they are enrolled in a Part D plan. This means that when the drugs included in the NCD are not covered by Part B under the terms of the NCD, regardless of whether a full-benefit dually eligible individual's Part D plan actually covers the drugs, Medicaid will not cover them. Generally, states are required to cover the drug if the manufacturer has in effect a National Drug Rebate Agreement with HHS and when the drug is used for a medically accepted indication, subject to any permissible restrictions or limitations on coverage applied by the state (e.g., prior authorization). Because the manufacturer of Aduhelm has entered into and has in effect a Medicaid drug rebate agreement and because Aduhelm also satisfies the definition of a covered outpatient drug, as set forth at section 1927(k)(2) of the Social Security Act (Act), state Medicaid programs are required to cover the drug when used for a medically accepted indication. However, state Medicaid programs could subject Aduhelm to utilization management techniques, such as prior authorization, and medical necessity criteria. As a covered outpatient drug, states may invoice the manufacturer for rebates on the drug, and manufacturers would be required to pay rebates, as appropriate, when dispensed and paid for under the state plan. For the complete press release visit: https://www.cms.gov/newsroom/press-releases/cms-finalizes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment For a fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease, visit https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease. To read the final NCD CED decision memorandum, visit https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305. For state Medicaid agencies, please contact your Medicaid State Lead with any additional questions or technical assistance requests. Stakeholder Call What: CMS invites you to join a stakeholder call on the Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Decision Follows Robust Stakeholder Input and Creates Pathway for Enhanced Access and Coverage of Drugs that Receive Traditional FDA Approval When: April 11, 2022 at 11:00 AM ET How to register: https://cms.zoomgov.com/webinar/register/WN_wkSaOWjWT4mMo8AUDRPW8g | 
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