Skip to main content
Sister Publication Links
  • ESG: THE IMPLEMENTATION IMPERATIVE
Subscribe
  • Sign Up Free
  • Login
  • Subscribe
  • News
    • Current News
    • Providers
    • Insurance
    • Digital Health
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Transformation
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Unwell in America
  • Opinion
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Diversity in Healthcare
      • - Luminaries
      • - Top 25 Diversity Leaders
      • - Leaders to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Digital Health Transformation Summit
    • ESG: The Implementation Imperative Summit
    • Leadership Symposium
    • Social Determinants of Health Symposium
    • Women Leaders in Healthcare Conference
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Diversity Leaders Gala
    • Top 25 Women Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Hospital at Home
    • - Workplace of the Future
    • - Digital Health
    • - Future of Staffing
    • - Hospital of the Future (Fall)
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
  • Data Center
    • Data Center Home
    • Hospital Financials
    • Staffing & Compensation
    • Quality & Safety
    • Mergers & Acquisitions
    • Data Archive
    • Resource Guide: By the Numbers
    • Surveys
    • Data Points
  • MORE+
    • Contact Us
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Medicare
January 11, 2022 04:35 PM

Medicare limits Aduhelm coverage to clinical trials

Maya Goldman
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print
    Copy of mh_20170626p14-Medicare card_WEB_i.jpg

    The Centers for Medicare and Medicaid Services proposed Tuesday to let Medicare cover monoclonal antibodies as an Alzheimer's treatment Aduhelm in the context of clinical studies.

    The coverage designation allows Medicare to cover the controversial Alzheimer's drug Aduhelm when used in clinical trials. The trials must seek to answer research questions about whether the use of monoclonal antibodies used for Alzheimer's treatment make a meaningful different in disease progression and what adverse events are associated with its use.

    "This is unusual... but we believe it is appropriate for the Medicare population to issue this proposed decision," Tamara Syrek Jensen, director of the coverage and analysis group at the CMS Center for Clinical Standards and Quality, said in response to a reporter question on a Tuesday press call.

    Medicare beneficiaries participating in trials must have a clinical diagnosis of mild cognitive impairment due to Alzheimer's and evidence of amyloid pathology consistent with Alzheimer's. Beneficiaries can't have other conditions that would contribute significantly to cognitive decline, medical conditions likely to increase significant adverse side effects or be expected to die during the study.

    Medicare will cover one beta amyloid positron emission tomography (PET) scan per patient for approved trials that require the scan as part of their protocol. CMS also covers PET scans for Alzheimer's only in the context of clinical trials.

    Jensen said CMS does not yet know how many patients will be enrolled in these trials, but said the agency expects to start accepting trial applications as soon as a final coverage determination is made. Payment and coding instructions will also come out after the final decision on coverage.

    That determination is expected in April. An additional 30-day comment period on the decision will open before the final ruling.

    Global Alzheimer's Platform Foundation, a not-for-profit devoted to reducing time and cost of Alzheimer's clinical trials, admonished the preliminary decision and urged CMS to issue a full coverage determination instead. Underserved Alzheimer's patients may have less access to the drug as a result of CMS' decision, GAP Foundation President John Dwyer said. Black and Hispanic individuals are more likely to develop Alzheimer's, according to the Alzheimer's Association.

    "This preliminary ruling throws patient access out the window for most Americans," Dwyer said in a statement.

    Jensen emphasized on the press call that clinical trials must be representative of the national population of Alzheimer's patients.

    Dually eligible beneficiaries will be able to receive Aduhelm through a clinical trial, and CMS plans to provide additional direction to states on covering the drug and others in its class once the final coverage determination comes out, a CMS spokesperson said. The National Association of Medicaid Directors previously expressed concern about the impact of Aduhelm on state budgets if Medicaid has to bear the costs of Aduhelm for dually-eligible beneficiaries.

    The Food and Drug Administration approved Aduhelm, the first monoclonal antibody targeting amyloid for the treatment of Alzheimer's, in June. The approval was granted despite questions over whether the drug is actually effective at treating Alzheimer's and some concerns over its safety.

    Biogen, which manufactures Aduhelm, slashed the price of the drug by nearly 50% in December in an effort to get more patients prescribed. But some experts say the medication is still overvalued, and some health systems have said they won't prescribe the medication at all due to doubts over its effectiveness. At its original price, experts predicted Aduhelm would cost Medicare $29 billion annually. CMS does not factor drug price into its national coverage determinations.

    CMS in November announced a 15% increase in beneficiaries' Medicare Part B premiums for 2022, citing Aduhelm's potential cost to the program as a reason for the increase. But Health and Human Services Department Secretary Xavier Becerra directed CMS to reevaluate Medicare Part B premiums Monday. A CMS spokesperson said Tuesday that the agency is still evaluating the premiums.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    older people - Medicare - insurance
    Medicare Advantage marketing was different in 2023. That's no accident.
    Most Popular
    1
    More healthcare organizations at risk of credit default, Moody's says
    2
    Centene fills out senior executive team with new president, COO
    3
    SCAN, CareOregon plan to merge into the HealthRight Group
    4
    Blue Cross Blue Shield of Michigan unveils big push that lets physicians take on risk, reap rewards
    5
    Bright Health weighs reverse stock split as delisting looms
    Sponsored Content
    Daily Dose Newsletter: Sign up to receive a late afternoon weekday roundup of that day’s breaking news and developments in healthcare.
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2023. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • Providers
      • Insurance
      • Digital Health
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Unwell in America
    • Opinion
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Excellence in Governance
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top 25 Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Digital Health Transformation Summit
        • ESG: The Implementation Imperative Summit
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Hospital at Home
        • - Workplace of the Future
        • - Digital Health
        • - Future of Staffing
        • - Hospital of the Future (Fall)
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • Data Center
      • Data Center Home
      • Hospital Financials
      • Staffing & Compensation
      • Quality & Safety
      • Mergers & Acquisitions
      • Data Archive
      • Resource Guide: By the Numbers
      • Surveys
      • Data Points
    • MORE+
      • Contact Us
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing