We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Health Insurers Criticize CMS Proposal for Breakthrough Device Coverage Pathway

Health Insurers Criticize CMS Proposal for Breakthrough Device Coverage Pathway

November 6, 2020

America’s Health Insurance Plans (AHIP), a health insurance company advocacy group, has taken issue with the Centers for Medicare and Medicaid Services’ (CMS) proposed rule for a new Medicare coverage pathway for FDA-cleared breakthrough devices.

AHIP took issue with the proposal because, under the pathway, Medicare coverage would begin the same day a breakthrough device receives FDA clearance and last up to four years. That could result in the coverage of devices that haven’t been adequately evaluated as there’s no requirement for additional clinical studies in the Medicare population during the coverage period, the group contended.

 “We recommended that CMS adapt and streamline existing processes to allow for rapid reviews of breakthrough devices, while still fully considering the evidence needed to ensure their safety and effectiveness,” AHIP said.

View today's stories

Medical Devices Regulatory Affairs

Upcoming Events

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Consortium Gets EU Funding to Develop Continuous Blood Pressure Monitoring Device

  • FDA Approves GSK’s Oral Drug for Chronic Kidney Disease-Related Anemia

  • Aspivix’s Carevix Cleared to Reduce Pain, Bleeding in Gynecological Procedures

  • FDA Warns That Energy Supplement Contains Active Cialis Ingredient

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing