• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Japan to Lead APAC Assisted Reproductive Technology Devices Market

    Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification

    FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

    Canada Authorizes COVID-19 Diagnostic Assay That Boosts Virus Testing Efficiency

    Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    K-Tube Technologies

    FUTEK Advanced Sensor Technology Inc.

    Medbio LLC

    PTI Engineered Plastics Inc.

    Forefront Medical Technology
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud

    Evolving Trends in the Medical and Orthopedic Devices Industry
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medicoil

    Creganna Medical, part of TE Connectivity

    Spectrum Plastics Group

    maxon

    Unicep
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    New Program with Payors Aims to Accelerate Patient Access to Medical Devices

    The Parallel Review Program lets FDA and CMS simultaneously review clinical evidence supporting both approval and coverage.

    Related CONTENT
    • 4 Trends Driving Medical Manufacturing in 2021
    • Pulse Biosciences Granted CE Mark Approval for CellFX System
    • Nonin Medical Adds Four New Board Members
    • Alleviant's Transcatheter Tech Obtains Breakthrough Status
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration09.05.18
    Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval. We take many steps to make sure products can be safely accessed in the post-market setting, and that new innovations continue to deliver their anticipated benefits. We actively monitor for safety findings in the post-approval period. We have updated labeling to provide modern guidance to providers and patients. And as part of our dedication to the promotion of public health, we also look for opportunities to help advance wider access to safe and effective innovations.
     
    Patients may not have access to an FDA approved or cleared device in the absence of adequate coverage. So, the FDA recognizes the importance of working collaboratively with the payor community to streamline the path from FDA market authorization to payor coverage and reimbursement.
     
    Over the past few years, we’ve sought creative solutions to decreasing the gap between the FDA’s decision to advance a product to the market and the time it takes both public (e.g., Medicare, Medicaid) and private payors to determine whether and how they will provide coverage.
     
    Today, we’re announcing some new steps to help narrow this chasm by expanding our work with private payors. First, some history on the efforts that we’ve undertaken to date:
    Previously, one of our early and most successful efforts was the creation of the Parallel Review Program. This program was piloted in 2011 with the Centers for Medicare and Medicaid Services (CMS). It was fully adopted in 2016 after proving to be a valuable mechanism for decreasing the time between the FDA’s approval of a pre-market medical device application and CMS national coverage determination.
     
    The Parallel Review Program enables the FDA and CMS to review, at the same time, the clinical evidence that supports both the approval and coverage of a new medical device. Traditionally, the FDA reviews the relevant non-clinical and clinical evidence first and then issues a regulatory decision. Then, after the FDA approves the device, payor organizations like CMS would begin reviewing the relevant clinical evidence. As one might expect, a parallel review process is much more efficient than a serial review process.
     
    Through the Parallel Review Program, we saw that earlier opportunities for collaboration during the process were critical for success. Manufacturers who design and conduct the clinical trials benefit from early feedback from the FDA and CMS as they develop their plans to conduct clinical investigations to gather valuable clinical evidence. Including CMS in the Pre-Submission meeting can allow manufacturers to obtain feedback from both the FDA and CMS while planning a clinical trial. Manufacturers can then factor this information into their design of a pivotal clinical trial. The development program can be structured to meet the needs of both regulators like the FDA and payors. Such an approach has many advantages in addition to timelier access, and lower costs. For example, if medical device manufacturers have a better understanding of the clinical evidence needed by both agencies, then manufacturers might consider ways to collect all the necessary evidence through clinical programs that are more efficient. They may be able to reduce the size and duration of trials, and expose fewer patients to an experimental product.
     
    To date, the FDA has received more than 75 inquiries into the process and 36 formal applications to participate in Parallel Review. The FDA treats these inquiries and applications as confidential. We don’t disclose a manufacturer’s participation in the program. However, the company may choose to make its participation public.
     
    While CMS covers a significant number of Americans, private payor organizations also play an important role in evaluating clinical evidence and making coverage decisions for patients in the U.S. Building on the lessons learned through the Parallel Review Program, in 2016 the FDA launched a new program aimed at engaging private payors and Health Technology Assessment groups through the Private Payor Program.
     
    The Private Payor Program is a voluntary opportunity for manufacturers to receive feedback from the FDA and other non-governmental health technology assessors/payors on what’s needed in order to develop a more efficient evidence generation strategy during the FDA pre-submission meeting.
     
    Today, we are announcing that CareFirst BlueCross BlueShield and United Health Group have joined the FDA’s growing list of private payors available to participate in medical device manufacturer pre-submission meetings.
     
    In addition to these two new participants, there are currently six other payor/health technology assessment organizations participating in the program, including BlueCross BlueShield Association, Duke Evidence Synthesis Group, ECRI Institute, Humana, Kaiser Permanente, and the National Institute for Health and Care Excellence (NICE).
     
    By facilitating communications between device makers and payors, the FDA hopes to shorten the time between FDA approval and coverage decisions. This can be particularly beneficial for manufacturers creating new and innovative devices who also need to secure coverage of their devices by payors.
     
    The process of acquiring clearance or approval from the FDA, and then coverage from a payor, can take several years to achieve. This delay can be challenging for patients, particularly those with limited alternatives for diagnosing and treating potentially serious medical conditions. In some cases, the long timeframe between those decisions may also have an adverse consequence on smaller medical device companies, which may be unable to sustain themselves for an extended duration of time with limited revenue streams. These challenges are significant. And they’re driving our continued efforts to identify new ways to improve the speed and efficiency of our regulatory review process and coverage decisions.
     
    To date, there have been 10 engagements between private payors or Health Technology Assessment (HTA) groups and manufacturers. This includes four pre-submission meetings.
     
    The program continues to gain momentum. We’re receiving new inquiries weekly.
     
    The FDA believes that early engagement with manufacturers and payors during the planning phase of medical device clinical trials will expedite patient access to high quality, safe, and effective medical devices. We appreciate the complexity of the process of achieving patient access to new medical devices. And we recognize that a variety of stakeholders have important roles in that process.
     
    In streamlining the process, our goal is to improve coordination so that access to approved products can be achieved without unnecessary delay. To that end, we continue to support and encourage the collection of clinical evidence that’ll not only support regulatory decisions but also inform coverage decisions—ultimately providing an opportunity for more timely patient access to new technologies.
     
    We’re all beneficiaries of this collaborative model to ensure the availability of safe, timely, effective and affordable health care options. For patients, it can mean earlier access to safe, effective, innovative technologies. And for payors, it can mean learning about new technologies beyond their current horizon scanning, and being able to provide suggestions about what data and analyses would be useful for evaluation, gaining insight and increased understanding of the FDA review process.
     
    For manufacturers, it’s early engagement of payors in discussions about evidentiary needs, being able to consider and address coverage-related issues earlier in the process, and gaining the potential for earlier reimbursement through earlier engagement with payors. For the FDA, it’s improving public health by facilitating more efficient patient access to innovative, safe, and effective medical devices.
     
    As our work continues to grow in scope and complexity, so must our efforts to collaborate on innovative and streamlined approaches to finding the best ways to serve the American public.
     
    I hope that by sharing this insight and vision, we inspire other organizations and manufacturers to come together early in the process so we can more effectively identify opportunities, challenges and approaches to access, and maximize our collective resources to get beneficial devices to patients.
     
    This blog originally appeared in FDA Voice.
    Related Searches
    • institute
    • development
    • quality
    • assessment
    Suggested For You
    4 Trends Driving Medical Manufacturing in 2021 4 Trends Driving Medical Manufacturing in 2021
    Pulse Biosciences Granted CE Mark Approval for CellFX System Pulse Biosciences Granted CE Mark Approval for CellFX System
    Nonin Medical Adds Four New Board Members Nonin Medical Adds Four New Board Members
    Alleviant Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
    New Study Validates the Efficacy of Ethicon’s LINXReflux Management System New Study Validates the Efficacy of Ethicon’s LINXReflux Management System
    MDIC Welcomes New Vice President of Health Economics and Patient Value MDIC Welcomes New Vice President of Health Economics and Patient Value
    Sony Updates NUCLeUS Imaging Platform Sony Updates NUCLeUS Imaging Platform
    The Lost Year: 2020 Year in Review The Lost Year: 2020 Year in Review
    Digital Health Delivers During a Year for the Ages Digital Health Delivers During a Year for the Ages
    Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes
    My 2020 Holiday Wish List My 2020 Holiday Wish List
    FDA Approves Boston Scientific FDA Approves Boston Scientific's Ranger Drug-Coated Balloon

    Related Breaking News

    • Japan to Lead APAC Assisted Reproductive Technology Devices Market

      Japan to Lead APAC Assisted Reproductive Technology Devices Market

      Sector forecast to grow 2.1 percent annually this decade.
      Michael Barbella, Managing Editor 02.25.21

    • Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification

      Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification

      Meet the highest quality standards for manufacturing.
      Charles Sternberg, Assistant Editor 02.25.21

    • Cardiovascular
      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.
      Michael Barbella, Managing Editor 02.25.21


    • Canada Authorizes COVID-19 Diagnostic Assay That Boosts Virus Testing Efficiency

      Canada Authorizes COVID-19 Diagnostic Assay That Boosts Virus Testing Efficiency

      The product is compatible with Thermo Fisher Scientific's Amplitude platform.
      Michael Barbella, Managing Editor 02.25.21

    • Digital Health
      Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences

      Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences

      Will enable personalized, predictive insights at the point of care.
      Sam Brusco, Associate Editor 02.24.21

    • Abiomed Leader Michael Minogue Named AdvaMed Board Chairman

      Abiomed Leader Michael Minogue Named AdvaMed Board Chairman

      He succeeds Stryker Chairman and CEO Kevin Lobo.
      Sam Brusco, Associate Editor 02.24.21


    • Surgical
      TransEnterix Changes Name to Asensus Surgical

      TransEnterix Changes Name to Asensus Surgical

      The rebranded firm also introduced a new surgical category—performance-guided surgery.
      Sam Brusco, Associate Editor 02.24.21

    • Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test

      Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test

      The pair will create and deliver COVID-19 PCR test kits to essential workers and at-risk populations.
      Michael Barbella, Managing Editor 02.24.21

    • Cardiovascular
      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NCVC in Japan will develop computational models while NTT Research MEI Lab will implement a bio digital twin platform.
      Michael Barbella, Managing Editor 02.24.21


    • Global Peripheral Intravenous Catheter Market to Reach $7.5 Billion by 2027

      Global Peripheral Intravenous Catheter Market to Reach $7.5 Billion by 2027

      The rise in chronic and life-threatening diseases will help drive the growth.
      Michael Barbella, Managing Editor 02.24.21

    • Diagnostics
      SpinTech Inc. Acquires MR Innovations

      SpinTech Inc. Acquires MR Innovations

      Includes an expert team of engineers and physicists and MR Innovations' patents, published papers and network of global collaborators.
      Charles Sternberg, Assistant Editor 02.24.21

    • Millstone Medical Outsourcing Reaches 600-Employee Milestone

      Millstone Medical Outsourcing Reaches 600-Employee Milestone

      Posts year-over-year growth of 16% in its 20th year of business.
      Charles Sternberg, Assistant Editor 02.23.21


    • FDA Approves Daytime Treatment for Sleep Apnea and Snoring

      FDA Approves Daytime Treatment for Sleep Apnea and Snoring

      Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.
      Michael Barbella, Managing Editor 02.23.21

    • Surgical
      FDA Green Lights EPI

      FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding

      Rapidly and reliably controls bleeding during GI procedures.
      Sam Brusco, Associate Editor 02.23.21

    • Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices

      Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices

      Doctors say manufacturers and implanting physicians should inform patients about the potentially dangerous magnet-implantable cardiac device interaction.
      Michael Barbella, Managing Editor 02.23.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA Approves Daytime Treatment For Sleep Apnea And Snoring
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    • Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
    • FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
    • Canada Authorizes COVID-19 Diagnostic Assay That Boosts Virus Testing Efficiency
    • Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    JRF Technology Debuts Elderberry Oral Film Strip
    Danone Adds to Plant-Based Portfolio with Acquisition of Follow Your Heart Brand
    Coatings World

    Latest Breaking News From Coatings World

    OQ Chemicals Increases Carboxylic Acids, Esters Prices
    Sensory Analytics Announces Issuance of Broad New Patent Covering Coating Thickness Measurement
    Arkema Reports Full-year 2020 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
    FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
    Contract Pharma

    Latest Breaking News From Contract Pharma

    High Purity New England Bolsters Biopharma Solutions Services
    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    CatSci Opens New Site in UK
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Biden Prioritizes PPP Relief for the Beauty Industry
    Christie Brinkley Joins SBLA Beauty
    Madison Reed Raises $52 Million in Financing Round
    Happi

    Latest Breaking News From Happi

    ACI Unveils New Online Resources
    Sales More Than Double at Madison Reed
    PBA Opposes House Bill 2325 in West Virginia
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Lowe-Martin Adds 2 KODAK NEXFINITY Digital Presses
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    S-OneLP adds to growing team
    Avery Dennison expands automotive portfolio
    Amberley Labels turns to Kurz for embellishments
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Believe Diapers Launch in U.S.
    Forbes Ranks Rockline Among Best U.S. Employers
    H&V Announces Price Increase
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    NuVasive Nabs Simplify Medical for $150M
    SeaSpine Begins Limited Launch of WaveForm TA (TLIF Articulating) 3D-Printed Interbody
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    RFID Locks Market to Reach $9.93 Billion by 2027: Allied Market Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login