By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    UV damage to eyes
    Warning Signs of Long-Term UV Damage to Your Eyes
    December 9, 2021
    degree for healthcare job
    The Ultimate Healthcare Recruiting and Staffing Guidebook
    March 21, 2022
    medicare part d benefits
    Everything that You Need to Know About Medicare Part D
    August 15, 2022
    Latest News
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
    The Hidden Impact Of Stress On Your Body’s Alignment And Balance
    May 22, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    nursing program
    7 Tips to Picking the Best Nursing Program
    February 5, 2018
    Health Care: A Modern-Day Blade Runner?
    December 10, 2014
    Occupational Therapy Assistant | Medical Assistant | Home Health Aide
    In-Demand Healthcare Support Jobs
    April 16, 2016
    Latest News
    Top HIPAA-Compliant Messaging Apps for Healthcare Teams
    June 25, 2025
    When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
    June 20, 2025
    Preventing Contamination In Healthcare Facilities Starts With Hygiene
    June 15, 2025
    Strengthening Healthcare Systems Through Clinical and Administrative Career Development
    June 13, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: A Victory for Coverage with Evidence Development
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Devices > A Victory for Coverage with Evidence Development
BusinessMedical Devices

A Victory for Coverage with Evidence Development

gooznews
Last updated: September 8, 2011 10:58 am
gooznews
Share
3 Min Read
SHARE

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

The Gateway-Wingspan system, manufactured by Stryker, was approved by the Food and Drug Administration in 2005 based on “a small, less rigorous study,” according to this morning’s Washington Post. But use has been limited by a decision by the Centers for Medicare and Medicaid Services to deny reimbursement unless patients receiving the device were enrolled in a clinical trial. This “coverage with evidence development” policy began during former CMS director Mark McClellan’s tenure during the Bush administration.

Walter Koroshetz, chief of NIHDK, told the Post, “This is an example of how to do it right.” I partially agree. The government did the right thing, given existing laws and policies. But Stryker should have done the larger trial in the first place. The potential profits from the device, if it was useful, would have far exceeded the $20 million spent by the government to prove it wasn’t.

More Read

robots play an important role in hospital settings
Robotic Technologies Can Improve Hospital Working Conditions
Multibriefs: Exclusives for Healthcare Administration Associations
Your Hospital Social Media Benchmark: How Do You Rank?
Paying People Not to Work
Florida Pill Mill Clinics

The company should be asked to reimburse the taxpayers. And this episode shows that the FDA’s device approval process should be made more stringent to require the same kind of trials for devices that it now requires of drugs — the trials that prove with statistical significance that new products do in fact improve public health.

TAGGED:coverage with evidenceFDAgateway-wingspanstent
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

women dental care
What Is a Smile Makeover and How Much Does It Cost?
Dental health
June 30, 2025
HIPAA-Compliant Messaging Apps
Top HIPAA-Compliant Messaging Apps for Healthcare Teams
Global Healthcare Policy & Law Technology
June 25, 2025
recovering from injury
Rebuilding After Injury: Path to Physical and Emotional Recovery
News
June 22, 2025
scientist using microscope
When Healthcare Ends, the Legal Process Begins: What Families Should Know About Probate and Medical Estates
Global Healthcare
June 18, 2025

You Might also Like

obamacare and employers
BusinessFinanceHealth ReformPolicy & LawPublic Health

What Employers Think About Healthcare

September 20, 2013

The Hidden Dangers of Working as a Health Care Professional

May 5, 2016
EHR and meaningful use
Hospital Administration

How Safe Is Your Hospital?

April 20, 2011
Image
BusinessDiagnosticseHealthHealth ReformHospital AdministrationMedical RecordsMobile HealthPublic HealthRemote DiagnosticsSocial Media

Disruptions on the Yellow Brick Road II

June 5, 2015
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?