All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Top Biopharma Trends of 2021
    • Top Med-tech Trends of 2021
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, August 19, 2022
Home » Blogs » BioWorld MedTech Perspectives » Dam it: CMS plays the part of Hoover

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech

Dam it: CMS plays the part of Hoover

Feb. 19, 2015
By Mark McCarty
No Comments

By chance or by design?
By chance or by design?

Interagency coordination at the Department of Health and Human Services is purported to be a routine fact of life nowadays, but there are signs that outside forces are pushing FDA into activity that could have a big effect on another important agency.

This might be strictly a problem of perception rather than reality, but its tough to avoid the conclusion that all the emphasis on speed at FDA might run up against a rather large obstacle elsewhere at HHS.

Breaking through to nowhere

AdvaMed held its annual policy briefing earlier this month, during which the association advocated mandatory Medicare coverage of pivotal clinical trials for any device FDA designates a breakthrough device. This is part of the congressional 21st Century Cures initiative and not necessarily an idea of AdvaMed’s provenance (though it could be), but there is an understandable lack of detail as to how CMS will be involved.

Parallel review is one obvious vector for this kind of collaboration, but one has to wonder whether this is really a game-changer for more than the occasional PMA. If a device is that important to CMS, it’d want to be involved in any event. If device makers have been wary of parallel review up to now because of the additional requirements for such a trial, will they suddenly jump on board now?

They might. Coverage of a pivotal trial might be pretty irresistible (even if the reimbursement proves miserly), but it’s still tough to imagine this kind of thing will suddenly give parallel review a handful of applications each year when it has produced only two applications over the past five years. At any rate, one has to imagine CMS will be very choosy about which applications it will sign on to cover.

The imprecision of precision medicine

The second issue in this FDA/CMS context falls under the President’s Precision Medicine initiative, and deals with those massively parallel genomic sequencing machines. FDA wants to make use of existing and yet-to-surface data repositories to ease its review of next-gen sequencing applications, but this seems to reintroduce us to the analytical-versus-clinical validity quandary.

A massively parallel machine can fly around the genomic space at warp speed all it wants, but development of clinical evidence sounds like more of a subsonic flight proposition to the untutored ear. Not to criticize FDA for trying to amp up its informatics game, but how is CMS not the rate-limiting step (pardon the cliché) here?

Alzheimer’s again out in the cold

I know I’ve ground this axe before, but you just have to love the Precision Medicine Initiative for its same-old/same-old approach. It offers $70 million for cancer and squadoosh for neurodegenerative states, which will cost the American economy twice as much as cancer in the decades to come. How’s that for responsible stewardship of the taxpayer’s dollar?

The more things stay the same, the more they stay the same.

You must login or register in order to post a comment.

Report Abusive Comment

Popular Stories

  • Free access to BioWorld coronavirus articles

    BioWorld
    The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note...
  • Today's news in brief

    BioWorld
    BioWorld briefs for Aug. 19, 2022.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Aug. 19, 2022.
  • Pig organ cells

    Whole body cellular function recovery in pigs after death

    Science
    A new system for restoring cell function and tissues in mammals after death could expand the availability of organs for transplantation. The research also opens...
  • TPOXX

    Siga leads monkeypox antiviral research, amid lack of interest from big pharma

    BioWorld
    After declarations from the World Health Organization and the U.S. government that monkeypox is a public health emergency, attention is turning to the pharma...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Archives
    • Today's news
    • Search BioWorld Science
    • About
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing