All Clarivate Analytics 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.

/images/Cortellis_Flagship_Logo_TM_RGB_Color.png
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Artificial intelligence
    • Coronavirus
    • Diagnosing and tracking COVID-19
    • Drugs to Watch 2020
    • The next pandemic
    • Premium reports
      • BioWorld Financings Reports
      • Disease Forecast Reports

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Sunday, March 7, 2021
Home » Blogs » BioWorld MedTech Perspectives » Parallel review: Still not a big deal?

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech / CDRH / CMS / FDA / Medicare

Parallel review: Still not a big deal?

Oct. 11, 2011
By Mark McCarty
No Comments

 

Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year.

When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers greater than that. However, it's also worth pointing out that the timing for coverage analysis is no different under parallel review if a device maker can't apply for parallel review until the device appears at an advisory committee hearing. Ditto the timing of disclosure.

Another peculiarity is that the notice states that CMS will have the option of using coverage with evidence development as a potential reimbursement outcome in parallel review. No point in stopping the presses for that one, is there?

The net result is that you're probably safe if you bet the cost of your kid's braces that parallel review will never attract industry in droves. In fact, if you can find someone foolish enough to take that bet, by all means take it.

Fans of conspiracy theory might smell cost containment in parallel review. After all, the FR notice does not say CMS can't inject itself into the device approval process before that device goes to advisory. Furthermore, the two agencies signed an MOU in 2010 regarding data sharing that does nothing to limit CMS's use of FDA's data. What better way for CMS to get its camel's nose in the tent?

That last part is admittedly speculative, but what's the alternative explanation? “We just wanna know” isn't it. Does CMS want to help FDA foster innovation? Sure, that's it.

Think I'm paranoid? Then describe the net benefit to industry if parallel review is of little (or no) help to five or fewer applications each year. Let's not forget that relatively inexpensive510(k) devices are ineligible, or about all the budget pressure in Washington. If there's one mantra regarding Medicare these days in this town, it's “cut costs.”

Of course it's possible that this whole thing will fizzle and become nothing more than a curiosity for future generations of med-tech policy geeks. Or maybe the only place it'll fly is on that topsy-turvy mess known to comic book fans as Bizarro World. In that case I'll eat a plate of crow, preferably with a dollop of bearnaise, please.

Still, I have to ask: Could parallel review as a screening mechanism for those really expensive PMA devices take root in our normal, non-Bizarro little corner of the Universe, where we drive on the parkway and park on the driveway?

Not a chance. Right?

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 outbreak. Note that we have added three critical tables which are...

  • Today's news in brief

    BioWorld
    BioWorld briefs for March 5.
  • Gloved hand places sample tubes in PCR system

    COVID-19 test makers are adapting for variants

    BioWorld MedTech
    As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their...
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech's briefs for March 5.
  • Coronavirus vaccine/therapeutics illustration

    Tonix looks to the past for the future of COVID-19 vaccines and testing

    BioWorld MedTech
    Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an...
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
    • About
    • Archives
    • Today's news
    • Search BioWorld Science
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
A Clarivate Analytic solution. Link to Clarivate website.
Follow Us

Copyright ©2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing