Monday, August 12, 2019

Thumbnail Summary: New Policy Themes for Breakthrough Devices

UPDATE: CMS finally published a Breakthrough rule in August 2020 - here.


There have been a number of Medicare health policy changes, or proposed changes, for Breakthrough Devices in the last couple years, and I provide an inventory of major sources here.

  • (1) EXCITE and PACER (2016/2017)
    • In 2016, 2017 there was an industry proposal called PACER - Provisional Accelerated Coverage to Encourage Research.
    • National Academy of Sciences produced a 16-page white paper in 2016
    • In 2017, CMS proposed a similar idea called EXCITE - Expedited Review of Innovation Technology.
    • For example, Jeff Shuren of FDA referred to unnamed CMS-FDA programs in preparation at JP Morgan January 2018.
    • For links to all the above, see a February 2018 blog here.
  • (2) AdvaMed/HR 5997.  In 2018, Advamed strongly supported a bill to encourage access to breakthrough products in the Medicare system - H.R. 5997 (sponsored by Delbene).  
    • See a November 2018 blog about HR 5997 here.
    • While HR 5997 expired with the old Congress, it could reappear in similar form in 2019.
  • (3) 2019 LCD Changes.  In October 2018, CMS released new processes for LCD creation, public LCD requests, and LCD revisions, effective for CY2019.  
    • For example, CAC (advisory) meetings were made optional.  CMS touted this as an important for speeding up the LCD process, but frankly, I didn't see it then and I haven't seen it yet (through August 2019).   For an October 2018 blog on LCD changes, and CMS press releases, here.
  • (4) May 2019 Verma Speech.  Seema Verma gave a major speech to the Medical Device Manufacturers Association (MDMA) on plans to encourage new technology - transcript here.  See also my discussion here.
  • (5) August 2019 Inpatient Final Rulemaking - Perks for Breakthrough Devices.  New inpatient technologies can get an extra add-on payment over the DRG - called NTAP - if they jump several hurdles.  In August 2019 rulemaking, CMS somewhat expedited the process if a device had been classified as Breakthrough by the FDA.   
    • Links and entry points, here.
    • Not only did CMS make these tweaks to NTAP, but CMS strongly highlighted their importance in the accompanying hospital rule press release (see Links entry point).
    • FDA page for Breakthrough Devices, here.  FDA final guidance (30pp) here.
  • (6) Pending CMS/FDA Breakthrough Rule at OMB.   Since September 2019, a rule "CMS 3372 P" has been pending at OMB.  As of August 2019, it's still pending.  The rule is "Medicare Coverage for Innovative Technologies."  One theory is that CMS wanted the FY2020 inpatient rule to be finalized in August 2019, so it can incorporate background and cross-references in the 3372 rule.   
    • I provide some background and links on CMS 3372 P here.  
    • (Note, this is the same blog from November 2018 in which I discussed HR 5997.)

Take home lesson - the next big thing to watch will be the release of CMS 3372 P, which will be the third or fourth generation of ideas that started in 2016 with PACER.  But -- From available information, I can't completely rule out that 3372-P might be a false lead, an orphan fragment of rulemaking, and simply reflected inpatient rulemaking that has now been completed inside the August 2019 final inpatient rule.  But 3372 P,as a draft proposed rule placeholder, is alive and online here.

Footnote.  Although not a breakthrough device, in a recent final NCD markedly simplifying access to CAR-T therapies, CMS emphasized its dedication to getting new technologies to Medicare patients quickly - here.