Wednesday, March 27, 2019

HHS FY2020 Plan Mentions CMS Parallel Review, CMS Payment for Breakthrough Devices

A couple weeks ago, the Trump Administration released the President's overall budget for FY2020.  A few days ago, CMS released its 350-page budget and strategic plan for FY2020. 

Now, the other shoe, or the third shoe, has dropped, which is the 162-page HHS budget and strategic plan for FY2020.

There are three interesting references to Medicare policy, on page 84.

Strengthen the Parallel Review Process to Streamline Medicare Coverage
The Parallel Review program is a collaborative effort between the Food and Drug Administration (FDA) and CMS that is intended to reduce the time between FDA approval of a drug or device and Medicare coverage of that item. This proposal strengthens the existing parallel review process to improve device manufacturer participation and increase transparency.

    Takeaway: It's not clear exactly what this would look like.  CMS has issued Parallel Review NCDs twice, for Exact Sciences Cologuard in 2014 and for Foundation Medicine F1 CDx in 2018.   In speaking to ACLA's annual meeting on March 26, CMS coverage director Tamara Syrek Jensen didn't add any color to this HHS remark.   She noted that there is more happening under the umbrella of Parallel Review than just the two NCDs the public has seen.

    Debbie Downer:  Since CMS can't release in advance the date or content of its decisions, and, it already is in extensive Q&A dialog with Parallel Review participants, it's unclear what the "increased transparency" would be.

Improve Clarity and Transparency around Medicare Coverage Process
Some stakeholders find the process and standards for the Medicare coverage determination process lack clarity. This proposal requires CMS to issue additional guidance around the Medicare coverage process, including sub-regulatory guidance on the evidence standards that CMS utilizes in assessing coverage and the process to appeal coverage determinations, in an effort to improve clarity around Medicare coverage.

    Takeaway:  I have worked on many coverage issues for 15 years, and it's hard to give general rules for "what justifies coverage."   The situations, alternatives, comparators, vary greatly from one scenario to another.   Very, very few coverage decisions are NCDs, so this would mostly apply to LCDs.   CMS markedly updated the LCD process in October 2018, with changes rolling out now in 2019.   
     * I reviewed a group of very recent MolDx LCDs, and found the coverage analysis and clarity was quite high.  Here.
    * But right now, a device can have FDA Breakthrough Status, rigorous CMS Inpatient New Tech approval for added payment for confirmed new benefit, and still not get LCD coverage.  That's just insane.
    * As far as NCDs, I reviewed the quite recent NCD production process for the Foundation Medicine NCD, and found it was just pretty awful (white paper here, some other notes here.)

   Debbie Downer:  This HHS paragraph might refer mostly to the LCD improved processes already released a few months ago.

Improve Medicare Beneficiary Access to Breakthrough Devices
There is currently no expedited pathway for Medicare beneficiaries to access innovative devices that have received FDA breakthrough designation. This proposal provides Medicare coverage of devices approved through the Breakthrough Device Program for beneficiaries participating in clinical trials for up to four years from the date of FDA approval.

    Takeaway:  While legislation was floated in 2018 to improve CMS coverage of "breakthrough devices," there's also potential regulation lodged in 2018 with OMB (here), and a history on this topic dating back a full two years with monikers like EXCITE and PACER (here, here).  

    Debbie Downer:  The quote here is about coverage of approved Breakthrough Devices just for patients "in clinical trials."  Really?  Medicare normally already covers many devices in clinical trials anyway, with or without the breakthrough status (webpage here).