Monday, December 23, 2019

Cures 2.0 Comment - December 2019


Cloud copy of House request for information:

Comment (12/16/2019)


Thank you for the chance to comment on the design goals for CURES 2.0.[1]  

The Request for Information flags the fact that substantial problems plague our outdated coverage and reimbursement system, discouraging some kinds of effective and cost-saving innovation and stopping others entirely.  

Key Point

Stakeholders in the medical device and diagnostics fields have found that, with a few well-intentioned sentences of text, Section 4009 of 21CC attempted to address problems at Medicare, but left many problems untouched and even had some unintended adverse consequences.  

Commenter – Background

I have worked full time on Medicare policy issues since 2004, both within the CMS system and outside it.  By training I am an MD-PhD and I have spent the larger part of my career in strategy consulting.

Medicare NCD System Painfully Slow

Nationally:  Medicare’s NCD system runs on a painfully slow timetable and CMS states its resources are understaffed.   CMS issued a national policy on genetic sequencing in cancer patients in November 2017, which would have had very major problems if not changed, and coming into 2020 there are still substantial problems with it.   Although CMS released a final version of the decision in February 2018, with some corrections, major flaws did not appear until CMS released implementation instructions in November 2018.   Stakeholders complained en masse to CMS in January 2019, and a revision came out in October 2019 which still had major errors based on over 40 comments from leading organizations.   CMS will release a new version in January 2020, but likely will not release implementation instructions until late 2020, which may start a new cycle of gaffes and problems.   

The NCD forces coverage and coding updates to a national level, which operates on a glacial pace.  I was involved in a client application for a new CPT code in March 2019; that code became effective in October 2019, but CMS will not issue instructions for its coverage until April or July 2020, we have learned.   That is a full 18 months after the March 2019 code application just to add a product that was pre-qualified under the principles of the NCD.  

Medicare LCD System Seems Swamped

Between (A) Section 4009 of 21CC and (B) LCD process changes made by CMS on its own initiative, since January 2019, LCDs have no longer been allowed to issue quick blanket non coverage of technologies even before review.  

That is good.  But some products are caught if they were put on “reflex non coverage” status in 2017 or 2018, and now it is taking multiple years to get off that status.  

CMS requires its contractors to log all LCD change requests from stakeholders, but has no timetable for the contractors to actually do anything with the requests they have logged.   This is similar to legislators logging thousands of bills, but having bandwidth to pass only dozens.   

I have one client which had a draft coverage LCD in Fall 2018, which was suspended in June 2019 without being finaled, and is being updated via a LCD that won’t even entire draft comment until February or March 2020, at which point it will take 6-12 months to finalize (mid 2020 or later).   The client’s discussions with Medicare began in Fall 2017

I have another client with an excellent and effect surgical product, which won endorsement by CMS central office for “substantial improvement.” But it is taking from Fall 2018 to Fall 2019 and into 2020 – literally 18-24 months – to work through the swamped-out LCD process.   Under this system, most of a three-year “New Technology Add On Payment” awarded for “substantial improvement” may expire before LCDs slowly appear a few years later that recognize the new code and new technology.

Speaking as an MD-PhD with nearly twenty years experience in policy decisions and policy consulting, the efficiency of medical review for new technologies is highly, highly variable among the different local regions and different CMS Baltimore staff.    Often misunderstandings are repeated, or worsen, or reappear as the months go by, making the coverage process almost Kafka-esque.

Next Steps

There are a lot of problems with the current system and they may defy resolution with just two or three sentences of statutory text.   Indeed, short instructions can lead to adverse consequences, as occurred with Section 4009.    Multi-stakeholder groups should be convened to hash out systematic improvements that will really work.   A paramount goal should be to encourage major improvements in both the quality and cost of care.   The technology is capable; the health system has to be trained to adapt to it and encourage it.

Bruce Quinn

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