New Article: Tunis et al, Improving Medicare's Coverage of Innovative Technologies

Just yesterday, I wrote about a new article in JAMA by CMS leadership on improving Medicare coverage of new technologies.   Here.

Today, new news.  An article by Tunis and colleagues in Health Affairs, "Improving Medicare Coverage of Innovative Technologies."  Find the article here:

https://www.healthaffairs.org/content/forefront/improving-medicare-coverage-innovative-technologies

Note that the Health Affairs blog article links through to a longer, 33-page white paper online at Tufts, here.

The article opens,

After advances and setbacks, policy makers have revived efforts to improve the Medicare coverage process for new medical devices. Industry groups and others have long argued that the existing process is inefficient and unpredictable, and that a streamlined pathway for coverage decision making is needed for novel technologies that address serious and life-threatening illness. However, more rapid coverage processes, with shorter review periods and greater reliance on intermediate or surrogate endpoints, often mean more uncertainty about a technology’s risks and benefits at the time of coverage. 

The enduring challenge is how to expedite the process to ensure that Medicare beneficiaries have appropriate, timely access to novel medical technologies, while providing robust and efficient mechanisms for evidence generation in the pre- and post-coverage period.

Tunis et al. cite to Holtzman 2018, a review of parallel review.  They cite four products in the P.R. pathway; I was only aware of Cologuard 2014 and Foundation Medicine 2017.   Both Cologuard and Foundation Medicine reflected complex or specialized policy circumstances.  (That is, one-offs from which generalizations would be dicey.)   The Cologuard test, as a preventive benefit, was flatly non covered w/o a CMS NCD, and for CMS, it was a chance to show it could use P.R. at least once, the first use.  And Cologuard clearly performed a good bit better than FIT, so the chance that FDA would not approve it or CMS would not cover it was, I would think, infinitesimal.  (As an original scientific achievement, it's a big deal; as a regulatory achievement for CMS, it was a six-inch putt, once the data was in.)  And the Foundation Medicine NCD was originally, in its first draft, as much about cancelling all coverage of LDTs, as of allowing coverage of the Foundation FDA test.

However, P.R. was also used for a Medtronic renal denervation system that got stuck without FDA approval, and the Boston Scientific cardioverter w/o transvenous pacing leads (EMBLEM).(*)   

Holtzman 2018 Table 2

In their white paper, Tunis et al. cite three possible reasons for little uptake of P.R.: (1) Company concern it will delay market entry or trigger a premature negative NCD which wouldn't occur otherwise; (2) CMS will request too many changes to the FDA plan; or (3) NCD will trigger "CED" which otherwise wouldn't come to attention.   I would add a different and 4th reason: I'm aware of several companies that tried to get into the P.R. process and were turned away at the door (declined even a pilot meeting; the initial P.R. request is routed through FDA staff and got canceled there with a quick "Dear John" email reply.)

As an aside, when CED is discussed (as in Tunis et al.) it's not usually mentioned that some examples of CED, I believe, simply match up to FDA-required post registrational clinical studies (thus, not requiring or reflecting any additional expertise at CMS).  

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(*) If I'm reading the 2017 decision on "leadless pacemakers" correctly, it requires CED but it doesn't mention parallel review, so even if I'd read it, I wouldn't have added it to my parallel review list.  I didn't see this on Google either; only in Holztman Table 2 line 4, above.