Nearly two months ago, CMS released a groundbreaking proposal to cover medical devices reviewed under the FDA Breakthrough Pathway for four years, based on the indication for use and the date of FDA approval. I covered the release here on August 31 and discussed some ins and outs here.
The comment period winds up on Monday, November 2, and there are already 94 comments submitted (here, see "comment' box.)
I'd like to circle back to my remarks, "Ins and Outs, #3" in an earlier blog. I'm still bothered and puzzled by ambiguities in the text, regarding diagnostics.
Regulation Includes Diagnostics by Definition; Body of Text Makes Odd Statements
In German, they have the word "Jein" meaning "ja" and "nein" at once. Does the Breakthrough Coverage proposal encompass diagnostics? Jein? Yes, but with some weird text that raises confusion.
YES: Diagnostics are Part of Breakthrough Coverage
CMS creates breakthrough device coverage under a proposed new regulation at 42 CFR 405.603. Devices are covered under Medicare Coverage for Innovative Technologies (MCIT) if they are within a Medicare benefit category, used according to their FDA indication, and are "FDA-designated breakthrough devices." A definition says simply that breakthrough devices are those designated under the FDA breakthrough regulation (FN1).
There's no question that FDA breakthrough law includes diagnostic devices (e.g. IVDs). A number of breakthrough diagnostics have already been approved, and press releases indicate many more in the FDA breakthrough pipeline. There's no question that FDA categorizes IVDs as medical devices (for one source on that, see Medicare's own quotation of the FDA definition of medical devices including diagnostics - here.)
So if the regulation at 405.601, 405.603 is finalized, it applies to the array of medical devices under Breakthrough, and that is well-known to include diagsostics.
NO: Puzzling CMS Text in Rulemaking
CMS writes on page 54331, Column 2:
- We specifically seek public comment on whether the MCIT pathway should ALSO include:
- drugs and/or biologics that utilize breakthrough or expedited pathways,
- or all diagnostics, drugs, and/or biologics.
- We seek data to supporting including THESE ADDITIONAL ITEM CATEGORIES in the MCIT pathway.
It sure sounds to me like the author of this paragraph thought that, as proposed, diagnostics were NOT included under the rubric "medical devices," but MIGHT be included as an "ADDITIONAL" type of coverage to that which was proposed. Weirdly, CMS scrambles together a category covered by Breakthrough Devices terminology (diagnostics) and something entirely outside breakthrough device terminology (drugs).
Resolution: Does It Matter?
If the regulation is finalized with the wording proposed, the legal regulation will include diagnostics (as it encompasses all breakthrough devices without qualification.)
However, my concern is, some author or authors at CMS did not want to include diagnostics. They think of "medical devices" as med/surg devices - pacemakers, artificial hips. At their most perverse, CMS could state that, "In our original discussion, we clearly indicated to the public that we did not intend to include diagnostics, unless we would be convinced to do so by public comment and data. We referred to diagnostics as an additional category that might be included under MCIT, at our discretion. Therefore, in finalizing the rule, we have edited the regulation to clarify, as we intended, that it does not include diagnostics, bringing the regulatory text into alignment with our public discussion." I think this would be a pretty unhappy outcome, but I'm not sure it's impossible.
Let's hope this plays out well for diagnostics but re-reading this text for several additional weeks I continue to feel that it's worth paying attention to.
I'm not sure the regulatory reference in the CMS rule to breakthrough devices as FDA Act 515B(d)(1) or USC 360e-3(d)(1) are correct.
I've seen comments that a phrasing on page 3 of the Federal Register document narrows the rule to medical devices other than diagnostics. This says, "At this time, we are limiting MCIT to medical devices because that is a category of products explicitly identified by E.O. 13890, and we have identified that breakthrough devices can experience variable coverage across the nation shortly after market authorization." Unlike some letters I have read, I wouldn't say this sentence excludes diagnostics, which FDA considers clearly includes as "medical devices." I would say this sentence explains why the MCIT is limited to breakthrough medical devices in general, and CMS didn't write it to include, for example, accelerated approval drugs.
And lest their be any confusion that Medicare had (somewhere, somehow) previously defined "medical devices" as only med-surg devices, it didn't. The official and manualized Medicare definition of "medical devices" quotes from FDA and explicitly includes diagnostics (here).