Breakthrough device reimbursement rule on the rocks

Despite industry outcry, new data question how relevant the rule would have been anyway.

Don’t count your chickens. A rule that would have provided four years' Medicare coverage for any device with FDA breakthrough designation once the device was approved in the US is now unlikely to come into force after all.

Though the decision is not yet final, the industry association Advamed is up in arms. But a new Evaluate Vantage analysis shows that vanishingly few of the devices approved over the past two years had breakthrough status, raising questions about how great an impact the proposal would actually have had. 

The Medicare Coverage of Innovative Technology (MCIT) pathway had been proposed under the Trump administration, and was immediately put on hold when President Biden took office. It started to look even more shaky when the Centers for Medicare and Medicaid (CMS) delayed its implementation in May, stating that MCIT did not require evidence that the devices would benefit Medicare patients. 

The CMS also said the MCIT would also have made it much harder to remove these products from market had they later been found to be dangerous.


On Monday the CMS reiterated its concerns and said it had decided against implementing the rule. A consultation period on this decision will run until mid-October, but the writing is on the wall.  

Advamed, which represents device makers, called the proposed kyboshing of the proposed rule “the wrong decision” for patients and companies. But on that last point, data compiled by Evaluate Vantage suggest that medtechs would have seen little benefit from the MCIT had it come into force.

Of the 55 premarket approvals granted to medical devices, diagnostics or digital health from the start of 2020 until the end of August 2021, just five were for devices with breakthrough designation. And all five went to large, well-known groups, including Roche and Medtronic – companies least in need of the financial boost Medicare reimbursement would bring. 

FDA breakthrough devices granted premarket approval, 2020-21
Device Company Description Approval date Review time (mth)
Harmony Medtronic Transcatheter pulmonary valve Mar 26, 2021 4.2
Shockwave lithotripsy system Shockwave Medical Device to dilate calcified coronary arteries   Feb 12, 2021 5.6
FoundationOne liquid CDx Roche Liquid biopsy (approval for additional biomarkers) Oct 26, 2020 8.7
FoundationOne liquid CDx Roche Liquid biopsy Aug 26, 2020 8.0
Guardant360 CDx Guardant Health Liquid biopsy Aug 7, 2020 5.9
Average of breakthrough devices 6.5
Average of non-breakthrough devices 13.0
Source: Evaluate Medtech & FDA.

Breakthrough devices can reach market via other regulatory routes, of course, such as the de novo pathway. Unlike with PMAs, the FDA does not release documents containing information on the presence or absence of breakthrough status of de novo cleared devices, so it is impossible to be definitive. Any information here is dependent on companies announcing it. 

Anecdotally, though, the rate of breakthrough de novo clearances is also low. Only two of the 15 de novos so far in 2021 are known to have gone to breakthrough products – Cognoa’s Canvas Dx, an AI-based diagnosis aid for childhood autism, and Helius Medical’s Pons neurostimulator, designed to improve gait in patients with multiple sclerosis.

The low rate of breakthrough approvals comes despite the FDA’s generosity in handing out these designations since the programme began in December 2016. The agency does not disclose these routinely, but the number of devices gaining breakthrough status is believed to be in excess of 100 per year. 

Had MCIT come into force, breakthrough designation might have been more useful as a species of marketing tool than an actual means of reimbursement. If a company were to be able to say that its device, once approved, will get automatic payer buy-in, the company becomes a much more attractive investment proposition – even if the device never actually makes it to market. 

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