There's a new article on Medicare coverage of Breakthrough products (NTAP, TCET, MCIT, legislation). It's in Health Affairs, and there is also an author commentary on Linked In by Dr. Lee Fleisher, prior chief medical officer at CMS.
Here's the article, Prasad et al.
Here's Dr. Fleisher's context and comment:
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I said I differed on a few points. Here they are.
#1 NTAP isn't a coverage decision
Several years ago, Medicare (through notice and comment rule-making) eased the path to New Technology Add-on Payments for hospital stays, if the product had Breakthrough designation.
But NTAP is a payment policy, not a coverage policy. There have been devices that achieve NTAP yet collide with local LCDs (and, in principal, NCDs) that disallow payment. There is no distinction at all in the coverage pathway for new devices with, or without, NTAP payment assignment.
#2 Trillions flow through general codes and DRGs
Through the ambulatory hospital APC system, the DRG system, and even in some cases the outpatient CPT system, new technologies with breakthrough status can often be paid at existing rates with no coverage review at all. In fact, this is probably how the great majority of new products get paid.
Yet this near-universal aspect of our general coding and payment system, through which trillions of dollars flow, gets no attention from the authors. The amount of money flowing through these generic payment codes, with countless new technologies invisibly streaming along, surely dwarfs the amount of funds through policy features like NTAP. CMS often reviews NTAP codes and finds they have only been used a handful of times for some NTAP products.
