Over the past several months, summer/fall 2018, there have been several "tips" dropped in the press that CMS is planning to produce a rulemaking change to encourage faster coverage of innovative devices.
Let me fill in some back-story. A full year ago, back about 12-18 months, there were rumors that Advamed and other stakeholders and CMS might shortly come up with a new special program for breakthrough devices and rapid coverage. But the topic went radio silent, at least on the CMS side, around the beginning of 2018. (I summarized this in a February 2018 blog, here. The CY2017 policy buzzwords for this topic included "EXCITE" and "PACER.")Now in late 2018, Holland & Knight's Ethan Jorgensen-Earp has a great pick-up in a new essay on CMS device innovation policy. Here. He reports that CMS has published notice of a "proposed rule" (meaning a future publication) for streamlined Medicare coverage of breakthrough technologies. It will be called CMS-3372-P and has a notification webpage, here. All we know, is that this is a new rule in the CMS rule pipeline. Fine print in the bottom of the notice suggested it is expected to appear in 03-2019.
See an earlier quote from Don May of Advamed in September, here, that CMS might make rules on its own, that are similar to the goals of H.R. 5997 (below). That fits to the clue about CMS-3372-P. See also: MedTechDive, September, here.
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See also: House Bill 5997, Breakthrough Products Access
See also H.R. 5997, a bill to encourage access to FDA breakthrough products in the Medicare system. Here. Delbene press release June 2018 here. AdvaMed June press release here. September trade press here, including AdvaMed quotes.
Don't Confuse with Recent LCD Rules Update
In early October, 2018, CMS released a wide set of updated LCD process rules, to be effective on or before January 1, 2019. Here. These were touted as "speeding the LCD process" but I don't see it at all.
For example, LCD reconsideration requests under the current rules, must get a yes/no reply within 90 days.
Under the "new rules," the MAC is now only allowed to respond that it has accepted the reconsideration and that...wait for it...that the MAC may or may not do an LCD, which may or may not be favorable, and may or may not occur at any unknown time in the future. Not an improvement to my eye. I believe the motivation was to avoid any risk of pre-public leaks of financially important information (see trial about CMS leaks, with criminal convictions, here), but the net result of not knowing the LCD reconsideration review decision, perhaps ever, is unsatisfactory.
...All the MAC now has to do is reply, after receipt, that they may or may not do an LCD that may or may not be positive and may or may not occur at any unknown time int he future. A perverse or overworked MAC would hardly even have to read the data to send back such a "Dear John" letter. and it would be a "true" letter, and would conform to the new rules.
I emphasis the LCD chapter because in some ways it short circuits the pending legislation, LCD Clarity Act. Possibly - I don't know - the CMS regulation on breakthrough products might get a jump on HR 5997 or relate to it in some way.
