Monday, October 21, 2019

Medicare Trivia: MACs Can Now Have LCD Public Meetings as Rarely As They Want

For many years, until January 2019, Medicare's instruction manual for LCDs required them to be presented in a cycle of no longer than every 3-4 months.   The presentation cycle included a public comment meeting, a CAC (contractor advisory committee) meeting, and a 45 day public comment.

Among the numerous changes to the LCD manual in January 2019, any references to the frequency of LCD cycles have been dropped.   Want to release a batch of new LCDs every two months?  That would be OK, but releasing new LCDs only once a year would also be OK.

I've heard one MAC suggest it was downgrading LCD releases to no more than twice a year, such as an April and a September cycle. 

Nerd Note: Details

I have a copy of the Internet Only Manual - instructions for MACs - Chapter 13, vintage 2015, v. 608, which describes frequency rules in section  Section F there used to state that LCD meetings must be held a minimum of 3 times a year, with no more than 4 months before meetings.

The currently effective version is v. 863, issued 2-22/2019.  It's been completely reformatted, but Section 13.2 describes the LCD release and comment process.

While there are clearly rules for submitting a New LCD Request and clear rules for an LCD Reconsideration Request, both of which the MAC must acknowledge in writing, there is simply no remark anywhere as to how often, or at what delay, the MAC has to do anything about the submitted request other than acknowledge it as received.

Notwithstanding, an LCD Timeline Is Easily One Year

Here's a potential timeline:
  • December 2019: You have your publications, request letter, overview PPT deck all prepared and request a MAC meeting.
  • January 2020:  You get a telecon or fly-in meeting with the MAC medical director(s)
  • February 2020: MAC considers what to do, does its own literature search, calls its own experts
  • March 2020:  MAC writes up LCD text, circulates internally, finalizes
  • April 2020:  Most sources say CMS requests 4 weeks to review draft LCD "to check for conflicts with NCDs."
  • May 15, 2020:  MAC posts draft LCD online. MAC sets public meeting date (June 15) and a deadline for submission of public meeting comments (June 1).
  • June 15, 2020: Public meeting.
  • June-July 2020:  Public 45 day written comment period.
    • This may start variably with the LCD release date (May 15) or the actual public meeting date (June 15)
  • August, September, October: MAC reviews those public comments
    • 100+ days is typical based on real world data
  • November 15: MAC releases new final LCD and its responses to comments
  • January 1, 2021:  After 45 days, LCD is active.
Regarding the timeline for comments review, MolDx (for example) released 8 LCDs in May, comment closing June 20, and as of late October, only 1 of 8 has been released-to-final.  That's 120 days or 4.0 months and counting for 7 of 8 LCDs.  Hence my remark that >100 days for review is typical.  (Here).

While each cycle of LCD releases must be accompanied by a public comment meeting, holding CAC meetings (ever) is now optional, and could occur before, after, or never, relative to the date of an LCD release.


I've put copies of documents referenced into a zip file in the cloud, here.

For the New Yorker cartoon, "How about never? Is never good for you?" - here.