21st Century Cures and LCDs
The 21st Century Cures Act contained a section impacting the writing of LCDs, which I discussed in October 2017 here. Final LCDs are required to be posted in advance of effective date (that's not new), and are also required to be posted along with a summary of public comments, a response to each comment from the MAC, and a hotlink to the original draft LCD. In addition, LCDs are required to provide a "summary of the evidence reviewed" and "rationale" for the decision. Technically, these were already requested of MACs by the Medicare program instructions, but 21CC gave them the force of law and higher visibility.
There is still much left to local discretion; summaries and rationales can still be variably detailed, "rational," or cryptic. MolDx LCDs contain an additional heading, "Level of Evidence," divided into a rating of "1) quality," "2) strength," and "3) weight" of evidence (limited, moderate, high), but I've complained that even as an expert I'm not sure exactly how either the 3 categories (or the 3 ratings) are defined. (What would be evidence with high strength but low weight? They may know the answer; why not tell us?)
CAP's Legislative Effort Adds to What 21CC Started
CAP and others are pursuing a broader impact than obtained by 21CC, as the "LCD Clarification Act." They update a map with their Senate and House sponsors, currently 97 (here). They have an 8 page issue brief online here. They also have a spiffy infographic here. I include a clipping from the infographic below (click to enlarge).
Read the full legislation here, H.R. 3635. MACs must post draft LCDs, hold public meetings, post minutes of meetings, follow these processes in every MAC jurisdiction, and provide rationales for LCDs. There is also a detailed reconsideration and "reconsideration appeal" process.
Most of these requirements still require cooperation of CMS or MACs. For example, rationales or meeting minutes could be cryptically brief despite the statute. I've seen clients submit 6-page reconsideration request with 5 new article attachments, and the response from the MAC is "Data is not sufficient" which is technically "a rationale," I suppose, but not much of one.
CAP's LCD Infographic
|click to enlarge|
Medicare humor - We're hearing that CMS is in the process of "revising the LCD manual." (The LCD manual still doesn't reflect the 21st Century Cures Act of 2016, and we're heading into the fourth quarter of 2018.) But I also recall that when I joined Medicare in 2004 as a medical director, they were already "in the process of revising the LCD manual" then, fully14 years ago and counting. CMS proposed some revisions to LCD processes in rulemaking several years ago, but didn't finalize them. [For an entry point into 2014 discussions of the LCD process and MACs, see 81 FR 41088ff].
Statline, CAP, 7/31/2018
More senators and representatives signed on as co-sponsors to the Local Coverage Determination (LCD) Clarification Act after CAP members lobbied their elected officials to support the legislation that increases transparency and accountability in the LCD process. The LCD bill has support from 97 MEMBERS OF THE HOUSE AND SENATE, with 76 members in the House and 21 Senators. The recent Senate co-sponsors include Sens. Catherine Cortez Masto (D-NV), Doug Jones (D-AL), and Rand Paul, MD (R-KY).
Recently, CAP members flew to Washington, DC, and helped secure support from Rep. Bill Huizenga (R-MI). In addition to Rep. Huizenga from the House, the CAP added Reps. Will Hurd (R-TX), Eric Crawford (R-AR), Adrian Smith (R-NE), Bennie Thompson (D-MS), Bruce Westerman (R-AR), Debbie Lesko (R-AZ), Bradely Byrne (R-AL), Eddie Bernice Johnson (D-TX), and John Duncan Jr. (R-TN) as co-sponsors of the LCD bill.
If enacted the legislation would pave the way for much-NEEDED LCD REFORM. For example, the legislation includes improvements to the LCD process that ensure that medical evidence is not used selectively to deny appropriate coverage to Medicare beneficiaries.
STATLINE will continue to report on LCD updates in the future.