CMS Releases Q&A on New LCD Process
On May 2, 2019, CMS posted an interesting 5-page Q&A on the new LCD process. The CMS LCD homepage is here and the PDF is currently online here.
LCD Q&A Is Tied to Seema Verma Speech on Medicare & Innovation
It seems to be timed with a speech today at the Medical Device Manufacturers (MDMA) annual meeting by CMS chief Seema Verma.
Press release here, 2600-word speech here. (That's half as long as the 2019 State of the Union Speech.)
The speech is worth reading; for example, I learned about changes for novel DME technology pricing that I didn't know about (see 83 FR 56922, p.57046, 11/14/2018). She also highlights advances under her leadership, such as covering continuous glucose meters and finally ensuring insulin "pod" devices are covered under Part D (here, here).
(Though not so focused on innovation and medtech, see also Verma's lengthy speech to Federation of American Hospitals, March 4, 2019, here.)
Summary of LCD Changes for 2019
Enjoy the reading. Here is a summary of the LCD changes (using both the program manual revision and the new detailed Q&A document).
- CAC meetings are no longer required for each new LCD, but are at the discretion of MACs.
- CAC meetings are open to the public to listen or watch, and recordings will be preserved online.
- CAC meetings can be held to review and discuss a particular proposed LCD (as in the past) or for informational purposes ahead of LCD creation (to discuss a topic in a general way.)
- CAC meetings can be live, or webinar, or teleconference.
- CAC meetings can span a contractor with multiple states (e.g. Noridian has "JE" and "JF") or multi-MAC.
- CMS held two multi-MAC meetings already, one for DME MACs to discuss a brain tumor therapy, and one for all the MACs to let their CAC members hear about and discuss a spinal surgery procedure. Example of "national scope MAC CAC meeting" is here. See also here with multi MAC kyphoplasty transcript here.
- So far, no LCDs have yet been released on the topics in the two informational CACs.
- Public meetings have to be held for each new set of LCDs. This means LCDs will probably continue to be released in batches. Public comment is 45 days.
- There is now a formal process to submit a request that a New LCD be created. (Previously, this happened commonly, but wasn't a manualized procedure.)
- However, this could cause MACs to have a large backlog of acceptable requests for new LCDs (13.2.2.3) but lack the bandwidth to produce them.
- Similarly, requests for existing LCD reconsiderations may be ruled "valid" (13.3.2) but there is no limit to the potential backlog.
- There is a formal process to have (at MAC's discretion) an Informal Meeting with stakeholders about their LCD idea. It's still elective for the MAC.
- In the past, some MACs gave these meetings pretty readily, and other MACs just about never. ("When can we meet to discuss your new product and an LCD? How about never? Is never good for you?")
- While the meeting has a "name" now, it's still elective on the par of the MAC.
- LCDs must have a listing of the evidence considered and a discussion of the MAC's rationale. Frankly, this has been a program manual instruction for twenty years or more, but apparently CMS is taking it more seriously now. (13.5.3)
- LCD finalization must include a public posting of all comments received, with responses. There is always a risk the answer will be tangential or telegraphic or obtuse (this is also true of NCD comments and responses.)
- CMS emphasizes in the Q&A that MACs can't post LCDs that ban payment for PLA codes, Category III codes, etc, without a public notice and a discussion of the evidence.
Some things haven't changed, e.g. final LCDs should be posted 45 days before they are active.
In the past, LCDs could be "expanded" without public comment. Now, an "expansion" of the LCD language requires public notice, public comment, response to Q&A, etc. Assuming, as I've heard, new LCDs are reviewed at CMS for a few weeks "to be sure it doesn't conflict with an NCD," a simple expansion could take 3 weeks at CMS, be posted 2 weeks ahead of a public meeting (13.2.4.4), then enter 6 weeks public comment (13.2.4.2), and a 3 week turnaround time in review, and a 6 week final public notice (13.2.6). I tally 20 weeks for something that used to be as fast as 2 weeks.
In the past, LCDs could be "expanded" without public comment. Now, an "expansion" of the LCD language requires public notice, public comment, response to Q&A, etc. Assuming, as I've heard, new LCDs are reviewed at CMS for a few weeks "to be sure it doesn't conflict with an NCD," a simple expansion could take 3 weeks at CMS, be posted 2 weeks ahead of a public meeting (13.2.4.4), then enter 6 weeks public comment (13.2.4.2), and a 3 week turnaround time in review, and a 6 week final public notice (13.2.6). I tally 20 weeks for something that used to be as fast as 2 weeks.
ICD-10 and CPT codes will be moved outside the LCDs and into attached articles. (The attached articles can be freely revised as CPT codes change, without following the rules for LCDs.) However, when this change happens, CMS will ensure that an LCD and its coding article are tightly linked since users need to search CPT codes to find out if there is a germane LCD.
Trivia.
There used to be a recommended list of CAC members, but it's been deleted. Now it's just "representatives of medical specialties, beneficiaries, and medical associations."
Some of the new PIM is duplicative. For example, an instruction to take 45 days of public comment on proposed LCDs appears similarly at 13.5.5 and at 13.2.4.2.
In the UK, NHS also shows high interest in the topic of "faster access to new treatments," e.g. 5/3/2019, here.
