- The 21st Century Cures Law, signed in December 2016, put into law some legal obligations for clarity in LCDs, many of which were already being practiced. LCDs must be posted in advance, follow comment periods, post responses to comments, provide rationales, and provide links to the draft LCD along with the final LCD. Final LCDs must be posted for an interval before they are effective.
- College of American Pathologists and others are supporting a new proposed law, the LCD Clarification Act, which overlaps some with topics in 21CC, but also expands requirements for LCD clarity and process, including open CAC meetings and more eyes on the reconsideration process, along with definitions of "evidence" that includes consensus opinion.
21st Century Cures and LCDs
The 21CC (HR 34) became law on December 13, 2016. The full text is here. Section 4009 is titled, "Improving Local Coverage Determinations." It's only 197 words long (LCD full text here). It's codified at SSA 1862(1)(5) [el 5].
CMS must require that before an LCD is finally effective, the MAC must post the LCD in advance in its entirety, along with a copy of its original LCD proposal and date, links to that proposed LCD and to public comments and response to comments, provide a "summary of the evidence considered" and "a rationale for the determination." These requirements became effective in July 2017 for all LCDs that are either "proposed or revised."
Analysis. MACs already posted LCDs in advance, and there was already a 45 day public notification period before a final LCD becomes effective. MACs already cited literature and rationale in the LCDs (per CMS manual instructions), and for at least a couple years a Q&A on public comments has been posted. I've heard a MAC medical director refer to 21CC as a big change they were still figuring out, but it seems to require very little. Before this, rationales could have been scanty or confusing, and I suspect that under 21CC a "rationale" can still be scanty and confusing. The legislation does seem to target LCDs that simply provide laundry lists of non-covered services with no rationale or literature cited. The current LCD instruction manual is online here, and as of October 2017, hadn't been revised to account for 21CC yet. 21CC Section 4009 is already codified at SSA 1862(l) where it adds to the existing section defining NCDs and LCDs (here).
- A newly issued LCD by the NGS MAC (NY, New England, and several midwestern states) is 21CC-compliant and shows that the contractor takes the "evaluation of the evidence" and "rationale" mandate seriously and diligently. I've put a PDF copy in the cloud here and a web cut/paste here. At the links just given, scroll down the LCD to see the detailed article-by-article evaluation and analysis.
The Local Coverage Determination Clarification Act of 2017
The LCD Clarification Act was announced in a press release in March 2017 (here). Senate sponsors include Isakson (R-GA), Carper (D-DE), Stabenow (D-MI), and Boozman (R-AR). The College of American Pathologists (CAP) describes "the LCD process [as] broken" and "lacks transparency, accountability, and stakeholder input."
CAP Infographic. CAP has an elaborate PDF Infographic on the law which calls out for criticism a Palmetto LCD on special stains (here).
Under the proposed law,
- MAC Contractor Advisory Meetings must be open to the public and on the record.
- MACs must provide evidence relied on, in the proposed LCD. If facts are withheld til the final LCD, it would impair the ability of the public to comment.
- LCDs must be reviewable by a "qualified disinterested party."
- Carbon copy adoption of LCDs from MAC to MAC overrides the ability of stakeholders to have meaningful and independent comments and creates "de facto NCDs."
- Supporters are cited as CAP, ASCO, American Society of Radiation Oncology, and others.
As of October 2017, the bill is tracked as S. 794 and as H.R. 3635. Text also archived here. As of October 2017, there were 10 current Senate sponsors and 12 current House sponsors. The bills are about 2300 words long. Tidbit: Although introduced later (8/2017), the HR3635 bill includes dated "carrier, fiscal intermediary" language whereas the S794 bill is for MACs.
Analysis. The LCDCA defines "qualifying evidence" as including both peer reviewed scientific publications AND a general consensus of the applicable medical community.[*] While MACs are requirered to "reconsider" LCDs now, the law provides a more detailed process and provides guardrails such as "Agency Evaluation of a Reconsideration Decision" and creation of a CMS "Ombudsman" for LCD issues. Currently, CMS coverage staff will often state they do not have authority to evaluate an LCD or a reconsideration decision (other than creating a new and over-riding NCD.)
CAP infographic (in part):
|click to enlarge|
[*] For a 2015 book on the development of consensus bodies and guidelines, see Miriam Solomon, "Making Medical Knowledge," Oxford.