There are a few major anomalies that turned up in my white paper research, which I capture here in two figures.
First, Insertion of Novel Non-Coverage Text
The March 2018 NCD did not contain a full section of non-coverage language that appears in the November 2018 "transmittal" of the decision.
OK, sit back in your chair. Here's what occurred.
Whereas the NCD coverage of the section is the same, and the LCD coverage section is the same, a new section documents "non-coverage." I realize that CMS may feel it can impute or imply the non-coverage from the decisional part of the NCD. However, if the NCD was originally clear and could only be interpreted one way anyway, why add new language? If the NCD was ambiguous (as many would argue), is it fair to add a one-way interpretation so late? I and many others have noted that the original NCD contained some crystal clear language that narowed its own scope to the material and rationale discussed and reviewed. See a sentence stating that the NCD did not extend to all types of NGS testing, but only applied to testing for targeted therapies (e.g. combination diagnostics).* That was clear enough for me... Made good sense.
To visualize what happened, see a comparison of the March 2018 version and the November 2018 version, below. (Click to enlarge; but see white paper for a full-size version).
|click to enlarge; see also white paper
Second, Completely Skipping NCD Process Requirements in Statute
You can call this one major anomaly or you can tally about six different missed steps, as shown in the figure below.
Statute has stringent requirements that CMS must present the public with a full rationale for its decision, all data sources, respond to comments, etc.
As I show below, the NCD doesn't provide any rationale for exclusion (the new interpretation at CMS and MACs) of NGS testing outside targeted therapies. It doesn't present the public with any such decision resources. (In fact, it states explicitly that things such as NCCN germline cancer guideline are out of scope). There were point blank comments about whether the NCD blocks germline testing, not directly responded to anywhere in the NCD Q&A.
Finally, the key word searches and bibliography excluded germline references. (In part, if course, the germline medical necessity literature was well-developed under Sanger sequencing, so it isn't fully replicated merely because the lab method switched to NGS. A BRCA founder mutation like the frameshift mutation 185delAG is the same under any sequencing (or PCR) method.) In short, there is severe inconsistency between the body of the NCD and the decisional part, and even the Supreme Court reads documents as a whole in order to find a decision that makes sense and avoid conclusions that are absurd. A final, and conscious, conclusion that PCR or Sanger sequence mutations in the same patient, same time, same purpose, are medically necessary, but an NGS report of that mutation is medically unnecessary - is absurd. It is like saying that a contract means one thing if written in Arial, but comes to mean the opposite if written in Times Roman.
|click to enlarge
In making a national coverage determination (as defined in paragraph (1)(B) of section 1869(f)) the Secretary shall ensure consistent with subsection (l) that the public is afforded notice and opportunity to comment prior to implementation by the Secretary of the determination; meetings of advisory committees with respect to the determination are made on the record; in making the determination, the Secretary has considered applicable information (including clinical experience and medical, technical, and scientific evidence) with respect to the subject matter of the determination; and in the determination, provide a clear statement of the basis for the determination (including responses to comments received from the public), the assumptions underlying that basis, and make available to the public the data considered in making the determination.These rules were met for tumor testing ("YES") but not for germline testing ("NO!").
CMS might argue that the "decisional" part of the NCD survives point-blank contradictions in the actual reasoning and explanatory section. But slow down. There are many examples from CMS itself where regulations per se can only be understood with reference to provided explanatory language or implementation policies. Also, interpretation should never lead to absurdity when other options are at hand.