Wednesday, April 18, 2018

White Paper: Three Rubik's Cube Puzzles of the CMS NGS NCD

We're celebrating one month after the publication of the final NCD from Medicare on the use of NGS testing in advanced cancer patients.   I've written up a 10-page white paper on three puzzles of the NCD.    Find the white paper online HERE  Click the "Down" arrow to download.

Based on incoming questions that I hear, andbased on some of my own puzzling, here are the three topics.  The short version is this blog; the long version is the online white paper.

     1.  Why does FMI assert pan cancer coverage under the NCD?
     2.  How does the NCD text limit the scope of the NCD?
     3.  Possible implications of the "advanced cancer" definition in the NCD.


1.  Why does FMI assert pan cancer coverage under the NCD?

The NCD provides coverage for tests that are NGS based, FDA-authorized CDx tests, when used in a patient who has an indication for that test.   FMI has two indications.  One indication for use as a CDx in several genes and several cancers (such as EGFR, lung, CDx).   A second indication is for "tumor profiling to inform the physician in solid cancers."   If a Medicare patient has lung cancer, the CDx for EGFR checks both boxes: the test is a CDx test, and, has an indication (EGFR) in that patient.   If a Medicare patient has bladder cancer, or skin cancer, or thyroid cancer, the test is still a CDx test (box 1) and it has "an indication" for that patient, e.g. tumor profiling to aid the physician in a solid cancer.   This analysis concords with FMI statements in several press releases.

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Getting a pan cancer definition isn't easy; FMI provided 80,000 blocks across 43 cancers, and MSK IMPACT provided >10,000 blocks across 17 cancers.

2.  How does the NCD text limit the scope of the NCD?

The proposed NCD had clear cut exclusionary language, which CMS simply deleted from the final version.  In addition, CMS deliberately added several additional sentences for the public, regarding the "scope" of the NCD:

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This language seems initially clear, then a little murky (to exactly what do some terms refer?) on closer reading.  I provide an analysis under Section 2 of this white paper. 

As I've said earlier, trying to read the NCD (including the text above) as broader and more exclusionary collides with common sense and lands in arbitrary and capricious.  For example, applying the NCD to unrelated NGS topics other than cancer therapy would be just like doing an NCD on cardiac devices, limiting the scope to valves, and then concluding that pacemakers aren't covered by implication.

3.  Possible Implications of the CMS "Advanced Cancer" Definition

The title of the NCD is "NGS testing in advanced cancers" and CMS provides coverage for targeted therapy NGS testing only in advanced cancers.  CMS seems to take pains to provide an explicit operational definition of "advanced cancers:" cancers that are recurrent, relapsed, refractory, metastatic, or Stage III or Stage IV. 

Is the NCD Language too restrictive?  For example, a new aggressive leukemia isn't relapsed or recurrent - it's new - and it's not refractory, because we're going to treat it for the first time.  Leukemia isn't usually called "metastatic" or "stage III or IV."  (There are staging systems for leukemia but they're unrelated to the metastatic Stage III/IV in solid tumors).   Could some auditor assert the leukemia doesn't meet any single one of the entrance criteria?

Can the LCD language in some cases too generous?  There's no question that skin cancer is a cancer, and millions of them are "recurrent."  When they recur, patients will certainly want "a therapy" (be it excision, radiation, topical drug, etc).   So here we go: The patient has a "cancer' and it is "recurrent' and he needs "a therapy" (not otherwise specified by NCD), so the skin cancer seems to qualify.  And if he has several (left hand, right hand, forehead) each is a distinct primary eligible for testing.   I'm not recommending this, I'm just reading the NCD.