Tuesday, November 24, 2015

My November, 2015 comment on PAMA regarding the definition of ADLTs.

My November, 2015 comment on PAMA regarding the definition of ADLTs.
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I disagree with CMS's interpretation of the PAMA definition of ADLT to necessarily include "DNA or RNA."

While the PAMA rule does not give a clear explanation how this was reached, at a CMS advisory board in October, CMS staff explained that the definition of ADLT - "DNA, RNA, or protein" - was read in context of the overarching term "Advanced diagnostic laboratory test" to exclude proteomics-only tests.

This does not make enough sense to hold as a reasonable interpretation of PAMA's ADLT definition, which in contrast should be virtually self implementing.

First, we look to context of a bill when the paragraphs in question are unclear. "A, B, or C" is simple English grammar, and does not require canons of interpretation. If I tell my daughter, "Come home on the bus, subway, or taxi" it does not require her to come home only on the bus or subway. The grammar of ADLTs is the same simple English. There is nothing unclear that requires context and labored interpretation in the concept: "Use A, B, or C."

Second, even though it is inappropriate in the first place, the conceptual outreach to the mere heading, "Advanced diagnostic laboratory test" to define the tests are requiring DNA, RNA, or both, at a minimum, does not pass the sense test either.

(A) The term ADLT has not existed before, therefore it has no pre established meaning.
(B) To the extent the ADLT category close resembles either the IVDMIA (FDA) or the MAAA (AMA CPT) categories, those include RNA, DNA, or protein tests, including protein only MAAAs. The differences between the IVDMIA, MAAA, and ADLT terms are hairsplitting, in reference to multi analyte algorithm tests with single results, AND that group has included MAAAs such as the Crescendo VECTRA test.
(C) There is no bias against proteomics being one of the fundamental modern "Omics" along with DNA and RNA. Proteomics is referred to as the next frontier of molecular medicine, not a backwater.

Thus, the outreach to the  four word category "advanced diagnostic laboratory test", cannot be used to support use of DNA or RNA, as required components.

Third, CMS has built nearly a house of cards (as shown above) in its logic and assertions that ADLT, viewed as a whole, almost magically excludes protein only ADLT tests. It defies belief that such a tortured logical path of assumptions and semantic inferences - not even very well justfied ones, and unexplained in the proposed rule itself - was the main and simple intent of Congress in writing and signing the definition as we have it.

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