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Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

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Source Article ID
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Article ID
A58984
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Article Title
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms
Article Type
Response to Comments
Original Effective Date
04/01/2022
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms LCD. The official notice period for the final LCD begins on February 10, 2022 and the final determination will become effective on April 1, 2022.

Response To Comments

Number Comment Response
1

NGS received almost fifty comments, all supportive of the draft LCD overall, some lauding specific aspects, most with modifications requests. This Response To Comments (RTC) will summarize and respond to this last category in order of decreasing frequency.

More limited testing- A majority commented on the requirement that “CGP NGS testing for patients with advanced cancer is reasonable and necessary only when more limited (e.g., individual analyte or targeted panel (5-50 genes)) testing is insufficient.” Comments ranged from a misunderstanding (only targeted testing is covered, or sequential testing is always mandatory), to requests that it be struck as confusing or obsolete, to others asking for more definition as to what constitutes “insufficient.”

This requirement was intended to emphasize that CGP testing is not mandatory in every advanced cancer case (especially Stage III). However, given that it is indicated in an ever-increasing majority (due primarily to the proliferation of tissue-agnostic agents requiring pan-tumor companion diagnostics), we agree to omit the wording, if not the principle. We rely on clinician judgement to keep up with the rapidly evolving target of what is reasonable and necessary (the underlying requirement for all Medicare services whether itemized in an LCD or not).
2

Analytic validity certification- About half the comments raised the issue of requiring that assays “have published, peer-reviewed studies supporting analytic validity.” Some requested it be struck as either unorthodox (no Clinical Laboratory Improvement Amendments (CLIA) program publication requirement), redundant (existing accreditation through CLIA and CMS-approved agencies such as the College of American Pathologists (CAP)), or impractical (journals reluctant to publish straightforward validation studies). Others robustly endorsed the requirement full stop, requested it be reduced to a single study, or asked for the addition of “third-party alternatives such as CAP and New York State (recognized by the FDA as a third-party review organization).”

NGS understands the impediments to peer-reviewed publication beyond lab control and agrees to 1/ reduce the publication requirement from plural to singular; and 2/ accept alternative “certification by a third-party consistent with the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) review standards.”
3

Policy scope- Approximately one-third requested coverage of some combination of elements deemed out of scope in the draft (hematologic malignancy, circulating tumor DNA testing (ctDNA), germline testing).

This LCD was created with genomic testing of biopsied, solid, somatic (acquired) cancer in mind, and lacks the summary and analysis of evidence, specific to those other topics, to responsibly address. Nor would adding such significant new content be appropriate sans another open meeting and comment period. However, coverage can be requested via Reconsideration Request of either this LCD (once effective), or LCD L37606 (Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases).
4

Repeat testing- About one-quarter of comments reflected concern that limiting retesting “for the same cancer genetic content” can miss evaluations of tumor heterogeneity or clonal evolution post targeted therapy. They note that “clinical guidelines recommend retesting tumors upon progression to evaluate resistance mutations and identify new therapeutic targets.”

Precluding retesting for “the same genetic content” is from NCD 90.2, somatic cancer criteria for Medicare Administrative Contractors (MACs) and cannot be exceeded. The nationally covered indication section employs the identical phrase. Both were revised from “the same primary cancer” to specifically allow for retesting short of a new primary. Progression after targeted therapy or recurrence are possible evidence of clonal evolution (i.e., not the same genetic content), and so are potential indications for repeat testing. We see no reason to explicate beyond wording currently understood and accepted in the NCD.
5

81455 only- About 10% objected to the utilization guideline in the Billing and Coding article that “any molecular procedure CPT code other than 81455 that is submitted on the same date of service as 81455 will be automatically denied as not medically necessary.” The reasons given range from the very specific (glioma copy number evaluation is assessed and performed separately from NGS Panel per NCCN CNS Disorders V2.2021), to the very general (conflicts with NCCI policy). One noted it “disincentivizes triaging samples to utilize CGP testing only for those patients most likely to benefit.”

NGS agrees there are appropriate indications for billing other molecular procedure codes along with 81455 and will delete the requirement. We also agree that this area is already managed by existing national edits (MUE, NCCI).
6

Essential biomarkers- Four commenters expressed concern with the requirement that tests “be able to detect at least the minimum genes and genomic positions required for the identification of clinically supported, FDA-approved therapies...listed in Category 1 or 2A of the most current version of the NCCN Biomarkers Compendium.” The fear expressed is that “every addition of a new biomarker could invalidate a clinical assay”, and “require repeat validation of analytic validity and peer-reviewed publication.” One asked for NGS to “define a date with regards to which version of the NCCN is indicated,” another to “clarify a specific version of the compendium, as opposed to passively suggesting a link to the latest version.” Another requested NGS allow labs time to expand and revalidate LDT content, and also “allow clinical laboratories to supplement their CGP offering and revised content guidelines through multiple tests.”

Given the rapidity and cancer-specific pace of NCCN updates, citing either a specific version or test update timeline, seems unworkable. Therefore, while providing imperfect direction, referring to the “most current version” would seem the only practical way to implement the principle in policy. However, a good faith effort to keep current and provide comprehensive clinically relevant results (including by using a modular approach), will be viewed favorably.
7

Adding diagnosis codes- A couple commenters asked for the addition of secondary cancer codes (C77, C78, C79, and C7B) since advanced cancer often involves metastasis. Others simply requested information on the process of adding codes generally.

We agree with the addition of the secondary cancer codes. Other codes can be added via an LCD Reconsideration Request. Of note, accepted code changes not impacting policy can be made expeditiously (i.e., without an open meeting, comment period).
8

Beyond NCD, etc.- A few isolated comments contemplated changes beyond MAC discretion (e.g., exceed NCD 90.2 constraints, a prior authorization-like option), or related to other policy sections not open to comment.

We appreciate the comments, however we have no discretion to waive NCD or other CMS constraints. We welcome Reconsideration Requests related to other parts of the LCD.
9

Updates/corrections- One commenter requested several updates to NCCN references, among other relatively minor corrections. Another noted the statement: “no companion diagnostic is currently approved for the detection of TRK fusion” is incorrect, pointing to the FDA’s website (List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) | FDA).

NGS agrees and has made the changes.
10

Personalized medicine- One commenter took exception to a sentence in the Analysis of Evidence section that noted: “the very concept of precision medicine, involving the widespread assumption of clinical utility for wholesale genetic testing, is coming under new scrutiny. ” Their argument is that if the impact of personalized medicine has fallen short of expectations, it is due to insufficient implementation rather than lack of accuracy or clinical utility.

This sentence was meant to point up some recent expectation downsizing around personalized medicine’s potential impact. Exploring the nuances of this debate is beyond the scope of both the policy and RTC. However, we do agree that the wording used may have unintentionally overstated the case, implying potential absence, rather than limitation, of value. We have revised it accordingly and, to augment balance, cite the counterargument of insufficient implementation.
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