LCD Reference Article Response To Comments Article

Response to Comments: Molecular Pathology Procedures

A59383

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Posted: 6/29/2023
Due to a typographical error in the Notice Period, the effective date incorrectly displayed on the Medicare Coverage Database as 8/1/2023 from 6/15 to 6/28/2023. The correct effective date is 8/6/2023.

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General Information

Source Article ID
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Article ID
A59383
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Molecular Pathology Procedures
Article Type
Response to Comments
Original Effective Date
08/06/2023
Revision Effective Date
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Revision Ending Date
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Retirement Date
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Article Text

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 Molecular Pathology Procedures LCD. The official notice period for the final LCD begins on June 15, 2023, and the final determination will become effective on August 6, 2023.

Response To Comments

Number Comment Response
1

The American Clinical Laboratory Association (ACLA) supports the addition of coverage for IGH and TP53 testing to facilitate decision-making in the medical management of Chronic Lymphocytic Leukemia (CLL) patients and urges NGS to finalize this proposal.

National Government Services appreciates your supportive comment. Thank you.

2

The Association of Molecular Pathology (AMP) supports the expansion of coverage for IGH and TP53 genes to facilitate decision-making in the medical management of Chronic Lymphocytic Leukemia (CLL) patients and has the following recommendation to ensure that the policy reflects the current standard of care for CLL:

  • “NCCN guidelines indicate that both Ig rearrangement by PCR and TP53 sequencing is needed in multiple lymphoma types, to aid diagnosis, and make therapy decisions. In addition, minimal residual disease monitoring with baseline testing by Ig rearrangement in CLL, ALL and multiple myeloma is recommended or required.”

The current NCCN citation will be reflected in the Bibliography section of the LCD. Please see response #5.

3

The Association of Molecular Pathology (AMP) also suggested the addition of several ICD-10-CM diagnosis codes for TP53 and for IGH genes.

NGS agrees and specific ICD-10-CM diagnosis codes will be added to the Billing and Coding Article A56199 as appropriate.

4

One individual commented that LCD L35000 refers to L36376 incorrectly in the section below; instead, the reader should be referred to LCD 37810.

Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (EG, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed is considered not medically necessary except when used to guide treatment decision making in individuals with non-small cell lung cancer (please refer to LCD L36376).

NGS agrees and appreciates your comment.

5

NCCN thanked NGS for using NCCN content regarding IGH and TP53 testing as an evidence-based reference. NCCN notes that this updated coverage is consistent with its guideline recommendations. NCCN also noted that within the LCD several outdated versions of NCCN Guidelines are cited.

NGS appreciates the supportive comment regarding the updated coverage for IGH and TP53 testing for patients with CLL. NCCN citations that appear in LCD L35000 reflect the evidence available at the time that coverage of the specific molecular testing was considered.

6

The College of American Pathologists (CAP) submitted supportive comments regarding NGS’ updates to LCD DL53000 and related Billing and Coding Guidelines DA56199 to include coverage of the IGH and TP53 genes. “Evaluation of these genes has been standard of care for patients with CLL for many years and the recognition of the IGH and TP53 genes is medically necessary for providers to choose the correct therapy for CLL patients needing treatment.”

NGS sincerely appreciates CAP’s supportive comments.

7

The New Hampshire Society of Pathologists requests “additional clarification of verbiage regarding laboratory analysis of the IGH gene specifically. There are two general laboratory evaluations of the IGH gene, which are separate and distinct from each other. These studies are both used in standard practice, have different utility in CLL patients, and we hope that NGS will amend the wording of the LCD to recognize the medical necessity of both of these evaluations: 1. IGH Somatic Hypermutation analysis (also known as IGHV) and 2. IGH clonalitv studies by sequencing, baseline and minimal residual disease.”

Given that the comment addresses billing and coding issues, the associated Billing and Coding Article will be clarified to include the proper use of Modifier 91. 

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
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Updated On Effective Dates Status View the document version
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