LCD Reference Article Response To Comments Article

Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms- Related to Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (L37810)

A56216

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A56216

Article Title
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms- Related to Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (L37810)

Article Type
Response to Comments

Original Effective Date
04/01/2019

Retirement Date
N/A

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Article Guidance

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 Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms LCD. The official notice period for the final LCD begins on February 14, 2019 and the final determination will become effective on April 1, 2019.

Response To Comments

Number	Comment	Response
1	A joint comment from the Association for Molecular Pathology (AMP) and the College of American Pathologists (CAP) noted: “We agree with the summary of evidence as articulated, but would request National Government Services (NGS) consider making the following changes to reflect recently published evidence.” “We suggest modifying the final sentence in paragraph two of Mismatch Repair Deficiency (dMMR) to read: “In sporadic tumors, epigenetic changes (e.g. acquired hypermethylation of the promoters of both alleles of MLH1 gene), rather than gene mutations, usually account for defective MMR gene expression”. A fraction of MSI-positive tumors which lack promoter methylation or germline mutations carry somatic mutations in MLH1 and MLH2 (Herfarth KK et al. 1997, Mensenkamp AR et al. 2014).”	NGS Agrees.
2	“Several additional studies have been published showing mismatch repair-deficient colorectal cancers respond to PD-1 therapy and provide further evidence for a relationship between MSI status and therapeutic response. We recommend adding the references from Overman M et al, 2017 and Le DT et al, 2017 to the final sentence in paragraph two of Mismatch Repair Deficiency (dMMR) subsection.”	NGS agrees but believes paragraph three (rather than two) was meant.
3	“AMP and CAP applaud NGS for proposing coverage for genomic sequential analysis panels for mCRC. We respectfully request that NGS consider removing clause 3 under the Indications and Limitations of Coverage Section of the dLCD, which requires that the patient “has not had prior RAS/BRAF testing.” Colon cancers evolve over time and a tumor that once tested to be RAS wild-type can develop RAS (or other) mutation as a mechanism of resistance over time. This mutation would make the patient resistant to epidural growth factor receptor (EGFR) targeted therapies (Misale et al, 2012). In one study, the KRAS mutations consistently occurred between 5 and 6 months post treatment (Diaz et al, 2012). Salient examples of acquired alterations associated with secondary resistance to EGFR targeted therapies include KRAS mutation, NRAS mutation, BRAF mutation, KRAS amplification, HER2 amplification and MET amplification (Leto, Trusolino, 2014). Therefore, re-testing in a patient that was previously tested and determined to be RAS wild-type will allow the ability to detect a resistance mutation and potentially discontinue the use of expensive EGFR targeted therapies in patients with advanced colorectal cancer.”	NGS agrees with the potential need for re-testing after initiation of anti-EGFR therapy if resistance develops. The exclusion of patients with prior RAS/BRAF testing targeted newly diagnosed mCRC, before initiation of anti-EGFR therapy, given the good concordance between the primary and synchronous metastasis. The draft clause will be qualified to allow for re-testing “after initiation of anti-EGFR therapy with evidence of acquired resistance.” Early and definitive identification of a resistance mutation will expedite discontinuation of EGFR targeted therapy.
4	The joint AMP/CAP comment also requested the addition of a number of malignancy related ICD-10 code additions (primary, secondary, and personal history of).	NGS agrees with the addition of malignant carcinoid tumor codes (C7A.02-C7A.026). The other primary tumor codes were either not colorectal specific or were too site nonspecific. NGS has opted not to include secondary malignancy diagnoses on the policy. Finally, since the “personal history of” Z codes “identifies a malignancy that has been previously treated or removed but for which there is no current treatment for the condition and no evidence of the disease,” those codes would not apply and will not be included.
5	AMP/CAP also requested a similar addition of codes to the NSCLC portion of the policy.	Only the mCRC section of the draft was open to comment but AMP/CAP is welcome to submit a reconsideration request after the draft becomes effective.
6	A comment from UMASS Memorial Health Care also requested the addition of secondary malignancy codes (C78.0 – C78.89, C79.0-C79.9).	NGS disagrees. See response 5.
7	An additional comment from UMASS Memorial Health Care requested the addition of “consideration of coverage of genomic sequence analysis panels in the treatment of ovarian cancer.”	Only the mCRC section of the draft was open to comment but UMASS is welcome to submit a reconsideration request after the draft becomes effective.

Coding Information

CPT/HCPCS Codes

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Group 1

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N/A

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N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

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N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

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Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

Bill Type Codes

Code	Description

Revenue Codes

Code	Description

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion
			N/A	N/A

Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

Revision History Information

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Associated Documents

Updated On	Effective Dates	Status
02/07/2019	04/01/2019 - N/A	Currently in Effect	You are here

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Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms- Related to Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (L37810)

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CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Revenue Codes

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Group 1

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