Local Coverage Determination (LCD)

MolDX: Repeat Germline Testing

L38353

Expand All | Collapse All
Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L38353
Original ICD-9 LCD ID
Not Applicable
LCD Title
MolDX: Repeat Germline Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL38353
Original Effective Date
For services performed on or after 08/03/2020
Revision Effective Date
For services performed on or after 04/25/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
06/18/2020
Notice Period End Date
08/02/2020

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This Medicare contractor herein identifies general limitations to coverage of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)-based testing of germline genetic material of the Medicare beneficiary.

This contractor does not consider any laboratory test that investigates the same germline genetic content, for the same genetic information, that has already been tested in the same Medicare beneficiary to be reasonable and necessary as it is duplicative.

Germline testing, including using gene panels that contain some genetic content that has already been tested in the same Medicare beneficiary may be considered reasonable and necessary provided that there is established clinical utility present in the remaining, non-duplicative genetic components of the test. Unit of Service (UOS) for any one specific germline DNA or RNA-based test is limited to one per lifetime. Examples of germline tests include (but are not limited to) single gene and gene panel tests for: hereditary cancer syndromes or cancer predisposition, inherited disorders, and pharmacogenomics/cytochrome P450 testing.

Providers should take reasonable measures to be aware of what if any germline testing a beneficiary has had prior to billing for germline testing so as to avoid billing Medicare for services that are not reasonable and necessary. Clinicians who order germline testing may wish to be aware of whether the test that they are ordering is covered under Medicare and may wish to verify that they are not ordering repeat germline testing.

Summary of Evidence

Background

Patient DNA and RNA testing typically identify alterations or variants of nucleotides in the genetic code, which can range from pathogenic mutations to benign polymorphisms. These alterations can take the form of single nucleotide variants, insertions and/or deletions, splice-site variants, copy number alterations of genes or chromosomes, and inversions or translocations, among others.1 They can be found in coding regions or non-coding regions. Germline testing is differentiated from somatic testing in that somatic testing identifies alterations specific to an individual cell or group of cells derived from that cell (such as a neoplasm or clonal hematopoietic cells) whereas germline testing seeks to identify inherited variants or alleles that are present in all the patient’s cells and make up a baseline genetic code of the individual.2 Although somatic alterations are constantly occurring during the life of an individual, the germline sequence of an individual does not change over time.

Clinical utility of germline testing in Medicare beneficiaries has previously been established for several conditions.3-7 However, as repeated testing of the same genetic information does not by its nature provide new clinical information, this contractor does not believe it is either reasonable or necessary to perform such services more than once.

Analysis of Evidence (Rationale for Determination)

Level of Evidence

Quality of evidence – Strong

Strength of evidence – Strong

Weight of evidence – Strong

By definition, germline alleles/variants do not change. Some allowance must be made for incidental repeat testing or for specific situations where technological changes require revisiting the same genomic regions with different approaches or targets. For more details, please review the associated Billing and Coding Article.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

N/A

Sources of Information
N/A
Bibliography
  1. Kassem HS, Girolami F, Sanoudou D. Molecular genetics made simple. Glob Cardiol Sci Pract. 2012;2012(1):6. doi:10.5339/gcsp.2012.6
  2. Griffiths AJF, Miller JH, Suzuki DT, et al. An Introduction to Genetic Analysis. 7th ed. W.H. Freeman; 2000.
  3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer. Version 3.2021. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed March 8, 2024.
  4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Ovarian Cancer. Version 3.2021. https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed March 8, 2024.
  5. Yadav S, Couch FJ. Germline genetic testing for breast cancer risk: the past, present, and future. Am Soc Clin Oncol Educ Book. 2019;39:61-74. doi:10.1200/EDBK_238987
  6. Cheng H, Powers J, Schaffer K, Sartor O. Practical methods for integrating genetic testing into clinical practice for advanced prostate cancer. Am Soc Clin Oncol Educ Book. 2018;38:372-381. doi:10.1200/EDBK_205441
  7. Ballester V, Cruz-Correa M. How and when to consider genetic testing for colon cancer? Gastroenterology. 2018;155(4):955-959. doi:10.1053/j.gastro.2018.08.031

 

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
04/25/2024 R2

Under CMS National Coverage Policy updated 3rd and 4th section headings. Under Bibliography changes were made to citations to reflect AMA citation guidelines.

  • Provider Education/Guidance
12/30/2021 R1

Under CMS National Coverage Policy removed regulation Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.2. Clinical Laboratory services. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD.

  • Provider Education/Guidance
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
04/18/2024 04/25/2024 - N/A Currently in Effect You are here
12/23/2021 12/30/2021 - 04/24/2024 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

Read the LCD Disclaimer