Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
| Contract | Contractor | Type | States |
|---|---|---|---|
| 15102 | CGS Administrators, LLC | MAC - Part B | KY |
| 15202 | CGS Administrators, LLC | MAC - Part B | OH |
| 15101 | CGS Administrators, LLC | MAC - Part A | KY |
| 15201 | CGS Administrators, LLC | MAC - Part A | OH |
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57141 (Billing and Coding: MolDX: Repeat Germline Testing) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A57141: Billing and Coding: MolDX: Repeat Germline Testing (Billing and Coding, effective 2026-07-01)
- Covered ICD-10-CM codes
- 0
- 0 groups
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 317
- Full article
- cms.gov record
Procedure codes: 0001U, 0004M, 0030U, 0032U, 0034U, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0079U, 0084U, 0094U, 0101U, 0102U, 0103U, 0129U, 0130U, 0133U, 0134U, 0136U, 0137U, 0138U, 0156U, 0157U, 0158U, 0159U, 0160U, 0161U, 0162U, 0169U, 0170U, 0173U, 0175U, 0180U, 0181U, 0182U, 0183U and 277 more in the article.
Coverage indications, limitations and 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 (opening)
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.
The contractor cites 7 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2020-06-07
- Current revision effective
- 2026-01-22
- Last reviewed by the contractor
- 2026-01-16
- MCD version
- 11
Other related documents: A58040 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the CGS Administrators, LLC hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L38288 cover?
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. The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L38288 apply to?
CGS Administrators, LLC applies it to Medicare claims in KY, OH. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L38288?
The current export links no billing and coding article with a diagnosis list to this LCD, so coverage is decided on the indications in the policy text and the documentation in the record rather than by an automated diagnosis edit.
How do I appeal a denial under LCD L38288?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.