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 A59472 (Billing and Coding: MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers) 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.
A59472: Billing and Coding: MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers (Billing and Coding)
- Covered ICD-10-CM codes
- 2
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 2
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C61 | Malignant neoplasm of prostate |
| C79.82 | — |
Procedure codes: 81479, 81542.
Coverage indications, limitations and medical necessity
This is a coverage policy for gene expression profile tests that assess risk or predict therapeutic response in men who have an established diagnosis of castration resistant or metastatic prostate cancer.
Such testing is considered reasonable and necessary to help guide treatment decisions in men with prostate cancer and a life expectancy such that they are candidates for prostate cancer treatment according to the most recent nationally recognized guidelines at the time of testing or based on FDA labelling of drugs and biologics available as potential treatment options.
The scope of this policy includes gene expression profile tests regardless of methodology. It is exclusive of targeted and comprehensive genomic profiles (CGP) by next generation sequencing (NGS) and single biomarker expression analyses.
Coverage criteria:
1. BOTH of the following criteria must be met:
• The beneficiary is being actively managed for castration resistant or metastatic (hormone sensitive or castration resistant) prostate cancer.
• The beneficiary is within the population and has the indication for which the test was developed and validated.
2. At least 1 of the following criteria are met:
• The patient is a candidate for more than one management option, which could be considered to have varied, or increasing/decreasing levels of intensity based on a nationally recognized consensus guideline, and the physician and patient must decide among these treatments OR
• The patient is a candidate for more than one management option, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized consensus guidelines and/or FDA labelling.
3. The patient has not been tested with the same or similar test for the same intended use.
4. The patient has not received pelvic radiation or androgen deprivation therapy (ADT) prior to the biopsy or prostate resection specimen on which the test will be performed.
• The only exception to this is for men who are naïve to secondary systemic therapies (that could be given after ADT monotherapy) AND at least 1 of the following is true:
a. They do not have other standard-of-care drug-targetable gene alterations to guide systemic therapy, as defined in nationally recognized guidelines OR
b. They have other standard-of-care drug-targetable gene alterations to guide systemic therapy, as defined in nationally recognized guidelines but they are not eligible for those therapies for another reason.
• The test demonstrates analytical validity (AV), clinical validity (CV) and clinical utility (CU), establishing a clear and significant biological/ molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management in a clearly defined population.
• Clinical validity of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.
• If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.
• Testing must be performed according to Clinical Laboratory Improvement Amendments (CLIA) and/or Food and Drug Administration (FDA) regulations in an accredited laboratory.
• The lab providing the test is responsible for clearly indicating to treating physicians the population and indication(s) for test use.
• The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) Technical Assessment that ensures that AV, CV, and CU criteria set in this policy are met to establish the test as Reasonable and Necessary.
Genomic expression profile tests that demonstrate equivalent or superior analytical and clinical validity to those covered by this contractor will be considered reasonable and necessary for the same indications.
Summary of evidence (opening)
In the United States, prostate cancer (PC) is the most common cancer in men, with an estimated 288,300 new cases projected in 2023 representing roughly 29% of all new cancer cases in men. 1 Men have a 12.6% chance of developing prostate cancer during their lifetime. 1 Prostate cancer is also the second most common cause of cancer death in men with an estimated 34,700 deaths due to prostate cancer in 2023, representing 11% of cancer-related deaths in men. 1 Prostate cancer incidence and deaths have increased since 2014 after two decades of decline; now, more than 30% of new cases are advanced cancers at diagnosis. 1 Reports of a shift toward higher grade and stage at initial diagnosis have been attributed in large part to changes in prostate-specific antigen (PSA) screening practices. 1 Prostate cancer incidence in African American men is 70% higher than in White men and prostate cancer mortality rates in African American men are approximately two to four times higher than those in every other racial and ethnic group. 1 African American men may benefit more from screening and from testing for genomic biomarkers because they are more likely to harbor genomically aggressive cancer, even in categorically lower risk tumors. 2,3 Most cases of prostate cancer are localized with excellent survival (>99%); however, the 5- year survival rate is substantially lower (~30%) for patients with distant metastasis. 1,4
A mainstay of therapy in prostate cancer is androgen deprivation therapy (ADT). However, most castration sensitive prostate cancer (CSPC), also known as hormone sensitive prostate cancer (HSPC) eventually becomes resistant to ADT, a condition known as castration-resistant prostate cancer (CRPC). 5 In recent years, the evidence has shown that combining additional therapies with ADT early during treatment for advanced and metastatic HSPC (mHSPC) prolongs time to CRPC and improves overall survival (OS). 6-10 For this reason, combination therapy has become the standard of care in treating mHSPC. 11-13 However, there are a number of options to use for combined therapy with ADT, including androgen receptor signaling inhibitors (ARSIs), chemotherapy, targeted therapy, immunotherapy, and combinations of these. Disease burden (i.e. volume of disease) plays an important differential role in response to therapy and is included in treatment guidelines. 11,12 However, with the exception of specific recommended triplet therapies currently recommended for high volume mHSPC, the nationally recognized guidelines do not provide a preferred approach for choosing among the various options when dual combination therapy is appropriate. 11-13 Further, some of the therapeutic options include agents with significant toxicities and side effects. In addition, prostate cancer is a heterogeneous disease with different underlying genomic signatures and phenotypes that respond differentially to available treatment options. As such, the use of molecular biomarkers to help guide the choice of therapy is a welcome addition to the treatment arsenal for advanced and metastatic prostate cancer.
Somatic and germline mutations in deoxyribonucleic acid (DNA) repair pathway genes occur in approximately 20% of prostate tumors. 14,15 Hereditary prostate cancers are associated with hereditary breast and ovarian cancer (HBOC) and Lynch syndromes, resulting from germline mutations in homologous recombination repair (HRR) genes and DNA mismatch repair (MMR) genes, respectively. 16,17 Patients with prostate cancer who have BRCA1/2 germline mutations in particular have increased risk of progression and decreased overall survival (OS). 17,18 Patients with such HRR gene mutations respond to poly(adenosine diphosphate–ribose) polymerase (PARP) inhibition. 19 Similarly, patients with MMR gene mutations, microsatellite instability and high tumor mutational burden may respond to pembrolizumab. 20 An estimated 89% of mCRPC tumors contain a potentially actionable mutation; many of these are in the androgen receptor (AR) gene and AR-signaling pathways with germline mutations reported in approximately 12% of patients. 15,21 For this reason, multigene tumor testing for somatic and/or germline mutations is recommended for patients with prostate cancer and is a covered service. Additionally, gene expression profile tests (GEPs) also take advantage of prostate cancer heterogeneity to further refine the risk for recurrence and metastasis and guide therapy selection for patients with prostate cancer.
Gene Expression Profile Tests
The contractor cites 53 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2024-09-22
- Current revision effective
- 2024-09-22
- Last reviewed by the contractor
- 2024-06-19
- MCD version
- 4
Other related documents: A59850 (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 L39648 cover?
This is a coverage policy for gene expression profile tests that assess risk or predict therapeutic response in men who have an established diagnosis of castration resistant or metastatic prostate cancer. 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 L39648 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 L39648?
The companion billing and coding article A59472 lists 2 ICD-10-CM codes in 1 group that support medical necessity; the first 2 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L39648?
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.