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Local Coverage Determinations Roundup: Veracyte, Sonic Healthcare USA, Tempus

NEW YORK – Medicare administrative contractors released proposed local coverage determinations (LCDs) for a number of molecular diagnostics this week.

Below is a list and brief description for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.

Proposed LCDs: 

Although the below tests were mentioned in each of the proposed LCDs, the MAC noted that those tests are not automatically covered under the final LCD. 

CGS Administrators: Veracyte's Decipher Prostate, PAM50

CGS Administrators released a draft LCD aligning its coverage with Palmetto's previous decision that would cover gene expression profile tests that predict therapeutic response or assess risk in patients with castration-resistant or metastatic prostate cancer, such as Veracyte's Decipher Prostate and the Prediction Analysis of Microarray 50 (PAM50), or Prosigna, gene expression profile, in certain circumstances. 

The testing is considered reasonable and necessary to help guide treatment decisions in prostate cancer patients with a life expectancy that makes them candidates for prostate cancer treatment based on the most recent nationally recognized guidelines or based on US Food and Drug Administration labeling of drugs or biologics available as possible treatment options. 

Gene expression profile tests to guide treatment decisions for men with castration-resistant or metastatic prostate cancer are covered for patients that are being actively managed for that cancer and are within the population and indication for which the test was developed and validated.

For the test to be covered, a patient must also be a candidate for more than one management option with varied levels of intensity based on a nationally recognized consensus guideline that the provider and patient are deciding among, or be a candidate for, more than one management option with a test that has been shown to predict response to a specific therapy among accepted therapy options. 

A patient cannot have been tested with the same or similar test for prostate cancer, and a patient is not eligible for coverage if they have received pelvic radiation or androgen deprivation therapy before the collection of the tested biopsy or prostate resection specimen. There is an exception for men who have not received secondary systemic therapies and who either do not have other standard-of-care drug-targetable gene alterations to guide systemic therapy, or who have those gene alterations but aren't eligible for those therapies.

CGS Administrators: Veracyte's Afirma, Sonic Healthcare USA's ThyroSeq

CGS also released a draft LCD aligned with Palmetto covering molecular tests used for patients with an indeterminate or suspicious thyroid nodule under certain conditions, referencing Veracyte's Afirma Genomic Sequencing Classifier and Sonic Healthcare USA's ThyroSeq test in its decision. To be covered for these kinds of tests, the patient must not have been tested with the same or similar assay for the same indication and must have either an indeterminate thyroid nodule as defined by Bethesda categories III or IV or a Bethesda category V nodule for which molecular testing can help further stratify the type of malignancy. 

The test results must be used to help in surgical decision-making after consideration of clinical, radiographic, and cytologic features. The patient must also be within the population and indication for which the test was developed. CGS noted that next-generation sequencing tests used to identify genetic variants in malignant samples aren't within the scope of the draft LCD but may be covered under other existing policies. 

Coverage Under Existing LCD:

Palmetto: Tempus xT

Tempus this week also announced its Tempus xT DNA sequencing panel was covered under two existing Palmetto LCDs, one for next-generation sequencing for solid tumors and one for NGS tests for myeloid malignancies and suspected myeloid malignancies. The 648-gene panel identifies clinically relevant alterations, immunotherapy biomarkers such as microsatellite instability and tumor mutational burden, and incidental germline findings, the company noted in a statement. The test is covered for tumor-only and normal match sequencing in all solid tumors, as well as for tumor sequencing for patients with myeloid and suspected myeloid malignancies.

Under the solid tumor LCD, a patient must have recurrent, relapsed, refractory, metastatic, or advanced cancer and must be seeking further treatment. The patient cannot have previously received the same test for the same genetic content. 

Under the myeloid malignancy LCD, a patient must have a diagnosis of acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms. If a patient doesn't have a diagnosed myeloid malignancy, where one is suspected a patient must have an undefined cytopenia for more than four months, and other possible causes must have been reasonably excluded. 

**Palmetto administers the MolDx program, in which three other Medicare administrative contractors (MACs) participate, including Noridian, CGS, and Wisconsin Physicians Service Insurance Corporation. Each MAC issues its own draft and final policy to align with Palmetto’s coverage terms for a specific test.