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Local Coverage Determinations Roundup: Veracyte, Sonic Healthcare USA

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. 

Wisconsin Physicians Service Insurance Corporation: Veracyte's Decipher Prostate, PAM50

Wisconsin Physicians Service Insurance Corporation released a draft LCD aligning its coverage with Palmetto's previous decision that would cover gene expression profile tests that assess risk or predict therapeutic response 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. 

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. To receive the test, 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 tested biopsy or prostate resection specimen was collected. 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.

WPS: Veracyte's Afirma, Sonic Healthcare USA's ThyroSeq

WPS also released a draft LCD aligned with Palmetto covering molecular tests used for patients with an indeterminate or suspicious thyroid nodule under certain conditions, and referenced Veracyte's Afirma Genomic Sequencing Classifier and Sonic Healthcare USA's ThyroSeq test in its decision. 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 stratify the type of malignancy. 

The test results must be used to aid 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. WPS 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. 

WPS: Veracyte's Percepta Genomic Sequencing Classifier

WPS issued a draft LCD aligned with Palmetto covering molecular assays to help diagnose or rule out lung cancer in patients with an indeterminate primary nodule (IPN) after a non-diagnostic bronchoscopy in some circumstances. The MAC mentioned Veracyte's Percepta Genomic Sequencing Classifier as a possible example. 

To be covered, a patient must have undergone a bronchoscopy for an IPN, the bronchoscopy must have failed to provide a specific histopathological diagnosis, and the test results must be used to meaningfully inform patient management within the framework of consensus guidelines. The test is not covered if a patient has a personal history of cancer or a current cancer diagnosis, or if the patient has an overall high enough or low enough risk for pulmonary malignancy that the test results wouldn't meaningfully affect patient management or significantly improve outcomes. 

The patient must not have been tested with the same or similar test for the same clinical indication and must be within the population and indication for which the test is covered.

CGS Administrators also released a draft LCD aligning with Palmetto's previous coverage determination.

**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.