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Local Coverage Determinations Roundup: Scipher Medicine, Veracyte, Sonic Healthcare USA

NEW YORK – Medicare administrative contractors released final and 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.

Final LCDs: 

Palmetto GBA: Scipher Medicine's PrismRA**

Palmetto GBA issued a final LCD covering molecular biomarker tests to guide targeted therapy selection in rheumatoid arthritis, including Scipher Medicine's PrismRA assay, under certain conditions. A patient must have a confirmed diagnosis of moderately to severely active rheumatoid arthritis with a history of failure, contraindication, or intolerance to at least one first-line therapy for treatment of the disease to receive the test. For a patient who has initiated a biologic or targeted synthetic therapy to be covered, a provider must be considering an alternate class of targeted therapies as a result of failure, contraindication, or intolerance. Patients must also not have previously received molecular biomarker testing for predictive therapy selection in rheumatoid arthritis. 

For a test to be covered under the LCD, it must predict response or non-response to at least one class of targeted or biologic therapies for rheumatoid arthritis according to multiple validated response and remission criteria with a higher accuracy than a combination of existing clinical and other data. The test must also demonstrate reproducibility across clinical study cohorts. 

The LCD goes into effect on Oct. 15, 2023.

CGS Administrators, Noridian Healthcare Solutions, and Wisconsin Physicians Service Insurance Corporation released final LCDs aligned with Palmetto's coverage decision. 

Proposed LCDs: 

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

Palmetto: Veracyte's Decipher Prostate, PAM50

Palmetto released a draft LCD that would cover gene expression profile tests for patients with castration-resistant and metastatic prostate cancer, such as Veracyte's Decipher Prostate and 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 as long as they are being actively managed for that cancer and are within the population and indication for which the test was 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 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.

Noridian Healthcare Solutions also released a draft LCD aligned with Palmetto's coverage. 

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

Palmetto released a draft LCD 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. The patient must not have been tested with the same 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. Palmetto noted that next-generation sequencing tests used to identify genetic variants in malignant samples isn't within the scope of the draft LCD but may be covered under other existing policies. 

Noridian Healthcare Solutions also released a draft LCD aligning with Palmetto's coverage decision.

Palmetto: Veracyte's Percepta Genomic Sequencing Classifier

Palmetto issued a draft LCD 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 potential example. 

To be covered, a patient must have undergone a non-diagnostic bronchoscopy for an IPN, 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 patient outcomes. 

Noridian Healthcare Solutions also released a draft LCD aligning with Palmetto's decision.

**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.