NEW YORK – Medicare administrative contractors released final 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.
Although the below tests were mentioned in each of the LCDs, the MAC noted that those tests are not automatically covered under the final LCD.
Palmetto: Veracyte's Decipher Prostate, PAM50
Palmetto released a final LCD covering 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. The MAC previously released a proposed LCD covering these types of tests in August 2023.
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 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 based on consensus guidelines or labeling from the US Food and Drug Administration.
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 for a different reason.
Wisconsin Physicians Service Insurance Corporation, CGS Administrators, and Noridian Healthcare Solutions also released final LCDs aligned with Palmetto's coverage.
Coverage for these services goes into effect on Sept. 22, 2024.
Palmetto: Veracyte's Percepta Genomic Sequencing Classifier
Palmetto also issued a final LCD covering molecular assays to help diagnose or rule out lung cancer in patients with an indeterminate pulmonary nodule (IPN) after a non-diagnostic bronchoscopy in some circumstances. The MAC mentioned Veracyte's Percepta Genomic Sequencing Classifier as an example. The draft LCD was originally posted in August 2023.
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 nationally recognized consensus guidelines. The nodule can't be evaluated by an alternate methodology for a specific diagnosis before the receipt of molecular test results.
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.
The patient also cannot have been tested with the same or a similar assay for the same clinical indication and must be within the population and indication for which the test was developed and is covered.
Wisconsin Physicians Service Insurance Corporation and Noridian Healthcare Solutions also released final LCDs aligning with Palmetto's decision. The services will be covered starting Sept. 22, 2024.
**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.