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.
Final LCDs:
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.
CGS Administrators: Veracyte's Afirma, Sonic Healthcare USA's ThyroSeq
CGS Administrators released a final LCD aligning its coverage with Palmetto for molecular tests 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. For these kinds of tests to be covered, the patient must not have been tested with the same or a similar assay for the same clinical 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.
If a patient has multiple nodules, concurrent or reflex testing may be medically necessary as long as the criteria are met, CGS said.
The test results must be used to help with surgical decision-making after clinical, radiographic, and cytologic features are considered. The patient must also be within the population and indication for which the test was developed.
The MAC also noted that these tests may safely preclude unnecessary surgical procedures and better select patients who could benefit from surgery.
CGS added that next-generation sequencing tests used to identify genetic variants in malignant samples aren't within the scope of the LCD but may be covered under other existing policies.
The LCD will go into effect on Oct. 13, 2024.
CGS Administrators: Veracyte's Percepta Genomic Sequencing Classifier
CGS also released a final LCD aligning its coverage with Palmetto for 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 but noted that the policy includes all molecular analytes that are within the scope of the MolDx program and is not limited to a single analyte, such as RNA.
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 receiving the molecular test results.
The test is not covered if a patient has a personal history of lung 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 and 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.
CGS noted that next-generation sequencing-based tests to identify genetic variants in malignant samples are not covered in the scope of this policy.
The services will be covered starting Oct. 13, 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.