Update on Palmetto’s Molecular Dx Testing LCDs

Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally the most cautious of payors, Medicare has demonstrated an increasing willingness to cover newfangled tests—at least in certain circumstances—with the expectation that they do work and that the studies will eventually catch up. The recent local coverage determinations (LCDs) issued by Palmetto, GBA, one of Medicare’s most important contractors, is an excellent illustration of where things seem to be evolving with regard to Medicare coverage of new molecular diagnostic tests.

What’s At Stake

First, a quick refresher on LCDs. Medicare covers only services that are “reasonable and necessary.” Each Medicare contractor has discretion to decide which services meet those criteria. LCDs set out the particular contractor’s coverage rules. So-called draft LCDs typically contain proposed revisions and updates to coverage rules and are open to comment for at least 45 days. Once the comment period ends, the contractor issues a final LCD.

The following lab test LCDs are draft LCDs that Palmetto issued on Dec. 23. The comment period runs between Feb. 6 and March 23.

1. Eliminate Coverage of Vectra DA for Rheumatoid Arthritis (DL37024)

Test: Vectra DA generates a test score based on 12 biomarkers associated with rheumatoid arthritis inflammation that is used to track disease activity and a patient’s response to treatment.

Proposed Change: The draft LCD proposes to end Medicare coverage of Vectra DA.

2. Coverage of Prolaris for Intermediate-Risk Prostate Cancer Patients (DL37043)

Test: Prolaris measures the aggressiveness of prostate cancer by analyzing 31 cell cycle progression genes.

Proposed Change: The LCD proposes to cover the test for men who have favorable intermediate risk of prostate cancer under National Comprehensive Cancer Network (NCCN) guidelines.

3. Limited Coverage of Xpresys for Lung Cancer Screening (DL37031)

Test: Xpresys is a molecular blood test in which expression levels of two proteins are assessed against five clinical risk factors to identify which lung nodules are likely benign and which patients are eligible for surveillance via noninvasive CT scans rather than invasive surgical procedures.

Proposed Change: Palmetto would cover Xpresys Lung version 2 (XL2) but only in limited circumstances. Under the LCD, XL2 would be covered only:

• To assess lung nodules of between 8 and 30 mm in diameter;
• For patients over age 40 who have a pre-test cancer risk of 50 percent or less.

4. Limited Coverage of DecisionDx-UM for Metastatic Cancer Risk (DL37033)

Test: DecisionDx-UM is a gene expression profile test assessing the expression levels of 15 messenger RNA transcripts to evaluate whether patients newly diagnosed with uveal melanoma (UM) are at risk for metastatic disease.

Proposed Change: Palmetto proposes limited coverage of DecisionDx-UM for patients diagnosed with UM when there is no evidence of distant metastatic disease at the time of diagnosis for purposes of determining whether the patient should be referred to a specialist for further surveillance. Physicians should not order the test unless they intend to act upon the results.

5. Coverage of Comprehensive Genomic Profiling (CGP) for Specific Cancers

Test: CGP cancer analysis is a single test that uses tissue from a tumor to detect genomic alterations and information that can guide diagnosis and individualized treatment.

Proposed Change: Palmetto issued LCDs covering CGP for patients with three different types of cancers: i. metastatic melanoma (DL37041); ii. metastatic colorectal cancer (DL37039); and iii. advanced primary peritoneal, fallopian tube and ovarian cancer (DL37045). All three of the LCDs include the same basic coverage conditions, including the requirement that:

• The patient be newly diagnosed with the cancer involved;
• The patient has not received CGP (or, in the case of metastatic melanoma, CGP or polymerase chain reaction (PCR)) testing for genomic alterations;
• The test is capable of detecting all four types of DNA alterations associated with cancer; and
• The test meets Palmetto’s Analytical Performance Specifications for CGP (APS).

For further explanation of these LCDs and their potential impact, see the December 2016 issue of Laboratory Industry Report.