Palmetto Gives Okay to Medicare Coverage of 5 New Molecular Tests

Medicare contractors are slowly coming around on covering unproven molecular assays. The most notable new baby steps come from, Palmetto GBA (Columbia, SC), one of Medicare’s most important contractors in the form of draft local coverage determinations (LCDs) providing limited coverage for five new tests.

1. Guardant360 for Advanced Lung Cancer

Test: Guardant360, Guardant Health’s liquid biopsy assay for lung cancer.

Proposed Coverage: Guardant360, which came onto the market in 2014 and is now widely ordered, would be covered only for patients with advanced nonsmall cell lung cancer, i.e., stage IIIB or higher. Conditions vary depending on treatment stage:

Offenses Justifying Imposition of CMPS—Before & After

The LCD would not cover Guardant360 for:

• Repeat testing for therapeutic monitoring; or
• Assessing germline variants.

Context: The new Guardant360 LCD comes less than three months after Palmetto’s approval of molecular blood test Xpresys XL2 for limited lung cancer screening:

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

2. Oncotype DX Genomic Prostate Score for Prostate Cancer Risk

Test: Genomic Health, Inc.’s Oncotype DX Genomic Prostate Score (GPS) for assessing the current state and future risk of prostate cancer.

Proposed Coverage: GPS, which is currently covered for clinicallylow risk men, would also be covered for patients with favorable intermediate-risk prostate cancer under National Comprehensive Cancer Network (NCCN) guidelines. This would expand the number of Medicare beneficiaries from 50,000 to 80,000.

Context: In January 2017, Palmetto approved the competing drug, Myriad’s Prolaris, which measures the aggressiveness of prostate cancer by analyzing 31 cell cycle progression genes, for men with favorable intermediate risk of prostate cancer under NCCN criteria.

3. EndoPredict Test to Help Breast Cancer Patients Avoid Chemotherapy

Test: Myriad Genetics’s EndoPredict test, which uses a 12-gene molecular assessment score combined with tumor size, nodal status and other features to determine if it’s medically safe for clinically low-risk breast cancer patients to skip chemo.

Proposed Coverage: EndoPredict would be covered only for postmenopausal women diagnosed with early-stage estrogen-receptor (ER) positive, HER2-negative breast cancer who either:

• Are lymph node-negative; or
• Have up to three positive nodes and are being considered for adjuvant endocrine therapy.

Context: Two other breast cancer prediction molecular assays on the market have received favorable Medicare coverage determinations from contractor Noridian:

• Oncotype DX Breast from Genomic Health, Inc;. and
• Prosigna from Nanostring Technologies.

4. AlloSure for Kidney Transplant Rejection Risks

Test: CareDx’s AlloSure targeted NGS test for quantifying donor-derived cell-free DNA in kidney transplant recipients.

Proposed Coverage: LCD would cover use of AlloSure only for measuring the probability of allograft rejection in kidney transplant recipients for whom there is a clinical suspicion of rejection at least two weeks post-transplant. Other limitations:

• Patients must be over 18; and
• Before ordering, physicians must assess patients for probability of active renal allograft rejection.

Context: CareDx claims that AlloSure is the only non-invasive test that uses donor derived cell-free DNA as a biomarker to identify probability of active rejection and directly measure allograft injury.

5. Nucleic Acid GI Pathogen Tests

Test: Another draft LCD proposes coverage of molecular tests that use nucleic acid amplification to detect gastrointestinal pathogens.

Proposed Coverage: Coverage is limited to tests identifying up to five bacterial targets that Palmetto claims account for 90-95 percent of all foodborne infections: i. Salmonella; ii. Shiga toxin-producing E. coli; iii. Shigella; iv. Cryptosporidium; and v. Campylobacter. Coverage would not include:

• Testing for viruses due to the lack of virus-specific therapies that viral test results would inform;
• Epidemiologic testing by national, state or local agencies; or
• Testing to confirm another test result.

In addition, GIP test panels cannot be unbundled and billed as individual components. Exception: Where c difficile is not included in a panel, testing for it “may be reasonable and necessary when ordered additionally,” as long as documentation in the medical record supports reasonableness and necessary.

Context: As Palmetto notes, at least five different companies produce FDAapproved GI pathogen assays that meet or exceed the LCD’s five-target limit:

GI Pathogen Assays Covered by New Palmetto LCD

Takeaway: Although these are positive developments for the molecular diagnostics community, the pace of Medicare coverage remains piecemeal and frustratingly slow. Although influential, Palmetto is only one of several key Medicare contractors. Moreover, the spate of favorable LCDs belies the fact that a number of other commercially popular molecular tests failed to make the cut.