Medicare Reimbursement: 4 Molecular Assays Score Big Coverage Wins

Molecular labs continue to gain ground with Medicare securing four key approvals via finalization of Local Coverage Determinations (LCDs) issued by principal contractor Palmetto GBA this spring. All of the determinations take effect Oct. 9.

1. Oncotype DX for Intermediate-Risk Prostate Cancer

Test: Genomic Health's Oncotype DX Genomic Prostate Score (GPS) for prostate cancer risk assessment.

Coverage: GPS, which is currently covered for clinically-low risk men, will also be covered for favorable intermediate-risk prostate cancer under National Comprehensive Cancer Network (NCCN) guidelines. Conditions:

• Testing must be by physicians enrolled in a Palmetto MolDX-approved Certification and Training Registry program; and

• Physicians must monitor for disease progression and report cases of metastasis or prostate cancer deaths in patients that the assay deemed low risk.

Context: The positive coverage decision expands the number of Medicare beneficiaries eligible for the test from 50,000 to 80,000. (See, LIR Jan. 6, 2017).

2. AlloSure for Kidney Transplant Rejection Risks

Test: CareDx's AlloSure targeted next-generation sequencing (NGS) test for quantifying donor-derived cell-free DNA in kidney transplant recipients.

Coverage: AlloSure covered for measuring probability of allograft rejection in kidney transplant recipients for whom there's a clinical suspicion of rejection at least two weeks post-transplant. Conditions:

• Patients must be over 18; and

• Physicians must assess active renal allograft rejection probability before ordering.

Context: Medicare contractor Noridian has also issued but not yet finalized a positive LCD for AlloSure.

3. DecisionDx-UM for Uveal Melanoma Prognosis

Test: DecisionDx-UM, Castle Biosciences' test for assessing metastatic risk of uveal melanoma.

Coverage: Test covered for newly diagnosed uveal melanoma patients and to guide oncology surveillance and referral.

Context: Castle announced that Aetna has also decided to cover the test which is also covered by 14 Blue Cross Blue Shield plans (in CA, FL, NJ, NC, MI, MA, WA, OR, AL, AZ, LA, UT, ID and AK)—58 million total recipients.

4. EndoPredict Test to Help Breast Cancer Patients Avoid Chemotherapy

Test: Myriad Genetics's EndoPredict, 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.

Coverage: EndoPredict 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 3 positive nodes and are being considered for adjuvant endocrine therapy.

Context: Other breast cancer prediction molecular assays on the market that have received favorable Medicare coverage determinations from Noridian include:

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

• Prosigna from Nanostring Technologies.

Takeaway: While positive, Medicare coverage for newfangled molecular assays remains piecemeal and frustratingly slow to attain.