Coverage Intelligence
Medicare NCD and LCD coverage status for oncology therapies administered at Mays Cancer Center, with focus on Pluvicto radioligand therapy.
7
Coverage Policies
6
Covered
1
Conditional
Novitas JL
Regional MAC
Medicare Coverage Policies
National and local coverage determinations relevant to Mays oncology therapies
Contractor: CMS National
J-Code: A9607
Effective: 2022-03-23
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is covered for PSMA-positive metastatic castration-resistant prostate cancer in patients who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
Contractor: Novitas Solutions (MAC JL)
J-Code: A9593
Effective: 2022-06-01
Ga-68 PSMA-11 PET/CT or F-18 DCFPyL (Pylarify) PET/CT covered for selection of patients with PSMA-positive mCRPC for Lu-177 PSMA therapy.
Contractor: Novitas Solutions (MAC JL)
Effective: 2023-01-15
Coverage for outpatient administration of radiopharmaceutical therapies including facility fees, radiation safety monitoring, and required post-treatment observation.
Contractor: Novitas Solutions (MAC JL)
Effective: 2023-03-01
Personalized dosimetry for Lu-177 PSMA therapy is covered when performed by qualified nuclear medicine physician. Coverage requires documentation of kidney function monitoring.
J-Code: J9399 (unclassified antineoplastic) transitioning to J9055
Effective: 2022-04-01
Medicare covers Pluvicto for FDA-approved indications under Part B as a physician-administered drug. Reimbursement via hospital outpatient or freestanding nuclear medicine facility. ASP-based reimbursement with buy-and-bill model.
Contractor: Palmetto GBA (MAC JM)
J-Code: J9055
Effective: 2023-01-01
Covers Pluvicto for PSMA-positive mCRPC per FDA labeling. Requires prior PSMA PET/CT demonstrating PSMA-positive disease. Documentation of prior ARPI therapy (and prior taxane for VISION indication) required.
Contractor: Novitas Solutions (MAC JL/JH)
J-Code: J9055
Effective: 2023-03-01
Covers Pluvicto for FDA-approved indications. Requires PSMA PET/CT within 90 days of treatment initiation. Site must be Pluvicto REMS-certified. Up to 6 cycles covered.
Coverage Summary
Quick-reference table of all coverage policies
| Policy | Type | Status | J-Code | Contractor |
|---|---|---|---|---|
| Radiopharmaceutical Therapy — Lu-177 PSMA | NCD | covered | A9607 | CMS National |
| PSMA PET Imaging for Patient Selection | LCD | covered | A9593 | Novitas Solutions (MAC JL) |
| Nuclear Medicine Therapy Administration | LCD | covered | — | Novitas Solutions (MAC JL) |
| Dosimetry for Radiopharmaceutical Therapy | LCD | conditional | — | Novitas Solutions (MAC JL) |
| Medicare National Coverage — Pluvicto for mCRPC | NCD | covered | J9399 (unclassified antineoplastic) transitioning to J9055 | — |
| Palmetto GBA LCD — Radioligand Therapy for Prostate Cancer | LCD | covered | J9055 | Palmetto GBA (MAC JM) |
| Novitas Solutions LCD — Radioligand Therapy Coverage | LCD | covered | J9055 | Novitas Solutions (MAC JL/JH) |