Medicare Coverage of Drugs
Medicare generally limits coverage and payment to those drugs and biologicals that are approved by the FDA, injected on or after the date of FDA approval and that meet all other coverage criteria. The local Medicare contractor monitors various aspects of Medicare payment policy and has recently completed an audit of the use of zoledronic acid by physicians at several area hospitals. Zoledronic acid is a FDA-approved intravenous biphosphonate for the treatment of hypercalcemia of malignancy (HCM). Medicare has recently expanded coverage of zoledronic acid to include the off-label use for the treatment of osteoporosis but only if oral biphosphonates are contraindicated or not tolerated by the patient. Medical record documentation must clearly indicate the need for intravenous zoledronic acid over the oral formulation.
Since FDA regulations permit physicians to prescribe approved medications for other than their intended indications, they are free to prescribe it for any other purpose that in their professional judgment is both safe and effective. However, physicians prescribing medications for off-label use must be aware that, with some exceptions, their Medicare patients will not have coverage. In those cases, physicians should discuss this coverage issue with their patient during the encounter and obtain a signed Advanced Beneficiary Notice (ABN) from the patient acknowledging their obligation to pay for the drug and the related injection. Prescribing physicians should work with their practice management to obtain the ABN and ensure that required processes are followed to ensure hospital payment.
Questions? Contact Neil Walsh at ext. 2-9377 or cwalsh6@partners.org