ASCO Working with CMS on Medicare Contractor Limitation for Off-Label Use of Cancer Drugs

June 26, 2018

The Centers for Medicare & Medicaid Services (CMS) has provided an update on their review of a 2017 Wisconsin Physician Service Insurance Corporation (WPS)—a Medicare Administrative Contractor (MAC)—local coverage decision limiting off-label prescribing.

The WPS policy limits off-label prescribing to what is listed in the National Comprehensive Cancer Network (NCCN) compendium, creating a de facto standard for the use of one compendium to support off-label use of anticancer chemotherapy drugs. While NCCN’s compendium is comprehensive and offers substantial evidence to support off-label prescribing, federal statute does not disqualify use of other compendia.

If off-label use of a chemotherapeutic agent is initially rejected, providing proof of listing in an approved compendium and documentation to support reasonable and necessary treatment should result in coverage upon appeal. Medicare-approved compendia include: Elsevier/Gold Standard Clinical Pharmacology, Lexi-Drugs/American Hospital Formulary Service-Drug Information, National Comprehensive Cancer Network Drugs and Biologics Compendium, and Truven Health Analytics Micromedex DrugDEX.

CMS advises providers to submit claims for off-label prescribing as usual, then resubmit rejected claims with supporting evidence. CMS reviewed the WPS policy and found that while some claims for off-label prescribing have been denied initially because of this policy, all claims have been paid on appeal.

An appeals process is no substitute for a clear and appropriate coverage policy that is consistent with the federal requirements. Timely access to the right drug for the appropriate patient is critical in cancer care, and treatment delays can have significant adverse effects on patient outcomes. ASCO opposes the WPS policy and is working with CMS toward a less-burdensome solution.

Updates on this and other cancer policy priorities are available at ASCO in Action.