Medicare and healthcare professionals can determine coverage of oncology drugs based on medically-accepted off-label uses found in Lexi-Drugs
The Health division of Wolters Kluwer, a leading global provider of information and point of care solutions for the healthcare industry, announced that Lexi-Drugs®, the flagship drug reference database of its Clinical Drug Information unit, has been officially recognized by the Centers for Medicare & Medicaid Services (CMS) as an approved compendium for off-label oncology uses of drugs. Accessible through Lexicomp® Online and Lexicomp® Mobile App offerings, Lexi-Drugs will now be used by CMS and healthcare professionals as a trusted knowledge resource to help determine coverage of "medically-accepted indications" of drugs in chemotherapeutic regimens for the purposes of Medicare reimbursement.
For a drug to be covered by Medicare for an off-label, oncologic indication, it has to be validated at a certain level of evidence by an approved CMS compendium, and it cannot be deemed inappropriate by any of the approved compendia. According the official statement issued by CMS, Lexi-Drugs, the core drug information database at the heart of all Lexicomp drug reference solutions, met all of the "desirable criteria" for an "authoritative" drug resource and received positive public comments from healthcare professionals who use it regularly.
Wolters Kluwer and its Clinical Drug Information unit submitted Lexi-Drugs for inclusion in the CMS compendia list in February. It underwent rigorous review and a 30-day public forum for comments before receiving approval.
The Lexi-Drugs team of pharmacists and physicians, aided by a nationwide network of clinician contributors, determines which off-label uses to include based on a well-defined assessment process with a vigorous review of evidence-based information. In the interest of transparency, Wolters Kluwer Clinical Drug Information provides public access to its policies and recent decisions regarding off-label oncologic use of drugs, including:
- Policy for assessment of potential off-label uses
- Assessment of potential conflicts of interest of content developers and review panel members
- Transparency documents of off-label uses assessed and those that are determined to be unsupported
"Wolters Kluwer is proud that CMS recognizes the high quality and reliability of our Clinical Drug Information knowledge base, particularly for such an essential and complex area as off-label oncologic drug use," said Denise Basow, MD, President & CEO of Clinical Effectiveness at Wolters Kluwer. "It is a testament to our dedicated staff and our decades-long commitment to excellence in providing drug information and enhancing care for cancer patients. But it is even more rewarding to know that this recognition would not have been possible without the support and positive feedback of our clinician users who trust our information to strengthen their decisions every day."
