Report Materials
WHY WE DID THIS STUDY
Federal law mandates that drug compendia publishers (publishers) that evaluate anticancer drug therapies maintain transparent processes for evaluating anticancer drug therapies and identifying potential conflicts of interest on the part of their staff. Medicare Parts B and D cover anticancer drugs for indications not approved by the Food and Drug Administration only if the drugs are supported by one or more of the four authorized compendia. Conflicts of interest on the part of compendia staff might result in anticancer drugs being included in the compendia that otherwise might not have been included.
HOW WE DID THIS STUDY
This study included (1) a review of each publisher's policies and procedures-as posted on its Web site-for evaluating anticancer drug therapies and for identifying potential conflicts of interest; (2) interviews with publishers' staff who were knowledgeable as to how potential conflicts were managed; and (3) an interview with CMS staff. Our review took place in September and October of 2013.
WHAT WE FOUND
We found that the each of the publishers of the four authorized compendia complied with Federal laws for maintaining a transparent process for evaluating anticancer drug therapies and identifying potential conflicts of interest. We also found that the number and nature of disclosures related to potential conflicts of interest varied across publishers.
WHAT WE CONCLUDE
All four publishers complied with Federal law to maintain a transparent process for evaluating anticancer drug therapies and identifying potential conflicts of interest among staff. Insufficient evaluation criteria and conflicts of interest among compendia staff could lead to anticancer drugs being inappropriately recommended for inclusion in a compendium. Because Medicare Parts B and D cover anticancer drugs supported by one or more of the four authorized compendia, transparency of publishers' policies helps safeguard against inappropriate Federal payments for these drugs and protects Medicare beneficiaries from being prescribed drugs for medically inappropriate uses.
Notice
This report may be subject to section 5274 of the National Defense Authorization Act Fiscal Year 2023, 117 Pub. L. 263.