Federal regulations and reimbursement for PET.

OBJECTIVE The regulatory and reimbursement environment for PET has changed significantly over the past several years. The Food and Drug Administration's (FDA) findings of the safety and efficacy of key PET drugs have been published, as well as guidelines for the applications to produce PET drugs. In addition, the national Medicare coverage policy for PET has been expanded, most recently with additional indications and coverage restrictions added as of July 2001. The payment rates under the new Hospital Outpatient Prospective Payment System (HOPPS) have been set for PET as well. This communication reviews these recent changes and discusses their impact on the development and operation of a PET center. After reading this article, the nuclear medicine technologist should be able to: (a) state the indications for the use of PET drugs that have been found to be safe and effective by the FDA; (b) detail the general procedures a PET drug production site would have to undertake to be in compliance with FDA regulations; (c) list specific studies that have been approved for payment by Medicare; and (d) describe billing codes used for PET scans. Clarification of regulatory and reimbursement issues is leading to rapid expansion of clinical PET. Keeping abreast of these changes will ensure the successful expansion of any nuclear medicine program to include PET services.