Subject(s)
Isotopes/chemical synthesis , Nuclear Reactors/legislation & jurisprudence , Canada , Isotopes/economics , Nuclear Reactors/economics , Nuclear Reactors/supply & distribution , Radionuclide Generators/economics , Radionuclide Generators/legislation & jurisprudence , Radionuclide Generators/supply & distribution , Radionuclide ImagingSubject(s)
Gallium Radioisotopes , Multimodal Imaging/methods , Neuroendocrine Tumors/diagnostic imaging , Octreotide/analogs & derivatives , Positron-Emission Tomography , Radiopharmaceuticals , Tomography, X-Ray Computed , Humans , Octreotide/chemical synthesis , Practice Guidelines as Topic , Radionuclide Generators/legislation & jurisprudence , Radiopharmaceuticals/chemical synthesis , Technetium , United KingdomABSTRACT
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.
Subject(s)
Medicare , Prospective Payment System , Radiopharmaceuticals/economics , Tomography, Emission-Computed/economics , Drug Approval , Humans , Insurance Coverage , Legislation, Drug , Radionuclide Generators/legislation & jurisprudence , United States , United States Food and Drug AdministrationABSTRACT
Today EPA is staying the effectiveness of subpart I of 40 CFR part 61, the National Emission Standards for Hazardous Air Pollutants for Radionuclide Emissions (54 FR 51654, December 15, 1989) as applied to facilities licensed by the Nuclear Regulatory Commission or an Agreement State ("NRC-licensed facilities"), other than nuclear power reactors, until November 15, 1992. The purpose or this rule is to afford EPA the time required to make an initial determination pursuant to section 112(d)(9) of the 1990 Clean Air Amendments before subpart I becomes effective for such facilities. EPA intends to propose a rule pursuant to section 112(d)(9) to rescind subpart I for nuclear power reactors, and to take final action no later than June 30, 1991, concerning a separate proposal to stay the effectiveness of subpart I for nuclear power reactors during the pendency of the rulemaking on recission. This rule staying subpart I for NRC-licensed facilities other than nuclear power reactors, and the Agency's final action on its proposal to stay subpart I for nuclear power reactors, will completely supplant all stays previously entered for such facilities during the Agency's reconsideration of subpart I under Clean Air Act section 307(d)(7)(B).
