ppt-thenationaloncologypetregistry.ppt

28-Nov-06 National Oncologic PET Registry  Evolution of Clinical PET PET well established as a research tool since its development in mid 1970s Research applications evolved into clinical applications Improvements in PET scanners made clinical studies practical However, acceptance into clinical practice occurred very slowly Factors Facilitating US Growth of Clinical PET Gamma camera coincidence imaging Commercial distribution of FDG by regional cyclotron/production facilities Mobile PET services FDA Modernization Act of 1997 (FDAMA) Coverage decisions by Medicare and other carriers PET/CT PET Reimbursement Complex, slowly evolving process Dependent on FDA approval of PET drugs Facilitated by FDAMA (1997) Reimbursable clinical indications Determined by technology assessment panels of third-party payers Process dominated by Centers for Medicare and Medicaid Services (CMS) Medicare Coverage of PET Centers for Medicare and Medicaid Services (CMS) Formerly Healthcare Financing Administration (HCFA) Standard for reimbursement is “reasonable and necessary” In 1990s, CMS adopted a new evidence-based approach for making coverage determinations Requires peer-reviewed scientific evidence to document that new technology leads to changes in patient management and to improved health outcomes for Medicare beneficiaries Medicare Coverage of PET CMS elected not to consider oncologic indications for PET broadly Rather evaluated the evidence on a cancer-specific and indication-specific basis Problematic because the specific evidence typically has not been very robust “Catch 22” Medicare Coverage of Oncologic PET 1998 Evaluation of solitary pulmonary nodules and initial staging of NSCLC 1999 Suspected recurrent colorectal cancer, lymphoma, melanoma (covered after public meeting, with considerable restrictions) 2001 Further expanded coverage for six prevalent cancers after new request for broad coverage and public meeting(PET must either resolve inconclusive results of standard