TY - JOUR
T1 - A “Short-lived” Orphan
AU - Coleman, R. Edward
AU - Briner, William H.
AU - Siegel, Barry A.
N1 - Funding Information:
perfusion, but the other indications require FDG, which is not yet approved. The HCFA has maintained that until an NDA for FDG is approved, the use of this drug for a PET study ipso facto renders the study investigational and thus not eligible for reimbursement under the Medicare and Medicaid programs. In discussions with officials from the OHTA, the necessity for outcome data to prove the effectiveness of a new technology frequently is stressed (personal communication). Although multiple peer-reviewed studies document the clinical utility of PET in the areas being evaluated, the reviewers at the OHTA need to ascertain not only that PET reliably detects disease and alters the treatment of patients but also that there is a resultant improvement in the patient's outcome. Outcome studies require large numbers of patients and long-term follow-up, and these types of studies are not available for PET at this time. Such studies are difficult and expensive to perform, and funding for these studies is not forthcoming from industry or, to any significant extent, from the National Institutes of Health (NIH). Moreover, the lack of reimbursement for most clinical PET studies and the greater likelihood of obtaining NIH funding to conduct physiologic and pathophysiologic research with PET means that university-based PET centers will not wish to divert resources into outcome research.
PY - 1992
Y1 - 1992
N2 - Positron emission tomography (PET) is a method of nuclear medicine imaging that uses short-lived radiopharmaceuticals to detect and quantify the metabolic abnormalities of disease processes. PET initially was developed in a research environment as a research tool; data from these research studies resulted in the gradual recognition that PET studies would be useful for various routine clinical applications. The diffusion of PET into clinical practice has been slow in comparison with other new imaging methods (e.g., magnetic resonance imaging). This slow diffusion is attributable to several factors, including the complexity and high cost of PET, the uncertain role of the U.S. Food and Drug Administration in regulating the radiopharmaceuticals that are produced and used on-site for PET studies, and the apparent slow pace at which the Health Care Financing Administration and other third-party payers are developing policies for reimbursing for PET.
AB - Positron emission tomography (PET) is a method of nuclear medicine imaging that uses short-lived radiopharmaceuticals to detect and quantify the metabolic abnormalities of disease processes. PET initially was developed in a research environment as a research tool; data from these research studies resulted in the gradual recognition that PET studies would be useful for various routine clinical applications. The diffusion of PET into clinical practice has been slow in comparison with other new imaging methods (e.g., magnetic resonance imaging). This slow diffusion is attributable to several factors, including the complexity and high cost of PET, the uncertain role of the U.S. Food and Drug Administration in regulating the radiopharmaceuticals that are produced and used on-site for PET studies, and the apparent slow pace at which the Health Care Financing Administration and other third-party payers are developing policies for reimbursing for PET.
UR - http://www.scopus.com/inward/record.url?scp=0026465357&partnerID=8YFLogxK
U2 - 10.1017/S0266462300002312
DO - 10.1017/S0266462300002312
M3 - Article
C2 - 1464482
AN - SCOPUS:0026465357
SN - 0266-4623
VL - 8
SP - 610
EP - 622
JO - International Journal of Technology Assessment in Health Care
JF - International Journal of Technology Assessment in Health Care
IS - 4
ER -