The U.S. National Oncologic PET Registry (NOPR) opened yesterday with the acceptance of its first patient entries. The registry permits participating Medicare beneficiaries to receive PET coverage for many types of cancers, including brain, cervical, small cell lung, pancreatic, testicular, and ovarian.
According to NOPR, some project design changes were necessary related to institutional review board (IRB) review and approval, and subject consent.
The major change to the original project design is that the research in which the NOPR entity will be engaged is no longer considered exempt from IRB approval. However, PET centers and referring physicians are not considered to be engaged in the NOPR research and do not need separate IRB approval, according to the organization.
The new project design requires both the patient and the referring physician to indicate their willingness to participate in the research component of the NOPR, although written informed consent is not needed, NOPR said. Should either the patient or referring physician choose not to participate in the NOPR research, the information pertaining to that specific patient's PET scan will be excluded from NOPR's research database, the organization said.
Refusal of either the patient or referring physician to participate in the NOPR research will not affect CMS reimbursement for the PET scan. However, U.S. Center for Medicare and Medicaid Services (CMS) reimbursement for PET scans covered by the NOPR is based on receipt of the required information from the referring physician within a designated timeframe.
Facilities interested in participating in NOPR can sign up here; for more information about IRB approval as well as HIPAA compliance in NOPR, the organization has made its operations manual available here.
By AuntMinnie.com staff writers
May 9, 2006
Related Reading
ACR and ACRIN to launch PET registry in May, April 27, 2006
PET registry primed for takeoff, March 27, 2006
CMS, NOPR to collect PET data, February 10, 2006
PET registry previewed at AMI, March 21, 2005
AMI, ACRIN partner on PET registry development, February 7, 2005
Copyright © 2006 AuntMinnie.com
