The NOPR Proves FDG PET's Powerful Impact
As the FDG PET component winds down, the research team looks back on significant milestones in the initiative's history.
The National Oncologic PET Registry (NOPR) closed accrual to its fluorodeoxyglucose (FDG) PET registry on June 12, 2013, after seven years of operation.
During that time, clinical data collected from the vast majority of PET imaging facilities in the United States confirmed that FDG PET scans provide vital information for determining the best treatment options for patients with cancer.
The NOPR, among the first CMS-sponsored Coverage with Evidence Development (CED) initiatives, provided hundreds of thousands of Medicare beneficiaries with access to FDG PET scans that otherwise would not have been covered. The registry had broad support among professional medical societies and was sponsored by the Academy of Molecular Imaging and managed by the ACR through ACRIN®.
January 2005: CMS indicates it intent to establish a new CED mechanism that will provide coverage of promising technologies contingent upon the collection of clinical data to demonstrate the impact on health outcomes.
April 2005: CMS posts the draft guidance document "Coverage with Evidence Development: National Coverage Determinations Requiring Data Collection as a Condition of Coverage." In response, a multidisciplinary team of investigators from an array of professional societies begins designing a program to collect clinical data about FDG PET's effect on physician treatment plans for many cancer indications for FDG PET scans not eligible for Medicare reimbursement.
May 2005-April 2006: Project managers, computer programs, data managers, and others join the NOPR development team, working with CMS representatives to successfully navigate numerous operational, regulatory, technical, and scientific hurdles.
"The NOPR has shown the feasibility of performing large-scale, policy-relevant imaging research that is minimally intrusive to patients and imagers." — Bruce E. Hillner, MD, NOPR chair
May 2006: The NOPR receives final approvals and goes into operation. The first electronic data are submitted to the registry's database, documenting referring physicians' care plans prior to and after an FDG PET scan.
October 2006: More than 1,300 PET facilities are signed up to participate in the NOPR. Data for over 12,500 patient scans have been successfully submitted.
April 2007: The NOPR investigators publish their first paper in the American Journal of Roentgenology, reporting on the registry's purpose and methods.
May 2007: More than 35,000 FDG PET scans have been performed under the NOPR auspices, and nearly 1,500 PET facilities have signed on to participate.
November 2007: The NOPR's design and analysis is published.
"NOPR positively impacted thousands of cancer patients." — Laurel Pracht, patient advocate, Ovarian Cancer National Alliance, Science and Policy Committee
March 2008: The first NOPR results are published, demonstrating that physicians often change their intended patient treatment plans based upon FDG PET scan results across the full spectrum of indications.
The NOPR investigators formally request that CMS 1) reconsider its current National Coverage Decision (NCD) on FDG PET; 2) provide coverage for diagnosis, staging, and restaging for all cancers; and 3) end the data collection requirements for these indications. The investigators further request that the registry continue to collect data for FDG PET studies of treatment monitoring.
April 2008: CMS initiates a review of the NOPR investigators' request and convenes a Medicare Evidence Development and Coverage Advisory Committee panel.
"Sufficient evidence was lacking that PET improved health outcomes. In the absence of Medicare coverage, researchers were unable to develop the clinical data necessary to demonstrate that broader coverage was warranted. CMS' novel coverage with evidence development mechanisms allowed for the collection of data to prove FDG PET reasonable and necessary for the vast majority of cancer types and indications — the legal threshold for coverage under Medicare." — Barry A. Siegel, MD, FACR, NOPR co-chair
November 2008: Two more NOPR analyses are published. NOPR investigators report that results from FDG PET affect how clinicians manage their cancer patients' care, regardless of the cancer type and reason for ordering the imaging scan.
The NOPR data show physicians change the treatment plan for 43 percent of their patients undergoing cancer treatment as the result of FDG PET information.
January 2009: CMS releases its proposed FDG PET-coverage decision to significantly expand coverage for diagnosis and initial staging for patients with nearly all cancer types. The proposal allows for restaging, detection of suspected recurrence, and treatment monitoring for an expanded number of cancer types. However, certain FDG PET indications continue to be covered only under a revised NOPR program. To address the new CED requirements, NOPR investigators develop the NOPR-2009 successor registry.
April 2009: CMS announces the new NCD expanding FDG PET coverage based on the NOPR-generated evidence. The NOPR 2009 registry is launched.
November 2009: CMS expands coverage for the use of FDG PET for initial staging of cervical cancer and ends the data collection requirement for this indication.
"The imaging and treating physicians' assistance was essential to obtain data about the scans, the state of the disease, and the treatment plan before and after the FDG PET scan. These data demonstrated the clinical impact of the study and led to improved access to this valuable diagnostic tool." — Anthony F. Shields, MD, PhD, NOPR investigator
February 2010: CMS announces the coverage of F-18 sodium fluoride (NaF-18) PET to identify bone metastasis only under and approved CED initiative. The NOPR investigators consider adapting the FDG PET registry to collect data about referring physicians' treatment plans before and after a NaF-18 PET scan.
June 2010: The NOPR investigators announce their decision to implement a data registry for NaF-18 PET. Registry development begins.
February 2011: CMS publishes a final NCD pertaining to the coverage of NaF-18 PET. The registry begins collecting data.
May 2012: The NOPR investigators publish results comparing data from the FDG PET registry begun in 2006 with data from the revised NOPR 2009. The datasets show similar results of the impact of FDG PET on physicians' planned treatment of their cancer patients.
July 2012: The NOPR investigators formally request that CMS expand coverage for the remaining oncologic FDG PET indications covered only through NOPR participation. They also request that CME end the CED requirement for coverage of oncologic FDG PET scans.
"We are pleased that the NOPR experience has led to fruitful collaborations in the advanced imaging community and has also facilitated more CMS engagement with that community." — Louis B. Jacques, MD, director, CMS Coverage and Analysis Group
March 2013: CMS releases a proposed NCD memorandum expanding coverage for remaining NOPR-covered FDG PET indications. However, the use of oncologic FDG PET for subsequent patient management is restricted to a single lifetime scan per cancer, with additional scans to be covered at the discretion of local Medicare administrative contractors.
April 2013: NOPR investigators submit a comment letter agreeing with the CMS recommendation to close the FDG PET registry. The letter also provides evidence to show that the single-scan limit for subsequent patient management would not be in the best interest of Medicare beneficiaries.
June 2013: CMS issues a final decision memorandum calling for the end of the NOPR's prospective data collection. The limit of one scan for subsequent FDG PET imaging is expanded to three. The NOPR 2009 registry ends data collection.
July 2013: The NaF-18 PET registry remains open, with over 860 participating PET facilities and data for more than 15,000 cases. Data analysis and manuscript development are well underway.
By Nancy Fredericks, MBA