· CMS Receives FDG-PET Comments
· Product Debut: Molecular CT: Improving Confidence, Comfort

CMS Receives FDG-PET Comments

The Academy of Molecular Imaging, the American Society for Therapeutic Radiology and Oncology, and the National Oncologic PET Registry (NOPR) have submitted comments to the Centers for Medicare and Medicaid Services regarding the NCD for FDG-PET for Solid Tumors.

The joint letter was written in response to CMS’s request for additional comments regarding whether an omnibus framework could replace the current framework of cancer-by-cancer coverage for oncologic FDG-PET imaging.

“We believe that there is strong empirical evidence to support an omnibus cancer framework that would provide for coverage of PET across all oncologic indications for diagnosis, staging, and restaging (including detection of suspected recurrence),” the letter states.

Additionally, the group believes it is both clinically appropriate and practical for CMS to adopt a comprehensive cancer coverage framework for PET.

“During the past 2 years, Medicare beneficiaries with cancer participating in the NOPR have benefited from better-informed clinical management,” according to the letter. “Patients with less-common cancers included in the NOPR comprise about 10 percent of the Medicare population imaged by PET in 2006-2008.” After evaluating the NOPR data, as well as findings of clinical and scientific publications on PET, the societies support CMS’s effort to update and modernize the current PET NCD policy.

In the societies’ model comprehensive coverage policy, they included a requirement of “a clear record of the clinical decision in question.” In doing so, CMS would “provide a clear basis for medical review, require targeted use of PET imaging, and ensure clear and uniform context for the interpreting physician.” They also recommend accreditation or professional requirements, which “will substantially help resolve CMS’ concern that clinically uninformed use of PET imaging might occur.”

Furthermore, the societies suggest that CMS adopt a new NCD that provides more detailed guidance for clinical situations, such as surveillance, “where PET coverage in not currently established as useful.”

However, the group notes that there is no “sufficiently mature” NOPR evidence to recommend that CMS stop the CED requirements for PET coverage for treatment monitoring. The societies say they will continue to use the NOPR to collect data to examine the value of PET for this purpose.

Also, the societies advise “CMS should consider whether new coverage for body imaging (granted beyond the legacy coverage as of 2005) should be limited to PET/CT scanners. Such limits are appropriate because almost all cases in the NOPR were studied with PET/CT scanners, most recent literature is based on PET/CT scans, and PET/CT improves the accuracy of PET-based evaluations.” Because PET/ CT scanners already use a distinct CPT code set, the societies argue that the restriction would create a minimal amount of additional administrative burdens, if any.

In the letter, the societies report that the SNM PET/CT Utilization Task Force is in the process of developing recommendations for FDG-PET and PET/CT Practices Guidelines in Oncology. The group met in September to present and review the recommendations of other professional organizations for the nine CMS-approved indications. Furthermore, SNM has worked with the NOPR to assist with accurate coding advice and to provide ongoing education regarding appropriate implementation of the CMS national coverage guidelines.

The letter addresses the fact that the ACR has published two Practice Guidelines on FDG-PET for the performance of FDG-PET/CT in oncology and for medical nuclear physics monitoring of PET/CT imaging equipment. The society offers a Nuclear Medicine/PET Accreditation program, designed to provide radiologists and nuclear medicine physicians with “an opportunity for comprehensive review and evaluation of their Nuclear Medicine/PET facility, personnel qualifications, image quality, equipment, quality control procedures, and quality assurance programs through a peer review mechanism.”

—Elaine Sanchez

Product Debut: Molecular CT: Improving Confidence, Comfort

Biograph mCT provides routine, whole-body PET scanning in just 5 minutes.

PET with unlimited CT capabilities. CT with molecular resolution. The Biograph mCT hopes to bring all of it to the end user.

The new comprehensive system from Siemens Healthcare, Malvern, Pa, seeks to address all molecular imaging and radiology demands from one source.

“Siemens is pleased to offer a powerful new platform in integrated imaging today,” said Michael Reitermann, CEO. “For institutions looking for cutting-edge technology, the greatest level of patient care, and maximum return on investment, Biograph mCT offers the complete solution.”

According to Siemens, Biograph mCT with ultra HD PET technology is the world’s only PET system that offers 2-mm uniform resolution throughout the field of view, along with enhanced contrast with reduced noise and added time of flight. The company says it is the only integrated imaging device to offer routine, whole-body PET scanning in only 5 minutes.

More accurate lesion depiction is accomplished through measurement of the time difference between photon detection, as well as better localizing the coincidence origins. Siemens researchers have found that the company’s TrueV extended field of view technology allows 70% more counts with 30% less bed positions.

Analyzing the value of TOF PET technology when used with advanced reconstruction algorithm such as HD PET, researchers from the University of Utah in Salt Lake City determined that the resulting data produced higher-quality images with less noise than conventional PET. In the study, “Impact of TOF on PET Tumor Detection,” the group concluded that the combined methods resulted in a noticeable improvement in cancer detection when evaluated at several milestones during PET image reconstruction.

“Our research adds to the growing number of studies that indicate reconstruction methods, such as HD PET and TOF, have the potential to significantly improve physicians’ abilities to accurately diagnose and treat cancer,” said lead researcher Dan Kadrmas, PhD, a professor in the department of radiology at the University of Utah in Salt Lake City. “While traditional PET scanners offer several advances over other types of diagnostic tools, these advanced systems could take those advantages to a whole new level.

Biograph mCT offers up to 128 slices, with 0.33-mm isotropic resolution and .30s rotation time. Advanced CT technology, such as Adaptive Spiral CT, and maximum slice configurations permit Biograph mCT to perform applications such as whole organ perfusion. Combined with FDG PET, users can view enhanced characterization of liver, brain, lung and retroperitoneal tumors, combining blood flow and metabolic information in a single study.

The technology also utilizes Adaptive Dose Shield, which reduces CT dose through dynamic collimators and automatically eliminates over-radiation before and after every spiral scan.

According to Siemens, the design team kept patient comfort in mind when developing the Biograph mCT. Alleviating claustrophobia and allowing for better positioning of radiation therapy planning, the system has a small footprint, a large bore (78 cm), a short tunnel, and an extrawide, 500-pound-capacity bed. Applications in oncology include the ability to delineate lesions for diagnosis, staging, and restaging of cancer.

—Elaine Sanchez