October 17, 2008

US Oncology Physicians Submit Comments to CMS on PET Coverage

HOUSTON, Oct. 17 /PRNewswire-USNewswire/ -- Early in 2008, the National Oncologic PET Registry (NOPR) published its initial results indicating that clinicians changed the intended care of more than one in three cancer patients as the result of FDG-PET scan findings. These findings were published on-line on March 24 in the Journal of Clinical Oncology (JCO).

On March 25, the NOPR Working Group submitted a formal request to the Centers for Medicare and Medicaid Services (CMS), asking that it reconsider the current National Coverage Decision on FDG-PET and end the data collection requirements for diagnosis, staging and restaging for all cancers. On April 10, CMS initiated its review of this request. US Oncology submitted comments to CMS strongly supporting this request.

On September 16, CMS broadened the scope of its National Coverage Analysis (NCA) on PET coverage after receiving public input indicating that the current coverage framework which requires cancer by cancer consideration of diagnosis, staging, restaging and monitoring response to treatment should be replaced by a more omnibus consideration. CMS requested comment on whether the current coverage framework should be retired and replaced with a general policy that could be developed and applied to oncologic FDG PET imaging.

On October 17, in comments submitted to CMS, US Oncology physicians expressed their belief that it is both clinically appropriate and practical for CMS to adopt a comprehensive omnibus cancer coverage framework for PET. During the past two years, Medicare beneficiaries with cancer participating in the NOPR have benefitted from better-informed clinical management. Patients with less-common cancers included in the NOPR comprise about 10% of the Medicare population imaged by PET in 2006-2008. Based on the data from the NOPR and the totality of the clinical and scientific publications on PET, US Oncology Physicians strongly support an effort by CMS to update and modernize the current PET NCD policy to allow for the coverage of PET for diagnosis, staging, and restaging/suspected recurrence purposes for oncologic indications.

The US Oncology Physician Network has one of the largest networks of PET facilities in the country, and is particularly interested in efforts to improve patient access to the vital information PET and PET-CT images can provide for cancer patients. Of the 1598 registered NOPR sites, sixty one were US Oncology network practices and as many as 10% of patients who received NOPR trial studies were from US Oncology network practices.

The results of the NOPR trial have confirmed the validity of network physicians' basic assumptions regarding FDG-PET: that FDG uptake, as a surrogate for glycolytic metabolic activity within malignant tissues, is generally applicable for tumor assessment in the vast majority of cancers and that FDG-PET imaging provides crucial additional information in the evaluation of cancer patients' information that often alters patient management.

US Oncology physicians strongly believe that the NOPR data support use of FDG-PET as an oncologic imaging tool of general applicability. The data support immediately ending the Coverage with Evidence Development (CED) requirements. Continuing these requirements could prevent many patients from receiving optimal care for their cancers, resulting in increased morbidity and mortality. The decision to use FDG-PET for oncologic imaging should be left to treating physicians, working in consultation with imaging specialists and with their patients.

US Oncology looks forward to continuing to work with CMS toward full coverage of PET imaging services for Medicare beneficiaries with cancer.

About US Oncology Research The US Oncology Research network is an established community-based research operation specializing in comprehensive Phase I-IV trials and translational Phase I research. The research network is currently enrolling patients at 109 research sites, and is involved in 63 open trials. Supported by US Oncology, the network has played a pivotal role in 24 of the last 30 cancer drugs approved by the Food and Drug Administration and more than 32,000 patients have participated in clinical trials. For more information, visit the "Research" section under "Our Services" on the company's Web site, http://www.usoncology.com/.

US Oncology

CONTACT: Courtney Davis for US Oncology, +1-703-966-1214

Web Site: http://www.usoncology.com/