The Centers for Medicare and Medicaid Services (CMS) is reconsidering the National Coverage Determination (NCD) for positron emission tomography (PET) in oncology based on a request from the National Oncologic PET Registry (NOPR) working group. The working group has requested that CMS reconsider Section 220.6 of the NCD Manual to end the data-collection requirements for PET with F-18 fluorodeoxyglucose (FDG) across all oncologic indications, except for monitoring response to treatment. A favorable decision would grant broad coverage to PET and PET/CT for all oncologic applications, except monitoring treatment response during therapy. The proposed decision memo is due October 10.

PET has gained widespread acceptance by primary care physicians, as well as oncologists, pulmonologists, and surgeons, as an invaluable tool in the management of patients with cancer. The introduction of PET/CT in 2001 accelerated the incorporation of PET into diagnostic and treatment algorithms. PET and PET/CT are included in the practice guidelines of the National Comprehensive Cancer Network (NCCN) and many other professional organizations. Despite the endorsement of these groups, only 1.5 million PET examinations are performed annually, compared to 15 to 20 million annual CT exams performed for the same reason. The main reason for underutilization of PET is lack of reimbursement by CMS and the private health care plans that follow CMS guidelines.

CMS approved PET for characterization of solitary pulmonary nodules and staging non-small cell lung cancer in 1998. By 2005, national coverage was expanded to specific indications for esophageal cancer, colorectal cancer, lymphoma, melanoma, breast cancer, head and neck cancer, thyroid cancer, and cervical cancer. There are, however, more than 200 types of cancer not covered by CMS. Recognizing the impossibility of doing prospective studies for all indications, NOPR was created by the American College of Radiology and the Academy of Molecular Imaging, with the guidance of CMS and the endorsement of the Society of Nuclear Medicine (SNM) and the American Society of Clinical Oncology (ASCO).

The purpose of NOPR was to collect data on the use of PET and PET/CT in the management of patients with cancers not covered by CMS. In its first year of operation, data were obtained for 34,358 PET exams. In a subset of 22,975 exams that formed the basis of the NOPR working group application to CMS, changes in management based on PET or PET/CT occurred in 74% of patients, with a 36.5% change in physician’s per-PET treatment or no-treatment decision. Additional data from the first 19 months of NOPR operation will be used to support a future request to extend national coverage to the use of PET in treatment monitoring.

In addition to review of scientific literature, CMS takes into consideration professional society position statements and public comments regarding proposed NCDs. Public comments enable CMS to consider scientific data that has not yet been published, as well as the opinions of physicians and other health industry professionals. The importance of public comments is evident in the March 12, 2008, CMS decision for cardiac computed tomographic angiography (CTA). In the decision memo, CMS decided that coverage should be determined by local contractors, effectively leaving in place the system that has allowed cardiac CTA to be widely used for the diagnosis of coronary artery disease. The decision was hailed as a victory for proponents of the technology.

The CMS decision memo on cardiac CTA is instructive on the review process for NCDs. CMS received 127 comments during the initial 30-day public comment period and 670 comments during the comment period for the proposed decision. The decision memo summarizes the comments and provides a point-by-point response. The memo also notes that CMS received a combined comment from six professional societies that disagreed with CMS’ proposal and recommended keeping coverage at the discretion of the local Medicare contractors. CMS acknowledged, “While public comments and specialty society opinions following the CMS proposed decision to use coverage with evidence development did not dispel the uncertainty of the test’s clinical utility, they did strongly favor maintaining the local coverage policies for CTA. In light of this, CMS has decided to make no change to the current NCD.”

SNM and other professional organizations have submitted position statements supporting the request for national coverage of PET across all oncologic indications. As of this time, CMS has received more than 300 public comments in support of the decision, with no negative comments. More comments are expected before the public comment period closes. As in all walks of life, public opinion is very important in shaping CMS policy, and every comment counts. People are urged to participate in the process and make their opinions known.

George Segall, MD, is president-elect of the Society of Nuclear Medicine PET Center of Excellence. For more information, contact .