The second quarter of 2009 may go down in history as the time when PET services and molecular imaging began their move into the mainstream of medicine. In case you haven’t heard, in early April, the Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) to expand coverage for initial testing with PET for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers.
R. Edward Coleman, professor of radiology and chief of the division of nuclear medicine at Duke University School of Medicine in Durham, N.C., and member of the National Oncologic PET Registry (NOPR) observational study, says that PET practitioners have had to work hard for reimbursement.
Unlike CT or MRI, CMS elected to approve coverage for PET scans on a cancer-by-cancer indication under the Coverage with Evidence Development (CED) program. Since 2005, Medicare coverage of PET scans for diagnosing some forms of cancer and guiding treatment has been tied to a requirement that providers collect clinical information about how the scans have affected doctors’ treatment decisions. This information was gathered through the National Oncologic PET Registry (NOPR) observational study.
“The road to coverage by Medicare has been long and complicated,” Coleman says. “For a great many patients, who would otherwise have to pay out-of-pocket for their PET scans, this CMS decision will save thousands of dollars. It also will allow more providers to offer this life-saving care to our nation’s seniors.”
The recent decision removes the requirement to report data to the NOPR when the PET scan is used to support initial treatment (or diagnosis and staging) of most solid tumor cancers. It also expands coverage of PET scans for subsequent follow-up testing in beneficiaries who have cervical or ovarian cancer, or who are being treated for myeloma, a cancer that affects white blood cells. For these cancers, NOPR data collection will no longer be required.
“This expansion in coverage for PET scans shows that the CED program is a success,” says CMS Acting Administrator Charlene Frizzera. “CED allowed us to cover an emerging technology, learn more about its usage in clinical practice, and adjust our coverage policies accordingly. Thanks to CED, Medicare beneficiaries have greater access to cutting-edge medical technologies and treatments.”
James H. Thrall, MD, FACR, chair of the American College of Radiology (ACR) Board of Chancellors, radiologist-in-chief at Massachusetts General Hospital and professor of radiology at Harvard Medical School in Boston, agrees with Frizzera’s assessment.
“Expanded CMS coverage for PET is a tremendous step forward for cancer care in this country. The NOPR is a shining example of how the medical community can interact with government on research that can ultimately save and extend patients’ lives,” he says.
NOPR is sponsored by the Academy of Molecular Imaging (AMI) and managed by the ACR and the ACR Imaging Network (ACRIN); the American Society of Clinical Oncology (ASCO) and SNM also have played key roles in guiding the project’s development.
Barry A. Siegel, MD, FACR, chair of the ACRIN PET Imaging Core Laboratory, co-chair of the NOPR working group, and professor of radiology and chief of nuclear medicine at the Mallinckrodt Institute of Radiology at Washington University in St. Louis, cites the results from the NOPR as the tipping point in the coverage decision.
“NOPR data undoubtedly served a primary role in this CMS decision, which will allow seniors far greater access to PET imaging to guide their care. The registry provided undeniable evidence that PET scans can serve a vital role in diagnosing, staging, restaging and monitoring treatment for patients with many types of cancer. We are proud that NOPR efforts have enabled CMS take this very important step to help cancer patients nationwide.”
Oncologist and NOPR working group co-chair Anthony F. Shields, MD, professor of medicine and oncology at the Karmanos Cancer Institute at Wayne State University in Detroit and chair of ACRIN’s Oncology Committee says the CMS decision is welcome news.
“Certainly it makes the availability of PET much greater for our patients given that basically almost every tumor type is now covered for the initial staging and diagnosis under the CMS ruling. In addition, they’ve extended the use of PET in subsequent treatment strategy to additional tumors, so that will make it easier for clinicians