CMS’ Coverage with Evidence Development Project Shows PET Scans as “Reasonable and Necessary” for Initial Treatment Decisions of Most Solid Tumor Cancers
The Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) to expand coverage for initial testing with positron emission tomography (PET) for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers.
This NCD removes a clinical study requirement for PET scan use in these patients.
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. This 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.
Medicare collects data from the NOPR under CMS’ Coverage with Evidence Development (CED) program. CED allows Medicare to develop evidence about how a medical technology is used in clinical practice so that Medicare can do the following:
(a) clarify the impact of these items and services on the health of Medicare beneficiaries;
(b) consider future changes in coverage for the technology; and
(c) generate clinical information that will improve the evidence base upon which providers base their recommendations to Medicare beneficiaries regarding the technology.
This decision is based, in part, on the information generated as a result of CMS’ 2005 decision to require NOPR reporting for many cancer PET scans. As a result of this evidence from NOPR, CMS reconsidered its 2005 coverage policy. This decision is the first time that CMS has reconsidered a coverage policy based on new evidence developed under the CED program.
“This expansion in coverage for PET scans shows that the Coverage with Evidence Development program is a success,” said 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.”
This decision applies to PET scans used to support initial diagnosis and treatment for most types of 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.
It is important to note that today’s decision still requires clinicians to report data to the NOPR when using PET scans to monitor the progress of treatment or remission of cancer in some cases. Although the evidence generated by the NOPR study helped CMS determine that PET scans are useful in helping guide treatment when cancer is first diagnosed, scientific evidence is not as strong in showing that PET scans are as useful in making subsequent treatment decisions for some types of cancer.
A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracer to evaluate glucose metabolism in tumors and in normal tissue. The test may provide important clinical information to guide the initial treatment approach (e.g., diagnosis and “staging”) for many cancers.
This additional information may help physicians to distinguish benign from cancerous lesions and better determine the extent of a tumor’s growth or metastasis. PET scans have also been used in subsequent testing for cancer patients, e.g., to monitor cancer progression or remission after cancer treatment has begun.
More information about the types of cancer covered by this new policy is available in CMS’ final decision memorandum. Read the final decision on the CMS Web site at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=218.