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.
