The Health Care Financing Administration (HCFA) announced today it is expanding
Medicare coverage of positron emission tomography (PET), an innovative imaging
technology, to improve the care of patients who have or may have one of six
types of cancer. Additional coverage is also provided for some patients with
refractory epilepsy or who may be candidates for coronary revascularization.
"PET is a technology that has tremendous promise," said Jeffrey Kang, director
of HCFA's Office of Clinical Standards and Quality. "Our expanded coverage of
this diagnostic tool provides additional clinical information to physicians that
may influence the management of care for many Medicare beneficiaries."
This science-based coverage decision provides important expanded coverage of
dedicated full circular ring PET scanners and some partial ring systems for any
clinically appropriate use for six types of cancer ? lung, colorectal, lymphoma,
melanoma, esophageal, and head and neck (but not brain or thyroid) cancer ? and
new coverage of the neurologic and cardiac applications. The effective date
will be announced shortly.
The use of PET may allow some Medicare beneficiaries to avoid undergoing
invasive procedures and may also give beneficiaries and their physicians
information that will increase confidence in the management of their care.
Consideration of requests for coverage of three additional applications ?
myocardial viability, dementia, and breast cancer ? will be referred to the
Medicare Coverage Advisory Committee, a panel of top private sector experts
created to advise HCFA on important coverage issues.
HCFA had received an external request for broad coverage of PET for a multitude
of cancers, one cardiac application, and two neurological applications. The
conditions not covered under this decision remain noncovered, and HCFA is
inviting interested parties to submit new formal requests for coverage for
individual cancers or for broad coverage.
"Our goal is to provide a national, science-based coverage decision that will
promote beneficiary access to this promising technology, " said Kang, HCFA's
chief clinical officer. "We expect to expand coverage for additional conditions
when we accumulate sufficient scientific evidence."
PET is a specialized imaging technique that was developed in the 1970s. It
involves the injection into a patient of a very small amount of a radioactively
labeled natural compound such as sugar or water. The most commonly used
radiopharmaceutical in PET is fluorodeoxyglucose (FDG), which is similar in
structure to glucose or simple sugar. Once FDG is injected, a PET scanner is
used to image a specific function or physiological process within the body by
measuring the concentration and distribution of the radioactive FDG throughout
Prior to today's coverage decision, only specific uses for PET, such as
localization of recurrence for any given cancer, have been covered by Medicare.
This new policy decision provides coverage for all clinically appropriate uses
of PET for six cancer types. This means broader coverage for previously covered
cancers as well as for two additional ones.
This change is a significant modification in HCFA's approach to PET scans and a
major step toward broad coverage. HCFA will now cover diagnosis, staging and
re-staging for any covered cancer for which there is empirical evidence for at
least one clinically appropriate indication. For example, HCFA previously
covered PET scans for colorectal cancer for one narrow indication ? in the case
of recurrent colon cancer evidenced by a rising carcinoembryonic antigen level.
Now, HCFA has expanded coverage of PET for colorectal cancer for all other
diagnostic, staging and re-staging reasons.
For coverage of PET in primary cancer diagnosis, PET must be used to potentially
avoid or direct an invasive diagnostic procedure. For use in staging or
restaging of disease, PET is only covered if the stage of the cancer remains
uncertain following a conventional imaging work-up and if the clinical
management of the patient may differ according to the stage of the disease.
Where the evidence demonstrates PET is not clinically useful, that use in a
specific cancer type will be explicitly excluded from coverage.