The CMS will continue to limit coverage for PET scans used to find metastasized cancer cells in bones, which most commonly happens in metastatic breast and prostate cancer.
Since 2010, the agency has paid for positron emission tomography or NaF-18 PET scans to find metastasized cancer cells in bones as long as physicians collected data on its use and put it in a clinical registry.
PET scans map hot spots inside the body by injecting radioactive tracers into the blood that attach themselves to hyperactive cells.
Earlier this year, physicians asked that the data reporting requirement be lifted because they felt they had fulfilled the request, pointing to a registry that has collected data from 35,468 scans performed on 28,713 patients through 2014.
But the CMS disagrees, saying in a notice posted Tuesday that the data shows that PET scans to find metastasized cancer cells in bones are “not reasonable and necessary to diagnose or treat an illness or injury.”
The agency said it will continue paying for PET scans for another 24 months, which is up from the 12 months it originally proposed, but unless evidence appeared in a peer-reviewed journal documenting that using PET scans actually improved patient outcomes, it will not reconsider the limited Medicare coverage.
This final decision comes after more than 200 comments were received asking for the data requirement to be dropped.
Dr. Stephen Kennedy, a radiologist at St. Anthony's Hospital in St. Petersburg, Fla., said in a comment letter that PET scans allowed him to “identify metastatic disease to the bone with greater certainty than traditional bone scintigraphy.”
Donald Hertel, manager of the Medicare Strategy Unit at the Mayo Clinic, agreed in his comment letter.
Many physicians say PET scans help identify cancer earlier on and help track their speed in hard to see places better than regular CT or MRI scans.
Not lifting the requirement could lead to some getting unnecessary care, or delay access to appropriate treatments of the patients, added Peter Choyke, senior investigator at the National Cancer Institute.
The CMS said it was ultimately unmoved by these and other remarks because “they provided no evidence or supporting studies.”
Siemens and Triad Isotopes are listed on the Food and Drug Administration website as manufacturers and distributors of NaF-18, the sodium agent used in PET scans. Neither company immediately responded to requests for comment on the coverage decision.
PET scans are not a cheap technology. Installing one can cost up to $2 million or more, but providers can receive payment of up to $1,000 a scan.
Some insurers have been trying to limit the use of PET to two per patient; others require prior authorization.
And the American Society of Clinical Oncology has put excessive use of PET, along with other expensive diagnostic imaging tests, such as CT and MRI tests, on its “Choosing Wisely” list of technologies to consider carefully before deploying.
ASCO now recommends against using imaging tests for low-risk, early stage breast cancer and prostate cancer.