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John R. Fischer, Senior Reporter | June 11, 2018
Patients prescribed a PET scan with 18F-sodium fluoride will still have to dip into their own pockets following the Centers for Medicare and Medicaid Services’ rejection of a request to reconsider covering the contrast agent.
Written and signed by the National Oncologic PET Registry (NOPR) working group, the request called for CMS to reevaluate its National Coverage Determination for NaF PET on the basis that the substance provided more appropriate forms of care to patients.
"The NOPR data clearly show that use of NaF PET led to more appropriate care for many cancer patients. We urge CMS to reconsider coverage for these potentially lifesaving and life-improving exams," NOPR principal investigator Dr. Bruce Hillner, said in a statement.
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Following its closure of NOPR in December 2017, CMS chose to
restrict reimbursements for the use of NAF PET in detecting cancerous bone metastases, asserting that such scans are “not reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member,” in a memo.
The agency agreed to continue reimbursing NaF-18 PET with evidence development programs for 24 months as it awaited the publication of evidence in The Journal of Nuclear Medicine, the findings of which ultimately supported the notion that the contrast agent offers more appropriate palliative and curative care in patient management.
The peer-review journal also
approved of its use in 2016 as part of a pilot study that associated it with better clinical outcomes and patient survival.
Backing the NOPR proposal is the Society of Nuclear Medicine and Molecular Imaging, which
made its own recommendations to CMS about the agent in March, along with The World Molecular Imaging Society (WMIS) and the American College of Radiology.
All three collaborated with CMS and NOPR upon its
launch in 2011 to collect clinical utility data supporting the use of NaF-18 PET. NOPR used applied these findings to more than 65,000 scans it performed on Medicare beneficiaries in that time.
Despite the recommendations and evidence, CMS declined the NOPR request, citing the information provided as insufficient.
"Many seniors may ultimately receive care that is not as effective or helpful as it could be if CMS does not reconsider Medicare coverage for NaF PET,” NOPR co-chair Dr. Anthony Shields said in a statement. “This is a step backward in care for these patients. We urge CMS to reconsider coverage so that these seniors can have access to care that can better help them.”
WMIS, ACR and SNMMI will continue to collaborate with CMS to establish Medicare coverage and access for patients to NaF PET.