Knowledge Base Article

I love a beautiful sunset, especially those where low level clouds in the western sky catch the rays of the waning sun and light up the sky with an orangish, pinkish, reddish glow. It always brings to mind a saying I learned as a child – “red sky at night, sailors delight; red sky at morning, sailors take warning.” For providers approved to participate in a study and bill Medicare for NaF-18 PET scans for bone metastasis, there is a warning for the upcoming sunset of NCD 200.6.19.

Although Medicare generally does not cover experimental or investigational items and services, the National Coverage Determination (NCD) Coverage with Evidence Development (CED) process allows Medicare coverage for some items and services on the condition they are furnished in the context of approved clinical studies or with the collection of additional clinical data. CMS performs an initial review of medical literature to determine if CED coverage is appropriate with the expectation the studies conducted under a CED NCD will produce evidence that will lead to revisions of Medicare coverage policies.  The CED process allows patients earlier access to innovative technology while ensuring patient safeguards. CED NCDs usually list the specific questions CMS expects the study or data collection to answer.

In February 2010, CMS approved coverage of NaF-18 Positron Emission Tomography (PET) to identify bone metastasis of cancer under the CED process. Specifically, under NCD 220.6.19, Medicare covers “NaF-18 PET imaging when the beneficiary’s treating physician determines that the NaF-18 PET study is needed to inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment, and when the beneficiary is enrolled in, and the NaF-18 PET provider is participating in, (a specified) type of prospective clinical study.”  Medicare expected the clinical studies to answer the following questions:

Does the addition of NaF-18 PET imaging lead to:

• A change in patient management to more appropriate palliative care; or
• A change in patient management to more appropriate curative care; or
• Improved quality of life; or
• Improved survival?

In 2015, the National Oncologic PET Registry (NOPR), which is the approved study for NaF-18 PET, asked CMS to reconsider NCD 220.6.19, end the CED data collection requirements, and authorize national coverage of NaF-18 PET for bone metastasis of all oncologic indications. On December 15, 2015, CMS issued a Decision Memo that did not end the CED data collection requirements for NaF-18 PET, but extended coverage under the CED process for an additional 24 months. This means the current NCD and Medicare coverage for NaF-18 PET (under CED) will sunset on December 14, 2017. NOPR has sent notices concerning the expiration of this NCD to the participating facilities and also has an announcement on their website, but I was unable to locate any information on Medicare’s websites concerning this.

I reached out to Medicare and have received confirmation that this is indeed correct. For dates of service on and after December 15, 2017, Medicare will no longer cover NaF-18 PET scans to identify bone metastasis of cancer. There have not been any published studies that conclusively answer the study questions. Medicare denials will likely be based on the presence of HCPCS code A9580 (Sodium fluoride F-18, diagnostic, per study dose, up to 30 millicuries) on the claim.    

It is likely CMS will receive another request for reconsideration of this policy from NOPR or other stakeholders. Be on the lookout for further guidance from CMS in the future as to whether they will reinstate coverage of NaF-18 PET to identify bone metastasis of cancer under CED, cover the service outright without CED, or continue to not cover the service at all. Until that time, providers take warning – this sunset isn’t pretty since it takes away your Medicare reimbursement for NaF-18 PET.