The Centers for Medicare & Medicaid Services (CMS), in a Feb. 26 final decision memorandum, proposed that “the available evidence is sufficient to determine that NaF-18 PET imaging to identify bone metastasis of cancer to inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment, is reasonable and necessary” through coverage with evidence development.
However, CMS has concluded that the evidence is not sufficient to determine that the results of NaF-18 PET imaging to identify bone metastases improve health outcomes of beneficiaries with cancer and therefore this use is not reasonable and necessary under the Social Security Act.
The agency said clinical studies, for which it will provide coverage, must answer one or more of the following questions: “Does the addition of NaF-18 PET imaging lead to a change in patient management to more appropriate palliative care or curative care; or improved quality of life; or improved survival?”
The research study must adhere to the following standards of scientific integrity and relevance to the Medicare population, according to CMS.
According to the requirements, the study should:
- Test whether a particular intervention potentially improves the participants’ health outcomes.
- Be well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
- Not unjustifiably duplicate existing studies.
- Be appropriately designed to answer the research question being asked in the study.
- Be sponsored by an organization or individual capable of executing the proposed study successfully.
- Comply with federal regulations concerning the protection of human subjects.
- Be conducted according to the appropriate standards of scientific integrity.
- Have a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.
- Not bet designed to test toxicity or disease pathophysiology in healthy individuals with some exceptions.
- Be registered on the www.ClinicalTrials.gov website.
- Have a protocol that specifies the method and timing of public release of all pre-specified outcomes to be measured.
- Have a protocol that explicitly discusses subpopulations affected by the treatment under investigation.
- Discuss how the results can be generalized to the Medicare population
On June 4, 2009, the CMS opened a reconsideration to review evidence on the use of NaF-18 PET imaging to identify bone metastasis of cancer. On November 30, 2009 CMS opened a second 30-day comment period in which it received thirty-four comments.