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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that if medically necessary and reasonable, Medicare will cover one Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) scan to determine the initial level of cancer treatment needed for an enrollee. After the completion of the initial anti-cancer therapy, additional FDG PET scans may be covered at the discretion of Medicare. You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only Manual, National Coverage Determinations Manual, Section 220.6.17. The rules say that the study must adhere to the following standards of scientific integrity and relevance to the Medicare population: a. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants' health outcomes. b. The research study is 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. c. The research study does not unjustifiably duplicate existing studies. d. The research study design is appropriate to answer the research question being asked in the study. e. The research study is sponsored by an organization or individual capable of executing the proposed study successfully. f. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it also must be in compliance with 21 CFR Parts 50 and 56. g. All aspects of the research study are conducted according to the appropriate standards of scientific integrity. h. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards. i. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life-threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options. j. The clinical research study is registered on the www.ClinicalTrials.gov Web site by the principal sponsor/investigator prior to the enrollment of the first study subject.
k. The research study protocol specifies the method and timing of public release of all pre-specified outcomes
to be measured including release of outcomes if outcomes are negative or study is terminated early. The results
must be made public within 24 months of the end of data collection. If a report is planned to be published in a
peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the
International Committee of Medical Journal Editors. However, a full report of the outcomes must be made
public no later than three (3) years after the end of data collection.
l. The research study protocol must explicitly discuss subpopulations affected by the treatment under
investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and
exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said
populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the
recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are
necessary.
m. The research study protocol explicitly discusses how the results are or are not expected to be generalizable
to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate
discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or
Medicaid eligibility.
Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and
Quality (AHRQ) supports clinical research studies that the Centers for Medicare and Medicaid Services (CMS)
determines meet the above-listed standards and address the above-listed research questions.
C. Nationally Non-Covered Indications
Effective February 26, 2010, CMS determines 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 is
not reasonable and necessary under 1862(a)(1)(A) of the Act unless it is to inform initial antitumor treatment
strategy or to guide subsequent antitumor treatment strategy after completion of initial treatment, and then only
under CED. All other uses and clinical indications of NaF-18 PET are nationally non-covered.
D. Other
The only radiopharmaceutical diagnostic imaging agents covered by Medicare for PET cancer imaging are 2-
[F-18] Fluoro-D-Glucose (FDG) and NaF-18 (sodium fluoride-18). All other PET radiopharmaceutical
diagnostic imaging agents are non-covered for this indication.
You can find this information in Medicare's National Coverage Determination (NCD) for Positron Emission
Tomography (NaF-18) to Identify Bone Metastasis of Cancer (220.6.19).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.