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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 noncovered.
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.