(Medicare National Coverage Determinations Manual)

c. The evaluation of the patient has been conducted by a physician experienced in the diagnosis and assessment of dementia;   d. The evaluation of the patient did not clearly determine a specific neurodegenerative disease or other cause for the clinical symptoms, and information available through FDG PET is reasonably expected to help clarify the diagnosis between FTD and AD and help guide future treatment;  e. The FDG PET scan is performed in a facility that has all the accreditation necessary to operate nuclear medicine equipment.  The reading of the scan should be done by an expert in nuclear medicine, radiology, neurology, or psychiatry, with experience interpreting such scans in the presence of dementia;   f. A brain single photon emission computed tomography (SPECT) or FDG PET scan has not been obtained for the same indication.  (The indication can be considered to be different in patients who exhibit important changes in scope or severity of cognitive decl ine, and meet all other qualifying criteria listed above and below (including the judgment that the likely diagnosis remains uncertain.)  The results of a prior SPECT or FDG PET scan must have been inconclusive or, in the case of SPECT, difficult to interpret due to immature or inadequate technology.  In these instances, an FDG PET scan may be covered after 1 year has passed from the time the first SPECT or FDG PET scan was performed.)   g. The referring and billing provider(s) have documented the appropriate evaluation of the Medicare beneficiary.  Providers should establish the medical necessity of an FDG PET scan by ensuring that the following information has been collected and is maint ained in the beneficiary medical record:   o Date of onset of symptoms;  o Diagnosis of clinical syndrome (normal aging; mild cognitive impairment (MCI); mild, moderate or severe dementia);  o Mini mental status exam (MMSE) or similar test score;  o Presumptive cause (possible, probable, uncertain AD);  o Any neuropsychological testing performed;  o Results of any structural imaging (MRI or CT) performed;  o Relevant laboratory tests (B12, thyroid hormone); and, o Number and name of prescribed medications.  The billing provider must furnish a copy of the FDG PET scan result for use by CMS and its MACs upon request.  These verification requirements are consistent with Federal requirements set forth in 42 Code of Federal Regulations, section 410.32 generally for diagnostic x- ray tests, diagnostic laboratory tests, and other tests.  In summary, section 410.32 requires the billing physician and the referring physician to maintain information in the medical record of each patient to demonstrate medical necessity [4 10.32(d) (2)] and submit the information demonstrating medical necessity to CMS and/or its agents upon request [410.32(d)(3)(I)] (OMB number 0938- 0685).   2. FDG PET Requirements for Coverage in the Context of a CMS -approved Practical Clinical Trial Utilizing a Specific Protocol to Demonstrate the Utility of FDG PET in the Diagnosis, and Treatment of Neurodegenerative Dementing Diseases   An FDG PET scan is considered reasonable and necessary in patients with MCI or early dementia (in clinical circumstances other than those specified in subparagraph 1) only in the context of an approved clinical trial that contains patient safeguards and pr otections to ensure proper administration, use and evaluation of the FDG PET scan.   The clinical trial must compare patients who do and do not receive an FDG PET scan and have as its goal to monitor, evaluate, and improve clinical outcomes. In addition, it must meet the following basic criteria:  a. Written protocol on file;  b. Institutional Review Board review and approval;  c. Scientific review and approval by two or more qualified individuals who are not part of the research team; and,  d. Certification that investigators have not been disqualified.  C.  Nationally Non -Covered Indications   All other uses of FDG PET for patients with a presumptive diagnosis of dementia -causing neurodegenerative disease (e.g., possible or probable AD, clinically typical FTD, dementia of Lewy bodies, or Creutzfeld- Jacob disease) for which CMS has not specifical ly indicated coverage continue to be non- covered.   D. Other  Not applicable.   220.6.14- FDG PET for Brain, Cervical, Ovarian, Pancreatic, Small  Cell Lung, and Testicular Cancers (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04 -10-23)    Please note section 220.6.14 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.15- FDG PET for All Other Cancer Indications Not Previously  Specified (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.15 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.    220.6.16- FDG PET for Infection and Inflammation (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January  1, 2021, the Centers  for Medicare & Medicaid  Services  determined  that no national coverage determination (NCD) is appropriate at this time for FDG PET for Inflammation and Infection. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act.   220.6.17 - Positron Emission Tomography (FDG PET) f or Oncologic Conditions (Effective June 11, 2013)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General  FDG (2 -[F18] fluoro -2-deoxy- D-glucose) Positron Emission Tomography ( PET) is a minimally -invasive diagnostic imaging procedure used to evaluate glucose metabolism in normal tissue as well as in diseased tissues in conditions such as cancer, ischemic heart disease, and some neurologic disorders.  FDG is an injected radionucl ide (or radiopharmaceutical) that emits sub -atomic particles, known as positrons, as it decays.  FDG PET uses a positron camera (tomograph) to measure the decay of FDG.  The rate of FDG decay provides biochemical information on glucose metabolism in the ti ssue being studied.  As malignancies can cause abnormalities of metabolism and blood flow, FDG PET evaluation may indicate the probable presence or absence of a malignancy based upon observed differences in biologic activity compared to adjacent tissues.  The Centers for Medicare and M edicaid Services (CMS) was asked by the National Oncologic PET Registry (NOPR) to r econside r section 220.6 of  the National Coverage Determinations (NCD) Manual to e nd the  prospective data collection re quirements under Coverage with Evidence Development (CED) a cross a ll oncologic indications of  FDG P ET imaging.  The  CMS receiv ed publ ic input indi cating  that the current coverage framework of prospective data collection under CED be ended for all oncologic uses of FDG PET imaging.   1. Framework  Effective for claims with d ates of service on a nd after June 11, 2013, C MS is adopting a coverage framework tha t ends the prospective data collection requirements by NOPR under CED for all oncologic uses of FDG PET imaging .  CMS is m aking this c hange for all NCDs th at address coverage of FDG PET for oncologic uses  addressed in this decisi on.  This decision does not change coverage for any use of PET imaging using radiopharmaceuticals NaF -18 (fluorine -18 labeled sodium fluoride), ammonia N -13, or rubidium -82 (Rb- 82).    2. Initial A nti-Tumor Treatment Strategy  CMS continues to believe that the  evidence is adequate to de termine  that the results of  FDG PET im aging ar e useful in de termining  the appropriate initia l anti- tumor trea tment strategy for beneficiaries with susp ected cancer  and improve health out comes and thus are reasonable and necessary under 1862(a)(1 )(A) of the Social Security Act (the Act).  Therefore, CMS continues to nationally  cover one  FDG PET  study f or beneficiaries who ha ve cancers th at are biops y proven or strongly suspected based on othe r diagnostic  testing whe n the  beneficiarys treating  physician determines that the FDG P ET study is needed to de termine  the location a nd/or e xtent of the tumor  for the following therapeutic purposes related to the  initia l anti-tumor t reatme nt strategy:   To determine  whether or not the  beneficiary is an appropriate candida te for an inva sive diagnostic  or therapeutic procedur e; or   To determine  the optim al anatomic  location for an inva sive procedu re; or   To determine  the anatomic extent of tumor  when the  recomm ended anti-tumor  treatme nt reasona bly depends on t he extent of the tumo r.  See the table at the end of this section for a synopsis of all nationally covered and non- covered oncologic uses of FDG PET imaging.  B.1. Initial Anti- Tumor Treatment Strategy Nationally Covered Indications   a. CMS continues to na tionally  cover FDG P ET im aging for the initia l anti- tumor tre atment strategy for male and fe male breast cancer only when used in staging distant metastasis.  b. CMS continues to nationally cover FDG PET  to determine  initia l anti -tumor treatme nt strategy for m elanoma  other than for the evaluation of regional lymph nodes.  c. CMS continues  to nationally  cover FDG P ET im aging for the detection of  pre-treatme nt metastasis (i.e., staging) in newly diagnosed cer vical cancers.   C.1 Initial Anti- Tumor Treatment Strategy Nationally Non- Covered Indications   a.  CMS continues to nationally non- cover initial anti -tumor treatment strategy in Medicare beneficiaries who have adenocarcinoma of the prostate.   b. CMS continues to nationally non- cover FDG P ET im aging for diagnosis of breast cancer and initi al staging of axillary node s.  c. CMS continues to natio nally non- cover FDG P ET imaging for initial anti- tumor treatment strategy f or the evaluation of  regional lymph nod es in m elanoma.  d. CMS continues to na tionally  non-cover FDG PET imaging  for the diagnosis of  cervical cancer related to initia l anti- tumor t reatme nt strategy.    3. Subs equent Anti-Tumor Treatment Strategy  B.2. Subsequent Anti -Tumor Treatment Strategy Nationally Covered Indications   Three FDG PET scans are nationally covered when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti- cancer therapy.  Coverage of more than three FDG PET scans to guide subsequent management of anti -tumor treatment strategy after completion of initial anti- cancer therapy shall be determined by the MACs.  4. Synops is of Coverage of FDG PET for Oncologic Conditions   Effective for claims with d ates of service on a nd after June 11, 2013, t he chart below summ arizes national F DG P ET c overage for oncologic conditions:   FDG PET for Cancers  Tumor Type  Initial Treatment Strategy  (formerly diagnosis & staging  Subsequent Treatment Strategy (formerly restaging & monitoring response to treatment  Colorectal  Cover  Cover  Esophagus  Cover  Cover  Head and Neck (not thyroid, CNS)  Cover  Cover  Lymphoma  Cover  Cover  Non-small cell lung  Cover  Cover  Ovary  Cover  Cover  Brain  Cover  Cover  Cervix  Cover with exceptions *  Cover  Small cell lung  Cover  Cover  Soft tissue sarcoma  Cover  Cover  Pancreas  Cover  Cover  Testes  Cover  Cover  Prostate  Non-cover  Cover  Thyroid  Cover  Cover  Breast (male and female)  Cover with exceptions *  Cover  Melanoma  Cover with exceptions *  Cover  All other solid tumors  Cover  Cover  Myeloma  Cover  Cover  All other cancers not listed  Cover  Cover   *Cervix:  Nationally  non-covered for the initia l diagnosis of  cervical cancer related to initia l anti-tumor t reatme nt strategy.  All o ther indications for initia l anti- tumor t reatme nt strategy for cer vical cancer are nationally  covered.