Humana Fusion Imaging for Noncancer Indications - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories Fusion Imaging for Noncancer Indications Page: 2 of 11 Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services §80 - Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4 §220 - Radiology Internet- Only Manuals (IOMs) Pub. 100-04, Medicare Claims Processing Manual, Chapter 1 (General Billing Requirements) & 35 (Independent Diagnostic Testing Facility [IDTF]) Pub. 100-08, Medicare Program Integrity Manual, Chapter 3 (Verifying Potential Errors and Taking Corrective Actions), 10 (Medicare Enrollment) & 13 (Local Coverage Determination) §30 - Provider Participation §10 - General Coverage and Payment Policies §3.2 - Overview of Prepayment and Postpayment Reviews §10.2.4 - Other Medicare Part B Services §13.2 LCD Process NCD NCD NCD PET for Perfusion of the Heart FDG PET for Myocardial Viability FDG PET for Refractory Seizures 220.6.1 220.6.8 220.6.9 NCD FDG PET for Dementia and Neurodegenerative Diseases 220.6.13 Fusion Imaging for Noncancer Indications Page: 3 of 11 LCA LCD LCA LCA LCA Independent Diagnostic Testing Facilities- physician supervision and technician requirements A54953 Positron Emission Tomography (PET) Scan for Inflammation and Infection L39521 A59318 Billing and Coding: Positron Emission Tomography Scans Coverage Billing and Coding: Positron Emission Tomography Scans Coverage A54666 A54668 L35083 A56423 LCD LCA Cardiology Non-emergent Outpatient Stress Testing LCD LCA Independent Diagnostic Testing Facility (IDTF) L35448 A53252 LCA LCA Billing and Coding: NCD Coding Article for Positron Emission Tomography (PET) Scans Used for Non-Oncologic Conditions A53134 Billing and Coding: Independent Diagnostic Testing Facilities (IDTF) A58559 J5 - Wisconsin Physicians Service J8 - Wisconsin Physicians Service Insurance Corporation J15 - CGS Administrators, LLC (Part A/B MAC) JE - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC JH - Novitas Solutions, Inc. (Part A/B MAC) JL - Novitas Solutions, Inc. (Part A/B MAC) JH - Novitas Solutions, Inc. (Part A/B MAC) JH - Novitas Solutions, Inc. (Part A/B MAC) JL - Novitas Solutions, Inc. (Part A/B MAC) JJ - Palmetto GBA (Part A/B MAC) IA, KS, MO, NE IN, MI KY, OH CA, HI, NV, American Samoa, Guam, Northern Mariana Islands AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY AR, CO, NM, OK, TX, LA, MS DE, D.C., MD, NJ, PA AR, CO, NM, OK, TX, LA, MS AR, CO, NM, OK, TX, LA, MS DE, D.C., MD, NJ, PA AL, GA, TN NC, SC, VA, WV LCD LCA LCD LCA LCD LCA LCA Cardiac Radionuclide Imaging Independent Diagnostic Testing Facility (IDTF) Cardiology Non-emergent Outpatient Stress Testing Billing and Coding: NCD Coding Article for Positron Emission Tomography (PET) Scans Used for Non-Oncologic Conditions L33457 A56476 L33910 A57807 L38396 A56952 A59049 Fusion Imaging for Noncancer Indications Page: 4 of 11 JM - Palmetto GBA (Part A/B MAC) JJ - Palmetto GBA (Part A/B MAC) JN - First Coast Service Options, Inc. (Part A/B MAC) JN - First Coast Service Options, Inc. (Part A/B MAC) JN - First Coast Service Options, Inc. (Part A/B MAC) AL, GA, TN FL, PR, U.S. VI FL, PR, U.S. VI FL, PR, U.S. VI Description Fusion imaging combines two different imaging scans to create a more detailed picture for screening or diagnosis than either individual scan. The following are examples of fusion imaging for noncancer indications: Positron emission tomography with concurrent computed tomography (PET/CT) – PET assesses the function of tissues and organs by monitoring the metabolic or biochemical activity while tracking the movement and concentration of a radioactive contrast agent. The technique uses special computerized imaging equipment and rings of detectors surrounding the individual to record gamma radiation produced when positrons (positively charged particles) emitted by the radioactive agent collide with electrons. CT combines digital computing with a rotating x-ray device to generate detailed cross-sectional pictures of the imaged body area. Integrated PET/CT imaging is a technique in which both PET and CT are performed during a single visit on a hybrid PET/CT scanner (eg, Biograph mCT). The CT and PET images are then co- registered using fusion software, enabling the physiologic data obtained on PET to be localized according to the anatomic CT images. When PET/CT is performed, a low radiation dose CT without contrast is typically used to keep the radiation dose as low as possible and to limit adverse events. A higher resolution CT requires a higher dose of radiation and intravenous (IV) contrast. PET/CT is used in myocardial viability or myocardial perfusion studies to determine problems in the heart such as reduced blood flow or ineffective heart muscle activity. During cardiac testing, the CT provides attenuation correction which clarifies certain small errors in the image. Absolute quantitation of myocardial blood flow is an adjunct to PET myocardial perfusion imaging that aids in analyzing coronary artery disease. Fusion Imaging for Noncancer Indications Page: 5 of 11 Neurological uses for PET/CT scanning include evaluation of seizure activity prior to surgery. It is also proposed for diagnosing and distinguishing between Alzheimer’s and other types of dementia. Magnetic resonance imaging/computed tomography (MRI/CT) – MRI uses nuclear magnetic resonance to detect atomic nuclei or electron particle energy absorption when exposed to electromagnetic radiation. The images produced are used to diagnose disorders of body structures (eg, soft tissues) that are not easily visualized on standard x-rays. Fusing MRI with CT generates detailed cross-sectional images of the targeted body areas. PET/MRI – PET/MRI combines PET functional imaging simultaneously with MRI soft-tissue morphological imaging to reportedly produce enhanced image quality with a reduced radiation dose and prevention of fusion software image mismatch. A PET/MRI using a hybrid imaging system is suggested for imaging anatomical, biochemical and functional characteristics of disease. The Biograph mMR is an example of a PET/MRI device. High-definition 3D volumetric imaging (HDVI) – See Factor CT3 is a platform that uses HDVI CT, fluoroscopy and digital radiography. It is proposed for diagnostic, interventional and intraoperative imaging of the head, neck, upper spine, upper and lower extremities. Single-photon emission computed tomography with concurrently acquired MRI (SPECT/MRI) – Simultaneous SPECT and MRI images are fused by software which is suggested to provide improved views of anatomical structures. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the above CMS guidance for fusion imaging for noncancer indications. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria. Fusion Imaging for Noncancer Indications The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Fusion Imaging for Noncancer Indications Page: 6 of 11