Humana Fusion Imaging for Cancer 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 Cancer Indications Page: 2 of 10 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) NCD NCD Positron Emission Tomography (FDG) for Oncologic Conditions Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer §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 220.6.17 220.6.19 LCA Independent Diagnostic Testing Facilities- physician supervision and technician requirements A54953 LCA LCA Billing and Coding: Positron Emission Tomography Scans Coverage Billing and Coding: Positron Emission Tomography Scans Coverage A54666 A54668 LCD LCA Independent Diagnostic Testing Facility (IDTF) L35448 A53252 LCD LCA LCA Multiple Imaging in Oncology L35391 A56848 Billing and Coding: Independent Diagnostic Testing Facilities (IDTF) A58559 LCD LCA Independent Diagnostic Testing Facility (IDTF) L33910 A57807 Fusion Imaging for Cancer Indications Page: 3 of 10 J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation 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) JL - Novitas Solutions, Inc. (Part A/B MAC) JJ - Palmetto GBA (Part A/B MAC) IA, KS, MO, NE IN, MI 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 DE, D.C., MD, NJ, PA AL, GA, TN JM - Palmetto GBA (Part A/B MAC) JN - First Coast Service Options, Inc. (Part A/B MAC) NC, SC, VA, WV FL, PR, U.S. VI Fusion Imaging for Cancer Indications Page: 4 of 10 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 cancer 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 scanning is frequently utilized in oncology for diagnosis, staging, restaging and monitoring cancer treatment response. The uEXPLORER is an example of a total-body PET/CT scanner which captures three-dimensional (3D) images of the entire body while using less radiation than other methods. Prostate-specific membrane antigen PET/CT (PSMA PET/CT) – PSMA PET/CT imaging enables detection of prostate cancer cells in an individual with recurrent or metastatic castration-resistant prostate cancer by using radiotracers that bind specifically to the PSMA proteins that are overexpressed in prostate cancer tissue. A PSMA PET/CT scan is used to localize and direct treatment for an individual at high risk for metastasis or recurrence following surgery or radiation therapy. Computer aided detection (CAD) is used in conjunction with magnetic resonance imaging (MRI) or ultrasound to purportedly define the location or position of the area requiring biopsy. Examples of CAD used for prostate biopsies include, but may not be limited to, DynaCAD (CAD with magnetic resonance imaging [MRI]) and Fusion Bx 2.0 (CAD with ultrasound). 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. MRI/transrectal ultrasound (MRI/TRUS) fusion imaging for biopsy of the prostate – MRI/TRUS uses software to combine detailed images obtained from a previously performed multiparametric MRI (mpMRI) with the less detailed real-time TRUS, through an overlaid 3D view. The fused images guide the placement of the biopsy needle to suspicious lesions identified from the MRI for prostate biopsy. An example of a US Food & Drug Administration (FDA)-approved MRI/TRUS fusion biopsy platform system is UroNav. Fusion Imaging for Cancer Indications Page: 5 of 10 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. SeeFactor CT3 is a high-definition 3D volumetric imaging (HDVI) 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 CT (SPECT/CT) – SPECT/CT uses radioactive contrast agents and a scanner to record data that a computer constructs into 2D or 3D images. A small amount of radioactive agent is introduced (intravenously or orally) while a scanner measures the emission of single photons to make detailed images of areas inside the body where the radioactive material is taken up by the cells. SPECT provides information about blood flow to tissues and chemical reactions (metabolism) in the body. SPECT and CT images can be fused by software or processed by combined SPECT/CT scanners. It is suggested that incorporating CT data with SPECT images allows improved views of the location and changes in tissue. The Symbia Intevo is an example of a SPECT/CT device. 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 cancer 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 Cancer 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 Cancer Indications Page: 6 of 10