Humana Brachytherapy - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Applicable States/Territories Brachytherapy Page: 2 of 26 Contractors (MACs) J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation JE - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC J6 - National Government Services, Inc. (Part A/B MAC) AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY IN, MI AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY IN, MI CA, HI, NV, American Samoa, Guam, Northern Mariana Islands AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY IL, MN, WI LCD LCA Category III Codes L35490 A56902 LCA Billing and coding: percutaneous coronary interventions A57479 Billing and coding: treatment with Yttrium-90 microspheres Billing and coding: treatment with Yttrium-90 microspheres A54072 A52950 Prostate Rectal Spacers L37485 LCA LCA LCD LCA Brachytherapy Page: 3 of 26 A56539 JK - National Government Services, Inc. (Part A/B MAC CT, NY, ME, MA, NH, RI, VT Description Brachytherapy, also known as internal radiation therapy, is a treatment in which radioactive sources are placed inside an individual either temporarily (via a catheter or tube for a specific time and withdrawn) or permanently (seeds or pellets in or near the tumor which are not removed). Brachytherapy can be used to treat cancer throughout the body. Brachytherapy can also be utilized to prevent intracoronary restenosis after stent placement. Based on the technique, either high-dose rate (HDR) or low-dose rate (LDR) brachytherapy can be utilized. There are two main types of brachytherapy, which include intracavity and interstitial. Intracavity treatment involves the placement of a radioactive source in the body cavity near the tumor (eg, cervix, trachea, vagina) and interstitial treatment is performed by placing the radioactive source in the form of seeds, pellets or sheets directly into or around the tissue. Examples of interstitial radiation therapy include, but may not be limited to, CivaSheet (eg, prostate cancer) or GammaTile (eg, brain tumors). Another type of treatment is surface brachytherapy (may also be known as plaque brachytherapy), which is performed when the radiation sources are placed directly on an external tumor or target surface (eg, eye, skin cancer). Brachytherapy can be delivered using several methods including, but may not be limited to: • Breast brachytherapy treatment delivers radiation via a balloon catheter following a lumpectomy to the space left after the cancerous tumor is removed and to the tissue directly surrounding the cavity. By delivering radiation to the area directly surrounding the original tumor, radiation exposure is minimized to the rest of the breast and other organs. Examples of delivery systems include, but may not be limited to, the CONTURA Multi-Lumen Balloon (MLB) Catheter, MammoSite Radiation Therapy System (RTS), the and the SAVI applicator, which is a single-entry device that allows physicians to customize radiation treatments based on individual-specific anatomy. • Electronic brachytherapy (EBT) is radiotherapy uses an HDR, low-energy X-ray source to apply brachytherapy to the cancerous site. Purportedly, EBT is utilized to provide intracavity, interstitial or surface brachytherapy. EBT is being studied for use during intraoperative radiation therapy (IORT) for brain tumors. Following surgical removal of the tumor and the placement of a radiation therapy applicator into the tumor cavity, EBT is reportedly delivered directly to the tumor bed. Examples of EBT devices include, but may not be limited to, the Xoft Axxent Electronic Brachytherapy System, the Esteya EBT system and the INTRABEAM system. • Intracoronary brachytherapy is used to prevent restenosis of an artery after angioplasty or stent placement by delivering a small amount of radiation to the treated area, which may reduce the need for additional angioplasty or bypass surgery. The radiation is intended to discourage the overgrowth of normal tissue as the healing process occurs. Brachytherapy Page: 4 of 26 • Intravascular brachytherapy has been investigated as an adjunct to angioplasty of the femoropopliteal segment to reduce the risk of restenosis. • Noninvasive brachytherapy of the breast involves the use of mammography, which reportedly provides real-time images of the lumpectomy cavity and identifies the size and location needed for the dosing applicators. Noninvasive HDR brachytherapy applicators are positioned on opposite sides of the breast and radiation is delivered directly to the target site. An example of a noninvasive brachytherapy device is the Accuboost system. • Selective internal radiation therapy (SIRT), also known as radioembolization, is a procedure in which tiny radiation-filled beads (eg, yttrium-90), called microspheres, are delivered directly to the tumor. The microspheres are delivered through a catheter placed in the femoral artery and threaded through the hepatic artery to the tumor site. Examples of this type of treatment include, but may not be limited to: o SIR-Spheres are resin spheres that are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer (CRC). o Theraspheres are spheres made of glass, which are indicated for unresectable primary hepatocellular carcinoma (HCC). The placement of a transperineal biodegradable spacer also known as prostate rectal spacers (eg, Barrigel, SpaceOAR, SpaceOAR Vue) positions the anterior (frontal) section of the rectal wall away from the prostate during external beam radiotherapy treatments for prostate cancer with the goal of limiting the radiation exposure to the anterior rectum. Because this material is biodegradable, it is absorbed over time by the individual’s body. SpaceOAR is comprised of a synthetic, absorbable polyethylene glycol-based hydrogel. SpaceOAR Vue contains PEGylated iodine, which is designed to enhance visibility via CT scan. Barrigel injectable gel is similar to the SpaceOAR product; however, it is made of stabilized hyaluronic acid. 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. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Please refer to the above CMS guidance for use of brachytherapy for percutaneous coronary interventions and electronic brachytherapy (category III codes). Brachytherapy will be considered medically reasonable and necessary when the following requirements are met: Brachytherapy Page: 5 of 26 • Breast cancer: o Accelerated partial breast irradiation (APBI) when the following indications are met22,64,89:  50 years of age or older; AND  Invasive carcinoma or ductal carcinoma in situ (DCIS); AND  Node negative; AND  Total tumor size less than or equal to 2 cm64; AND  Tumor removed with negative surgical margins; OR o Adjunctive boost to the tumor bed in an individual receiving whole breast radiation therapy (WBRT) following breast conserving surgery (eg, lumpectomy)89; OR • Cholangiocarcinoma as secondary or adjuvant treatment when the following indications are met138: o Carcinoma in situ at margin; OR o Positive regional nodes; OR o Resected gross residual disease (R2); OR o Resected, positive margin (R1); OR • Esophageal cancer when the following indications are met18,125: o Palliative treatment for dysphagia; OR o Unresectable, nonmetastatic disease; OR • Gynecologic cancer (cervical, endometrial/uterine, vaginal or vulvar); OR • Head and neck cancer (brain, lip, nasopharyngeal, oral cavity, salivary gland, uveal melanoma); OR • Intracoronary application for in-stent restenosis following angioplasty or stent placement10; OR • Lung cancer when the following indications are met12,26,97: o Endobronchial treatment of the central airway in an individual who are not candidates for surgical resection; OR o Palliative treatment for an individual with unresectable disease and symptomatic airway obstruction; OR • Neuroendocrine tumors when the following indications are met96: o Metastasis to the liver when systemic therapy is contraindicated; OR o Systemic therapy has failed to control symptoms (eg, carcinoid syndrome); OR • Penile cancer when the following indications are met98: Brachytherapy Page: 6 of 26 o Node negative; AND o T1 or T2 disease; AND o Tumors less than 4 cm confined to the glans and prepuce; OR • Prostate cancer when the following requirements are met: o Low risk localized prostate cancer when the following indications are met36,82:  Grade group 1 (Gleason score less than 6); AND  Serum PSA less than 10 ng/ml; AND  Stage T1 or T2a; OR o Intermediate-risk prostate cancer when the following indications are met36,82:  Grade group 2-3 (Gleason score 7); AND  Serum PSA greater than or equal to 10 ng/ml and less than 20 ng/ml; AND  Stage T2b – T2c; OR o High-risk prostate cancer as a boost when the following indications are met36,82:  Grade group 4-5 (Gleason score 8-10); AND  Serum PSA greater than or equal to 20 ng/ml; AND  Stage T3 or greater60; OR • Retinoblastoma when the following indications are met6,64: o As a secondary treatment after local treatment failure (eg, cryoablation, external beam radiation therapy [EBRT], laser therapy, local or systemic chemotherapy); OR • SIRT when the following indications are met: o SIR-Spheres for unresectable metastatic liver tumors from primary colorectal cancer (CRC) with adjuvant intra-hepatic artery chemotherapy145; OR o TheraSphere when the following indications are met146:  Unresectable HCC of solitary tumor (1-8 cm in diameter); AND  Child-Turcotte-Pugh Score A cirrhosis; AND  Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2; AND  No macrovascular invasion; AND  Well-compensated liver function (eg, no signs or symptoms of decompensation such as ascites, hepatic encephalopathy, jaundice or variceal hemorrhage) Brachytherapy Page: 7 of 26 • Soft tissue sarcoma when the following indications are met64,101: o Positive margins; AND o Tumor size greater than 5 cm Electronic brachytherapy will be considered medically reasonable and necessary with documentation of medical necessity for the following38: • Interstitial applications • Intracavity applications • Skin surface applications Transperineal biodegradable spacer also known as prostate rectal spacers (eg, Barrigel, SpaceOar, SpaceOAR Vue) will be considered medically reasonable and necessary for use during prostate cancer radiation therapy. 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 The following services will not be considered medically reasonable and necessary: • Age-related macular degeneration • Intravascular brachytherapy following femoropopliteal angioplasty • Noninvasive brachytherapy • Pancreatic cancer A review of the current medical literature shows that there is no evidence to determine that these services are standard medical treatments. There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management. The following service will not be considered medically reasonable and necessary: Brachytherapy Page: 8 of 26 • Bladder cancer A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management. Summary of Evidence Bladder cancer Interstitial brachytherapy has been used in a number of specialized centers to treat small, solitary muscle- invasive bladder cancers; however, the quality of this evidence is low and the role of selection is paramount. It has not been determined whether interstitial brachytherapy reduces local recurrence rates.37