Intensity Modulated Radiation Therapy (IMRT) Policy Number: Original Effective Date: MM.05.006 03/09/2004 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 05/01/2017 Section: Radiology Place(s) of Service: Outpatient I. Description Intensity modulated radiation therapy (IMRT) is an advanced form of three-dimensional conformal radiotherapy (3D CRT) that uses varying intensities of radiation to produce dose distributions that are more conformal than those possible with standard 3D CRT. The beam intensity is varied across the treatment field, delivering a more uniform dose of radiation to the tumor. This method of radiation delivery targets the tumor while sparing the surrounding normal tissues and/or organs. IMRT also allows for dose escalation which can potentially improve local tumor control resulting in prolonged survival for patients who have already received the maximum amount of radiation through conventional means. II. Criteria/Guidelines A. IMRT is covered (subject to Limitations and Administrative Guidelines) to treat the following conditions: 1. Tumors of the central nervous system, when the tumor is in close proximity to organs at risk (brain stem, spinal cord, cochlea and eye structures, including optic nerve and chiasm, lens and retina) and 3-D CRT planning is not able to meet dose volume constraints for normal tissue tolerance 2. Head and neck cancers defined as cancers arising from the oral cavity and lip, larynx, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, nasal cavity, salivary glands and occult primaries in the head and neck region 3. Localized prostate cancer defined as: a. Cancer confined to the prostate gland T1-T2N0-NXM0 or locally advanced cancer. Locally advanced cancer is confined to adjacent structures and includes T3a-T3bN0- NXM0. The presence of tumor invasion beyond extracapsular extension or other than seminal vesicles, or with evidence of regional lymph node involvement, in the absence of distant metastases T4N0-N1M0, does not necessarily preclude definitive therapy. The National Comprehensive Cancer Network (NCCN) has recommended a dose of 75.6 to 79.2 gray (Gy) in conventional fractions (with or without seminal vesicles) for patients with low-risk cancers.
Intensity Modulated Radiation Therapy 2 b. Low-risk features in localized prostate cancer are defined as stage T1-T2a, a Gleason score of 6 or less, and prostate-specific antigen (PSA) level less than 10 ng/ml. NCCN has recommended doses up to 81.0 Gy for patients with intermediate- and high-risk cancers, defined as: intermediate risk: stage T2b-T2c or Gleason score of 7 or PSA levels between 10 ng/ml and 20 ng/ml; and high risk: stage T3a or Gleason score of 8 to 10 or PSA level greater than 20 ng/ml 4. Post prostatectomy: radiotherapy as adjuvant or salvage therapy a. Adjuvant therapy is the use of radiotherapy after prostatectomy in patients at a higher risk of recurrence (before recurrence). In the adjuvant setting, adverse pathologic findings at prostatectomy include positive surgical margins, seminal vesicle invasion, extraprostatic extension, and Gleason scores of 8 to 10. b. Salvage therapy when there is evidence of biochemical or local recurrence without evidence of distant metastatic disease. Salvage radiotherapy to the prostate bed and possibly to surrounding tissues, including lymph nodes, in a patient with locoregional recurrence after surgery. In the salvage setting, biochemical recurrence is a detectable or rising PSA level of 0.2 ng/ml or higher after surgery, with a confirmatory test level of 0.2 ng/ml or higher. 5. Thyroid cancers in close proximity to organs at risk (esophagus, salivary glands, and spinal cord) and 3-D CRT planning is not able to meet dose volume constraints for normal tissue tolerance 6. Anal carcinoma 7. Tumors of the abdomen and pelvis (stomach/gastric, hepatobiliary tract, pancreas, rectal locations or cervical, endometrial and vulvar) when dosimetric planning with standard 3D conformal radiation predicts that the radiation dose to an adjacent organ would result in unacceptable adjacent critical structure toxicity 8. Lung cancer when all of the following criteria are met: a. Radiation therapy is being given with curative intent b. 3D conformal will expose >35% of normal lung tissue to more than 20Gy dose-volume (V20) c. IMRT dosimetry demonstrates reduction in the V20 to at least 10% below the V20 that is achieved with the 3D plan (e.g., from 40% down to 30% or lower) 9. Breast cancer: a. As a technique to deliver whole breast irradiation in patients receiving treatment for left-sided breast cancer after breast conserving surgery when all of the following conditions are met: i. Significant cardiac radiation exposure is expected to be greater than or equal to 25Gy to 10cm 3 or more of the heart (V25 greater than or equal to 10cm 3 ) with 3D conformal RT despite the use of a complex positioning device ii. With the use of IMRT, there is a reduction in the absolute heart volume receiving 25 Gy or higher by at least 20% (e.g., volume predicted to receive 25Gy by 3D RT is 20 cm 3 and the volume predicted by IMRT <16 cm 3 )
Intensity Modulated Radiation Therapy 3 b. In individuals with large breasts when the treatment planning with 3D conformal results in hot spots (focal regions with dose variation greater than 10% of target) and the hot spots are able to be avoided with IMRT B. For all indications, including those listed above, one or more of the following criteria for coverage must be documented in the medical record: a. The target volume is irregularly shaped and in close proximity to critical structure(s) that must be protected b. The volume of interest is in such location that its parameters can only be defined by MRI or CT c. Important structures adjacent to, but outside the volume of interest are sufficiently close to the margin such that IMRT is required for additional safety and morbidity reduction related to radiation d. IMRT is the only option to cover the volume of interest with narrow margins and protect adjacent structures e. An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision f. The target volume margins are concave and in close proximity to critical structures g. The tumor tissue lies in areas associated with target motion caused by cardiac and pulmonary cycles, and the IMRT is necessary in order to protect adjacent normal tissues h. Non-IMRT techniques would cause grade 2 or grade 3 radiation toxicity in greater than 15 percent of radiated cases. i. Only IMRT can produce dose distributions that can cover extremely concave target geometries. C. In addition, written documentation must include all of the following: 1. A written prescription that defines the goals and requirements of the treatment plan, including specific dose constraints for the targets and nearby critical structures 2. A statement by the radiation oncologist that documents the medical necessity for IMRT instead of conventional or 3D CRT which includes dose calculation and dose comparisons showing that the radiation dose to an adjacent organ would result in unacceptable normal tissue toxicity. III. Limitations A. IMRT is not covered as a replacement therapy for conventional and 3-D conformal radiation therapy methods. B. Real-time intra-fraction target tracking during radiation therapy to adjust radiation doses or monitor target movement during individual radiation therapy treatment sessions does not meet payment determination criteria (See HMSA s Real-Time Intra-Fraction Target Tracking during Radiation Therapy Policy for clarification). IV. Administrative Guidelines A. Precertification is required except for the conditions listed below. Complete HMSA's Precertification request and mail or fax the form as indicated. The request must include the following documentation:
Intensity Modulated Radiation Therapy 4 1. A written prescription that defines the goals and requirements of the treatment plan, including specific dose constraints for the target(s) and nearby critical structures 2. A statement by the radiation oncologist that documents the medical necessity for IMRT instead of conventional or 3D CRT which includes dose calculations and dose comparisons. 3. A signed and dated IMRT inverse plan that meets prescribed dose constraints for the PTV and surrounding normal tissue B. For the conditions that do not require precertification, the documentation listed above must be kept in the patient s medical records and be made available to HMSA upon request. HMSA reserves the right to perform periodic reviews on this service. C. HMSA has adopted Medicare s Correct Coding Initiative (CCI) coding edits for payment of IMRT services. A complete listing and explanation of the CCI edits may be found on the following web site: http://www.cms.hhs.gov/nationalcorrectcodinited/ D. Applicable codes: CPT Codes Description 77301 Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specification 77338 Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan 77385 Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple 77386 Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex HCPCS Codes G6015 G6016 Description Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session Compensator-based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session E. Code that does not meet payment determination criteria: CPT Codes Description 77387 Guidance for localization of target volume for delivery of radiation treatment delivery, includes intrafraction tracking, when performed G6017 Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy (eg,3d positional tracking, gating, 3d surface tracking), each fraction of treatment
Intensity Modulated Radiation Therapy 5 F. Codes that do not require precertification: ICD-10 Codes C00.0-C00.9 C01 C02.0-C02.9 C03.0-C03.9 C04.0-C04.9 C05.0-C05.9 C06.0-C06.2 C06.80-C06.89 Description Malignant neoplasm of lip, code range Malignant neoplasm of base of tongue Malignant neoplasm of other and unspecified parts of tongue, code range Malignant neoplasm of gum, code range Malignant neoplasm of floor of mouth, code range Malignant neoplasm of palate, code range Malignant neoplasm of other and unspecified parts of mouth, code range Malignant neoplasm of overlapping sites of other and unspecified parts of mouth, code range C06.9 Malignant neoplasm of mouth, unspecified C07 C08.0-C08.9 C09.0-C09.9 C10.0-C10.9 C11.0-C11.9 C12 C13.0-C13.9 C14.0-C14.8 C10.0-C10.9 C11.0- C11.9 C12 Malignant neoplasm of parotid gland Malignant neoplasm of other and unspecified major salivary glands, code range Malignant neoplasm of tonsil, code range Malignant neoplasm of oropharynx, code range Malignant neoplasm of nasopharynx, code range Malignant neoplasm of pyriform sinus Malignant neoplasm of hypopharynx, code range Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, code range Malignant neoplasm of oropharynx, code range Malignant neoplasm of nasopharynx, code range Malignant neoplasm of pyriform sinus C13.0 C13.9 Malignant neoplasm of hypopharynx, code range C14.0 C14.8 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, code range, code range C30.0 Malignant neoplasm of nasal cavity C31.0-C31.9 C32.0-C32.9 Malignant neoplasm of the accessory sinuses, code range Malignant neoplasm of the larynx, code range
Intensity Modulated Radiation Therapy 6 C61 Malignant neoplasm prostate C69.00-C69.92 Malignant neoplasm of eye and adnexa, code range C71.0-C71.9 Malignant neoplasm of brain, code range C75.1 Malignant neoplasm of pituitary gland C75.2 Malignant neoplasm of craniopharyngeal duct C79.31 Secondary malignant neoplasm of brain D32.0 Benign neoplasm of cerebral meninges D32.9 Benign neoplasm of meninges, unspecified D33.3 Benign neoplasm of cranial nerves D35.2 Benign neoplasm of pituitary gland D35.3 Benign neoplasm of craniopharyngeal duct D35.4 Benign neoplasm of pineal gland V2. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii s Patients Bill of Rights and Responsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. VI. References 1. Gregoire V, De Neve W, et. al. Intensity-Modulated radiation therapy for head and neck carcinoma. The Oncologist 2007; 12; 555-564. 2. International Radiosurgery Association (IRSA). Radiosurgery Practice Guidelines for IMRT. Copyright IRSA 2008.
Intensity Modulated Radiation Therapy 7 3. Kuppersmith RB, Greco SC, Teh BS, et al. Intensity modulated radiotherapy: first results with this new technology on neoplasms of the head and neck. Ear Nose Throat J. 1999; 78(4):238-248. 4. Lee N, Chuang C, Quivey JM, et al. Skin toxicity due to intensity-modulated radiotherapy for head and neck carcinoma. Int J Radiat Oncol Biol Phys. 2003; 55(4):1150. 5. Lee N, Xia P, Quivey JM, et al. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: An update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002; 53(1):12-22. 6. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Breast Cancer. Version 3. 2015 7. NCCN. Clinical Practice Guidelines in Oncology. Prostate Cancer V. 4. 2016. 8. NCCN. Clinical Practice Guidelines in Oncology. Gastric Cancer V. 3.2016. 9. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer V.3. 2016. 10. NCCN Clinical Practice Guidelines in Oncology. Small Cell Lung Cancer V. 1. 2016. 11. NCCN Clinical Practice Guidelines in Oncology. Anal Carcinoma. V. 1.2016. 12. NCCN Clinical Practice Guidelines In Oncology. Pancreatic Adenocarcinoma. V.2.2016. 13. Noridian LCD for Intensity Modulated Radiation Therapy (IMRT) L34217. Revised 10/01/2016. 14. BCBSA Medical Policy Reference Manual. Intensity Modulated Radiation Therapy (IMRT) of the Breast and Lung. #8.01.46. Reviewed April 2016. 15. BCBSA Medical Policy Reference Manual. Intensity Modulated Radiation Therapy (IMRT) of the Abdomen and Pelvis #8.01.43. Last reviewed December 2016. 16. BCBSA Medical Policy Reference Manual. Intensity Modulated Radiation Therapy (IMRT): Cancer of the Head and Neck or Thyroid. #8.01.48. Reviewed August 2016. 17. BCBSA Medical Policy Reference Manual. Intensity Modulated Radiotherapy of the Prostate. #8.01.47. Reviewed April 2016. 18. Sethi A, et al. Role of IMRT in reducing penile doses in dose escalation for prostate cancer. Int J Radiation Oncology Biol Phys. 2003; 55(4):970-978. 19. Zelefsky MJ, Fuks Z, Hunt M, et al. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 722 patients. Int J Radiation Oncology Biol Phys. 2003; 53(5):1111-1116. 20. Samson DM, Ratko TA, Rothenberg BM et al. Comparative effectiveness and safety of radiotherapy treatments for head and neck cancer. Comparative Effectiveness Review No. 20. (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidencebased Practice Center under Contract from the Agency for Healthcare Research and Quality. May 2010.