Intensity Modulated Radiation Therapy (IMRT)

Transcription

1 Intensity Modulated Radiation Therapy (IMRT) Policy Number: Original Effective Date: MM /09/2004 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST 02/01/2013 Section: Radiology Place(s) of Service: Outpatient I. 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 IMRT is covered (subject to Limitations/Exclusions and Administrative Guidelines) in the following situations: A. 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 B. 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 C. Prostate cancer D. 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

2 Intensity Modulated Radiation Therapy 2 E. Squamous cell cancer of the anus/anal canal F. Lung cancer when all of the following criteria are met: 1. Radiation therapy is being given with curative intent 2. 3D conformal will expose >35% of normal lung tissue to more than 20Gy dose-volume (V20) 3. 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) G. Breast cancer: 1. As a technique to deliver whole breast irradiation in patients receiving treatment for leftsided breast cancer after breast conserving surgery when all of the following conditions are met: a. Significant cardiac radiation exposure is expected to be greater than or equal to 25Gy to 10cc or more of the heart (V25 greater than or equal to 10cc) with 3D conformal RT despite the use of a complex positioning device b. 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 cc and the volume predicted by IMRT is 16 cc or less) 2. 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 H. IMRT may be covered (Subject to Limitations/Exclusions and Administrative Guidelines) for other indications not listed above if the treating physician has written documentation* that the isodose curves substantiate the advantage of IMRT when compared to other radiation treatment techniques (including conventional or 3-D conformal) AND the patient has at least one of the following: 1. The target volume is in close proximity to critical structure(s) that must be protected 2. The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures 3. An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision 4. The target volume is concave or convex and critical normal tissues are within or around that convexity or concavity 5. Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional radiation treatment * Written documentation must include all of the following: A written prescription that defines the goals and requirements of the treatment plan, including specific dose constraints for the targets and nearby critical structures

3 Intensity Modulated Radiation Therapy 3 A statement by the treating physician that documents the medical necessity for IMRT instead of conventional or 3D CRT treatment planning and delivery, including the need to protect pertinent vital structures III. Limitations/Exclusions 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: 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 treating physician that documents the medical necessity for IMRT instead of conventional or 3D CRT treatment planning and delivery, including the need to protect pertinent vital structures B. HMSA reserves the right to perform periodic reviews on this service for all indications. The following documentation must be kept in the patient's medical records and be made available upon request: 1. The reason IMRT was chosen over other radiation treatments 2. A prescription, defining the goals and requirements of the treatment plan, including the specific dose constraints for the targets and nearby critical structures 3. A signed and dated IMRT inverse plan that meets prescribed dose constraints for the PTV and surrounding normal tissue using either dynamic multi-leaf collimator or segmented multi-leaf collimator to achieve intensity modulation radiation delivery 4. The target verification methodology including: a. Documentation of the clinical treatment volume and the PTV b. Documentation of immobilization and patient positioning c. Means of dose verification and secondary means of verification 5. An independent check of the monitor units generated by the IMRT treatment plan, prior to the patient's first treatment 6. Fluence distributions re-computed in a phantom 7. Plan to account for structures moving in and out of high and low dose regions created by respiration. Voluntary breath holding is not considered appropriate and the solution for movement can best be accomplished with gating technology

4 Intensity Modulated Radiation Therapy 4 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: D. Applicable codes: CPT Codes Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specification Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan *Report once per IMRT plan and cannot not be reported with 0073T 0073T Compensator-based beam modulation treatment delivery of inverse planned treatment using three 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 0197T Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy, each fraction of treatment F. Codes that do not require precertification: ICD-9 Codes Malignant neoplasm of lip, oral cavity, and pharynx, code range nasal cavities of the accessory sinuses, code range Larynx, code range 185 Prostate Malignant neoplasm of eye, code range of brain, code range pituitary gland and craniopharyngeal duct Secondary malignant neoplasm of brain and spinal cord Benign neoplasm of cranial nerves

5 Intensity Modulated Radiation Therapy cerebral meninges of other endocrine glands and related structures, pituitary gland and craniopharyngeal duct (pouch) pineal gland ICD-10 codes are provided for your information. These will not become effective until 10/1/2014: 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-C06.9 C07 C08.0-C08.9 C09.0-C09.9 C10.0-C10.9 C11.0-C11.9 C12 C13.0-C13.9 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 hard palate, code range Malignant neoplasm of other and unspecified parts of mouth, code range Malignant neoplasm of parotid gland Malignant neoplasm of other and unspecified major salivary glands 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 C14.0-C14.8 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity, and pharynx, code range C30.0 Malignant neoplasm of nasal cavity C31.0-C31.9 C32.0-C32.9 C61 C C69.92 C71.0-C71.9 Malignant neoplasm of the accessory sinuses, code range Malignant neoplasm of the larynx, code range Malignant neoplasm prostate Malignant neoplasm of eye and adnexa, code range Malignant neoplasm of brain, code range

6 Intensity Modulated Radiation Therapy 6 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 VI. 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. ECRI institute. Custom Hotline Response. Intensity modulated radiation therapy for breast cancer. Updated 04/01/ Gregoire V, De Neve W, et. al. Intensity-Modulated radiation therapy for head and neck carcinoma. The Oncologist 2007; 12; International Radiosurgery Association (IRSA). Radiosurgery Practice Guidelines for IMRT. Copyright IRSA 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):

7 Intensity Modulated Radiation Therapy 7 5. 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): 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): National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Breast Cancer. Version NCCN. Clinical Practice Guidelines in Oncology. Prostate Cancer v NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer V NCCN Clinical Practice Guidelines in Oncology. Small Cell Lung Cancer Version NCCN Clinical Practice Guidelines in Oncology. Anal Carcinoma. Version Palmetto GBA. LCD for Intensity Modulated Radiation Therapy (IMRT) L Revision effective date 10/01/ BCBSA Medical Policy Reference Manual. Intensity Modulated Radiation Therapy (IMRT) of the Breast and Lung. # Reviewed March BCBSA Medical Policy Reference Manual. Intensity Modulated Radiation Therapy (IMRT) of the Abdomen and Pelvis # Last reviewed 08/ 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): 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): 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.