Radiation Therapy for Non-Cancerous Conditions - CAM 758HB

Description/Backgound
Radiation therapy may have appropriate use in several non-malignant conditions. The treatment goal in patients with non-malignant conditions is to achieve relief of the indicated condition with radiation therapy with minimal risk of radiation exposure to sensitive structures.

GENERAL INFORMATION

It is an expectation that all patients receive care/services from a licensed clinician. All appropriate supporting documentation, including recent pertinent office visit notes, laboratory data, and results of any special testing must be provided. If applicable: All prior relevant imaging results and the reason that alternative imaging cannot be performed must be included in the documentation submitted.

Where a specific clinical indication is not directly addressed in this guideline, medical necessity determination will be made based on widely accepted standard of care criteria. These criteria are supported by evidence-based or peer-reviewed sources such as medical literature, societal guidelines and state/national recommendations.
 

Policy 
INDICATIONS FOR RADIATION THERAPY 
2D or 3D Conformal (3D CRT) is considered medically necessary for several non-malignant conditions, including but not limited to:1,2,3,4,5,6,7,8,9,10,11,12

  • Prevention of keloid scars as an adjunctive therapy following excisional surgery: superficial X-ray, electron beam, or conventional isodose technique photon beam therapy in 4 or fewer fractions.13
  • Heterotopic ossification: 7 Gy to 8 Gy in a single fraction of 2D.
  • Pterygium in cases that cannot be medically managed: contact beta brachytherapy in 3 fractions.
  • Villonodular synovitis (recurrent after resection, or diffuse or bulky disease-causing bone destruction: 28 or fewer fractions of 2D/3D-CRT.
  • Pinealoma (pineal parenchymal tumors): Postoperative radiation for incomplete resection, 45 – 60 Gy in 25 –30 fractions of 3D-CRT, and from 12 – 36 Gy of SRS/FSRT.
  • Pituitary adenoma for medically inoperable cases, recurrence after surgery, incomplete resection, or persistence of elevated hormones after resection of functional adenomas: 3D-CRT, SRS, or IMRT, 45 – 54 Gy up to 30 fractions.
  • Precancerous melanosis (lentigo maligna, Hutchinson's melanotic freckle, or circumscribed precancerous melanosis of Dubreuilh): for recurrence or more extensive lesions, superficial and orthovoltage therapy, 35 – 57 Gy in 5-23 fractions.
  • Rosai-Dorfman disease for lesions involving the airway not responding to more conservative measures, up to 22 fractions of 2D/3D.
  • Splenomegaly (hypersplenism): Very low doses of radiation on a less than daily basis, 10 or fewer fractions of 2D/3D.
  • Total body irradiation (TBI): For non-malignant, pre-malignant and quasi-benign marrow disorders such as aplastic anemia or myelodysplastic disorders.14,15
    • 12 – 15 Gy given in 6 to 12 fractions over 3 – 5 days, fractionated in 2 to 3 treatments per day
    • Low-dose TBI, with doses of 2 – 6 Gy given in 1 to 4 fractions in combination with chemotherapy, is an effective conditioning regimen for hematopoietic stem cell transplantation in patients who cannot tolerate myeloablation due to age or comorbidities.
  • Peyronie's disease (Morbus Peronie, Induratio penis plastica): 2D, orthovoltage, or electron beam radiation in 5 or fewer fractions.
  • Parotid adenoma: for > 4 cm, positive margin status, and multinodularity, up to 30 fractions.
  • Paraganglioma (chromaffin positive): for unresectable, recurrence, or as adjuvant therapy for incomplete resection, 25 – 28 fractions of 3D/IMRT, SRS 12 – 18 Gy.
  • Orbital pseudotumor (lymphoid hyperplasia): Up to 10 fractions of 2D/3D.
  • Orbital myositis (failed conservative therapy): up to 15 fractions of 2D/3D.
  • Non-cutaneous neurofibromas: for symptomatic unresectable non-cutaneous lesions, up to 30 fractions.
  • Lethal midline granuloma: for localized presentations or in conjunction with systemic therapy, 45 – 50 Gy up to 25 fractions.
  • Lymphangiomas (capillary, cavernous, cystic hygromas, and lymphangial): for refractory lesions with repeated recurrence after resection (and chylothorax due to pleural involvement, 20 – 40 Gy in 10 – 20 fractions).
  • Langerhans cell histiocytosis (LCH): for localized growth, up to 28 fractions of 3D.
  • Inverted papilloma: for incomplete resection, or suspected malignant component, 45 – 70.4 Gy up to 39 fractions.
  • Hyperthyroidism/thyroiditis: systemic 131-I.
  • Hemangiomas (brain, spinal cord, subglottis, glottis, liver, GI tract, urinary tract, joints and orbit): Up to 30 fractions of IMRT.
  • Gynecomastia: up to 5 fractions of electron beam therapy.
  • Graves’ ophthalmopathy: up 20 10 fractions of 2D/3D.
  • Gorham-Stout syndrome (disappearing bone syndrome): up to 25 fractions of 3D.
  • Giant cell tumor of bone (osteoclastoma): for unresectable, up to 30 fractions.
  • Dupuytren's contracture (fibromatosis) of hands/feet: up to 10 fractions of 2D or electron beam.
  • Aneurysmal bone cyst: as the last resort, up to 10 fractions.
  • Angiofibroma of nasopharynx (juvenile nasopharyngeal angiofibroma): for unresectable disease, up to 20 fractions.
  • Angiomatosis retinae (von Hippel Lindau syndrome): beta plaque.
  • Bowen's disease (squamous cell carcinoma in situ)/Erythroplasia of Queyrat: when typical alternatives (surgery, electrodessication and curettage, topical 5FU), are not possible, superficial radiation up to 20 fractions.
  • Desmoid tumor: for inoperable cases, up to 28 fractions of 3D.
  • Degenerative skeletal disorder: for symptomatic degenerative skeletal and joint disorders (i.e., plantar fasciitis, trochanteric bursitis) refractory to conventional treatments, up to 8 fractions of 2D.
  • Choroidal hemangioma: for diffuse lesions, especially if near the macula or papilla, and for those not responding to other treatments, LDR brachytherapy, or 2D/3D up to 20 fractions.
  • Castleman's disease (giant lymph node hyperplasia): for orbital pseudotumor and Waldeyer’s ring, LDR brachytherapy, or 2D/3D up to 25 fractions.
  • Carcinoid tumors: for symptomatic unresectable non-secretory, or secreting tumors, up to 25 fractions.
  • Hypersalivation of amyotrophic lateral sclerosis (ALS): when other means of management are ineffective or impractical, up to 4 fractions.

Stereotactic radiation therapy (SRS, SBRT) is considered MEDICALLY NECESSARY when used in the treatment of non-malignant cranial lesions, including the following (ASTRO, 2014):

  • Arteriovenous malformation (AVM) of the brain or spine
  • Trigeminal neuralgia that has not responded to other more conservative treatments
  • Non-cancerous brain tumors such as acoustic neuroma, benign schwannomas, meningioma, hemangioma, pituitary adenoma, craniopharyngioma, neoplasm of the pineal gland and chordomas

TREATMENT OPTIONS REQUIRING PHYSICIAN REVIEW: 
Treatment for other non-malignant conditions utilizing proton beam, stereotactic radiation therapy (SBRT) or intensity modulated radiation therapy (IMRT) modalities should be referred to physician review.

References 

  1. McKeown SR, Hatfield P, Prestwich RJ, Shaffer RE, Taylor RE. Radiotherapy for benign disease; assessing the risk of radiation-induced cancer following exposure to intermediate dose radiation. Br J Radiol. 2015;88(1056):20150405. doi:10.1259/bjr.20150405
  2. Assembly of Life Sciences (U.S.). Committee to Review the Use of Ionizing Radiation for the Treatment of Benign Diseases. Bureau of Radiological Health. National Academies; 1977.
  3. Eng TY, Boersma MK, Fuller CD, et al. The role of radiation therapy in benign diseases. Hematol Oncol Clin North Am. Apr 2006;20(2):523-57. doi:10.1016/j.hoc.2006.01.023
  4. Meyer J. The Radiation Therapy of Benign Disease: Current Indications and Techniques: 33rd San Francisco Cancer Symposium, San Francisco, Calif., April 3-4, 1999. vol 35. Karger Medical and Scientific Publishers; 2001.
  5. Micke O, Seegenschmiedt MH. Consensus guidelines for radiation therapy of benign diseases: a multicenter approach in Germany. International Journal of Radiation Oncology* Biology* Physics. 2002;52(2):496-513.
  6. Order SE, Donaldson SS. Radiation Therapy of Benign Disease: A Clinical Guide (Medical Radiology). Springer; 2003.
  7. Seegenschmiedt MH, Micke O, Muecke R. Radiotherapy for non-malignant disorders: state of the art and update of the evidence-based practice guidelines. Br J Radiol. Jul 2015;88(1051):20150080. doi:10.1259/bjr.20150080
  8. Gunderson & Tepper. Clinical Radiation Oncology, 2nd Edition. Seegenschmiedt MH Nonmalignant Disease. Elsevier - Health Sciences Division; 2006.
  9. Royal College of Radiologists. A review of the use of radiotherapy in the UK for the treatment of benign clinical conditions and benign tumours. Royal College of Radiologists; 2015.
  10. US Department of Health, Education and Welfare, Public Health Service. Food and Drug Administration, Bureau of Radiological Health. A review of the use of ionizing radiation for the treatment of benign diseases. September 1977;Volume I. HEW Publication (FDA) 78-8043
  11. Halperin EC, Brady LW, Wazer DE, Perez CA. Perez & Brady's principles and practice of radiation oncology, 6th Edition. Winkfield KM, Bazan JG, Gibbs IC, et al Nonmalignant Diseases. Lippincott Williams & Wilkins; 2013.
  12. Gofman JW. Preventing breast cancer: The story of a major, proven, preventable cause of this disease. 2nd Edition. San Francisco: Committee for Nuclear Responsibility; 1996:243-254.
  13. Borok TL, Bray M, Sinclair I, Plafker J, LaBirth L, Rollins C. Role of ionizing irradiation for 393 keloids. Int J Radiat Oncol Biol Phys. Oct 1988;15(4):865-70. doi:10.1016/0360-3016(88)90119-8
  14. McKay C, Knight KA, Wright C. Beyond cancer treatment - a review of total lymphoid irradiation for heart and lung transplant recipients. J Med Radiat Sci. Sep 2014;61(3):202-9. doi:10.1002/jmrs.63
  15. American College of Radiology, American Radium Society. ACR-ARS practic parameter for the performance of total body irradiation. American College of Radiology (ACR). Updated 2022. Accessed December 6, 2022. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/tbi.pdf?la=en
  16. American Society for Radiation Oncology. Model Policies: Stereotactic Body Radiation Therapy. American Society for Radiation Oncology (ASTRO). Updated June 2020. Accessed October 3, 2022. https://www.astro.org/ASTRO/media/ASTRO/Daily%20Practice/PDFs/ASTROSBRTModelPolicy.pdf
  17. American Society for Radiation Oncology. Model Policies: Stereotactic Radiosurgery (SRS). American Society for Radiation Oncology (ASTRO). Updated 2014. Accessed October 13, 2022. https://www.astro.org/uploadedFiles/_MAIN_SITE/Daily_Practice/Reimbursement/Model_Policies/Co ntent_Pieces/ASTROSRSModelPolicy.pdf

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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