Low-Dose Radiotherapy for Non-Oncologic Indications

Low-dose radiation therapy (LDRT) for non-oncologic indications is a non-invasive treatment modality that uses radiation at lower doses than traditional cancer radiotherapy. Targeted LDRT is proposed to modulate cellular processes in benign conditions by leveraging radiation's anti-inflammatory and anti-proliferative effects to inhibit abnormal tissue growth and remodeling after conventional therapies have failed.

POLICY

Adjuvant low-dose radiotherapy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Low-dose radiotherapy for the treatment of other conditions/diseases, including, but not limited to, osteoarthritis and plantar fasciitis is considered investigational.

MEDICAL APPROPRIATENESS

Adjuvant low-dose radiotherapy is considered medically appropriate if ANY ONE the following are met:
- Prevention of heterotopic ossification if ALL of the following are met:
  - Low-dose radiotherapy will be performed following surgery
  - Individual is at high risk for the development of heterotopic ossification if ANY ONE of the following are met:
    - Age over 65 years
    - Arthroplasty of the hip, knee, elbow, and shoulder
    - Deep vein thrombosis
    - Diffuse idiopathic skeletal hyperostosis
    - Long bone fractures
    - Male gender
    - Paget's disease
    - Pre-existing rheumatologic conditions such as ankylosing spondylitis
    - Pressure ulcers
    - Prior episodes of heterotopic ossification
    - Prior injury to the same area
    - Severity of injury
    - Spasticity
    - Spinal canal stenosis
    - Traumatic brain injury
- Treatment of keloids if ALL of the following are met:
  - Low-dose radiotherapy will be performed following surgical excision of keloids
  - Evidence of impaired function due to keloids as evidenced by ANY ONE of the following:
    - Keloids near eyes, mouth, or ears that impede vision, speech, facial expressions, communication, respiration, eating, or swallowing
    - Keloids on the trunk or extremities limiting range of motion or manual dexterity
    - Keloid formation that distorts nearby body parts
    - Keloids that cause physical, social, or psychological impairment
    - Keloids that cause chronic pain or intractable pruritus
    - Keloids that compromise skin integrity
    - Keloids treated as part of a comprehensive reconstructive plan following cutaneous trauma
- Prevention of keloid recurrence if ALL of the following are met:
  - Treatment begins immediately post-surgery to 48 hours post-surgery
  - Total radiation dose ranges from 7 Gray (Gy) to 20 Gy
  - Radiation is delivered as ANY ONE of the following:
  - As a single dose
  - Up to 4 fractions daily
  - Up to 4 fractions weekly

IMPORTANT REMINDERS

Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

SOURCES

Akinbiyi, T., Kozak, G. M., Davis, H. D., Barrette, L. X., Rios-Diaz, A. J., et al. (2021). Contemporary treatment of keloids: A 10-year institutional experience with medical management, surgical excision, and radiation therapy. American Journal of Surgery, 221 (4), 689-696. Abstract retrieved December 10, 2024 from PubMed database.

American College of Radiology (ACR), American Brachytherapy Society (ABS), and the American Radium Society (ARS). (2021). ACR-ABS-ARS practice parameter for electronically generated, low-energy radiation sources (ELS). Retrieved December 13, 2024 from www.acr.org.

Bhattacharya, N., Bhattacharya, K., & Chandran, T. C. (2023). Treatment of keloids with surgery and immediate postoperative radiotherapy: knowledge gained over 17 Years. Indian Journal of Plastic Surgery, 56 (3), 251-259. (Level 4 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (11, 2024). Low-Dose Radiotherapy for Non-Oncologic Indications (7.01.179). Retrieved November 8, 2024 from https://www.bcbsaoca.com/eps/. (79 articles and/or guidelines reviewed)

Dove, A. P. H., Cmelak, A., Darrow, K., McComas, K. N., Chowdhary, M., et al. (2022). The use of low-dose radiation therapy in osteoarthritis: a review. International Journal of Radiation Oncology, Biology, Physics, 114 (2), 203-220. (Level 1 evidence)

Fu, S., Duan, L., Zhong, Y., & Zeng, Y. (2024). Comparison of surgical excision followed by adjuvant radiotherapy and laser combined with steroids for the treatment of keloids: A systematic review and meta-analysis. International Wound Journal, 21 (3), e14449. (Level 1 evidence)

Jutkowitz, E., Rieke, K., Caputo, E. L., Yan, S. X., Rudolph, J., et al. (March, 2024). Radiation Therapy for Benign Conditions: A Systematic Review. Washington, DC: Department of Veterans Affairs (US); VA ESP Project #22-116; 2024. (Level 1 evidence)

Khalid, F. A., Farooq, U. K., Saleem, M., Rabbani, J., Amin, et al. (2018). The efficacy of excision followed by intralesional 5-fluorouracil and triamcinolone acetonide versus excision followed by radiotherapy in the treatment of ear keloids: A randomized control trial. Burns: Journal of the International Society for Burn Injuries, 44 (6), 1489–1495. Abstract retrieved November 13, 2024 from PubMed database.

Mohamed, R., Iqbal, A., & Elawadi, A. A. (2022). Fifteen years' experience of radiation therapy for resected advanced heterotopic ossification following motor vehicle accidents: outcome and side effects. Journal of the Egyptian National Cancer Institute, 34 (1), 48. Abstract retrieved December 13, 2024 from PubMed database.

Nardone V, D'Ippolito E, Grassi R, Sangiovanni A, Gagliardi F, et al. (October, 2022). Non-oncological radiotherapy: a review of modern approaches. Journal of Personalized Medicine, 12 (10), 1677. (Level 2 evidence)

Ott, O. J., Niewald, M., Weitmann, H. D., Jacob, I., German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD), et al. (2015). DEGRO guidelines for the radiotherapy of non-malignant disorders. Part II: painful degenerative skeletal disorders. Strahlentherapie und Onkologie: Organ der Deutschen Rontgengesellschaft, 191 (1), 1–6. Abstract retrieved December 11, 2024 from PubMed database.

Pakos, E. E., Papadopoulos, D. V., Gelalis, I. D., Tsantes, A. G., Gkiatas, I., et al. (2020). Is prophylaxis for heterotopic ossification with radiation therapy after THR associated with early loosening or carcinogenesis? Hip International: The Journal of Clinical and Experimental Research on Hip Pathology and Therapy, 30 (5), 559–563. Abstract retrieved November 13, 2024 from PubMed database.

Reinartz, G., Eich, H. T., Pohl, F., & German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD) (2015). DEGRO practical guidelines for the radiotherapy of non-malignant disorders - part IV: Symptomatic functional disorders. Strahlentherapie und Onkologie: Organ der Deutschen Rontgengesellschaft, 191 (4), 295-302. Abstract retrieved December 11, 2024 from PubMed database.

Rühle, A., Tkotsch, E., Mravlag, R., Haehl, E., Spohn, S. K. B., et al. (2021). Low-dose radiotherapy for painful osteoarthritis of the elderly: A multicenter analysis of 970 patients with 1185 treated sites. Strahlentherapie und Onkologie: Organ der Deutschen Rontgengesellschaft ... [et al], 197 (10), 895-902. (Level 4 evidence)

Seegenschmiedt, M. H., Micke, O., Niewald, M., Mücke, R., German Cooperative Group on Radiotherapy of Benign Diseases (GCG-BD), et al. (2015). DEGRO guidelines for the radiotherapy of non-malignant disorders: part III: hyperproliferative disorders. Strahlentherapie und Onkologie: Organ der Deutschen Rontgengesellschaft, 191 (7), 541-548. Abstract retrieved December 12, 2024 from PubMed database.

Shapira, J., Yelton, M. J., Chen, J. W., Rosinsky, P. J., Maldonado, D. R., et al. (2022). Efficacy of NSAIDs versus radiotherapy for heterotopic ossification prophylaxis following total hip arthroplasty in high-risk patients: a systematic review and meta-analysis. Hip International: The Journal of Clinical and Experimental Research on Hip Pathology and Therapy, 32 (5), 576-590. Abstract retrieved November 13, 2024 from PubMed database.

ORIGINAL EFFECTIVE DATE: 4/30/2025

MOST RECENT REVIEW DATE: 4/30/2025

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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