Low-Dose Radiotherapy for Non-Oncologic Indications

POLICY NUMBER

A.7.01.179

DESCRIPTION

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.

Low-Dose Radiotherapy

Radiation therapy (RT) is a standard treatment for many types of cancer. Low-dose RT (LDRT), doses of less than 1 Gray (Gy) per fraction, has been shown to have anti-inflammatory effects and has been explored as a treatment for a variety of noncancerous inflammatory and degenerative musculoskeletal, orthopedic, and soft tissue diseases, typically after conventional medical treatments fail. These indications include the use of prophylactic LDRT for the prevention of heterotopic ossification (HO) after total hip arthroplasty (THA) or fracture and keloids after surgical resection, as well as the treatment of painful inflammatory diseases such as osteoarthritis (OA) and plantar fasciitis. LDRT is commonly used for benign inflammatory and degenerative musculoskeletal diseases in Germany, where an estimated 10-30% of RT is applied to individuals with noncancerous conditions. However, in the United States, LDRT is infrequently used to treat benign conditions. For benign conditions, treatment schedules often involve multiple fractions, such as 0.5 Gy twice weekly for 3 weeks or 1.0 Gy once weekly for 6 weeks, with total doses generally below 20 Gy. Various types of ionizing radiation may be used and are most commonly delivered externally via photon or heavier particle beams. This therapeutic approach has a long history, with renewed interest in recent decades due to an improved understanding of LDRT's biological effects and advancements in radiation delivery techniques. Current research focuses on optimizing dose fractionation, understanding long-term outcomes, and exploring new treatment indications.

Osteoarthritis

OA is the most common form of arthritis globally, affecting approximately 3.3-3.6% of the population worldwide and causing moderate to severe disability in 43 million people. It can be classified as primary (idiopathic) or secondary (due to a predisposing condition). Management includes non-pharmacologic approaches (e.g., exercise, weight loss) and pharmacologic interventions (e.g., acetaminophen, NSAIDs, intra-articular corticosteroid injections). For severe cases unresponsive to conservative measures, surgical options like joint replacement may be considered. OA is characterized by joint pain, stiffness, and locomotor restriction, but its presentation and progression vary greatly between individuals. Diagnosis is primarily clinical, based on symptoms and physical examination findings, with imaging studies used for confirmation and staging. The pathophysiology involves an interplay of risk factors, mechanical stress, and abnormal joint mechanics, leading to pro-inflammatory markers and proteases that mediate joint destruction. Management includes non-pharmacologic approaches (e.g., exercise, weight loss) and pharmacologic interventions (e.g., acetaminophen, NSAIDs, intra-articular corticosteroid injections). For severe cases unresponsive to conservative measures, surgical options like joint replacement may be considered. In some settings, LDRT has been explored as a treatment option for OA, typically involving the application of radiation to affected joints in multiple fractions over a short period.

Plantar Fasciitis

Plantar fasciitis is a common cause of heel pain resulting from degenerative irritation of the plantar fascia and surrounding structures. It affects approximately 1 million patients annually in the United States, with peak incidence between ages of 40 to 60 years. Diagnosis is primarily clinical, based on localized heel pain that is worst with initial steps in the morning or after prolonged rest. While imaging is not typically needed for diagnosis, ultrasound may reveal thickening and heterogeneity of the plantar fascia. Treatment generally begins with conservative measures such as rest, NSAIDs, stretching exercises, orthotics, and night splints. For recalcitrant cases, more advanced therapies like extracorporeal shock wave therapy, botulinum toxin injections, platelet-rich plasma, prolotherapy, or corticosteroid injections have been considered. Surgery is reserved as a last resort for cases that fail to respond to at least 6-12 months of non-operative management. LDRT represents another alternative to surgical treatment for plantar fasciitis and typically involves the application of fractionated doses of radiation to the affected area. Total doses generally range from 3 to 6 Gy, delivered in fractions of 0.5 to 1 Gy, 2-3 times per week. The mechanism of action is thought to involve anti-inflammatory effects, including decreased expression of certain enzymes and reduction in the adhesion of peripheral blood mononuclear cells.

Keloid

Keloids are benign raised scars that form due to excessive tissue proliferation and collagen deposition during abnormal wound healing. They result from pathological wound healing and excess dermal fibrosis, characterized by an imbalance in the destruction and deposition of extracellular matrix. Keloids can appear months to years after injury and continue to grow indefinitely without regression, expanding beyond the original borders of injury and invading surrounding tissue. They affect 30-90% of patients, with higher prevalence in darker-skinned individuals (African-Americans, Hispanics, and Asians) and those with a family history. Facial keloids, particularly those near the eyes, nose, or mouth, may impair vision, speech, and facial expressions, while keloids on the trunk or extremities can restrict range of motion and dexterity, potentially diminishing quality of life. Keloids can also cause varying degrees of pain, often correlating with the keloid's size, growth rate, and depth of tissue involvement. When located in high-tension areas, over joints, or in regions with dense nerve innervation, the pain associated with keloids may be severe and impede daily activities. While numerous treatment options exist, including intra-lesional corticosteroid injections, pressure therapy, and cryotherapy, surgical excision followed by immediate adjunctive postoperative LDRT has emerged as an effective approach to recurrence prevention. Radiation is typically indicated for recurrent keloids or those at high risk of recurrence, such as marginal resections, wider spread, and unfavorable locations. Treatment usually targets the scar plus a 1 cm radial margin to a depth of 0.5-1 cm. Electrons are the most commonly used modality, though superficial x-rays and brachytherapy are also options. The recommended total radiation dose ranges from 12 to 20 Gy.

Heterotopic Ossification

Heterotopic ossification (HO) is the abnormal formation of mature, lamellar bone in extraskeletal soft tissues where bone does not normally exist. It is a common complication in rehabilitation settings, affecting patients with burns, stroke, spinal cord injury (SCI), traumatic amputation, joint replacement, and traumatic brain injury (TBI). The exact incidence varies by population, with rates as high as 90% in high-risk total hip arthroplasty (THA) patients, 20-30% in adult SCI patients, and 10-20% in adult TBI patients. The hip is the most commonly affected site for HO, followed by the elbow. Diagnosis is primarily clinical, based on pain, decreased range of motion, and local signs like edema and erythema, typically occurring 3-12 weeks after the inciting event. Management focuses on prevention in high-risk patients through range of motion exercises, NSAIDs, bisphosphonates, and LDRT in joint replacement cases. LDRT is typically prescribed as 7-8 Gy in a single fraction, given either preoperatively within 24 hours or postoperatively within 72 hours. Treatment consists of mobilization with ROM exercises, pharmacological interventions (NSAIDs, bisphosphonates), and surgical resection for mature HO causing functional limitations, typically performed 12-18 months after initial presentation to allow for full maturation of the ectopic bone. While several studies have reported similar HO prevention effectiveness for LDRT compared to NSAIDs, concerns remain regarding the risk of secondary malignancies, nonunion, and wound healing complications.

Low-Dose Radiotherapy for Other Indications

Several other dermatologic or benign tissue disorders, including achillodynia, Dupuytren's contracture, medial and lateral epicondylitis, Graves ophthalmopathy, hidradenitis suppurativa, ledderhose disease, Peyronie's disease, pterygium, tendinopathies, and trochanteric bursitis have some published evidence for the use of LDRT. However, these conditions are not addressed in this medical policy due to limited high-quality evidence, varying clinical practices, or the availability of alternative standard treatments. The use of LDRT for these and other unlisted non-oncologic conditions should be considered on a case-by-case basis, taking into account the specific clinical context, potential risks and benefits, and current clinical guidelines. It is important to note that the absence of these conditions from this medical policy does not necessarily indicate a lack of efficacy or appropriateness of LDRT in these cases but reflects the focused scope of this policy. Additional indications may be added when the accrual of higher-quality evidence permits a decision regarding the net health benefit of LDRT.

The Food and Drug Administration (FDA) regulates medical devices, including radiotherapy products such as linear accelerators (product codes IYE, JAD, KPQ, and MUJ) and brachytherapy (product code KXK), ensuring their safety and effectiveness before market approval. This oversight includes setting manufacturing quality control standards and conducting post-market surveillance to monitor ongoing safety of these devices. The most common modalities of low-dose radiotherapy used for the treatment or prevention of heterotopic ossification, keloids, osteoarthritis, and plantar fasciitis typically involve external beam radiation therapy. This approach often utilizes X-rays or electron beams, delivered in fractionated doses over multiple sessions, with the specific energy levels and treatment protocols tailored to each condition and patient.

POLICY

Adjuvant low-dose radiotherapy may be considered medically necessary for the prevention of heterotopic ossification following surgery in individuals who are determined to be at high risk for the development of heterotopic ossification (see Policy Guidelines section).

Adjuvant low-dose radiotherapy may be considered medically necessary following surgical excision for the treatment of keloids (see Policy Guidelines section).

Low-dose radiotherapy is considered investigational for the treatment of osteoarthritis.

Low-dose radiotherapy is considered investigational for the treatment of plantar fasciitis.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Individuals at a high risk for heterotopic ossification may present with one or more risk factors:

• 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

Individuals with functionally impairing keloids may present with:

• 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

The evidence base for the use of low-dose radiotherapy for prevention of keloid recurrence reports the initiation of treatment beginning immediately post-surgery to 48 hours post-surgery. Total radiation doses ranged from 7 Gy to 20 Gy and were delivered as a single dose or as up to 4 fractions daily or weekly.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

03/15/2025: New policy added. Approved by the Medical Policy Advisory Committee.

01/15/2026: Code Reference section updated to revise the code descriptions for CPT codes 77402, 77407, and 77412. Effective 01/01/2026.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.179

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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