BCBSNJ Medical Policy for - (Radiology) Policy Number

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Horizon BCBSNJ
Uniform Medical Policy Manual	Section:	Radiology
	Policy Number:	146
	Effective Date:	01/01/2020

	Original Policy Date:	10/27/2015
	Last Review Date:	04/14/2020
	Date Published to Web:	10/30/2015

Subject:
Radiation Therapy for Non-Malignant Disease

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Over the past several decades, methods to plan and deliver radiation therapy have evolved in ways that permit more precise targeting of tumors with complex geometries. Earlier methods involved two-dimensional treatment planning based on flat images, and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. These methods were collectively termed conventional external beam radiation therapy (EBRT).

Subsequent enhancement evolved using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the tumor, its boundaries with adjacent normal tissue, and organs at risk for radiation damage. Radiation oncologists used these images, displayed from a "beam's-eye-view", to shape each of several beams (e.g., with compensators, blocks, or wedges) to conform to the patient's tumor geometry perpendicular to the beam's axis. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. Methods also were developed to position the patient and the radiation portal reproducibly for each fraction, and immobilize the patient, thus maintaining consistent beam axes across treatment sessions. However, "forward" planning used a trial and error process to select treatment parameters (the number of beams and the intensity, shape, and incident axis of each beam). The planner/radiotherapist modified one or more parameters and recalculated dose distributions, if analysis predicted underdosing for part of the tumor or overdosing of nearby normal tissue. Furthermore, since beams had uniform cross-sectional intensity wherever they bypassed shaping devices, it was difficult to match certain geometries (e.g., concave surfaces). Collectively, these methods are termed 3-dimensional conformal radiation therapy (3D-CRT).

Other methods were subsequently developed to permit beam delivery with non-uniform cross-sectional intensity. This often relies on a device (multi-leaf collimator, MLC) situated between the beam source and patient that moves along an arc around the patient. As it moves, a computer varies aperture size independently and continuously for each leaf. Thus, MLCs divide beams into narrow "beamlets", with intensities that range from zero to 100% of the incident beam. Beams may remain on as MLCs move around the patient (dynamic MLC), or they may be off during movement and turned on once the MLC reaches prespecified positions ("step and shoot" technique). Another method of delivering radiation beam uses a small radiation portal emitting a single narrow beam that moves spirally around the patient, with intensity varying as it moved. This method, also known as tomotherapy or helical tomotherapy, is described as the use of a linear accelerator inside a large "donut" that spirals around the body while the patient laid on the table during treatment. Each method (MLC-based or tomotherapy) is coupled to a computer algorithm for "inverse" treatment planning. The planner/radiotherapist delineates the target on each slice of a CT scan, and specifies that target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally-reconstructed radiographic image of the tumor and surrounding tissues and organs at risk, computer software optimizes the location and shape of beam ports, and beam and beamlet intensities, to achieve the treatment plan's goals. Collectively, these methods are termed intensity-modulated radiation therapy (IMRT).

According to ECRI Institute, there are two different approaches to image-guided radiation therapy that are in current use: pre-treatment imaging and real-time guidance. IMRT is an example of a method that uses pre-treatment imaging to prepare a treatment plan. In contrast, real-time guidance utilizes real-time imaging (at the time of treatment) to guide treatment. It provides real-time, online images of the radiation target area from a computed tomography (CT) scanner before, during, and after therapy. Patient positioning, radiation field alignment, and collimator positioning can be verified and adjusted before and during irradiation. This approach should, in theory, provide more accurate radiation delivery than conventional IMRT. Organ motion, day-to-day variations in tumor position, and differences in patient positioning in each treatment session could be taken into account with real-time imaging.

Policy:
(NOTE: This policy only applies to adult members. It does not apply to pediatric members.

For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

Radiation therapy is considered medically necessary for the following non-malignant disorders:
Radiation Therapy is medically necessary for the following non-malignant disorders when there is failure, intolerance, or contraindication to established medical therapy and surgical treatments:
Radiation therapy is considered investigational for the following non-malignant disorders:

Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for External beam photon radiation therapy (EBRT), Proton Beam Radiation Therapy, Stereotactic radiosurgery (SRS), or 3DCRT. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Therapy for Non-Malignant Disease.

Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). For additional information and eligibility for IMRT, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711) and Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56725). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36711&ver=18&name=314*1&UpdatePeriod=749&bc=AAAAEAAAAAAAAA%3d%3d&.

[RATIONALE: It was not long after the discovery of x-rays in 1895 that radiation was used for therapeutic purposes. Since benign disorders do not always follow a benign course, radiation was employed for many conditions for which there was no suitable therapeutic alternative. As improvements in competing therapies have been developed, such as antibiotics, antifungals, antivirals, chemotherapies, improved surgical techniques, and immunological therapy, radiation therapy is no longer appropriate for many disorders, yet has become the preferred therapy for others. New indications have evolved over time. Where applicable, comments regarding changed indications are included in the brief discussion that follows of disorders for which radiation may have been used in the past or is presently in use. Each of the disorders listed is addressed in at least one of the references and, therefore, included in this policy.

Disorders treatable with radiation fall into the general categories of inflammatory, degenerative, hyperproliferative, functional, or "other" in nature.

Acceptance of the appropriateness of using radiation has developed using several means. Historically a trial and error approach prevailed, not different from the empiric use of pharmacological agents and surgical procedures that satisfied logic but lacked validation by now-customary rigor of prospective trials. Current indications may be based on experience-based consensus or on higher-level evidence that has resulted from formal study. Over the past five decades, consensus has been measured by polling practitioners on what is considered the appropriate uses of radiation. Such surveys in the United States, Germany and the United Kingdom supplement peer-reviewed journal publications and chapters in major radiation oncology texts, the latter reporting more evidence-based guidance that is the result of clinical studies. Both necessarily serve as the foundation for this policy.

As should be the case with all therapies, a decision whether to use radiation to treat a non-cancerous disorder should be based on safety, efficacy, and availability as measured against competing modalities, including the natural history of the disorder if left untreated, and must be subjected to informed consent. Consistent with that end, disorders have been grouped into categories for which radiation is considered: generally accepted; accepted if more customary therapy is unavailable, refused or has failed, or appropriate only as a last resort; or inappropriate under any circumstance. When utilized, radiation should be delivered using a technique that is not unnecessarily complex, and to the lowest dose that is sufficiently likely to achieve the desired result.

The earlier (more than 50 years ago) history of the use of radiation therapy to treat non-cancerous conditions is also very rich, but precedes the overview below. For a review of pre-1965 thoughts, the review by Dr. Stephen Dewing is recommended. Additional information regarding specific disorders may also be obtained from subscription services such as the Cochrane Review and UpToDate.

Condition
1. AbortionI
  t is known that radiation at sufficient dose can cause an abortion. There is no support for its use in any of the references cited.
2. Acne
  Historically, superficial x-ray therapy was used to treat acne by 41.8% of dermatologists in the U.S. Department of Health, Education, and Welfare survey report of 1977. No subsequent modern era radiation oncology review supports the use of ionizing radiation in the treatment of acne. Improved alternative treatments and the risk of radiation-induced cancer render its use obsolete for the treatment of acne.
3. Adamantinoma (ameloblastoma)
  These rare, locally aggressive but usually histologically benign tumors are of epithelial origin and are most commonly of jaw or tibial location. The etiology of epithelial tissue in an unusual location is the subject of debate. These tumors tend to recur and require aggressive surgery. Being rare, experience is very limited. Most references agree surgery is the treatment of choice. The use of radiation is reported historically as beneficial, but with little evidence. The 2002 text by Order and Donaldson supplies several references, each with few cases to report, and mainly of mandible or maxillary origin.
4. Amyloidosis
  There is only an occasional case report of the use of ionizing radiation therapy in the treatment of amyloidosis. There is no support for its use in the modern era. Policy: Not indicated and considered investigational.
5. Aneurysmal bone cyst
  These are relatively rare and benign osteolytic lesions of bone usually occurring in children or young adults. They are not true neoplasms, rather are a hyperplasia filled with blood-filled channels. Initial management is surgical. Interventional radiology procedures are also available. Because of the availability of alternative therapy and the typically young age of patients, the use of ionizing radiation is a last resort.
6. Angiofibroma of nasopharynx (juvenile nasopharyngeal angiofibroma)
  While optimum management is controversial, there is general agreement that surgery is preferred if considered safe, as in cases when there is no extension into the orbital apex or base of skull. Since the typical patient is young, regard for the long-term hazard of radiation is important. When radiation is used, the radiation dose is lower than in malignant tumors of the same location. Response to treatment tends to be slow and may take several years to be evident.
7. Angiomatosis retinae (von Hippel Lindau syndrome)
  Capillary hemangiomas associated with von Hippel Lindau syndrome may be single or multiple, and can severely affect vision. They may be associated with hemangiomas in the cerebellum and brainstem. Multiple therapies exist including thermal and laser photocoagulation, cryotherapy, vitreoretinal surgery, beta plaque radiation therapy, and external beam radiation therapy (EBRT). Reports have described the successful use of EBRT for salvage.
8. Ankylosing spondylitis
  The use of radiation therapy in the treatment of ankylosing spondylitis is of historical interest. The risk of radiation-induced cancer and other morbidity contraindicates its use and is often cited as a common example of radiation carcinogenesis in radiobiological studies.
9. Anovulation
  The use of radiation therapy in the treatment of anovulation is of historical interest only and is occasionally discussed in the treatment of functional pituitary adenomas.
10. Arachnoiditis
  In the pre-antibiotic era the beneficial use of radiation for the treatment of arachnoiditis was described. This is obsolete in the modern era.
11. Bowen's disease (squamous cell carcinoma in situ)
  This entity is considered pre-malignant and may progress into invasive cancer. The term "Bowen's disease" refers to the specific anatomic locations of the shaft of the penis or the hairy skin of the inguinal or suprapubic regions. It can be mistaken for other disorders because of the features it shares with psoriasis and eczema. Earlier references include superficial radiation as a means of treatment. Evidence consists only of case reports and modest consensus in older literature. The use of superficial radiation should be limited to situations in which typical alternatives (surgery, electrodessication and curettage, topical 5FU), are not possible.
12. Carcinoid tumors
  These may be secretory or non-secretory. Surgical resection is the indicated initial treatment if removal is possible. For those unresectable non-secretory lesions causing symptoms such as pain, radiation may be beneficial. For secreting tumors, radiation therapy is limited to those causing symptoms that are not controllable by medical means.
13. Castleman’s disease (giant lymph node hyperplasia)
  This disorder is characterized by angiofollicular lymphoid hyperplasia and can occur in any location in the body, commonly in the orbit (orbital pseudotumor) and Waldeyer's ring. The relationship to subsequent malignant lymphoma is unclear, with malignant lymphoma reported in as many as 30% of cases. Synonyms include giant follicular lymph node hyperplasia, follicular lymphoreticuloma, angiomatous lymphoid hamartoma, and giant benign lymphoma. As described by Castleman, it is a benign condition. True lymphoma should be ruled out by biopsy to prove a polyclonal nature. Steroids are indicated as initial management. Low dose radiation therapy has been reported as effective in refractory or relapsed cases if further use of steroids is contraindicated.
14. Castration
  There is evidence that with sufficient dose radiation can effectively and permanently cease gamete production and hormone production in the testes and ovaries. The indications for doing so are very limited. Surveys reported by Order and Donaldson (1998) indicated 75% of surveyed radiation oncologists would use radiation for this purpose with the appropriate indication. The U.S. Department of Health, Education, and Welfare survey report of 1977 included castration as an acceptable indication. The availability of drugs which achieve the same result has largely rendered this as obsolete.
15. Choroid plexus papilloma
  Choroid plexus papillomas range from the very benign (WHO grade 1) to the invasive carcinomas (WHO grade III). They are more common in very young children. Surgery is the treatment of choice. Adjuvant radiation is not indicated unless there is progression that cannot be dealt with surgically.
16. Choroidal hemangioma
  These are rare vascular tumors and may be circumscribed or diffuse, the latter associated with Sturge-Weber syndrome. Non-radiation treatments are available (photodynamic, laser, thermotherapy.) Radiation therapy is preferable for diffuse lesions, especially if near the macula or papilla, and for those not responding to other therapeutic maneuvers. Typically, radiation therapy is given using complex or three dimensional conformal external photon beam technique, or using low dose rate brachytherapy plaque.
17. Corneal vascularization
  Radiation therapy is not indicated in the treatment of corneal neovascularization. The entity is not to be confused with pterygium.
18. Corneal xanthogranuloma
  Corneal xanthogranulomas may develop in association with generalized juvenile xanthogranuloma and generalized histiocytosis. Reports in old literature of the treatment by contact radiation or photons do not establish any definite benefit. They commonly regress spontaneously. First line therapy, when observation is not selected, is steroid therapy or surgery.
19. Degenerative skeletal disorders
  Radiation therapy may be used for symptomatic degenerative skeletal and joint disorders (i.e. plantar fasciitis, trochanteric bursitis) that are refractory to conventional methods. For plantar fasciitis, for example, 1 Gy per week for 6 weeks was associated with a response rate approaching 80% and durable at 48 weeks. Using complex radiation planning, up to 8 fractions is considered appropriate.
20. Desmoid tumor
  Also known as aggressive fibromatosis or deep musculoapeuronotic fibromatosis, a desmoid tumor is a histologically benign connective tissue tumor with a high recurrence rate after resection. Most common sites are trunk, extremity, abdominal wall, and intra-abdominal sites, including bowel and mesentery. If stable, observation is appropriate. Surgical resection with negative surgical microscopic margins in the treatment of choice for most. Radiation therapy is indicated for inoperable cases, and may be used in conjunction with surgery and chemotherapy. Typical treatment is with 3DCRT in 28 or fewer fractions. Fractionated radiation therapy in excess of 50 Gy is needed for control, which may preclude its use in those of intra-abdominal location.
21. Dupuytren’s contracture (fibromatosis)
  This may develop in the hand (Morbus Dupuytren) or foot (Morbus Ledderhose) and is a connective tissue disorder of the palmar or plantar fascia. Radiation therapy is useful, especially in the earlier stages of development, and has been demonstrated in prospective clinical trials. Typical treatment is with photon beam therapy using, at most, Complex treatment planning, or with electron beam therapy in 10 or fewer fractions.
22. Erythroplasia of Queyrat
  This in situ form of epidermoid carcinoma involves the mucosal or mucoepidermoid areas of the prepuce or glans penis. An invasive component is not infrequent. Sometimes it is referred to as Bowen's disease of the penis. Erythroplasia of Queyrat involves the mucosal or mucoepidermoid areas of the prepuce or glans penis, whereas the term Bowen's disease refers to squamous cell carcinoma in situ involving the shaft of the penis or the hairy skin of the inguinal or suprapubic region. While radiation treatments were used in the past, as Erythroplasia of Queyrat is non-invasive, its treatment can be managed with a non-radiotherapeutic approach using topical agents.
23. Extramammary Paget’s disease (adenocarcinoma of the skin)
  When it occurs, adenocarcinoma of the skin usually arises in areas of abundant apocrine glands. Most commonly, treatment is surgical. Radiation therapy is indicated when resection is inappropriate or incomplete. The entity is discussed this Guideline due to historical references to its being a benign condition.
24. Extramedullary hematopoiesis (hypersplenism)
  This is a myeloproliferative syndrome that most commonly involves the spleen, but can occur in the liver, lymph nodes, lungs, kidneys, GI tract, and central nervous system. Chemotherapeutic management is the initial treatment of choice. Radiation therapy is considered necessary in those cases in which medical management is ineffective or otherwise contraindicated.
25. Fibrosclerosis (sclerosing disorders)
  Unifocal and multifocal episodes of sclerosis have been treated in the past using radiation therapy. Sites reported include retroperitoneum, mediastinum, bile ducts, thyroid, meninges, orbits, and others. While anecdotal reports of improvement have been reported, generally radiation therapy is regarded as ineffective and should not be used.
26. Fungal infections (see Infections, fungal)
  In the 1940s and 1950s x-rays were used, not infrequently, to treat tinea capitis and other skin fungal infections. In the modern era of available pharmacologic agents for the treatment of fungal infections, the benefit of use of radiation therapy is outweighed by the risk of carcinogenesis.
27. Gas gangrene
  Before the discovery of antibiotics, radiation therapy was used to treat open wounds to prevent infections, and reports exist that this was of benefit. There is no benefit of the use of radiation in the era of antibiotics.
28. Giant cell tumor of bone (osteoclastoma)
  Once thought to be a benign disorder, these tumors are best regarded as malignant with a potential for metastasis. Surgery is the initial treatment of choice, but many osteoclastomas arise in bones (spine and pelvis) in which surgical resection would be unnecessarily debilitating. Local control with radiation is reported in the 75% to 85% range and can be administered safely using modern era equipment.
29. Gorham-Stout Syndrome (disappearing bone syndrome)
  Also known as phantom bone, this entity is characterized by a destructive proliferation of endothelial-lined sinusoidal or capillary proliferation that may or may not be progressive, causing bone destruction most commonly in the pelvis or shoulder girdle that results in a functional deformity. Surgery is an alternative to radiation. Typical treatment is with 3DCRT in 25 or fewer fractions.
30. Graves’ ophthalmopathy
  This is an autoimmune disorder associated with hyperthyroidism that affects the eye musculature and retrobulbar tissues causing proptosis and visual impairment. It may be unilateral or bilateral. Carefully selected cases that do not respond to medical measures may be improved with the use of carefully administered conformal radiation. Typical treatment is with complex or three dimensional conformal radiation therapy (3DCRT) in 10 fractions.
31. Gynecomastia
  In the older era of orchiectomy or the use of diethylstilbestrol for the treatment of metastatic or locally advanced prostate cancer, it was commonplace to irradiate the breasts on a prophylactic basis to prevent uncomfortable gynecomastia. In the modern era of chemical androgen deprivation for the treatment of prostate cancer, the use of modest doses of radiation to the breasts may arrest or prevent the resultant gynecomastia and is medically appropriate. Typically the radiation is given with electron beam therapy in 5 or fewer fractions.
32. Hemangiomas
  Though benign by histology, these vascular tumors that may arise in the brain, spinal cord, subglottis, glottis, liver, GI tract, urinary tract, joints and orbit may be disastrous. The use of radiation therapy is a suitable alternative to surgical or medical management. It is especially important to explore alternative therapy in pediatric cases. Depending on circumstances, the technique employed may range from simple to IMRT, and is usually delivered in 30 or fewer fractions.
33. Herpes zoster
  Presented here only for historical perspective, the use of radiation to treat the nerve roots associated with cutaneous eruption of zoster was once employed, and even said to be sometimes acceptable in the 1977 survey of the U.S. Department of Health, Education and Welfare. More recent surveys and study have shown no benefit. The subsequent development and use of antiviral drugs is appropriate.
34. Heterotopic ossification (before or after surgery)
  Radiation is known to prevent the heterotopic bone formation often seen in association with trauma or joint replacement in high risk patients. The radiation is most effective if given shortly (within four hours) prior to surgery, or within three or four days after surgery. A radiation dose of 7 Gy to 8 Gy in a single fraction of Complex planned therapy is typical.
35. Hypersalivation of amyotrophic lateral sclerosis (ALS)
  It is well known that radiation will decrease saliva production as a consequence of treating head and neck cancer. This phenomenon has occasionally been exploited in cases of excess saliva production in patients with ALS. While literature is scant, surveys indicate general acceptance of the use of radiation in this situation when other means of management are ineffective or impractical.
36. Hyperthyroidism
  The use of systemic 131-I is an accepted alternative to surgery and/or medical management.
37. Infections (bacterial)
  In the antibiotic era, there is no recognized indication for the use of radiation therapy in the treatment of bacterial infections.
38. Infections (fungal and parasitic)
  The experimental use of radiation to treat unusual and rare fungal and parasitic disorders, such as ocular histoplasmosis and cerebral cisticercosis, has been reported in the literature. This is regarded as investigational.
39. Inflammatory (acute/chronic) disorders not responsive to antibiotics (furuncles, carbuncles, sweat gland abscesses).
  Variations exist worldwide as to the appropriateness of using ionizing radiation for these disorders. The German review of 2002 lists them as potential indications, however elsewhere this opinion is not supported. The U.K. policy states that for a refractory case with no other alternative, low dose radiation therapy "might be worth considering".
40. Inverted papilloma
  The treatment of choice is surgical resection of these usually benign lesions of the nasal cavity and paranasal sinuses. However, a malignant component is found in a small percentage of cases, and radiation therapy is then indicated. In cases of incomplete resection or suspected malignant component, radiation therapy is considered medically necessary.
41. Keloid scar
  Data is abundant that a few fractions of a relatively small amount of radiation will reduce the chance of recurrence after a keloid is resected. This is medically necessary when other means are less appropriate or have proven ineffective. Typical radiation treatment utilizes superficial x-ray, electron beam, or Complex photon beam therapy in 4 or fewer fractions.
42. Keratitis (bullous and filamentary)
  Bullous and filamentary keratitis were listed in the 1977 U.S. Department of Health, Education and Welfare as entities for which radiation therapy was sometimes appropriate. They are not included in the more recent German and U. K. reviews. Current literature does not support the use of radiation for either form of keratitis.
43. Langerhans cell histiocytosis
  The literature has consistently supported the use of radiation therapy for treatment of this disorder over the time period studied. Involvement can be focal or systemic, and behavior variable. The etiology is unknown, and it may prove to be a non-benign entity. Chemotherapy is commonly utilized when treatment is necessary, with radiation more commonly used to treat localized growths. Typical treatment is with 3DCRT in 28 or fewer fractions.
44. Lymphangiomas
  There are four types: capillary; cavernous; cystic hygromas; and lymphangeal hemangiomas. Surgery is the treatment of choice. In rare instances, radiation therapy may be appropriate for refractory lesions with repeated recurrence after resection. These may cause a chylous effusion if there is pleural involvement, in which case radiation therapy may be useful in managing chylothorax. A specific presentation of lymphangioma may be Gorham-Stout syndrome (see above).
45. Lethal midline granuloma
  This is a progressive, destructive process which involves the mid-facial structures. It has many synonyms depending on its anatomic presentation. It has been considered a benign entity, may mimic other lymphoproliferative processes, requires caution in diagnosis, and may be a malignant T-cell disorder. Alternative therapy may be more appropriate, but radiation therapy is considered appropriate for management of localized presentations or in conjunction with systemic therapy.
46. Macular degeneration
  There was great optimism that age related wet macular degeneration could be controlled by the use of radiation therapy to arrest the progression of choroidal neovascularization. Radiation was a preferred method of treatment in the USA in the 1990s and early 2000s. Subsequent multi-centered randomized trials have not proven benefit. The use of intraocular injections of anti-VEGF drugs has emerged as the first line of management. Newer approaches to the use of radiation therapy, such as epimacular brachytherapy and SRS are being investigated as alternatives or as complementary methods so as to reduce the frequency of intraocular injections. Until the results of these studies are known, the appropriateness of using radiation is unproven.
47. Neurofibromas (benign, von Recklinghausen)
  Benign neurofibromas most commonly develop in association with von Recklinhausen disease, and may occur in central nervous system (CNS) and non-CNS locations. Symptomatic lesions may benefit from treatment with relatively high doses of radiation if not amenable to resection.
48. Ocular trichiasis (epilation)
  Of historical interest, on occasion, to cause epilation of eyelashes, radiation has been used in dermatology or ophthalmology practices to aid in the clearance of trachoma or ocular pemphigoid. Radiation is not medically necessary for this in the modern era.
49. Orbital myositis
  This entity is an idiopathic inflammatory condition of the extraocular muscles and may be of autoimmune etiology. It can mimic other similar-appearing orbital inflammatory disorders. Management without radiation, usually with steroids, is first line. Failing conservative measures, radiation is given typically using 3DCRT or Complex planning in 15 or fewer fractions.
50. Orbital Pseudotumor (lymphoid hyperplasia)
  The indications for the use of radiation therapy are for those lesions which recur after surgery, or become refractory to steroids and are not amenable to other management. Typical treatment is with Complex or 3DCRT in 10 fractions.
51. Osteoid osteoma (osteoblastoma, giant osteoid osteoma)
  Osteoid osteoma, osteoblastoma, giant osteoid osteoma are synonyms. Old literature reports included anecdotes of the use of radiation to treat this entity, for which surgery is the treatment of choice.
52. Otitis media
  Bilateral otitis media caused by swollen lymphoid tissue in the nasopharynx was in the past sometimes treated by placement of radioactive material in the nasopharynx to reopen the eustachian tubes. The carcinogenic effect of this makes this treatment inappropriate.
53. Pancreatitis
  Radiation therapy has been used in the past for its anti-inflammatory effect in the treatment of pancreatitis. There is no role for its use for this purpose in the modern era.
54. Paraganglioma (chromaffin positive)
  As with their chromaffin negative counterparts, radiation therapy is indicated in those cases which are inaccessible by surgery, for salvage if recurrent, or as adjuvant therapy if incompletely removed. Typical treatment is with 3DCRT, SRS, or IMRT.
55. Parotid adenoma
  Pleomorphic adenomas of the parotid gland more commonly occur in younger persons and the use of radiation must be approached judiciously. There are indications for radiation therapy such as size > 4 cm. positive margin status, and multinodularity.
56. Parotitis
  Although historically appropriate in the pre-antibiotic era because of a high mortality rate for post-operative suppurative parotitis, radiation is not indicated in the present era.
57. Peptic ulcer disease
  Subsequent to the availability of H2 blockers, radiation therapy is not indicated in the management of peptic ulcer disease despite prior evidence of its efficacy. The increased risk of carcinogenesis of the pancreas, colon, and stomach is a strong contraindication.
58. Perifolliculitis (scalp)
  The use of radiation to cause hair loss and allow the infection of this disease to then clear has been described in older literature. The availability of topical agents and of laser treatment has rendered obsolete the use of radiation for this purpose.
59. Persistent lymphatic fistula
  Lymphatic leaking, most commonly after arterial reconstruction surgery in the groin, is usually treated with additional surgery (ligation, flap construction), direct pressure, application of hemostatic healing agents, and the use of negative pressure. It is listed in the German literature as an indication for the use of radiation therapy, without reference.
60. Peyronie's disease (Morbus Peronie, Induratio penis plastica)
  There is sufficient (older and current) literature support to justify the use of low doses of radiation in the treatment of this disease of the penis. Simple, complex-planned photon beam radiation, orthovoltage, or electron beam radiation in five or fewer fractions is typical.
61. Pigmented villonodular synovitis (tenosynovial giant cell tumor)
  Surgical resection and synovectomy or joint replacement is the treatment of choice. However if recurrent after resection, or diffuse or bulky disease causing bone destruction is present, the use of radiation is justified. Radiation treatment with photon beam therapy using complex treatment planning or three dimensional conformal radiation therapy (3DCRT) planning in twenty-eight or fewer sessions is typical.
62. Pinealoma (Pineal parenchymal tumors)
  Pinealoma refers to tumors that arise in the pineal gland. For the tumors at the benign end of the spectrum of such tumors, surgical resection is preferred. Postoperative radiation is appropriate for those that cannot be removed completely. For higher grades of tumor, refer to the separate Guideline, Radiation Treatment of Primary Cranial and Spinal Tumors and Neurologic Conditions.
63. Pituitary Adenoma
  Surgical removal is the treatment of choice, with radiation therapy indicated for medically inoperable cases, recurrence after surgery, incomplete resection, or persistence of elevated hormones after resection of functional adenomas. Typical treatment is with 3DCRT, SRS, or IMRT.
64. Plasma cell granuloma (benign)
  Treatment of a true benign plasma cell granuloma is surgical resection.
65. Precancerous melanosis
  Precancerous melanosis may also be called Lentigo Maligna, Hutchinson's melanotic freckle, or circumscribed precancerous melanosis of Dubreuilh, and has lentigo maligna melanoma as an invasive counterpart. About one third of these will transform into the malignant version if left untreated. Radiation therapy is indicated for those which recur or for more extensive lesions.
66. Pregnancy
  Radiation therapy has been used in the past for both an attempt at improving fertility (see anovulation) and for the termination of intrauterine or tubal pregnancy (see abortion). Presently, neither indication is medically appropriate.
67. Psoriasis
  Both the German and the U.K. reviews include psoriasis as an indication for the use of low dose radiation in the treatment of some cases. Generally radiation is a treatment of last resort and is reserved for inaccessible locations such as the nail beds. Typical radiation treatment utilizes superficial x-ray, electron beam, or complex photon beam therapy in four or fewer fractions.
68. Psychiatric Disorders
  Radiation therapy has been used to treat some psychiatric disorders in mimicry of surgical procedures with the same intent, such as SRS to achieve a ventral capsulotomy in the treatment of obsessive compulsive disorder. The use of radiation for this purpose is considered investigational and unproven.
69. Pterygium
  The use of radiation to treat a pterygium is supported in the clinical references reviewed. It is usually performed with contact beta brachytherapy in 3 fractions.
70. Pyogenic granuloma
  Despite one case report in the literature of successful treatment of a pyogenic granuloma of the middle ear with radiation, treatment of a pyogenic granuloma is surgical. There is no current support in the American or European literature.
71. Rheumatoid arthritis
  Attempts at treating rheumatoid arthritis with radiation have included single joint external beam radiation, intra-articular infusions of radioactive isotopes, and total lymphoid irradiation for immunosuppression. None is standard of care.
72. Rosai-Dorfman disease
  Rosai-Dorfman disease is a rare disorder characterized by a benign histiocyte proliferation. It can produce massive adenopathy. Treatments used have included surgery, chemotherapy, and steroids. In lesions involving the airway not responding to more conservative measures, radiation therapy has been used with success. When utilized, radiation planning using Complex or 3DCRT and delivered in up to 22 sessions is typical.
73. Sinusitis
  Sinusitis caused by infection does not have literature support for treatment by radiation therapy.
74. Splenomegaly
  Splenomegaly treated by radiation therapy is most commonly caused by leukemic or myeloproliferative diseases, and to a lesser extent by metastases from solid tumors. The policy for the use of radiation therapy in these malignant conditions is not covered in this Guideline. However, the use of radiation therapy for the treatment of hypersplenism or splenomegaly caused by a "benign" or pre-malignant myelodysplastic syndrome also has a basis in the literature. Very low doses of radiation on a less than daily schedule are usually advised. Typically radiation is delivered in 10 or fewer fractions, planned using Complex or 3DCRT.
75. Thyroiditis
  Presently there is no indication for the use of radiation therapy for the treatment of thyroiditis.
76. Tolosa-hunt syndrome (episodic orbital pain)
  This is caused by nonspecific inflammation of the cavernous sinus or superior orbital fissure. Steroids commonly are used first. For refractory cases, drugs such as methotrexate may be used. The successful use of low dose radiation has been reported and may be used as a last resort.
77. Tonsillitis
  In the modern era of antibiotics, the use of radiation to treat inflamed or infected tonsils is obsolete.
78. Total body irradiation
  For the preparation of patients for bone marrow or stem cell transplant for malignant disorders, see the Guideline for the primary disease. For non-malignant, pre-malignant and quasi-benign marrow disorders such as aplastic anemia or myelodysplastic disorders, total body irradiation prior to transplant may be appropriate if chemotherapeutic preparation is not possible. The use of total body irradiation for immunosuppression as treatment of totally non-malignant disorders, such as auto-immune diseases is not medically appropriate.
79. Total lymphoid irradiation
  Total lymphoid irradiation has been used for the purpose of immunosuppression in the treatment of immune-mediated disorders (e.g. autoimmune disorders) and for the purpose of prevention of rejection of transplanted organs, where it has been found useful in the short term, but with decreased subsequent efficacy and the development of myelodysplasia. Further research is needed to establish its role, but it remains an option in situations of chronic rejection in which conventional anti-rejection treatment is no longer viable.
80. Tuberculosis lymphadenitis
  Prior to the availability of antibiotics for tuberculosis, lymphadenitis caused by this disease responded to therapeutic radiation. Available antibiotics obviates this disorder as an indication for radiation.
81. Vernal catarrh
  This disorder is characterized by inflammation of the conjunctiva associated with infiltration by eosinophils, lymphocytes, plasma cells and histiocytes. The resultant hyperplasia of the conjunctival epithelium may respond to ionizing radiation, but alternative therapy is readily available, and the use of radiation is no longer supported in any literature.
82. Warts
  Older literature describes an 80% response rate in treating warts with a relatively low dose of radiation and it is described in at least one modern text (Gunderson). With the availability of alternative therapy, the use of radiation should be reserved for those cases requiring treatment for which alternative, simpler therapy has been unsuccessful.]

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Radiation Therapy for Non-Malignant Disease
Radiation Treatment of Non-Malignant Disease
Non-Malignant Disease, Radiation Treatment
Stereotactic Radiotherapy of Non-Malignant Disease
Stereotactic Radiotherapy of Benign Conditions
Non-Malignant Disease, Stereotactic Radiotherapy
SBRT, Non-Malignant Disease
SBRT, Benign Conditions
Benign Conditions, Stereotactic Radiotherapy

References:

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.
Borok TL, Bray M, Sinclair I, et al. Role of ionizing irradiation for 393 keloids. Int J Radiat Oncol Biol Phys. 1998 Oct; 15(4):865-870.
Chao KS, Perez, CA, Brady LW, eds. Radiation Oncology: Management Decisions. Philadelphia, PA: Lippincott-Raven. 1999.
Dewing SB. Chapter 36: Radiotherapy of Benign Diseases: Overview by Dr. Dewing. In: Gofman JW, O’Connor E, eds. Preventing Breast Cancer: The Story of a Major, Proven, Preventable Cause of This Disease. 2^nd Edition. San Francisco, CA: Committee for Nuclear Responsibility, Inc. Book Division; 1996; (36):243-254.
Eng TY, Boersma MK, Fuller CD, et al. The role of radiation therapy in benign diseases. Hematol Oncol Clin North Am. 2006 Apr; 20(2):523-527.
McKay C, Knight KA, Wright C. Beyond cancer treatment – a review of total lymphoid irradiation for hearl and lung transplant recipients. J Med Radiat Sci. 2014 Sep; 61(3): 202-209.
Medicare Fee, Payment and Reimbursement Guideline, CPT, ICD, Denial.
Mendenhall WM, Mancuso AA, Kiorwan JM et al. Skin: Principles and practice of radiation oncology. In: Halperin EC, Wazer DE, Perez CA, Brady LW, ed. Perez and Brady’s Principles and Practice of Radiation Oncology. 6^th Edition. Philadelphia, PA:Lippincott Williams & Wilkins, a Wolters Kluwer business. 2013626-637.
Meyer JJ (ed): The Radiation Therapy of Benign Diseases. Current Indications and Techniques. Front Radiat Ther Oncol. Basel, Karger; 2001;(35) 1-17.
Micke O, Seegenschmiedt MH. The German Working Group on Radiotherapy of Benign Disease. Consensus guidelines for radiation therapy of benign diseases: a multicenter approach in Germany. Int J Radiat Oncol Biol Phys. 2002 Feb; 52(2):496-513.
Order SE, Donaldson SS. Radiation Therapy of Benign Diseases: A Clinical Guide (Medical Radiology). Berlin, Heidelberg, New York Springer-Verlag. 2003.
Seegenschmiedt MH. Chapter 63: Nonmalignant Disease. In: Gunderson L, Tepper J, eds. Clinical Radiation Oncology. 2^nd Edition. Philadelphia, PA: Elsevier Churchill Livingstone; 2007; (63):1551-1568.
Seegenschmiedt MH, Micke O, Muecke R. The German Cooperative Group on Radiotherapy for Non-malignant Diseases (BCB-BD). Radiotherapy for non-malignant disorders: state of the art and update of the evidence-based practice guidelines. Br J Radiol. 2015; 88(1051).
The Royal College of Radiologists. Faculty of Clinical Oncology. A review of the use of radiotherapy in the UK for the treatment of benign clinical conditions and benign tumours. Clinical Oncology. 2015.
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. Volume I. HEW Publication (FDA) 78-8043. September 1977.
Winkfield KM, Bazan JG, Gibbs IC, et al. Chapter 91: Nonmalignant Diseases. In: Halperin EC, Wazer DE, Perez CA, and Brady LW, eds. Perez and Brady’s Principles and Practice of Radiation Oncology. 6^th Edition. Philadelphia, PA: Lippincott Williams & Wilkins, a Wolters Kluwer business. 2013: 1729-1752.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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