Commercial

Medical Policy

Notification

Brachytherapy and Accelerated Whole Breast Irradiation using Three-Dimensional Conformation Radiation Therapy

Notification Issued Date:

This version of the policy will become effective 07/15/2019.

The following indication was added to Brachytherapy (Breast and Lung) as Medically Necessary:

Accelerated partial breast irradiation using high dose rate (HDR) brachytherapy (intracavitary or interstitial)

The following indication was added to Brachytherapy as Experimental/Investigational:

electronic brachytherapy for accelerated partial-breast irradiation (APBI)

The following Experimental/Investigational indication was revised for Brachytherapy:

FROM:

Accelerated partial-breast irradiation (APBI), including interstitial APBI

TO:

Accelerated partial-breast irradiation (APBI), including interstitial

low dose rate

APBI

Title:

Brachytherapy and Accelerated Whole Breast Irradiation using Three-Dimensional Conformation Radiation Therapy

Policy #:

09.00.10z

Policy

This policy only applies to members for whom AmeriHealth Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program. For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services.

MEDICALLY NECESSARY

BRACHYTHERAPY
Brachytherapy as a primary or adjunctive therapy is considered medically necessary and, therefore, covered for all of the following conditions:

Head and Neck

Individuals with primary endobronchial tumors who are not otherwise candidates for surgical resection or external beam radiation therapy due to comorbidities or location of the tumor
As palliative therapy for airway obstruction or severe hemoptysis in individuals with primary, metastatic, or recurrent endobronchial tumors
Dysphagia caused by esophageal cancer
Head and neck cancers (including lip cancer, cancer of the oral cavity, oropharynx, nasopharyngeal, and esophagus)
Malignant brain tumor(s)
Uveal melanoma

Breast and Lung

Locoregional, symptomatic, recurrent non-small cell lung cancer
Interstitial or balloon brachytherapy as initial treatment for stage I or II breast cancer when used as a local boost irradiation in patients who are also treated with breast-conserving surgery and whole-breast external beam radiotherapy
Intracavitary breast brachytherapy (e.g., MammoSite® brachytherapy) after breast-conserving surgery for individuals with unilateral stage 1 or stage 2 breast cancer
Accelerated partial breast irradiation using high-dose rate (HDR) brachytherapy (intracavitary or interstitial)

Abdomen, Pelvis, and Prostate

Localized prostate cancer using permanent transperineal implantation of radioactive seeds as a monotherapy or when used in conjunction with external beam radiation therapy
Localized prostate cancer treated with high-dose rate prostate brachytherapy when used as a monotherapy or in conjunction with external beam radiation therapy
Cervical, endometrial, or vaginal cancer
Recurrent gastrointestinal cancer, rectal cancer, or anal cancer
Intraoperatively for resectable pancreatic adenocarcinoma with close margins
Urethral cancer

OTHER INDICATIONS

Soft-tissue sarcomas

ACCELERATED WHOLE BREAST IRRADIATION (AWBI)
Accelerated whole breast irradiation (AWBI) using three-dimensional conformation radiation therapy (3DCRT) is considered medically necessary and, therefore, covered for the following scenarios:

Following breast-conserving surgery for early-stage breast cancer, accelerated whole-breast irradiation for individuals who meet all of the following:
- Invasive carcinoma of the breast
- Tumors ≤5 cm in diameter
- Negative lymph nodes
- Technically clear surgical margins, i.e., no ink on tumor on invasive carcinoma or ductal carcinoma in situ
- Age at least 50 years old

EXPERIMENTAL/INVESTIGATIONAL

BRACHYTHERAPY
Intracavitary balloon catheter brain brachytherapy is considered experimental/investigational and, therefore, not covered for the following scenarios because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature:

Alone or as part of a multimodality treatment regimen for the treatment of primary or recurrent malignant brain tumors
Alone or as part of a multimodality treatment regimen for the treatment of metastasis to the brain from primary solid tumors outside the brain

All other uses for brachytherapy, including but not limited to the following, are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature:

Endobronchial brachytherapy as a radiation boost to curative external-beam radiotherapy
Endobronchial brachytherapy as a treatment for asymptomatic recurrences of non-small-cell lung cancer
Endobronchial brachytherapy as a treatment of hyperplastic granulation tissue
Focal or subtotal prostate brachytherapy for the treatment of prostate cancer
High-dose rate prostate brachytherapy as salvage therapy in the treatment of prostate cancer
Accelerated partial-breast irradiation (APBI), including interstitial low dose rate APBI, balloon APBI, external-beam APBI, noninvasive brachytherapy using Accuboost®, electronic brachytherapy, and intra-operative APBI
Noninvasive brachytherapy using Accuboost® in individuals undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in individuals who are also treated with breast-conserving surgery and whole-breast external-beam radiotherapy

Electronic brachytherapy for the treatment of nonmelanoma skin cancer, using ionizing radiation (e.g., the Xoft® Axxent® Electronic Brachytherapy System, the Esteya® Electronic Brachytherapy System), is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Ocular brachytherapy for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet, age-related macular degeneration is considered experimental/investigational and, therefore, not covered because the safety and effectiveness of this technology cannot be established by review of available published literature.

ACCELERATED WHOLE BREAST IRRADIATION (AWBI)
Accelerated whole-breast irradiation in situations involving treatment of early-stage breast cancer following breast-conserving surgery that does not meet the medical necessity criteria above is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the physician's office, hospital, nursing home, home health agencies, therapies, other healthcare professionals, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request.

Guidelines

Supporting medical necessity documentation must be maintained in medical records and made available to the Company upon request.

Pulsed-dose rate (PDR) brachytherapy uses sources of intermediate strength and delivers a series of doses once or twice an hour over a 1- to 2-day period. It is also a form of remote afterloading.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, brachytherapy is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met.

Description

Radiation oncology consists of two primary treatment modalities: external beam radiation therapy (EBRT) and brachytherapy. Brachytherapy entails placement of sealed radioactive sources, natural or manufactured radioactive isotopes or radionuclides, very close to, or in contact with, target tissues. The absorbed doses diminish rapidly with increased distance from the radioactive sources, thereby enabling the safe delivery of high-radiation doses to a localized target region over short periods of time. Brachytherapy techniques are classified according to surgical approach to target volume (i.e., interstitial, intracavitary, transluminal, or surface molds); methods for controlling dose rates (i.e., temporary or permanent implants); source-loading technology (i.e., preloaded, manually afterloaded, remotely afterloaded); and dose rate (i.e., low, medium, or high).

Brachytherapy may be performed concomitantly with surgical resection or in conjunction with procedures that may be required to achieve access to the disease site, such as endoscopy or angioplasty. There are two distinct phases of the brachytherapy process: the insertion of nonradioactive applicators or conduits (e.g., needle, balloon catheter) that receive or transmit the radioactive material into the body, and the loading of the radioactive material (e.g., seeds, wires, liquid colloid isotopes) into the conduits or directly into the tissue. Brachytherapy may be used alone or as an adjunctive treatment in combination with EBRT to increase the total radiation dose directed at a specific target.

Low-dose rate (LDR) and high-dose rate (HDR) brachytherapy deliver intensive radiation therapy to a well-defined local site (treatment volume). LDR and HDR brachytherapy may be used to cure, palliate, or obtain local control of a neoplasm, while sparing sensitive, healthy tissues that may be nearby. Treatment may be given in conjunction with a course of EBRT, or as a single modality.

LDR brachytherapy implants deliver doses at rates generally ranging from 40 to 200 cGy/hr (0.2 Gy to 2 Gy/hr), requiring treatment times of 24 to 144 hours, during which time the patient is normally confined to an inpatient treatment room. However, LDR may also be performed as an ambulatory or inpatient procedure in which permanently implanted source(s) deliver radiation as the isotope decays. Permanent interstitial LDR implants that remain in place indefinitely deliver an ultra-low-dose range, generally of 0.01 to 0.3 Gy/hr. The source strength of these permanent implants is chosen so that the prescribed dose is fully delivered when the implanted radioactive source has decayed to a negligible level.

HDR brachytherapy can deliver dose rates in excess of 0.2 Gy/min (12 Gy/hr). The application of remote afterloading in heavily shielded vaults, instantaneous rates as high as 0.12 Gy/sec (430 Gy/hr) at distances of 1 cm. These HDR brachytherapy applications allow the dose to be delivered in minutes and usually on an outpatient basis; it is often given in a series of multiple fractions.

Generally, cancers with clinically and radiologically well-defined margins that have a low potential for regional and metastatic spread are the most applicable applications for brachytherapy as a single treatment modality. Increasingly, brachytherapy is being utilized in conjunction with EBRT to give a highly localized boost. Combination treatment regimens utilize EBRT as a method to sterilize a larger area of possible microscopic or nodal disease spread, with brachytherapy used in the treatment of areas with gross macroscopic or microscopic residual disease. The combination of these techniques ensures the delivery of high doses of radiation within tumors while normal surrounding tissue is not taken beyond recognized organ tolerance levels, and has the potential for conformal localized dose escalation to areas at high risk for tumor reoccurrence.

Several breast lumpectomy bed brachytherapy devices (e.g., MammoSite®) use a specialized procedure to treat early-stage breast cancer. It is typically performed during initial lumpectomy, but it can also be done as a separate procedure. The MammoSite® catheter, for example, which has a balloon at the tip, is temporarily implanted into the breast zone where the tumor was removed. Once inserted, the balloon is expanded. A radioactive source is then inserted through the catheter directly to the tumor site to allow for treatment of the tumor bed and the surrounding tissue that may contain residual microscopic tumor cells. In this way, side effects such as irradiation of healthy tissue (which is commonly seen with EBRT) are avoided, and treatment can be completed in 4 to 5 days (outpatient) compared with 7 weeks for traditional EBRT.

Accuboost® (also called noninvasive breast brachytherapy) is breast-conservation therapy that delivers a targeted dose of radiation directly to the tissue surrounding the tumor bed. The Accuboost® system provides image-guided radiotherapy, usually in combination with surgical lumpectomy and other forms of radiation therapy, to treat any remaining pre-cancerous cells around the surgical excision site that, if left untreated, may grow into a new tumor. The breast is placed between X-ray imaging mammography paddles, where images are taken and radiation is delivered to create a focused radiation field pointed directly at the lumpectomy site. A proposed benefit of this therapy is that it reduces radiation exposure to adjacent tissues, including the heart and lung, since the radiation can be delivered from one side of the breast to the other, or from the top of the breast to the bottom. However, no long-term studies are available to confirm this. There is only one comparative study evaluating Accuboost® for this use. In a matched retrospective study, subjects received the boost dose using Accuboost® (n=47) or electron beams (a type of EBRT; n=93). Accuboost® subjects were compared with two electron beam controls matched on age, stage, chemotherapy use, fractionation, and when possible, breast size, comorbidities, and smoking status. Main differences between the two treatment groups were in radiation dose received and timing of radiotherapy administration. With a median follow-up period of 13.6 months, skin/subcutaneous tissue toxicity occurred less often among patients treated with Accuboost® than among those treated with electron beam (P=0.046). Study limitations included the between-group differences in whole-breast radiation dose and timing of boost, as well as selection bias and the study’s retrospective design.

The Xoft® Axxent® Electronic Brachytherapy System (Fremont, CA) is a proprietary platform designed to deliver nonradioactive, isotope-free, ionizing radiation therapy. Although the US Food and Drug Administration (FDA) has given this system a 510(k) approval, there is a paucity of literature available and only a few clinical studies have been conducted on this method of brachytherapy. Therefore, the safety and/or efficacy of this service cannot be established by review of the available published literature.

The Esteya® Electronic Brachytherapy System is designed for high-dose rate (HDR) brachytherapy treatment of skin surface lesions. The system utilizes a mobile treatment unit that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. Typical applications include treatment for basal cell carcinoma, squamous cell carcinoma, Kaposi's sarcoma, Merkel cell carcinoma, lentigo maligna, lentigo maligna melanoma, keloids, and cutaneous lymphomas (B and T cell).

Ocular brachytherapy using the Epi-Rad90™ Ophthalmic System (NeoVista, Inc., Fremont, CA) is aimed at providing a therapeutic option for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet, age-related macular degeneration (AMD), a leading cause of vision loss. The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. This device was given an investigational device exemption (IDE) in order to begin clinical trials; recruiting for the phase III CABERNET (CNV secondary to AMD treated with BEta RadiatioN Epiretinal Therapy) clinical trial started in April 2007, and the study was to conclude in April 2011. The experimental arm of the study used the Epi-Rad90™ Ophthalmic System plus two injections of an antiangiogenic drug, Lucentis® (Genentech, South San Francisco, CA), administered 1 month apart. The comparator arm used Lucentis® injections administered monthly for the first three injections followed by quarterly injections. At this time, the safety and efficacy of the Epi-Rad90™ Ophthalmic System cannot be established because there is limited available published literature. Also, the device has not yet received FDA approval.

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Smith BD, Bellon JR, Blitzblau R, et al. Radiation therapy for the whole breast: executive summary of an American Society for Radiation Oncology (ASTRO) evidence-based guideline. Pract Radiat Oncol. 2018;8(3):145-152.

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Smith GL, Xu Y, Buchholz TA, et al. Association between treatment with brachytherapy vs whole-breast irradiation and subsequent mastectomy, complications, and survival among older women with invasive breast cancer. JAMA. 2012;307(17):1827-1837.

Steen-Bansik E M van der, Ploeg M, Witjes JA, et al. brachytherapy versus cystectomy in solitary bladder cancer: a case control, multicenter, East Netherlands study.
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Stewart A, Parashar B, Patel M, et al. American Brachytherapy Society consensus guidelines for thoracic brachytherapy for lung cancer. Brachytherapy. 2016;15(1):1-11.

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Tendulkar RD, Fleming PA, Reddy CA, et al. High-dose-rate endobronchial brachytherapy for recurrent airway obstruction from hyperplastic granulation tissue. Int J Radiat Oncol Biol Phys. 2008;70(3-Jan):701-706.

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Tormo A, Celada F, Rodriguez S, et al. Non-melanoma skin cancer treated with HDR Valencia applicator: clinical outcomes. J Contemp Brachytherapy. 2014;6(2):167-172.

Tselis N, Tunn UW, Chatzikonstantinou G, et al. High dose rate brachytherapy as monotherapy for localised prostate cancer: a hypofractionated two-implant approach in 351 consecutive patients. Radiat Oncol. 2013;8:115.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

19296, 19297, 19298, 20555, 31643, 32553, 41019, 43241, 49411, 55860, 55862, 55865, 55875, 55876, 55920, 57155, 57156, 58346, 76000, 76873, 76965, 77261, 77262, 77263, 77280, 77285, 77290, 77293, 77295, 77300, 77316, 77317, 77318, 77331, 77332, 77333, 77334, 77336, 77370, 77470, 77750, 77761, 77762, 77763, 77767, 77768, 77770, 77771, 77772, 77778, 77789, 77790, 77799

EXPERIMENTAL/INVESTIGATIONAL

0394T, 0395T

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N/A

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

A9527 Iodine I-125, sodium iodide solution, therapeutic, per millicurie

A9600 Strontium Sr-89 chloride, therapeutic, per millicurie

A9604 Samarium sm-153 lexidronam, therapeutic, per treatment dose, up to 150 millicuries

C1715 Brachytherapy needle

C1716 Brachytherapy source, nonstranded, gold-198, per source

C1717 Brachytherapy source, nonstranded, high dose rate iridium-192, per source

C1719 Brachytherapy source, nonstranded, nonhigh dose rate iridium-192, per source

C1728 Catheter, brachytherapy seed administration

C2616 Brachytherapy source, nonstranded, yttrium-90, per source

C2634 Brachytherapy source, nonstranded, high activity, iodine-125, greater than 1.01 mCi (NIST), per source

C2635 Brachytherapy source, nonstranded, high activity, palladium-103, greater than 2.2 mCi (NIST), per source

C2636 Brachytherapy linear source, nonstranded, palladium-103, per 1 mm

C2637 Brachytherapy source, nonstranded, ytterbium-169, per source

C2638 Brachytherapy source, stranded, iodine-125, per source

C2639 Brachytherapy source, nonstranded, iodine-125, per source

C2640 Brachytherapy source, stranded, palladium-103, per source

C2641 Brachytherapy source, nonstranded, palladium-103, per source

C2642 Brachytherapy source, stranded, cesium-131, per source

C2643 Brachytherapy source, nonstranded, cesium-131, per source

C2645 Brachytherapy planar source, palladium-103, per square millimeter

C2698 Brachytherapy source, stranded, not otherwise specified, per source

C2699 Brachytherapy source, nonstranded, not otherwise specified, per source

C9725 Placement of endorectal intracavitary applicator for high intensity brachytherapy

C9726 Placement and removal (if performed) of applicator into breast for intraoperative radiation therapy, add-on to primary breast procedure

G0458 Low dose rate (ldr) prostate brachytherapy services, composite rate

Q3001 Radioelements for brachytherapy, any type, each

EXPERIMENTAL/INVESTIGATIONAL

C2644 Brachytherapy source, cesium-131 chloride solution, per millicurie

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 09.00.10z:

03/06/2024

The policy has been reviewed and reissued to communicate the Company's continuing position on Brachytherapy and Accelerated Whole Breast Irradiation using Three-Dimensional Conformation Radiation Therapy.

10/18/2023

07/01/2022

Effective July 1, 2022, the policy disclaimer was revised to communicate:

03/24/2021

This policy has been reissued in accordance with the Company's annual review process.

07/15/2019

The following indication was added to Brachytherapy (Breast and Lung) as Medically Necessary:

Accelerated partial breast irradiation using high dose rate (HDR) brachytherapy (intracavitary or interstitial)

The following indication was added to Brachytherapy as Experimental/Investigational:

electronic brachytherapy for accelerated partial-breast irradiation (APBI)

The following Experimental/Investigational indication was revised for Brachytherapy:

FROM:

Accelerated partial-breast irradiation (APBI), including interstitial APBI

TO:

Accelerated partial-breast irradiation (APBI), including interstitial low dose rate APBI

Revisions From 09.00.10y:

01/01/2019

The title of the policy was changed to: Brachytherapy and Accelerated Whole Breast Irradiation using Three-Dimensional Conformation Radiation Therapy

The following indication was added to Head and Neck in the Policy Section:

Uveal melanoma

The following clarification was made to the criteria in the Policy Section:

MEDICALLY NECESSARY

BREAST AND LUNG
Accelerated whole breast irradiation (AWBI) is considered medically necessary and, therefore, covered for the following scenarios:

Following breast-conserving surgery for early-stage breast cancer, accelerated whole-breast irradiation for individuals who meet all of the following:

FROM:

tumors >5 cm in diameter

TO:

tumors ≤ 5 cm in diameter

Coding

The following CPT codes have been termed and have been removed from this policy: 76001, 0190T

Revisions From 09.00.10x:

01/01/2018

This policy has been identified for the CPT code update, effective 01/01/2018.
The following CPT narrative has been revised in this policy: 76000

Revisions From 09.00.10w:

11/17/2017

The following changes were made to this policy:

Policy Section

The criteria regarding the use of Accelerated Whole Breast Irradiation following breast-conserving surgery was revised as follows:

FROM:

Accelerated whole breast irradiation (AWBI) is considered medically necessary and, therefore, covered for the following scenarios:

Following breast-conserving surgery for early-stage breast cancer, accelerated whole-breast irradiation for individuals who meet all of the following:

TO:

Accelerated whole breast irradiation (AWBI) is considered medically necessary and, therefore, covered for the following scenarios:

Following breast-conserving surgery for early-stage breast cancer, accelerated whole-breast irradiation for individuals who meet all of the following:

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

7/15/2019

Version Issued Date:

7/15/2019

Version Reissued Date:

3/6/2024