Breast Brachytherapy

Medical Policy: 08.01.11 
Original Effective Date: February 2005 
Reviewed: June 2011 
Revised: April 2010 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

Brachytherapy for breast cancer involves the direct placement of radioactive material inside the breast. Brachytherapy techniques differ in timing of implantation, dose rate, loading techniques, and the radioisotopes used in the implanted sources.

 

Intracavitary balloon brachytherapy involves the temporary placement of a single balloon-tipped catheter into the cavity left by the excised breast tumor. When filled with saline the balloon conforms to the cavity walls. Through a lumen within the saline-filled balloon, a radiation seed (iridium-192) is deployed to the target site using a high-dose-rate afterloader system. The seed delivers high dose radiation to the surrounding breast tissue for up to 20 minutes. The standard intracavitary brachytherapy protocol for breast cancer includes 2 treatments per day for 5 days.  At the conclusion of the 5 day treatment period the balloon-tipped catheter is deflated and removed.

 

Interstitial brachytherapy uses multiple radiation sources placed in 2 or more planes through the breast, with computerized treatment planning to optimize dose homogeneity in the target. The number, spacing, and radiation strength of sources vary with the breast volume to be treated. Both low-and high-dose rate interstitial techniques are used. In the low-dose rate technique, radioactive seeds are temporarily implanted and deliver radiation continuously over 4 days and then are removed. Low-dose rate brachytherapy is usually administered to hospitalized patients. In the high-dose rate technique, a computer-controlled device loads highly radioactive isotope sources into catheters that have been placed in the tumor bed. The patient is then exposed to the radiation for a brief period and then the radioactive sources are withdrawn. High-dose rate brachytherapy is usually administered in the outpatient setting as 8 fractions twice daily over 4 days.

 

Electronic brachytherapy devices are intended to control tissue exposure to radiation by placing the source directly within the tissue. A miniature x-ray tube rather than radioactive isotopes generate low-energy radiation at a high dose rate. The high dose rate x-ray source kit is disposable, and less protective shielding is required when electronic brachytherapy is administered. Currently, the devices are subject only to medical device review by the U.S. Food and Drug Administration (FDA) and do not fall under the jurisdiction of the Nuclear Regulatory Commission (NRC).  .  Regulation among individual states varies widely. There are no accepted calibration standards for electronic brachytherapy and according to Park et al (2010), such a lack of standardization can lead to significant uncertainties associated with absorbed dose measurement at low energies. While the treatment source is low energy, the radiation dose per fraction is very high leading to the potential for patient injury not unlike that which can occur with high dose rate radioisotope brachytherapy. Thus, electronic brachytherapy is a widely unregulated method of delivering cancer treatment. Randomized trials or comparison studies demonstrating improvement in health outcomes and long-term assessments of treatment efficacy and effects are warranted.

 


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Prior Approval: 

 

Not applicable


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Policy: 

Breast brachytherapy to deliver additional conformal boost dose to the surgical bed and margins following whole-breast radiation therapy may be considered medically necessary.

 

Accelerated partial breast irradiation (APBI) may be considered medically necessary as a sole form of radiation therapy, in lieu of whole breast irradiation, when the following criteria are met:

  • Age 45 years old or greater
  • Invasive ductal carcinoma or ductal carcinoma in situ
  • Total tumor size less than or equal to 3 cm in size
  • Negative microscopic surgical margins of excision
  • Sentinel lymph node negative.

Breast brachytherapy is considered investigational in patients not meeting the above criteria.

 

Electronic brachytherapy is considered investigational in all care settings and for all indications including breast cancer.



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Procedure Codes and Billing Guidelines: 

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.

The following codes or code ranges may be used to report brachytherapy:

  • 77326 Brachytherapy isodose plan; simple (calculation made from single plane, 1 to 4 sources/ribbon application, remote afterloading brachytherapy, 1 to 8 sources)
  • 77327 Brachytherapy isodose plan; intermediate (multiplane dosage calculations, application involving 5 to 10 sources/ribbons, remote afterloading brachytherapy, 9 to 12 sources)
  • 77328 Brachytherapy isodose plan; complex (multiplane isodose plan, volume implant calculations, over 10 sources/ribbons used, special spatial reconstruction, remote afterloading brachytherapy, over 12 sources)
  • 77750 Infusion or instillation of radioelement solution (includes 3-month follow-up care)
  • 77761 Intracavitary radiation source application; simple
  • 77762 Intracavitary radiation source application; intermediate
  • 77763 Intracavitary radiation source application; complex
  • 77776 Interstitial radiation source application; simple
  • 77777 Interstitial radiation source application; intermediate
  • 77778 Interstitial radiation source application; complex
  • 77785 Remote afterloading high dose rate radionuclide brachytherapy; 1 channel
  • 77786 Remote afterloading high dose rate radionuclide brachytherapy; 2-12 channels
  • 77787 Remote afterloading high dose rate radionuclide brachytherapy; over 12 channels
  • 77789 Surface application of radiation source           
  • 77790 Supervision, handling, loading of radioelement
  • 19296 Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy
  • 19297 Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; concurrent with partial mastectomy (List separately in addition to code for primary procedure)
  • 19298 Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and button type) into the breast for interstitial radioelement application following (at the time of or subsequent to) partial mastectomy, includes imaging guidance
  • 0182T High dose rate electronic brachytherapy, per fraction      

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Selected References: 

  • Edmundson GK et al. Accelerated treatment of breast cancer: dosimetric comparisons between interstitial HDR brachytherapy, MammoSite balloon brachytherapy, and external beam quadrant radiation. Int J Radiat Oncol Biol Phys 2003 Oct 1;57(2Suppl):S307-8.
  • Fisher B, Anderson S, Bryant J et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. NEJM 2002 Oct 17;347(16):1233-41.
  • King TA, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T1,2 breast cancer. AM J Surg 2000 Oct;180(4):299-304.
  • Pawlik TM, et al. Potential applicability of balloon catheter-based accelerated partial breast irradiation after conservative surgery for breast carcinoma. Cancer 2004 Feb 1;100(3):490-8.
  • Huang E, Buchholz TA, Meric F et al.  Classifying local disease recurrences after breast conservation therapy based on location and histology. Cancer 2002; 95(10): 2059-67.
  • Dragun AE, Aguero EG, Harmon JF et al. Chest wall dose in MammositeTM  breast brachytherapy: radiobiologic estimations of late complication risk based on dose-volume considerations. Brachytherapy. 2005; 4(4):259-63.
  • Vicini FA< Beitsch PD, Quiet CA et al. First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer. 2005 Sep 15; 104(6):1138-48.
  • McCormick B. Partial-breast radiation for early staged breast cancers: hypothesis, existing data, and a planned phase III trial. J Natl Compr Canc Netw. 2005 May;3(3):301-7.
  • Chen PY, Vicini FA, Benitez P et al. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer 2006; 106(5):991-9.
  • Jeruss JS, Vicini FA, Beitsch PD et al. Initial outcomes for patients treated on the American Society of Breast Surgeons MammoSite clinical trial for ductal carcinoma-in-situ of the breast. Ann Surg Oncol 2006; 13(7):967-76.
  • Kuske RR, Winter K, Arthur DW et al. Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG 95-17. Int J Radiat Oncol Biol Phys 2006; 65(1):45-51.
  • The American Society of Breast Surgeons. Consensus Statement for Accelerated Partial Breast Irradiation. October 2008.
  • Blue Cross Blue Shield Association Technology Evaluation Center. Accelerated Partial Breast Irradiation as Sole Radiotherapy After Breast-Conserving Surgery for Early Stage Breast Cancer. 2007 TEC Assessment.
  • Benitez P, Keisch M, Vicini F et al. Five-year results: the initial clinical trial of Mammosite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg 2007;194(4):456-62.
  • Ko EC, Koprowski CD, Dickson-Witmer D et al. Partial vs. whole breast irradiation in a community hospital: A retrospective cohort analysis of 200 patients. Brachytherapy. 2010 Feb 12 [Epub ahead of print]
  • Harper JL, Watkins JM, Zauls AJ et al. Six-year experience: long-term disease control outcomes for partial breast irradiation using MammoSite balloon brachytherapy. Am J Surg. 2010 Feb; 199(2): 204-9. Epub 2009 Oct 17.
  • Nelson JC, Beitsch PD, Vicini FA et al. Four-year clinical update from the American Society of Breast Surgeons MammoSite brachytherapy trial. Am J Surg. 2009 Jul; 198(1):83-91. Epub 2009 Mar 6.
  • Antonucci JV, Wallace M, Goldstein NS et al. Differences in patterns of failure in patients treated with accelerated partial breast irradiation versus whole-breast irradiation: a matched-pair analysis with 10-year follow-up. Int J Radiat Oncol Biol Phys. 2009 Jun 1; 74(2): 447-52. Epub 2008 Dec 6.
  •  Sher DJ, Wittenberg E, Suh WW et al. Partial-breast irradiation versus whole-breast irradiation for early-stage breast cancer: a cost-effectiveness analysis. Int J Radait Oncol Biol Phys. 2009 Jun 1; 74(2): 440-6. Epub 2008 Oct 27.
  • ECRI Institute. Electronic Brachytherapy. Plymouth Meeting (PA): ECRI Institute; 2009 Jun 12. 6 p. [ECRI hotline response]. Available: http://www.ecri.org
  • Park CC, Yom SS, Podgorsak MB et al. American Society for Therapeutic Radiology and Oncology (ASTRO) Emerging Technology Committee report on electronic brachytherapy. Int J Radiat Oncol Biol Phys. 2010 Mar 15; 76(4): 963-72.
  • Dickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2; 7:24.
  • Dickler A, Kirk MC, Coon A et al. A dosimetric comparison of Xoft Axxent electronic brachytherapy and iridium-192 high-dose-rate brachytherapy in the treatment of endometrial cancer. Brachytheapy. 2008 Oct-Dec; 7(4):351-4. Epub 2008 Sep 9.
  • ECRI Institute. Electronic Brachytherapy. Plymouth Meeting (PA): ECRI Institute; 2011 August 9. 8 p. [ECRI hotline response]. Available: http://www.ecri.org
  • Dooley WC, Wurzer JC, Megahy M et al. Electronic  brachytherapy as adjuvant therapy for early stage breast cancer: a retrospective analysis. OncoTargets Ther. 2011 Jan 12; 4:13-20.
  • Dooley WC, Algan O, Dowlatshahi K et al. Surgical perspectives from a prospective, nonrandomized, multicenter study of breast conserving surgery and adjuvant electronic brachytherapy for the treatment of breast cancer. World J Surg Oncol. 2011 Mar 7; 9:30.
  • Ivanov O, Dickler A, Lum BY et al. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb; 18(2):453-8. Epub 2010 Aug 25.
  • Mehta VK, ALgan O, Griem KL et al. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug; 33(4):327-35.
  • Njeh CF, Saunders MW, Langton CM. Accelerated Partial Breast Irradiation (APBI): A review of available techniques. Radiat Oncol. 2010 Oct 4; 5:90.
  • Vicini F, Arthur D, Wazer D et al. Limitations of the American Society of Therapeutic Radiology and Oncology Consensus Panel Guidelines on the use of accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys 2011; 79(4):977-84.
  • Shaitelman SF, Vicini FA, Beitsch P et al. Five-year outcome of patients classified using the American Society for Radiation Oncology Consensus Statement Guidelines for the application of accelerated partial breast irradiation. Cancer 2010; 116(20):4677-85.
  • Beitsch P, Vicini F, Keisch M et al. Five-year outcome of patients classified in the “unsuitable” category using the American Society of Therapeutic Radiology and Oncology (ASTRO) Consensus Panel Guidelines for the Applications of Accelerated Partial Breast Irradiation: An Analysis of Patients Treated on the American Society of Breast Surgeons MammoSite® Registry Trial. Ann Surg Oncol 2010; 17(Suppl 3):S219-25.

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Policy History: 

 

Date                                        Reason                              Action

June 2011                               Annual review                    Policy renewed


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
     
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
 
 
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