Medical Policy: 08.01.11 
Original Effective Date: February 2005 
Reviewed: January 2016 
Revised: January 2016 


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:

Electronic brachytherapy (EBT) is the administration of high dose radiotherapy (HDR) brachytherapy without the use of radioactive isotope and with minimal shielding requirements due to the low energies utilized with the system. Therefore, it can be used in controlled settings without a specially shielded vault, such as in the office of an authorized user or in an operating room. Electronic brachytherapy is a treatment modality being utilized to treat breast cancer, non-melanoma skin cancer, gynecological and other cancers.

 

EBT uses a disposable miniature low energy (50Kv) X-ray tube into a pre-positioned applicator within body/tumor cavities or skin surfaces to rapidly deliver high doses of radiotherapy. Through the manipulation of radiation intensity and dose distribution, EBT delivers more intense therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue.  Another potential advantage includes a shorter treatment schedule.

 

Non-melanoma Skin Cancer
Non-melanoma skin cancer consists primarily of squamous cell carcinoma and basal cell carcinoma and are the most common types of malignancy in the United States. The primary risk factor for non-melanoma skin cancer is sun exposure. Although these cancers rarely cause mortality, they can impact quality of life, functional status and physical appearance.

 

Treatment of non-melanoma skin cancer is primarily surgical. The choice of surgical procedure depends on the histologic type, size and location of the lesion. Patient characteristics and preferences may also be part of the decision making process, with consideration of comorbidities, patient risk factors such as anticoagulation and cosmetic outcomes. Mohs surgery is the preferred procedure for those who qualify.

 

Radiotherapy is indicated for certain non-melanoma skin cancers that are not amendable to surgery. In some cases, this is due to the location of the lesion on the eyelid, nose, or other structures that make surgery more difficult and which may be expected to have less desirable cosmetic outcome. In other cases, surgery may be relatively contraindicated due to clinical factors such as bleeding risk or advanced age.

 

Electronic brachytherapy (EBT) for skin application (surface brachytherapy) uses a direct contact applicator and a flexible clamp. The lightweight surface applicator (less than 150g) can be precisely oriented to the desired location on the patient i.e. the target lesion. Surface applicators range in size from 10mm to 50mm providing flexibility in treating a variety of lesion sizes. A miniaturized X-ray source is placed in the applicator and energized to deliver radiation for a few minutes. With the reduced shielding requirement, the physician can remain near the patient. Furthermore, faster dose fall-off of the low-energy miniaturized X-ray source minimizes exposure to healthy adjacent tissues.

 

Summary
There is a small body of evidence that evaluates electronic brachytherapy as a treatment for non-melanoma skin cancer. This evidence consists of case series, and usually with a mixed patient population of basal and squamous cell carcinomas. No controlled trials were identified that compared electronic brachytherapy with alternative treatment options. Controlled trials are needed that compare electronic brachytherapy with alternatives, either other forms of radiotherapy or surgical approaches. As a result of the lack of high-quality evidence of efficacy, electronic brachytherapy is considered investigational for the treatment of non-melanoma skin cancer.

 

Breast Cancer and Other Cancers      
Other intraoperative radiotherapy (IORT) modalities are being researched, e.g., electronic brachytherapy using Xoft® Axxent® eBx system. The use of Xoft® Axxent® eBx system is intended to deliver intracavitary radiation to treat breast, gynecological cancers and other organs. The system consists of three components: a high dose radiation (HDR) controller, balloon applicators, and a disposable HDR x-ray source kit. To perform electronic brachytherapy using this system, the surgeon inserts a balloon catheter into the area where the cancer is present or had been surgically removed and fills the balloon with saline to approximate surgically created lumpectomy cavity or natural cavity. The surgeon then inserts the x-ray source attached to a flexible cable into the central lumen of the appropriately filled balloon applicator, permitting delivery of radiation to the target site via a disposable micro-miniature x-ray tube. The balloon applicator can be safely left in place between treatments.

 

The Axxent® eBx system is designed to mimic the therapeutic effects of iridium (Ir)-192, a commonly used radioisotope for high dose rate brachytherapy. The purported advantage of using Axxent® eBx system is the dose fall-off rate is lower, so the patient receives less dose to critical organs and healthy tissue, there are no radioisotopes which eliminates the need for heavy shielding and the favorable cosmetic outcomes:

  • For breast application: Breast eBx with Xoft® system delivers a prescribed, targeted dose of radiation directly to the site where cancer recurrence is most likely. Compared to traditional radiotherapy, eBx requires fewer treatments and minimizes exposure to healthy tissue and organs, such as ribs, lungs, heart and opposite breast. 
  • For vaginal application: The Xoft® eBx system is designed to simplify the radiation therapy process and make it more accessible to patients who are suitable candidates for vaginal brachytherapy. While reducing the number of required treatments, eBx delivers a targeted prescribed dose of radiation directly to the site where cancer recurrence is most likely, minimizing exposure to healthy tissue such as the bladder and rectum.

Summary
There is insufficient evidence in peer reviewed scientific literature to support electronic brachytherapy for the treatment of breast cancer to include all other cancer related indications. Studies are small, mostly single center studies with limited follow up. Furthermore, studies comparing health outcomes of electronic brachytherapy with health outcomes of conventional radioactive source brachytherapy are lacking. Randomized trials or comparison studies demonstrating improvements in health outcomes and long term assessments of treatment efficacy and effects are warranted. Therefore, electronic brachytherapy is considered investigational for all indications.  

 

Practice Guideline and Position Statements
American Society for Radiation Oncology (ASTRO)
The American Society for Therapeutic Radiology and Oncology (ASTRO) Emerging Technology Committee's report on EBT (Park et al, 2010) stated that "advantages of EBT over existing technologies are as yet unproven in terms of efficacy or patient outcomes".  The report explains the impact of clinical use of electronic brachytherapy could be far-reaching, and if used improperly, potentially harmful to patients.  The report explains that electronic brachytherapy is currently an unregulated treatment delivery modality for cancer therapy, with minimal clinical data available from small single institution, studies, none with significant follow-up.  It also noted that there are currently no accepted calibration standards for EBT.  Thus, there can be large uncertainties associated with absorbed dose measurement at low energies.  Furthermore, the report stated that the effects of EBT on tumor and normal tissues are not yet well understood, given the paucity of clinical studies.


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.

 

American Academy of Dermatology
In 2013, the American Academy of Dermatology issued a position statement on electronic surface brachytherapy for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) which was revised August 9, 2014. 

 

This position statement is intended to offer dermatologists guiding principles regarding provision of electronic surface brachytherapy services in order to provide high quality care for patients, but is not intended to establish a legal or medical standard of care:

  • Based on current evidence, surgical management remains the most effective treatment for BCC and SCC, providing the highest cure rates.
  • The Academy supports consideration of electronic surface brachytherapy as a secondary option for the treatment of BCC and SCC, for use in special circumstances, such as when surgical intervention is contraindicated or refused and after the benefits and risks of treatment alternatives have been discussed with the patient.
  • The Academy believes additional research is needed on electronic surface brachytherapy particularly on long term outcomes. 

National Comprehensive Cancer Network (NCCN)
The National Comprehensive Cancer Network (NCCN) guidelines did not discuss electronic brachytherapy in the following:

  • Squamous Cell Skin Cancer Version 1.2016
  • Basal Cell Skin Cancer Version 1.2016
  • Breast Cancer Version 1.2016
  • Uterine Neoplasms Version 2.2016

Regulatory Status
The Esteya® Electronic Brachytherapy System (Nucletron BV) and the Xoft® Axxent® Electronic Brachytherapy System (iCAD Inc.) are 2 systems that recently received FDA clearance through the 510(k) process.   


Prior Approval:

 

Not applicable


Policy:

Electronic brachytherapy is considered investigational for all indications including but not limited to the following:

  • Non-melanoma skin cancers (basal cell carcinoma (BCC)/squamous cell carcinoma (SCC)
  • Breast cancer
  • Gynecological cancers (endometrial/vaginal/cervical)

There is insufficient evidence in peer reviewed scientific literature to support electronic brachytherapy for the treatment of breast cancer to include all other cancer related indications. Studies are small, mostly single center studies with limited follow up. Furthermore, studies comparing health outcomes of electronic brachytherapy with health outcomes of conventional radioactive source brachytherapy are lacking. Randomized trials or comparison studies demonstrating improvements in health outcomes and long term assessments of treatment efficacy and effects are warranted. Therefore, electronic brachytherapy is considered investigational for all indications.  



Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

 

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

  • 0394T High dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, when performed
  • 0395T High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed

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 InstituteExternal Site  2009 Jun 12. 6 p. [ECRI hotline response].
  • 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 InstituteExternal Site ; 2011 August 9. 8 p. [ECRI hotline response].
  • 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.
  • American Society of Breast Surgeons. Consensus Statement for Accelerated Partial Breast IrradiationExternal Site Revised August, 2011.
  • ECRI InstituteExternal Site Contura Multi-lumen Balloon Catheter (SenoRx, Inc.) for Accelerated Partial Breast Irradiation. Plymouth Meeting (PA): Dec 8, 2011. Custom Hotline Product Brief.
  • American College of RadiologyExternal Site Expert Panel on Radiation Oncology-Breast; Moran MS, Bai HX, Haffty BG et al. ACR Appropriateness Criteria®. Ductal Carcinoma In Situ. 2011.
  • American College of RadiologyExternal Site Expert Panel on Radiation Oncology-Breast; Bellon JR, Haffty BG, Harris EER et al. ACR Appropriateness Criteria®. Conservative Surgery and Radiation-Stage I and II Breast Carcinoma. 2011.
  • Wilder RB, Curcio LD, Khanijou RK et al. Preliminary results in 173 breast cancer patients treated with post-lumpectomy MammoSite Single-lumen brachytherapy or multi-catheter brachytherapy. Breast J. 2010 Nov-Dec; 16(6):581-6.
  • Yashar C, Scanderbeg D, Kuske R et al. Initial clinical experience with the strut-adjusted volume implant (SAVI) breast brachytherapy device for accelerated partial-breast irradiation (APBI): First 100 patients with more than 1 year of follow-up. Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):765-70.
  • 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):1827-37.
  • ECRI InstituteExternal Site  Product Brief. Axxent Electronic Brachytherapy System (Xoft, Inc) for Adjuvant Treatment of Breast, Vaginal and Skin Cancers. December 2012.
  • Conference of Radiation Control Program Directors, Inc.External Site (CRCPD). Technical White Paper: Guidance for State Programs that Regulate the New Therapy Modality Electronic Brachytherapy. January 2011.
  • American Society for Radiation Oncology (ASTRO) Brachytherapy Model Policy. January 2012.
  • American Society of Radiation Oncology (ASTRO), Emerging Technology Committee Report on Electronic Brachytherapy, May 23, 2008, Catherine C. Park, M.D. et al. Int. J. Radiation Oncology Biol.Phys. Vol. 76, No. 4 pp 963-972, 2010  
  • Xoft, IncExternal Site 
  • American Academy of DermatologyExternal Site Position Statement on Electronic Surface Brachytherapy for Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC), (Approved by the Board of Directors November 13, 2013; revised March 22, 2014; revised August 9, 2014).
  • ECRIExternal Site  Product Brief. Axxent Electronic Brachytherapy System (Xoft, Inc.) for Adjuvant Treatment of Breast, Vaginal and Skin Cancers. April 2015.
  • National Comprehensive Cancer Network (NCCN) Breast Cancer Version 1.2016.
  • National Comprehensive Cancer Network Clinical Practice Guidelines in OncologyExternal Site Squamous Cell Skin Cancer Version 1.2016.
  • National Comprehensive Cancer Network Clinical Practice Guidelines in OncologyExternal Site Basal Cell Skin Cancer Version 1.2016.
  • National Comprehensive Cancer Network Clinical Practice Guidelines in OncologyExternal Site Uterine Neoplasms Version 2.2016.
  • Dooley W, Thropay J, Schreiber G, et. al. Use of Electronic Brachytherapy to Deliver Postsurgical Adjuvant Radiation Therapy for Endometrial Cancer: A Retrospective Multicenter Study. OncoTargets and Therapy 2010:3 197-203
  • National Guideline Clearinghouse. Lee LJ, Jhingran A, Kidd E, et. al. ACR Appropriateness Criteria Management of Vaginal Cancer. American College of Radiology (ACR); 2013. 11p.
  • National Guideline Clearinghouse. Klopp A, Smith BD, Alektiar K, et. al. The Role of Postoperative Radiation Therapy for Endometrial Cancer: An ASTRO Evidence-Based Guideline. Pract Radiat Oncol. 2014;(Suppl):1-22
  • UpToDateExternal SiteExternal Site Radiation Therapy Techniques for Newly Diagnosed, Non-Metastatic Breast Cancer, Lori J. Pierce, M.D. Topic last updated October 21, 2013.
  • UpToDateExternal Site Radiation Therapy Techniques in Cancer Treatment. Timur Mitin M.D., PhD, Topic last updated May 22, 2014.
  • UpToDateExternal Site Adjuvant Treatment of Intermediate Risk Endometrial Cancer, Heidi J Gray, M.D., Wui-Jin Koh, M.D., Topic last updated April 10, 2014.
  • Dickler A, Putawala M, Thropay J, et. al. Prospective Multi-Center Trial Utilizing Electronic Brachytherapy for the Treatment of Endometrial Cancer, Radiation Oncology 2010, 5:67
  • Beithsch P, Patel R, Lorenzetti J, et. al. Post-Surgical Treatment of Early-Stage Breast Cancer with Electronic Brachytherapy: An Intersociety, Multicenter Brachytherapy Trial, OncoTargets and Therapy 2010:3 211-218
  • Bhatnagar A, Loper A, The Initial Experience of Electronic Brachytherapy for the Treatment of Non-Melanoma Skin Cancer, Radiat Oncol 2010 Sep 28:5:87
  • Njeh C, Saunders M, Langton C, Accelerated Partial Breast Irradiation (APBI): A Review of Available Techniques. Radiat Oncol 2010 5;90
  • PubMed. Patel RR, Beitsch PD, Nichols TD, et. al. Postsurgical Treatment of Early Stage Breast Cancer with Electronic Brachytherapy: Outcomes and Health Related Quality of Life at 1 Year. Am J Clin Oncol 2013 Oct:36(5):430-5
  • PubMed. Kamrava M, Chung MP, Demarco J. et. al. Electronic Brachytherapy for Postsurgical Adjuvant Vaginal Cuff Irradiation Therapy in Endometrial and Cervical Cancer: A Retrospective Study. Brachytherapy 2013 Mar-Apr 12(2):141-7
  • MedscapeExternal Site Alexander M. Castellino, PhD, Concerns Over Sudden Increase in Radiation for Skin Cancer, October 21, 2015.

Policy History:

  • January 2016 - Annual Review, Policy Revised 
  • February 2015  - Annual Review, Policy Renewed 
  • March 2014 - Annual Review, Policy Revised
  • May 2013 - Annual Review, Policy Revised 
  • June 2012 - Annual Review, Policy Renewed
  • June 2011 - Annual Review, Policy Renewed

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 © 2012 American Medical Association. All Rights Reserved.