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Date Printed: June 28, 2017: 11:47 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

04-77260-14

Original Effective Date: 04/17/00

Reviewed: 05/28/09

Revised: 05/11/14

Subject: Intravascular Brachytherapy for Prevention and Management of Restenosis after Percutaneous Transluminal Angioplasty (PTA)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

DESCRIPTION:

Intravascular brachytherapy is a technique that utilizes ionizing radiation to treat atherosclerotic plaques within arteries. Intravasacular brachytherapy in conjunction with percutaneous transluminal angioplasty (PTCA) has been investigated primarily in the coronary arteries.

Intravascular brachytherapy has also been investigated as an adjunct to percutaneous transluminal angioplasty (PTA) of the femoropopliteal systems, as a technique to reduce the risk of a de novo restenosis, either in native or grafted vessels, both (with or without) stent placement. The greatest amount of clinical experience with intravascular brachytherapy is in the coronary artery system. There are a number of important differences that preclude extrapolation of results from the coronary to the peripheral arterial system. There is greater anatomic variability in peripheral arteries than coronary arteries in factors such as length, diameter, thickness, curvature, and orientation. The larger size of peripheral arteries necessitates treatment with a high-energy gamma radiation source rather than the beta radiation, which is more commonly used for the coronary arteries. High-energy radiation sources cannot be administered in most catheterization labs or radiology suites, necessitating treatment in the radiation oncology department, which increases logistical complexity for treating peripheral vessels. The use of adjunctive agents, such as stenting and anti-platelet drugs, while extremely common in the coronary arteries, is not as well established for peripheral angioplasty.

The U.S. Food and Drug Administration (FDA) has approved devices intended for use in intracoronary Brachytherapy: the Beta-Cath system (Novoste Corp), which delivers beta radiation and the CheckMate system (Cordis), which delivers gamma radiation. In 2001, a second beta radiation device, the Galileo Intravascular Radiotherapy System (Guidant) was approved. Both of the beta devices have similar labeling approved by the FDA that limits the approved use of the devices to delivery radiation to “the site of successful percutaneous coronary intervention” for the treatment of in-stent restenosis in native coronary arteries with discrete lesions. The wording of the gamma device’s approval is slightly different, stating it is “for use in the treatment of native coronary arteries with in-stent restenosis following percutaneous revascularization using current interventional techniques.” There are currently no brachytherapy devices approved specifically for use in the peripheral arterial system. As of May 2007, the CheckMate and Galileo systems and devices for intravascular brachytherapy are no longer available, having been discontinued by their respective manufacturers. The Beta-Cath system is manufactured and distributed by Best Vascular Inc.

POSITION STATEMENT:

Intravascular coronary brachytherapy using gamma or beta-emitting radiation meets the definition of medical necessity as a treatment of restenosis of a previously placed bare-metal stent in a native coronary artery.

Intravascular coronary brachytherapy using gamma radiation only meets the definition of medical necessity as a treatment of in-stent restenosis of a non-native coronary artery (e.g., saphenous vein graft).

Intravascular coronary brachytherapy as a treatment to reduce the risk of a de novo (type of lesion) restenosis in conjunction with a PTCA with or without stent placement is considered experimental or investigational, as there is insufficient clinical data to support the use of intracoronary brachytherapy in the prevention of restenosis.

Intravascular brachytherapy of the femoropopliteal system is considered experimental or investigational due to insufficient published clinical evidence to permit scientific conclusions regarding health outcomes of brachytherapy as an adjunct to peripheral artery angioplasty.

Intravascular coronary brachytherapy using gamma or beta-emitting radiation is considered experimental or investigational to treat or prevent restenosis of drug-eluting stents, as there is insufficient clinical studies to determine if vascular brachytherapy is useful in the treatment of restenosis in drug-eluting stents.

BILLING/CODING INFORMATION:

There is no assigned CPT or HCPCS code to report intracoronary brachytherapy. CPT coding for services associated with intracoronary brachytherapy may include a medical physicist, radiation therapist, and cardiologist.

REIMBURSEMENT INFORMATION:

Claims for intracoronary brachytherapy require separate reimbursement of the cardiovascular surgeon and radiation therapist service(s).

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Coronary artery disease: Narrowing of the coronary arteries sufficiently that the narrowing interferes with blood flow to the myocardium.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report intravascular brachytherapy:

Brachytherapy, intracoronary arteries
Brachytherapy, intravascular
Intra-arterial radiation therapy
Intracoronary radiation therapy
Intra-arterial radiation therapy as adjunct
PTCA, intracoronary radiation therapy as adjunct

REFERENCES:

  1. ACC/AHA Guidelines for Percutaneous Coronary Intervention (Revision of the 1993 PTCA Guidelines) Executive Summary, Circulation 2001; 3019-3041.
  2. American College of Cardiology and American Heart Association. ACC/AHA Pocket Guideline; Based on the ACC/AHA/SCAI 2005 Guideline Update. Accessed 05/07.
  3. American College of Radiology. ACR Practice Guideline for the Performance of Coronary Vascular Brachytherapy (CVBT). 10/01/07.
  4. American College of Radiology. ACR Practice Guideline for the Performance of Coronary Vascular Brachytherapy (CVBT). 2007.
  5. American Medical Association, CPT (current edition).
  6. Blue Cross Blue Shield Association Medical Policy. Intra-arterial Brachytherapy for Prevention and Managing Restenosis after Percutaneous Translumina Angioplasty (PTA) (2.02.11), 08/02/07.
  7. Blue Cross Blue Shield Association Medical Policy. Intravascular Brachytherapy for Preventing and Managing of Restenosis after Percutaneous Transluminal Angioplasty (PTA) (2.02.11), 07/10/08.
  8. Blue Cross Blue Shield Association TEC Assessment. Brachytherapy for the Prevention of Restenosis in Peripheral Arteries Following PTA of the Femoropopliteal System, Vol. 17, No. 22, 02/03.
  9. Blue Cross Blue Shield Association TEC Assessment. Intracoronary Brachytherapy for the Prevention and Management of Restenosis, Vol. 15, No. 19, 03/01.
  10. Blue Cross Blue Shield Association TEC Assessment. Intracoronary Brachytherapy as an Adjunct to Percutaneous Revascularization to Prevent and Manage Restenosis, Vol. 17, No. 9, 08/02.
  11. Blue Cross Blue Shield of Florida physician consultant, 03/27/00.
  12. Centers for Medicare and Medicaid Services (CMS). National Article for Intracoronary (Intravascular) Brachytherapy (A13316), 11/08/02.
  13. ECRI Target Report. Catheter-Based Intravascular Beta Brachytherapy for Prevention of Coronary Artery and In-Stent Restenosis, 08/02.
  14. ECRI Target Report. Catheter-Based Intravascular Gamma Brachytherapy for Prevention of Coronary Artery and In-Stent Restenosis, 08/02.
  15. ECRI Target Report. Radioactive Coronary Stents for Prevention of Coronary Artery and In-Stent Restenosis, 10/00.
  16. Feldman TE, Hirshfeld JW, Jacobs AK et al. ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention Practice Guidelines.
  17. Ferrero V, Ribichini F, Piessens M et al. Intracoronary beta-irradiation for the treatment of de novo lesions: 5-year clinical follow-up of the BetAce randomized trial. American Heart Journal 2007; 153 (3): 398-402.
  18. Gruberg L, Caiati R, Aronson D et al. Five-year clinical follow up after intracoronary radiation for the prevention of in-stent restenosis. Journal of Invasive Cardiology 2006; 18 (10): 494-498.
  19. Hayes Medical Technology Directory, Intracoronary Radiation Therapy, 11/00, 08/06/04 – archived 2007.
  20. Holmes DR, Teirstein P, Satler L et al. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents. JAMA 2006; 295 (11): 1264-1273.
  21. King SB, Smith SC, Hirshfeld JW et al. 2007 Focused Update of the ACC/AHA/SCAI 2005. Guideline Update for Percutaneous Coronary Intervention. Journal of the American College of Cardiology 2008; (2): 172-208.
  22. Nikas DN, Kalef-Ezra J, Katsouras CS et al. Long-term clinical outcome of patients treated with beta-brachytherapy in routine clinical practice. International Journal of Cardiology 2007; 115 (2): 183-189.
  23. Price MJ, Giap H, Teirstein PS. Intracoronary radiation therapy for multi-drug resistant in-stent restenosis: initial clinical experience. Catheter Cardiovascular Intervention 2007; 69 (1): 132-134.
  24. Sabate M, Pimentel G, Prieto C et al. Intracoronary brachytherapy after stenting de novo lesions in diabetic patients. Journal of the American College of Cardiology 2004; 44: 520-527.
  25. Stone, GW, Ellis SG, O’Shaughnessy CD et al. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents. JAMA 2006; 295 (11): 1253-1263.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/28/09.

GUIDELINE UPDATE INFORMATION:

04/17/00

Medical Coverage Guideline developed.

09/15/01

Coverage criteria revised to be consistent with BCBSA medical policy. Added in-stent restenosis of native coronary arteries.

01/01/02

HCPCS Coding changes.

09/15/02

Annual Review. Coverage criteria revised to be consistent with BCBSA medical policy. Added in-stent restenosis of saphenous vein graft. Deleted CPT codes that may be used to report services associated with intracoronary radiation therapy.

10/15/03

Annual review. Revised coverage statement and added investigational statement.

07/15/04

Scheduled review. No change in policy statement.

08/15/05

Scheduled review. Revised description section (risk of restenosis PTCA statement). Deleted non-covered statement (intracoronary brachytherapy utilizing any other radioactive source). Updated references.

08/15/06

Scheduled review. Updated references.

07/15/07

Scheduled review. Investigational statement added regarding drug-eluting stent restenosis; title revised; reformatted guideline; updated references.

05/15/08

Scheduled review. No change in position statements. Updated references.

06/15/09

Annual review. Revised guideline name, deleted “intra-arterial” and added “intravascular”. Maintain position statements. Updated references.

05/11/14

Revision: Program Exceptions section updated.

Date Printed: June 28, 2017: 11:47 PM