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Date Printed: June 26, 2017: 01:27 AM

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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.

01-93000-31

Original Effective Date: 06/15/04

Reviewed: 04/30/09

Revised: 05/11/14

Subject: Drug-Eluting Stents – Coronary Vessels

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:

When percutaneous transluminal coronary angioplasty (PTCA) is performed to open a partially blocked artery, the rate of restenosis within a six-month period is 30% to 50%. When a metal stent is inserted to keep the vessel open, in-stent restenosis occurs in about 20% of the cases. Those with additional conditions such as diabetes have an even higher risk for in-stent restenosis. Stents are usually inserted in 70% of angioplasty procedures. The restenosis is thought to occur because of damage done to the artery wall during the angioplasty, causing a new overgrowth of cells in the inner vessel lining. This increases during the first three months, slows by six months and gradually decreases by the third year. The in-stent buildup of scar tissue leads to a re-narrowing of the vessel, symptom recurrence and the need for repeat revascularization.

In an attempt to further decrease restenosis in the vessel, stents containing a drug (e.g., sirolimus or paclitaxel) that is emitted over a few days to a few weeks are now being used. After implantation, the stent becomes covered with cells after two to three weeks, becoming a permanent part of the blood vessel wall. The drug delivery is local, which avoids potential risks associated with systemic exposure to the drug. The expected result is the blocking of intimal cell division or the inhibition of the inflammation process.

Several drug-eluting stents have received U.S. Food and Drug Administration (FDA) approval including:

POSITION STATEMENT:

Any FDA-approved stent meets the definition of medical necessity when implanted for FDA-approved indications.

Any stent without FDA-approval does not meet the definition of medical necessity and is not eligible for coverage.

BILLING/CODING INFORMATION:

CPT Coding:

92928

Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch

92929

Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major coronary artery (List separately in addition to code for primary procedure)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow contract guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Percutaneous Transluminal Angioplasty (20.7) located at cms.gov.

DEFINITIONS:

De novo lesions: new lesions.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Advisory Board Company – Future Finance Brief “Drug-Eluting Stents – Financial Outlook for Hospital Cardiac Services”, (02/03).
  2. American College of Cardiology, 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Updated for Percutaneous Coronary Intervention, 12/07, accessed at acc.org on 04/01/09.
  3. Canadian Coordinating Office for Health Technology Assessment (CCOHTA) – Technology Overview #15 – “Drug eluting stents: an economic evaluation”, (02/05).
  4. Centers for Medicare & Medicaid Services, NCD for Percutaneous Transluminal Angioplasty (20.7), 01/26/09.
  5. ECRI – Target Database “Drug-eluting coronary stents for the treatment of coronary artery stenosis” (06/02), (07/04 & 03/04 updates).
  6. ECRI – Windows on Medical Technology “Drug-Eluting Stents for the Treatment of Coronary Artery Disease”, (08/03).
  7. ECRI Institute, News Release: Does the Type of Drug-Eluting Stent Used Affect Patient Outcome? 05/15/06.
  8. Hayes Medical Technology Directory – “Drug-Eluting Stents for Treatment of Coronary Artery Disease” (08/03); (Update Search 10/04).
  9. Hayes, Inc., Hayes Alert: FDA Reviews Safety concerns for Circulatory System Devices, 12/28/06
  10. Staff. (2005, April). No clear winner in drug-eluting-stent trials. ECRI Health Technology Trends, 17, (4), 1.
  11. U.S. Food and Drug Administration (FDA), Summary of Safety and Effectiveness Data, CYPHER Sirolimus-eluting coronary Stent, 04/24/03.
  12. U.S. Food and Drug Administration (FDA), Summary of Safety and Effectiveness Data, Endeavor Zotarolimus-Eluting Coronary Stent, 02/01/08.
  13. U.S. Food and Drug Administration (FDA), Summary of Safety and Effectiveness Data, TAXUS Liberte’ Paclitaxel-eluting Coronary Stent, 10/10/08.
  14. U.S. Food and Drug Administration (FDA), Summary of Safety and Effectiveness Data, TAXUS Express2 Paclitaxel-eluting coronary Stent, 09/24/08.
  15. U.S. Food and Drug Administration (FDA), Summary of Safety and Effectiveness Data, XIENCE V Everolimus Eluting Coronary Stent, 07/02/08.
  16. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) Public Health Web Notification. “Final Update of Information for Physicians on Sub-actue Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent”. Issued 10/18/2004.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Practice & Coverage Committee on 04/30/09.

GUIDELINE UPDATE INFORMATION:

06/15/04

New Medical Coverage Guideline.

06/15/05

Scheduled review; no change in coverage, review change to every two years.

06/15/07

Annual review; maintained current coverage and limitations; reformatted guideline; references updated.

05/15/09

Biennial review: maintained position statements, updated description section and references.

01/01/13

Annual HCPCS update. Added codes 92928, 92929; deleted codes 92980, 92981, G0290 & G0291.

05/11/14

Revision: Program Exceptions section updated.

Date Printed: June 26, 2017: 01:27 AM