BlueCross and BlueShield of Montana Medical Policy/Codes
Optical Coherence Tomography (OCT) for Imaging of Coronary Arteries
Chapter: Surgery: Procedures
Current Effective Date: September 24, 2013
Original Effective Date: August 20, 2012
Publish Date: September 24, 2013
Revised Dates: July 29, 2013
Description

Intravascular ultrasound (IVUS) is the most widely used and validated clinical intravascular imaging technique; although IVUS is currently the most commonly employed adjunctive method to define lesions, it is limited by low resolution.  Optical coherence tomography (OCT) is an imaging modality that is analogous to ultrasound imaging, but uses light instead of sound.  OCT uses near-infrared light for the cross-sectional visualization of the vessel wall at the microscopic level.  It is thought to enable excellent resolution of coronary architecture and precise characterization of plaque architecture.  Quantification of macrophages within the plaque is also possible.  These capabilities allow identification of the most common type of vulnerable plaque, the thin-cap fibroatheroma.  OCT is able to generate images of the coronary artery with much better resolution than IVUS.  This has offered new insights into atherosclerotic plaque pathology as well as into acute and long-term vessel wall response to stent implantation.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers optical coherence tomography (OCT) experimental, investigational and unproven for imaging of coronary arteries, including but not limited to:

  • As an adjunct to percutaneous coronary interventions (PCI) with stenting;
  • Risk stratification of intracoronary atherosclerotic plaques; or
  • Follow-up of stenting.

Rationale 

Gonzalo et al. conducted a study to assess the reproducibility of the new generation, intracoronary OCT systems for plaque and stent assessment in vivo.  They concluded that the second generation FD-OCT technology (frequency-domain OCT) with high speed data acquisition shows good interstudy, interobserver and intraobserver reproducibility for plaque characterization and stent implantation assessment in patients undergoing percutaneous coronary interventions (PCI).  However, they pointed out that the study was observational and had a limited sample size, and that some aspects of the study may have influenced the reproducibility.

A study by Jang et al. was performed to evaluate the feasibility and the ability of OCT to visualize the components of coronary plaques in living patients.  The goals of this study were: 1) to demonstrate the feasibility and safety of OCT imaging in patients; and 2) to assess OCT images of human coronary pathology acquired in vivo by comparison with IVUS images obtained from corresponding locations.  The authors concluded that the study demonstrated the feasibility of intracoronary OCT to visualize coronary plaque microstructure in patients.  The OCT images of human coronary atherosclerotic plaques obtained in vivo provide additional, more detailed structural information than intravascular ultrasound (IVUS).  The unique capability of OCT to resolve micrometer-scale features of coronary plaques in patients suggests that this new technique holds promise for identifying features of coronary plaques at risk for rupture.  The findings of this initial experience should be supported by a prospective clinical trial to test the ability of OCT to identify vulnerable plaques.  Once the predictive capability of OCT is established, a trial demonstrating effective treatment could potentially contribute to the prevention of acute myocardial infarction and sudden cardiac death.

Kawamori et al. investigated the usefulness of OCT to evaluate vessel response after stent implantation by comparing with that of IVUS.  Their data suggested that OCT might provide more detailed information on the presence of tissue prolapse, thrombus formation and edge dissection than IVUS.  Further study is warranted to assess its clinical utility. OCT is a feasible method for the evaluation of PCI procedure without serious complications.  There were several limitations to their study.  First, this is a non-randomized retrospective study based on a relatively limited sample size, raising the possibility of selection bias.  A study involving a larger population would be needed to establish and refine the clinical applications and safety of the OCT imaging system.  Second, OCT has limited ability to visualize certain lesions, such as ostial lesions due to the risks associated with producing a blood-free environment by occlusion balloon.  Also, severely calcified tortuous vessels could not be imaged with OCT due to the difficulty of passing the occlusion balloon through the lesion.  Finally, the current OCT system has a limited penetration depth, which can be a disadvantage in visualizing whole vessel structure.  Therefore, if a new imaging device can achieve greater penetration depth without sacrificing its resolution (e.g., combined imaging device of IVUS and OCT), this may provide more comprehensive information, possibly offering more benefit during PCI.  

OCT is a promising new technology for intravascular imaging that has advantages over IVUS for imaging coronary arteries.  However, further large randomized controlled studies are needed to demonstrate clinical utility for OCT; as a result OCT is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

38.24, 410.00-414.9

ICD-10 Codes

I20.0-I25.9, B221Z2Z, B223Z2Z

Procedural Codes: 0291T, 0292T
References
  1. Fitzgerald PJ, Oshima A, Hayase M et al.  Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study.  Circulation 2000; 102(5):523-30.
  2. Smith SC, Jr., Dove JT, Jacobs AK et al.  ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)-executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions.  Circulation 2001; 103(24):3019-41.
  3. Jang IK, Bouma BE, Kang DH et al.  Visualization of coronary atherosclerotic plaques in patients using optical coherence tomography: comparison with intravascular ultrasound.  J Am Coll Cardiol 2002; 39(4):604-9.
  4. Low AF, Tearney GJ, Bouma BE et al.  Technology Insight: optical coherence tomography--current status and future development.  Nat Clin Pract Cardiovasc Med 2006; 3(3):154-62; quiz 72.
  5. Yamaguchi T, Terashima M, Akasaka T et al.  Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting.  Am J Cardiol 2008; 101(5):562-7.
  6. Roy P, Steinberg DH, Sushinsky SJ et al.  The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents.  Eur Heart J 2008; 29(15):1851-7.
  7. Capodanno D, Prati F, Pawlowsky T et al.  Comparison of optical coherence tomography and intravascular ultrasound for the assessment of in-stent tissue coverage after stent implantation.  EuroIntervention 2009; 5(5):538-43.
  8. Barlis P, Gonzalo N, Di Mario C et al.  A multicentre evaluation of the safety of intracoronary optical coherence tomography.  EuroIntervention 2009; 5(1):90-5.
  9. Jakabcin J, Spacek R, Bystron M et al.  Long-term health outcome and mortality evaluation after invasive coronary treatment using drug eluting stents with or without the IVUS guidance.  Randomized control trial. HOME DES IVUS.  Catheter Cardiovasc Interv 2010; 75(4):578-83.
  10. Kawamori H, Shite J, Shinke T et al.  The ability of optical coherence tomography to monitor percutaneous coronary intervention: detailed comparison with intravascular ultrasound.  J Invasive Cardiol 2010; 22(11):541-5.
  11. Prati F, Regar E, Mintz GS et al.  Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis.  Eur Heart J 2010; 31(4):401-15.
  12. Gonzalo N, Tearney GJ, Serruys PW et al.  Second-generation optical coherence tomography in clinical practice.  High-speed data acquisition is highly reproducible in patients undergoing percutaneous coronary intervention.  Rev Esp Cardiol 2010; 63(8):893-903.
  13. Yonetsu T, Kakuta T, Lee T et al.  In vivo critical fibrous cap thickness for rupture-prone coronary plaques assessed by optical coherence tomography.  Eur Heart J 2011; 32(10):1251-9.
  14. Lindsay AC, Viceconte N, Di Mario C.  Optical coherence tomography: has its time come?  Heart 2011; 97(17):1361-2.
  15. Kubo T, Nakamura N, Matsuo Y et al.  Virtual histology intravascular ultrasound compared with optical coherence tomography for identification of thin-cap fibroatheroma.  Int Heart J 2011; 52(3):175-9.
  16. Miyamoto Y, Okura H, Kume T et al.  Plaque characteristics of thin-cap fibroatheroma evaluated by OCT and IVUS.  JACC Cardiovasc Imaging 2011; 4(6):638-46.
  17. Uemura S, Ishigami KI, Soeda T et al.  Thin-cap fibroatheroma and microchannel findings in optical coherence tomography correlate with subsequent progression of coronary atheromatous plaques.  Eur Heart J 2011 (Epub ahead of print).
  18. Inoue T, Shite J, Yoon J et al.  Optical coherence evaluation of everolimus-eluting stents 8 months after implantation.  Heart 2011; 97(17):1379-84.
History

April 2012 Policy created with literature search through August 2011, and with clinical input. Considered investigational for all indications
July 2013 Policy formatting and language revised.  Policy statement unchanged.

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Optical Coherence Tomography (OCT) for Imaging of Coronary Arteries