Oscar Optical Coherence Tomography (CG025) Form

Optical Coherence Tomography, or “OCT”

Optical Coherence Tomography, or “OCT”, is a medical imaging test that uses light waves to capture live 3-dimensional images. It is similar in principle to ultrasound (which uses sound echoes, rather than light wave reflections), however OCT provides much higher spatial resolution. OCT has been used to image different structures of the body, including the eye, the heart, the gastrointestinal (GI) system, the breast, and the upper airway.

In the eyes, OCT allows for imaging of the retina and optic nerve. This imaging is helpful in monitoring and treating retinal disorders or optic nerve disorders such as glaucoma. It does not require any contact with the target surfaces and does not produce any ionizing radiation. In some cases, OCT can be used with other instruments such as an endoscope in the GI system or as an intravascular device in the arteries of the heart. OCT is a relatively novel technology and is rapidly evolving in both technique and clinical utility.

This guideline provides the clinical criteria and exclusions for the currently supported clinical applications of Optical Coherence Tomography.

Definitions

• "Retinopathy" refers to diseases of the retina that may impair vision, and is most often due to diabetes or hypertension. Diabetic retinopathy can be "proliferative" or "nonproliferative", depending on the severity of the disease.
• "Macular Degeneration" is a condition that affects the macula, which is the central portion of the retina responsible for fine detail vision. It can be further categorized as "wet" or "dry" depending on the underlying process, and stratified by stage (early, intermediate, late). Macular degeneration is a leading cause of vision loss.
• "Macular Edema" occurs when fluid builds up behind the macula of the eye, leading to swelling and distortion of central vision. Macular edema can occur in a number of diseases, including macular degeneration, diabetic retinopathy, and retinal vein occlusions.
• "Optical Coherence Tomography (OCT)" is an imaging technique that uses the reflections of light particles to create live 3-D images. Because OCT is based on light, it has significantly higher spatial resolution than comparable imaging techniques such as ultrasound and MRI. However, given the poor penetration of light into tissue, OCT is limited to relatively superficial surfaces. OCT does not generate ionizing radiation.
• "Spectral Domain OCT" is a newer version of OCT technology which can obtain images up to 50 times faster than traditional "time domain" and may be more appropriate in the diagnosis and assessment of certain conditions.
• "OCT Angiography" or "Intravascular OCT" refers to OCT imaging conducted with specialized, miniature devices from within a blood vessel.

"Posterior Segment" refers to the back two-thirds of the eye, and includes the vitreous humor, retina, choroid, macula, and optic nerve

"Anterior Segment" refers to the anterior one-third of the eye, and includes the cornea, iris, ciliary body, and lens.

"Glaucoma Suspect" refers to an individual with clinical findings and/or risk factors that indicate an elevated risk of developing primary open angle glaucoma. Risk factors include age older than 50 years, family history of glaucoma, and black race. Clinical findings include optic nerve or nerve fiber layer defect suggestive of glaucoma, visual field abnormality consistent with glaucoma, and/or elevated intraocular pressure (IOP) >21 mm Hg.

Clinical Indications

The Plan considers Optical Coherence Tomography medically necessary when any ONE of the following criteria is met:

1. Spectral Domain OCT is indicated when a member is taking chloroquine, hydroxychloroquine, ezogabine, or vigabatrin and ONE of the following criteria are met:
   1. Baseline exam within the first year of medication use; or
   2. As a once yearly exam for patients with 1 or more of the following:
      1. 5 years or more of use; or
      2. Documentation of elevated risk for developing retinopathy, defined by:
         1. Concurrent macular disease; or
         2. Concurrent renal disease; or
         3. Concomitant use of tamoxifen; or
         4. High-dose chloroquine (>2.3mg/kg) or hydroxychloroquine (>5mg/kg).
2. Macular edema when at least ONE of the following criteria is met:
   1. Needed to establish the diagnosis of macular edema; or
   2. When the results may impact the treatment plan (e.g., the need for antiangiogenic treatment).
3. Neovascular age-related macular degeneration when at least ONE of the following criteria is met:
   1. Needed to establish the diagnosis when fluorescein angiography is contraindicated or unavailable; or
   2. When the results may impact the treatment plan (e.g. the need for antiangiogenic treatment).
4. OCT may be indicated to document the appearance of posterior segment structures in members who have a diagnosis of at least ONE of the following:
   1. Age-related macular degeneration; or
   2. Central Serous Retinopathy (CSR); or
   3. Diabetic retinopathy; or

5. Glaucoma or glaucoma suspect, no more than once per year; or
6. Inherited retinal dystrophy (e.g., RPE65 gene mutations); or
7. f. Macular hole; or
8. g. Macular edema; or
9. h. Retinal vein occlusion; or
10. i. Pseudotumor cerebri; or
11. Posterior vitreous detachment (vitreous degeneration); or
12. k. Vitreomacular adhesion or vitreomacular traction; or
13. l. Vogt-Koyanagi-Harada

Experimental or Investigational / Not Medically Necessary

The Plan considers Optical Coherence Tomography experimental and investigational for the following indications, as the current evidence is insufficient to demonstrate clear clinical benefit:

• Gastrointestinal usage, including but not limited to assessment or diagnosis of:
  • Esophageal mucosal diseases (e.g. Barrett's esophagus or squamous cell carcinoma)
  • Gastric mucosa
  • Diseases of the colon and small bowel (e.g. inflammatory bowel disorders, polyps)
  • Biliary and pancreatic duct measurements
• Upper airway OCT for obstructive sleep apnea
• Any intraoperative OCT, including OCT for the purpose of lymph node or tumor margin assessment
• Ocular indications other than those defined above, including but not limited to:
  • Anterior segment imaging (e.g., cornea, iris, ciliary body, and lens), as it has not been shown to improve net health outcomes
    • Gonioscopy is the gold-standard for evaluating the anterior segment of the eye, per the American Academy of Ophthalmology.
    • For primary angle closure (PAC):
      • The American Academy of Ophthalmology (AAO) Preferred Practice Patterns for Primary Angle Closure (2015) state that AS-OCT is "limited to evaluating the iridocorneal angle" and that it "may prove useful in evaluating secondary causes of angle closure". Gonioscopy is discussed as the gold standard to be performed in all patients with suspected angle closure.
      • Smith et al (2013) - Study conducted on AS-OCT for primary angle closure by the AAO. 79 of the 371 potential studies met their inclusion criteria and were reviewed in full. Authors concluded that while AS-OCT may provide useful anatomic and pathologic information, the evidence is insufficient to consider using AS-OCT as a substitute for gonioscopy, and that further long-term studies are required.

• Routine screening, including but not limited to the following:
  • Glaucoma, pre-glaucoma, or ocular hypertension
    • Rationale: Bussel et al (2014) summarized the findings of 7 studies on glaucoma screening and monitoring of progression using OCT. They found that "in summary, OCT currently lacks the necessary diagnostic performance for general population glaucoma screening." While there is some evidence of the ability of OCT to differentiate normal and glaucomatous eyes, the current clinical evidence has not been fully validated.
  • Cataracts
    • Rationale: OCT is not used for the diagnosis or screening of cataracts. OCT has been used in the pre-operative planning or for monitoring of post-operative complications following cataract surgery; however, the clinical evidence is limited for these indications. Furthermore, the presence of cataracts may impact OCT image quality and retinal thickness measurements (Van Velthoven 2006)

Further research is needed to identify the clinical outcomes using OCT for this indication.

• Posterior capsule opacification
• Neurodegenerative disorders affecting the optic nerve (e.g., multiple sclerosis and optic neuritis)
  • Rationale: While the role for optic nerve measurements using OCT has been outlined above, routine screening using OCT for neurodegenerative orders that may affect the optic nerve is not indicated. OCT has not been adequately studied for this purpose.
• Papilledema, Unexplained vision loss, (not caused by diabetic retinopathy or pseudotumor cerebri)
  • Rationale: Extensive literature review by the AAO states that there is not currently enough randomized evidence to use OCT for routine evaluation of unexplained vision loss, in routine screening for diabetic retinopathy, or for “other causes” of macular swelling. OCT is not mentioned as indicated or not indicated for other disease processes in the AAO guidelines.
• Identification of fungal endophthalmitis after cataract surgery
  • Rationale: The evidence for the use of AS-OCT in the identification of fungal infections after cataract surgery is limited to case reports (Kitahata 2016) and has not been validated in a randomized, prospective clinical trial.
• Imaging of extra- or intra-ocular musculature
  • Rationale: Several studies (Pihlblad 2016, Ngo 2015, Park 2014) have looked at AS-OCT for imaging of the ocular musculature. While the results on the ability to accurately and reproducibly measure the muscle insertion distances for pre-operative planning have been promising, the current evidence has not been validated in clinical studies nor has it demonstrated any improved clinical outcomes.

Any other procedure or indication not meeting the above medical necessity criteria

The Plan considers “OCT Angiography” or “Intravascular OCT” experimental or investigational, as the current evidence is insufficient to demonstrate clear clinical benefit. This includes, but is not limited to:

• Diagnosis of spontaneous coronary artery dissection (SCAD)
• Diagnosis or assessment of coronary artery plaques
• Treatment of coronary disease (as an adjunct to percutaneous coronary intervention (PCI))
• Assessment or guidance of coronary artery stent placement (including evaluation of arterial bifurcations)
• Assessment of coronary artery stent failure (malposition)
• Identification of angiographically unclear lesions
• Assessment of acute coronary syndromes
• Diagnosis or assessment of intracranial aneurysms, ruptured or intact
• Assessment of carotid artery stenosis and/or stroke risk
• Assessment of pulmonary arterial wall fibrosis

Clinical Evidence on Intravascular OCT

• A systematic review of 15 studies was published in 2015 by D'Ascenzo et al. to evaluate the accuracy of intravascular OCT and intravascular ultrasound (IVUS) in identifying functional coronary stenosis. The group found that both modalities had only a moderate diagnostic accuracy for hemodynamically significant lesions. The authors concluded that both the sensitivity and specificity were inadequate to guide revascularization. (D’Ascenzo F, Barbero U, Cerrato E, etal. Accuracy of intravascular ultrasound and optical coherence tomography in identifying functionally significant coronary stenosis according to vessel diameter: a meta-analysis of 2,581 patients and 2,807 lesions. Am Heart J. 2015;169(5):663-673)
• The Society of Cardiovascular Angiography and Interventions released a consensus statement in 2014 evaluating IVUS and intravascular OCT, concluding that "the appropriate role for optical coherence tomography in routine clinical decision making has not bee established". (Lotfi A, Jeremias A, Fearon WF, et al. Society of Cardiovascular Angiography and Interventions. Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound, and optical coherence tomography: a consensus statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2014;83(4):509-418)
• The ILUMIEN IV study (NCT NCT03507777) is underway for a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific. After hospital discharge, all patients will have clinical follow-up at 30 days, 1 year, and 2 years. The ILUMIEN III: OPTIMIZE PCI trial was performed to compare IVUS, OCT, and coronary angiography (CA) in guiding coronary stent placement. The randomized study demonstrated that IVUS and OCT were non-inferior, however CA was superior to both modalities. (Ali ZA, Maehara A, Généreux P, et al. Optical coherence tomography compared with intravascular ultrasound and angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet 2016;388:2618)

For coronary plaque characterization and stent implantation for coronary artery revascularization

The FDA has 510(k) clearance for Tigereye Cto-Crossing Catheter, Pantheris System, Optis Mobile Next Imaging System, Optis Integrated Next Imaging System, Otis 2.1 Optical Coherence Tomography System, Thia Optical Coherence Tomography System, Apollovue S100 Image System. The 2021 ACC/AHA/SCA Guideline states that, "In patients undergoing coronary stent implantation, OCT is a reasonable alternative to IVUS for procedural guidance, except in ostial left main disease”(2a) and “In patients with stent failure, IVUS or OCT is reasonable to determine the mechanism of stent failure. (2a)" However, because OCT requires blood clearance, its effectiveness for imaging ostial left main disease is limited. The results of the ILUMIEN IV study will be pivotal for practice guidance.