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Retinal Telescreening for Diabetic Retinopathy

Policy Number: MP-509

Latest Review Date: April 2020                                                                                                                                                         

Category: Medical                                                                 

Policy Grade: B

POLICY:

For dates of service April 02, 2020 and after:

Retinal telescreening with digital imaging and manual grading of images may be considered medically necessary as a screening technique for the detection of diabetic retinopathy.

Digital retinal imaging with automated image interpretation is considered not medically necessary and investigational for the detection of diabetic retinopathy.

Retinal telescreening is considered not medically necessary and investigational for all other indications, including the monitoring and management of disease in individuals diagnosed with diabetic retinopathy.

For dates of service prior to April 02, 2020 :

Retinal telescreening with digital imaging and manual grading of images may be considered medically necessary as a screening technique for the detection of diabetic retinopathy.

Retinal telescreening is considered not medically necessary and investigational for all other indications, including the monitoring and management of disease in individuals diagnosed with diabetic retinopathy.

DESCRIPTION OF PROCEDURE OR SERVICE:

Retinopathy screening and risk assessment with digital imaging systems are proposed as an alternative to conventional dilated fundus examination in diabetic individuals. Digital imaging systems use a digital fundus camera to acquire a series of standard field color images and/or monochromatic images of the retina of each eye. Captured digital images may be transmitted via the Internet to a remote center for interpretation by trained readers, storage, and subsequent comparison.

Diabetic Retinopathy

Diabetic retinopathy is the leading cause of blindness among adults aged 20–74 years in the United States. The major risk factors for developing diabetic retinopathy are duration of diabetes and severity of hyperglycemia. After 20 years of disease, almost all patients with Type I and greater than 60% of patients with Type II diabetes will have some degree of retinopathy. Other factors that contribute to the risk of retinopathy include hypertension and elevated serum lipid levels.

Diabetic retinopathy progresses, at varying rates, from asymptomatic, mild nonproliferative abnormalities to proliferative diabetic retinopathy (PDR), with new blood vessel growth on the retina and posterior surface of the vitreous. The two most serious complications for vision are diabetic macular edema and PDR. At its earliest stage (nonproliferative retinopathy), the retina develops microaneurysms, intraretinal hemorrhages, and focal areas of retinal ischemia. With disruption of the blood-retinal barrier, macular retinal vessels become permeable, leading to exudation of serous fluid and lipids into the macula (macular edema). As the disease progresses, retinal blood vessels are blocked, triggering the growth of new and fragile blood vessels (proliferative retinopathy). The new blood vessels that occur in PDR may fibrose and contract, resulting in tractional retinal detachments with significant vision loss. Severe vision loss with proliferative retinopathy arises from vitreous hemorrhage. Moderate vision loss can also arise from macular edema (fluid accumulating in the center of the macula) during the proliferative or nonproliferative stages of the disease. Although proliferative disease is the main cause of blinding in diabetic retinopathy, macular edema is more frequent and is the leading cause of moderate vision loss in people with diabetes.

Screening

There is potential value in screening for diabetic retinopathy because diabetic retinopathy has few visual or ocular symptoms until vision loss develops. Because treatments are primarily aimed at preventing vision loss, and retinopathy can be asymptomatic, it is important to detect disease and begin treatment early in the process. Annual dilated, indirect ophthalmoscopy, coupled with biomicroscopy or 7-standard field stereoscopic 30 degree fundus photography, has been considered the screening technique of choice. Because these techniques require a dedicated visit to a competent eye care professional, typically an ophthalmologist, retinopathy screening is underutilized. This underuse has resulted in the exploration of remote retinal imaging, using film or digital photography, as an alternative to direct ophthalmic examination of the retina.

Treatment

With early detection, diabetic retinopathy can be treated with modalities that can decrease the risk of severe vision loss. Tight glycemic and blood pressure control is the first line of treatment to control diabetic retinopathy, followed by laser photocoagulation for patients whose retinopathy is approaching the high-risk stage. Although laser photocoagulation is effective at slowing the progression of retinopathy and reducing visual loss, it causes collateral damage to the retina and does not restore lost vision. Focal macular edema (characterized by leakage from discrete microaneurysms on fluorescein angiography) may be treated with focal laser photocoagulation, while diffuse macular edema (characterized by generalized macular edema on fluorescein angiography) may be treated with grid laser photocoagulation. Corticosteroids may reduce vascular permeability and inhibit vascular endothelial growth factor production, but are associated with serious adverse events including cataracts and glaucoma, with damage to the optic nerve. Corticosteroids can also worsen diabetes control. Vascular endothelial growth factor inhibitors (e.g., ranibizumab, bevacizumab, pegaptanib), which reduce permeability and block the pathway leading to new blood vessel formation (angiogenesis), are being evaluated for the treatment of diabetic macular edema and PDR.

Digital Photography and Transmission Systems for Retinal Imaging

A number of photographic methods have been evaluated that capture images of the retina to be interpreted by expert readers, who may or may not be located proximately to the patient. Retinal imaging can be performed using digital retinal photographs with (mydriatic) or without (nonmydriatic) dilating of the pupil. One approach is mydriatic standard field 35-mm stereoscopic color fundus photography. Digital fundus photography has also been evaluated as an alternative to conventional film photography. Digital imaging has the advantage of easier acquisition, transmission, and storage. Digital images of the retina can also be acquired in a primary care setting and evaluated by trained readers in a remote location, in consultation with retinal specialists.

KEY POINTS:

The most recent literature review was updated through January 27, 2020.

SUMMARY OF EVIDENCE:

For individuals who have diabetes without known diabetic retinopathy who receive digital retinal imaging with optometrist or ophthalmologist image interpretation, the evidence includes systematic reviews and an RCT. The relevant outcomes include test validity, change in disease status, and functional outcomes. Data from systematic reviews have demonstrated there is concordance between direct ophthalmoscopy and grading by mydriatic or nonmydriatic photography and remote evaluation. An RCT that compared a telemedicine screening program with traditional surveillance found that patients who were randomized to the telemedicine arm were more likely to undergo screening (95% vs 44%). There is limited direct evidence related to visual outcomes for patients evaluated with a strategy of retinal telescreening. However, given evidence from the ETDRS that early retinopathy treatment improves outcomes, coupled with studies showing high concordance between the screening methods used in ETDRS, and an RCT demonstrating higher uptake of screening with a telescreening strategy, a strong chain of evidence can be made that telescreening is associated with improved health outcomes. Digital imaging systems have the additional advantages of short examination time and the ability to perform the test in the primary care physician setting. For individuals who cannot or would not be able to access an eye care professional at the recommended screening intervals, the use of telescreening has a low risk and is very likely to increase the likelihood of retinopathy detection. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have diabetes without known diabetic retinopathy who receive digital retinal imaging with automated image interpretation, the evidence includes a prospective study comparing the validity of automated scoring of digital images to remote interpretation. The relevant outcomes include test validity, change in disease status, and functional outcomes. One automated AI system for evaluating diabetic retinopathy in primary care has received De Novo marketing clearance from the U.S. Food and Drug Administration. The pivotal study for this system met its non-inferiority margin compared to expert photography and image evaluation from a centralized site with sensitivity of 87.2% and specificity of 90.7%. The PPV, which would be an important determinant of the value of a screening method to refer to an ophthalmologist, was not included in the published report, but could be calculated at 74.9%. Further development of this algorithm is needed to increase the clinical validity the evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American Diabetes Association

In 2020 the American Diabetes Association updated its position statements on standards of medical care for diabetes. Included in the guidelines were specific recommendations for initial and subsequent screening examinations for retinopathy:

  • "Adults with Type 1 diabetes should have an initial eye examination by an ophthalmologist or  optometrist within 5 years after the onset of diabetes. (B)"
  • "Patients with Type 2 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist at the time of the diabetes diagnosis. (B)"
  • "Eye examinations should occur before pregnancy or in the first trimester in patients with preexisting Type 1 or Type 2 diabetes, and then these patients should be monitored every trimester and for 1 year postpartum as indicated by the degree of retinopathy. (B)"
  • "If there is no evidence of retinopathy for one or more annual eye exams and glycemia is well controlled, then screening every 1–2 years may be considered. (B)"
  • "Programs that use retinal photography (with remote reading or use of a validated assessment tool) to improve access to diabetic retinopathy screening can be appropriate screening strategies for diabetic retinopathy. Such programs need to provide pathways for timely referral for a comprehensive eye examination when indicated. (B)"

"Artificial intelligence systems that detect more than mild diabetic retinopathy and diabetic macular edema authorized for use by the FDA represent an alternative to traditional screening approaches. However, the benefits and optimal utilization of this type of screening have yet to be fully determined."

American Academy of Ophthalmology

A preferred practice pattern from the American Academy of Ophthalmology (2017) has provided the following on screening for diabetic retinopathy:

“The purpose of an effective screening program for diabetic retinopathy is to determine who needs to be referred to an ophthalmologist for close follow-up and possible treatment and who may simply be screened annually. Some studies have shown that screening programs using digital retinal images taken with or without dilation may enable early detection of diabetic retinopathy along with an appropriate referral.”

American Telemedicine Association

The American Telemedicine Association (2011) published guidelines on the clinical, technical, and operational performance standards for diabetic retinopathy screening. Recommendations were based on reviews of current evidence, medical literature, and clinical practice. The Association stated that Early Treatment Diabetic Retinopathy Study 30°, stereo 7-standard field, color 35-mm slides are an accepted standard for evaluating diabetic retinopathy. Although no standard criteria have been widely accepted as performance measurements of digital imagery used for diabetic retinopathy evaluation, clinical trials sponsored by the National Eye Institute have transitioned to digital images for diabetic retinopathy assessment. Telehealth programs for diabetic retinopathy should demonstrate an ability to compare favorably with Early Treatment Diabetic Retinopathy Study film or digital photography as reflected in κ values for agreement of diagnosis, false-positive and false-negative readings, positive predictive value, negative predictive value, sensitivity and specificity of diagnosing levels of retinopathy, and macular edema. Inability to obtain or read images should be considered a positive finding, and patients with unobtainable or unreadable images should be promptly reimaged or referred for evaluation by an eye care specialist.

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force (USPSTF) has not addressed screening for retinopathy in patients with diabetes.

KEY WORDS:

Diabetic Retinopathy Detection and Tracking System, DigiScope, Fundus AutoImager, ImageNet Digital Imaging System, Inoveon, IRIS Intelligent Retinal Imaging System, iScan,  Visual Pathways, VISUPAC Digital Imaging System. , RetinaVue, EyeSuite Imaging, Retinalyze,IDx-DR

APPROVED BY GOVERNING BODIES:

Several digital camera and transmission systems (see Table 5 for examples) have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process and are currently available. In 2018, the FDA gave De Novo clearance for the automated retinal analysis system (IDx-DR) that uses artificial intelligence.

IDx-DRis indicated "for use by health care providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400. "

Table 1. Examples of Digital Camera and Transmission Systems Cleared by FDA for Retinal Telescreening

Camera and Transmission Systems

Manufacturer

FDA Clearance

Approved

RetinaVue™ Network REF

901108 PACS Medical Image

System

Welch Allyn

K181016

2018

IRIS Intelligent Retinal Imaging System™

Ora Inc.

K141922

2015

EyeSuite Imaging

Haag-Streit AG

K142423

2014

CenterVue Digital Retinography System (DRS)

Welch Allyn

K101935

2010

ImageNet™ Digital Imaging System

Topcon Medical Systems

 

2008

The Fundus AutoImagerä

Visual Pathways

 

2002

Zeiss FF450 Fundus Camera and the VISUPACâ Digital Imaging System

Carl Zeiss Meditec

 

2001

DigiScope®

Eye Tel Imaging with Johns Hopkins Medicine

 

1999

FDA: Food and Drug Administration.

Table 2. Automated Analysis Systems

Automated Analysis Systems

Manufacturer

Clearance

Approved

IDx-DR Artificial Intelligence Analyzer for the Topcon NW400

IDx, LLC

FDA De Novo

2018

EyeArt(TM)

Eyenuk(TM)

CE

 

Retmarker

Retmarker

CE

 

iGradingM

EMIS Health

CE

 

Retinalyze

ReitnaLyze A/S

 

 

CE: Conformite Europeenne; FDA: Food and Drug Administration.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

92227

Remote imaging for detection of retinal disease (e.g., retinopathy in a patient with diabetes) with analysis and report under physician supervision, unilateral or bilateral

92228

Remote imaging for monitoring and management of active retinal disease (e.g., diabetic retinopathy) with physician review, interpretation and report, unilateral or bilateral

92250

Fundus photography with interpretation and report

92499

Unlisted ophthalmological service or procedure

Previous Coding:

0380T

Computer-aided animation and analysis of time series retinal images for the monitoring of disease progression, unilateral or bilateral, with interpretation and report (Deleted 12/31/19)

REFERENCES:

  1. Abramoff MD, Folk JC, Han DP et al. Automated analysis of retinal images for detection of referable diabetic retinopathy. JAMA Ophthalmol 2013; 131(3):351-7.
  2. Abramoff, MD, Lavin, PT, Birch, M, Shah, N, Folk, JC. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary. npj Digital Medicine (2018) 1:39 ; doi:10.1038/s41746-018-0040-6.
  3. Abramoff MD, Lou Y, Erginay A, et al. Improved automated detection of diabetic retinopathy on a publicly available dataset through integration of deep learning. Invest Ophthalmol Vis Sci. Oct 01 2016; 57(13):5200-5206.
  4. American Academy of Ophthalmology Retina Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. 2008. Available online at: //www.aao.org/ppp.
  5. American Academy of Ophthalmology. American Academy of Ophthalmology Clinical Statement. Screening for diabetic retinopathy. 2006. Available online at: one.aao.org/CE/PracticeGuidelines/ClinicalStatements_Content.aspx?cid=ed55ed3c-b34b-4f10-ae13-09e063d8d773.
  6. American Academy of Ophthalmology. American Academy of Ophthalmology Clinical Statement: Screening for Retinopathy in the Pediatric Patient with Type 1 Diabetes Mellitus. 2008. Available online at: one.aao.org/CE/PracticeGuidelines/ClinicalStatements.aspx.
  7. American Academy of Ophthalmology. Diabetic Retinopathy, Preferred Practice Pattern. September 2008. Available online at: one.aao.org/CE/PracticeGuidelines/PPP_Content.aspx?cid=d0c853d3-219f-487b-a524-326ab3cecd9a.
  8. American Diabetes Association. 9. Microvascular Complications and Foot Care. Diabetes Care. Jan 2016; 39 Suppl 1:S72-80.
  9. American Diabetes Association. Standards of medical care in diabetes--2010. Diabetes Care 2010; 33(Suppl 1):S11-61. Available online at: care.diabetesjournals.org/content/33/Supplement_1/S11.full.pdf+html.
  10. American Telemedicine Association. Telehealth practice recommendations for diabetic retinopathy. 2011. Available online at: www.americantelemed.org/practice/standards/ata-standards-guidelines/telehealth-practice-recommendations-for-diabetic-retinopathy.
  11. An, JJ, Niu, FF, Turpcu, AA, Rajput, YY, Cheetham, TT. Adherence to the American Diabetes Association retinal screening guidelines for population with diabetes in the United States.. Ophthalmic Epidemiol, 2018 Jan 16;25(3).
  12. Bawankar P, Shanbhag N, Smitha KS, et al. Sensitivity and specificity of automated analysis of single-field non-mydriatic fundus photographs by Bosch DR Algorithm-Comparison with mydriatic fundus photography (ETDRS) for screening in undiagnosed diabetic retinopathy. PLoS One. Dec 27 2017; 12(12):e0189854.
  13. Bragge P, Gruen RL, Chau M et al. Screening for Presence or Absence of Diabetic Retinopathy: A Meta-analysis. Arch Ophthalmol 2011; 129(4):435-44.
  14. Cunha, LL, Figueiredo, EE, Araújo, HH, Costa-Cunha, LL, Costa, CC, Neto, JJ, Matos, AA, de Oliveira, MM, Bastos, MM, Monteiro, MM. Non-Mydriatic Fundus Retinography in Screening for Diabetic Retinopathy: Agreement Between Family Physicians, General Ophthalmologists, and a Retinal Specialist.. Front Endocrinol (Lausanne), 2018 Jun 6;9:251.
  15. Delori FC, Gragoudas ES, Francisco R et al. Monochromatic ophthalmoscopy and fundus photography. The normal fundus. Arch Ophthalmol 1977; 95(5):861-8.
  16. Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Ophthalmology 1991; 98(5 Suppl):823-33.
  17. Early Treatment Diabetic Retinopathy Study Research Group. Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology 1991; 98(5 Suppl):786-806.
  18. Fenner, BB, Wong, RR, Lam, WW, Tan, GG, Cheung, GG. Advances in Retinal Imaging and Applications in Diabetic Retinopathy Screening: A Review.. Ophthalmol Ther, 2018 Nov 12;7(2).
  19. Fong DS, Aiello L, Gardner TW et al. American Diabetes Association position statement: retinopathy in diabetes. Diabetes Care 2004; 27:S84-S87.
  20. Fransen SR, Leonard-Martin TC, Feuer WJ et al. Clinical evaluation of patients with diabetic retinopathy: accuracy of the Inoveon diabetic retinopathy-3DT system. Ophthalmology 2002; 109(3):595-601.
  21. Garg S, Davis RM. Diabetic retinopathy screening update. Clinical Diabetes 2009; 27(4):140-5. Available online at: clinical.diabetesjournals.org/content/27/4/140.full.
  22. Handelsman Y, Mechanick JI, Blonde L et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011; 17 Suppl 2:1-53.
  23. Heaven CJ, Cansfield J, Shaw KM. The quality of photographs produced by the non-mydriatic fundus camera in a screening programme for diabetic retinopathy: a 1 year prospective study. Eye (Lond) 1993; 7 (Pt 6):787-90.
  24. Kinyoun JL, Martin DC, Fujimoto WY et al. Ophthalmoscopy versus fundus photographs for detecting and grading diabetic retinopathy. Invest Ophthalmol Vis Sci 1992; 33(6):1888-93.
  25. Li HK, Horton M, Bursell SE, et al. Telehealth practice recommendations for diabetic retinopathy, second edition. Telemed J E Health. Dec 2011;17(10):814-837.
  26. Liesenfeld B, Kohner E, Piehlmeier W et al. A tele-medical approach to the screening of diabetic retinopathy: digital fundus photography. Diabetes Care 2000; 23(3):345-8.
  27. Mansberger SL, Sheppler C, Barker G, et al. Long-term comparative effectiveness of telemedicine in providing diabetic retinopathy screening examinations: a randomized clinical trial. JAMA Ophthalmol. May 2015; 133(5):518-525.
  28. Mizrachi Y, Knyazer B, Guigui S, et al. Evaluation of diabetic retinopathy screening using a non-mydriatic retinal digital camera in primary care settings in south Israel. Int Ophthalmol. Aug 2014; 34(4):831-837.
  29. Moss SE, Klein R, Kessler SD et al. Comparison between ophthalmoscopy and fundus photography in determining severity of diabetic retinopathy. Ophthalmology 1985; 92(1):62-7.
  30. Murgatroyd H, Ellingford A, Cox A et al. Effect of mydriasis and different field strategies on digital image screening of diabetic eye disease. Br J Ophthalmol 2004; 88(7):920-4.
  31. Oliveira CM, Cristovao LM, Ribeiro ML, et al. Improved automated screening of diabetic retinopathy. Ophthalmologica. 2011; 226(4):191-197.
  32. Peters AL, Davidson MB, Ziel FH. Cost-effective screening for diabetic retinopathy using a nonmydriatic retinal camera in a prepaid health-care setting. Diabetes Care 1993; 16(8):1193-5.
  33. Piyasena, MM, Murthy, GG, Yip, JJ, Gilbert, CC, Peto, TT, Gordon, II, Hewage, SS, Kamalakannan, SS. Systematic review and meta-analysis of diagnostic accuracy of detection of any level of diabetic retinopathy using digital retinal imaging.. Syst Rev, 2018 Nov 9;7(1).
  34. Rajalakshmi, RR, Subashini, RR, Anjana, RR, Mohan, VV. Automated diabetic retinopathy detection in smartphone-based fundus photography using artificial intelligence.. Eye (Lond), 2018 Mar 10;32(6).
  35. Rasmussen ML, Broe R, Frydkjaer-Olsen U, et al. Comparison between Early Treatment Diabetic Retinopathy Study 7-field retinal photos and non-mydriatic, mydriatic and mydriatic steered widefield scanning laser ophthalmoscopy for assessment of diabetic retinopathy. J Diabetes Complications. Jan-Feb 2015; 29(1):99-104.
  36. Rudnisky CJ, Hinz BJ, Tennant MT et al. High-resolution stereoscopic digital fundus photography versus contact lens biomicroscopy for the detection of clinically significant macular edema. Ophthalmology 2002; 109(2):267-74.
  37. Sanchez CI, Niemeijer M, Dumitrescu AV, et al. Evaluation of a computer-aided diagnosis system for diabetic retinopathy screening on public data. Invest Ophthalmol Vis Sci. Jun 2011; 52(7):4866-4871.
  38. Scanlon PH, Malhotra R, Thomas G et al. The effectiveness of screening for diabetic retinopathy by digital imaging photography and technician ophthalmoscopy. Diabet Med 2003; 20(6):467-74.
  39. Shi L, Wu H, Dong J, et al. Telemedicine for detecting diabetic retinopathy: a systematic review and meta-analysis. Br J Ophthalmol. Jun 2015; 99(6):823-831.
  40. Solomon, SS, Chew, EE, Duh, EE, Sobrin, LL, Sun, JJ, VanderBeek, BB, Wykoff, CC, Gardner, TT. Diabetic Retinopathy: A Position Statement by the American Diabetes Association.. Diabetes Care, 2017 Feb 23;40(3).
  41. Tennant MT, Greve MD, Rudnisky CJ et al. Identification of diabetic retinopathy by stereoscopic digital imaging via tele-ophthalmology: a comparison to slide film. Can J Ophthalmol 2001; 36(4):187-96.
  42. Tufail A, Kapetanakis VV, Salas-Vega S, et al. An observational study to assess if automated diabetic retinopathy image assessment software can replace one or more steps of manual imaging grading and to determine their cost-effectiveness. Health Technol Assess. Dec 2016; 20(92):1-72.
  43. Tufail A, Rudisill C, Egan C, et al. Automated diabetic retinopathy image assessment software: diagnostic accuracy and cost-effectiveness compared with human graders. Ophthalmology. Dec 23 2016.
  44. Walton OBt, Garoon RB, Weng CY, et al. Evaluation of automated teleretinal screening program for diabetic retinopathy. JAMA Ophthalmol. Dec 17 2015:1-6.
  45. Wong, TT, Sun, JJ, Kawasaki, RR, Ruamviboonsuk, PP, Gupta, NN, Lansingh, VV, Maia, MM, Mathenge, WW, Moreker, SS, Muqit, MM, Resnikoff, SS, Verdaguer, JJ, Zhao, PP, Ferris, FF, Aiello, LL, Taylor, HH. Guidelines on Diabetic Eye Care: The International Council of Ophthalmology Recommendations for Screening, Follow-up, Referral, and Treatment Based on Resource Settings.. Ophthalmology, 2018 May 20;125(10).

POLICY HISTORY:

Medical Policy Group, October, 2012 (4)

Medical Policy Administration Committee, October 2012

Available for comment October 24 through December 10, 2012

Medical Policy Group, October, 2013 (4): Updated Key Points, added Practice and Position statement, updated References.  No changes to the policy statement at this time.

Medical Policy Panel October 2014

Medical Policy Group, October 2014 (1): Update to Key Points and References. No changes in Policy.

Medical Policy Group, November 2015:  2015 Annual Coding update. Added code 0380T to Current Coding.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6): Update to Description, Key Points, Key Words, Approved by Governing Bodies, & References. No change in policy statement.

Medical Policy Panel March 2017

Medical Policy Group, March 2017 (6): Updates to Key points, Governing Bodies, Practice Guidelines and References.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Key Points, Practice Guidelines, Approved by Governing Bodies and References. No change to policy statement.

Medical Policy Group, December 2019 (6): Annual Coding Update, 0380T deleted, added 92499.

Medical Policy Panel, March 2020

Medical Policy Group, April 2020 (6): Updates to Policy Statement, Key Points, Practice Guidelines, Governing Bodies, Key Words (RetinaVue, EyeSuite Imaging, Retinalyze,IDx-DR). On Draft through May 17, 2020.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.