This statement is intended to 1) provide an overview of telemedicine for ophthalmology (incorporating features of tele health) and 2) highlight issues that we anticipate will shape the development and implementation of telemedicine for ophthalmology in the near future. As new technology is developed and incorporated into patient care, additional information on validity and reliability is generated and payment systems evolve, we anticipate that future guidance will be incorporated into this summary.

Telehealth describes health care delivery over distance or time using electronic communication technologies and serves to enhance health care access, quality and patient satisfaction. Telemedicine is used to describe provision of a traditional clinical service delivery using electronic communication technology, often in a live format. The term telehealth adds diagnosis, management, education and administration well beyond traditional health care delivery. The rapid improvement of electronic imaging capability and biometric data acquisition in ophthalmology, combined with parallel advancements in health information technology and widely available broadband connectivity, has created new pathways for delivery of eye care services. These pathways improve access by extending the reach of medical eye care services, improve clinical outcomes by providing care in a timely fashion, and enhance patient satisfaction by providing care in a setting and at a time convenient for the patient.

Telehealth includes four primary domains:

• Live audio-video (synchronous) telemedicine: Real-time, bidirectional communication between a patient and provider using audiovisual telecommunications and data collection technology.
• Store-and-forward (asynchronous) telemedicine: Electronic transmission of health care data (e.g., images, text, or other digital data) to a provider for evaluation and service delivery using methods other than real-time interaction with the patient.
• Remote patient monitoring (RPM): Health data collection directly from the patient, typically during their usual activities of daily living, with transmission to a provider for analysis and possible action (e.g., tele-intensive care)
• Mobile Health (mHealth): Health care, patient communication, and education based on mobile communication platforms, e.g. fitness tracker, cell phones, tablet computers, etc.

These domains employ different technologies – optimized for a particular clinical process, setting, and disease or condition – to improve clinical and public health outcomes. Use of telehealth tools should occur in the context of established clinical practices and evidencebased standards of care. The best features of telehealth are derived through integration with traditional processes to improve current practices (sustaining innovation) and creation of new workflows and clinical settings to allow new approaches (transformational innovation). To ensure safe and effective patient care, evidence of effectiveness and safety is required to validate telehealth practices, including the technology to create new standards of health care. These strategies will require new risk management practices, reimbursement strategies, and approaches to regulatory oversight.’ The secure exchange and storage of tele health data between devices, systems and providers is required to protect patient privacy, but also ensures data availability for appropriate patient care.

A related and emerging area of tele health is the use of decision analytics and artificial intelligence for the interpretation of images and other patient care data collected electronically. A complete discussion is outside the scope of this document. Future reports will be needed to describe the validation and introduction of these approaches to clinical care, many of which may move the analysis to the point of care.

Telemedicine for Ophthalmology

Ophthalmology has multiple opportunities for utilizing telemedicine.² Two mature domains, diabetic retinopathy (DR) and retinopathy of prematurity (ROP), illustrate how telemedicine can be deployed to improve access and quality of health care. Successful use of telemedicine in these domains has delivered benefits to patients, providers, health care systems, and society. Telemedicine for remote surveillance of DR is an established use. Research has demonstrated clinical, public health, and economic benefits. Although effective treatments for high-risk DR have existed for more than four decades, DR remains a leading cause of blindness among working-age adults. The inability of half the population to access retinal examinations in a timely fashion is a major contributor to vision loss from diabetes. Telemedicine programs can improve patient access to the annual DR screening through patient imaging in a primary care setting.³ These programs have led to improved clinical outcomes. Given the high proportion of patients currently unable to obtain a retinal screening or an eye examination at the appropriate frequency, expansion of telemedicine for ophthalmology programs would likely result in earlier provision of eye care for DR and non-DR eye conditions.

Telemedicine for ROP has a proven ability to improve access to eye care for premature infants at high risk for retinopathy of prematurity (ROP).² Timely diagnosis and treatment of ROP are key to successful outcomes. There are shortages of examiners skilled in indirect ophthalmoscopy and trained in ROP screening who can provide care for low birth weight infants. Telemedicine provides an attractive alternative, especially in more remote areas. In addition, imaging can improve documentation compared to traditional retinal drawings.

These two clinical areas demonstrate that telemedicine can successfully improve and extend ophthalmic care through the use of imaging technology. Other areas of telemedicine within ophthalmology—such as intraocular pressure monitoring, optic nerve analysis, macular disease monitoring, visual field analysis, and anterior segment diagnosis—are being developed. In addition, the capacity to perform remote, face-to-face exams and consultations in both routine and emergent clinical situations is advancing with improved two-way communication technologies.

Validation

Telemedicine programs for ophthalmology must ensure that quality of care and long-term outcomes are not compromised by insufficient performance of the technology or the system. Validation of clinical performance against an accepted standard is necessary, as is instituting an ongoing quality assurance program. These assessments need to be conducted in the clinical settings where these technologies will be deployed, and with the devices and clinical and technical staff in place. For instance, telemedicine programs for diabetic retinopathy (DR) should be assessed in primary care settings, while programs for retinopathy of prematurity (ROP) need to be assessed in neonatal intensive care units.

Additional validation challenges include assessing the available imaging devices, the image field of view, the use of eye drops for pupillary dilation, and the training of imagers and readers.¹⁰–¹²

One example of a validation standard is the Early Treatment Diabetic Retinopathy Study (ETDRS), which uses seven standard-field stereoscopic color photographs as the reference standard for the detection of diabetic retinopathy.¹³ Based on this standard, the American Telemedicine Association (ATA) describes four categories for telemedicine programs based on their capability to detect DR:

• Category 1 – Differentiate the presence or absence of none or very mild non-proliferative diabetic retinopathy (NPDR) from mild NPDR or more severe DR.

• Category 2 – Distinguish sight-threatening disease (greater than moderate NPDR, proliferative DR, or diabetic macular edema) from less severe disease.

• Category 3 – Identify defined levels of diabetic retinopathy and macular edema, and may be used to remotely manage the disease.

• Category 4 – Match or exceed the accuracy of ETDRS imaging; can replace the 7-field reference standard in clinical or research settings.

The selected validation category for DR evaluation should be based on the program’s goals. To assess performance in a category, performance thresholds for sensitivity and specificity need to be established. Importantly, the validation program needs to evaluate all components of image acquisition, compression, transmission, and review. Equipment cost, technical difficulty, operational complexity, and training requirements generally increase with increasing program performance.

Another validation standard for telemedicine programs could be a clinical examination by ophthalmologists with varied levels of training. For ROP, the reference standard is dilated pupil bedside indirect ophthalmoscopy for the detection of moderate or severe stages of ROP.¹⁴ Notably, validation standards may evolve over time. For instance, recent studies have suggested that detection of ROP through imaging may be more accurate than bedside examination. Thus, there is potential for a new reference standard to be adopted for the detection of moderate or severe ROP, possibly combining wide-field fundus imaging and indirect ophthalmoscopy.¹⁵

IV. Clinical

A. Equipment

There are two broad categories of equipment used in a telemedicine program for ophthalmology:

Information acquisition devices (e.g., cameras, optical coherence tomography machines, tonometers, autorefractors, visual field machines, etc.)

Image communication devices (e.g., computers, servers, network devices, etc.) used to send the data.

These devices should have the following characteristics:

• FDA approval for medical devices

• Compliance with Underwriters Laboratories (UL) and ISO standards

• Adherence to local, state, federal, and international guidelines for health care information acquisition, transmission, and retention

• Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance

• DICOM compatibility (if applicable)

• Ability to interface with widely used electronic health records (EHR) and picture archiving and communication systems (PACS), preferably using standards-based interoperability protocols

• Performance capabilities necessary to support a comprehensive ophthalmology evaluation

Imaging and other diagnostic acquisition device performance should be periodically confirmed according to manufacturers’ recommendations. Diagnostic displays should be checked regularly for normal function and recalibrated as needed.

Additionally, proper data security, integrity, and availability—including backup and archiving—must be ensured and continually monitored by information technology staff.

B. Setting and Space Requirements

The setting—whether a medical office, urgent care, emergency room, or community health care center—should have the ability to:

• Monitor test-appropriate vital signs

• Take a detailed clinical history and review of systems

• Conduct and transmit the telemedicine ophthalmology examination

• Organize appropriate follow-up care

Telemedicine examinations will have differing space requirements based on the use of synchronous versus asynchronous technology:

• Synchronous visits require space for the patient, local provider, and remote provider to privately conduct the exam and discuss findings. These typically require audio and video equipment, a computer for transmitting examination data, and devices for performing a remote eye exam.

• Asynchronous visits require space for imaging equipment and other diagnostic devices, along with an area for data preparation and submission.

In most cases, a small footprint within an existing clinical space is adequate for telemedicine examinations and consultations.

C. Personnel

There is limited regulatory guidance on the personnel involved in acquiring, transmitting, and interpreting telemedicine data. Each team member should:

• Meet qualifications established by the program

• Have those qualifications verified initially

• Provide ongoing evidence of competence

A task-based (function-based) assessment should be conducted to determine personnel requirements. The method of image analysis—whether by a trained reader supervised by a physician or by a physician directly—should be transparent to the requestor. The reading center holds liability for errors in interpretation.

Basic requirements for staff at the remote imaging site:

• Familiarity with ocular anatomy, diagnostic equipment, potential complications of pupillary dilation (if mydriatic imaging is used), universal precautions, antiseptic technique, HIPAA regulations, and informed consent

• Training for safe and proper patient contact in clinical settings, per applicable hospital/facility protocols

• Training and certification on specific equipment, adherence to quality control metrics (e.g., percentage of gradable images or missing clinical data)

• Periodic reevaluation of competence

Requirements for the supervising physician and readers at the reading center:

• Ophthalmologists serving as remote physicians should receive initial and periodic training to meet quality standards

• The reading physician should confirm medical malpractice liability coverage for this activity

• Reading physicians must meet state licensure requirements for the state where the patient resides (or have alternative permissions in compliance with evolving state laws)

D. Data Acquisition

Most current telemedicine programs in ophthalmology use a store-and-forward model, where images are acquired for later evaluation by a trained reader under physician supervision. Newer models may include at-home testing with patient-initiated transmission and web-based interactions.

Diabetic Retinopathy (DR)

Many DR surveillance systems use one, two, or three central field photographs to detect the presence or absence of significant retinopathy. These systems must be validated against the 7-field ETDRS standard or full clinical exams across the spectrum of diabetic retinopathy.

As performance data improves, new imaging systems—such as non-mydriatic ultra-wide-field imaging (with or without concurrent OCT)—can be adopted in appropriate settings. Validation against appropriate standards remains necessary. Tradeoffs between performance, accessibility, and cost will help determine optimal approaches for different settings and clinical outcomes.

Retinopathy of Prematurity (ROP)

ROP telemedicine evaluations are typically performed in the neonatal intensive care unit (NICU). Personnel performing imaging—such as a neonatal nurse or trained photographer—must be trained to obtain the necessary images.¹⁶

Throughout the evaluation, the baby’s medical status must be monitored by a nurse who is not performing the imaging. Training should be provided by the imaging platform vendor in conjunction with oversight from ROP screening physicians.¹⁷ An ophthalmologist with expertise in ROP treatment should be available in a timely manner to manage findings.

Anterior Segment Disease

Although less common, two-way audio-video technology is increasingly being used for anterior segment disease evaluations. This includes the use of slit-lamp and indirect ophthalmoscope imaging. A common intermediate model involves image acquisition by a technician, followed by physician review to determine whether an in-person exam is necessary.¹⁸

Home Monitoring and Automated Refraction

Home monitoring for chronic ophthalmologic disease is emerging and expected to grow due to its potential to expand access and enable remote reporting to physicians. Early applications include:

• IOP measurements

• Macular visual field testing

These tools may help patients and physicians recognize the need for in-person visits.

Web-based refraction systems offer convenience for prescription updates but must be:

• Properly validated

• Evaluated for regulatory compliance (e.g., FDA clearance)

• Clearly disclose that a refraction does not replace a comprehensive eye exam

As multiple digital applications enter the market, they must be validated across a range of hardware and software configurations. Consultation with the FDA will be necessary in most cases.¹⁹

E. Data Transmission

Patient data transmission must strictly comply with all regulatory and patient care requirements, including the following:

• HIPAA compliance: Ensuring privacy and security
• Standards-based verification of successful data transmission and storage
  • Text: HL7 standard
  • Images: DICOM format
  • Use of automated protocols via IHE-Eye Care frameworks is preferred
• Alternative information transfer methods in case of system failure (failover and disaster recovery procedures)

All systems should affirmatively acknowledge the transmission status. However, originating site staff should maintain a low threshold for suspecting failed transmission in the absence of expected responses or reports from the reading center. Clearly defined procedures should be in place to manage such occurrences.

F. Reading

Image grading, reading, and reporting of results should be performed by an ophthalmologist or a team of trained readers under ophthalmologist supervision. Personnel must:

• Possess adequate training, expertise, and authority to provide accurate and timely diagnoses
• Meet qualifications determined for each telemedicine application

G. Communication of Results

The primary goal of a telemedicine encounter is the identification of pathology requiring clinical management. Accordingly, communication from the reader to the requesting physician must meet the following minimum standards:

• Timely reporting within defined medical or regulatory timelines, with efforts to expedite review as appropriate
• HIPAA-compliant transmission (privacy and security)
• Verifiable transmission and receipt of data
• Secure and persistent storage of reports
• Prompt availability of results to both the imaging site and reading center
• For ungradable images, include a recommendation for referral

H. Quality Control and Continuous Systems Improvement

A comprehensive quality assurance (QA) program should monitor operations and clinical outcomes to ensure consistent adherence to program goals. This includes periodic evaluation of:

• Equipment performance
• Personnel competence
• Clinical outcomes

Quality assurance measures should include:

• Rereads for consistency
• Inter- and intra-reader variability assessments

Process and workflow metrics should be established to evaluate program quality. For example:

• The rate of referred patients who complete follow-up care
• The proportion of eligible individuals screened within a given population

Telemedicine programs must adopt continuous improvement strategies to address system failures, integrate new technologies, and enhance care quality and access.

I. Data Security

All telemedicine programs must address concerns regarding data security and integrity, including:

• Patient privacy and confidentiality (compliance with HIPAA)
• Data availability and recovery protocols
• Use of encryption for all image and video transmissions

V. Telemedicine Impact on Ophthalmology Practice

Telemedicine may shift certain patients-particularly those with lower disease burdens-away from traditional practices. However, these programs often serve populations not previously accessing care, thereby increasing the number of patients entering the health care system.

• In some cases, pathology identified will be directly related to the telemedicine purpose (e.g., severe diabetic retinopathy).
• In others, opportunistic findings (e.g., retinal tumors) may be discovered.

Overall, telemedicine contributes to:

1. Increased patient volume
2. Higher disease acuity at traditional clinics affiliated with telemedicine programs²⁰

VI. Legal Considerations in Telehealth

Legal considerations in telehealth include traditional medical concerns such as malpractice, informed consent, patient privacy (HIPAA), and agency responsibility, as well as unique issues created by geographic and temporal separation between physicians and patients.²¹

A. Establishment of Physician-Patient Relationship

Once a telemedicine interaction begins, a physician-patient relationship is established. This relationship subjects the encounter to the same standards as in-person care, including:

• Standard tort liability (malpractice)
• Informed consent requirements
• Physician accountability for oversight of services

B. Use of Images and Documentation

Although there is concern about missed diagnoses, photographic documentation serves as strong evidence of findings present (or not) at the time of the exam. In many cases, submission of images-by the patient or a care provider-can imply informed consent, though some states require explicit consent for telemedicine.

C. FDA-Regulated Devices

This document does not cover:

• Devices not approved or exempt by the FDA
• Use of approved devices in off-label or non-FDA-cleared contexts (allowed under the “practice of medicine”)

Nonetheless, all devices and procedures should have adequate scientific support and be endorsed by a respectable minority or more of peers.

D. Special Legal Issues in Telemedicine

1. Intermediate Systems (Agents)
   • Imaging and data transmission often involve third-party agents.
   • A business associate agreement is required to comply with HIPAA.
2. Cross-State Licensing
   • Physicians must be licensed in the state where the patient is located.
   • Options include:
     • Full licensure in multiple states
     • Referral by an in-state physician (allowed with limitations in some states)
     • Special telemedicine licenses
     • The Interstate Medical Licensure Compact (as of April 2017) offers streamlined licensing across participating states
     • For up-to-date legal requirements: http://www.cchpca.org
3. Liability for Non-Physician Readers
   • If non-physicians interpret images, a licensed physician must be responsible for final diagnosis to avoid unauthorized practice concerns
   • Courts may apply the specialist standard of care, possibly requiring expertise consistent with a retinal specialist, depending on service presentation
4. Results Communication
   • Failure to communicate test results is a common basis for malpractice litigation
   • Errors or delays caused by technical issues or miscommunication also pose legal risks
   • Physicians are likely to be liable for system failures within their control
   • Use of contractual indemnification clauses may mitigate certain risks

VII. Coverage Policies and Limitations

One of the major hurdles for telemedicine to reach its full potential has been infrequent and inconsistent coverage by both commercial and government healthcare insurance providers. The lack of widespread reimbursement has hindered these programs from becoming self-sustaining. Notably, coverage often lags behind improvements in telehealth technology and availability, especially among government payers.

Medicare

Medicare Part B provides coverage for synchronous telemedicine services, defined as two-way, real-time audio and video communication between the provider and patient. However, this coverage is limited:

• Applies only to patients residing in rural counties or designated rural physician shortage areas, as determined by CMS
• Services must be delivered from an originating site, such as a medical office-not from the patient’s home

These services are billed using evaluation and management (E/M) codes, telehealth codes, or subsequent hospital care codes, with the -95 modifier (previously -GT) indicating telehealth delivery. The originating site submits a claim using HCPCS code Q3014.

Note: CPT includes a list of acceptable codes for telehealth in Appendix P, but eye codes (CPT® 92002-92104) are not yet included in covered services.

Asynchronous Services (Store-and-Forward)

Asynchronous telehealth services are only covered under a federal demonstration project in Alaska and Hawaii. These services use the -GQ modifier and are limited to medical remote opinions, similar to synchronous services.

There are two CPT® codes related to asynchronous teleophthalmology:

• CPT® 92227 – Imaging for detection of retinal disease
• CPT® 92228 – Imaging for monitoring and management of active retinal disease

However, due to statutory language, these codes are non-covered services unless specifically allowed by CMS. Once these codes were introduced, CPT® 92250 is no longer reimbursed when used for remote evaluations as described in CPT®.

Remote Monitoring

Remote monitoring is reimbursed for a limited number of activities. In ophthalmology, one example is:

• Visual field monitoring for macular degeneration, reimbursed by some Medicare contractors (CPT® 0378T, 0379T)

As of 2018, CMS approved payment for:

• CPT® 99091 – Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient or caregiver to a physician, requiring a minimum of 10 minutes of physician time

Medicare Advantage (Part C)

Medicare Advantage is administered by commercial insurers who must provide all services covered under traditional Medicare Part B. These carriers are also permitted to provide non-covered services, including telehealth, if they align with:

• Company priorities
• Patient care goals

Some companies are starting to cover telemedicine services to improve healthcare quality indicators.

Medicaid

Medicaid is administered independently by each state, the District of Columbia, and Puerto Rico, using a mix of federal and local funding. Coverage for telehealth services varies by jurisdiction.

As of the end of 2017:

• 48 states and DC provide coverage for live video telehealth encounters, although many impose site-of-service restrictions
• 13 states reimburse for store-and-forward services
• 21 states offer some coverage for remote patient monitoring

Commercial Insurance

Coverage for telehealth under commercial insurance is carrier-specific. Many private insurers have adopted:

• Synchronous consultations
• E-consultations for minor issues, often considered patient-friendly and clinically efficient
• Remote retinal imaging programs, especially in support of diabetic care management, frequently conducted in primary care settings

References

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Approvals

Approved by the American Academy of Ophthalmology Board of Trustees, February 2018.

AAO Telemedicine Task Force:

• Michael Trese, MD (Chair)
• Michael Chiang, MD, MA
• Paul Lee, MD, JD
• Mark Horton, OD, MD
• Maria Woodward, MD, MS
• Ingrid Zimmer-Galler, MD
• Lloyd Paul Aiello, MD, PhD
• Darius Moshfeghi, MD
• Michael Repka, MD, MBA

© 2018 American Academy of OphthalmologyP.O. Box 7424 / San Francisco, CA 94210 / 415.561.8500