Diabetic Retinopathy Toolkit

diabetic retinopathy TOOLKIT

JULY 2020

TABLE OF CONTENTS 03 / S U M M A RY 0 4 / G E T T I N G S TA R T E D W H Y W E SCREEN....................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . . . . . . ..............4 SCREENING RECOMMENDATION & TIME TABLES. . . . . . . . ....... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............5 PROGRAM PERSONNEL.............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............6 PROMISING PRACTICES & BARRIERS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............8 10 / W O R K F LO W SA M PL E WORKF LOWS................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ . . . . . . . . . . . . . . . . . . . . . . . . ............10 RETINAL SCREENING PROCESS MAP.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............12 1 3 / C A M E R A S O F T W A R E O P E R AT I O N S COOPERATIVE PATIENT............ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............13 DILATION................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........14 CAMERA SOFTWARE OPERATION.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........15 TA K I NG GOOD PHOTOGRAPH S... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........16 INTERPRETING PHOTOGRAPHS.............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............18 20 / B I L L I N G C ODI NG FOR DIABET IC RET INOPATHY SCR EENI NG. . . . . . . . . . . ......... . . . . . . . . . . . . . . . . . . . . ...........2 0 UNDERSTANDING PROFESSIONAL & TECHNICAL COMPONENTS. . . . . . . . . . . . . . . . . . . . . ...........2 0 EMR DOCUMENTATION............................................................... . . . . . . . . . . . . . . . . . . . ............21 22 / R E F F E R A L S MEDICARE......................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............2 2 MEDIC A I D.................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............2 3 G LO S SA RY.................................

RY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........2 4 A PPEN DIX ................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............2 6 R EF ER ENCES..............................

ENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........2 8

ZO O M / 2

SUMMARY The Associations for the Utah Community Health’s diabetic retinopathy Toolkit is a blueprint of promising practices to improve the prevention and treatment of diabetic retinopathy among patients in a primary care clinic. The toolkit includes resources on care integration, clinical workflow, billing guidelines, referral tips, retinal camera software, employee training, telehealth services, and ophthalmology.

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GETTING STARTED WHY WE SCREEN Diabetic retinopathy is the leading cause of blindness among working-age adults in the United States (NIH, 2015).

This disease is characterized by microaneurysm formation and intraretinal hemorrhages in the eye, leading to complete vision loss (AAO.org, 2014). Diabetic patients who have high A1C levels and hypertension are at high risk for developing retinopathy. For the patient, retinopathy usually does not present any noticeable symptoms until the disease has caused significant damage to small blood vessels in the eye. Symptoms include blurred vision, floaters/flashes, and sudden loss of vision.

With the right strategy diabetic retinopathy can be identified in the eye prior to the onset of symptoms and before irreparable retinal damage. The first stage to preventing and treating diabetic retinopathy involves educating the diabetic patient and their family early about the symptoms and causes of diabetic retinopathy. A recent study found that 40% of American adults with diabetic retinopathy were unaware of what their disease was (Skaggs 2017). This highlights the importance of educating diabetic patients on the risks of high A1C levels and hypertension as it relates to eyesight. It is very important that patients properly manage their diabetes in order to prevent retinopathy.

The second stage involves regular retinal examinations using a non-mydriatic or mydriatic fundus camera.

These retinal devices can identify retinopathy in its earliest stages before it causes any significant retinal damage. Resulting retinal images are read by licensed and trained offsite reviewers who can diagnose and recommend treatment for retinopathy. Treatment includes better diabetic management for mild retinopathy through medication and behavior change and surgery for more advanced cases. Treatments are more effective during the early stages of retinopathy.

Any damage that is identified in the retinal images is a sign of end-organ disease, and treatment can slow end-organ disease found in the kidneys and feet. The American Diabetes Association recommends that diabetic patients receive a retinopathy screening once per-year—more depending on the patient’s condition (Solomon, 2017).

Telemedicine fundus photography is a cost-effective and convenient way to screen patients for retinopathy. This process involves a trained photographer screening a patient for retinopathy using a fundus camera. The resulting retinal images are sent to an off-site ophthalmologist who reads the images and makes a recommendation/ diagnosis. Should any problems be identified in the patient’s retinal images, the patient is referred for an in person examination with an ophthalmologist.

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SCREENING RECOMMENDATIONS • Adults with type 1 diabetes should have an initial dilatiom and comprehensive eye examination by an ophthalmologist or optometrist within 5 years of diagnosis.

• Patients with type 2 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist at the time of diagnosis.

• If there is no evidence of retinopathy for one or more annual eye exams, then exams every two years may be considered.

• If any level of diabetic retinopathy is present, subsequent dilated retinal examinations for patients with type 1 or type 2 diabetes should be repeated at least annually by an ophthalmologist or optometrist. If retinopathy is progressing or sight-threatening, then examinations will be required more frequently.

• Women with preexisting type 1 or type 2 diabetes who are planning pregnancy or who have become pregnant should be counseled on the risk of development and/or progression of diabetic retinopathy.

• 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.

• While retinal photography may serve as a screening tool for retinopathy, it is not a substitute for a comprehensive eye exam, which should be performed at least initially and at intervals thereafter as recommended by an eye care professional.

Screening strategies depend on the rates of appearance and progression of diabetic retinopathy and risk factors that alter these rates. While population-based studies often are the best source for evaluating the rates of progression, data from other studies, including observational studies and clinical trials, have provided important information as well.

SCREENING TIMETABLES / REFERRAL GUIDELINES

TIMETABLE BASED ON RETINOPATHY FINDINGS RETINAL ABNORMALITY Normal (No Apparent diabetic retinopathy)

SUGGESTED FOLLOW-UP Annually

Mild Non-proliferative diabetic retinopathy (NPDR) Every 6-12 months Moderate NPDR

Every 3-6 months

Severe NPDR

Refer to ophthalmologist*

Suspected Macular Edema or IRMA**

Refer to ophthalmologist*

Proliferative diabetic retinopathy

Refer to ophthalmologist*

*Once a patient is identified with any of these conditions, they should be seen by an ophthalmologist **Intraretinal Microvascular Abnormality TIMETABLE BASED ON AGE OF PATIENT OR PREGNANCY AGE OF ONSET OF DIABETIES MELLITUS (DM) OR PREGNANCY

RECOMMENDED TIME OF FIRST EYE EXAMINATION

ROUTINE MINIMUM FOLLOW-UP

Age 0-30

Within 5 years of diagnosis

Annually

Age 31 and older

Upon diagnosis

Annually

Pregnancy

Before conception or early in first trimester (San Francisco: American Academy of Ophthalmology; 1998) 5 / DIA B ET I C R ET I N OPAT H Y TOOLK I T

Every 3 months or at discretion of ophthalmologist

PROGRAM PERSONNEL A diabetic retinopathy Screening (DRS) requires a primary care provider, photographer, reviewers, administrator, and technical support. The following are recommendations for ensuring adequate assignment of personnel for DRS. Personnel involved in the screening personnel include: • primary care clinicians who refer patients for DRS • photographers who acquire and transmit retinal images • reviewers who interpret images and generate assessments of retinopathy • administrators who oversee the process DRS programs also require policies and procedures including: • templates and protocols to manage data • procedures for interfacing with medical records, billing, and administrative tasks.

PRIMARY CARE PROVIDERS Primary care providers are usually in charge of coordinating the care of their chronic disease patients so it is crucial that they understand and agree on the importance of onsite DRS. Any DRS program should include meetings with all providers and staff to present the rationale for the program, address any concerns, and develop the processes and protocols for referring patients for screening and subsequent care. These meetings should occur early in the program development process.

PHOTOGRAPHERS Digital retinal photography is generally much easier to learn than film-based retinal photography. Personnel at all levels can usually be trained to perform adequate digital photography in a matter of hours. Sites that perform DRS have designated medical assistants, x-ray techs, interpreters, volunteers, medical and pre-medical students, optometric interns, diabetic care coordinators, diabetic educators, nurses, and doctors to acquire retinal images.

High level personnel (e.g. nurses and educators) may use retinal images to educate patients and to assess their general microvascular status; however, all levels of photographers can acquire adequate images for DRS. Individuals that are well-suited as retinal photographers have the following qualities: • Familiarity and comfort with technological devices, such as digital cameras, video games, and computers.

• Patience in working with patients.

• Attention to detail. Consistent high-quality images are important for the success of DRS. • Dedicated time for performing the photography. If the photographer has too many other assigned activities, then DRS may be avoided.

• Enthusiasm for DRS. Most photographers soon become enthusiastic about performing DRS, which creates motivation to overcome the changes to clinic activities that are necessary during the initial phase of the DRS program.

Certification of photographers is important to ensure consistently adequate images. Certification programs for photographers are available through the University of Wisconsin Fundus Photograph Reading Center (http:// eyephoto.ophth.wisc.edu/) as well as the University of California, Berkeley Retinal Reading Program (https://www. eyepacs.org). Continuous quality improvement should also be implemented by tying quality assessment of retinal images with the remote clinical consultation. The clinicians that interpret the images should provide feedback to the photographers regarding the quality of their images. Retraining and remediation can then follow the reviewers’ feedback.

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REVIEWERS The professionals that read transmitted retinal images for DRS programs are varied and can be anywhere in the world. DRS programs have used retinal specialists, general ophthalmologists, optometrists, and other licensed physicians with ophthalmic training, or trained non-clinical staff. Other programs, including Kaiser Permanente and the Veterans Administration, have employed both ophthalmologists and optometrists to read images, while others, like the University of Wisconsin Fundus Photograph Reading Center, have employed trained non-clinical staff to interpret images using a highly developed lesion detection protocol. The Association for Utah Community Health (AUCH) uses a boarded family physician with previous ophthalmic training and more than 20 years of experience interpreting retinal images.

The folowing are qualities of clinical reviewers that should be considered when selecting and contracting with appropriate reviewers: • Experience • Capacity • Availability • Cost • Liability • Turnaround time Quality assurance of clinical reviewers is of utmost importance. Inconsistent assessments and recommendations among reviewers can cause uncertainty regarding the disposition of screened patients. An adjudicating reviewer makes decisions resolving issues of ambiguous or controversial interpretation. In most cases, reviewers will be a retinal specialist ophthalmologist. Adjudicating reviewers may also perform quality control by reviewing a subsample of cases that are reviewed by other clinical reviewers. AUCH utilizes a third-party retinal specialist that the reviewer sends images to for another opinion/clarification.

ADMINISTRATORS In most retinopathy screening programs, high-level administrators participate in the initial interactions to review the expected benefits and costs of the program. Once the decision has been made to incorporate retinopathy screening in a clinic, the administration will usually assign a project manager who will perform the following ongoing administrative duties: • Manage schedules and duties of photographers and assistants involved in the day-to-day processing of encounters • Coordinate billing for services • Manage referrals for treatment of patients by retinal specialists • Act as liaison between retinal reviewers and the clinic • Communicate technical difficulties to retinal camera vendors • Ensure compliance with DRS policies and procedures • Generate reports on performance of program

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PROMISING PRACTICES According to Calt.org5, the success of a DRS program can be measured by the percentage of diabetic patients who receive annual retinal examinations. Identifying diabetic patients without a retinal exam within one year of diagnosis will improve screening and treatment. The following recommendations improve compliance with annual retinal exams: • Identify and screen diabetic patients without requiring a referral from the primary care provider. Providers are often very busy and will neglect to initiate the referral for screening. Diabetic registries or electronic medical records are often effective in identifying patients who need DRS. • Screen all diabetic patients regardless of previous eye exams. Patients often report having had a regular eye exam, but a report of the findings is not available in the patient record. Patients are sometimes mistaken when they receive a simple eye examination for eyeglasses, thinking that a thorough view of the retina was performed.

• Closely follow patients that fail the screening and are referred for retinal treatment. Diabetic retinopathy is often asymptomatic, even in the late stages, and patients will often neglect to obtain treatment. It is incumbent upon the primary care staff, as well as the retinal consultants, to ensure that the patient actually receives proper treatment.

Sample protocols and consent forms can be found in Appendix A.

HOW TO ENSURE A SUCCESSFUL DRS PROGRAM: 1. Communicate your support for the program at its inception and on an ongoing basis – your buy-in is absolutely essential in motivating the clinic staff. Ask for updates at staff meetings, and promote the clinic’s goals, milestones and successes.

2. Take a team approach to integrating screening into clinic workflow, enlisting the support of case managers, providers, photographers, and support staff. This may require the flexibility to accept walk-in appointments for people who were not aware at the time of making their appointment that they should be having retinopathy exams.

3. Emphasize the critical role of primary care in overall management of diabetic eye health. Make sure that everyone at the clinic understands that screening is part of every diabetic’s care management program at the normal site of care, not something performed only by specialists.

4. Embrace telemedicine as a new model of care, communicate with IT professionals to ensure their support, and educate your clinic team about the key benefits of this approach, including speed of service, ease of process, lower costs, and better patient care.

5. Provide training, support, and recognition for staff to fit retinopathy screening into a comprehensive diabetes management plan. Make sure that participation in the program is reflected in performance measures.

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BARRIERS FIVE TYPICAL CONCERNS FOR OFFERING DRS: 1. Duplication of services with regular eye exams with eye care providers. Why perform DRS if patients are already getting eye exams? Review of a clinic’s own compliance level with yearly eye exams (usually less than 50%) can effectively address this concern, given that high-risk patients are often the least likely to receive yearly eye exams. Furthermore, eye exams reported by patients are often not accurate. Patients often state that they have had a DR exam when they have only had a simple eye exam for eyeglasses or visual acuity.

Patients sometimes misunderstand the results of their retinal exams or can not effectively relay the pertinent information to their primary care provider. Often the reports from the eye care providers are not available in the patients’ records. It is important to emphasize that DRS does not take the place of a regular eye exam, whereas, DRS is more effective for detecting retinopathy.

2. DRS requires the participation of high-level clinicians, taking resources away from other necessary services. The DRS process requires minimal to no active participation by physicians. The photography and communication can be managed by medical assistants, interpreters, volunteers, and others (see section on photographers below).

3. Insufficient resources for treating patients with detected retinopathy. Providers are sometimes concerned that patients that are found to have sight-threatening retinopathy will not have access to treatment. This is a real concern (discussed further in the section on follow-up), however, the rationale for screening at the primary care site is to refer only those patients with sight threatening conditions to the local retinal specialists, thereby preserving retinal specialist resources for treatment, rather than using their time to see diabetic patients that do not have serious retinopathy. Furthermore, it is usually better for the patient to be aware of sight-threatening retinopathy rather than to think that the eyes are normal.

4. Inadequate follow-up on referrals. Who will refer the patient in the event of a positive finding on the screening? The clinic and off-site retinal consultants must have a mechanism for ensuring that patients can be contacted and referred to appropriate eye care providers in the event that serious retinopathy is found.

Primary care providers should use their regular specialty referral mechanisms to follow-up with patients.

5. Inadequate validation of DRS and reading consultants. Several landmark studies have validated the use of digital retinal imaging, summarized by John Whited for the US Veterans Administration. Ensuring that the proposed DRS is validated against the standard programs should effectively address this concern.

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WORKFLOW EXAMPLE 1

SIMPLE WORKFLOW

CHECK-IN: See if patient is up-to-date on screening

REVIEWER: Interprets images and creates report

PROVIDER: Refers all diabetic patients for screening

PHOTOGRAPHER: See if patient is up-todate on screening

PROVIDER: Communicates results to patient and makes referral if needed

Tip for Workflow Integration: Use charts and notes as reminders for referrals. If possible, make retinal screenings available without an appointment so that a patient who is already in the clinic does not have to schedule a return trip for the screening. (Many patients do not comply with scheduled return visits.) If electronic registries are available, set up alerts and reminder for annual retinopathy exam.

FIGURE 1.1. diabetic retinopathy Toolkit Example - Simple (Yogesan, Goldschmidt & Cuadros, 2012)

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EXAMPLE 2

GENERAL WORKFLOW & BARRIERS KEY:

01

WORKFLOW

Identify Diabetic Patients & Schedule Screening

DIFFICULTY IDENTIFYING AND SCHEDULING PATIENTS

BARRIER

03

02

External Specialists Deliver Consultation Report Telemedically

Acquire Retinal Images

LIMITED INSURANCE COVERAGE, AVAILABILITY AND ACCESSIBILITY

POOR TRACKING AND REFERRALS

05

04 Primary Care Staff Referral or Recall

POOR EDUCATIONAL RESOURCE AND COMMUNICATION

Communicate Referral to Patient

An Appointment is Created

08

07

Eye Specialist Care & Instruction on Diabetes Management

Patient Keeps Appointment

BARRIER TO ADHERENCE

06

RRESISTANCE TO TREATMENT

FIGURE 1.2. diabetic retinopathy Toolkit Example - General and Barriers (Bouskill, Smith-Morris, Bresnick, Cuadros & Pedersen, 2018) 11 / D I A B ET I C R ET I N O PAT H Y TOOLK I T

EXAMPLE PROCESS MAP

AUCH RETINAL SCREENING

PREP WORK DONE FOR EACH PATIENT (GET INFORMATION FROM CHART) 2-3 MINUTES PER PT

UPLOAD IMAGES INTO EHR IN PATIENT CHART

PICTURES ARE UPLOADED ONTO A SECURE ONLINE PORTAL MANAGED BY AUCH ALONG WITH PT INFORMATION TO BE REVIEWED BY DR. LIBRE

PT INFORMATION ENTERED INTO CAMERA’S INTERFACE FOR PICTURE STORAGE

PT ARRIVES AT THE CLINIC FOR RETINAL SCREENING

DR. LIBRE REVIEWS THE PICTURES ON AUCH PORTAL AND INPUTS THE RESULTS

DI ORDER CREATED

ANY OTHER NEEDED INFORMATION COLLECTED, VISION CHECKED AND RECORDED

PT LEAVES

PICTURE TAKEN

RESULTS COPIED FROM AUCH PORTAL AND INPUT INTO THE PATIENT’S CHART UNDER THE DI ORDER

(OPTIONAL)

PT SIGNS CONSENT IF DILATION REQUIRED

CONSENT FOR DILATION IS SCANNED INTO PT’S CHART

DI SENT TO PROVIDER TO BE REVIEWED

IF NO FOLLOW UP NEEDED, DI IS CLOSED AND PT WILL BE DUE FOR NEXT RETINAL SCREENING IN 1 YEAR

IF PT NEEDS FOLLOW UP BASED ON RESULTS, FOLLOW UP APPOINTMENT OR REFERRAL IS MADE AND DI IS CLOSED

PT WILL NEED RETINAL SCREENING IN 1 YEAR OR SOONER AS DIRECTED BY DR. LIBRE

FIGURE 2.1 diabetic retinopathy Toolkit Example - Retinal Screening Process

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CAMERA SOFTWARE OPERATIONS COOPERATIVE PATIENTS

HOW TO GET A COOPERATIVE PATIENT 1. Explain the process of conducting a retinal screen. This will increase understanding and cooperativeness (i.e.

What is being photographed, and why they are being photographed.)​.

2. Show the patient where to place their head and chin on the retinal camera.

3. Tell the patient to expect bright flashing lights when retina is photographed.

4. Assure patient that the procedure is quick and easy, but very important.​ In the course of taking images, one may encounter several challenges that interfere with the ability to take good quality images. The challenges and their solutions are divided into two catergories below, Photographic or Camera Challenges: PHOTOGRAPHIC CHALLENGES

CHALLENGE

SOLUTION

Fixation

Instruct patient to focus on camera’s interior fixation point, normally a flashing light.

Cataracts

Dilate patient

Synechia

Dilate patient

Hemorrhages

Refer patient to an ophthalmologist. Hemorrhages are often a warning sign for a greater complication.

Corneal Dryness

Patient’s eyes quickly go out of focus. Have patient blink a few times and that should resolve the issue.

No natural dilation

Dilate patient

Shadow at the top of image

The camera is positioned too high or patient’s eyelid is encroaching the pupil. Lower the optical head or raise the patient’s eyelid manually and​re-photograph.​

Shadow at the bottom of image

The camera is positioned too low. Raise the optical head and rephotograph.

Shadow at side

Diopter lens is not switched to the proper position, or when photographing the optic disk at the center of the display, working dots of fundus were not located off toward yellow dots. Make adjustments and re-photograph.

Circular or linear white blur

Eyelash in optical path, instruct patient to open eyes wider and re-photograph.

White reflection at left/right

Optical head too far to the left/right. Make adjustments and rephotograph.

White flare in periphery

Optical head too close to subject eye. Make adjustments and re-photograph.

Out of focus in general

Too much or too little tear on cornea surface. Instruct the patient to blink a few times and​ re-photograph.

Partially blue

Objective lens is dirty. Clean the lens and re-photograph.

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DILATION Ideally a teleophthalmology program is run without the need to dilate patients. However, in certain situations (such as photographing older patients, the inability to dilate, or a patient with genetically smaller pupils), image quality will be enhanced if a patient’s eyes are dilated. Before beginning to dilate patients, clinics should assure that their liability insurance covers dilation and the patient is properly informed of the risk factors.​ EXAMPLE DILATION PROTOCOL​ If patient is difficult to photograph (i.e. due to patient or camera operation challenges), ask the following:​ 1. Have you ever had your eyes dilated?

2. Did you have any complications?​ 3. Have you ever been told that you have a type of glaucoma called acute angle closure?

If so, did you experience eye pain, redness or blurred vision after dilation?

If NO to questions 2 or 3 above – proceed: Educate patient about the risks of dilation and request the patient’s signature on a consent to dilate form.​ Risks to dilating the eyes: 1. Blurred vision 2. Light sensitivity​ 3. Burning sensation upon installation of dilation drops Dilate patient using a trained clinic staff.​ Dilation training video can be viewed at www.auch.org.

Recommended medications: • 1% tropicamide​ (Note: Patient who has had diabetes for less than 10 years, over 10 years with poor diabetes control) • 2.5% phenylepherine.

(Note: The risk of angle-closure with dilating drops is 1:20,000 if both tropicamide and phenylepherine are used.

The risk of using tropicamide alone is almost 0.)​ ​Document, on the Retinal Screening Form, that the patient’s eyes were dilated.​ Notation for charts:​ T 1 OU = Tropicamide for both eyes T 1 OD = Tropicamide, right eye only T 1 OS = Tropicamide, left eye only​ Wait 10-15 minutes and re-photograph dilated patient.​ ​ istribute dark glasses and assist patient to determine if it safe for them to drive. (Note: Only the patient should D determine whether they feel safe to drive after dilation. Driving is an option for many patients with sunglasses, but a clinic staff member should not make that determination if dilated patient is able to drive.)​

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ADVERSE REACTIONS TO DILATION​ S​ igns of an adverse reaction to dilation 1. Pain​ 2. Redness to the eye Treating an adverse reaction​ If a patient has an adverse reaction to dilation, there are inexpensive effective medications to reverse or break an attack: timolol 0.5%, brimonidine 0.2%, and pilocarpine 4% (wait two minutes between each, repeat the pilocarpine once more). A patient must follow-up with​an ophthalmologist if there is any adverse effects to dilation.​ • Dilation medications have an effective shelf life of at least 2-3 years.

CAMERA SOFTWARE OPERATION​ ​Each non-mydriatic style camera will come with an image capturing software and accompanying handbook.​ In general:​ 1. Assure that there is a connection cord between the computer (lap top or desk top) and non-mydriatic camera.

2. Set-up equipment in a room where lights can be dimmed and there are sufficient electrical outlets for the adjustable table/chair, screening camera and lap top.

For each patient:​ 1. Input patient information in the software program.​ 2. Adjust camera for proper patient alignment.

3. Capture images, 1-2 pictures of each retina, starting with the patient’s right​eye. The software will automatically capture or “freeze” and save the images in the software.

4. Transfer images and patient information to the web-based storage and interpretation program for review.

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TAKING GOOD PHOTOGRAPHS PATIENT POSITIONING To begin, ensure that the patient is positioned correctly. The patient’s head should fit in the cup of the chin-rest and forehead should be touching the forehead rest.

The chin rest​assembly has an adjustment knob that will align the patient’s eye level with a black band on the column on the chin rest assembly. The patient’s eyes should face forward and the head should not be tilted. In this position, the camera will not need to be further adjusted as images are taken of both eyes.​ CAMERA ALIGNMENT​ Look on both sides of the camera to align the camera to the eye before looking at the infrared video image. Once the eye is aligned and centered in the video image, move the camera closer to the eye until it registers the retina image mode (where the retinal vessels are visible). The camera will “click” as it changes from external to retina mode. Once the retinal vessels are visible, use the focus knob to sharpen the image. In most cameras there is a focusing mire with two vertical lines. The two vertical lines will line up on top of each other to make a continuous line to properly focus the camera to the patient’s eye. Once that is established, raise and lower the camera to reduce any artifacts.​ Another visual tool for correcting the camera distance are two dots on the central horizontal position. In some cameras, the correct eye-to-camera distance is achieved by having the two dots align in the central circle. In some cameras the dots appear as soft large globes on either side of the center point. The proper distance is achieved when the two dots come into focus.​ Once the alignments (up and down, side to side), and eye to camera distance is achieved, a picture is taken by pressing down on the top of the joystick control. Immediate feedback is given as the frozen image is displayed shortly after depressing the joystick. Here you can evaluate: • Sharpness • Exposure​ • Field definition (placement of the macula center and disc) If any of these are not of acceptable quality, make the adjustments necessary and take additional images.​

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​E XPOSURE VARIATIONS​ Sometimes the exposure (flash) does not allow the camera to capture a high-quality image. There is a flash adjustment on the camera base that has a plus sign and minus sign. A dark image, makes it difficult to see the vessels and also makes the image difficult to interpret diagnose. Make proper adjustments to the brightness by increasing or decreasing the flash and take additional images.

PHOTO PROTOCOLS​ In the original photo studies on diabetic retinopathy, the Reading Center developed a 7-standard series of images to document retinopathy changes that occurred in patients. It consisted of the following:​ 1. disccentered,​ 2. maculacentered,​ 3. temporal to the macula,​ 4. superiortemporal,​ 5. inferiortemporal,​ 6. superiornasal and​ 7. inferiornasal

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INTERPRETING PHOTOGRAPHS The findings in DRS may range from only a few scattered microaneurysms and dot blot hemorrhages (mild nonproliferative retinopathy) to extensive retinal hemorrhages, venous beading, cotton-wool spots and IRMA (intraretinal microvascular abnormalities), and severe nonproliferative retinopathy. Hard exudates may be seen in any stage and are often indicative of macula edema. Retinal neovascular is the hallmark of proliferative retinopahy and may or may not be associated with pre-retinal or vitreous hemorrhage.

HARD EXUDATES

COTTON-WOOL SPOTS

MICROANEURYSMS (ARROWS)

VENOUS BEADING

DOT BLOT HEMORRHAGES

DI A B ETI C RETI NOPATH Y TO O LKIT / 18

STAGES OF DIABETIC RETINOPATHY

MILD

MODERATE

OCULAR ANATOMY

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SEVERE

PROLIFERATIVE

RETINAL HEMORRHAGE

BILLING CODING FOR DNS SCREENING PATIENTS WITH NO KNOWN RETINOPATHY: 92227 Remote imaging for detection of retinal disease with analysis and report under physician supervision, unilateral or bilateral • CPT reports a screening examination.

• This patient has no visual complaints but has a history of diabetes.

• Images are taken but there is no physician involvement.

Coverage for this screening varies. Some Medicare contractors consider the service noncovered.

FOR PATIENTS WITH KNOWN RETINOPATHY 92228 Remote imaging for monitoring/management of active retinal disease with physician review, interpretation and report • CPT reports remote imaging for monitoring/management of active retinal disease.

• Images are taken remotely, sent to and reviewed by a physician.

• Physician generates an interpretation and report.

Most Payers consider this to be a Covered Service.

BILLING FAQ: Q: What about CPT code 92250 Fundus photography?

A: For Medicare Part B, do not report 92250 -26 for telemedicine, code 92228 that describes this service.

Q: What about commercial plans that have published policies which state 92250 -26 is appropriate?

A: Follow the rules of the commercial payer.

UNDERSTANDING

TECHNICAL & PROFESSIONAL COMPONENTS

THE TECHNICAL COMPONENT (TC) Represents the cost of the equipment, supplies and personnel performing a dilated fundus examination to obtain retinal photography images. Identified by appending modifier TC to the procedure code.

THE PROFESSIONAL COMPONENT (PC) Represents the interpretation of the retinal images by a qualified physician. Identified by appending modifier 26 to the procedure code.

WHEN COMPONENTS DO NOT REQUIRE SEPARATION: Some health clinics may contract with an outside provider to whom retinal images are forwarded for interpretation. If the compensation they have agreed upon does not necessitate the interpreting provider to bill the patient’s insurance, the health center may bill for the full amount (both the technical and professional components).

INDICATING PROFESSIONAL VS TECHNICAL WHEN BILLING 92227 OR 92228 No Modifier - Indicates No Split Modifier 26 - Professional Component Only Modifier TC - Technical Component Only Rules: PCP or the ophthalmologist can bill with 92227 or 92228 and collect the entire amount.

A separate contract with the other provider for their portion is appropriate.

DI A B ETI C RETI NOPATH Y TO O LKIT / 20

EMR DOCUMENTATION WHAT KIND OF CHART NOTE IS REQUIRED? This question takes on added urgency since insufficient chart documentation is reason enough to require repayment of any reimbursement.

Medicare Regulations and Guidance the Medicare guidelines for interpretation of diagnostic tests, are discussed in the Medicare Claims Process Manual (MCPM) Chapter 13 §100, Interpretation of Diagnostic Tests.

Centers for Medicare & Medicaid Services (CMS) makes a distinction between a “review” of a test and an “interpretation and report”.

“Carriers generally distinguish between an “interpretation and report” of an x-ray or an EKG procedure and a “review” of the procedure. A professional component billing based on a review of the findings of these procedures, without a complete, written report similar to that which would be prepared by a specialist in the field, does not meet the conditions for separate payment of the service. This is because the review is already, Included in the … E/M payment.”

The review of a test is not separately payable because it is part of an evaluation and management (E/M) service.

“For example, a notation in the medical records saying “fx-tibia” or EKGnormal would not suffice as a separately payable interpretation and report of the procedure and should be considered a review of the findings payable through the E/M code.

An “interpretation and report” should address the findings, relevant clinical issues, and comparative data (when available).”

Simple, brief notations such as “normal” or “abnormal” are construed as a review of the test rather than as an interpretation and report. As a condition of payment. “(a) Services to beneficiaries. The carrier pays for radiology services furnished by a physician to a beneficiary on a fee schedule basis only if the services meet the conditions for fee schedule payment in § 42 CFR 415.120 (a) states: 415.102(a) and are identifiable, direct, and discrete diagnostic or therapeutic services furnished to an individual beneficiary, such as interpretation of x-ray plates, angiograms, myelograms, pyelograms, or ultrasound procedures. The carrier pays for interpretations only if there is a written report prepared for inclusion in the patient’s medical record maintained by the hospital.”

THE VALUE OF AN “INTERPRETATION AND REPORT” DERIVES FROM THE ANSWERS TO IMPORTANT QUESTIONS ABOUT THE DIAGNOSTIC TEST. • Physician’s order – Why is the test desired?

• Date performed – When was it performed?

• Technician’s initials – Who did it?

• Reliability of the test – Was the test of any value?

• Patient cooperation – Was the patient at fault?

• Test findings – What are the results of the test?

• Assessment, diagnosis – What do the results mean?

• Impact on treatment, prognosis – What’s next?

• Physician’s signature – Who is the physician?

WHERE TO WRITE? An interpretation can be written on its own separate page in the patient’s health record or in the blank space on the printout of the test result. Within an EHR, we often find a designated spot to record the physician’s interpretation of a test as a report. If the interpretation is written as part of the office visit note, it might appear to be an element of the evaluation and management service. Better to keep it separate or differentiate it from the rest of the eye exam by surrounding the notations with a box and a title like “fundus photo report”.

TIMING Ideally, the interpretation of a test follows immediately after the technical component is finished. In practice, there may be a delay; however, the delay should not be lengthy or effect patient care. Since fundus photography requires only general supervision, 20 and the physician need not be present during the performance of the test, the interpretation might take place the next day. If a weekend intervenes, there may be a two day delay.

21 / D I A B ET I C R ET I N O PAT H Y TOOLK I T

REFERRALS MEDICARE SALT LAKE CITY / METRO

SOUTHERN UTAH

CENTRAL UTAH

INTERMOUNTAIN HEALTHCARE SERVICES

ST GEORGE EYE CENTER LL

RETINA AND VITREOUS SURGEONS OF UTAH

Specialties: Ophthalmology 389 S 900 E SALT LAKE CITY, UT 84102 (385) 282-2205

Specialties: Ophthalmology 617 EAST RIVERSIDE DR, STE 101 ST. GEORGE, UT 84790 (435) 628-4507

Specialties: Ophthalmology 1055 N 300 W, STE 210 PROVO, UT 84604 (801) 357-7704

OLIVER LI-WEI YEH

NICHOLAS L BEHUNIN JASON WAYNE HENDRIX DAVID SLADE

DAVIS VISION CENTER ASSOCIATES

RETINA ASSOCIATES OF SOUTHERN UTAH

RETINA ASSOCIATES OF UTAH PC

BRIAN R DAVIS

JOSHUA NOREN CARLSON RON KENNETH LORD

ROBERT C KWUN

Specialties: Ophthalmology 1325 W S JORDAN PKWY, STE 103 SOUTH JORDAN, UT 84095 (801) 253-3080

RETINA ASSOCIATES OF UTAH PC

Specialties: Ophthalmology 5169 S COTTONWOOD ST, STE 630 MURRAY, UT 84107 (801) 312-2020 ERIC P BRINTON VICTORIA M KNUDSEN

JOHN ALAN CARVER

Specialties: Ophthalmology 1055 N 300 W, STE 420 PROVO, UT 84604 (801) 371-7999

Specialties: Ophthalmology 230 N 1680 E, BLDG F ST GEORGE, UT 84790 (435) 216-7032

RETINA AND VITREOUS SURGEONS OF UTAH

NORTHERN UTAH MT OGDEN EYE CENTER LLC

Specialties: Ophthalmology, Optometry 214 W 1500 S, STE 300 BOUNTIFUL, UT 84010 (801) 476-0494

Specialties: Ophthalmology 54 E 100 N PRICE, UT 84501 (435) 637-2414 JACK D STRINGHAM II

CLARON D ALLDREDGE BRADLEY J ANDERSON

COUNTRY HILLS EYE CENTER Specialties: Ophthalmology 875 COUNTRY HILLS DR OGDEN, UT 84403 (801) 399-1149 DAVID E BRODSTEIN BENJAMIN DASTRUP JONATHAN B GUNTHER

DI A B ETI C RETI NOPATH Y TO O LKIT / 22

MEDICAID UDAC

Specialties: Ophthalmology

100 E 800 S BLANDING, UT 84511 (801) 587-2255 ALLDREDGE, CLARON D *

UDAC

Specialties: Ophthalmology

1275 E FAIRFAX RD SALT LAKE CITY, UT 84103 (801) 587-2255 HARTNETT, MARY E *

UTAH EYE CENTERS

Specialties: Ophthalmology

4360 WASHINGTON BLVD OGDEN, UT 84403 (801) 476-0494 HOFFMAN, ROBERT O

23 / D I A B ET I C R ET I N O PAT H Y TOOLK I T

GLOSSARY CATARACTS A cataract is a clouding of the lens in the eye and affects your vision. Cataracts are very common in older adults. More than half of all people over the age of 80 in the United States either have a cataract or have had cataract surgery.​ Common symptoms are: • Blurry vision​ • Colors that seem faded • Glare​ • Trouble seeing at night • Double vision​ • Frequent prescription changes in your eye wear Cataracts usually develop slowly. New glasses, brighter lighting, anti-glare sunglasses or magnifying lenses can help at first.

Surgery is also an option. It involves removing the cloudy lens and replacing it with an artificial lens. Wearing sunglasses and a hat with a brim to block ultraviolet sunlight may help to delay cataracts.

CORNEAL DRYNESS The clear area in the front of the eye often becomes dry and cause blurred vision. Artificial tears can improve corneal dryness.

GLAUCOMA Glaucoma damages the eye’s optic nerve. It is a leading cause of blindness in the United States. It usually happens when the fluid pressure inside the eyes slowly rises, damaging the optic nerve. Often there are no symptoms at first, but a comprehensive eye exam can detect it.​ People at risk should get eye exams at least every two years. They include • African Americans over age 40​ • People over age 60, especially Mexican Americans • People with a family history of glaucoma Early treatment can help protect your eyes against vision loss. Treatments usually include prescription eye drops and/or surgery.

HEMORRHAGES An eye hemorrhage is a discharge of blood within the eye. It often occurs inside the conjunctiva, the membrane that covers the front of the eyeball. This type of bleeding is called a sub conjunctival hemorrhage and produces an easily visible red patch on the eye.​ Less commonly bleeding may also take place in the vitreous body, the large, round chamber located between the lens, near the front of the eye, and the retina at the back of the eye. This space contains the vitreous humor, a clear, gelatinous fluid.​ The most serious eye hemorrhages take place in the retina itself. If the eye is thought of as a camera, the retina could be considered the film. It contains the rod cells that perceive light and the cone cells that perceive both light and color.​ MACULA​ The macula is located roughly in the center of the retina, temporal to the optic nerve. It is a small and highly sensitive part of the retina responsible for detailed central vision. The fovea is the very center of the macula. The macula allows us to appreciate detail and perform tasks that require central vision, such as reading.​ ​ OPHTHALMOLOGIST​ Ophthalmologists are surgical and medical specialists who complete medical school (MD) and an ophthalmology residency.

This requires eight or more years of post college training.​ Ophthalmologists diagnose and treat diseases affecting the eye, orbit, and visual system of the brain using all available methods including surgery, medicine, and lenses.​ DI A B ETI C RETI NOPATH Y TO O LKIT / 24

OPHTHALMOLOGY​ Ophthalmology is the branch of medicine which deals with disease and surgery of the visual pathways, including the eye, brain, and surrounding areas, such as the lacrimal system and eyelids.​ OPHTHALMOLOGY SUBSPECIALTIES​ Cornea specialist: An ophthalmologist that diagnose and treats diseases of the cornea. (See diagram on page 19).​ Glaucoma specialist: An ophthalmologist that treats increased intraocular pressure with surgery or medicine eye drops.

Neuro-ophthalmologist: A neurologist or ophthalmologist that specializes in disorders of the optic nerve and visual pathways to and in the brain.​ Retina Specialist: An ophthalmologist that diagnosis and treats diseases of the retina or back part of the eye.​ OPTOMETRY​ Optometrists are primary health care providers for the diagnosis and management of eye diseases and visual system refractive disorders. They can examine and diagnose many disorders of the eyes and visual system, and treat some primary ocular diseases, including refractive problems (i.e., near or far sightedness).​ PHOTOGRAPHER OR OPHTHALMIC PHOTOGRAPHER​ Photographers are trained at getting good clear images of a patient’s retina. By combining a knowledge of the camera with insight to eye problems or diseases, a photographer can accurately record the condition of the patient’s retina at the time of the exam.​ RETINA​ The retina is a multi-layered sensory tissue that lines the back of the eye. It contains millions of photoreceptors that capture light rays and convert them into electrical impulses. These impulses travel along the optic nerve to the brain where they are turned into images.​ RETINOPATHY​ Diabetic retinopathy involves damage to the retina caused by complications of diabetes mellitus, which can eventually lead to blindness. Diabetes affects many parts of the body, including the eyes. It can affect up to 80% of all patients who have had diabetes for at least 10 years. However, research shows that at least 90% of these new cases could be reduced if there is proper and vigilant treatment and monitoring of the eyes.

SYNECHIA​ An eye condition where the iris adheres to either the cornea (i.e. anterior synechia) or lens (i.e. posterior synechia). Synechiae can be caused by ocular trauma or iritis and lead to certain types of glaucoma. It is sometimes visible on careful examination but usually more easily through an ophthalmoscope or slitlamp.

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APPENDIX RETINAL IMAGING CONSENT FORM EXAMPLE

As part of your eye exam, we recommend a special diagnostic procedure called Retinal Photography.

In this procedure a Retinal Camera is used to take a photograph of the back of the eye (the retina). This is not an X-ray or an ultrasound, nothing will touch your eye, it is simply a highly magnified photograph.

This permanent digital record is very valuable in assessing the current health of your eyes and in safeguarding the health of your eyes in the future. We are able to observe the retina, optic nerve, macula, and blood vessels and arteries of the eyes. It will also serve as an initial point with which to compare any changes as we monitor your health in subsequent years.

The fee for this additional part of your eye exam is $25. Depending on your diagnosis, if there is a medical issue such as diabetes, glaucoma, etc., this procedure may be covered under your medical insurance. Retinal Photography is not covered under most vision plans such as VSP, EyeMed or Davis Vision. This office will advise you of your coverage.

______ Yes, I want to have retinal photos taken of my eye for documentation. ______ No, I do not wish to have retinal photos taken.

Patient Signature ______________________________ Print Name __________________________ (Or person authorized to sign for patient) Date ___________________ (Clearviewi.com, 2019) DI A B ETI C RETI NOPATH Y TO O LKIT / 26

EYE DILATION

CONSENT FORM

EXAMPLE: REMOVE NOTE AND PUT ON LETTERHEAD CHANGE FONT SIZE FOR LARGE PRINT Please review the form, modify it to fit your actual practice, and place on your letterhead. Please offer the patient a copy of the form. The last page serves to verify that the surgeon has obtained informed consent from the patient; it can be copied and sent to the ambulatory surgery center if needed as verification of consent. This consent form is intended as a sample only and is provided as a risk management service. It is not intended to constitute a standard of care and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted.

Version 12/2/2002 INFORMATION REGARDING DILATING EYE DROPS Dilating drops are used to dilate or enlarge the pupils of the eye to allow the ophthalmologist to get a better view of the inside of your eye.

Dilating drops frequently blur vision for a length of time which varies from person to person and may make bright lights bothersome. It is not possible for your ophthalmologist to predict how much your vision will be affected. Because driving may be difficult immediately after an examination, it is best if you make arrangements not to drive yourself.

Adverse reaction, such as acute angle-closure glaucoma, may be triggered from the dilating drops. This is extremely rare and treatable with immediate medical attention.

I hereby authorize Dr. and/or assistants that as may be designated by them to administer dilating eye drops. The eye drops are necessary to diagnose my condition.

Patient (or person authorized to sign for patient)

Date

Witness Date

(Clearviewi.com, 2019) 27 / DI A B ET I C R ET I N O PAT H Y TOOLK I T

REFERENCES 1. (2019). Retrieved 24 September 2019, from https://www.clearviewi.com/uploads/4/3/1/5/43158435/

retinal imaging_consent.pdf 2. (2019). Retrieved 24 September 2019, from https://www.clearviewi.com/uploads/4/3/1/5/43158435/

retinal_imaging consent.pdf 3. American Academy of Ophthalmology (2014). Screening for diabetic retinopathy. www.aao.org/ clinical-statement/screening-diabetic-retinopathy#disqus_thread.

4. Bouskill, K., Smith-Morris, C., Bresnick, G., Cuadros, J., & Pedersen, E. (2018). Blind spots in

telemedicine: a qualitative study of staff workarounds to resolve gaps in diabetes

management. BMC Health Services Research, 18(1). doi: 10.1186/s12913-018-3427-9 5. Calt.org. (n.d.). Retrieved from https://www.caltrc.org/wp-content/uploads/2013/10/09-0636-final_ ctec_practice_guide_design.pdf 6. Modified from Preferred Practice Patterns Committee. (1998) Retina Panel, diabetic retinopathy,

San Francisco: American Academy of Ophthalmology.

7. National Eye Institute - U.S. Department of Health and Human Services (2015). Facts About Diabetic

Eye Disease. https://nei.nih.gov/health/diabetic/retinopathy 8. Skaggs, Julie B., et al. (2017). Screening for diabetic retinopathy. North Carolina Medical Journal,

North Carolina Medical Journal. www.ncmedicaljournal.com/content/78/2/121.full 9. Solomon, Sharon D., et al. (2017). diabetic retinopathy: A Position Statement by the American

Diabetes Association. Diabetes Care, American Diabetes Association. care.diabetesjournals.org/ content/40/3/412 10. Solomon, S., Chew, E., Duh, E., Sobrin, L., Sun, J., & VanderBeek, B. et al. (2017). Erratum.

diabetic retinopathy: A Position Statement by the American Diabetes Association. Diabetes

Care 2017;40:412–418. Diabetes Care, 40(9), 1285-1285. doi: 10.2337/dc17-er09 11. Yogesan, K., Goldschmidt, L., & Cuadros, J. (2012). Digital teleretinal screening. Berlin: Springer.

This toolkit was guided and co-written by DR. KEN LIBRE, M.D. ADDRESS 860 East 4500 South, Suite 206 Salt Lake City, Utah 84107 CONTACT US www.auch.org info@auch.org GET SOCIAL www.facebook.com/AUCH.org www.twitter.com/AUCHUtah/ DI A B ETI C RETI NOPATH Y TO O LKIT / 28