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A new model to catch diabetic retinopathy

How one practice is getting involved in tele-diabetes screening.

Diabetes is at an epidemic proportion in this country, and the vision implications are equally epidemic. The overall global prevalence for diabetic retinopathy (DR) is 34.6%, 10.2% for vision-threatening DR and 6.81% for diabetic macular edema (DME), according to Yau et al for the Meta-Analysis for Eye Disease (META-EYE) Study Group, published in 2012.

DR and DME take a high toll on society as more develop these diseases and suffer a loss of independence (for example, no longer being able to drive).

To contain costs, CMS began an initiative to ensure all patients with a diagnosis of diabetes (including those with pre-diabetes) undergo annual diabetic eye exams. Some commercial insurance carriers are also mandating annual diabetic eye exams in the hopes of diagnosing and treating earlier in the disease state.

The Healthcare Effectiveness Data and Information Set (HEDIS) scores (https://www.ncqa.org/hedis ) include more than 90 measures over six domains of care, and the resultant scores are used to hold practices accountable. An annual diabetic eye exam is one of the HEDIS requirements. We know anecdotally that about 50% of patients with diabetes do not have annual eye exams, even after they have been asked to do so by their primary care physician (PCP). The causes are numerous — people don’t want to take time off from work, don’t want to incur another copay or may be asymptomatic and not realize they have retinal hemorrhages that have not yet impacted their central vision.

Figure 1. Normal fundus image of the right eye, taken by VISUSCOUT 100.

Because the percentage of diabetics who do not comply with their annual dilated eye exams is so high, I began to “think outside the box,” looking to our technology-driven world for answers. What if, I wondered, we brought the technology to the patients rather than wait for patients to come to us. If we placed a non-mydriatic fundus camera in the PCP offices, the medical assistants could be charged with taking an image of each eye after measuring weight, blood pressure, etc. The learning curve on how to use these cameras is minimal, and no dilation is needed. The most time-consuming portion of this concept is the data entry before uploading the images to a HIPAA-compliant cloud-based platform to be read at a reading center. After the images are uploaded, we could analyze them without initially seeing the patient in our offices.

My practice is now in the process of starting a pilot program based on this concept; if it works, it can be installed “plug and play” anywhere in the country. Here’s my plan.

THE TELE-DR SCREENING

Images taken at the PCP’s office (we are starting with those whose practices are owned by the hospital) will be uploaded to a reading center (the ophthalmology practice), where an assigned physician will interpret the images and create a report on the retinal health of the eye. The clinician who is assigned to reading the images may be a comprehensive ophthalmologist or a retina specialist; we have not yet made that determination.

Our practice has been working with Carl Zeiss Meditec to use an artificial intelligence (AI)-driven template to simplify these reports. Once the report is populated, it’s returned to the primary doctor. The diabetic eye exam is considered “complete” under HEDIS requirements. The PCP now has a report from the specialist with a directive to either let the patient know he or she needs to see a retina specialist or that there was no DR detected.

WHEN WE TAKE OVER

In the next stage, our office takes the responsibility of contacting the patient, with the PCP’s help.

Figure 2. Diabetic retinopathy-affected fundus image of the left eye, taken by VISUSCOUT 100.

We plan to design an informational postcard for the PCP to hand each patient that outlines the reasons why they had their retinal images taken and to expect a follow-up call from our office. The PCP will have to stress, however, that these images do not replace a regular eye exam; these are solely to rule out (or confirm) the presence of DR. We have to ensure the patient does not think they’ve had a complete eye exam simply because they’ve had photos taken of their fundi.

We will work closely with the PCP offices to emphasize the need for annual eye exams by any eye-care provider who tests for vision changes, glaucoma, ocular surface disease and more.

PAY STRUCTURE

Noteworthy legal issues surround the coverage and reimbursement structure for this endeavor (see “As for legal considerations,” page 21). For example, the camera cannot be gifted to the PCP (by the practice or by the reading center), as this could be viewed as inducement.

We think leasing a camera by the PCP makes the most sense — it’s a $300-$500 per month lease — or PCPs can purchase the camera. Multiple cameras are commercially available and range in price from $8,000 to $12,000. The PCP can determine which camera will be best for its practice and patients depending on factors such as portability, design and size.

The PCP bills the patient’s insurance carrier for taking the fundus images. CPT codes 92250, 92227 and 92228 provide coverage for retinal photos. Medi-Cal, Medicare and several other third-party payers cover these costs.

From the PCP’s perspective, the cost of the lease would be offset from as few as five patients a week receiving this kind of screening. In the area where I practice, most PCPs see more than five patients with diabetes a week, so this could create a small positive cash flow for the practice.

Most importantly, though, patients will now get the best possible care because every diabetic patient will undergo an annual screening fundus exam for retinal damage during his or her PCP visit.

READING THE IMAGES

The funding issue is not as clear-cut. Most insurance companies will not authorize payment if the image is deemed unreadable. We are presuming it will take one to two minutes for the ophthalmologist to read images, populate the template and return them to the PCP. If the image can be read, there is no issue. But, if it cannot be read due to poor quality, how will the ophthalmologist be reimbursed for his or her time reviewing the image and reporting it as too blurry for interpretation? These details still need to be sorted out.

The reading center has to charge the PCP to read the images. For the pilot program, we’re using a fee of $10-$12 per report generated. There is one fee per report and each report includes data from both eyes.

As for legal considerations
By Allison Shuren, JD

One of the issues surrounding diabetic eye exams is whether they are considered screening or medically necessary, and that response determines whether it is a reimbursable expense and to whom reimbursement is due. Different payers have different rules. Medicare, for example, has strict rules about who must order a test (it must be a physician who is using the test in a patient’s treatment plan). It’s questionable if PCPs will use results of a diabetic eye exam in their overall treatment, as they are still likely to recommend the patient see an ophthalmologist. Medicare is likely to see these as screening exams and may not reimburse them at the higher rate at which “medically necessary tests” are reimbursed. Some private insurance companies follow suit. It is still an ongoing process as the ultimate goal is to get patients into the system before they develop a costly disease.

Secondly, the relationship that is being created between the ophthalmologist and the PCP has to be compliant with state and federal fraud and abuse laws.

There is a potential issue of malpractice — i.e., is the person reading the image confident in the results? If the patient is in your office and the image is questionable, you send the patient back for an additional image just to be safe. But telemedicine is a different scenario; it comes down to who is responsible for the patient and what message is being delivered (i.e., a diabetic eye exam image does not replace an annual eye exam).

Ms. Shuren is an attorney with the law firm Arnold & Porter in Washington, D.C.

ENSURE THE PROGRAM WORKS

When we contact patients with pathology needing further evaluation, it is imperative to impress upon them that they will need to see a retina specialist.

As for communicating with PCP practices, at Matossian Eye we have created a position called a practice liaison. Responsibilities include visiting PCP offices and optometrists to create a relationship with them, answer their questions, make sure they’re getting our letters, etc. We have tasked this position to be a “super user” of the non-mydriatic camera to remove the burden of training medical assistants on how to use the fundus camera within the PCP practice in the event of staff turnover. We anticipate that the program will be beneficial for diabetic patients, PCPs and ophthalmologists. This could result in a closer working relationship for referrals that include diseases besides diabetes.

We hope our pilot program will launch in Q1 2019. OM

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