Telemedicine is the remote diagnosis and management of patients by means of telecommunication technology. In eye care, digital fundus photography (FP) lends itself to successful telemedicine¹ because the camera can be placed in a primary care physician’s (PCP’s) office and operated by the PCP’s staff. Images are then transmitted to an ophthalmologist for interpretation. The result: patients benefit from access to specialists who are not otherwise available.^2-5 However, legal and regulatory issues apply to screening for retinal diseases using a nonmydriatic fundus camera in the context of asynchronous telemedicine. In this first part of a 2-part series, we will discuss the issues related to patient care and reimbursement.

PATIENT CARE

A complete eye exam by an ophthalmologist usually includes ophthalmoscopy, generally dilated. A stereoscopic, detailed view of the fundus, including the macula, retinal blood vessels, and optic disc, can be achieved with binocular indirect ophthalmoscopy. With the patient’s cooperation, even the peripheral retina can be seen. For PCPs, dilation of the pupil with mydriatics or cycloplegics is impractical, as is the lack of an indirect ophthalmoscope or the skill to use it. Generally, PCPs assess patients’ retinal health with direct ophthalmoscopy through an undilated pupil, so the view of the fundus is limited. From this practice and its limitations evolved the National Committee for Quality Assurance’s strong recommendation for an annual eye exam of all diabetic patients as a Healthcare Effectiveness Data and Information Set⁶ measure. Unfortunately, patients do not always follow through with an eye exam, increasing the risk of undetected eye disease.⁷ Enter telemedicine.⁸

Fundus cameras have improved dramatically over time, and many incorporate a variety of useful features:

• Nonmydriatic imaging,
• Automatic electronic illumination control,
• Automated eye alignment,
• Autofocus,
• High-resolution digital image capture,
• Widefield and ultrawidefield FP,
• Portability, and
• Secure connection to electronic medical record systems.

REIMBURSEMENT

Health policy specialists, health insurers, legislators, and regulators generally support the concept of telemedicine because it can improve access to health care at a low cost, which may prevent disease or speed intervention at an early stage. Despite this, adoption of telemedicine has been slow. A variety of legal and regulatory obstacles, as well as some misuses of the delivery model early in its evolution, are to blame for this slow adoption. The Medicare program presents challenges, and many of them extend to other third-party payers as well.

Medicare’s policy on telehealth does not address eye care.^9,10 Instead, it focuses on incentivizing the use of technology to improve access to care in rural areas, and a demonstration project in Hawaii and Alaska. Most of the policy speaks to synchronous telemedicine rather than asynchronous (ie, store and forward), as is used in screening FP.

Part B Medicare follows the straightforward principle that preventive medicine and screening is noncovered in almost all cases (unless there is a statutory exception, such as glaucoma screening exams¹¹). So, testing a beneficiary with no symptoms or documented abnormal condition, is usually “not medically necessary” and not reimbursed.¹²

Also, Medicare and other payers expect that the physician ordering the test will use the test and has the capability to do so. For example, it’s reasonable and appropriate for ophthalmologists to order FP to plan laser treatment for proliferative diabetic retinopathy. It’s not reasonable for PCPs to order FP that they cannot interpret and would not use to treat eye disease. A diagnosis of diabetes, by itself and absent any prior history of diabetic retinopathy, does not warrant FP, because there may be nothing but a normal fundus to photograph. At best, a PCP seeing an abnormal fundus with a direct ophthalmoscope refers the patient to an eye-care professional; this does not satisfy the basic Medicare policy for diagnostic tests.

In addition, because telemedicine provides a triage mechanism for sorting patients who need further evaluation and treatment for diabetic retinopathy or other eye disease, it may be an important source of referrals to ophthalmologists from PCPs for services that probably will be covered and paid for by Medicare or other third-party payers. As such, ophthalmologists must be careful to avoid providing PCPs with anything of value, such as a fundus camera, that could be construed as a means to secure referrals. This raises the specter of the federal Anti-Kickback Statute (AKS)¹³ and corresponding state laws.

The federal law “prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal health care program business.” The AKS is broadly drafted and establishes penalties for individuals and entities on both sides of the prohibited transaction, up to and including mandatory exclusion from federal health care programs.

In the second part of this series, next month, we will discuss coding and payer contracting. RP

REFERENCES

1. Sanchez CR, Silva PS, Cavallerano JD, Aiello LP, Aiello LM. Ocular telemedicine for diabetic retinopathy and the Joslin Vision Network. Semin Ophthalmol. 2010;25(5-6):218-224.
2. 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. 2015;133:518-525.
3. Cuadros J, Bresnick G. Can commercially available handheld retinal cameras effectively screen diabetic retinopathy? J Diabetes Sci Technol. 2017;11(1):135-137.
4. Kanjee R, Dookeran RI, Mathen MK, Stockl FA, Leicht R. Six-year prevalence and incidence of diabetic retinopathy and cost-effectiveness of tele-ophthalmology in Manitoba. Can J Ophthalmol. 2016;51(6):467-470.
5. Gupta A, Cavallerano J, Sun JK, Silva PS. Evidence for telemedicine for diabetic retinal diseases. Semin Ophthalmol. 2017;32(1):22-28.
6. National Committee for Quality Assurance (NCQA). Comprehensive diabetes care. HEDIS. https://www.ncqa.org/hedis/measures/comprehensive-diabetes-care/ .
7. Lee PP, Feldman ZW, Ostermann J, Brown DS, Sloan FA. Longitudinal rates of annual eye examinations of persons with diabetes and chronic eye diseases. Ophthalmology. 2003;110(10):1952-1959.
8. Garg S, Zimmer-Galler I. An update on telemedicine and remote imaging for evaluating diabetic retinopathy. Retin Physician. 2013;10(2):49-51.
9. Centers for Medicare & Medicaid Services. Telehealth services. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/TelehealthSrvcsfctsht.pdf .
10. Medicare Claims Processing Manual (MCPM). Chapter 12 §190. List of Medicare telehealth services. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c12.pdf .
11. Social Security Act. Sec.1861(uu). Glaucoma screening. https://www.ssa.gov/OP_Home/ssact/title18/1861.htm .
12. Medicare Learning Network. July 2016. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Items-and-Services-Not-Covered-Under-Medicare-Booklet-ICN906765.pdf .
13. 42 U.S.C. §1320a-7b. Criminal penalties for acts involving federal health care programs. https://www.govinfo.gov/app/details/USCODE-2010-title42/USCODE-2010-title42-chap7-subchapXI-partA-sec1320a-7b .