showing the absence of a negative effect if FA is omitted, although it may represent a response to lower level evidence.8

Besides the scientific aspect, the use of ancillary testing in the management of diabetic retinopathy has an economic dimension. In the modern care of patients with diabetic retinopathy and retinal diseases in general, ancillary testing provides an important source of the ophthalmologist’s revenue. In the author’s group practice, there are 4 retina specialists who manage all the diabetic retinopathy for patients served by the 25 ophthalmologists and 4 optometrists. The percentage of total collections provided by ancillary testing for these four retina specialists ranged from 15.7 to 21.1% in 2008. The 5.4% differential applied to the $1.5 million lower end estimated collections of a retina specialist implies a lower bound estimated $81,000 in yearly collections potentially attributable to variable use of imaging.11 Potential financial conflicts of interest in ordering ancillary tests by physicians are well known.12 The present example simply makes the problem specific to the management of diabetic retinopathy within a fee-for-service healthcare system.

15.2Patients with Sight-Threatening Diabetic Retinopathy and Insufficient or No Ability to Address Medical Bills

Most ophthalmologists across the world agree on what constitutes evidence-based medicine with respect to the treatment of diabetic retinopathy (DR). For example, under ideal circumstances and without constraints of money, equipment, and logistics, most ophthalmologists would manage a case of disk neovascularization with vitreous hemorrhage similarly across the world. However, the actual circumstances in which ophthalmologists work and patients live vary widely, yet little is published on the effects that these factors have on the actual as opposed to ideal management of DR. In the United States, certain situations with socioeconomic aspects repeatedly arise and bear discussion. For these situations, there is little published literature to provide guidance, despite their daily

importance in clinical practice. Two examples are discussed below, and a third will be covered in Chapter 16.

15.2.1 Case 1

A 63-year-old man with type 2 DM not on insulin, hypertension, hypercholesterolemia, a previous right-sided stroke, and amputation of the right great toe was examined on December 10, 2007, with a complaint of painless blurred vision of the right eye for 3 weeks. The visual acuity was 20/25 on the right and 20/20 on the left. Early nuclear sclerosis of both lenses was present. Both eyes had severe nonproliferative diabetic retinopathy. The right eye had clinically significant macular edema. He declined fluorescein angiography because of lack of insurance, but an OCT documented the macular thickening (Fig. 15.5A and B). Focal/grid laser photocoagulation was recommended, but the patient declined because of lack of insurance. He was offered treatment at a reduced rate (Medicaid rate) and declined. He stated that he would return for care when he became eligible for Medicare in November 2008, and he did so. By this time, his vision had dropped to 20/60 right and remained 20/20 on the left. He had worsening of clinically significant macular edema of the right eye and new CSME of the left eye. Fundus photographs, fluorescein angiography, and OCT images of both eyes are shown in Fig. 15.5C–H. Focal/grid photocoagulation was recommended in both eyes and was performed.

This case illustrates a type of clinical experience familiar to many ophthalmologists managing patients with diabetic retinopathy in the United States. The nature of the clinical problem is clear and an evidence-based course of action exists, but socioeconomic obstacles prevent proper application of known effective treatment and visual loss results. There are many possible perspectives that one might take in considering such a case. One is to deprecate the ophthalmologist. He could have provided the care as charity. This can be a solution for an occasional case, but is not a practical systemic solution. The expenses of providing care must be covered by some payor ultimately. The

profligately charitable ophthalmologist will soon be out of practice for economic reasons. As stated by Cohen et al., ‘‘In countries with large numbers of such individuals, it is unreasonable to expect individual physicians to carry a burden that rightfully rests with the broader community.’’1 Another perspective is to criticize the patient for putting off needed care for a year rather than accepting the offer of timely care at a reduced cost. Finally, the system of healthcare payment in the United States might be identified as the root of the problem. Such a situation would not exist in countries with nationalized health care, but those systems have their own faults, and we cannot constructively enter the debate on healthcare delivery here. The point of the case is to show how the healthcare delivery system affects the care and outcomes of patients with diabetic retinopathy as much as the patient’s blood pressure and glycosylated hemoglobin.

Another relevant concern in such cases is the extent of ancillary testing to be done. Should the ophthalmologist have a standard of care and stick to it for all, or should the standard vary with the available resources? For 15 years after the Early Treatment Diabetic Retinopathy Study, DME was managed without OCT. But in 2009, when OCT is integral in the management of DME, should the ophthalmologist revert to the pre-OCT standard for economic reasons? Likewise, one can manage DME without the use of fluorescein angiography, and half or more of ophthalmologists do so.13 Should the economic facts of a particular case influence one’s practice? Our purpose here is to raise the question for discussion, not answer it. The author’s practice – mentioned only for the purpose of disclosure and discussion and not put forth as a suggested norm – is to tailor the ancillary testing to the resources available. I will treat such patients without OCT or fluorescein angiography rather than defer all care because a desired standard of ancillary evidence cannot be afforded. An acknowledged pitfall of this approach in the United States is the potential for legal liability if a dissatisfied patient with a bad outcome should turn what begins as an intended act of compassion into a portrayed act of negligence. The legal system in the United States thus joins the list of considerations to be weighed in such cases.

15.2.2 Case 2

A 42-year-old woman with type 2 diabetes for 16 years and hypertension was seen with complaints of blurred vision in the left eye in association with redness, tearing, sensitivity to light, and a left-sided headache. Examination showed that she had corrected visual acuity of 20/40 right and counting fingers left. Intraocular pressures were 15 right and 45 left. She had neovascularization of the iris and a hyphema on the left. Both eyes had disk neovascularization and neovascularization of the midperipheral retina. The left eye received an intravitreal injection of bevacizumab followed by panretinal laser photocoagulation and subsequently an Ahmed tube shunt with normalization of pressure and eventual counting fingers visual acuity. The right eye received panretinal laser photocoagulation with regression of neovascularization, but contracture of a premacular membrane. Vitrectomy surgery was recommended, but the patient’s coverage under the Medicaid program expired and she was unwilling to accept a recommendation to have surgery through the offices of the State Commission for Services for the Blind. As a result, lacking money, she did not return for 16 months. She did return when her visual acuity in the right eye dropped abruptly to counting fingers interfering with her ability to ambulate. A dense contracted premacular membrane with macular traction retinal detachment was found (Fig. 15.6). The patient agreed to have vitrectomy surgery. Vitrectomy, membrane peeling, laser panretinal photocoagulation, and intravitreal silicone oil instillation were done. The visual acuity returned to 20/100 on the right (Fig. 15.7).

In this case, the lack of coverage led to procrastination in applying care with compromise of the patient’s final visual outcome. The primary obstacle preventing appropriate treatment was financial. In such a case, several questions arise.

1.Should the ophthalmologist have volunteered to provide the care without cost to the patient?

2.What is the responsibility of the society in which

nearly 50 million persons are uninsured for the sequence of events that occurred in this case?14

3.Is there a solution for such cases within the current system of health care in the United States?

4.How would such a case be handled in alternate systems of health care?

Fig. 15.6 Appearance of the right fundus of the patient in case 2. The macula is detached with a dense premacular fibrotic membrane

health care. In the past 50 years, other western nations have come to consider this as a newfound right, and the United States may be evolving in that direction. It is beyond the scope of this chapter to address the matter further except to emphasize that ophthalmologists caring for patients with diabetic retinopathy see examples like these daily. In answer to question 4, nationalized healthcare systems seem to be better prepared to treat such cases than is the healthcare system in the United States, but they have their own flaws such as limitations and restrictions on individualization of care, loss of attraction of the brightest students to other career choices, failure to incentivize medical innovation through low reimbursements, and rationing of care based on bureaucratic regulation and waiting. Which ensemble of flaws is worse is sharply debated.

Fig. 15.7 Postoperative appearance of the right fundus of the patient in case 2. The macula is attached under silicone oil

In answer to the first question, a fair answer probably involves the proportion of charity patients in the ophthalmologist’s practice. No ophthalmologist can be expected to provide charity care if the number in need renders the burden economically unviable.1 However, as members of a profession rather than a business, ophthalmologists have a responsibility to share in providing care for the uninsured and underinsured. Where this balance is struck varies. ‘‘The tragedy of the commons’’ is a concept that applies to physicians as to all humans, thus it is not surprising that some physicians choose to accept little or no responsibility.15 Questions 2 and 3 are controversial topics of debate in the United States. Historically, social beneficence in the United States has limits. The United States constitution and laws have not historically recognized a right to universal welfare or

15.3Communications with PrimaryCare Physicians

Ophthalmologists have an obligation to provide the primary-care physicians of their patients with diabetes a periodic report of the ocular status.16 Although it is recognized that the primary physician should encourage the patient to seek annual dilated eye examination, the need for communication between primary physician and ophthalmologist has not been emphasized. Many patients do not know their glycosylated hemoglobin or their list of medications, yet knowledge of the glycosylated hemoglobin is important in developing a rational ocular prognosis for a patient and plays into decisions on re-examination intervals. Unless in-office testing of glycosylated hemoglobin becomes a reality, it would be advantageous if such information was shared. Broadening use of electronic medical records may facilitate such information sharing.

15.4Working in a Managed Care Environment (Capitation)

The economic and ethical dimensions of ancillary testing under a fee-for-service system of medical reimbursement were acknowledged earlier. At the