Primary Open-Angle Glaucoma (POAG): Reduction of Intraocular Pressure (IOP) by 20% OR

Measure Specification

1. Scientific basis for intraocular pressure (IOP) control as outcomes measure (intermediate): In a recent randomized clinical trial comparing phaco/Kahook Dual Blade to phaco/iStent, success was defined as at least a 20% reduction in IOP or reduction of 1 or more glaucoma medications from baseline. In the only multicenter randomized clinical trial comparing minimally invasive glaucoma surgery standalone procedures, the COMPARE Study defined success as an unmedicated IOP reduction of at least 20% from baseline or unmedicated IOP less than or equal to 18 mmHg.

As such, an appropriate “failure” indicator is to NOT achieve at least a 20% IOP reduction. The rationales for a failure indicator are that 1) the results of different studies can lead experienced clinicians to believe that different levels of IOP reduction are appropriate; 2) to minimize the impact of adverse selection for those patients whose IOPs are more difficult to control; and 3) because each patient’s clinical course may require IOP reduction that may vary from 18 to 40+%.

In addition, “…several population-based studies have demonstrated that the prevalence of POAG as well as the incidence of POAG, increases as the level of IOP increases. These studies provide strong evidence that IOP plays an important role in the neuropathy of POAG. Furthermore, studies have demonstrated that reduction in the level of IOP lessens the risk of visual field progression in open-angle glaucoma.

In addition, treated eyes that have a greater IOP fluctuation are at increased risk of progression. Intraocular pressure is the intermediate outcome of therapy used by the FDA for approval of new drugs and devices and, as noted above, has been shown to be directly related to ultimate patient outcomes of vision loss. As such, failure to achieve minimal pressure lowering, absent an appropriate plan of care to address the situation, would constitute performance whose improvement would directly benefit patients with POAG.

2. Evidence for gap in care: Based on studies in the literature reviewing documentation of IOP achieved under care, the gap could be as great as 50% or more in the community of ophthalmologists and optometrists treating patients with primary open-angle glaucoma. Based on loose criteria for control, IOP was controlled in 66% of follow-up visits for patients with mild glaucoma and 52% of visits for patients with moderate to severe glaucoma.

Another study of a single comprehensive insurance plan suggested that a large proportion of individuals felt to require treatment for glaucoma or suspect glaucoma are falling out of care and are being monitored at rates lower than expected from recommendations of published guidelines.

The goal of treatment is to maintain the IOP within a range at which visual field loss is unlikely to significantly reduce a patient’s health-related quality of life over his or her lifetime. The estimated upper limit of this range is considered the “target pressure.” The initial target pressure is an estimate and a means toward the ultimate goal of protecting the patient’s vision.

The target pressure should be individualized and may need adjustment further down or even up during the course of the disease. When initiating therapy, the ophthalmologist assumes that the measured pretreatment pressure range contributed to optic nerve damage and is likely to cause additional damage in the future. Factors to consider when choosing a target pressure include the stage of overall glaucomatous damage as determined by the degree of structural optic nerve injury and/or functional visual field loss, baseline IOP at which damage occurred, age of patient, and additional risk factors (e.

g., central corneal thickness (CCT), life expectancy, prior rate of progression). Lowering the pretreatment IOP by 25% or more has been shown to slow progression of POAG. Choosing a lower target IOP can be justified if there is more severe optic nerve damage, if the damage is progressing rapidly, or if other risk factors such as family history, age, or disc hemorrhages are present.

Choosing a less aggressive target IOP may be reasonable if the risks of treatment outweigh the benefits (e.g., if a patient does not tolerate medical or laser therapy well and surgical intervention would be difficult or if the patient’s anticipated life expectancy is limited). The intent of this measure is to have this indicator apply to both optometrists and ophthalmologists (and any other physician who provides glaucoma care); the use of “ophthalmologists” only in the preceding verbatim section reflects the wording in the American Academy of Ophthalmology Preferred Practice pattern.

This measure contains one strata defined by a single submission criteria. This measure produces a single performance rate. For the purposes of MIPS implementation, this patient-process measure is submitted a minimum of once per patient during the performance period. The most advantageous quality data code will be used if the measure is submitted more than once.