EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78708
June 2012 Sink continued from page 3 Important Safety Information: TECNIS® Monofocal Intraocular Lens (IOL) Caution: Federal law restricts this device to sale by or on the order of a physician. Indications: TECNIS® 1-Piece IOLs are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag. Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Precautions: Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or in temperatures over 45°C. Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was macular edema, which occurred at a rate of 3.3%. Other reported reactions, occurring in less than 1% of patients, were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic). Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. TECNIS® Multifocal 1-Piece Intraocular Lens (IOL) Caution: Federal law restricts this device to sale by or on the order of a physician. Indications: TECNIS® Multifocal IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate and distance vision with increased spectacle independence. The IOLs are intended to be placed in the capsular bag. Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared with a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor-visibility conditions. Patients with a predicted postoperative astigmatism >1.0 D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Care should be taken to achieve centration, as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions. Precautions: The central one-millimeter area of the lens creates a far image focus; therefore, patients with abnormally small pupils (~1mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near-vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements, as two different wavefronts are produced (one will be in focus [either far or near], and the other will be out of focus); therefore, incorrect interpretation of the wavefront measurements is possible. The long-term effects of IOL implantation have not been determined; therefore, implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or in temperatures over 45°C. Emmetropia should be targeted, as this lens is designed for optimum visual performance when emmetropia is achieved. Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal IOL was surgical reintervention, which occurred at a rate of 3.7% (lens-related: 0.6%; non-lens-related: 3.2%). Surgical reintervention included lens exchange, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning and lens removal due to patient dissatisfaction. The second most frequent adverse event was macular edema, which occurred at a rate of 2.6%. Other reported reactions were hypopyon and endophthalmitis, each occurring at a rate of 0.3%. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. 2012.01.05-CT4462 pare physicians based on all of the measures on the list. Physicians can only be responsible for reporting clinical quality measures document- ing their individual specialty care, therefore as it stands, the reports cannot accurately represent the quality of care provided by any indi- vidual physician. Comparing a spe- cialist to an internist or a primary care physician is inherently imbal- anced. A physician who received and evaluated the QRUR reported that the cost analysis in the report does not appear to identify and compare specific care for which the individual physician is responsible. Rather, the methodology makes analysis of information attrib- uted to the individual patient, and re- ports the findings as allocated to the individual physician. Such conclusions would not meet accepted standards of data use. It is of great concern how this study might be interpreted and utilized to rank physician payment under the proposed "value-based purchasing" (specifically, the value-based payment modifier mentioned in the cover letter). Risk adjustment One of the most complicated ele- ments of quality reporting and valid performance measures is risk adjust- ment for the demographic and clini- cal characteristics of the patient population. Linking quality meas- urement and performance with pub- lic reporting and payment incentives and financial penalties without proper risk adjustment would have a host of negative consequences. It could cause doctors to turn away the kinds of patients that might detract from their quality scores, dispropor- tionately affecting the most vulnera- ble patient populations—the poor, the frail, and those in certain geographic areas. Also, doctors have little control over a variety of per- patient variables, such as socio- economic status, disease history, and patient compliance, but these vari- ables still greatly impact patient outcomes, and thus, physician per- formance measures. It is crucial to account for risk adjustment to avoid potentially adverse effects to patient care that measuring, incentivizing, and/or penalizing performance can have. In fact, many health policy analysts who agree with the princi- ple of value-based purchasing also believe that it may be impossible to actually design a system that is both fair and accurate and that is not sub- ject to provider gaming. Implications for specialty medicine and small practices Specialists continue to have serious concerns that there are too many unresolved issues with the intended uses of these reports. Also, ASCRS remains opposed to the implementa- tion of the budget-neutral value- based purchasing modifier and has been pushing for the program to be delayed. Because quality reporting depends on an electronic health record (EHR) system to report the quality and cost measures, the ag- gressive timeline of the program competes against the adoption of EHR. Even though Medicare designs its incentives to reward both achievement and improvement, it could turn out that it is much easier for larger practices with more re- sources to maintain a high level of quality as defined by CMS than it is for smaller or solo practices to invest in the infrastructure and training that's necessary to improve, espe- cially when factoring in EHR imple- mentation and lack of specialty care outcomes measures within the PQRS program. There is no new money avail- able to add to the Medicare physi- cian pool of dollars, and with the value-based modifier being budget neutral there will be large variations in payment, with no cap on the per- centage of reductions or bonuses. In the very near future, patient out- comes and health status—as well as patients' opinions of their health- care experience—will determine how the reimbursement pie gets di- vided, with very visible winners and losers. EW Notes 1. Originally a voluntary program, the PQRS gives bonus payments to eligible professionals (EP) if they provide basic benchmark data about the care they deliver (0.5% in 2012). In 2010, 39.9% of ophthalmologists participated via claims-based reporting, and 60% of those who participated qualified for the 2% incen- tive payment. Beginning in 2015, EPs will be penalized if they do not report basic quality of care data to the PQRS program. The penalties were included in the healthcare reform law. 2. Ophthalmology, for example, has a limited number of practice-specific measures in the PQRS program that would indicate tangible physician performance, as viewed through the lens of the consumer. With the exception of the new Cataract Measure Group for 2012, the majority of measures is process related and offers little to no relevance related to reporting actual quality or outcomes. Contact information Liljeberg: 703-591-2220, jliljeberg@ascrs.org