Eyeworld

EW NEWS & OPINION 18 August 2015 THE PRESBYOPIA SOLUTION THEY'VE BEEN WAITING FOR. The KAMRA inlay provides a full range of vision and long-term performance, while leaving the natural lens in place. Summary of Important Information: The KAMRA inlay procedure may not eliminate the need for reading glasses. The KAMRA inlay procedure may cause blurred vision, difficulties with contrast sensitivity, problems with night vision, double vision, ghost images, glare, halos, and color disturbances. Patients may also feel pain, dryness, burning, discomfort and look red. Other risks the patient may experience include infection, swelling, thinning, or inflammation of the cornea, and changes in the patient's vision. The KAMRA inlay CAN be removed. During the clinical study, after removal of the inlay, vision generally returned to the level the patient had prior to the implantation with the KAMRA inlay. However, this does not guarantee that the patient's vision will return to exactly what it was before surgery or that the eye will not have permanent damage. Non-surgical alternatives to the KAMRA inlay procedure include the use of reading glasses or contact lenses. Before considering the KAMRA inlay procedure the patient should: 1) Have a complete eye examination and, 2) Talk with their eye surgeon about the alternatives to treatment, potential benefits, complications, risks, and time required for healing. KAMRA; the KAMRA logo; Across the page. Across the room. Across the years; and The Presbyopia Solution are trademarks of AcuFocus, Inc. ©2015 AcuFocus, Inc. MKU-157 Rev C Mean near acuity improved about 3 lines to 20/25 at 1 month and was maintained over the 5 year follow-up. The US pivotal clinical study data reported an average gain of about 3 lines of near visual acuity.** *Dexl AK et al. Long-term outcomes after monocular corneal inlay implantation for the surgical compensation of presbyopia. J Cataract Refract Surg. 2015 Mar;41 (3):566-75. **PMA data on file at AcuFocus, Inc. 20/200 20/125 20/80 20/50 20/32 20/20 20/12.5 0 10 20 30 40 50 60 SNELLEN ACUITY MONTH UNCORRECTED NEAR VISUAL ACUITY (INLAY EYE ONLY)* INLAY EYE J2 Across the page. Across the room. Across the years. Visit us at ESCRS Booth #E02 ® by J.C. Noreika, MD, MBA the cliff, stampeding cattle, or political fundraiser before the screen faded to black. So too the SGR guar- anteed melodrama as menace and deadline came and went. Improved outcomes, exemplary patient satis- faction, restored vision, lower costs; and the reward? No cut this year. But 38% next year and we really, really mean it. Scheduled payment reductions were enacted exactly once. But past performance does not guarantee future intent. Significant cuts were likely. In an effort to rein in abuses of Hsiao's Resource-Based Relative Value System (RBRVS), the precursor to the SGR, the Medicare Volume Performance Standard (MVPS) took effect in 1992. In 1997, the SGR replaced the MVPS and was based on the nation's GDP, number of Medicare recipients, and exceed- ing the previous year's allocation; deficits were cumulative, rolling over year to year. No one physician could influence these factors; the cap was fantasy enacted. Economists call this the "Tragedy of the Commons." "Flawed SGR" became hyphenated. Threatening Draconian cuts since 2002, the SGR went to legisla- tive hell in 2015. President Obama signed its replacement, H.R.2 or the Medicare Access and CHIP Reau- thorization Act of 2015 (MACRA), on April 16. Why the change of political will? Cynics say that SGR adjustments over the next 10 years would outpace MACRA's estimated $141 billion addition to the deficit. A billion here, a billion there, and soon it's real money. MACRA is law; physicians will be paid for delivering "value." There are 2 pathways to participation: (1) the Merit-Based Incentive Payment System (MIPS), a framework built on fee-for-service (FFS); or (2) the Alternative Payment Model (APM) favoring integrated networks with lots of covered lives; accountable care organizations (ACOs) and patient-centered medical homes (PCMHs) are contemporary exam- ples. HHS thinks more will emerge. Providers accept different finan- cial risk based on their choice. The law permits participants to switch models. How this works is unclear. Much is unclear. Rule-writing by HHS, CMS, medical organizations, and others will flesh out the legisla- tive skeleton. Gail Wilensky, chair MACRA! Even Luddites concede that the Sustainable Growth Rate (SGR) "fix" may toll the knell for conven- tional small medical practice. In old matinee serials, the soon- to-be-doomed hero careened toward "L et not Ambition mock their use- ful toil," elegized Thomas Gray on the lot of little people. SGR is dead! Long live Elegy written in a country clinic J.C. Noreika, MD, MBA Insights

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