1. Laser Assisted Cataract Surgery J. Alberto Martinez, M.D. Visionary Ophthalmology September 18, 2011

2. OUTLINE LACS technique Who is a good candidate for LACS? Getting paid for LACS Is LACS cost effective for patient and doctor? Who is operating the laser? Implications Ethical Considerations

3. Landmark Events in Cataract Surgery Intraocular lenses Phacoemulsification femtosecond Assisted Cataract Surgery?

4. Current limitations of manual cataract surgery Visual Outcomes: Distance accuracy 1/2 of that achieved with LASIK Unpredictable astigmatism correction Effective lens power IOL-capsulorhexis Safety: 10x more complications than LASIK Ultrasound complications (endothelial cell loss)

5. LensX Animation

6. Anterior Capsulotomy

7. Lens Fragmentation

8. Lens Aspiration

9. Why jump into LACS? Mounting evidence of better efficacy and safety from day one IOLs and phaco took years to become safe and effective LACS learning curve is very short: “like going from analog to digital” Better for hypermature lenses, weak zonules, endothelial dystrophies Downsides: Increased cost and time

10. LACS: Patients Perspective Add BLADELESS to needleless (topical) stitchless (clear cornea, self sealing) True laser cataract surgery Improved predictability Improved safety Latest technology More predictable outcomes/quality of life Patient confidence

11. Medical Coverage Advisory Committee Reviews quality of the the evidence about evidence of a procedure Explores many sources of evidence Is routine use in clinical practice Bias? Is there a need and what is the size of the healthcare benefit? Should we go with it, or should we wait?

12. Medicare Reimbursement Realities Work: pre-op, intra-op and post-op Takes into account only skin to skin Covered: incision, capsulorhexis, fragmentation Cannot bill for anything else Can bill for: astigmatism Long term reimbursement: quality, outcomes, efficiencies Based on QUALITY and EFFICIENCY BUDGET neutral (no more money into the system)

13. Medicare reimbursement realities Somebody gets a bonus? Somebody else gets a reduction ( to maintain neutrality) CE is the most successful procedure We are in the process of evaluating quality Summary: cannot bill for anything COVERED UNDER MEDICARE Careful word choice: quicker? (less time, less reimbursement) easier? (why pay more?) these words jeopardize reimbursement

14. Practice Management Considerations Where will the laser be used?: critical. Enormous implications ASC?: Better (have a relationship with CMS) Patients’ expectations? (no glasses, does not care either way) For covered procedures: must follow some rules Covered: CE and IOL, physician: CE Non-covered: deluxe IOL, refractive care (by MD)

15. Practice Management Considerations Covered: exam (no mater how long is it), measurement of eye, surgery (incision, capsulorhexis, phaco, IOL) Endothelial cell photography? Yes! For pre-op evaluation Facility fee: not included: premium IOL, astigmatism Astigmatism correction (refractive keratoplasty) considered cosmetic Not covered: refraction, tests for ametropia, screening, refractive surgery, IOL upgrade

16. Astigmatism Iatrogenic IS covered LRI, wedge, etc Fee must be a number that can be defended List of tasks (refraction, topo, pachy, wavefront, LRI, enhancement) needed to correct astigmatism Contingency for enhancements Assign fee (need to be defensible, justifiable)

17. Controversies Is CE with FS safer/better Is Astigmatism correction with FS safer/better FS: expensive, slower, ASC only can charge for refractive surgery

18. Discussion on Reimbursement Is it a good result that the patient ends up wearing glasses? Should we pursue emmetropia? Elective: refractive (no glasses) Patients have decided that price for getting rid of glasses is about $2000 +/- If patient is happy with glasses, you can’t charge

19. Financial Viability Pros: Will it happen? Yes, we are convinced it will become a standard Break-even: 15 cases/month Open the ability to bring other providers to Fempto facility?

20. Financial Viability Cons: Emotional. Moving cheese for staff Some physicians reluctant Cost Change in flow (slow down things) Cannibalize premium IOLs Projected rates of conversion: unclear

21. Positioning (S. Lane) Educate ALL patients — even non-candidates Choice for all patients with pre-existing astigmatism (desire only distance or both) Happy patients? Treat to within 0.5 D of astigmatism

22. Overhead at the ASC Increase volume? Increase overhead? Decrease premium IOL conversion? Increase for astigmatism conversion? Increase bottom line?

23. Marketing Expenditures PR Educational materials Careful about making false claims Under promise/over deliver

24. Why small practices will not be able to do it alone and what can be done If alone: band together, talk about it, get people thinking about it) Practice without walls Must have enough patients! Could one ophthalmologist run the femto while the other does the phaco? Cataract and refractive surgeons should partner Must have a refractive mindset Bottom line: need Vision and Business expertise Total expenditure from scratch: 1.5 to 2 million dollars!

25. Why patients will pay (Lindstrom) Cataract surgery market is growing Want to get rid of your glasses? 50% yes Want to pay additional fees? 50% yes Why is conversion low? Need better refractive outcomes: < 0.5 D astigmatism Need to get people off glasses!

26. How are we going to pay for? ( Lindstrom) Refractive surgery Want to get rid of glasses: How much: price similar to LASIK Doctors debate, patients decide He feels is viable

27. Why not cost effective ( Steve Safran) Not cost effective

28. It will not work? ( S. Safran) Not cost effective Concerns: waiting time for acutal removal of lens material: antigen sensitizing more CME second eye? Inability to cut through dense lenses An very expensive tool to do a simple task (capsulorhexis)

29. Who is not a candidate? Does not dilate past 6.5 mm Retinal and optic nerve disease: h/o AION Advanced glaucoma w/ VF loss Effects of IOP elevation during docking? Fuch’s/ corneal edema Not a problem if one can visualize iris detail AN ADVANTAGE with Fuch’s (easier capsulorhexis), reduction in endothelial cell loss

30. Relative contraindications Inability to dock: Corneal surface irreg, conjuntivochalasis, trabec bleb, unusual orbital anatomy (small, deep, excess retropulsion), agitated patients Poor dilation

31. Not So Good Candidates Small ( not large pterygia) ok <6.0 mm pupil Posterior synechia Subluxated lens Black cataracts (absorb the energy) Too small palpebral fissures IN SUM: applicable to most patients

32. Unmet need: Astigmatic correction Lasik has set a higher standard for Astigmatic correction 53% of patients > 0.75 D astigmatism ( warren Hill) Vast majority of surgeons feel this astigmatism should be corrected

33. IDEAL PROCEDURE FOR ASTIG CHEAP, REPRODUCIBLE, accurate easy to do LASIK: the best, but: a separate surgery TORIC IOL: staar vs. acrysoft Toric plus LRI? Effective Need perfect axis placement

34. femtoSECOND LRI Automated They are an art, unpredictable in younger patients,, need age-based nomogram Intra-operative aberrometer helpful femtosecond more accurate than manual Manual LRI are not as reproducible. femto LRI will allow for better studies and increase the reproducibility of the procedure

35. HOW I HAVE SET UP MY FLOW. STEPHEN LANE Where place the laser: Best outside OR Inside ASC firewall, not in the OR Right-size the room (10X10 space) Clean, not sterile room Took a pre-op bay to place the Laser Minor construction No transfer of patients from one bed to another

36. Who should operate the femto? (S. Safran) OD? No? surgery be done by surgeons OK technician assisted with MD present Must avoid delays between femto and phaco Recc two MD.s one for femto, one for phaco Dr. Lane: OD’s should be operators! Kentucky and Oklahoma allow use of lasers by OD’s Not really going inside the eye. (bladeless)

37. Who should operate the fempto? a technician (Dr UY) 5 reasons for a technician Computer controlled, automated Docking not as hard as phaco Imaging easy to operate Low risk, not as invasive Technician cheaper need back up Increase utilization of femto Medico-legal. Who is responsible

38. Ethical Considerations/ John Banja Lack of clinical freedom. If I want to use the femto because is clinically better but I don’t get paid, what to do? What if is indicated, you don’t do it, get into trouble and lawyer says why didn’t you? Once data available that clearly shows femto is better, should non-femto surgeons refer to femto surgeon?