OPHTHALMIC SURGEONS AND EXPERTS SHARE THEIR SECRETS OF SUCCESS IN THE ASC the MAY 2015 www.ophthalmologymanagement.com Ophthalmic ASC + Surgical Pearls PAGE 26 Femtosecond Lasers and the Correction of Astigmatism During Cataract Surgery PAGE 12 Retina Surgery PAGE 18 Is it Time to Add Another OR? PAGE 30 Here’s how one group reached a decision. PAGE 6 Cents and Sensibility: To Update, Renovate or Build a New OASC? An official publication of
Transcript
OPHTHALMIC SURGEONS AND EXPERTS SHARE THEIR SECRETS OF SUCCESS IN THE ASC
the
MAY 2015www.ophthalmologymanagement.com
OphthalmicASC
+Surgical PearlsPAGE 26
Femtosecond Lasers and the Correction of Astigmatism During Cataract SurgeryPAGE 12
Retina SurgeryPAGE 18
Is it Time to Add Another OR?PAGE 30
Here’s how one group reached a decision.PAGE 6
Cents and Sensibility:To Update, Renovate or Build a New OASC?
An official publication of
References: 1. Kempe CH. The use of antibacterial agents: summary of round table discussion. Pediatrics. 1955;15(2):221-230. 2. Kowalski RP. Is antibiotic resistance a problem in the treatment of ophthalmic infections? Expert Rev Ophthalmol. 2013;8(2):119-126. 3. Recchia FM, Busbee BG, Pearlman RB, Carvalho-Recchia CA, Ho AC. Changing trends in the microbiologic aspects of postcataract endophthalmitis. Arch Ophthalmol. 2005;123(3):341-346. 4. Freidlin J, Acharya N, Lietman TM, Cevallos V, Whitcher JP, Margolis TP. Spectrum of eye disease caused by methicillin-resistant Staphylococcus aureus. Am J Ophthalmol. 2007;144(2):313-315. 5. Hecht G. Ophthalmic preparations. In: Gennaro AR, ed. Remington: the Science and Practice of Pharmacy. 20th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2000. 6. Bacitracin Ophthalmic Ointment [package insert]. Minneapolis, MN: Perrigo Company; August 2013. 7. Data on file. Perrigo Company.
Please see adjacent page for full prescribing information.
The Quintessential
Bacitracin Ophthalmic Ointment is indicated for the treatment of superf cial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
Important Safety Information
The low incidence of allergenicity exhibited by Bacitracin means that adverse events are practically non-existent. If such reactions do occur, therapy should be discontinued.
Bacitracin Ophthalmic Ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic.
This product should not be used in patients with a history of hypersensitivity to Bacitracin.
Proven therapeutic utility in blepharitis, conjunctivitis, and other
superficial ocular infections● Profound bactericidal effect against gram-positive pathogens1
● Excellent, continued resistance profile—maintains susceptibility,2,3 even against
methicillin-resistant Staphylococcus aureus 4
● Ointment provides long-lasting ocular surface contact time and greater bioavailability5
● Anti-infective efficacy in a lubricating base6
● Unsurpassed safety profile—low incidence of adverse events6
● Convenient dosing—1 to 3 times daily6
● Tier 1 pharmacy benefit status—on most insurance plans7
www.perrigobacitracin.com
PERBAC002_JNL_AD_OphthalmicASC_R1.indd 1 1/9/15 9:27 AM
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Tableof ContentsT H E O P H T H A L M I C A S C | M AY 2 0 1 5
30
FEATURESCents and Sensibility: To Update, Renovate or Build a New OASC?Here’s how one group reached a decision.
Femtosecond Lasers and the Correction of Astigmatism During Cataract SurgeryImproved precision benefits doctors and patients.
Retina SurgeryFinding the Right Fit for Your ASC
Is it Time to Add Another OR?Five experts share the brick-and-mortar foundations of this complex decision.
Washington WatchASC Quality and Patient Safety — The New Regulatory Horizon
Surgical PearlsThe Telescope Implant May Benefit Your Advanced AMD Patient
Eye on OOSSConsider the OOSS Advantage
CodingLaser-assisted Surgery & Medicare Compliance
06
12
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Bacitracin OphthalmicOintment USPSTERILE Rx Only
0S400 RC J1 Rev 08-13 A
Manufactured For
Minneapolis, MN 55427
®
DESCRIPTION: Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
CLINICAL PHARMACOLOGY: The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram- negative organisms. It is ineffective against fungi.
INDICATIONS AND USAGE: For the treatment of superfcial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
CONTRAINDICATIONS: This product should not be used in patients with a history of hypersensitivity to Bacitracin.
PRECAUTIONS: Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.
ADVERSE REACTIONS: Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.
To report SUSPECTED ADVERSE REACTIONS, contact
Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION: The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
HOW SUPPLIED:
NDC 0574-4022-13 3 - 1 g sterile tamper evident tubes with ophthalmic tip.
NDC 0574-4022-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
3
On Dec. 7, 1854, as dean of the new fac-ulty of sciences at the University of Lille Nord de France, Louis Pasteur presented
an opening speech in which he said, “In the fields of observation, chance only favors the mind which is prepared.” Pasteur was speaking of Danish physicist Hans Christian Ørsted and the almost “fortuitous” way in which he discovered the basic principles of electromagnetism.
Last month at ASCRS, we had the opportunity to converse with and learn from a hero we can all relate to — Captain Chesley “Sully” Sullenberger. After all, every one of us imagines the unimagi-nable while putting our faith in another human being.
On Jan. 15, 2009, Captain Sullenberger shep-herded all the passengers on Flight 1549 to safety during a perfect water landing in the Hudson River in New York City. What could have been a tragedy of enormous proportions became instead a seemingly miraculous success and the stuff of legends. Underpinning that miracle were Captain Sullenberger’s years of disciplined training, prac-tice and study. He spent most of his life prepar-ing himself for that moment, knowing not when, where, how or even if it would come, only that he should be ready if it did.
In his book, Making a Difference, Captain Sullenberger reflects that Charles “Lucky Lindy”
Lindbergh was successful crossing the Atlantic Ocean consequent to his exceptional pilot prepa-ration. Lindy and Sully are the ultimate examples of chance favoring the prepared mind.
In this issue, we address topics that embrace the new — facilities in which we perform and serve our patients, technologies that improve the surgi-cal care we provide and procedures that extend our resources to more surgeons and the patients they serve, adding vibrancy and vitality, and enhancing the efficiency of our ophthalmic ASCs.
Inherent in our positive embrace of the new is an underlying faith and commitment to the very lessons taught by Pasteur so many years ago, and so courageously demonstrated by Captain Sullenberger — a philosophy and steadfast belief that judgment must go hand in glove with, and never be replaced by, the tools of our endeavors.
Standing on the shoulders of a prepared Pasteur and a diligent Ørsted, Captain Sullenberger reminds us of the virtues that stimulate our quest for surgical skill and successful outcomes and that resonate with our surgical intellect.
Indeed, chance favors the prepared mind.In the words of Captain Sullenberger, “One of
the greatest qualities a leader can have is a posi-tive outlook grounded in reality and rooted in competence.”
Thank you, Captain Sullenberger. n
150 Years (More or Less) Later
From the Editor
William J. Fishkind, MD, FACS, is Chief Medical Editor of The Ophthalmic ASC and past President of OOSS.He is Director of the Fishkind, Bakewell & Maltzman Eye Care and Surgery Center in Tucson, Ariz.
BY WILLIAM J. FISHKIND, MD, FACSCHIEF MEDICAL EDITOR
T H E O P H T H A L M I C A S C | M A Y 2 0 1 54
OUTCOMES THAT STAND THE TEST OF TIME.
Cataract surgery is an opportunity to give your patients vision for their life ahead. True to that,
Bausch + Lomb’s innovative technologies focus on long term vision that can help
you achieve outstanding outcomes and continued practice success.
LONG TERM VISION FOR YOUR PATIENTS FOR YOUR PRACTICE
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T H E O P H T H A L M I C A S C | M A Y 2 0 1 5
OASC | DEVELOPMENT
6
By Joseph F. Jalkiewicz, Contributing Editor
The key to future success is to deliver high-volume, cost-effective care with technologically advanced services. We have extreme space constraints in our current location, so we knew we had to expand. A new center will give us opportunities to net-work with physicians who are interested in using our center.”
“
— Jeffrey Whitman, MD, president and chief surgeon,
Key-Whitman Eye Center, Dallas, TX
If all goes according to schedule, by this time next year, Jeffrey Whitman, MD, and his team at Key-Whitman Eye Center in Dallas, Texas, will be operat-ing out of a new and much larger ophthalmic ASC in North Dallas.
“The key to future success is to deliver high-volume, cost-effective care with technologically advanced services,” says Dr. Whitman, president and chief surgeon at Key-Whitman. “We have extreme space constraints in our current location, so we knew we had to expand. A new center will give us opportunities to network with physicians who are interested in using our center.”
Currently located in the Uptown area of Dallas, Key-Whitman is one of the oldest OASCs in Texas, having been founded in 1984 by Charles Key, MD. Employing nearly a dozen staff members, including two registered nurses, two licensed vocational nurses, three scrub technicians and three ophthalmic assistants, Key-Whitman performs about 5,000 cataract-related and general ophthalmic surgical procedures each year, with revenue totaling about $5.5 million annually, says Executive Director Dan Chambers, MBA, COE.
“We’re known to offer high-technology procedures in a very efficient operation — often patients go from reception to discharge in about an hour,” says Mr. Chambers, noting that the ASC offers such procedures as intraocular lens implants and femtosecond laser-assisted surgeries.
Overcoming HurdlesBut, as Dr. Whitman made clear, the practice has been tough-ing it out through some significant growing pains in recent years, thanks to steadily climbing patient volumes and local
construction projects that have aggravated traffic congestion in the growing Uptown area.
“Parking has been a big issue — our patients would call us on the phone en route to the ASC telling us they were a block away and didn’t know if they could get here in time. Some had to walk to our ASC because the traffic was so bad with all the local construction. Even after we hired a valet service, we still had problems,” says Dr. Whitman.
“We also had to ask some surgeons to move cases to other ASCs because we couldn’t accommodate the volume,” Dr. Whitman adds.
The current center’s layout has posed particular challenges to Key-Whitman’s desires for expansion, agrees Associate Administrator Nikki Hurley, RN, MBA, COE.
“At the current location, the clinical and ASC space are located on the same floor, making it difficult to add outside
DEVELOPMENT | OASC
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 7
HERE’S HOW ONE GROUP REACHED A DECISION.
Cents and Sensibility: To Update, Renovate or Build a New OASC?
Figure 1. A computer rendering of Key-Whitman’s future waiting area.
T H E O P H T H A L M I C A S C | M A Y 2 0 1 58
OASC | DEVELOPMENT
physicians to the ASC,” Ms. Hurley says. “Their patients would have to enter the shared floor space.” In addi-tion, “we wanted better and increased space to add more equipment, create a more pleasing environment and pre-serve flexibility for future opportuni-ties,” she says.
The Commitment to GrowThe burgeoning patient base, com-bined with the looming 2016 expiration of their current lease, led the Key-Whitman team to begin exploring their options. By mid-2014, they had signed an agreement with a local developer to design and build their new ophthalmic office and OASC in North Dallas, and retained Eckert Wordell, a Michigan-based architectural firm, to assist in the ophthalmic planning, design and regu-latory compliance review.
At two stories tall and 35,000 square feet, the medical building will host a new OASC as well as an optical center, a LASIK center and a specialty eye clinic
and research center. The 12,500-square-foot OASC will include four operat-ing rooms, a separate femtosecond laser OR, an exam room and a YAG laser treatment room and will be more than twice the size of Key-Whitman’s current surgery center.
Decisions, DecisionsAt a total estimated cost of $3 mil-ion to $3.5 million, the project is not small by any measure. Why not just update, remodel or expand the current center? For Key-Whitman, the answer came down to two major issues: money and government regulation.
“The expense of renovation, down-time, clinic impact and risk factors of regulatory compliance could result in enormous out-of-pocket opportunity costs — in the millions of dollars,” says Dr. Whitman, noting that the estimated price tag of renovations could have exceeded $1.5 million. Not only that, but the practice likely would have been forced to reduce the size of the clinic to
meet state and federal building codes. Even then, Dr. Whitman says, “we feared we might not meet all compli-ance regulations due to the building limitations, even with a renovation.”
It was a realistic fear, says Jeffery S. Eckert, AIA, senior principal of Eckert Wordell. In considering updating, re-modeling or expanding an existing facility, Mr. Eckert says the first order of business is to determine the feasibil-ity of meeting current codes and stan-dards.
“Whether you’re updating, remodel-ing or expanding your facility, comply-ing with the Life Safety CMS rules is required for continued licensure com-pliance,” Mr. Eckert says. While minor cosmetic updates (e.g., new finishes) won’t trigger the need for regulatory review and approval, major changes such as increasing the number of ORs and/or enlarging an ASC will.
Compliance Issues“In the case of the Key-Whitman
Figure 2. An architectural drawing of the ASC’s entry level.
project, the regulatory requirements for a four-OR facility wouldn’t have been possible given the footprint of the existing facility, even if they vacated the clinic space for the ASC expansion,” Eckert says.
Stephen C. Sheppard, managing principal for real estate and operations at Medical Consulting Group, LLC, in Springfield, Mo., agrees and notes that regulatory mandates have grown in recent years, leading to more compli-cated and expensive growing pains for OASCs. “Over the last 15 years, the reg-ulatory requirements for ASC physical plants have changed enormously,” says Mr. Sheppard, who is working as a con-sultant on the project. “In 1999-2000, I worked on small, one-OR ophthal-mic ASCs and we could meet all of the requirements in 1,800 to 2,000 square feet. For that same center today, we ini-tially budget 3,500 square feet.”
“It’s very expensive to build a new reg-ulatory-compliant ASC,” Mr. Chambers says. “The expense has escalated in the past 5 years with all the new regulatory
demands, infection control require-ments, backup systems, and so on.”
Benefits In addition to these practical finan-cial and regulatory reasons, Key-Whitman cited expected benefits, such as increased patient capacity, operat-ing profits, flexibility and return on investment, as reasons for choosing new construction over staying put and attempting to renovate.
“Changes in technology continue at a rapid rate and it makes sense to create as much flexibility in the physical plant as you can,” Mr. Sheppard says. “Even 3 years ago there were questions about the market penetration of femtosecond laser-assisted cataract surgery. That’s no longer the case. New ASCs need to incorporate space for a femto laser. It’s usually sub-optimal to place the laser in an OR, since it impedes the flow.”
“The cost of the new facility will be more [than renovating], but the return on the investment at the end of a 5-year term would favor a new facil-
ity at higher volumes, which is what we expect with the baby boomer growth for eye care,” Dr. Whitman says. “We can increase our capacity, double our size, add revenue and operating profits in a new, highly compliant, state-of-the-art facility with the latest ophthal-mic surgical equipment.
“And more importantly,” he adds, “[building new] offers an opportunity to add new physician equity partners to our organization.”
Indeed, Key-Whitman’s new facil-ity will be paid for through a combina-tion of equity contributions from new partners, tenant allowances and debt financing, Mr. Chambers says. The new facility is slated to open its doors in February 2016.
“We already have some potential partners who want to move into our location and there is no way we could have accommodated them in our exist-ing ASC space,” he says. “We expect to have strong utilization for three ORs by the middle of our first year, and good utilization by the end of year 2.” n
DEVELOPMENT | OASC
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 9
Figure 3. An architectural drawing of the upper level clinic and office space.
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5
OASC | DEVELOPMENT
10
REMODEL? EXPAND? BUILD?HOW TO CHOOSE WHEN YOU’RE
AT A CROSSROADS
▲
Key-Whitman effectively had no other option than to build a new facility to balance regulatory mandates with its desire to grow. This isn’t always the case for OASCs, so careful analysis is important to determine the best
course of action. Here are some guidelines to follow when you’re at the crossroads.
Update when you’re looking to make mostly cosmetic or slight modifications. “But be very careful with the size of your update, as it can trigger a major intervention by state and federal regulatory bodies,” says Jeffrey Whitman, MD.
Also consider the size of your market, adds Stephen Sheppard. “Can you attract additional surgeons to increase utilization of the facility? Key-Whitman can in Dallas, and the community itself is growing rapidly. But in a town of 100,000, those opportuni-ties may not be available, so renovations to update cosmet-ics and technology are often a better option than expansion.”
Utilization is also important to consider, Mr. Sheppard says, by centers that primarily focus on anterior segment procedures, heavily weighted by cataract procedures. “I work with a group of cataract surgeons who are performing more than 3,500 procedures annually out of one OR and it is dark on Friday. They have a significant share of their market. Thus, there’s no need to substantially expand their physical plant,” he says.
Remodel when you have 5-plus years remaining on your lease and a run-down facility with no added volume projected, says Dr. Whitman. “Many state and federal guidelines require complete and major updates, which can be more difficult to undertake than moving to a newer facility,” he says.
“Control of the space is criti-cal,” agrees Mr. Sheppard. “If you lose control of the space via expiration of your lease, you’re essentially starting over with the licensure and Medicare certification process, and you’ll have to construct the space to 2015 standards. I wouldn’t undertake a major remodel with less than 10 years worth of control of the space – and I’d like a renewal option or two to extend that.”
Also consider your physicians’ exit strategy, Mr. Sheppard says. “If the surgeons are retiring and want to realize the ‘fair value’ of their investment in the ASC, but the lease only has 2 years left, they’ll be faced with a material discount in the expected sales price. Successor surgeons are buying a future income stream, which isn’t worth much if it’s going away in 2 years.”
Expand when you’re confi-dent you can obtain increased patient volumes and are able to add physician partners to mitigate financial risks and increase valuation.
“The critical element is increas-ing surgical volume,” says Mr. Sheppard. “There are only two ways to fail in the develop-ment of an ASC: 1. Overbuild it so that it can’t carry the debt service or 2. Overestimate future surgical volume. If you haven’t ‘locked in’ the future volume growth via selling interests to additional doctors, a costly expansion is risky. In my experience, typically 85 percent-plus of the surgical volume originates from owner-surgeons or their employees. It’s unrealistic to anticipate that a non-owner surgeon will deliver substantial volume over an extended period of time. An ownership opportunity will open up in a competing facility, and that volume will move.”
Build when your facility and practice are 25-plus years old and the infrastruc-ture of your ASC can no longer handle the physical demands of future regulatory compliance.
“When the facility is no longer efficient and/or com-petitive in your marketplace, is out of compliance, and/or you’re about to lose control of the space, it’s time to move,” says Mr. Sheppard.
In addition, “there are many more “dynamic” consider-ations relating to changing technology, demographic shifts in your market, and other factors.
“OASCs have to balance three resource groups: sur-geon OR hours demanded, staff labor hours and the throughput capacity of the physical plant,” states Mr. Sheppard. “Surgeon OR hours demanded and physical plant throughput are typically hard to change rapidly. Additionally, one of those two items frequently drives staff labor hours.”
EDITORIAL BOARDCHIEF MEDICAL EDITOR
William J. Fishkind, MD, FACS
MEDICAL SPECIALTY EDITORS
Frank Cotter, MDPravin Dugel, MD
Victor Gonzalez, MDRichard Hoffman, MD
Stephen H. Johnson, MDCathleen McCabe, MDJay Pepose, MD, PhDMaria C. Scott, MD
R. Bruce Wallace, III, MD, FACSRobert J. Weinstock, MD
ASC OWNERSHIP &ADMINISTRATION EDITORS
John Blanck, CPAGlenn A. deBrueys
John R. Grant, MHA, MBAStephanie J. Harvey, MBA
Robert B. Nelson, PA-CLouis I. Sheffler, MHA
ASC SPECIALTY EXPERTS
Regina Boore, RN, BSN, MSKevin J. Corcoran, COE, CPC, CPMA, FNAO
Jeffery S. Eckert, AIA, MAMichael A. Romansky, JD
Stephen C. Sheppard, CPA, COEMaureen Waddle, MBA
OphthalmicASCthe
EDITORIAL STAFF
DIRECTOR, SPECIAL PROJECTS: Angela JacksonMANAGER, SPECIAL PROJECTS: Leslie Goldberg
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Copyright 2015, PentaVision LLC. All Rights Reserved.
An officialpublication of
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T H E O P H T H A L M I C A S C | M A Y 2 0 1 512
Cataract surgery, currently the most fre-quently performed ophthalmic proce-dure in the U.S. and around the world, is projected to become still more common as the population ages.1 Also increas-
ingly common will be the desire on the part of patients to have longstanding visual problems, such as astigmatism, addressed at the time of
cataract surgery. Many patients will choose to pursue refractive procedures even though Medicare and most forms of private insurance don’t cover their costs.
More recently, femtosecond lasers, which a growing number of experts believe can improve safety, accuracy and clinical outcomes associated with cataract surgery, have brought
O A S C | S U R G E RY
Improved precision benefits doctors and patients.
Femtosecond Lasers and the Correction of Astigmatism During Cataract Surgery
By Susan Worley, Contributing Editor
Figure 1. Real-time OCT imaging assists surgeons in creating incisions with extreme precision.
FIG
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OV
IDED
BY
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DEV
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MD
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 13
with them additional financial and clinical considerations. Here we exam-ine femtosecond technology, including its use to correct astigmatism during cataract surgery, and some challenges associated with incorporating the use of these lasers in clinical practice. This article assumes that decisions to use this technology must be made jointly by patients and clinicians, after careful discussion of all relevant financial and clinical considerations.
The Arrival of Femtosecond LasersThe use of femtosecond lasers for cataract surgery emerged far more recently than many patients and other non-clinicians believe. While this technology was first introduced in 2001, it was initially approved only as a technique for creating lamellar flaps during LASIK surgery. It wasn’t until 2009 that the U.S. FDA approved the use of the first femtosecond laser for capsulorhexis, lens fragmentation or liquefaction, and corneal and arcuate incisions. Since that time, three other femto lasers have become available in the U.S. (Table 1)
As various indications for these instruments were approved in stages, many ophthalmic surgeons who were initially impressed by femtosecond laser capabilities during LASIK surgery were eager to try the technology for new indications. Enthusiasm over this technology continues to grow, although it’s estimated that fewer than 10% of all cataract surgeries today are performed with femtosecond lasers, and that fewer than 20% of all U.S. cataract surgeons have regular access to these lasers.
“Since femtosecond lasers were first introduced for flap creation during LASIK,” says Cathleen M.
McCabe, MD, of The Eye Associates in Bradenton, Fla., “the technology has steadily improved. These machines are faster and much more precise than they were originally. But even back in 2001, when I first observed a femtosec-ond laser being used for flap creation, I remember being impressed. I remem-ber thinking that this was a very elegant and precise way of cleaving tissue plains in the cornea.”
Douglas D. Koch, MD, professor of ophthalmology at the Cullen Eye Institute, Baylor College of Medicine in Houston says that he also initially used the femtosecond laser to make flaps during LASIK procedures.
“It took about 3 or 4 months before
I realized how superior the use of the laser was in terms of predictability and safety,” says Dr. Koch. “Within 6 months, we actually abandoned use of the steel microkeratome, and stopped offering it as an option, except in very rare situa-tions when femto wasn’t an option.”
Over time, as the FDA further vali-dated the safety and efficacy of femto-second laser use for a broader range of applications, Dr. Koch was among the many cataract surgeons who were encouraged to try the machine for new procedures.
“When this technology was brought into the realm of cataract surgery, I was excited,” Dr. Koch says, “because I was already familiar with the many poten-
S U R G E RY | OASC
Table 1. Femtosecond laser platforms available in the U.S.The four different laser platforms available in the U.S. vary with regard to several features. Perhaps most notable are differences in patient-interface systems, which may be fluid or constitute a disposable curved contact interface. Femtosecond laser imaging also varies, with platforms using either spectral-domain OCT or 3D confocal structural illumination. All femtosecond lasers have been credited with helping to provide consistent and customizable surgical results for all phases of nuclear fragmentation and for corneal and arcuate incisions, as well as for capsulorhexis.
The LENSAR Laser System (Lensar)
The CATALYS Precision Laser System (AMO)
The VICTUS Laser system
(Bausch + Lomb)
The LenSx Laser system (Alcon)
The LENSAR Laser System has been cleared by the FDA for anterior capsulotomy, lens fragmentation, and corneal and arcuate incisions.
The system has received recent ap-proval of five appli-cation upgrades that permit automation and customization of essential steps of the refractive cataract surgery procedure.
The CATALYS Preci-sion Laser System is indicated for use in patients undergo-ing cataract surgery for removal of the crystalline lens. It is FDA Cleared and CE Marked for:• Capsulotomy• Lens fragmentation• Corneal arcuate
incisions• Primary and side-
port incisions
The VICTUS femtosecond laser combines cataract and corneal applications in a single platform.
VICTUS enables surgeons to perform capsulotomies, fragmentation, arcu-ate incisions, corneal incisions, and LASIK flaps.
Recent additions include an advanced swept source OCT imaging system and updated software.
The LenSx Laser provides a one-piece patient interface, OCT technology, pro-cedure automation and customizable incision architecture for:• Capsulotomies • Primary, second-
ary and arcuate incisions
• Versatile fragmen-tation patterns
tial benefits of the laser, and I believed the key factor that was going to make the laser work for cataract surgery was going to be the imaging. Imaging isn’t a major issue when femtosecond lasers are used for LASIK, but it’s a critical fac-tor for cataract surgery. It’s necessary to have a 3-D model of the cornea and the anterior segment of the eye to perform surgeries safely. That is where the man-ufacturers have done such an amazing job in bringing us this technology for cataract surgery — in melding the pre-cision of the femtosecond laser with the superb imaging capabilities of OCT, or confocal microscopy.”
Greater Confidence During Planning While experienced cataract surgeons may be exceptionally proficient when planning the steps for manual cataract surgery, femtosecond lasers provide surgeons with a greater degree of confidence that their surgical plan will be executed with precision.
“When you make a plan for a surgi-cal procedure with a femtosecond laser, you’re absolutely sure that the laser is going to do what you want it to do,” says Dr. McCabe. “For example, during the capsulorhexis step, we typically strive to make the opening very consistent in size and shape, as close as possible to an absolute circle, and with precise centra-tion.”
As cataract surgeons have learned from Warren Hill, MD, says Dr. McCabe, the effective lens position — where the intraocular lens implant ultimately sits in the eye —is affected by the size, centration and circularity of the capsulorhexis.
“If a surgeon chooses to make the opening 5.0 mm, which happens to be what I choose, this can be done with
absolute precision and certainty using a femtosecond laser. If I attempt to do this manually, I’m limited by just how precise my estimation of 5.0 mm is, and I can get very close to creating a circle, but the difference is between trying to draw a circle versus allowing a com-puter to accomplish it.”
To further assist surgeons in pre-operative planning, software programs — either integrated or available in optional, product-specific equipment — enable input of high-resolution digi-tal images of the eye, kerotometry and other biometry. This information in turn allows surgeons to carefully plan LRIs and other astigmatism correc-tions, and make real-time adjustments, such as changes in the location of inci-sions, during surgery.
“My laser allows me to program my personal preferences for arcuate inci-sions, the specific patient’s anatomical dimensions, and other diagnostic data into the laser treatment plan, which then helps me tailor an efficient proce-dure to the patient, to support achiev-ing the best possible visual outcomes,” says Mitchell A. Jackson, MD, founder and CEO, Jacksoneye, Lake Villa, Ill.
Addressing Astigmatism With the LaserAs with manual procedures, each surgeon tends to adopt a unique approach to addressing astigmatism with the femtosecond laser.
“In general,” says Uday Devgan, MD, private practice at Devgan Eye Surgery, chief of ophthalmology at the Olive View UCLA Medical Center and clini-cal professor of ophthalmology at the UCLA School of Medicine, “I believe that the femtosecond laser is best for treatment of 0.75 to 1.5 diopters of astigmatism only. More than 1.5 diop-ters of astigmatism is best treated with a toric lens implant, and toric IOLs are available to treat up to 4 diopters. Even with lower amounts of astigmatism, the toric IOLs tend to provide better results than the femtosecond laser.”
In some cases, experts opt to make incisions in lieu of using toric lenses, because the latter can be considerably more expensive than arcuate cuts. On other occasions, rather than deciding between the use of the laser and the use of a toric lens, some experts employ a combination of techniques, using the femtosecond laser to fine-tune results. Regardless of personal preferences, surgeons generally agree that incisions made with femtosecond lasers are more accurate.
“When I use femtosecond lasers I can be very accurate about two things: the length of each incision and the depth of each incision,” says Jeffrey Whitman, MD, of the Key-Whitman Eye Center in Dallas, Texas. “If you program X num-ber of millimeters or degrees, the com-puter will do exactly what you program it to do, and it will perform it again and
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“It took about 3 or 4 months before I realized how superior the use of the laser was
in terms of predictability and safety, and within 6 months, we actually abandoned use of the
steel microkeratome, and stopped offering it as an option, except in very rare situations when
OMIDRIA™ (phenylephrine and ketorolac injection) 1% / 0.3% is
the fi rst and only FDA-approved treatment that both1:
Preemptively inhibits intraoperative miosis
Decreases postoperative ocular pain for 10 to 12 hours
again. It’s also a great advantage to be able to use the OCT to look at the thick-ness of the cornea where you are mak-ing an incision. There are many debates about manual limbal relaxing incisions, and some surgeons won’t perform them because they assume that they won’t last. What many of us involved in radial keratometry realized years ago is that these incisions have to be deep. So you need to know what the depth of the lim-
bal area is where you are going to make your incisions.”
Whitman says that guessing can cre-ate problems.
“If you make a 600-micron inci-sion,” says Whitman, “and the depth is 850 microns, your incision won’t be very deep. On the other hand, if the depth is 550 microns, and you make a 600-micron incision, you’re going to have a hole in the eye, and you’re going to have to suture it. My femto-second laser will give me the thickness at the middle part of my incision, and I can have it calculate 80% of that, so I can make my incisions deep, and I can know that I won’t have a perfora-tion. I also know my incisions are deep enough that they can be expected to last. With manual incisions, we never had this capability. Many people make very shallow incisions and this doesn’t result in a long-lasting effect. With my femtosecond laser, I have more predict-ability and precision when I make inci-sions than I ever had before.”
Dr. Koch notes that although a good peer-reviewed study comparing
manual blade incisions to those made by femtosecond laser has yet to be pub-lished, he believes there is a benefit to performing corneal relaxing incisions with the laser. He adds that in his own practice he uses the laser for astigma-tism correction in three different ways.
“For some patients who require relatively low astigmatic corrections, I actually perform intrastromal relaxing incisions, which never penetrate the
surface,” says Dr. Koch. “Patients have absolutely no discomfort, and there is no risk of dry eyes; it’s a wonder-ful approach. A second approach is to program the laser to make penetrating incisions, and then I determine whether to open these, either by using wave-front aberrometry intraoperatively, or by checking the patient postoperatively. If the patient, either on the operating room table or postoperatively, is under-corrected, then I can open the femto-second laser incision to get a better benefit. That’s something I’ve just been exploring and liking.”
“A third way I use the laser is to make tiny little marks in the cornea — align-ment marks for the toric IOL. I’ll make these toric marks at the intended merid-ian, and then I’ll use a device that makes a topography image, and with that, cal-culate the site of the lens implant, and in so doing, we can put the implant exactly where I plan it. I then look at the femto marks and I can compare them. They provide a marker that I can use postop-eratively to check lens stability, and cor-roborate that the lens actually ended up
where I expected it to.”
Patient SelectionSome cataract surgeons who use the femtosecond laser are unlikely to aban-don the use of manual techniques entirely. Even some laser enthusiasts continue to perform certain cataract procedures manually. For example, some surgeons prefer not to make entry incisions with the laser, because they find these openings difficult to make or difficult to enter. Moreover, all sur-geons continue to encounter patient situations in which they’ll choose not to use a laser at all.
“In every practice, there are some patients who for one reason or another are not good candidates for femtosec-ond laser,” says Dr. McCabe. “Use of the laser is always an out-of-pocket expense, for one thing, and some patients just can’t afford to pay the additional fees. In addition, traditional cataract surgery is sometimes the better choice when, for example, the anatomy of a patient’s eye or lack of cooperation on the part of the patient prohibits cou-pling of the eye to the laser. A patient who can’t lay prone won’t be able to fit underneath a laser. And of course, there are some well-known contraindications to the use of a laser, and to the use of incisions to correct astigmatism.”
An excellent review of femtosecond lasers by Zoltan Nagy, MD, published in Clinical Ophthalmology in 2014, pro-vides an overview of contraindications to use of the laser, with an emphasis on the small non-dilating pupil, as well as approaches to challenging surgical cases.
Dr. Devgan notes that for some cases of irregular astigmatism, incisional approaches should be avoided, whether with laser or with manual techniques.
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“You need the volume to support acquiring a femtosecond laser. An ASC should have about 1000
surgical cases per month to support a new laser.”— Albert Castillo, OOSS Membership Development Servicess
C O N T I N U E D O N PA G E 2 5
Au
tom
ati
on
“Value and cost are important components of the quality of medical care. The
TRS Refraction System meets all the utility criteria of advanced technology; the
task of refraction is done more effciently and accurately, while at the same time
decreasing cost–my costs. And, I daresay, it makes refracting fun again.”
J.C. Noreika, MD | Medina, OH
EFFICIENCY
Designed and Manufactured by NIDEK - Represented by Marco • 800.874.5274 • marco.com
400 Auto Noreika-MD-OASC.indd 1 4/22/15 5:11 PM
Au
tom
ati
on
“Value and cost are important components of the quality of medical care. The
TRS Refraction System meets all the utility criteria of advanced technology; the
task of refraction is done more effciently and accurately, while at the same time
decreasing cost–my costs. And, I daresay, it makes refracting fun again.”
J.C. Noreika, MD | Medina, OH
EFFICIENCY
Designed and Manufactured by NIDEK - Represented by Marco • 800.874.5274 • marco.com
400 Auto Noreika-MD-OASC.indd 1 4/22/15 5:11 PM
T H E O P H T H A L M I C A S C | M A Y 2 0 1 518
Should you bring a retina surgeon into your ASC?
If you’re a vitreoretinal subspecial-ist, should you move your surgery to an ASC?
Experts on both the facility and the surgeon side agree that technology and technique have evolved to where it’s feasible to provide quality, efficient retina surgery in an ASC.
“Vitreoretinal surgery has a long history of being a hospital-based, and often an inpatient, procedure. But technology and training have changed and moving retinal surgery to the ASC is a natural evolution, not a radical shift,” says Pravin U. Dugel, MD, managing partner of Retinal Consultants of Arizona, Clinical Professor of USC Eye Institute and a found-ing partner of Spectra Eye Institute. Dr. Dugel,
who has performed most of his retina surgery in ASCs since the 1990s and is co-owner of his own facility, believes ASC operators and retina specialists should explore working together — but doing so is not a foregone conclusion. He believes operating in a well run ASC offers advantages in quality, cost and patient experi-ence, but warns that the wrong ASC relation-ship can threaten the referrals that are the lifeblood of a retina practice. For example, a retina surgeon who joins a primarily general ophthalmologist-owned ASC may risk losing referrals from the center’s general ophthalmol-ogy competitors.
“In a consulting practice, it’s always impor-tant to keep in mind that referrals are your first priority,” Dr. Dugel says. (See The Retina Surgeon’s Perspective.)
O A S C | R E T I N A
By James Knaub, Contributing Editor
Finding the right fit for your ASC.
Retina Surgery
R E T I N A | OASC
While the retina surgeon must care-fully assess referral relationships before joining an ASC, the facility’s chief con-cerns are the economics of adding retina surgery and finding an efficient, com-patible surgeon. From the economic perspective, adding retina surgery starts with the idea that most ASCs are sig-nificantly underutilized, says Stephen C. Sheppard, CPA, COE, the managing principal of Medical Consulting Group. When you consider the time physicians are out of the office for vacation and conferences, plus the cases that could be added through improved efficiency, Mr. Sheppard says most ASCs have the capacity to add a significant number of cases.
“It’s rare to find an ASC with a utilization rate above 55% or 60%,” Mr. Sheppard says. “Most have much more available capacity than they think they have.” Filling one-half of that typi-cally available capacity could translate to a 50% boost in volume or revenue, depending on a facility’s case and payor mix.
While posterior segment proce-dures generally require more time, their facility fee reimbursement is higher. Mr. Sheppard says the national aver-age facility fee that covers about 80% of the common retina CPT codes is $1,680, compared to $945 for cataract surgery. That means two retina proce-dures can generate the same facility fee reimbursement as 3.5 cataract cases. Retina patients also tend to be younger than cataract patients and more likely to have commercial insurance that reim-burses better than Medicare, according to Mr. Sheppard. Those factors need to be considered in business plan revenue projections.
Offering retina surgery also adds significant costs. Mr. Sheppard says it
can easily cost $200,000 to $300,000 to add the service to an ASC — including a vitrector with a 532 nm laser, instru-ments, surgical trays, cryo equipment and an operating microscope with an indirect view system and image capture. He notes that if an ASC already owns upgradeable surgical microscopes, it may be able to reduce that cost by $70,000 to $90,000 by only adding an image capture system rather than pur-chasing a new microscope.
Start-up costs are also affected by whether the ASC already has a Class
C operating room and whether or not it will provide general anesthesia. Mr. Sheppard says that bringing in a retina surgeon who will utilize general anesthesia helps an ASC support its anesthesia staff.
Consumable supplies are another considerable cost consideration Mr. Sheppard says vitrectomy case packs typically cost $325 to $600 per case and silicone oil and perflurocar-bon liquid are in that same price range. Finding an efficient surgeon who stays
The Retina Surgeon’s PerspectiveAlways Remember, You’re a Referral-based Subspecialist
Facility reimbursement rates, supply costs and the opportunity to provide efficient
quality care are all components of a retina surgeon’s decision whether to operate
in an ASC, but one factor a consulting physician cannot overlook is his or her
local competitive environment.
“If you partner with a general ophthalmologist’s ASC, that center’s competitors might
not refer to you,” warns Pravin U. Dugel, MD. “You have to consider referrals as a top
priority.”
A retina subspecialist whose practice depends on referrals must evaluate the local
healthcare marketplace differently than a general ophthalmologist. In a highly competi-
tive location, Dr. Dugel says adding the traditional anticipated benefits of operating in
an ASC environment may not be worth the risk of losing referrals from area general
ophthalmologists. But Dr. Dugel also stresses that each local situation must be evalu-
ated individually. An arrangement that might alienate referrals in a saturated, competi-
tive region, might not pose any problems in a less-crowded area.
Another issue retina surgeons need to work out with an ASC is whether they will pur-
sue an ownership interest in the facility or simply maintain privileges to operate there.
A surgeon’s anticipated case volume and the ASC’s available capacity affect whether
a retina surgeon’s investment makes sense—as well as whether the facility wants to
partner with the surgeon or just offer privileges. Dr. Dugel says a retina surgeon must
do the appropriate due diligence to evaluate each specific situation, but the right
arrangement can provide both top-notch care and an excellent investment.
“In a well-run ASC, retina surgery can be a win, win, win situation — for the patient,
the surgeon and the facility,” Dr. Dugel concludes.
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C O N T I N U E D O N PA G E 2 1
T H E O P H T H A L M I C A S C | M A Y 2 0 1 520
Cataract surgery is one
of the safest surger-
ies performed with one
of the highest rates of
patient satisfaction, but as with any
surgery, complications are possible.
The anterior capsulotomy can influ-
ence the rate of complications and
the resultant refractive outcomes.
Femtosecond lasers have only recently
been approved for use in cataract
surgery, and studies are beginning to
show outcomes are at least as suc-
cessful as those that can be accom-
plished with manual techniques. With
newer software versions being intro-
duced, there is emerging evidence
of better wound architecture, with
greater precision and accuracy of the
anterior capsulotomy.
Like any new device, there is a
learning curve, and complications
will occur, says Ronald Yeoh,Medical
Director, Founding Partner & Senior
Consultant Ophthalmic Surgeon at
Eye & Retina Surgeons, Camden
Medical Centre, Singapore. As
surgeons begin to adopt this
technology, some complications
unique to femtosecond are also being
noted. In Singapore, patients or their
health insurance pays for the femto-
second component.
Dr. Yeoh has been using the
femtosecond laser in cataract surgery
for the past 3 years, and has used
the Catalys (Abbott Medical Optics),
LenSx (Alcon) and Victus (Bausch +
Lomb) platforms. Currently, about
30% of his patients opt for
femtosecond laser surgery.
Femtosecond Laser ComplicationsDuring one of his earlier surgeries,
there was no indication of anything
unusual, he says. “This was a 65-year-
old male, with good dilation, a normal
retina and a straightforward NS2+
cataract. I fully expected a straightfor-
ward, routine surgery,” he says.
During the phaco portions of the
surgery, Dr. Yeoh inadvertently aspi-
rated an unseen capsulorhexis tag,
“leading to a large torn crescent of
anterior capsular rim being aspirated
and an unusual circumferential (rather
than radial) extension.”
Critical to the management of
this unnoticed capsular tag “was
early awareness that the torn anterior
capsular rim had been aspirated. The
aspirated capsule was freed from the
aspiration port of the I/A cannula, the
rest of the I/A of cortex was carefully
completed and then the crescent of
torn capsule removed to round off the
continuous curvilinear capsulorhexis
(CCC). A single-piece IOL was success-
fully implanted in the bag,” says
Dr. Yeoh.
Managing Femtosecond Laser Cataract Complications
BY MICHELLE DALTON, ELS, CONTRIBUTING EDITOR
COMPLICATED CASES
Learning curves are to be expected — but with proper preparation, complications can be easily managed.
A tear in the anterior capsular rim (see arrow) can lead to unintentional aspiration.
R E T I N A | OASC
current on technique is important to the ASC because he or she will tend to use silicone oil and perflurocarbon liquid in fewer cases.
“Efficient surgeons should be using silicone oil and perflu-rocarbon in 5% to 15% of cases,” Mr. Sheppard says. “If they’re using them in 50% of cases, they probably shouldn’t be oper-ating in your ASC.”
He says finding an efficient, compatible surgeon is the best indicator for success in an ASC arrangement. He notes that surgeon efficiency is more important in an ASC because it receives only about 56% of the facility fee that hospitals receive per procedure for a Medicare case. The difference between 60 minutes per case and 2 hours per case is signifi-cant over time.
Dr. Dugel agrees with the need for efficiency. “Both the surgeon and the ASC have to be totally committed to efficient, quality care,” he says. Efficiency is more important than high volume. You don’t need to perform 15 or 20 cases a week for a move to an ASC to make sense; Dr. Dugel says five or six cases handled efficiently can work.
Dr. Dugel operates in his ophthalmology-only ASC, which
also performs cataract, glaucoma and oculoplastic proce-dures. The center doesn’t offer general anesthesia, but he says the ASC can still handle 100% of his adult retina cases.
Patients also benefit economically having their surgery done in an ASC. As the Affordable Care Act and other health-care reform increases deductibles and copays, out-of-pocket costs are less than in a hospital because of the ASC’s lower facility fees. Mr. Sheppard says those lower costs attract increasingly cost-conscious patients, who also tend to prefer the ASC environment over the hospital experience.
Moving retina surgery to an ASC is not just an economic decision. Like their anterior segment colleagues, retina sur-geons are likely to prefer the ASC operating experience. Mr. Sheppard points out that ASCs operating schedules are more predictable and cases don’t get bumped by trauma cases as often happens in a hospital.
“A specialized ASC offers a consistent, team-oriented envi-ronment that supports quality,” Mr. Sheppard says. “Surgeons work with the same team every week. In larger hospitals, that’s not necessarily the case. The ASC gives surgeons the opportu-nity to provide the kind of care they want for their patients.” n
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 21
R E T I N A S U R G E R Y C O N T I N U E D F R O M PA G E 1 9
In this case, the outcome was
excellent (final visual acuity of 20/25
unaided), and the patient was satisfied.
Advice and Pearls for SurgeonsDr. Yeoh offers several pearls for
surgeons who might run across an
incomplete capsulotomy.
1. First, examine the femtosecond
laser CCC carefully before begin-
ning the phaco step. Typically,
whether the CCC is complete or
incomplete can be ascertained by
visual inspection.
2. Where there are uncut areas of
the capsule, great care has to be
exercised when performing phaco
and I/A. Certainly, the aspiration
port of the I/A cannula should be
positioned beyond the edge of the
femtosecond laser CCC to avoid
inadvertently snagging an uncut
tag, as happened in this case.
3. For those new to the technology,
recognizing that the femtosecond
laser CCC is suboptimal requires
that the phaco procedure is done
using lower parameters i.e., sur-
geons should use lower and safer
flow and vacuum settings than nor-
mal in doing ‘slow motion’ phaco.
(Dr. Yeoh learned this from Robert
Osher, MD.)
4. Finally, the posterior extension of
an anterior radial or circumferential
tear is unlikely if the above points
are heeded.
Today’s TechnologiesDr. Yeoh says today’s iterations of the
femtosecond laser are much more
advanced than the first generation
devices, and the rate of an incomplete
capsulotomy is “well under 5%,” says
Dr. Yeoh. (With earlier versions, tags
and bridges occurred in as many as
20% of eyes.) He is quick to point out
this particular complication happened
during his own learning curve, and
he hasn’t had another instance of an
incomplete CCC in years.
“This complication happened in
the early femtosecond laser cataract
surgery days and today, the newest
generation femtosecond lasers give
almost perfect CCCs every time,” he
says. He added that some devices
may create the capsulotomy in as little
as 1.5 seconds, which significantly
decreases the potential for an incom-
plete capsulotomy.
The more experience a surgeon has
with the femtosecond laser, the less
likely complications will occur, Dr. Yeoh
concludes. n
COMPLICATED CASES
T H E O P H T H A L M I C A S C | M A Y 2 0 1 522
In the last issue of the Ophthalmic ASC, we focused
on ASC payment issues. In this article, we turn to the
expanding array of government endeavors to ensure
that patients are afforded high-quality care in the
outpatient surgical environment.
The ASC industry has an exemplary record of provid-
ing surgical services in a cost-effective, patient-centered
and accessible way. Infection and complication rates are
infinitesimally low. Patient satisfaction rates are astronomi-
cally high. Yet there is little data to corroborate what ASCs
and ophthalmologists know to be a reality — that the care
provided in the ASC is of optimal quality, equal to or higher
than that of the hospital. And in the absence of such data,
our facilities can find themselves subject to burdensome
and unnecessary regulation that can be costly, stifling
innovation and actually impeding the delivery of quality
care to patients. In this issue, I’ll explore two important and
contemporary issues – Medicare ASC quality reporting and
ophthalmic ASC sterilization policy.
Quality Reporting in the ASC – the Good, the Bad, and the UglyThe Beginning A half-decade ago, CMS proposed its first ASC measure.
It was cataract specific, and it was a doozy. Developed by
a CMS contractor with nary the input of an ophthalmolo-
gist, the measure would have required hospital outpatient
departments and, ultimately, ASCs, to determine whether
a patient scheduled for cataract surgery would achieve
a 20% improvement in vision, and, if not, disallow the
procedure. This measure, of course, had little to do with
quality; rather it was a bold and crude attempt to reduce
cataract surgery utilization and assign to the ASC the role
of enforcer. Upon vociferous objection by OOSS, AAO and
ASCRS, the measure was quickly withdrawn, but some of
the more recently proposed quality measures, while less
clumsy, incorporate similar flaws.
In 2012, CMS launched the ASC Quality Reporting
Program in earnest. Most of the measures adopted were
developed by the ASC Quality Collaboration (on whose
Board of Directors OOSS sits) and endorsed by the National
Quality Forum. They included: wrong site, patient, proce-
dure, implant; hospital transfer; and patient burns and falls.
While it could be debated whether these measures provide
useful information to consumers, the ASC industry is doing
its part — a remarkable 98+ percent of ASCs are in compli-
ance with reporting requirements!
Ophthalmology-specific MeasuresWhile quality reporting hasn’t posed a particularly bur-
densome exercise to date, the ophthalmology and ASC
communities have been extremely concerned with CMS
initiatives to transition from process- to outcomes-based
measures that focus on cataract surgery. To date, CMS has
proposed several — very misguided, we believe — ophthal-
BY MICHAEL ROMANSKY, ESQ.
WASHINGTON WATCH
ASC Quality and Patient Safety — The New Regulatory Horizon
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 23
mic measures, including reporting on
(1) Complications that occur within 30
days following cataract surgery that
require additional surgical interven-
tion, and (2) Improvement in Patient’s
Visual Function Within 90 days
Following Cataract Surgery.
OOSS, the Ambulatory Surgery
Center Association (ASCA), AAO and
ASCRS have vehemently objected
to all of the ophthalmic measures
proposed to date by the government.
Why? They fail to meet what we
believe are the foundational criteria for
facility-level quality reporting measures
in the ASC. Any ASC quality measure
should:
• Relate to an episode of care that
occurs within the confines of the
ASC
• Encompass data that is available
within the ASC
• Be collectible by the ASC staff, and
• Generate conclusions that are
actionable by the facility, thereby
enabling the ASC to potentially
improve the quality of care offered
to its patients
The good news is that CMS has
withdrawn some of the problematic
eye guidelines and has determined
that the rule mandating that the ASC
report a cataract patient’s visual func-
tion within 90 days of surgery will be
voluntary, meaning that facilities need
not report at all.
The Best Defense is a Good OffenseLet’s be clear, though — the govern-
ment is clearly intent on devising and
implementing measures relating to
high-volume services and specialties
such as ophthalmology. Increasingly
impatient with the efforts of CMS and
other agencies to develop and prof-
fer reasonable and appropriate ASC
quality measures, the ophthalmology
and ASC communities have decided to
develop our own measures that meet
the aforementioned parameters, which
are not unduly burdensome, and will
potentially generate meaningful data
for consumers. To date, our organiza-
tions have recommended that three
ophthalmic measures be considered
for adoption for ASC quality reporting
purposes:
• Unplanned anterior vitrectomy
in cataract surgery patients.
This measure has been endorsed
by the ASC Quality Collaboration
and approved by the Measures
Application Partnership. It may be
proposed by CMS in the ASC pay-
ment rulemaking this summer.
• Incidence of toxic anterior
segment syndrome (TASS) in
cataract surgery patients.
• Incorrect intraocular lens
implantation in cataract surgery
patients.
These incidents are well supported
by the clinical literature. We believe
that measuring these events in the
ASC and HOPD settings presents an
opportunity to improve the qual-
ity of cataract surgery for Medicare
patients receiving their care in the
ASC. Moreover, they would serve
as in important complement to the
outcomes measures already being
reported through the Physician Quality
Reporting System.
Sterilization of Ophthalmic Instruments in the ASC –Confusion and ClarificationThis past fall, OOSS reported that CMS
had issued an update to the Medicare
ASC Conditions for Coverage mandat-
ing that immediate use steam steriliza-
tion (IUSS) could no longer be used
in the ASC on a routine basis. Such
a policy appeared to require ASCs
to utilize terminal sterilization units
and perhaps acquire many more sets
of instruments. In response, OOSS,
ASCRS, and the AAO met on two
occasions with the agency to express
our concerns about the new policy,
focusing on educating CMS staff
regarding the etiology of TASS and
endophthalmitis and to provide the
results of a recent survey of ASCs of
their current sterilization and
instrument-cleaning practices.
Our efforts have resulted in the
agency’s further clarification that the
practices of most ophthalmic ASCs
should be in compliance with its rules
governing instrument sterilization.
What are the key elements of the new
policy?
• CMS believes that the term
“immediate use steam sterilization
(IUSS)” reflects the process formerly
referred to as flash sterilization.
“IUSS is the term currently accepted
to describe the process for steam
sterilizing an instrument that is
needed immediately, not intended
to be stored for later use, and
which allows for minimal or no dry-
ing after the sterilization cycle. IUSS
is not acceptable for use as a
routine method of sterilization.”
• The agency is defining short cycle
as a “form of terminal sterilization
that is acceptable for routine use
for a wrapped/contained load
where pre-cleaning of instru-
WASHINGTON WATCH
“THE GOVERNMENT IS
CLEARLY INTENT ON
DEVISING AND
IMPLEMENTING MEASURES
RELATING TO HIGH-
VOLUME SERVICES AND
SPECIALTIES SUCH AS
OPHTHALMOLOGY.”
ments is performed according to manufacturers
instructions for use (IFU), includes use of a com-
plete dry time and is packaged in a wrap or rigid
sterilization container validated for later use.”
We’re expecting confusion in the trenches as surveyors
apply the updated policy. Please contact OOSS if your
facility is cited for deficiencies related to your sterilization
processes.
What’s a Progressive Ophthalmic ASC to Do?Over the course of these two articles, we have dis-
cussed a plethora of legislative, regulatory and payment
developments that embody the potential to impact the
ophthalmic ASC. It’s also important to appreciate just
how effective OOSS — working with you, our grassroots
advocates, and with other ophthalmology and ASC
organizations — has been in securing relief from intrusive
regulation and proposing solutions that work! How do we
maintain — in fact, accelerate — our progress in meeting
the challenges emanating from regulators at the federal
and state levels and from the market place? I would offer
a few suggestions:
• Join the Outpatient Ophthalmic Surgery Society. It
starts and ends with a strong and vibrant OOSS. Check
us out at: www.OOSS.org.
• Educate Your Elected Officials. As healthcare provid-
ers, we accomplish our legislative and regulatory objec-
tives by educating policymakers about the benefits of
innovative ophthalmic surgical care and the quality,
convenience, and cost benefits of ambulatory ophthal-
mic surgery. OOSS, through our website’s Advocacy
Center, will provide you with all of the tools to develop
a relationship and convey an effective message with
just a few keystrokes.
• Contribute to OOSPAC. The Outpatient Ophthalmic
Surgery Political Action Committee (OOSPAC) is the
only PAC whose sole purpose is to advance the
interests of surgeons who own and/or practice in
ophthalmic ASCs. n
WASHINGTON WATCH S U R G E RY | OASC
Michael Romansky, JD, is a senior lobbyist and vice president of corporate development for the Outpatient Ophthalmic Surgery Society.
Pathologies such as keratoconus, pellucid marginal degenera-tion and corneal scars are among those that should be consid-ered for a traditional, manual procedure.
Deciding Whether to PurchaseTo date, the hefty price tags for femtosecond lasers, which range from approximately $300,000 to $500,000, have perhaps been the greatest obstacle to ownership. However, experts say another problem is anticipating the new developments that may be on the horizon for any given laser, and how quickly these might receive FDA approval. As Dr. McCabe puts it, “obviously you want to be able to do what you want to do with a laser when you’re purchasing it, without having to wait for critical applications to be approved.”
Albert Castillo of the Outpatient Ophthalmic Surgery Society (OOSS) says an ASC should carefully consider its patient base before purchasing a laser. Clinicians who aren’t ready to purchase may consider using a femtosecond laser at a nearby open-access ASC, or may consider leasing a laser.
“You need the volume to support acquiring a femtosecond laser,” says Mr. Castillo. “An ASC should have about 1000 sur-gical cases per month to support a new laser. For those which lack the volume to support the purchase of a laser, it’s possible to lease one instead. There are mobile units that can be made available to facilities for use, in exchange for a per-use fee.”
Dr. Whitman notes that surgeons should keep in mind that each of the currently available lasers has a unique set of fea-tures.
“I think it’s important for surgeons to know that just like excimer lasers, femtosecond lasers are not generic,” says Dr. Whitman. “For example, the way that beams actually fire in the laser, in terms of spot separation and energy, among other things, are different with each laser. Laser X is not the same as Laser Y or Z.”
Dr. Devgan, who has tested multiple lasers, strongly recommends that other surgeons do the same. He likens comparison-shopping for femtosecond lasers to that of shop-ping for automobiles. “The best way to decide which one you want is to try multiple models, and arrive at your own conclusions. Surgeons should do the same with femtosecond lasers — test drive before you buy.” n
Reference1. Hatch W, de L. Campbell E, Bell C. Projecting the growth of cataract surgery during the next 25 years. Arch Ophthalmol. 2012;130(11):1479-1481.
C O R N E A L A S T I G M AT I S M C O N T I N U E D F R O M PA G E 1 6
S U R G E RY | OASC
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OP MD Half Vert_OMD Reader PCard.qxd 9/2/14 10:47 AM Page 1
As AMD progresses,
central vision can
deteriorate to the point
where patients are chal-
lenged to see fine detail and images
in their center zone. While treatment
options for AMD have improved
over the past 10 years with the use
of intravitreal anti-VEGF medications
for neovascular AMD, some patients
inevitably progress to advanced AMD,
in which central vision is often poor
in both eyes. As a result, patients
find their quality of life negatively
affected when it becomes a challenge
to perform tasks previously taken
for granted, such as recognizing
faces, reading or watching television.
Driving often becomes impossible,
limiting a patient’s independence.
In fact, advanced AMD is associated
with increased depression and stress.1
Treating Younger AMD PatientsSince 2010, the Implantable Miniature
Telescope (IMT), developed by Isaac
Lipshitz, MD, has been an important
treatment option for patients living
with bilateral end-stage AMD as it
has been shown to improve qual-
ity of life in select patient groups.2
In October 2014, the U.S. Food and
Drug Administration expanded the
telescope prosthesis indication to
include patients as young as 65 years
old (it had been limited to 75 years
and older) based on long-term study
results demonstrating that younger
patients (aged 65 to <75) have
similar or better visual outcomes after
implantation than their older
counterparts (aged 75+) and also
retained more vision than older
patients over time with fewer adverse
events.3 Hence, there is now an
opportunity to evaluate younger
patients who may be candidates for
the IMT.
Finding the Right Candidate
The most obvious candidate is a
patient who has been diagnosed with
atrophic AMD who has progressed to
stable bilateral central vision loss, is
phakic in at least one eye, and whose
BCVA is 20/160 to 20/800 in the
better-seeing eye. The neovascular
patient requires more monitoring. The
best candidates have already received
2 to 5 years of anti-VEGF injections
and/or laser treatments. Following
6 months of stability, the neovascular
patient is a potential candidate for
evaluation.
The telescope prosthesis is part of
a comprehensive CentraSight treat-
ment program that matches patients
with a team of professionals, includ-
ing a retina specialist, cornea surgeon,
a low vision optometrist and a low
vision occupational therapist who
work with patients one-on-one from
diagnosis through surgery and then
during post-operative care and visual
rehabilitation training.
Patient selection is critical to
ensure a successful outcome. Beyond
meeting age requirements, patients
must be diagnosed with stable, bilat-
eral, end-stage AMD (BCVA of 20/160
to 20/800) with either geographic
atrophy or disciform scarring involving
the fovea. Importantly, the potential
candidates cannot have undergone
prior cataract surgery in the eye
The Telescope Implant May Benefit Your Advanced AMD Patient
BY RICHARD HOFFMAN, MD, CPI & LAURIE K. BROWN, MBA, COMT, COE
SURGICAL PEARLS
T H E O P H T H A L M I C A S C | M A Y 2 0 1 526
Richard Hoffman, MD, CPI, is in practice at Drs. Fine, Hoffman & Sims, LLC. in Eugene, Ore.Laurie K. Brown, MBA, COMT, COE, is an administrator at Drs. Fine, Hoffman & Sims, LLC.
Figure 1. The Implantable Miniature Telescope
targeted for implantation and must
have adequate peripheral vision in the
eye not scheduled for surgery. (The
telescope implant is only implanted in
one eye and limits peripheral vision.
The other eye doesn’t receive an
implant so peripheral vision, which
is vital for orientation and balance, is
maintained.) Beyond meeting other
eye and health criteria, the best
patient is one motivated to participate
in post-operative occupational therapy
to practice exercises that retrain the
brain to understand the patient’s new
way of seeing using the telescope
implant. Many ocular comorbidities,
which may increase the likelihood of
complications, are criteria for exclu-
sion. Examples are those who have
had previous intraocular surgery or
have a history of steroid-responsive
rise in intraocular pressure, uncon-
trolled glaucoma, or preoperative
IOP >22 mm Hg, while on maximum
medication. Also, Stargardt’s macular
dystrophy is currently excluded for IMT
implantation.
A candidate will also undergo
pre-surgery training using an external
telescope to test whether the visual
acuity gained from that device, evalu-
ated using the ETDRS (Early Treatment
Diabetic Retinopathy Study), equals at
least a 5-letter improvement in the eye
scheduled for surgery.
Moderate improvement using
ETDRS criteria actually underestimates
the improved vision most telescope-
implanted patients report follow-
ing implantation and occupational
therapy. Data show that in younger
patients (65 to <75 years) mean
BCDVA improvement at 24 months
was 3.3 lines and 2.6 lines at
60 months and in older patients (those
75+), mean BCDVA improvement was
3.1 lines at 24 months and 2.1 lines at
60 months. In both cases, this is a very
meaningful and significant improve-
ment in vision, leading to associated
improvements in quality of life.3
Access and OpportunityFollowing the original FDA approval in
2010,4 the telescope implant became
a Medicare-eligible procedure,5 which
meant it was financially within reach
of most patients. Yet for many sur-
geons, access to this technology was
limited to hospital outpatient depart-
ments due to Medicare reimbursement
methodologies. While some surgical
practices worked with hospitals to
coordinate surgical privileges and
schedule procedures, this administra-
tive burden may have reduced excite-
ment and uptake of a surgery that
essentially uses similar instruments and
supplies to the cataract and cornea
procedures routinely performed in the
ASC setting.
Beginning in March of this year,
CMS announced that they will reim-
burse ASCs at levels comparable to
the hospital setting.6 This is an enor-
mous benefit to ophthalmic surgeons
as they can now offer and perform
the telescope implantation in the
same place they already perform the
majority of their other surgeries. The
convenience of offering this relatively
new and first-of-a-kind procedure
in the ASC setting, combined with
economically viable reimbursement,
provides the mechanisms needed for
broad ASC adoption of the therapy.
This should significantly improve
patient access.
Important Treatment Option Advanced AMD (both geographic
atrophy and neovascular) affects nearly
2 million people in the United States.7
Data show that the permanent loss of
central vision is so distressing that the
typical end-stage AMD patient would
be willing to give up as much as half
their remaining life in exchange for
healthy vision.8 Therefore, while the
telescope implant isn’t a cure for AMD,
it’s an important treatment option to
consider for patients who are eager to
improve their quality of life. n
References1. Bennion AE, Shaw RL, Gibson JM. What do we know about the experience of age related macular degeneration? A systematic review and meta-synthesis of qualitative research. Soc Sci Med. 2012;75(6):976-985.
2. Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE; IMT002 Study Group. Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008:146;664-673.
3. Professional Use Booklet. VisionCare Ophthalmic Tech-nologies, Inc. Accessed on March 17, 2015 at http://www.centrasight.com/pdf/PUI_final_Rev4_Nov2014.pdf
4. Press release. VisionCare Announces FDA Approval for First-Ever Implantable Telescope for End-Stage Macular Degeneration. July 6, 2010. Accessed on March 25, 2015. http://www.visioncareinc.net/press_releases/pr_1277848108
5. Press release. Telescope implant for end-stage macular degeneration now available across the nation. June 8, 2012. Accessed on March 25, 2015 http://www.visioncare-inc.net/press_releases/pr_1339122658
6. Press release. CMS Establishes New Ambulatory Surgical Center Payment for VisionCare’s Telescope Implant for Macular Degeneration. Nov. 3, 2014. Accessed on March 25, 2015 http://www.visioncareinc.net/press_releases/pr_1414800263
7. Vision Problems in the U.S. Prevent Blindness America. Accessed on March 17, 2015 at http://www.visionproblem-sus.org/amd/amd-map.html
8. Brown GC, Sharma S, Brown MM, Kistler J. Utility values and age-related macular degeneration. Arch Ophthalmol. 2000;118(1):47-51.
SURGICAL PEARLS
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 27
BEGINNING IN MARCH OF THIS YEAR, CMS ANNOUNCED THAT
THEY WILL REIMBURSE ASCS AT LEVELS COMPARABLE TO THE
HOSPITAL SETTING.6 ... SURGEONS CAN NOW OFFER AND PER-
FORM THE TELESCOPE IMPLANTATION IN THE SAME PLACE THEY
ALREADY PERFORM THE MAJORITY OF THEIR OTHER SURGERIES.
T H E O P H T H A L M I C A S C | M A Y 2 0 1 528
As our esteemed
General Counsel,
Mike Romansky often
writes in his prescient
Washington Updates, “If OOSS
doesn’t represent you on these
issues, who will?” Implicit in Mike’s
question is the confident and asser-
tive declaration that OOSS plays a
unique and critical role in the life of
the ophthalmic ASC community.
Mike is right. For well over 30
years, OOSS has been the principal
voice for ophthalmic surgery centers,
the surgeons who use and own
them, the staff who operate them,
and the patients and payers who
benefit from them.
The Pros of OOSSToday’s OOSS is the voice of a matur-
ing industry model for delivering
superb surgical outcomes and patient
care, efficiency, and affordability.
And it’s with this voice that OOSS
leverages information, research and
education to promote and propel
the advantages inherent in the
ophthalmic ASC model. OOSS is
indeed unique in both its pioneering
heritage and lean business model
— which translates every dollar of
member dues and partner support
into the fulfillment of a clear, discrete
and focused mission. This is the
advantage of OOSS.
Working as a TeamWhile what we do is unique, discrete
and focused, we are not alone in our
pursuits. We enjoy rich collabora-
tions with our partner associations
— ASCRS/ASOA, AAO/AAOE, ASCA,
ACES/SEE, AECOS and a growing
range of specialty societies. Our
industry partners deliver trusted
expertise, products and services
and they underwrite initiatives that
continually move us forward. Most
important are our members who
serve on our board and committees,
share expertise and information,
and underwrite the lion’s share of
programs and services that benefit
our industry.
As a member or partner of OOSS: • You’re part of an organization that
promotes and propels what you
do.
• You have access to a network of
ASC owners, surgeons and staff
that represent the best in the
business.
• You experience the OOSS advan-
tage, as both a contributor and
as a beneficiary of programs and
services designed to enhance the
success of the ophthalmic ASC.
By belonging to OOSS today, you
shape a better tomorrow — for your
organization and the patients and
communities your serve. n
Consider the OOSS Advantage
BY KENT JACKSON, PhD,
EXECUTIVE DIRECTOR OF OOSS
EYE ON OOSS
» To join OOSS, visit our website at www.ooss.org
TODAY’S OOSS IS THE
VOICE OF A MATURING
INDUSTRY MODEL FOR
DELIVERING SUPERB
SURGICAL OUTCOMES AND
PATIENT CARE, EFFICIENCY,
AND AFFORDABILITY.
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T H E O P H T H A L M I C A S C | M A Y 2 0 1 530
Are your ORs booked to capacity? Could you increase volume in your ASC if only you had more space? Would your surgeons like to switch between two ORs, rather than working in one?
There are several reasons that partners expand their ASCs, just as there are several reasons they decide against it. Here, five expe-rienced decision makers share how growth, finances and physical factors have impacted their own expansion plans.
Crunching the Numbers How much will it cost to add an OR, and will the investment pay off? These are the most important questions for shareholders to ask when considering adding an OR, according to Maureen Waddle, MBA, Partner and Senior Consultant at BSM Consulting. Ms. Waddle helps clients who are contemplating expansion perform a financial impact analysis.
“I evaluate the cost versus the potential revenue. If the current surgeons have pent-up
O A S C | B U S I N E S S
Five experts share the brick-and-mortar foundations of this complex decision.
Is it Time to Add Another OR?
By Erin Murphy, Contributing Editor
INVESTMENT SUMMARY CAPITAL NEED
Construction Costs $386,391 Borrowed Amount $555,130 Medical Equipment 193,050 Cash Required 138,783
85,500 Certificate of Need, Legal and Consulting Fees Other 28,972
NET INCREMENTAL INCOME BEFORE TAXES ($137,061) ($31,891) $75,821 $181,247 $282,916
Plus Depreciation $77,249 $77,249 $77,249 $77,249 $77,249 Less Principal Payments on Debt Service (23,547) (24,999) (26,541) (28,178) (29,916)
ADDITION OR REDUCTION TO CASH AVAILABLE FORDISTRIBUTION BEFORE TAXES ($83,359) $20,359 $126,530 $230,318 $330,249
CUMULATIVE ($63,000) $63,530 $293,848 $624,097
FOOTNOTES:(1) Refer to Revenue Forecast, for details regarding revenue assumptions.(2) Refer to Income Statement for details regarding operating expense assumptions.(3) Principal payments on debt (see Capital Costs).
SAMPLE: ASC Expansion - Incremental Income Analysis (1 OR) Figure 1. Incremental Income Analysis: ASC Adding One OR
Sour
ce: M
aure
en W
addl
e, M
BA
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 31
demand — they’re asking for more OR days or patients are waiting more than 6 weeks for surgery — then I can cal-culate the actual numbers showing that a new OR will add income,” she states.
Whether that future income will exceed the cost of expansion depends on the individual facility, Ms. Waddle says. She estimates that a majority of her clients choose to renovate, which involves loss of revenue during con-struction. Others decide to lease or build a larger facility. State certificate of need requirements can also influence the expansion decision. (Figure 1)
Efficient OperationAnother key part of this evaluation is to take a hard look at how efficiently the ASC uses its current number of ORs. “The ASC may be operating inefficiently, and it’s much less expensive to increase efficiency than to add an OR,” says Ms. Waddle.
To gauge efficiency, she includes benchmarking exercises in her finan-cial analysis. “I take a facility’s average number of cases per day, average wait time to schedule surgery and turnover rate and compare them to benchmark-ing data offered by OOSS,” she says. “Sometimes, I can show how increasing efficiency will enable the ASC to meet demand without adding an OR, and we can estimate when expansion may become necessary in the future. This is especially helpful for practice-tied, single-OR ASCs for which adding an OR presents major regulatory hurdles.”
Ms. Waddle offers an example in which four ophthalmic surgeons (all partners) using an ASC 4 days per week add an OR. “Even with an aggres-sive 10% case volume growth every year for 5 years, cumulative positive
cash flow takes 3 years, and they don’t achieve a full return on their invest-ment in 5 years,” she says. “Instead of adding an OR, this center would be bet-ter off meeting demand by operating 5 days per week (1 more day per month per surgeon) and incurring only some added staffing costs.” (Figure 2)
Benchmarking data also allow Ms. Waddle to estimate the staffing changes that a new OR will require. “If an ASC goes from one OR to two, that doesn’t mean the OR staff is doubled. I compare the staff ’s hours per case, revenue per full time employee (FTE) and income per FTE against OOSS benchmarks. In many cases, going from one to two ORs requires only 50% more staff for addi-tional pre-op and post-op time, circula-tion and turnover.”
Operating in Two Rooms“Contrary to conventional wisdom and pressures from surgeons, going from room to room with one surgeon isn’t always the most logical or efficient plan,” suggests Robert B. Nelson, PA-C, Executive Director at Island Eye
Surgicenter in Carle Place, N.Y., who has been involved in expansion projects at several ASCs. “Our fastest and most efficient surgeons can use two rooms, but we have to choose those surgeons wisely.”
Mr. Nelson points out that many sur-geons like the convenience of working two ORs, but unless a surgeon works quickly, the added staffing costs and possible lost OR productivity reduce revenues. Here’s why.
“Most cataract surgeons say that sur-gery takes 8 minutes, but they actually spend 15 to 20 minutes per procedure. With 15 cases booked in two rooms, staff prep and drape in less than 5 min-utes, and then wait around for 10 to 15 minutes while the surgeon is in the other room. But when two surgeons occupy those two ORs, each surgeon performs 15 cases with the same staff — double the volume. With an addi-tional staff member dedicated to room turnover, surgeons’ downtime between cases can be just 2 or 3 minutes.”
Even previously reluctant surgeons at Mr. Nelson’s ASC now support this
B U S I N E S S | OASC
Certificate of Need
W hen clients want to add an OR, Maureen Waddle, MBA, Partner and
Senior Consultant at BSM Consulting in Incline Village, Nev., helps them
complete the financial impact analysis. According to Ms. Waddle, 27
states require these certificates to prevent oversaturation of healthcare facilities.
“To add an OR, the applicant has to justify the community need. It’s a detailed
process that is different for each state. It may include demonstrating the demographic
demand, providing CMS numbers and estimating current and future healthcare
demand and capacity,” Ms Waddle says. “To demonstrate that the ASC will survive,
the state may require a financial analysis with ROI and projections. These are cumber-
some evaluations, but if the need is there and the ASC can show that it will be filling
that OR with procedures, then expansion is likely to be approved.”
approach because it minimizes incon-venience and increases overall case volume, helping the bottom line.
Stephanie Harvey, CEO of Inde- pendent Surgery Center in Chippewa Falls, Wisc., was considering adding an OR to the 4-year-old ASC to allow sur-geons to alternate between two rooms. Her financial analysis showed the addi-tion wasn’t feasible.
“Running two ORs simultaneously requires more staff and twice the equip-ment, and it creates twice the oppor-tunities for citations,” she says. “We may do it in the future if our volume increases to justify the investment, but it isn’t a solution for us right now.”
Expanding the Facility When you know that your ASC has the surgical volume to expand, the facil-ity’s physical considerations take center stage. It may or may not be possible and financially feasible to add space. When partners at Ms. Harvey’s ASC consid-ered adding an OR, they realized that expanding the existing building was a complicated option.
“By adding an OR, we would also need to increase pre-op and post-op space, boost the administrative and storage areas, and rearrange the center’s entire layout and flow,” she explains. “When it’s time for us to expand, we’ll either build new or be forced to shut down while we renovate. In retrospect,
I wish we had built the ASC with expan-sion in mind.”
Ahad Mahootchi, MD, owner of The Eye Clinic of Florida in Zephyrhills, did exactly that, largely based on discus-sions with ASC owners who wished they’d anticipated the need to expand.
“I spent one and a half years plan-ning the ASC, talking to people about what they’d done right and wrong.
When it came to the facility, people complained about space most often. So I built a facility that’s easy to expand, has plenty of storage and houses a sepa-rate laundry facility outside.”
Dr. Mahootchi started with two ORs using a modular design that will facili-tate adding three more without having to close down during construction. The waiting room, pre-op and post-op areas are already large enough for five ORs.
Three years after opening his doors, he has no regrets. “The cost was higher initially, but adding on later will cost less,” he says. “Future growth will be relatively easy.”
Building a New Location Albert Castillo, Director of Business and Financial Development for San Antonio Eye Center, has seen his clinic and ASC go from four physicians to 13. Currently, the ASC can handle about 35 procedures per day, 4 days per week, in a single OR. With space getting tight, shareholders have looked into expanding the build-
ing, a converted historic house. “An older facility like ours is grand-
fathered in with earlier CMS life safety codes. Adding on means modifying the entire facility to the most current codes,” explains Mr. Castillo. “In short, to add a second OR, we would need to renovate the entire building, and the cost would be three to four times that of building a new facility. Currently, we’re planning to keep our facility and con-sidering building a second location.”
For shareholders who don’t want to operate two locations, building or mov-ing to a new facility is another option. At Island Eye Surgicenter, three ORs are operating at 95% capacity, handling 14,000 cases per year. The center has 40 surgeons on staff, 14 of whom are part-ners. More surgeons want to join the staff, but there isn’t enough space, and building an addition would impact the clinical operation and sacrifice much-needed parking.
“That’s a missed opportunity,” Mr. Nelson points out. “So we made a decision to build a larger facility a quar-ter mile away. We’re going from three ORs to six, from 9,400 square feet to about 26,000. We hope to start con-struction in a few months.”
Despite the leap in size, Mr. Nelson isn’t hiring staff just yet. “We’re well staffed today, and we will add staff gradually in the future as we go through a ramp-up period adding capacity from three to six ORs.”
Asked what advice he would offer other facilities’ administrators and shareholders considering expansion, Mr. Nelson keeps it simple. “Look at the cost and current utilization patterns. If the risk is balanced by the opportunity to grow case volume and increase revenues, then partners usu-ally will support expansion.” n
O A S C | B U S I N E S S
T H E O P H T H A L M I C A S C | M A Y 2 0 1 532
“Running two ORs simultaneously requires more staff and twice the equipment,
and it creates twice the opportunities for citations.”
— Stephanie Harvey, CEO of Independent Surgery Center
With the constant barrage of informa-
tion that one needs to keep up with in
ophthalmology, 3 years is a very long time.
And it has been 3 years since the AAO/
ASCRS and the CMS issued their guidelines (January 2012
and November 2012 respectively) regarding when patients
may be billed for surgical services — or portions of surgical
services — that involve the use of laser-assisted ophthalmic
surgery.1,2 Below I will clarify issues surrounding femtosec-
ond laser billing such as the Q&A below — which offers an
incorrect listserv answer.
Q. Have any practices used the femtosecond laser for performing cataract surgery? Can
you bill this to insurance or does it go with the 66984?
A. This is elective for patients, so they must pay out of pocket. Medicare does not pay
for this service.There are specific guidelines when billing patients for
the premium services that aren’t covered by Medicare. In
order to correct misconceptions, this review addresses the
three main areas in which laser-assisted ophthalmic surgery
is currently being utilized: cataract, refractive and cornea
surgery.
LASER-ASSISTED CATARACT SURGERYMessage from CMS: Misleading advertising
prompted CMS Guidance.
“We are providing this guidance because of a recent
press release from an ophthalmology practice that
described use of bladeless, computer-controlled laser
surgery for cataract removal. The press release may imply
a different Medicare policy regarding non-covered services
that may be charged to the beneficiary if the cataract sur-
gery is performed using a bladeless, computer-controlled
laser. The press release states:
‘While traditional cataract surgery is fully
covered by most private medical insurance and
Medicare, bladeless cataract surgery requires
patients to pay out-of-pocket for the portion of
the procedure that insurance does not cover.’
Neither the physician nor the ASC may bill patients for
any portion of cataract surgery since all types of cataract
surgery, when medically necessary, are a covered benefit
of the Medicare program. Early on there was a good deal
of confusion about this, so the AAO and ASCRS issued
joint guidelines to address the issues. These guidelines
addressed when patients could be billed for the refractive
(non-covered) portion of surgeries and we will examine
them in detail. After these guidelines were issued, CMS
issued a statement clarifying prior rulings and this was fol-
lowed by minor revisions in the AAO/ASCRS Guidelines.
Message from CMS: Neither the surgeon nor the ASC
is permitted to bill the patient for cataract surgery no
matter what technique is used.
“Medicare coverage and payment for cataract sur-
gery is the same irrespective of whether the surgery is
performed using conventional surgical techniques or a
bladeless, compact controlled laser. Under either method,
Medicare will cover and pay for the cataract removal and
insertion of a conventional intraocular lens. If the blade-
less, computer-controlled laser cataract surgery includes
implantation of a PC-IOL [Medicare’s term for presbyopia
correcting intraocular lens] or AC-IOL [Medicare’s term
for astigmatism correcting intraocular lens], only charges
for those non-covered services specified above may be
charged to the beneficiary.”
Laser-assisted Surgery & Medicare Compliance
BY RIVA LEE ASBELL
CODING & COMPLIANCE
Riva Lee Asbell is principal of Riva Lee Asbell Associates, an ophthalmic reimbursement firm specializing in Medicare reimbursement and compliance. She may be contacted at [email protected]
T H E O P H T H A L M I C A S C | M A Y 2 0 1 5 33
In summary, at this time, as far as Medicare is con-
cerned, the patient can never be charged extra for any
technique used in conjunction with any form of medi-
cally necessary cataract surgery by either the surgeon
or the facility.
The global surgery package for Medicare includes inci-
sions and closure and thus laser-assisted cataract surgery is
not paid by Medicare and cannot be billed to the patient.
CATARACT SURGERY COMBINED WITH REFRACTIVE SURGERY (SAME SESSION)The aforementioned guidelines issued by AAO and ASCRS
for both physicians and facilities explicitly delineates when
a patient may be billed. Essentially, a patient may only be
billed for services that aren’t covered by Medicare and, in
this context, are refractive in nature.
Refractive Lens Exchange.
• The surgeon and the facility may bill the patient for
refractive lens exchange and for an astigmatic kera-
totomy (AK) performed in conjunction with medically
necessary cataract surgery.
• The surgeon and the facility may charge an additional fee
to the patient for the use of a refractive intraocular lens
(presbyopia correcting or astigmatism correcting).
• Since this is a totally non-covered procedure, an addi-
tional fee to use the femtosecond laser for any lens
removal steps may be charged by the physician and/or
facility. It’s critical to have the proper chart documenta-
tion including a proper informed consent.
Medically Necessary Cataract Extraction with a
Conventional IOL or Premium IOL and No Astigmatic
Keratotomy.
• In either instance, billing the patient if laser-assisted surgery
is used is prohibited. The patient may only be billed within
Medicare’s parameters for the premium IOL package.
Medically Necessary Cataract Surgery Plus Astigmatic
Keratotomy Performed for Refractive Indications.
• If laser-assisted cataract surgery is performed as well as
laser-assisted AK, the patient may be charged only for
the laser-assisted AK portion. This should be well docu-
mented in advance of the surgery.
Note that Medicare does cover correction of astigma-
tism alone if it resulted from previous surgery or trauma.
However, you may not bill the patient additionally for
the use of laser-assisted surgery for these medically nec-
essary procedures.
LASER-ASSISTED CORNEA SURGERYThe codes below were developed for the laser incisions
based on the incisions being performed in the laser suite
and the keratoplasty procedures being performed in the
operating room of the hospital or ASC. They are add-on
codes (noted by the + sign before the code) signifying
the codes cannot be used independently. Since these are
Category III codes, Medicare reimbursement as well as
the coverage itself is at the discretion of CMS or the MAC
(Medicare Administrative Contractor). The codes are pack-
aged on the national fee schedule with the surgery fee in
2015 and therefore cannot be billed to the patient. Neither
the surgeon nor the ASC will be reimbursed.
CPT Listings for Category III codes:
+0289T Corneal incisions in the donor cornea created
using a laser, in preparation for penetrating or
lamellar keratoplasty (list separately in addition to
code for primary procedure)
(Use 0289T in conjunction with 65710, 65730,
65750, 65755)
+0290T Corneal incisions in the recipient cornea created
using a laser, in preparation for penetrating or
lamellar keratoplasty (list separately in addition to
code for primary procedure)
(Use 0290T in conjunction with 65710, 65730,
65750, 65755)
The above codes are for keratoplasty only and not
cataract surgery. n
References 1. Eye-surgery organizations provide medicare billing guidance to physicians for laser technology used in cataract procedures. AAO News Release. http://www.aao.org/newsroom/release/20110130.cfm. Accessed March 23, 2015.
2. Report to Congress: Medicare ambulatory surgical center value-based purchasing implementation plan. CMS. http://www.cms.gov/Center/Provider-Type/Ambulatory-Surgical-Centers-ASC-Center.html. Accessed March 23, 2015.
CODING & COMPLIANCE
For more information on properly billing for the femtosec-ond laser, please visit http://ascrs.org/sites/default/files/resources/12-04-2012%20FS%20Laser%20Guidelines%20Document%20%282%29_0.pdf and www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/Downloads/CMS-PC-AC-IOL-laser-guidance.pdf.
• Combo Laser — combining the unique YC-1800 andGYC-1000 for two systems that act like one, with an easyupgrade path from older Nidek lasers
• MC-500 VixiMulticolor Pattern Scan Laser — equalspace pattern, multiple scanning modes, plus short pulseduration (20ms) and spacing control
Call us today for more information or a demo.
Connect with us . . .
Caution: U.S. Federal Law restricts these devices to sale, distribution, and use by
or on the order of physician or other licensed eye care practitioner. Specification
may vary depending on circumstances in each country. Specifications and design
are subject to change without notice.
NIDEK Inc. | 47651 Westinghouse Drive
Fremont, California 94539-7474
Web: usa.nidek.com | Phone: 800-223-9044
Laser2014_OP.qxd:Layout 1 4/14/15 1:20 PM Page 1
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COMPACT INTUITIV is a trademark owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV SYSTEM
Federal (USA) law restricts this device to sale by or on the order of a physician.
ATTENTION: Reference the directions for use for a complete listing of Indications and Important Safety Information.
INDICATIONS: The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with
ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene
Oxide and is designed for single use only.
IMPORTANT SAFETY INFORMATION: Do not attempt to use the system if it fails to perform properly and do not use near flammable objects,
anesthetics, gases, fluids, and oxidizing agents. Obtain qualified advice prior to the use of the COMPACT INTUITIV System on patients with a cardiac
pacemaker, as the system might interfere with this device. Ensure that the irrigation solution bottle height and fluid level are monitored at all times as
a low bottle or empty bottle will affect intraocular pressure during aspiration and may lead to inadvertent chamber shallowing or collapse, aspiration
or abrasion of the iris or other eye tissue, and ultrasonic wound burn. Do not come into contact with grounded metal parts or parts that have
appreciable capacitance to ground. The use of an antistatic mat is recommended. Use proper handling and disposing methods for biohazards when
disposing single-use components. Failure to properly attach the tubing to the appropriate vacuum source or pressure source affects the vitrectomy
handpiece operation. Be sure to read the handpiece package insert for correct assembly procedures and connection procedures. Follow good
operating room procedures to prevent injury or contamination. Place all monitoring electrodes or other types of equipment as far from the COMPACT
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electrodes. Keep the diathermy cord, handpieces, leads and active electrodes away from the patient. Do not allow skin to skin contact of the patient,
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electrode cables upon evidence of deterioration. All non-sterile accessories must be sterilized prior to use. Examine all
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