Phakic IOLs: In-Office Implantation
A surgical suite can make it possible to offer this new refractive option without an ASC. Here's what you need to know.
BY PAUL J. DOUGHERTY, M.D.

Because LASIK isn't an appropriate treatment option for many refractive patients (such as some higher myopes), phakic lenses will greatly expand the number of people who can be treated. It's also an option that doesn't involve cutting or reshaping the cornea, and it's potentially reversible -- points that should appeal to many prospective patients.

Best of all, implanting a phakic IOL can safely be done in a clinical setting. Many surgeons can use their Class B operating rooms (designed for cataract surgery) for this purpose. Other surgeons and laser vision centers will have to add an in-office suite that complies with federal regulations in order to offer phakic IOL implantation on the premises.

The In-Office Advantage

Performing surgery in your own office or clinic has a number of advantages:

• Being able to work with a hand-picked and personally trained staff will help to produce better results and lead to optimized quality of care. In contrast, working with a different scrub nurse on any given day in a shared operating room environment can reduce your efficiency and increase your rate of complications.
• Your patients benefit from a continuity of care; they see the same staff on the day of surgery and at all of their postoperative visits.
• An in-office O.R. offers financial benefits. You don't pay a fee to an outside facility, so the additional income stays in your center.
• Being able to handle other procedures between ICL cases helps to generate more revenue for the practice.
• Because it's your own surgical suite, you can control the level of organization and turnover time. Typical turn-over time at an average non-surgeon-owned ASC can result in case speed as slow as one case per hour. By contrast, in our in-office surgical suite we can operate on three LASIK patients (six eyes) per hour. Using the same surgical staff, we expect to be able to implant at least two ICLs per hour.

Making It Happen

Implanting phakic IOLs in an office-based surgical suite is a significant practice enhancement. However, because this is an elective procedure, you won't be able to bill third-party insurers for reimbursement. As a result, word-of-mouth referrals will be crucial to making back your investment. Creating a positive patient experience and good outcomes will be essential.

At the same time, you'll be following federal guidelines, both physical and procedural. This requires attention to important details, ranging from environmental considerations to procedural controls.

Of course, a key issue when deciding whether or not to create an in-office surgical suite is cost. The final cost will depend on a host of factors including size of the space, location, and so forth, but a ballpark estimate is that creating an in-office suite in a 10-foot by 12-foot space will probably run between $3,000 and $12,000.

If you decide to prepare an in-office surgery suite so that you can offer phakic IOL implantation, plan to focus on the following key areas:

Environment. An in-office suite for phakic IOL procedures should meet as many of the criteria for an ophthalmic-only ASC as possible -- although trying to meet all of them may not be realistic. (For example, federal guidelines for an ASC require 400 square feet per operating room, which wouldn't be possible for many clinics.)

For cataract surgeons who have their own ASC, phakic IOL implantation will only require minor changes to the O.R. environment. LASIK centers, however, will have to make modifications to the surgical suite to mirror the federal guidelines for full-scale operating rooms.

Efficiency. An in-office O.R. suite requires the same emphasis on efficiency and productivity that an ophthalmic clinic or a laser vision correction surgery center require. Among other things, this means designing the suite to:

• optimize patient flow
• provide adequate work area for staff
• have plenty of accessible storage space.

Fortunately, maximizing efficiency in an office environment is easier than at a third-party facility because you have complete control of your operating suite environment.

Sterility. The same sterility precautions and protocols followed in an ASC must be used in an in-office suite. For example, operating room grade flooring and a hard-lid ceiling are required so that an antimicrobial solution can be used to scrub the surfaces to maintain a sterile environment. (Avoiding complications such as endophthalmitis is especially important in elective refractive surgery cases.)

Personnel. At a minimum, staffing an in-office suite for phakic IOL implantation should include:

• a scrub technician
• an RN circulator who is CPR and ACLS certified
• a pre-op technician.

Many centers also prefer to have a certified registered nurse anesthetist responsible for patient monitoring.

State guidelines for O.R. personnel vary, so it's important to check local requirements for staffing.

Equipment. Proper equipment is an essential ingredient for maximizing productivity and outcomes. Key pieces of equipment include:

• a surgical chair
• a standard cataract tray
• an operating microscope
• surgical instruments for phakic IOL implantation
• a pulse oximeter
• an EKG monitor
• a crash cart.

It's also advisable to have an automated external defibrillator on hand, like those used by first-responders at airports and other public facilities.

Development of a policy and procedures manual. A policy and procedures manual documents the mission and function of the surgical suite; it specifies the steps being taken to ensure safe and efficient surgery, control risks and improve healthcare delivery.

The manual helps staff understand -- and remain focused on -- core issues crucial to the success of the surgical suite. At the same time, it enables anyone, inside or outside the practice, to assess the surgical suite's mission and function and determine how well the facility is accomplishing its intended goals.

An intraocular procedure means a higher liability profile for the practice. A policy and procedures manual goes a long way toward limiting that liability.

Accreditation. Accreditation isn't necessary because insurance companies are not currently reimbursing for ICL procedures. However, having your clinic accredited by the Accreditation Association for Ambulatory Health Care would certainly provide an additional level of marketing credibility and could also provide some legal benefits.

Malpractice insurance. When developing your plan for an in-office surgical suite, be sure to obtain the appropriate malpractice coverage and get written permission, if possible, from the malpractice insurance carrier.

Potential Payoff: High

In-office implantation of phakic IOLs will give refractive and cataract surgeons in the United States a potentially lucrative new option in their treatment armamentariums. If you're looking for ways to enhance your practice's appeal, increase practice income and enlarge your patient base, it's definitely an option worth considering.

Dr. Dougherty is medical director of Dougherty Laser Vision in Los Angeles, Camarillo and Santa Barbara, Calif. He is a principal investigator for the U.S. clinical trial of STAAR Surgical's ICL for the treatment of hyperopia. Some information in this article was provided by Mike Grasham of Custom Surgical Consultants. You can reach Mike at (443) 417-5957 or via e-mail at gras36@aol.com.