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Who Will Pay for Femtosecond Cataract Surgery?

Femtosecond cataract surgery has generated a lot of excitement with its promise of safer, more precise surgery, as well as a fair share of resentment. But there's one thing most can agree on: The high cost of this high-tech laser may prevent it from gaining widespread adoption.

Who will pay the extra cost of femto-cataract surgery? How much will they be willing to pay? These are some of the questions that will shape the future direction of this latest advancement in refractive cataract surgery.

"It's really very simple. The femtosecond laser is a wonderful piece of technology. But it lacks a business plan," said William L. Rich, MD, a Falls Church, Va., comprehensive ophthalmologist, who is medical director of health policy for the American Academy of Ophthalmology.

Dr. Rich spent 15 years as the Academy's representative on the U.S. government's committee responsible for updates to relative value payment schedules. These payment schedules govern how much physicians and hospitals receive for performing cataract surgery on elderly patients covered by Medicare, who make up the bulk of cataract patients.

All of the medical and surgical services of the procedure are bundled under a single-payment CPT (Current Procedural Terminology) code, for which the physician and the surgery center each receive a flat fee. 

Consequently, anything that increases procedural costs affects the bottom line. This, in turn, is a disincentive for using the laser routinely, he said.

"You can make the capsulorhexis using a bent 27-gauge needle, and it costs you about a buck," Dr. Rich said. "You can use a disposable cystome for about $15. You can use an automated Fugo blade for $1,000. Or you can use a $500,000 femtosecond laser, with the laser company charging you a $500 fee every time you use it. Which would you use?"

Patients Can't Be Billed in the U.S.
It is a federal crime to charge a patient extra for anything included in the federal billing code, such as a capsulotomy. The vast majority of U.S. cataract surgeries are in elderly patients, to whom this law applies, and they cannot be asked to waive the law's provisions.

There appears to be no way to recover the user fees and other costs associated with replacing conventional cataract surgery tools with a $500,000 laser, Dr. Rich said.

"The insurance companies and Medicare don't care what tool you use. It's all part of the procedure. No matter what you use, the doctor gets paid the same, and the facility gets paid the same," he said. "So there's no way you can charge for the use of a femtosecond laser to make the incision or the capsulorhexis for a covered cataract extraction."

There has been intense interest in the last few years in expanding the repertoire of the femtosecond laser beyond its initial use for creating LASIK flaps, but published reports are few so far.

Research Reports
In peer-reviewed journal articles, researchers have reported lab, animal or, in a few cases, human studies in which the laser performs a variety of feats, including: 

• creating strong, multiplanar, self-sealing corneal incisions,1 
• improving the centration of the capsulorhexis, and making its shape and size more predictable,1,2
• producing continuous anterior capsule incisions that are twice as strong and more than five times as precise in size and shape than manual capsulorhexis,1
• being used to pre-soften hard lenses, reducing phaco time,2
• enabling exact placement of limbal-relaxing incisions, when combined with imaging capability such as OCT,1
• demonstrating the potential to bleach senile lenses back to their pre-cataract state,3
• showing the potential to address presbyopia by softening the aging crystalline lens and enabling accommodation.4-6

Even if subsequent studies confirm that the femtosecond laser has some limited but demonstrable benefits compared to conventional cataract surgery, this news may fall on deaf ears in Europe and other regions with government-paid health care systems. These systems already have been forced by the slow economy to tighten their budgets, ophthalmologists in these places point out.

Germany: Cost Prevents Adoption
If cost were no object, the femtosecond laser unequivocally would be an attractive new tool for cataract surgeons in Germany, said Aljoscha S. Neubauer MD, MBA, of Ludwig-Maximilians University in Munich, Germany.

"Most surgeons are interested, but few actually are performing cataract procedures with the laser," Dr. Neubauer said. "The high-volume cataract thought leaders, non-university surgeons, are likely to be first to move and invest in a laser for this purpose ? partly for improved quality and partly to grow their business."

It is unlikely that Germany's statutory health insurance system would ever agree to pay the costs of adding femtosecond lasers to routine cataract surgeries, he added.

Government Balks at Premium IOLs
"Given the experience with long fights over paying just for the surgery, not the IOL, for nonstandard IOLs, such as toric and multifocal lenses, reimbursement for femto-cataract is very unlikely," Dr. Neubauer said. "Some centers may be able to negotiate contracts with some sick funds, but coverage still is likely to be limited."

This combination of factors will push the practice of ophthalmology in Germany further along the path of consolidation, he predicted.

"Due to the expected investment and reimbursement issues, I believe that femtosecond laser cataract will increase the concentration process already ongoing in ophthalmology in Germany," he said. "This will mean in the future that only a few centers will remain which can perform surgery at extremely high numbers, while most smaller (-volume) surgeons and centers will disappear."

Greece: Skeptical Surgeons
George Kymionis, MD, PhD, of the Institute of Vision and Optics at the University of Crete, said that most Greek ophthalmologists are skeptical about adding a femtosecond laser to the cataract surgery tool kit because the additional costs would be borne by their patients. 

In a time of recession, the cash-strapped national health system is expected to stick with hand tools and phacoemulsification as the preferred implements of cataract surgery, he said. 

"I definitely would switch to this technology if cost was not an issue and if the laser did not increase patients' costs," Dr. Kymionis said.

His colleague at the Institute, Dimitra Portaliou, MD, agreed. "If cost were not an issue, I would certainly switch to femtosecond laser for all cataract surgery steps, since the incisions are precise and reproducible and since the individual profile created for each eye would refine the method and of course the result," Dr. Portaliou said.

Despite the higher price tag, patient demand eventually might force ophthalmic surgeons to perform femtosecond cataract surgery exclusively, not just on a subset of patients, Dr. Kymionis said.

"All ophthalmic surgeons know that surgery using laser technology is something that patients ask for, and this could be an important reason for surgeons to switch to this technology," Dr. Kymionis said. "The advantages of this technique and patients' demands that we adopt it could outweigh the expensive cost in the near future."

Laser Enables Better Precision
Dr. Kymionis' department is considering purchase of a femtosecond laser. Doctors there plan to use it largely for premium IOL cases. Its precision and accuracy at making incisions and capsulotomies are the reasons, he said.

"This is important, since cataract surgery in the near future will more and more become a refractive procedure. This will create a need for precision due to the new IOLs, such as multifocal and accommodating IOLs. Their benefits in terms of optical rehabilitation mainly depend on optimal surgeries," Dr. Kymionis said.

Steven C. Schallhorn, medical director of the international refractive surgery chain Optical Express, likened the current situation with femtosecond laser cataract surgery to that of phacoemulsification in its early years.

Phaco Was Controversial, Too
"You could have asked the same questions 30 years ago for phaco compared to extracapsular cataract extraction," Dr. Schallhorn said.

"Phaco was more expensive to do than extra-cap. It was technology that you couldn't make in your garage, very high-tech. It took time for that technology to become standard practice," he said. "Now we look at phaco and say, 'That was a no-brainer.'"

The reimbursement issue will slow this transition, but it is inevitable, Dr. Schallhorn predicted.

"It's phenomenal technology. I personally think the patient will benefit from it because we'll have better, more consistent outcomes," he said. "There's no question in my mind that after a number of years, we will be doing cataract surgeries in this way."

Until then, with femtosecond cataract procedures limited to patients who can afford to pay for them, the laser will be cost effective only for certain surgeons, Dr. Rich said.

The Bottom Line Is Key
Dr. Rich suggests that surgeons ask: Do I have enough refractive cataract patients to justify the expense of having the femtosecond laser in my practice?

"If you have a pure refractive practice, where you're doing refractive cataract surgery on people who don't have a medically-covered cataract, you can charge them whatever you want. And for you, having a femtosecond laser would make sense," he said.

But for the nine-physician group in which Dr. Rich practices, it wouldn't make sense, even though they are very busy performing conventional cataract surgeries.

Some U.S. ophthalmologists might be tempted to "hide the cost of using a femtosecond laser somehow in the allowable billing for a premium IOL implant. And I have heard that some industry reps are suggesting this to doctors," Dr. Rich said. "But that seems very risky to me."

"AAO has a responsibility to protect both the patients and our member doctors," he added. "If the companies keep saying these things, we have to let the doctors know they could get into trouble."

References
1. Palanker DV, Blumenkranz MS, Andersen D, et al. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010;2(58):58ra85.
2. Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12):1053-1060.
3. Kessel L, Eskildsen L, van der Poel M, Larsen M. Non-invasive bleaching of the human lens by femtosecond laser photolysis. PLoS ONE. 2010;5(3):e9711.
4. Schumacher S, Fromm M, Oberheide U, Gerten G, Wegener A, Lubatschowski H. In vivo application and imaging of intralenticular femtosecond laser pulses for the restoration of accommodation. J Refract Surg. 2008;24(9):991-995.
5. Schumacher S, Oberheide U, Fromm M, et al. Femtosecond laser induced flexibility change of human donor lenses. Vision Res. 2009;49(14):1853-1859.
6. Lubatschowski H, Schumacher S, Fromm M, et al. Femtosecond lentotomy: generating gliding planes inside the crystalline lens to regain accommodation ability. J Biophotonics. 2010;3(5-6):265-268.  

Conflict of Interest:
Drs. Rich, Neubauer and Kymionis have no financial interests related to femtosecond laser-assisted cataract surgery.
Dr. Schallhorn has no direct financial interest in femtosecond laser surgery. He is a consultant/adviser to Abbott Medical Optics, owner of IntraLase.