FEMTO CATARACT FOR ALL

In 2010 and 2011, early clinical reports convinced Shachar Tauber MD that femtosecond laser-assisted cataract surgery would improve outcomes and reduce complications. But he also believed the technology should be available to all patients – not just those who can pay extra. “If we accept the premise that femtosecond laser surgery is better for the patient, then it’s the right thing to do for all patients,” said Dr Tauber, who is ophthalmology section chair for Mercy Clinic, a multispecialty medical group affiliated with Mercy health system, which operates 32 hospitals and 300 outpatient clinics serving three million people in four south-central US states.

Despite equipment costs approaching $1m, Mercy managers signed on to the all-patient approach because it supported the system’s charitable mission. In March, Mercy opened its new eye and ear clinic in Springfield, Missouri, featuring two cataract surgery suites equipped with Catalys femtosecond laser systems (OptiMedica). Eight months and 2,296 cataract cases later, it’s well on its way to breaking even, without charging a penny extra – even though more than 60 per cent of patients are covered by public insurance. It may be the first clinic in the world to offer femtocataract for all at no extra charge.

Mercy’s financial strength, as well as its expertise in purchasing, process engineering and management, were critical in making it financially possible. That the US Medicare program pays hospitals more than freestanding surgery centres didn’t hurt, either. But as the benefits of femto-cataract surgery, particularly in complicated cases, become clearer, a few surgeons around the world are finding a way to pay, and embracing it as their standard procedure. They believe that costs will eventually come down, and a combination of public and legal pressures could soon make femto-cataract the standard.

Expanding indications

Femtocataract laser manufacturers still recommend excluding most complicated cases. But in the real world, cataract patients are mostly old, and many have co-morbidities, H Burkhard Dick MD, PhD told the annual symposium of the American Society of Cataract and Refractive Surgery in San Francisco. So with Ethics Committee approval, Dr Dick conducted a prospective controlled study comparing safety and outcomes of femto-cataract surgery in complicated patients with a conventional phaco control group at his University Eye Hospital clinic in Bochum, Germany.

Out of 850 consecutive cataract cases, 26 per cent had some co-morbidity, including 91 on anti-coagulants, and 62 with floppy iris syndrome, 55 with corneal guttata, 53 with glaucoma, 40 with small pupils, 38 with pseudoexfoliation and 32 cases of mature cataracts. Among these, seven capsulotomy tags were seen, five in small pupil cases and two in mature cataracts, of which one resulted in an extension. Nine patients on anti-coagulants had minimal conjunctival alterations or conjunctival haemorrhage. No complications were seen in glaucoma patients. “With standard phaco technique we would expect higher complication rates,” Dr Dick noted.

Overall for the 850 cases, 99 per cent of capsulotomies were complete, Dr Dick reported. Effective phaco time was reduced 96 per cent overall, with a 100 per cent reduction in LOCS III grade 2, 98 per cent reduction in grade 3 and 95 per cent reduction in grade 4 using a Stellaris phaco machine. Dr Dick also noted a trend towards less phaco over time. Looking at his entire experience with femto-cataract, he used phaco in 59 per cent of his second 200 cases, but in just nine per cent in cases 1,200 to 1,400, with comparable mean cataract grades. “In my last 100 cases I didn’t need phaco in 97 per cent of cases.”

Less phaco is associated with less endothelial cell damage, less corneal oedema, less inflammation and quicker vision recovery. Dr Dick is currently conducting a contralateral eye study to quantify these effects, but has observed the benefits clinically in patients at risk of corneal decompensation, including those with small pupils, loose zonules, Fuchs' Dystrophy and cornea guttata. Other surgeons report similar results. In a study of 27 eyes in 26 patients, comparing complicated and uncomplicated cases undergoing femto-cataract surgery, Gerd U Auffarth MD, Heidelberg, Germany, reported three cases of transient corneal oedema as well as one case of subconjunctival bleeding in a patient on anti-coagulants and one posterior capsule tear at the end of phaco in a patient with pseudoexfoliation out of 11 patients with hard cataracts and other anterior segment pathologies.

“Complicated cases are suitable for laser refractive cataract surgery. The complication rate is not zero but it is low,” he told the ASCRS symposium. Johann Ohly MD, a glaucoma specialist at Mercy, also believes femto-cataract surgery is easier on delicate eyes. In six months he has operated several eyes with Fuchs' Dystrophy with endothelial cell counts in the 1,400 to 1,500 range, and so far all have been successful with none requiring subsequent transplant. Safety is the major reason Mark Cherny MD, Melbourne, Australia, uses femtocataract for all his cases.

“Just about every complication can be reduced in theory. After 700 cases, my own observation is cases go smoother and there is greater consistency in handling difficult cases. It makes every surgery better.”

Paying for it

But cost remains a significant obstacle to making femtocataract available to all. Including the laser, maintenance, a technician to run the laser, per-case consumables and longer surgery times, Dr Cherny said it adds $800 to $1,000 to his costs, with consumables alone making up $400 to $500. A 2013 survey of more than 200 surgeons by market researcher SM2 Strategic foundreimbursement rules and their own capacity to work within them.

For Dr Dick, public payment restrictions are not an issue because he operates a private clinic. Under Australian rules, Dr Cherny bills patients $300 extra for femtocataract to cover consumables, absorbing the rest of the cost in his professional fee. Under US rules, Mercy breaks even on femto-cataract without charging patients extra. However, as a hospital-owned facility, it has advantages. On average, the US Medicare system paid hospital-based clinics $740 more per case in 2011 than it did free-standing ambulatory surgery centres or ASCs, of which $306 was paid out-of-pocket by patients, according to MedPac, which advises the US Congress. These higher payments are intended to offset higher costs in hospitals for standby emergency services and higher average patient acuity.

Still, the list price for femto-cataract was beyond what Mercy could absorb when Dr Tauber first investigated it in late 2011. But working with system managers, he figured with a volume target of 4,000 cases annually, he could negotiate discounts and improve workflow efficiency enough to break even. With its expertise in purchasing, Mercy approached several laser providers with its concept, and OptiMedica responded with a workable offer, Dr Tauber said. Mercy’s five cataract surgeons also standardised anaesthesia, IOLs and OVDs, and obtained volume discounts that further reduced costs, and eliminated now-unneeded items including some disposable knives.

Initially, femto-laser added about seven minutes to surgical times that had run nine to 10 minutes – more than anticipated. Over three months, this was trimmed three to four minutes with help from Mercy analysts trained in techniques such as Six- Sigma. Surgeons who had cut back to 12 cases a day are back to 16. Kevin Rash, Mercy’s vice president of operations for surgery services, is satisfied with the financial progress. “I’m not losing any sleep over it.”

New standard of care?

Femtocataract is also a hit with patients. Before he received his laser, Dr Cherny gave patients the option of delaying surgery. Despite the anticipated extra charge, many did, and he had a two-month waiting list when the machine arrived. Mercy is having no problem increasing its volume, Dr Tauber said. Continuing medical education for optometrists and its extensive primary care network is building referrals, while consumer outreach has created a buzz.

Dr Cherny believes femto-cataract will become the standard of care. “Once it’s accepted that the laser adds safety, you will have to counsel patients that it is available as an option. All it will take is one malpractice case where the laser wasn’t used.” Many believe femto-cataract will become more affordable. “The cost will come down, but it will take time,” Dr Dick said. The technology may also have the potential to “de-skill” cataract surgery. Some managers in the UK National Health Service, where ophthalmic nurse practitioners already perform Nd:YAG laser capsulotomy and minor surgery such as chalazia, have already toyed with the idea of nurse-led cataract surgery, according to Oliver Findl MD, Vienna, Austria.

But Dr Dick discounts the possibility. “The laser is still surgery. It looks smart like a smart phone but you are still cutting and you are changing the anatomy of the eye. I see no appropriate education in the nurse compared with the medical doctor.”

Still, the technology’s complexity is likely to change cataract practice, Dr Cherny said. Surgeons likely will need to band together to share laser system expenses. “As [ASCRS President] Eric Donnenfeld said, we can no longer afford underutilised surgery centres.” Femto-cataract already has affected referral patterns in his community, and not all his colleagues are happy to see it, Dr Cherny added. “This is a very disruptive technology, but it is here to stay because of the precision it gives to surgeons, and the safety it gives to patients.”