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British committee wants crackdown on eye centers

Market Scope

A British parliamentary panel is asking for a sweeping crackdown of eye surgery centers, making Great Britain the most regulated market in the world.

The report, released on Dec. 15, calls for major changes in handling patients as well as introduction of annual inspections of eye surgery centers, clinical outcomes reporting and licensing, among other things.

The changes would be overseen by the UK government's Healthcare Commission and by the Royal College of Ophthalmology, representing the specialty. Centers would pay three new sets of new fees to cover the oversight and pay for the medical care of patients who have complications from eye surgery. The size of the fees has not been proposed yet.

The report was prepared by four members of Parliament, based on recent hearings with 18 experts, including ophthalmologists, eye surgeons, regulators and critics of eye surgery.

Rather than propose legislation any time soon, the MPs first want to refine their proposals with the British Department of Health, said Gwyneth Dunwoody , the leading member of the panel, in an e-mail message. The panel also wants to ask the 25-nation European Union to adopt its recommendations.

Representatives of the eye surgery industry, which has sales of $191 million a year and includes seven chains, say the report is an overreaction and they hope for a better hearing with the Department of Health.

The authors of the report are “a self-appointed group of members of Parliament who had no government brief to do this,” says Emanuel Rosen , an eye surgeon near Manchester who testified to the panel. “They decided as sort of semi-authorities that, in the public interest, they had better look into this.”

Christopher Neave , chairman of the Eye Laser Association who also testified, said in an e-mail message that his group “looks forward to a close dialogue with the Department of Health.”

Neave added that formulating new regulations “may take some time” and could be postponed until after the next national election, which is expected in May 2005.

Major recommendations

In the area of patient relations, the parliamentary report would require a standardized handout and consent form, advertising standards that include warnings about complications, and limits on who can qualify for eye surgery. The panel says only patients with prescriptions between a range of + 3 to – 8 should be routinely operated on.

Also, clinics would have to give candidates cooling-off periods of three days between counseling and signing the consent form and then seven more days between signing and going in for surgery.

The proposal would allow only certified subspecialists to perform eye surgery, require continuing medical education for them and set up new licensing for all practitioners and clinics.

Clinics would be inspected annually and be required to report their surgical outcomes, which would be published annually.

The plan would also set up guidelines for payments to optometrists to avoid kickbacks for referrals.

Seen as part of a British backlash

The report was released at about the same time as a stinging report by the National Institute for Clinical Excellence, an advisory group that concluded that eye surgery is not safe enough to be considered “a routine alternative” to glasses or contact lenses.

Echoing the Nice report, the parliamentary report raised concerns about lack of supervision of clinics and found cases of non-ophthalmologists performing eye surgery.

But Rosen says both reports and newspaper stories on eye surgery have overstated the problem. For example, he says eye centers have been accused of a 10% failure rate, but that figure includes “enhancements” in a second operation to adjust the eyes.

Rosen conceded that some proposals by the parliamentary panel made sense, such as issuing indications for laser eye surgery and limiting advertising. But he objects to the sheer amount of oversight, noting that “we're becoming a ‘nanny state' – they're trying to regulate everything.”

Reporting clinical outcomes data is “a laudable goal” but “the data is a bit difficult to interpret,” he said. He added that eye surgeons do not need more training, because “laser surgery is probably more intensively taught then practically any other branch of medicine.”

He said many clinics such as his own generally use cooling-off periods, but he objects to setting limits into law. Patients who come to clinics have already done extensive research on the internet and other sources and some “have to travel long distances,” which makes it impractical t come back several times, he said.

Rather than extensive oversight, Rosen said a more effective regulator is “the fear of being sued.”

“There have been a spate of lawsuits (in the UK ) and the professional indemnity subscriptions have shot up,” he said. “This has a good side because it makes (practitioners) stop and think and limit what they do. That's the best regulator of all.”

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