Mistakes with LASIK are costing ophthalmologists lots of money, but it
could be worse, according to preliminary results of a
first-of-its-kind study.
The landmark study, by the world's largest insurer of ophthalmologists
- the U.S.-based Ophthalmic Mutual Insurance Company (OMIC) - has
found that LASIK mistakes are costing an average of about $50,000
each.
That figure compares to average pay out of about $130,000 for
malpractice claims involving all types of ophthalmic procedures,
according to the company, which covers 2,400 members of the American
Academy of Ophthalmology.
<"So far, the risk of LASIK has been worse than the reality,"> says
Paul Weber, OMIC's risk manager. "We are not seeing actual losses in
LASIK that are any greater than any other procedure being done in the
United States. In fact, we are seeing that the average cost of a LASIK
claim is actually less than that of more frequently performed
procedures, such as cataract and retinal surgery."
Among the most frequently cited reasons for LASIK malpractice lawsuits
are patient complaints of post-operative halos, glare and pain, Mr.
Weber adds. As a result, out-of-court settlements and in-court pay
outs aren't generally as expensive as in other surgical procedures
where a patient could suffer a catastrophic injury.
"A LASIK injury is a little nebulous," Mr. Weber says. "It's not like
an ‘eye in the bottle case' where a lawyer stands up with the
patient's eye in a bottle and points to the ophthalmologist and says,
‘If it were not for the negligence of this doctor, this eyeball would
be in the head of the patient before you."
Despite the relatively good news about the cost of LASIK claims, Mr.
Weber isn't counting any chickens just yet.
Because the study represents only a few years' worth of malpractice
claims, it is difficult to predict whether the trend will continue,
says Mr. Weber. In fact, the trend probably will get worse because
costlier claims usually take longer to settle or come to court. Of the
55 LASIK malpractice claims filed against the company's
ophthalmologists, only about one-third have been closed, according to
the study.
Also, OMIC officials expect increasing numbers of ophthalmologists to
use LASIK - thus exposing the company to even more risk of malpractice
suits. Currently, the company has certified coverage for about 40 per
cent of the OMIC'S ophthalmologists to perform refractive procedures,
including LASIK.
So far, the statistics bear out the rise in LASIK malpractice claims.
In 1999, LASIK claims accounted for about 10 percent of all of OMIC's
ongoing malpractice claims. In 2000, that figure rose to 13 percent.
In the first six months of 2001, LASIK accounted for 19 percent of the
company's ongoing claims.
The company, which covers ophthalmologists across the United States,
charges an annual premium that reflects the risk of being sued and the
average pay out for such lawsuits in a given geographic area
As a result, an ophthalmologist in some parts of California pays as
little as $3,000 a year for the same level of insurance coverage that
costs an ophthalmologist in Miami, Florida more than $20,000 a year.
The largest award for LASIK malpractice to date - of just over $1
million - arose after an American ophthalmologist - who was not
insured by OMIC - operated on a patient with bilateral hyperopia. (See
related story for details.)
Despite the added exposure from LASIK, the company has refused to
charge its ophthalmologists any extra premium for performing LASIK or
any other refractive procedure, says Jim Holzer, OMIC's chief
executive officer.
"We do not surcharge doctors for doing LASIK because we feel the
control isn't a financial one - it's a practice management one," Mr.
Holzer says. "And proper practice management entails looking at
patient selection, communicating with patients to ensure that they
have realistic expectations, and informed consent - which is also
about communicating the realities of the procedure."
In deciding whether to extend coverage for LASIK to an ophthalmologist
already covered for traditional procedures, the company also takes
into account the number of LASIK procedures that the ophthalmologist
usually performs, Mr. Holzer adds.
"We used to be concerned about the cataract mill; now the worry is the
LASIK mill," he says. "Any procedure that is performed at high volume
and is the only one of its kind performed in a practice is certainly a
red flag for a malpractice underwriter. And, as a result, often we
will not underwrite such a practice."
Detailed results of the LASIK study, which are currently being
reviewed by the chairman of the company's underwriting committee,
Richard L. Abbott, MD, are expected later this year,
So far, a preliminary review of the OMIC study indicates that many
claims arose because ophthalmologists failed to follow the company's
practice management guidelines. The most common causes for the
malpractice claims included:
• Errors in programming the laser, which resulted in overcorrection or
astigmatism;
• Improper patient selection, which resulted in intraoperative flap
complications and poor outcome;
• Postoperative failure to diagnose or delay in diagnosing
complications.
LASIK guidelines can reduce risk of errors - and lawsuits
To obtain malpractice insurance coverage for LASIK from the Ophthalmic
Mutual Insurance Company, American ophthalmologists must ensure that
they follow a number of rules:
• Surgeon must be certified on the laser to be used as well as be
certified for LASIK;
• Patient must be at least 18 years old, with stable refraction
without contact lenses;
• Criteria for the degree of patient astigmatism, myopia, or
hyperopia, must fall within guidelines set down by U.S. Food and Drug
Administration. Off-label treatment of up to 6.0D astigmatism, -15.0D
myopia, and +6.0D hyperopia permitted subject to special consent
language;
• Surgeon must personally conduct informed consent discussion with
patient about LASIK;
• Surgeon must document in medical record that the risks and benefits
of LASIK - as well as any alternatives to LASIK - were discussed with
the patient as part of the consent process;
• Surgeon must offer each patient a copy of the consent form to take
home and consider before agreeing to the procedure;
Bilateral simultaneous LASIK is permitted if the surgeon has previous
LASIK experience of at least 10 such cases and the patient signs a
special consent form;
Surgeons must follow government guidelines that prohibit ads that
mislead the patient about expectations from LASIK or that guarantee
results. For example, ophthalmologists should not boast that patients
can throw away their glasses after LASIK or that the procedure is
always fast, easy, or painless. Also ophthalmologists should not claim
that LASIK will last a lifetime or offer patients their money back if
it doesn't.
Since 1999 OMEC has had 55 LASIK claims made against a total of about
960 ophthalmologists covered for LASIK. Where are these "thousands"
of malpractice cases the zealots keep telling us about? I know this
is only one company, but even if you applied this percentage of 6% to
the estimated 6,000 US ophthalmologists doing refractive surgery, that
would still be about 360 malpractice claims out of over 5 million
surgeries.
Of course malpractice is one thing and the presence of an unresolved
complication is another. Everyone should be mindful that about 3% of
all refractive surgery patients have some sort of unresolved problem
at six months postop, with about 0.5% being catastrophic problems.
The presence of a complication does not necessarily mean the presence
of malpractice.
Currently an average payout of $50k when other procedures' average is
$130k doesn't seem to support the zealots either. At least not yet.
One can expect that number to rise as the big cases come up, but the
extent of the payout tends to indicate the extent of the damage, and
thus far damage caused by malpractice during LASIK is less than 40% of
the average non-LASIK claim. Again, where is evidence of the massive
damage the zealots claim?
>The largest award for LASIK malpractice to date - of just over $1
>million - arose after an American ophthalmologist - who was not
>insured by OMIC - operated on a patient with bilateral hyperopia. (See
>related story for details.)
They must mean the largest LASIK malpractice claim that is fully
settled. The Post v. UPI case in Arizona had a jury award the patient
85% of $4 million, but that case is being appealed. This statement
was not artfully written.
> Mr.
>Holzer says. "And proper practice management entails looking at
>patient selection, communicating with patients to ensure that they
>have realistic expectations, and informed consent - which is also
>about communicating the realities of the procedure."
You go Holzer! Even if the reason is to lower malpractice exposure,
good practice management, patient selection, and communicating with
patients about expectations should always be encouraged.
>The most common causes for the
>malpractice claims included:
>• Errors in programming the laser, which resulted in overcorrection or
>astigmatism;
>• Improper patient selection, which resulted in intraoperative flap
>complications and poor outcome;
>• Postoperative failure to diagnose or delay in diagnosing
>complications.
An affirmation of my position that LASIK malpractice is preventable
with proper preoperative evaluation, intraoperative technique, and
knowledgeable care.
>• Surgeon must be certified on the laser to be used as well as be
>certified for LASIK;
This is not us folks. Laser certification for LASIK is a course,
sometimes on a weekend, provided by the laser manufacture. After the
doctor provides a copy of the chart of one LASIK patient, the doctor
is "certified" by the laser manufacturer. That certification is for
life, although there is continuing education.
Yes, in theory a doctor could know just about nothing on Monday, take
the course, do a case on Friday, and celebrate being a "certified"
LASIK surgeon that weekend. Yet another reason to use our 50 Tough
Questions For Your Doctor to evaluate a potential surgeon.
>(To be covered by OMIC) Surgeons must follow government
>guidelines that prohibit ads that
>mislead the patient about expectations from LASIK or that guarantee
>results. For example, ophthalmologists should not boast that patients
>can throw away their glasses after LASIK or that the procedure is
>always fast, easy, or painless. Also ophthalmologists should not claim
>that LASIK will last a lifetime or offer patients their money back if
>it doesn't.
Well, we know there are some ophthalmologists who will never be
insured by OMEC.
LASIK is not perfect, is not for everybody, has complications, and
some of those complications are due to malpractice, but this article
does not IMO support the zealots' claims that LASIK is some sort of
public health crisis.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.