May 19, 2005 – The announcement by Medicare on May 3 that beneficiaries
now may choose a cataract replacement lens that corrects close,
intermediate and distance vision, rather than just the lens for
distance vision correction, has caused excitement among senior citizens,
eye doctors and certainly at the companies that makes the approved
intraocular lens (IOL).
Crystalens, made by Eyeonics, Inc., is the only FDA-approved
“naturally focusing vision-correction” lens replacement for adults
with cataracts and presbyopia, says the company. Eyeonics claims
they led the way in affecting this policy change, working with U.S.
Congressman Christopher Cox ( Newport Beach, Calif. ), the Centers
for Medicare & Medicaid Services, physicians and ophthalmic industry
leaders.
"More than 2.2 million cataract surgeries are performed each
year on patients age 65 and over," said J. Andy Corley, co-founder,
chairman and CEO of Eyeonics. "Yet as vision technologies advanced,
Medicare reimbursement did not keep pace."
"We applaud CMS for its decision to allow Medicare patients access
to new technologies, like the recently approved AcrySof(R) ReSTOR(R)
IOL," said Cary Rayment, chairman, president and chief executive
officer, Alcon, Inc. "Physicians and patients now have the freedom
to select technology to treat cataracts consistent with the patient's
lifestyle needs."
Approved on March 21 by the FDA, AcrySof(R) ReSTOR(R) is “the
first and only IOL that uses apodized diffractive technology to
provide cataract patients with and without presbyopia a quality
range of vision,” the company said. In clinical trials, 80 percent
of AcrySof(R) ReSTOR(R) patients reported never wearing reading
glasses or bifocals following bilateral cataract surgery.
"This policy change means that patients will have the right to
choose a vision correction technology that best meets their lifestyle
and visual demands. It also gives doctors the freedom to offer innovative
technologies such as the crystalens for their Medicare patients,"
said ophthalmologist Steven J. Dell, MD, of the Texan Eye Care in
Austin, Texas.
“The CMS ruling now opens the path for senior citizens, the same
quality of premier care and quality vision as Lasik patients have
enjoyed for a decade,” said Dr.Kerry Assil, of the Assil Sinskey
Institute in Santa Monica, CA, a pioneer in modern cataract surgery
and the primary investigator for the FDA, specializing in testing
for lenses such as the ones used in this surgery. He is also frequently
seen on television news as an expert reference and was the eye doctor
on the FOX reality show “The Swan.”
Another eye doctor who regularly does cataract surgery said he
is approaching the multi-focal lenses with caution. “I would like
to see a higher patient satisfaction level,” he said.
The catch is that the new choice doesn’t come without a price.
The IOL is designed to treat two conditions: cataract removal
with lens replacement ( a procedure covered by Medicare ) and presbyopia
( a non-covered service ). Patients who select IOL will receive
the standard Medicare reimbursement for cataract surgery, and can
now pay privately for the presbyopic portion of the treatment, which
is estimated at about $2,500.
Medicare patients were excluded from receiving this type of lens
before this ruling due to these lenses being produced at a greater
cost than Medicare was willing to pay. They were not allowed for
Medicare patients, even if they paid the extra cost.
Presbyopia is an inevitable age-related eye condition that makes
it difficult to read or see objects up-close without the use of
reading glasses. Presbyopia is the first sign of a cataract and
is the most prevalent eye condition in America. It causes the crystalline
lens to increasingly stiffen, lose flexibility and cloud, diminishing
its focusing ability.
These lens correct vision at all distances and in most cases
eliminates the need for glasses and contacts for everyday tasks.
Its ability to focus at all distances frees most patients from the
need for glasses following cataract surgery. In clinical trials,
nearly three-times the number of patients ( 85 percent ) who received
the crystalens could see at all distances compared to a standard
IOL, according to the company.
Eye doctors see this as a business boom that is a good reason
to hang on to Medicare patients that many had considered dropping
due to Medicare payment levels.
The vast majority of cataract surgery patients - over two million
a year - are on Medicare, since the problem usually develops late
in life. A cataract is a clouding of the eye’s lens that usually
occurs as part of the aging process. Cataracts affect about 50%
of Americans between the age of 65 and 75, and nearly 70% of people
over 75.
Not all cataracts require surgery and the presence of cataracts
does not always produce impairments, therefore cataract surgery
should only be performed if the patient chooses.
About Crystalens
The crystalens is the result of more than 14 years of research
and development by J. Stuart Cumming, M.D., F.A.C.S., and was approved
by the FDA in November 2003. More than 24,000 lenses have been implanted
worldwide to date. During clinical trials, all of the patients who
received the crystalens greatly reduced their need for corrective
lenses or eyeglasses. The patented crystalens technology is designed
to allow the lens to move in the eye in a manner similar to the
natural lens. By using the eye's muscle to move the lens back and
forwards naturally, patients can focus through a continuous range
of vision including near, far and everywhere in between. All other
intraocular lenses are designed to remain fixed in the eye. For
more information about the crystalens go to http://www.crystalens.com
About AcrySof(R) ReSTOR(R) IOL
The AcrySof(R) ReSTOR(R) IOL features a unique, proprietary apodized
diffractive optic design that provides the ability to focus images
from various distances correctly on the retina without mechanical
movement of the lens. This optic design results in an increased
range of quality vision that delivers a high level of spectacle
freedom. Apodization improves image quality by optimizing light
energy delivered to the retina by distributing the appropriate amounts
of light to near and distant focal points, regardless of lighting
situation. This new IOL is particularly well-suited for patients
who wish to reduce their dependency on reading glasses and bifocals
once their cataractous lens is removed. For more information on
Alcon, Inc., visit the company's Web site at www.alconinc.com.
