CONTACT LENSES TODAY

October 9, 2005

Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This week CLToday® reaches more than 12,000 readers in 74 countries.


Senate Proposes Less Restriction on CL Distribution
Pending legislation in the U.S. Senate would require contact lens manufacturers to guarantee availability to alternative suppliers, regardless of whether the supplier is affiliated with any prescriber. H.R. 2744 is entitled, “Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006.” Robert F. Bennett (R-Utah) has proposed an amendment (S10314) that would prevent any federal funds from being used for the review, clearance or approval of any contact lens unless the manufacturer certifies the lenses are distributed in a non-discriminatory manner, directly to alternative channels of distribution. This means the FDA would be restricted in reviewing any applications from companies that do not make lenses available directly to all channels of distribution such as mail order houses, internet retailers, pharmacies, buying clubs, and other distribution alternatives.
The author of the proposed amendment notes that this should not be interpreted as waiving any obligation of the seller under the Fairness to Contact Lens Consumers Act, which would also be amended to reflect this change. At press time, the bill had been sent to the Senate conference committee for consideration.  

Tougher U.K. Contact Lens Regulations
An amendment to The Opticians Act, a law that regulates the sale of contact lenses in the United Kingdom, is making news in the country’s business sector. First, Boots Opticians reports a revenue loss of 5 million pounds in the six months prior to Sept. 30th, with sales down by 12%. Boots CEO Richard Baker attributes the slump to changes to the law governing contact lenses, saying the company was forced to cut prices in order to compete with rivals.
Also, the General Optical Council has announced it will sue the online auction site E-bay for “aiding and abetting” the sale of contact lenses without the involvement of a qualified optician. The GOC claims it found over 200 contact lens sales advertised on eBay.co.uk. Sales ranged from prescription daily disposables to cosmetic/plano lenses, which were previously no regulated by the Opticians Act. EBay plans to contest the charges, which will be heard in a London court on October 10.

AOA Paraoptometric Education
The American Optometric Association Paraoptometric Section is sponsoring breakfast continuing education seminars at three upcoming industry meetings. Rebecca Johnson, C.P.O.T, C.OT., C.O.E., founder of the consulting company, Foundation Ophthalmic Training & Development, will present the courses. The seminars will take place on October 13-16 at the Greater Western Council of Optometry (GWCO) meeting, Oct. 27-30 at the East-West Eye Conference in Cleveland and Feb. 22-26 at the Southern Council of Optometrists (SECO) in Atlanta.

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Retisert Reimbursement
The Centers for Medicare and Medicaid Services has designated Bausch & Lomb’s Retisert implant as eligible for Medicare pass-through payment under the Hospital Outpatient Prospective Payment System (OPPS), effective October 1. Using billing HCPCS code C9225, the payment rate to hospitals for Retisert is set at $19,345. The payment methodology is based upon 106% of wholesale acquisition cost. Coding amounts for non-Medicare procedures varies by insurer.

Abstract: Identifying Dry Eye
A group of researchers from the Optometric Technology Group Research & Consultancy in London attempted to identify which questions during history taking were most predictive of dry eye in contact lens wearers and non-wearers. A questionnaire was distributed to 502 daily soft contact lens wearers and 309 non-contact lens wearers. Nearly 43% of soft contact lens wearers were identified as symptomatic versus 15% of non-wearers. Of those, 28% of contact lens wearers reported moderate to severe dry eye compared with 5% in the control group. Questions on frequency of dryness were found to be most predictive of actual dry eye. Among subject who reported never experiencing dryness, 87% of soft contact lens wearers and 95% of wearers were found to have normal tear levels. That number rose to 94% and 99% respectively if the respondents also indicating never experiencing scratchiness or burning. For soft contact lens wearers who reported frequent dryness, 90% were found to be symptomatic, 96% if they responded positively to being sensitive to smoke. Systemic associations were more relevant for non contact lens wearers.
Researchers conclude that frequency of ocular dryness was the most predictive question for detection of dry eye. Scratchiness, burning and sensitivity to cigarette smoke and cosmetics were also indicators.
Guillon M, Maissa C. Dry eye symptomology of soft contact lens wearers and nonwearers. Optom Vis Sci. 2005 Sep;82(9):829-34.


Editor's Commentary: Contact Lenses Legally Purchased at a Gas Station?
Although occasionally contact lenses are sold without a prescription, legislation is pending (H.R. 2744) that would force the FDA "not discriminate in the distribution of, or restrict consumer access to contact lenses and make lenses available directly to all channels of distribution such as mail order houses, internet retailers, pharmacies, buying clubs, and other distribution alternatives." Senator Robert F. Bennett (R-Utah) Chair of the Senate Appropriations Committee has sponsored an amendment to the proposed appropriations bill that contains the above language.
Under these new requirements, a prescription would still be necessary for patients to obtain contact lenses, but manufacturers would have to sell to just about anyone. This could increase contact lens availability without a prescription.
One wonders what prompted such legislation. Certainly it wasn't an interest in increased public health and healthy contact lens wear. Certainly it was economically motivated. Are constituents of the Senator indicating they can't find a place to acquire contact lenses? Or are the alternative vendors asking the Senator to increase contact lens distribution indiscriminately.


Fitting Tip: Ask the Tough Questions
When a patient shows up wearing contact lenses, the interview process should be very detailed. A dedicated amount of time spent asking the appropriate questions will give you clues to how compliant a patient is with his or her wearing schedule. Furthermore, spending time asking these questions also gives the patient the correct perception that contact lenses are important to you, that you consider them something worth the time to sit down and talk about. Here are the questions I ask during an exam:
  • Do you wear soft or RGP lenses?
  • What brand of lens do you wear?
  • What is your average wearing time?
  • What is the maximum amount time you wear your lenses?
  • How often do you sleep in your lenses?
  • What is your lens disposal schedule?
  • What care solution do you use?
Did you notice that I did not ask, "Do you sleep in your lenses?" This is a totally different question than, "How often do you sleep in your lenses?" This will also generate a totally different response! Asking the former question always garners a "No," where the latter will illicit a more truthfully response.
Kevin Gee, O.D., F.A.A.O.
Houston


This month at http://www.siliconehydrogels.org, review the significance of Śmodulus of elasticity‚ as well as the aetiology of soft contact lens-induced superior epithelial arcuate lesions, look into the performance of lotrafilcon B lenses intended for daily, flexible or extended wear, and read a recap of silicone hydrogel-related presentations at the 2005 BCLA conference.
Report adverse contact lens reactions here: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.

Access a reporting form for complications you've seen that were a result of contact lenses dispensed without a valid prescription at the Association of Regulatory Boards of Optometry's (ARBO's) Web site: http://www.arbo.org/arbo.asp?dt=R&doc=Complications. Complete and send the form online or print it out and fax it to (866) 886-6164.

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