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Thread: Mandatory CL Release Law

  1. #1
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    Exclamation Mandatory CL Release Law

    The federal government is fast tracking a mandatory CL release law that will require the release of a valid CL Rx at the end of every CL fitting, with a $10,000 fine for those who "forget" to release the Rx. Some info is here:

    http://biz.yahoo.com/rc/031001/health_contacts_1.html

    The proposed text is as follows (but may have been somewhat ammeded over the past few weeks): ===========================================

    The Bill is H.R. 2221, and here it is as of 10/3/2003:

    108th CONGRESS

    1st Session

    H. R. 2221
    To provide for availability of contact lens prescriptions to patients,
    and for other purposes.

    IN THE HOUSE OF REPRESENTATIVES

    May 22, 2003
    Mr. BURR (for himself, Mr. TAUZIN, Mr. SENSENBRENNER, and Mr. MATHESON) introduced the following bill; which was referred to the Committee on Energy and Commerce

    ----------------------------------------------------------------------

    A BILL
    To provide for availability of contact lens prescriptions to patients,
    and for other purposes.

    Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

    SECTION 1. SHORT TITLE.

    This Act may be cited as the `Fairness to Contact Lens Consumers Act'.

    SEC. 2. AVAILABILITY OF CONTACT LENS PRESCRIPTIONS TO PATIENTS.

    (a) IN GENERAL- Upon completion of a contact lens fitting, a
    prescriber--

    (1) whether or not requested by the patient, shall provide to the
    patient a copy of the contact lens prescription; and

    (2) shall, as directed by any person designated to act on behalf of the patient, provide or verify the contact lens prescription by electronic or other means.

    (b) LIMITATIONS- A prescriber may not--

    (1) require purchase of contact lenses from the prescriber or from
    another person as a condition of providing a copy of a prescription or verification of a prescription under subsection (a);

    (2) require payment in addition to the examination fee as a condition of providing a copy of a prescription or verification of a prescription under subsection (a); or

    (3) require the patient to sign a waiver or release as a condition of verifying or releasing a prescription.

    SEC. 3. EXPIRATION OF CONTACT LENS PRESCRIPTIONS.

    A contact lens prescription shall expire--

    (1) on the date specified by the law of the State involved, if that date is one year or more after the issue date of the prescription;

    (2) not less than one year after the issue date of the prescription if such State law specifies no date or a date that is less than one year after the issue date of the prescription; or

    (3) notwithstanding paragraphs (1) and (2), on the date specified by the prescriber, if that date is based on the medical judgment of the prescriber with respect to the ocular health of the patient.

    SEC. 4. CONTENT OF ADVERTISEMENTS AND OTHER REPRESENTATIONS.

    Any person that engages in the manufacture, processing, assembly, sale, offering for sale, or distribution of contact lenses may not represent, by advertisement, sales presentation, or otherwise, that contact lenses may be obtained without a prescription.


    SEC. 5. PROHIBITION OF CERTAIN WAIVERS.

    A prescriber may not place on the prescription, or require the patient to sign, or deliver to the patient a form or notice waiving or disclaiming the liability or responsibility of the prescriber for the
    accuracy of the eye examination.

    SEC. 6. VIOLATIONS.

    Any violation of this Act shall be treated as a violation of a rule
    under section 18 of the Federal Trade Commission Act (15 U.S.C. 57a) regarding unfair or deceptive acts or practices.

    SEC. 7. STUDY AND REPORT.

    (a) STUDY- The Federal Trade Commission shall undertake a study to examine the strength of competition in the sale of prescription contact lenses. The study shall include an examination of the following issues:

    (1) The States that have laws that require active or passive
    verification for the sale of contact lenses.

    (2) With respect to the States that require active verification, the
    practices of prescribers in complying with State law, the effect of
    noncompliance, and the harm to competition and consumers that results from noncompliance.

    (3) With respect to the States that require active verification, the
    level of enforcement and any problems relating to enforcement.

    (4) The impact on competition of verification standards adopted by retail sellers of prescription contact lenses.

    (5) With respect to States that require passive verification or have no applicable verification laws, the possible effect of such laws or lack thereof on the ocular health of patients. In addition, the effect of such laws or lack thereof on compliance by sellers in confirming valid contact lens prescriptions, including expiration dates. The Commission shall consult the Food and Drug Administration on this particular issue.

    (6) The incidence, if any, of contact lens prescriptions that specify
    brand name or custom labeled contact lenses, the reasons for the incidence, and the effect on consumers and competition.

    (7) Any other issue that has an impact on competition in the sale of prescription contact lenses.

    (b) REPORT- Not later than 9 months after the date of the enactment of this Act, the Chairman of the Federal Trade Commission shall submit to the Congress a report of the study required by subsection (a).

    SEC. 8. DEFINITIONS.

    As used in this Act:

    (1) CONTACT LENS FITTING- The term `contact lens fitting' means the process that begins after the initial eye examination and ends when the prescriber is satisfied that a successful fit has been achieved or, in the case of a renewal prescription, ends when the prescriber determines that no change in prescription is required, and such term may include--

    (A) an examination to determine lens specifications;

    (B) except in the case of a renewal of a prescription, an initial
    evaluation of the fit of the lens on the eye; and

    (C) medically necessary followup examinations.

    (2) PRESCRIBER- The term `prescriber' means, with respect to contact lens prescriptions, an ophthalmologist, optometrist, or other person permitted under State law to issue prescriptions for contact lenses in compliance with any applicable requirements established by the Food and Drug Administration.

    (3) CONTACT LENS PRESCRIPTION- The term `contact lens prescription' means a prescription, issued in accordance with State and Federal law, that contains the specifications necessary for a patient to obtain contact lenses and may include such items as the following:

    (A) The name of the patient.

    (B) The date of the examination.

    (C) The issue date and the expiration date of the prescription.

    (D) A clear notation contact lenses are suitable for the patient.

    (E) The parameters and instructions that are necessary for manufacture and duplication of the lenses.

    (F) The name, postal address, telephone number, and facsimile telephone number of the prescriber.

    (G) The expiration date of the prescription.

    SEC. 9. EFFECTIVE DATE.

    This Act shall take effect 60 days after the date of the enactment of this Act.

    -----------------------------------------------------------------

    It's interesting to note that a fitter who violates the rule can be fined up to $10,000, yet a distributer/dispenser who ignores the rule and fills an order without a valid Rx, also in violation of the law, will not.

    If you fit an RGP that takes a few set of lenses, when you get to what you consider the final Rx, you must give the patient an Rx and let him decide if you or another entity should fill the Rx.

    UPDATE: The newest version of this bill is at this link:

    http://energycommerce.house.gov/108/...03/3140sub.pdf
    Last edited by Foveator; 10-20-2003 at 10:02 PM.

  2. #2
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    Foveator:

    Note the wording of the law: Fitter is not described only precriber. If you write Rx: Usual spectacle Rx + the words "O.K. for contact lenses" The fitting is left in the hand of whomever supplies the contact lenses. He is not a "precriber" so has no obligation to furnish contact lens specifications to anyone.

    You might want to make friends with your local indepenent optician/contact lens fitter.

    Chip

    At least you cut Linda Carter out of the loop.

  3. #3
    Master OptiBoarder LENNY's Avatar
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    So how is it going o work in reality?
    We are going to go throug 3 sets of toric or RGP lenses to make patient comfortable and then release the rx to 1 800 to fill.
    My fees would triple right away and let them themselves fit cLs

    And by the way i love an RX with -2.00 cyl and OK for contact lenses ( patient thinks he was fitted for CLs)

  4. #4
    OptiBoard Professional Dannyboy's Avatar
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    The cost of fittings will undoubtly go up. I see no way on earth labs taking lenses back. The labs have such liberal returns because 100% of the times the patient ends up buying the lenses, but if the patient only wants the prescription that courtsey will end. We will now have to take into account the cost of lenses during the fit. warranties will end.

    As far as ODs and MDs fitting lenses, this may become a thing of the past. It may fall more on the shoulders of opticians just as glasses do. How many ODs or MDs actually do eyeglasses dispensing personally? Few if any.

    Wonder what they mean :

    or other person permitted under State law to issue prescriptions for contact lenses
    Dannyboy:drop:

  5. #5
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    Lenny:

    True...your fitting fees will increase, but then you can GIVE the lenses away for free.

    Example:

    Now:

    Fitting= $100
    Contacts= $100


    If new law:

    Fitting= $225
    Contacts= N/C to our loyal customers.

    "Oh, and by the way, here's a copy of you prescription, plus a $25 gift certificate towards sunglasses. Oh, and incidentally, you are under no obligation whatsoever to accept our free contact lenses. You are free to call Linda Carter if you'd rather buy them."


    It's not the end of the world, it's the beginning !

  6. #6
    OptiBoard Professional Dannyboy's Avatar
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    good idea....:D

  7. #7
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    Dannyboy and Johns,
    I agree, Contact lens fitters should be making a living on the services they provide not the lenses they sell. The mark up on lenses has been gone for a long time. Fitters should have started doing this long ago and gradually gotten the fees to a respectable level. Changing fees dramatically overnight may cause a little backlash and explaining to all the patients.

    As noted before that dispensers who sell lenses to patients with expired or no prescriptions are not subject to fines. I think the bill should add fines for dispensers who violate dispensing laws. If you contact your legislator ask them to add that to the bill.

    Life is too short to drink cheap beer.:cheers:

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    Now as long as we are fussing about this, I don't know why since contact lenses haven't been profitable enough to fool with for the last decade but:

    If you are a fitter who designs his own lenses, can modify the rigid ones in the office, provides follow-up care as part of his services, you are indeed entittled to a fee.

    If you " Take K readings, consult a chart for soft lenses, and send the Rx and K's to the lab for them to design rigid lenses. What is the fitting fee for 15 seconds to take the K readings which any semi-intelligent person can be taught to measure in a few minites?

    Get real, write the Rx, let the supplier figure out the fit an charge for trouble shooting follow-ups through the nose. You're already getting $ 100.00 for a 5 minite eye exam and contact lens exam need consist of no more than a standard eye exam + K readings.

    While we are at it what is a "complete eye exam" is the such a thing perpetrated on the public as an "incomplete eye exam?"

    Chip

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    Chip,

    I've wondered that myself! To some establishments, "complete" could mean the bare miminum required by law or insurance or cover-your-behind. To other establishments, it could mean the doctor does many more tests than the bare minimum. It would be interesting to ask them how they define "complete exam."

  10. #10
    Master OptiBoarder LENNY's Avatar
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    So the package idea sounds good and it is used in a lot of chain stores near us. Unfortunately this does not work well all the time, especialy in disposables.
    But charging more for exam and giving CL for almost cost is a good idea

  11. #11
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    chip anderson said:
    Get real, write the Rx, let the supplier figure out the fit an charge for trouble shooting follow-ups through the nose. You're already getting $ 100.00 for a 5 minite eye exam and contact lens exam need consist of no more than a standard eye exam + K readings.

    Chip
    But when the customer asks you for the lens parameters BEFORE you dispense the contacts and decides to get them from the internet instead, you're stuck. It doesn't matter who "fit" the lenses; you may not actually be the "dispenser" after all. The language seems vague and different interpretations are bound to surface.

    BTW, I've been folllowing this same discussion over on an OD board, and I'm quite surprised that a group of ODs just don't care. They said that mandatory CL Rx release is good and, essentially, what's the big deal?

    I noticed that it's mainly the recent OD grads who don't see a problem with this. They don't fit complex toric, bifocal or RGP cases. They aren't exposed to custom labs who can tweak specifications to perfection. I'm sure they've never modified a lens themselves. To them, this is a disposable lens bill. An Rx for a simple commodity box of disposable lenses, which might as well be over-the-counter. In fact, I expect this bill to be the first step in the cascade of changes leading to contacts becoming an over-the-counter product, available everywhere. It will be a windfall for manufacturers, nothing for dispensers.

    Do new newly minted LO's feel the same way as the new OD's?

    PS $100 for a 5 minute exam x 12 patients an hour is $1200 or $9,600 per day or, conservatively, $1,900,000 per year just doing exams. If this business model exsits anywhere, I haven't found it. According to a salary website, average ophthalmology MD's earn $150-200,000 per year; ODs about half.
    Last edited by Foveator; 10-24-2003 at 11:03 AM.

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    IMO, this bill was written with only the 2-week or daily disposable CL in mind. The majority of CL wearers wear disposables, and this bill was written for them and for the mail order places who are putting pressure on legislators.

    We need to write our congressmen (& women!) to tell them this is a bad bill.

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    This is going to make the internet providers really happy! I'm sure the exam fees will go up in response, to make up for the lost sales.

    shutterbug

  14. #14
    OptiBoard Professional Dannyboy's Avatar
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    I can see how the young ODs really do not care about contact lenses because they have practiced in an era in which corporate optometry is going strong. They have parity with ophthalmology and can expand into medical areas that actually pay better than "fitting" contact lenses. For these young ODs contact lenses are disposables, a minute of thinking and an extra $20 buck in their exam fees. They can live wihout cls.

    I tend to agree with Chip about the prescription being the spectacle Rx with an OK for contact lenses, but then if the industry turns towards this type of "fitter" who is not to say that the definition of prescriber will not include opticians who determine the parameters? It will be interesting what rules the FTC with respect to opticians who actually fit contact lenses.



    Dannyboy

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    Don't laugh but the day will come when you have to write Rx including: Bifocal type, PD, Potential frame size and seg. ht., I know mail order glasses are on the net now, but soon things will get ugly if the present mail order house can show the idiots (translation liberals) in congress: "How much the consumer has saved with mail order contacts."

    See what happens whe a few folks get too gready and things are taken to their "logical" conculsion.

    Chip

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    Foveator: Whoever gave you that quote on OMD's income must have been concidering teaching positions and salary alone (not private patients and surgery done on thier "fifth day." Ask any divorce lawyer who has had to dig an find the good doctor's "hidden income and assetts" very few OMD's make less that 500K and those are usually the semi-retired type. I personally know dozens who make over a million some over two.

    I also know that when I was on the board of "Save Sight Mississippi" we couldn't find an O.D., an O.M.D., practiceing , retired, semi-retired drunk, druggie, or sober any type with a license to examine for the mobile examination unit at $ 500 a day ($100,000 yr.)

    Chip

    Note: We are in the poorest state in the country with the lowest per capita income and we still couldn't find help. When we called the state board of optometry we were told: "The lowest these guys start at just out of school is 100K+.

  17. #17
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    Wow!

    I'm moving down.

    Around here, OD per diem positions run anywhere from $300 to $400 tops. $500 is unheard of. Some positions will guarantee $300+ with a percentage of the gross above a certain threshhold. The only place I know where you can do much more than that is a commercial location where exams are cranked out as fast as possible.

    You would have had MANY takers for $500 around here. I volunteer (for free) for the Lions and Prevent Blindness screenings because 1) I'm in private practice and it helps me become better known 2) I believe in the ideals of these organizations and feel screenings are part of what I can do to help the community and 3) it's the right thing to do. That being said, I just turned 50. I wonder how many 20-something and 30-something year old docs are as committed to their profession as us older ones? This thread shows that a lot of the newer docs just don't care about serious issues facing the professions -- or they don't yet understand the consequences. Someday they will, but it may be too late.

    Some MDs volunteer for the screenings too. I'm amazed that you couldn't find a doc to participate.

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    Chip, I respectfully disagree. Getting spectacles over the internet will never approach what CL over the internet has become, because people can't see what they look like with the frame on, or feel how well they fit.

    We have people who like a frame, but not the color. I will tell them what other colors are available. If we don't have the color on hand, they often want us to order the frame in the desired color for them to look at because they can't visualize what the other color looks like on them. Mail order couldn't be effective in dealing with that.

    Also, there is no way an Rx could specify a seg height, since that is dependent on the frame chosen.

  19. #19
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    Paw:

    We both know there are in office and on line services that can superimpose a frame on a face via video camera. Seg. ht. could be determined in the same way. Watch out someone like dip will try to "protect the consumer" and it will come.

    Chip

  20. #20
    sub specie aeternitatis Pete Hanlin's Avatar
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    This bill isn't exactly a new idea with legislators. As I recall, the FDA has been telling the State Attorney offices not to vigorously enforce actions against the 1-800 services for some time now.

    As for mandating that the Rx must be released, I think it actually removes some liability from the eye care provider. After all, as long as a statement is given to the patient along with the Rx stating that follow-up care is essential for safe CL wear, the OD/MD is a bit off the hook if something does go awry with a purchase made outside the office.

    Finally, the OD/MD profession has brought this law upon themselves- in my humble estimation. I think we all know the practices that were put into place to avoid having an Rx "walk." Stuff like- "Oh, we need to have you sign a release form," or "the doctor has to sign off on the release of the Rx." Nothing wrong in principle with these practices- in fact, some are required by law. However, it always seemed like it took forever to get around to approving the release of the Rx or responding to the release form... I've seen some offices where properly signed release forms that were sent by a 1-800 were simply ignored or discarded. In other words, making the Rx difficult to obtain was used as leverage to make purchasing the contacts "in house" more convenient. I think this- more than anything else- is what has prompted this kind of legislation.

    Anyway, there is zero money in soft contacts at this stage- so the point is really moot. The 1-800 companies aren't going to be interested in selling the RGPs because they aren't "mass produced" commodity items. Also, the returns and service on these lenses doesn't fit into the 1-800 business plan.

    So, the OD/MD is left to make his or her fees on the services and then give their findings to the patient so s/he can make a decision regarding where to purchase product. What a novel concept- naturally, this is meant with some sarcasm as this is the way it is done everywhere else in the healthcare industry already! Of course, if there is a problem with the outside-purchased product, I hope the patient doesn't expect the eye care practitioner to remedy the problem without charging an office visit!

  21. #21
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    Contact Lens "Rx"

    Hello Everyone,

    When I fit contact lenses ( a while back, in Massachusetts), there was some debate over exactly what is entailed in a contact lens Rx.

    We worked under two assumptions:

    1. A prescription must include sphere, cylinder, and axis.

    2. The brand or type of lenses I chose to fit (i.e. Acuvue, 8.6 BC, 14.0 Diameter), was MY OPINION of a good fit for the patient, NOT an Rx. It was based on my K-readings and slit lamp evaluation.

    If I fit CL today, I would lean towards private label.

    And, PAW, Chip is correct...there are many places already doing prescription specs over the net. Our job is to schmooze our clientele to the point that they would not even consider going outside our office for ophthalmic products and services.

    : )

    Laurie

  22. #22
    OptiBoard Professional Robert Wagner's Avatar
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    Big Smile Food for thought

    I know this is going to sound a bit "snobbish" however, in our practice, we see and fit many patients with both soft and gas-perms. After the "final fit" and the patient wants a contact lens prescription to take with him/her, no problem we will give them the exact parameters and whatever else in needed to order from whoever, (that is after the patient is fit properly by us) then we FIRE THE PATIENT! we will not see the patient again for anything, not even an exam. Once the patients leaves with the contact lens Rx, we are done, complete done. We want to be the office that cares about the patients eyehealth as well as a good and proper fit.

    Robert
    There are many things in life that catch your eye... but very few things will catch your heart.... Pursue those!

  23. #23
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    Robert,

    Nothing snobbish about it. Many practices however, cannot face the prospect of letting go of a patient, even an unprofitable one. I like your idea...

    Johns

  24. #24
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    Re: Food for thought

    --
    Last edited by grapetonix; 06-19-2006 at 08:52 AM.

  25. #25
    OptiBoard Professional Robert Wagner's Avatar
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    Grapetonix

    Hi Grapetonix,

    I do welcome you to opti board and your opinion on this topic. In this practice, we have been in business over 52 years, it has been passed down from Grandfather, to the Father, and now to the Son, all being Optometrist's. Over the years we have, and always will put the patient's eye-health first, and most important retain our skills and professional status with our patients with their eye-care be it contacts, glasses or treating an eye infections.

    "Firing" a patient in this practice is a last resort, of course if the patient is going out of the country and needs the parameter's etc.
    He or She is more than welcome to all of their information. This is only used for the patient who after we succusfully fit them with contacts, and they want to "abuse" the 1-800"s and not be seen by an eyecare porfessional.

    In the last 20 or so years it has not affected our bottom line in business.

    Again welcome to Opti-Board! :)

    Robert
    ;)
    There are many things in life that catch your eye... but very few things will catch your heart.... Pursue those!

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