Analysis

Topic: Contact Lens Prescriptions
Sponsors: Representatives Jacobs, Woronchak, Ehardt, and Hardman
Committee: Senate Health Policy Committee
Date Introduced: November 1, 2001
Date Passed the House: February 13, 2002
Date of Analysis: March 1, 2002

Position: The Department of Consumer and Industry Services supports the concept of the bill.

Background: The federal Food and Drug Administration classify Contact lenses as medical devices. Consequently, a valid prescription is necessary in order to obtain them. To obtain a prescription a consumer must be fitted by an eye care professional authorized to do so. Although a Federal Trade Commission rule requires an eye care professional to give the consumer his or her eyeglass prescription, the FTC has declined to extend their rule to contact lenses. However, 26 states have laws mandating release of the contact lenses upon request of the consumer.

Recently, attorneys general in 32 states, including Michigan, filed suit against major contact lens makers, eye care associations, and some optometrists alleging that they conspired to stifle competition by withholding prescriptions from consumers. This case was subsequently settled.

In July 2001 Congressman Pete Stark introduced legislation to require the Federal Trade Commission to adopt a rule requiring release of contact lens prescriptions.

Bill Content: House Bill 5376 requires a physician or optometrist to release a contact lens prescription to a patient upon request. Exceptions are made for situations in which the contact lens prescription has expired, the patient has not paid the physician or optometrist for good or services, or a good faith determination has been made that giving the patient a copy of the prescription may jeopardize the patient's ocular health. The reason for denial must be recorded in the patient's record and provided to the patient in writing. The bill also contains language granting a physician or optometrist immunity from liability in a civil action for injuries caused directly or indirectly by the manufacturing, packaging, or dispensing of the contact lenses if the physician or optometrist does not fill the prescription.

House Bill 5377 requires registration of contact lens providers. The bill provides for a $20 application processing fee for the initial license and a $30 fee for a two-year renewal. A physician or optometrist is not required to register until his or her next license renewal date.

House Bill 5378 requires a contact lens provider to provide contact lenses only pursuant to an unexpired prescription. The bill contains specific requirements relating to the prescription content. The bill was amended in the House to clarify that a House brand, co-brand, or private label name alone is not sufficient to meet requirements that the prescription include the manufacturer's name and product name.

Specific requirements for soft hydrophilic contact lenses include:
· Brand or trade name
· Quantity
· Number of refills
· Special features, if applicable

Specific requirements for rigid gas permeable contact lenses include:
· Peripheral curve or curves, including curvature and width
· Optical zone diameter
· Lens material
· Special features, if applicable

Specific requirements for both types of contact lenses include:
· Dioptric power
· Base curve or inside radius of curvature
· Diameter
· Color or tint
· Lens wearing schedule
· Typed or commercially printed name, office address, and telephone number of prescribing physician or optometrist
· Issue date
· Patient's name
· Prescriber's signature
· Expiration date
· Number of refills.

Prescriptions are required to be valid for a minimum of one year. However, the physician or optometrist can write a prescription for a period of less than one year if the patient's history or current circumstances establish a reasonable probability of changes in the patient's vision of sufficient magnitude to necessitate reexamination earlier than one year.

A contact lens prescription is required to be based upon a comprehensive vision and eye health examination, a diagnostic trial contact lens evaluation, and a follow-up evaluation of the contact lens on the patient's eye by the prescriber. The contact lens evaluation will be presumed to be completed if there is no contact lens related appointment scheduled within 30 days after the most recent visit by the patient to the prescribing physician or optometrist. The patient's health record is not a contact lens prescription. A contact lens provider may not refill a contact lens prescription that is within 60 days of its expiration date with more than the quantity of replacement lenses needed for the remaining time.

If the original written prescription is not available to the contact lens provider, the contact lens provider is required to confirm the specifics of the prescription with the prescriber or his or her agent prior to dispensing. A written record of the communication is required to be maintained by the provider. The prescriber within 10 business hours of the request must confirm the specifics of the prescription. The 10 business hours was a compromise between proponents of the original bill, which provided for turnaround in two business days, and opponents who argued that the prescription should be confirmed immediately.

House Bill 5379 amends the disciplinary sections of the Public Health Code to provide for investigation of violations of the new requirements and penalties. Violation of the new requirements relating to contact lens are made a violation of the Public Health Code and are punishable by denial, revocation, restitution, probation, suspension, limitation, reprimand, or fine. Discipline will be handled by the disciplinary subcommittee of the respective boards, or, if there is no disciplinary subcommittee, by the department. The department may impose an administrative fine of not more than $10,000 for violation of the new requirements.

Arguments For: A consumer should have the right to shop around for the best price on his or her contact lens. Since the mid-1980's the choices for consumers to purchase their contact lens have increased dramatically, and there is significant potential for cost savings for the consumer who shops. Twenty-six states now require an eye care professional to release the contact lens prescription to the consumer. Some eye care professionals have refused to provide prescriptions to consumers, arguing their concern for patient care and protection of the patient's health. These are exactly the same arguments that were made years ago regarding eyeglasses. Ultimately, the Federal Trade Commission interceded and adopted a rule requiring release of eyeglass prescriptions. It is time that Michigan joined 26 other states and did the same thing.

The bill closes a gap in current regulation of contact lenses. The Public Health Code regulates filling contact lens prescriptions if it occurs in the office of an ophthalmologist or optometrist. However, if one of the chain optical retailers (like LensCrafters or Pearle Vision) or an Internet provider (like 1-800-Contact) fills the prescription it is not regulated. One of the reasons some eye care professionals may not release a contact lens prescription is concern that the prescription will be filled by an unregulated entity. If a physician writes a prescription for a medication, a licensed pharmacist in a licensed pharmacy will fill the prescription. Contact lens consumers should enjoy the same protection.

Arguments Against: Consumers generally do not have a problem obtaining their prescription. The Federal Trade Commission recently affirmed this by declining to extend the existing Eyeglass Prescription Release Rule to contact lenses.

The House-passed bill creates the potential for uneven discipline. The Board of Medicine will handle disciplinary matters involving ophthalmologists. The Board of Optometry will handle these issues for optometrists. However, the department will have responsibility for discipline for the chains or from an Internet provider. The department is concerned that at some time in the future a registrant disciplined by the department or one of the boards will complain that their penalty was harsher than registrants disciplined by another entity. The potential for such an outcome is very real and should be avoided. The department has suggested that the department should handle disciplinary issues for all of those registered under the contact lens provisions.

Positions: The Michigan Optometric Association and the Michigan Opthalmological Society support the bills. A group of Internet and retail contact lens dispensers oppose the bills.

Fiscal Information: The bill provides for a $20 application processing fee and a $30 license fee for contact lens dispensers. The license is valid for two years and may be renewed upon payment of a $30 renewal fee. Fees are deposited in the Health Professions Regulatory Fund.

Administrative Rule Impact: New administrative rules should not be necessary to implement the bill.