FAQs: Complying with the Contact Lens Rule

The Federal Trade Commission enforces the Contact Lens Rule (amended in 2020), which requires eye care providers to give customers copies of their prescriptions.

Changes to the Rule go into effect October 16, 2020.

The Federal Trade Commission enforces the Contact Lens Rule (amended in 2020), which requires eye care providers to give customers copies of their prescriptions.

Eye care providers must give customers their contact lens prescriptions once the lens fitting is complete.

Here are some FAQs to help eye care providers comply with the Contact Lens Rule.

Who — and What — the Rule Covers

I’m an optician. Am I considered a “prescriber” under the Contact Lens Rule?

Opticians are prescribers if state law allows them to fit contact lenses and issue prescriptions. Opticians are sometimes called “dispensing opticians.”

I’m a prescriber. What if I verify a prescription and then something is wrong with the contact lenses the consumer bought from another seller? Am I liable?

The Fairness to Contact Lens Consumers Act and the Contact Lens Rule don’t impose liability on a prescriber for problems with contact lenses sold by someone else. Traditionally, state law determines the liability.

I’m a prescriber. If I don’t act on a verification request, the prescription is passively verified. The consumer gets the contacts from another seller. Am I liable if something is wrong with the contact lenses?

Neither the Act nor the Rule imposes liability on a prescriber for problems with contact lenses. State law determines who would be liable if problems arise.

I’m a prescriber. What if I can’t verify my patient’s prescription during the “eight business hours” period, and later learn that the prescription was inaccurate, expired, or invalid? Am I required to contact the seller?

It would be in your patient’s best interest to contact the seller and your patient to alert them to a possible error in the prescription. It’s possible that the seller hasn’t yet shipped the lenses. Also, the seller may be providing your patient with lenses as part of a subscription service. If you let the seller know that the prescription provided was inaccurate, expired, or invalid, the seller should not make additional shipments of lenses without re-verifying the request or getting a copy of your patient’s valid prescription.

Does the Contact Lens Rule apply to contact lens sellers located outside the U.S.?

The Rule applies to all sellers who provide contact lenses to people living in the U.S.

Does the Contact Lens Rule apply to non-corrective “cosmetic” or “decorative” contact lenses?

Yes. Contact lenses that correct users’ vision and decorative, cosmetic, or plano lenses require a valid contact lens prescription.

The Prescription

When do I have to give my patients their contact lens prescriptions?

When the lens fitting is complete. Some patients may require follow-up visits after the initial exam before their contact lens fitting is complete. All follow-up exams must be medically necessary, and eye care providers should use sound professional judgment — based on appropriate and objective standards of care — to make that call.

In the case of a renewal prescription, a contact lens fitting ends when the prescriber determines that no change in the existing prescription is required. To renew a prescription, the Rule does not require an evaluation of the fit of the contact lens on the eye.

What if my patient asks for a copy of the contact lens prescription before the lens fitting is complete?

You don’t have to give your patient a copy of the prescription before the fitting is complete. However, if you’re prepared to sell your patient contact lenses, you can’t refuse to give them a copy of their prescription on the grounds that their fitting isn’t complete. If you’re willing to sell them the lenses, that means their fitting is complete, and you must give them a copy of the prescription. Similarly, if you’re willing to sell your patient lenses after renewing their prescription, you must give them a copy of the renewed prescription.

Can I give the prescription digitally instead of on paper?

Yes, if all of these conditions are met:

  • the patient affirmatively agrees —in writing or electronically—to get it digitally instead of on paper
  • the patient affirmatively agrees —in writing or electronically—to the specific method of receipt (for example, e-mail, text message, or portal), and
  • the electronic means can be accessed, downloaded, and printed by the patient.

You should keep records showing a patient’s consent to digital delivery for at least three years.

Do I have to ask patients to confirm receipt of their prescriptions?

If you sell contact lenses, or have a direct or indirect financial interest in the sale of contact lenses, you have to ask your patients to confirm receipt of their prescriptions by:

  • signing a statement confirming receipt of the contact lens prescription
  • signing a prescriber-retained copy of the prescription that has a statement confirming receipt of the prescription, or
  • signing a prescriber-retained copy of the receipt for the examination that has a statement confirming receipt of the prescription

You must keep records showing confirmation of receipt for at least three years.

Alternatively, you can provide a digital copy of the prescription (by methods including e-mail, text, or a portal) to the patient. If you provide a digital copy of the prescription, you must first obtain the patient’s affirmative written consent to do so, and keep a copy of such consent. You also have to keep records for at least three years showing the prescription was sent, received, or made accessible, downloadable, and printable.

If you do not have a direct or indirect financial interest in the sale of contact lenses, you do not have to ask patients to confirm receipt of their prescriptions.

What do I do if a patient refuses to sign?

If a patient refuses to sign a confirmation receipt, make note of it on the receipt, sign it, and keep it for at least three years.

How do I determine if I have a direct or indirect financial interest in the sale of contact lenses, which requires that I ask my patients to confirm prescription receipt?

If you have an association, affiliation, or are co-located with a contact lens seller, you have a financial interest in the sale of contact lenses. But there may be other ways where you have a financial interest with a contact lens seller so, if you are not sure if your interest qualifies, err on the side of caution and ask your patients to confirm receipt of their prescriptions.

 In my state, a contact lens prescription expires two years after it’s written. Does the Contact Lens Rule change that?

No. The Rule sets a floor, or minimum, expiration date of one year unless there is a legitimate medical reason for setting a shorter expiration date. If a prescriber’s state law specifies an expiration date of more than one year, that law would govern for those prescribers. Even if a prescriber’s state law does not set an expiration date of more than the one-year minimum required by the Rule, prescribers are free to set a date of more than one year if they feel it is appropriate. The Rule merely prohibits prescribers from setting an expiration date of less than a year unless there is a medical justification for a shorter duration. If the prescriber has such a medical justification, the prescriber must document the medical reason for the shorter expiration date with enough detail to allow for review by a qualified medical professional, and maintain the records for at least three years.

In my state, the law says I have to give contact lens prescriptions to patients only if they ask for them. But the Contact Lens Rule says I have to give the prescriptions regardless. Which law applies?

The Contact Lens Rule applies. You must give your patients their contact lens prescription at the completion of the contact lens fitting, whether the patient asks for it or not, regardless of your state law.

As an eye care provider, can I charge a patient for trial lenses or require a patient to buy them?

You can, but only if the trial lenses are necessary to complete the fitting process. This is sometimes the case with “specialty” or custom-made lenses. You may not require a patient to buy contact lenses — such as a six-month supply of disposable lenses — as a condition of giving them a copy of their prescription, or as a condition of renewing their prescription.

I’m a contact lens seller. Can I substitute one brand of contact lenses for another under the Rule?

Yes, but only for private label lenses if:

  • the prescription specifies one lens, and
  • the substitute lenses are made by the same manufacturer and are identical to the prescribed lenses

Example: BestEye, Inc. manufactures and sells identical lenses under both the “BestEye” brand and the “BigBox” brand. If the prescription specifies “BestEye” brand lenses, the seller many substitute “Big Box” brand lenses. In addition, if the prescription specifies “Big Box” brand lenses, the seller may substitute “BestEye” brand lenses. The seller may not substitute non-identical lenses manufactured by BestEye, Inc., or lenses manufactured by another company.

I’m a contact lens seller. I know the Rule prohibits alteration, but what specifically does it prohibit?

Submitting a verification request for a brand other than the customer’s prescribed brand may violate the Rule by altering the prescription. The only exception is if you’ve submitted a verification request for a brand that the customer has told you is listed on their prescription. To qualify for this exception, you must request the manufacturer or brand listed on the customer’s prescription, and the customer must state their brand in response.

There are certain things you must not do, or you will not meet the exception:

  • You must not rely on a box stating “I agree I have a prescription for this brand,” or something similar, to qualify for the exception.
  • You must not rely on a preselected or prefilled entry of manufacturer or brand.
  • You must not assume that a customer who searches online for a brand has a prescription for such lenses. You also must not ask the customer what brand they wear or want to buy because the customer may wear or want a non-prescribed lens.
  • You must not suggest that, or persuade, the customer to give you a brand or manufacturer other than the one listed on their prescription.

For phone orders, the customer must give the name of the manufacturer or brand on the prescription when you ask for it.  

The Contact Lens Rule says prescribers must provide or verify contact lens prescription information “as directed” by a third party designated by a patient. But according to HIPAA (Health Insurance Portability and Accountability Act of 1996), don’t I have to get written authorization from a patient before providing or verifying the contact lens prescription to a seller?

No. HIPAA lets covered entities use or disclose protected health information without patient authorization if the use or disclosure is for “treatment” or “required by law.” Providing, confirming, correcting, or verifying a contact lens prescription to a seller designated by the patient constitutes treatment or is required by the Fairness to Contact Lens Consumers Act and the Rule.

Do I have to respond to requests for an additional copy of a prescription from a patient or a patient’s designated agent?

Yes. You have 40 business hours from the time of the request to respond.

As the eye care provider, may I include a specific number of refills on a contact lens prescription?

The Rule does not expressly require or prohibit listing a specific number of refills on a contact lens prescription. However, the Rule does require that prescriptions be good for at least one year, unless medical judgment about the ocular health of a patient requires otherwise. The Rule does not allow prescribers to specify a limited number of lenses in a way that undercuts the required minimum duration of a year — not without a legitimate medical reason due to a patient’s condition. Also, check your state law. It may require a duration longer than one year (which would be permissible under federal law), and may expressly require or prohibit including refill quantities on a prescription.

Prescription Presentation Requirement for Sellers

As a contact lens seller, do I have to give customers an opportunity to give me a contact lens prescription when buying lenses?

Yes. You must have a clear and easy to understand way for a customer to give you a copy of their prescription (for example, by e-mail, text message, or file upload) before asking for the prescriber’s contact information to verify it, and before placing the order.

How do I comply with this requirement for phone orders?

You have to tell your customers how they can present their prescriptions before asking for a prescriber’s contact information for verification. In this instance, you must offer the prescription presentation by e-mail, text message, or file upload.

 “Eight business hours” for Verification

I’m a prescriber. How much time do I have to verify a prescription?

The Fairness to Contact Lens Consumers Act and the Rule give prescribers eight business hours to verify a prescription regardless of when the prescriber gets a properly completed verification request. “Eight business hours” is not the same as “eight hours.”

A “business hour” is an hour during the period from 9 a.m. to 5 p.m., Monday through Friday (excluding federal holidays), plus hours on Saturday that the seller actually knows the prescriber is regularly open for business. Business hours are calculated based on the prescriber’s time zone.

How is the “eight business hour” period calculated if the seller’s verification request is received during business hours?

If you get the verification request during business hours, the “eight business hour” period starts when the prescriber gets the request from the seller and ends when eight business hours have passed.

For example, say the verification request is received at 4 p.m. on Monday. The “eight business hour” period begins at 4 p.m. on Monday and ends at 4 p.m. on Tuesday. If the eye care provider doesn’t respond, the seller can ship at 4:01 p.m. on Tuesday.

But say the verification request is received at 11 a.m. on Friday. The seller has documented knowledge that the eye care provider’s office is regularly open from 10 a.m. to 4 p.m. on Saturday. In this case, the “eight business hour” period would begin at 11 a.m. on Friday and end at noon on Saturday. If the provider doesn’t respond, the seller can ship at 12:01 p.m. on Saturday.

What if you get a verification request at 11 a.m. on Friday, but the eye care provider’s office isn’t regularly open Saturdays? The “eight business hour” period begins at 11 a.m. on Friday and ends at 11 a.m. on Monday. If the provider doesn’t respond, the seller can ship at 11:01 a.m. on Monday.

Or suppose you get a verification request at 2 p.m. on Monday, July 3. The “eight business hour” period begins at 2 p.m. on Monday and ends at 2 p.m. on Wednesday, because Tuesday is July 4, a federal holiday. If the eye care provider doesn’t respond, the seller can ship at 2:01 p.m. on Wednesday.

How is the “eight business hour” period calculated if the seller’s verification request is received outside of business hours?

The “eight business hour” period would start at 9 a.m. the next weekday that isn’t a federal holiday (or on Saturday, if appropriate). It ends eight business hours later.

For example, say the verification request is received at 7 p.m. on Tuesday. The “eight business hour” period begins at 9 a.m. on Wednesday and ends at 5 p.m. the same day. If the eye care provider doesn’t respond, the seller can ship at 5:01 p.m. on Wednesday.

Or, the verification request is received at 2 p.m. on Saturday. The eye care provider’s office isn’t open Saturdays, and Monday is July 4. In this case, the “eight business hour” period begins at 9 a.m. on Tuesday and ends at 5 p.m. on Tuesday. If the eye care provider doesn’t respond, the seller can ship at 5:01 p.m. on Tuesday.

I sell contact lenses on a subscription basis. Can I continue to sell lenses if the prescriber denies or revokes the initial verification request after the first shipment went out?

No. If a prescriber denies or revokes the prescription outside of the “eight business hour” time period, you must not send any more shipments without re-verifying the request with the prescriber or getting a valid prescription for the lens you’re sending.

Record-keeping Requirements for Sellers

As a contact lens seller, I’ve called a lot of eye care providers to find out whether they have Saturday business hours. What records do I keep to show I have “actual knowledge” of their Saturday business hours?

You have to keep a record of the eye care provider’s regular Saturday hours, and how you know those are the hours. If you call eye care providers to find out their business hours, keep your notes from those calls. You must include Saturday business hours on a verification request, especially if you want to include those hours in the “eight business hour” verification period.

Can my verification request form say I assume all prescribers’ offices have Saturday business hours, unless the prescriber’s office tells me otherwise?

No. You may count a prescriber’s Saturday business hours as part of the “eight business hour” verification period only if you know for certain that the prescriber has Saturday hours. Assuming that a prescriber has Saturday business hours unless the prescriber tells you otherwise does not constitute actual knowledge for purposes of the Rule.

As a seller, can I depend on information a customer gives me about an eye care provider’s Saturday business hours?

Depending on the circumstances, information you get from a customer may be acceptable under the Rule. For example, if a customer gives you the prescriber’s business card, which says the office is open from 9 a.m. to 3 p.m. on Saturdays, you may rely on it. Remember to document that this information is the basis for your determination.

What if the customer tells me, “I think my eye doctor’s office is open from 9 a.m. to 5 p.m. on Saturdays”?

Don’t rely on a customer’s statement alone as a basis for your actual knowledge of a prescriber’s regular Saturday hours. Verify an eye care provider’s Saturday hours some other way.

Direct Communication In the Verification Process

What is Direct Communication and when is a direct communication “completed” under the Contact Lens Rule?

A direct communication is a completed communication by telephone, fax, or email and is required when a seller verifies a prescription with a prescriber.  The prescriber also must use direct communication when responding that the prescription is accurate or inaccurate.  Such a communication is complete when the recipient gets all the required information. For example, direct communication by phone means reaching and speaking with the intended recipient, or leaving a voice message, including all the required information, on the person’s voicemail or answering service. Similarly, a direct communication by fax or email is completed when the intended recipient gets the fax or email message.

How do I know that a direct communication by fax or email has been completed?

A fax confirmation sheet showing that a fax was transmitted is enough to confirm that the communication is completed.

Confirmation that an email was sent generally is enough to confirm that it was received. Of course, if the sender has reason to believe that an email message was not transmitted instantly (such as an electronic notice stating that the email could not be sent), the communication is not considered completed until it is successfully transmitted to the recipient’s account.

I’m a seller who uses the phone for direct communication with eye care providers. Do I have to keep a written log of all communications, or can I store this information electronically?

The Rule allows you to store the required information electronically, and the information can be made available for review by the Commission, if necessary.

Automated Telephone Systems

My company sells contact lenses to consumers. Can I use an automated phone system to send a verification request to an eye care provider?

Yes, as long as the request includes all the required information, and you wait eight business hours before selling contact lenses to the consumer.

The call must begin by identifying it as a request for prescription verification made in accordance with the Rule. The information required by the Rule must be delivered in a slow and deliberate manner, at a reasonably understandable volume, and repeatable at the prescriber’s option. Sellers using an automated phone system also must record and retain the entire call, including both the automated and non-automated portions.

When I respond to a verification request, I’d like to get some confirmation — a call, email or fax — indicating that the seller got my response. Does the Rule require that?

Neither the Act nor the Rule requires sellers to provide confirmation to prescribers.

My calls to the seller are answered by an automated response system or by their contact person’s voicemail. Does the Rule require sellers to have a person available to respond to my calls?

The Rule requires sellers to provide “a reasonable opportunity” for prescribers to communicate with them, but it doesn’t require them to have a person available to respond to calls. If you left a response on a seller’s verification response line, indicating that the prescription has expired or is otherwise invalid, the seller is not allowed to ship the lenses.

I got a seller’s verification request by an automated phone message, but I can’t understand it. What can I do?

Automated phone verification messages must be delivered in a slow and deliberate manner and at a reasonably understandable volume, so if you can’t hear or understand an automated verification request, promptly contact the seller directly. Sellers also must make the information required by the Rule repeatable at the prescriber’s option. If you can’t get in touch with the seller, report it to the FTC at ftc.gov/complaint.

Sometimes I can’t get my calls or faxes through to the sellers. What can I do?

Try another way. For example, if your fax transmission fails, try calling or emailing the seller. If that doesn’t work, report it to the FTC at ftc.gov/complaint. Document your attempts; details make complaints more helpful.

Report problems to the FTC

You can file make a report to the FTC online or by phone. To report online, visit ftc.gov/complaint, click “File a Complaint,” and enter your information into the form. At the section entitled, “Subject of Your Complaint,” click on “Health.” In the final section, “Explain Your Problem,” include as many details as possible. Click “Submit Complaint” to complete the process.

Your report should include specific details — for example, the date and time your call was made, or the reason the call you received wasn’t understandable. Prescribers with evidence, like an audiotape of a call or the recording left on voicemail or answering service, should keep the evidence because it may be very helpful.

While the FTC doesn’t resolve individual issues, your reports help the agency investigate Rule violations and may lead to enforcement action.

YOUR OPPORTUNITY TO COMMENT

The National Small Business Ombudsman and 10 Regional Fairness Boards collect comments from small businesses about federal compliance and enforcement activities. Each year, the Ombudsman evaluates the conduct of these activities and rates each agency’s responsiveness to small businesses. Small businesses can comment to the Ombudsman without fear of reprisal. To comment, call toll-free 1-888-REGFAIR (1-888-734-3247) or go to www.sba.gov/ombudsman.

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