Ophthalmic Practice Rules (Eyeglass Rule)

Federal RegisterJul 26, 2024

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FEDERAL TRADE COMMISSION

16 CFR Part 456

RIN 3084-AB37

Ophthalmic Practice Rules (Eyeglass Rule)

AGENCY:

Federal Trade Commission.

ACTION:

Final rule.

SUMMARY:

The Federal Trade Commission (“FTC” or “Commission”) is publishing a final rule to implement amendments to the Ophthalmic Practice Rules (“Eyeglass Rule” or “Rule”). These amendments require that prescribing eye care practitioners obtain a signed confirmation after releasing an eyeglass prescription to a patient and maintain each such confirmation for a period of not less than three years. The Commission is permitting prescribers to comply with automatic prescription release via electronic delivery if they first obtain verifiable affirmative consent from the patient and maintain a record of such consent for a period of not less than three years. The amendments further clarify that the presentation of proof of insurance coverage shall be deemed to be a payment for the purpose of determining when a prescription must be provided. Finally, the Commission amends the term “eye examination” to “refractive eye examination” throughout the Rule.

DATES:

This rule is effective September 24, 2024.

FOR FURTHER INFORMATION CONTACT:

Alysa S. Bernstein, Attorney, (202) 326-3289; Sarah Botha, Attorney, (202) 326-2036; or Paul Spelman, Attorney, (202) 326-2487, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Statement of Basis and Purpose

Table of Contents

I. Background

A. Overview of the Eyeglass Rule

B. Background of Prescribers' Failure To Release Prescriptions and the Commission's Automatic-Release Remedy

C. Evidentiary Standard for Promulgating or Amending the Rule

D. The Current Eyeglass Rule Review

1. Advance Notice of Proposed Rulemaking

2. The Contact Lens Rule Review

3. The Notice of Proposed Rulemaking and Eyeglass Rule Workshop

4. Overview of the Final Rule

5. The Eyeglass Marketplace

II. Final Rule Pertaining to the Automatic-Prescription-Release Provision

A. Separation of Examination and Dispensing

1. Comments and Evidence Regarding the Automatic-Prescription-Release Provision

a. Prescriber Compliance With Automatic Release, and Consumer Receipt of Their Prescriptions

b. Whether the Automatic-Release Provision Is Still Necessary and Beneficial for Consumers

2. Analysis of Evidence Regarding Failure To Release Prescriptions

B. The Remedy for Failure To Release Prescriptions Remains the Automatic-Release Requirement

C. Commission Determination To Update the Rule To Clarify Requirements for Prescription Release

III. Final Rule Pertaining to Affirmative Consent to Digital Delivery of Eyeglass Prescriptions

A. Digital Delivery Option in the NPRM and the Basis for Such Amendment

B. Comments on the NPRM and Discussion at the Workshop Regarding the Proposal To Permit Digital Delivery of the Eyeglass Prescription With Patient's Affirmative Consent

1. Comments About the Benefits and Burdens of the Proposed Affirmative Consent to Digital Delivery Provision

2. Comments in Favor of Allowing Prescribers To Choose Whether To Offer Digital Delivery of Prescriptions

3. Comments Regarding Giving Patients a True Choice as to How To Have Their Prescription Delivered

C. Additional Discussion and Commission Determination Regarding the Affirmative Consent to Digital Delivery

1. Final Rule Determination To Add Option for Digital Delivery of Eyeglass Prescriptions

2. Final Rule Moves Requirement for Obtaining Patient's Verifiable Affirmative Consent for Digital Delivery to a New Section and Out of Definitions

3. Final Rule Adds Explicit Recognition of the Ability To Obtain Affirmative Consent on Paper or in a Digital Format

4. Final Rule Clarifies That Digital Delivery Methods Identified in Affirmative Consent Request Must in Fact Be Used

IV. Final Rule Pertaining to Confirmation of Prescription Release

A. Proposed Confirmation Requirement in the NPRM and the Basis for Such Proposal

B. Comments on the NPRM and Discussion at the Workshop Regarding Confirmation of Prescription Release

1. Comments in Favor of Confirmation-of-Prescription-Release Proposal

2. Comments Against the Confirmation-of-Prescription-Release Proposal

3. Comments About the Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Eyeglasses

4. Comments About Alternatives to the Confirmation-of-Prescription-Release Proposal

C. Additional Discussion and Commission Determination Regarding the Confirmation-of-Prescription-Release Proposal

1. Final Rule Determination To Amend the Rule To Require Confirmation of Prescription Release

a. Alternatives to Confirmation of Prescription Release Not Adopted

b. The Burdens of the Confirmation of Prescription Release Are Not Substantial

c. Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Eyeglasses

2. Comments About Options for Obtaining the Confirmation and Commission Determination

a. Comments at the Eyeglass Rule Workshop

b. Commission Determination Regarding Options for Obtaining the Confirmation

3. Final Rule Modification To Add Explicit Recognition of a Prescriber's Ability To Obtain a Confirmation on Paper or in a Digital Format

V. Final Rule Pertaining to Proof of Insurance Coverage as Payment

A. Proposed Requirement in the NPRM To Treat Proof of Insurance Coverage as Payment and the Basis for Such Proposal

B. Comments on NPRM and Discussion at Workshop Regarding the Insurance Coverage as Payment Proposal

C. Additional Discussion and Commission Determination Regarding the Insurance Coverage as Payment Proposal

VI. Final Rule Regarding “Eye Examination” Terminology

A. Proposed Revision in the NPRM To Change “Eye Examination” Term to “Refractive Eye Examination” and the Basis for Such Proposal

B. Comments on NPRM and Discussion at Workshop Regarding the “Refractive Eye Examination” Proposal

1. Comments About the Proposed Terminology Change

2. Comments About the Need To Allow Prescribers To Make a Medical Decision To Withhold the Prescription, Where Appropriate

3. Comments About the Permissibility To Charge for the Refraction, as Opposed To Charging for the Prescription Release

C. Additional Discussion and Commission Determination Regarding the “Refractive Eye Examination” Proposal

VII. Miscellaneous Issues Raised in Comments

A. Pupillary Distance

1. Background and Comments

2. Pupillary Distance Requirement Determination

B. Consumer and Business Education

VIII. Paperwork Reduction Act

A. Comments Regarding the NPRM Estimate for the Confirmation-of-Prescription-Release Requirement

B. Commission Estimate of the Total Burden = 3,208,333 Hours

1. Estimated Hour Burden of 1,375,000 Hours for Prescribers To Release Prescriptions

2. Estimated Hour Burden of Prescribers' Staff To Obtain and Store Patient Confirmation of Prescription Release = 1,375,000 Hours (343,750 Hours for Patients To Read and Sign Confirmations, 1,031,250 Hours for Prescribers' Offices To Scan and Store Such Confirmations)

3. Estimated Hour Burden on Prescribers' Offices To Obtain and Store Patient Consents to Electronic Delivery = 458,333 Hours (114,583 Hours To Obtain Signed Consents and 343,750 Hours To Store Same)

C. Estimated Labor Cost

D. Capital and Other Non-Labor Costs

IX. Final Regulatory Analysis and Regulatory Flexibility Act Analysis

A. Need for and Objectives of the Final Rule

B. Significant Issues Raised by Public Comments in Response to the IRFA and the Agency's Response, Including Any Changes Made in the Final Rule

C. Description and Estimate of the Number of Small Entities to Which the Amendments Will Apply or Explanation Why No Estimate Is Available

D. Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Amendments, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Type of Professional Skills That Will Be Necessary To Comply

E. Steps Taken To Minimize the Significant Impact, if Any, of the Amendments, Including Why Any Significant Alternatives Were Not Adopted

X. Congressional Review Act

I. Background

A. Overview of the Eyeglass Rule

The Eyeglass Rule (16 CFR part 456) declares it an unfair practice for an optometrist or ophthalmologist to fail to provide a patient with a copy of the patient's eyeglass prescription immediately after an eye examination is completed.

The prescriber may not charge the patient any fee in addition to the prescriber's examination fee as a condition of releasing the prescription to the patient.

The Rule defines a prescription as the written specifications for lenses for eyeglasses which are derived from an eye examination, including all of the information specified by State law, if any, necessary to obtain lenses for eyeglasses.

The Rule prohibits an optometrist or ophthalmologist from conditioning the availability of an eye examination on a requirement that the patient agree to purchase ophthalmic goods from the ophthalmologist or optometrist.

The Rule also prohibits the prescriber from placing on the prescription, or requiring the patient to sign, or deliver to the patient, a waiver or disclaimer of prescriber liability or responsibility for the accuracy of the exam or the ophthalmic goods and services dispensed by another seller.

The Rule was implemented after findings that many consumers were being deterred from comparison shopping for eyeglasses because eye care practitioners would not release prescriptions, even when requested to do so, or charged an additional fee for release of the prescription. The Rule's operative provision, which requires prescription release and prohibits fees and waivers for prescription release, is entitled “Separation of Examination and Dispensing.”

Keeping the exam process and prescription separate from the retail sale of eyeglasses is the key underpinning of the Rule.

B. Background of Prescribers' Failure To Release Prescriptions and the Commission's Automatic-Release Remedy

The FTC has been regulating the optical goods industry for more than six decades, and this experience continues to inform and guide the Rule. As early as 1962, the Commission took steps to protect consumers and competition by adopting the “Guides for the Optical Products Industry,” declaring it an unfair practice to “tie in or condition” refraction services to eyeglass sales when there was a “reasonable probability” of harming competition.

However, the Guides were not binding, the FTC never sought to enforce them, and prescribers did not comply with them.

In light of such non-compliance, on June 2, 1978, the Commission issued the Advertising of Ophthalmic Goods and Services Rule (the “Eyeglass I Rule”), which, among other things, contained the provision “Separation of Examination and Dispensing” requiring prescribers to automatically release prescriptions—regardless of whether or not patients requested them—so as to draw a line between exams and eyeglass sales, and ensure consumers had unconditional access to prescriptions.

The Commission found that consumers suffered substantial economic loss and lost opportunity costs due to an inability to comparison-shop for glasses,

and that such practices offended public policy and inhibited competition by denying consumers the ability to use available information.

The Commission explained that while it considered requiring prescriptions be released only upon request, it chose “automatic release” due to consumers' lack of awareness of their prescription rights, and to immunize such rights from an “evidentiary squabble” over whether a consumer did or did not request their prescription.

Upon issuance of the Eyeglass I Rule, the American Optometric Association (“AOA”) filed suit, and the D.C. Circuit upheld the automatic-release requirement, finding there was “extensive” evidence that withholding prescriptions harmed consumers.

The court also noted there was considerable evidence that prescribers used certain practices “to frighten consumers” into purchasing from the prescriber.

In 1985, the Commission re-reviewed the Rule and held public hearings, after which FTC staff proposed changing to release-upon-request,

due to what staff perceived to be altered market conditions and increased public awareness, and the challenges staff faced trying to enforce the automatic-release provision.

According to staff at that time, automatic release had not prevented evidentiary squabbles,

but rather increased them, since whether a prescriber released a prescription could not, in most cases, be ascertained without documentary evidence.

In contrast, the hearing officer recommended the automatic-release requirement remain in effect, since prescribers were still not releasing prescriptions to consumers.

The Commission sided with the presiding officer's recommendation and issued the “Eyeglass II Rule,” which preserved automatic release.

The Rule was again challenged in court and parts of it were vacated, but not the automatic-release component, which remained lawful and in effect.

In 1997, the Commission again sought input on the Rule's prescription-release requirement but withheld taking action while it evaluated whether contact lenses should be covered by the Rule.

That question was resolved by Congress, which passed the Fairness to Contact Lens Consumers Act (“FCLCA”),

directing the FTC to issue a separate rule with automatic prescription-release requirements for contact lenses that were similar to those required by the Eyeglass Rule.

When the Commission looked again at the Eyeglass Rule in 2004, it determined that prescribers continued to withhold prescriptions, and consumers were still not sufficiently aware of their rights.

The Commission felt that were it to eliminate the automatic-release remedy, even more prescribers might fail to release prescriptions. Due to this, and because the Commission found that prescription-release enhanced consumer choice at minimal cost, the Commission opted to again retain the automatic-release remedy.

By retaining the requirement, the Commission also ensured that prescription-release requirements for eyeglasses and contact lenses would be largely aligned.

C. Evidentiary Standard for Promulgating or Amending the Rule

The Commission promulgated the Eyeglass Rule under section 18 of the FTC Act, which grants the Commission

the authority to adopt rules defining unfair or deceptive acts or practices in or affecting commerce.

When amending or repealing the Rule, the Commission follows the same section 18 procedures governing the adoption of rules

and, in doing so, engages in a multi-step inquiry. To make a determination that an act or practice is unfair, the Commission evaluates the following questions: (1) Does the act or practice cause or is it likely to cause substantial injury to consumers? (2) Is the injury to consumers outweighed by countervailing benefits that flow from the act or practice at issue? and (3) Can consumers reasonably avoid the injury?

If an act or practice is deemed unfair, the Commission may issue a notice of proposed rulemaking under section 18 only where it has “reason to believe” that the unfair act or practice at issue is “prevalent.”

The Commission can find prevalence where information available to it indicates a widespread pattern of conduct.

The evidence necessary to answer the aforementioned questions will vary depending on the circumstances of each rulemaking and the characteristics of the industry involved.

When inviting public comment, the Commission requests that commenters provide useful factual data, and, in particular, empirical data such as surveys or other methodologically sound quantitative analyses.

The Commission may also consider other reliable evidence and input from experts.

Documentary and testimonial evidence, and the absence of any substantial or persuasive contrary evidence, may also be considered.

Once the Commission finds that an unfair act or practice is prevalent, the Commission has wide latitude in fashioning a remedy, and need only show a “reasonable relationship” between the unfair act or practice and the remedy.

D. The Current Eyeglass Rule Review

1. Advance Notice of Proposed Rulemaking

In 2015, as part of a periodic review of its rules and regulations, the Commission simultaneously published notices in the

Federal Register

initiating reviews of both the Eyeglass Rule and the Contact Lens Rule. The Commission published a request for comment (“RFC”) seeking public input on the efficiency, costs, benefits, and regulatory impact of the Contact Lens Rule, including its prescription release requirement.

The Commission published an advance notice of proposed rulemaking (“ANPR”) for the Eyeglass Rule inviting comments on, among other things: the continuing need for the Rule; the Rule's economic impact and benefits; and the effect on the Rule of any technological, economic, or other industry changes.

The Commission also sought comment on whether: the definition of “prescription” should be modified to include pupillary distance, to require that a prescriber provide a duplicate copy of a prescription to a patient who does not have access to the original, and to require that a prescriber provide a copy to or verify a prescription with third parties authorized by the patient.

In response to its Eyeglass Rule ANPR, the Commission received and considered 868 comments from a variety of individuals and entities, including ophthalmologists, optometrists, opticians, trade associations, consumers (and consumer-advocacy representatives), and eyeglass sellers.

Virtually all comments supported retaining the Rule. Some commenters, including trade associations representing opticians and retailers who employ optometrists and opticians, stated that the Rule is needed because some prescribers are still not automatically releasing prescriptions, and some consumers face resistance when they try to obtain their prescriptions.

The AOA, on the other hand, questioned the continued need for the Rule based on its view that optometrists widely comply with the Rule's requirements, but also commented that the Rule—as currently codified—is not necessarily harmful.

2. The Contact Lens Rule Review

The Commission focused on finalizing changes to the Contact Lens Rule (CLR) before considering amendments to the Eyeglass Rule. During its CLR review, the Commission considered over 8,000 comments and issued both a notice of proposed rulemaking

and a supplemental notice of proposed rulemaking

(“SNPRM”) before issuing a final rule on August 17, 2020.

While the CLR differs from the Eyeglass Rule in some respects, many of the issues and concerns regarding prescription release and portability are the same, and therefore, some of the comments and data submitted during the CLR review are pertinent to the Commission's review of the Eyeglass Rule.

In its CLR final rule, the Commission determined that the evidentiary record, as well as the Commission's enforcement and oversight experience, demonstrated that prescriber compliance with the automatic-prescription-release requirement was deficient, and as a result, millions of consumers were not receiving their contact lens prescriptions as required by law.

The Commission further found that many consumers remained unaware that they have a right to their prescriptions.

To remedy this, the Commission implemented a confirmation-of-prescription-release provision, requiring that prescribers request that patients confirm receipt of their contact lens prescription.

According to the Commission, the patient confirmation requirement was intended to, among other things, increase the number of patients in possession of their contact lens prescription, improve flexibility and choice for consumers, foster improved competition in the market, and result in lower prices and more efficient contact lens sales for consumers.

The Commission noted that the requirement would also increase the Commission's ability to enforce and assess the CLR.

The final CLR included an additional amendment addressing a concern relevant to the Eyeglass Rule review, in that the Commission recognized the value in allowing prescribers to deliver prescriptions to patients digitally, so long as prescribers provide the prescription in a format that can be accessed, downloaded, and printed by the patient, and the patient agrees to receive their prescription in the format identified by the prescriber.

The final CLR expressly made this permissible by adding a definition of the term “provide to the patient a copy” to allow the prescriber to provide the patient with a digital copy of the prescription in lieu of a paper copy, so long as the prescriber adheres to certain requirements.

3. The Notice of Proposed Rulemaking and Eyeglass Rule Workshop

After the amended CLR final rule took effect, the Commission resumed its review of the Eyeglass Rule. Based on a review of comments received in response to the ANPR, a regulatory review of the CLR, and the Commission's enforcement experience, the Commission issued a notice of proposed rulemaking (“NPRM”) on January 3, 2023.

In the NPRM, the Commission proposed to: (1) require that prescribers obtain a signed confirmation after releasing an eyeglass prescription to a patient, and maintain each such confirmation for a period of not less than three years; (2) permit prescribers to comply with automatic prescription release via electronic delivery if the prescription is provided in a digital format that can be accessed, downloaded, and printed by the patient,

and if the prescriber obtains the patient's verifiable affirmative consent to the electronic delivery method; (3) clarify that the presentation of proof of insurance coverage shall be deemed to be a payment for the purpose of determining when a prescription must be provided; and (4) amend the term “eye examination” to “refractive eye examination” throughout the Rule.

In response to the NPRM, the Commission received 27 comments from various individuals and entities, including consumers, optometrists, ophthalmologists, opticians, trade associations, consumer advocates, and eyeglass sellers.

The Commission also announced it would hold a public workshop to consider: the proposed confirmation-of-prescription-release requirement for eyeglass prescriptions; consumers' and prescribers' experiences with the implementation of the similar requirement for contact lens prescriptions; other proposed changes to the Rule; and other issues raised in response to the NPRM.

The workshop notice invited interested parties to request to participate as a panelist or to file a comment.

Staff convened the workshop, titled “A Clear Look at the Eyeglass Rule,” with three panels and a total of 13 panelists in Washington, DC, on May 18, 2023, and the discussion was transcribed.

At the conclusion of the workshop, panelists, audience members, and the general public were invited to share additional views, data, and other information related to the NPRM and the subjects discussed, after which the Commission received an additional 20 comments, providing further perspectives from consumers, prescribers, opticians, trade associations, and retailers, as well as a U.S. Congressman.

4. Overview of the Final Rule

The Commission now issues this final rule that largely adopts the amendments proposed in the NPRM, with some minor modifications based on public comments and other considerations, as discussed below. In issuing this final rule, the Commission has relied on an extensive record that includes comments received in response to the ANPR, the NPRM, and the workshop notice. The Commission also relies on the discussion at the May 2023 workshop, the Commission's experience enforcing the Eyeglass Rule and Contact Lens Rule, and the rulemaking record for the 2020 amendments to the CLR, to the extent that such record is pertinent to the Eyeglass Rule.

The Commission has also examined the current state of the marketplace, and the content of consumer complaints about prescriber practices. Further, the Commission remains cognizant of the lengthy regulatory history and evidentiary record pertaining to prescribers' failure to release prescriptions, and eyewear-specific market incentives (such as that many eye doctors sell the same items that they prescribe) that provided the initial impetus for both the Eyeglass Rule and the CLR.

Based on the entirety of the record, the Commission finds that prescribers' failure to provide consumers with prescriptions at the completion of an eye exam—held to be an unfair act or practice when the Eyeglass Rule was enacted

—remains prevalent, and tens of millions of Americans every year are not receiving their eyeglass prescriptions as required.

The Commission also finds that significant harm to consumers continues to exist and that, without the Rule's requirements, consumers could not reasonably avoid the injury resulting from the unfair acts and practices prohibited by the Rule. The Commission further determines that the Rule's automatic-release requirement remains the best remedy for failure to release prescriptions, and that documentation of prescription release is necessary to better effectuate and enforce this remedy. Consequently, the Commission is amending the Rule to implement a confirmation-of-prescription-release requirement similar to that already in place under the amended CLR, albeit a simpler version.

Pursuant to these amendments, prescribers will be required to do one of the following:

(i) If a paper copy of the prescription was provided to the patient, request that the patient acknowledge receipt of the prescription by signing a separate statement on paper or in a digital format confirming receipt of the prescription; or

(ii) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable.

As with the CLR provision, this final rule provides sample language for the confirmation option, but also allows prescribers to craft their own confirmation wording if they so desire. As with the CLR's confirmation requirement, the requirement for eyeglass prescriptions would apply only to prescribers with a financial interest in the sale of eyeglasses.

The Commission believes that revising the automatic-release remedy to require a confirmation of prescription release will provide an educational benefit to consumers and prevent consumer harm. This amendment is necessary due to demonstrated failures of prescribers to comply with the automatic-release remedy, and to ensure the separation of eye examination and eyeglass dispensing, which engenders a competitive marketplace for eyeglasses. The Commission is sensitive to any additional burden that this rule change imposes. However, it finds that this amendment maximizes the benefits of comparison-shopping while imposing a relatively small cost. The potential benefit of increasing the number of patients in possession of their prescriptions is substantial: namely, increased flexibility and choice for consumers; increased competition among eyeglass sellers; a reduced likelihood of errors associated with incorrect, invalid, and expired prescriptions, and consequently, improved patient safety; and an improved ability for the Commission to enforce and monitor prescriber compliance.

The confirmation requirement also brings the prescription-release-related provisions of the Rule into congruence with those of the CLR, thereby reducing the confusion and complexity that arise for both consumers and prescribers from having inconsistent requirements for eyeglass and contact lens prescriptions. In addition, because the CLR already obligates ophthalmologists and optometrists to obtain a confirmation and maintain a record, their marginal cost associated with the confirmation requirement in the Eyeglass Rule should be extremely low. Prescribers in compliance with the CLR should already have in place forms, systems, and staff training for prescription release, and should only need to make minor adjustments for eyeglass prescriptions.

The Commission is also amending the Rule to permit prescribers to comply with automatic prescription release via electronic delivery in certain circumstances. In order to do so, the prescriber must identify the delivery method to be used—such as portal, text, or email—and the prescription must be provided in a format that can be accessed, downloaded, and printed by the patient. Further, a prescriber may only opt for digital delivery after obtaining the patient's verifiable affirmative consent, and must maintain evidence of that consent for a period of not less than three years. The Commission is also revising the Rule to clarify that presentation of proof of insurance coverage shall be deemed a payment for the purpose of determining when a prescription must be provided

under 16 CFR 456.2(a). Again, these revisions harmonize the Eyeglass Rule with the existing Contact Lens Rule, which should reduce confusion and complexity. And lastly, the Commission is further clarifying that the term “eye examination” in the Rule refers to a refractive eye exam, and is amending that term accordingly.

This final rule summarizes the public comments the Commission received, and explains why the Commission continues to believe that the Rule and its automatic-prescription-release provision are necessary. It also explains the Commission's rationale for adopting the amendments previously proposed in the NPRM, with some minor modifications.

Finally, this final rule sets forth the Commission's regulatory burden analyses under the Regulatory Flexibility and Paperwork Reduction Acts, as well as the regulatory text of the final rule.

5. The Eyeglass Marketplace

The retail vision care industry in the United States consists of several types of participants, namely ophthalmologists, optometrists, opticians, and eyewear retailers. The services provided by these different participants often overlap, and different participants often have business affiliations with each other.

Ophthalmologists are medical doctors who specialize in treating diseases of the eye. They are the only eye care professionals who can treat all eye and vision-system diseases, perform eye surgery, prescribe nearly all manner of drugs, and use any treatment available to licensed physicians. Ophthalmologists can prescribe and sell eyeglasses and contact lenses, and their offices may be attached to an associated optical dispensary. Ophthalmologists have typically completed four years of college, four years of medical school, a year of general internship, and three years of specialized hospital residency training in ophthalmology. It is estimated that there are approximately 18,000 active ophthalmologists in the United States.

Many ophthalmologists, especially those who specialize in surgery or particular eye conditions, do not sell eyewear, although some do.

Optometrists are doctors of optometry. They have not completed medical school, but have instead completed four years of medical training in optometry school, typically following a four-year college degree. They are trained and licensed to examine eyes, diagnose refractive problems, prescribe and dispense eyeglasses and contact lenses, and detect eye disease.

As with ophthalmologists, optometrists can prescribe and sell eyeglasses and contact lenses, and their offices are often attached to, or part of, an associated optical dispensary. A government estimate reports that in 2020 there were some 43,000 active optometrists in the United States.

While professional services—such as eye health and refraction examinations—generate significant revenue for optometrists, the majority of optometrists still derive a larger percentage of their income from product sales, including the sale of eyeglasses and contact lenses.

According to some estimates, product sales typically account for roughly 45 to 60% of optometrist revenue.

Opticians, also known as dispensing opticians or ophthalmic dispensers, act primarily as retail providers of eyeglasses and contact lenses. Opticians fabricate, fit, adjust, and repair eyeglasses, primarily on the basis of prescriptions issued by optometrists and ophthalmologists. Opticians typically are not authorized to examine eyes to determine prescriptions, but may conduct pupillary distance examinations in order to fit a pair of eyeglasses to an individual. According to one source, twenty-one States currently require opticians to obtain licenses,

usually through a State-approved course of study and completion of an exam. The remaining States have no formal requirements for practice, but many opticians in these States complete some form of apprenticeship or training. A 2020 estimate put the number of active opticians in the United States at approximately 73,000.

Opticians sometimes co-locate their optical dispensaries with examination offices of optometrists or ophthalmologists and, sometimes, although not always, share revenue from the sale of eyeglasses and contact lenses.

Eyewear retailers are companies and independent merchants that sell glasses. They often are owned by, employ, or associate themselves with, ophthalmologists, optometrists, and opticians. Some are considered independent optical retailers (defined as a retailer with three or fewer locations that has either an ophthalmologist, optometrist, optician, or optical retailer on site

), while others may be optical chain stores, such as LensCrafters and America's Best, mass merchandisers, such as Costco and Sam's Club, department stores, such as Macy's, or online entities, such as Zenni Optical and

GlassesUSA.com

The overall retail eyeglass market continues to grow in both the number of eyeglass wearers as well as the number of eyeglasses purchased. It is currently estimated that approximately 165 million American adults regularly wear prescription eyeglasses, representing nearly two-thirds of the country's adult population,

and the overall market for eyeglass frames and lenses is estimated at $35.6 billion.

That represents an 18% increase in value from 2019.

An industry report found that more than half of Americans surveyed between January 10 and March 19, 2023 had had an eye exam within the previous twelve months, and of those who had an eye exam in the previous three months and use eyeglasses, 50% purchased new eyewear.

While online eyeglass sales have increased significantly (in just the four years of 2019-2022, online sales of frames and lenses nearly doubled from $1.82 billion to $3.24 billion),

roughly four out of five eyeglass purchases still occur in person.

Furthermore, of those who have an eye exam and proceed to purchase eyeglasses, the vast majority purchase from their prescriber on the day of the exam.

This is often referred to as a prescriber's “capture rate,”

and remains relatively high for a variety of reasons, even though the average unit price for frames and lenses in 2022 was $360 from independent optical retailers and prescribers compared to just $183 from online eyewear sellers.

For many consumers, the convenience of being able to shop at the same location that they have their exam makes it worthwhile to buy glasses from their prescriber, even if they are more expensive. Many consumers also find it advantageous to try on glasses in person and have an expert tell them, based on their prescription and physical characteristics, the pros and cons of particular eyewear.

In-person optical dispensaries can also perform precise facial measurements to provide a more personalized fit.

Buying from one's prescriber can also make it simpler to have glasses adjusted post-purchase, if necessary.

As discussed

infra,

however, some consumers buy eyeglasses from their prescriber because they feel pressured or obligated to, or are unaware that they can take their prescription and shop elsewhere for glasses.

Final Rule Pertaining to the Automatic-Prescription-Release Provision

A. Separation of Examination and Dispensing

Section 456.2(a) of the Eyeglass Rule provides that it is an unfair act or practice for a prescriber to fail to provide to the patient one copy of the patient's prescription immediately after

the eye examination is completed. This provision allows, however, that a prescriber may refuse to give the patient a copy of the patient's prescription until the patient has paid for the eye examination, but only if that prescriber would have required immediate payment from that patient had the eye examination revealed that no ophthalmic goods were required.

Sections 456.2(b) and (c) prohibit prescribers from imposing conditions for patients to receive eye examinations and prescriptions. Section 456.2(b) provides that it is an unfair act or practice for a prescriber to condition the availability of an eye examination on a requirement that the patient agree to purchase any ophthalmic goods from the prescriber. Section 456.2(c) provides that it is an unfair act or practice for a prescriber to charge any fee in addition to the examination fee as a condition for releasing the prescription to the patient. Section 456.2(d) provides that it is an unfair act or practice for a prescriber to waive or disclaim prescriber liability for the accuracy of the eye examination or the accuracy of the ophthalmic goods and services dispensed by another seller.

These provisions, often referred to as the automatic-prescription-release requirement (also referred to as the required “separation of examination and dispensing”),

were intended to make it clear that the purchase of eyeglasses is separate and distinct from the act of obtaining an eye exam, and to ensure consumers have possession of their ophthalmic prescriptions so they are able to “price shop” for eyeglasses.

Absent physical possession of their prescriptions, consumers do not have the ability—and in some cases, the knowledge—to buy eyeglasses wherever they want. Consequently, there is less comparison-shopping, and less incentive for eyeglass sellers to advertise or compete with each other on price or service.

1. Comments and Evidence Regarding the Automatic-Prescription-Release Provision

In response to the Commission's NPRM, and during and after the Eyeglass Rule workshop, numerous commenters addressed the Rule's automatic-prescription-release provision, weighing in on whether (a) prescribers comply with the requirement and consumers receive their prescriptions, and (b) compliance is still necessary and beneficial for consumers.

a. Prescriber Compliance With Automatic Release, and Consumer Receipt of Their Prescriptions

Several commenters stated that even though the automatic-release provision has been in effect for decades, prescribers still do not adhere to this requirement, and thus consumers often do not receive a copy of their prescription. Longtime eyewear consumer and ER workshop panelist Felecia Neilly, for instance, recounted how she has visited various eye doctors at least 50 times over the course of her life, and yet has rarely been handed her prescription without having to request it.

“It just always felt like there was a reluctance [on the part of the prescriber] in getting the complete information needed to fill the prescription, always,” commented Neilly, adding that if the Rule has been in effect since the '70s, it should be automatic.

Neilly added that even when she did request her prescription, she did not always receive the complete copy, thus making it a challenge for her to purchase eyewear.

Likewise, the National Association of Retail Optical Companies (“NAROC”),

a trade association comprised of retail optical companies with co-located eye care services (such as LensCrafters, Costco Optical, and Walmart Vision Center), submitted a comment stating, “We have no evidence to contradict the [previous Commission] finding that prescribers' failure to automatically provide customers with prescriptions at the completion of an eye exam—held to be an unfair act or practice when the Eyeglass Rule was enacted—remains prevalent, and millions of Americans every year are not receiving their eyeglass prescriptions as required by law.”

One Michigan optometrist, Dr. David Durkee, commented that “the far majority of my colleagues do not engage in such practices [automatic release of prescriptions] out of fear of losing [retail] business.”

Other members of the ophthalmic community, on the other hand, typically felt that compliance with the automatic-prescription-release provision is routine and common practice. Workshop panelist Dr. Jeffrey Michaels, a Virginia optometrist, commented, “I think that the automatic compliance with this [prescription release] is so ingrained in optometrists and ophthalmologists that it's just a normal part of their day.”

He noted that in his optometric office, 100% of prescriptions are automatically uploaded to a patient portal “the very second the prescription is finalized.”

The American Academy of Ophthalmology (“AAO”) volunteered that ophthalmology practices “have a tremendous track record of compliance with existing prescription release requirements,”

and the Opticians Association of America (“OAA”) and American Optometric Association both noted that online eyeglass sales have been steadily increasing year over year, which they believe indicates that consumers have copies of their prescriptions.

The American Optometric Association also pointed to the fact that, over the past five years, there had been fewer than fifty prescribers warned by the FTC for potential violations of the Eyeglass Rule (such as failure to release prescriptions).

The dearth of complaints was also emphasized by other optometrists, such as Dr. Michaels,

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who said, “Well, we heard that there were 30-some-odd letters [relating to complaints of non-compliance] out of 55,000 doctors who prescribe,” and Dr. Scott Sanders, a Mississippi optometrist, who commented, “The FTC is trying to fix something that is not broken . . . Prescriber compliance is 99.99999%.”

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Additionally, the American Optometric Association cited a consumer survey, performed at its behest by NERA Economic Consulting, which purportedly found that only 3 of 1072 eyeglass consumers polled mentioned a possible Eyeglass Rule automatic-release compliance issue, and this, according to the American Optometric Association, indicates that non-compliance is not prevalent.

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However, the NERA survey did not specifically address prescription-release compliance,

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did not directly ask consumers whether they received their prescription from their prescriber, and did not ask consumers if they were aware of their right to their prescription.

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Rather, the survey focused on where consumers purchased their eyeglasses and contact lenses, and why they purchased from that particular location. When consumers were asked to select the reasons that they purchased from that location, none of the 17 options offered included the availability or unavailability of their prescription (such as “Because my prescriber didn't give me my prescription.”). The only way for survey respondents to reference prescription availability or unavailability was when asked open-ended questions such as “In your own words, why did you purchase glasses from [the location that you did]?” and “Why did you ONLY consider purchasing glasses from [the location that you did]?” In response to these questions, three consumers volunteered that they either thought they were required to buy from their doctor, or

that they bought from their doctor because the prescriber would not provide them with a copy of their prescription.

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Since only three consumers mentioned the lack of prescription release, the American Optometric Association contends that noncompliance must not be an issue.

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Though the NERA survey provides some insights discussed later in this document, the Commission does not find the survey to be probative as to whether prescribers are releasing prescriptions (either automatically or on request). The fact that only three consumers

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proactively mentioned that prescribers had not provided them with their prescriptions could, perhaps, suggest that prescribers typically comply, but cannot be accorded significant evidentiary weight since consumers were not actually asked whether they received their prescriptions.

The Commission also notes, as it has repeatedly in the past, that the raw number of consumer complaints about prescriber non-compliance is an unreliable barometer of prescriber compliance. As discussed in some detail during the Contact Lens Rule review, the Commission's experience has shown that the vast majority of injured or impacted consumers do not typically register complaints with the government, and even fewer are likely to submit a complaint about an FTC rule violation such as a prescriber's failure to release their prescription.

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This is especially true when—as will be discussed later in this final rule—evidence shows that many consumers remain unaware that they have an unconditional right to their prescription and should be receiving them automatically after each refractive exam. As workshop panelist Neilly commented, the lack of consumer complaints may correlate to the lack of knowledge about the prescription-release requirement “because people don't even know there's an Eyeglass Rule.”

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And even if consumers are aware that they have a right to their prescription and should have received it, they might not know to whom to complain in instances when it wasn't given to them.

Apart from the NERA survey, none of the commenters to the NPRM or Eyeglass Rule workshop supplied new or updated empirical evidence. The extensive evidentiary record, however, includes two previously submitted surveys that shed light on the percentage of patients that do or do not receive their prescriptions. A survey conducted on behalf of Warby Parker by the polling firm SurveyMonkey reported that, of consumers who had purchased eyeglasses within the last three years, 47% of those who saw optometrists and 31% of those who visited ophthalmologists were not automatically provided with a physical copy of their eyeglass prescription.

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The survey also found that 14% of consumers had to pay their prescriber for a copy of their prescription when they requested a copy at a later time.

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Another survey—conducted on behalf of 1-800 CONTACTS by the polling firm Survey Sampling International (“SSI”)—found that only 34% of eyeglass wearers automatically received their prescriptions on the day of their office visit, with another 19% receiving it during their visit, but only after asking for it.

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According to the SSI survey, some consumers were able to obtain their prescription at a later point by returning to their prescriber's office, but 39% of consumers never received their prescription at all.

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It is important to note that these surveys reveal more than simply that many prescribers fail to always comply with the automatic-release requirement. The surveys reveal that, even if prescribers will provide prescriptions

when asked,

a significant percentage of consumers leave their prescriber's office without their prescriptions. Which means that, for the next year or two (until their next eye exam), those consumers might be unable to shop for eyeglasses at an alternative location without having to contact their prescriber and ask for their prescription (and possibly have to pay for it). Although it is possible for other eyeglass sellers to call prescribers' offices and request patient prescriptions, this can lead to delays, and—in sharp contrast to the Contact Lens Rule—there is no legal requirement under the Eyeglass Rule that prescribers comply with requests to verify patient eyeglass prescriptions to third-party sellers.

The two surveys cited herein have been criticized by optometrists and the American Optometric Association, which contend the Commission should disregard their results because the surveys were submitted by retail competitors with a financial stake in the outcome of the rulemaking,

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and were submitted as part of the FTC's Contact Lens Rule review, and the markets and patient experiences for eyeglasses and contact lenses are not the same.

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The American Optometric Association cited to NERA's survey and comment for the premise that “Commission conclusions and decisions regarding regulation in the contact lenses market cannot be presumed to apply to the eyeglasses market.”

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As evidence of this dissimilarity, AOA has pointed to the NERA survey finding that eyeglass users are more likely than contact lens users to buy their corrective eyewear from someone other than their prescriber.

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AOA also noted that because contact lens fittings are not always complete in office due to patients taking home trial lenses to test, surveys of contact lens users may produce imperfect results in that consumers may report that they didn't receive their prescriptions at the end of their exam when, in fact, their contact lens fittings hadn't been finalized and so they weren't actually entitled to receive their prescriptions at that point.

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With respect to AOA's first argument, the Commission acknowledges that both Warby Parker and 1-800 CONTACTS have a financial interest in the outcome of the Rulemaking. The Commission recognizes, however, that nearly all commenters have some form of interest in the outcome. And thus, as a general practice, the Commission does not simply disregard data or opinions submitted by interested parties. Rather, the Commission takes into account the financial interests of submitting parties, but also, when possible, examines the underlying data and methodology submitted to gauge a survey's usefulness, and considers factors such as how many people are queried, how the questions are phrased, and whether the surveys are conducted in-house (by the interested parties themselves) or by independent and established third-party polling firms. Lastly, the Commission recognizes that all surveys are likely to have some methodological limitations, and thus the Commission will often decide not to treat any single survey as controlling or dispositive. The Commission is also aware, however, that multiple surveys conducted by different sources at different times with similar results tend to bolster the credibility of each individual survey.

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In this case, the surveys submitted by Warby Parker and 1-800 CONTACTS are not flawless or immune to criticism, but were performed by reputable third-party polling firms and appear sufficiently reliable based on an examination of their questions and methodology.

As for AOA's assertion that the two surveys were submitted during the Contact Lens Rule review and thus are not relevant to this Eyeglass Rule review, the Commission cannot concur. The contention that the SurveyMonkey survey was submitted during the Contact Lens Rule review is incorrect. While the Survey Monkey data was referenced during the Contact Lens Rule review, it was submitted in response to

the Commission's Eyeglass Rule Advance Notice of Proposed Rulemaking in 2015 and was a survey of eyeglass wearers.

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As for the SSI survey, that was indeed included as part of a submission during the Contact Lens Rule review, but that particular survey polled

both

contact lens users and eyeglass users about their experiences with prescription release, and distinguished between the two in its results. The SSI results cited above—showing that approximately only 34% of eyeglass wearers automatically received their prescriptions following their refractive eye exam, and 39% did not receive their prescription at all—are results

solely

of eyeglass users' experiences.

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Any impact or effect caused by a dissimilarity in eyeglass and contact lens markets or experiences would not apply.

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Thus, criticism that these surveys do not reflect the appropriate target group or take into account differences between eyeglass and contact lens users is misdirected, and these surveys merit the Commission's full consideration.

Moreover, the Commission cannot agree that other surveys detailing how contact lens users have not received their prescriptions do not have relevance in the context of the Eyeglass Rule. As noted above, there are, admittedly, differences in the examination and prescription processes for eyeglasses and contact lenses,

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but the mandatory prescription-release requirements are similar, and there is little evidence to indicate that prescribers release eyeglass prescriptions in dramatically different numbers than they release contact lens prescriptions. And while the NERA survey indicates that contact lens users are less likely than eyeglass wearers to purchase from someone other than their prescriber, this has little or no bearing on whether consumers are receiving their prescriptions from their prescriber (although it may have some bearing on whether automatic release is necessary or beneficial, as discussed below).

The Commission therefore views the five additional consumer surveys submitted and considered during the CLR review—which found that between 21 and 34% of contact lens users did not receive their prescriptions when they were supposed to—as additional indications that prescriber compliance with prescription release, and overall consumer receipt of their prescriptions (whether contact lens prescription or eyeglass prescription), is sub-optimal.

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Furthermore, the Commission notes, as it did in the CLR final rule, that despite multiple opportunities and requests for comment since 2015, the Commission has yet to locate or receive any reliable consumer-survey data rebutting or contradicting the prescription-release data in the record for either contact lens users or eyeglass wearers, or establishing, other than anecdotally, that consumers consistently receive their prescriptions from prescribers as they are supposed to under the applicable FTC rule.

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Based on the evidence in the record, it is thus the conclusion of the Commission that tens of millions of American consumers in need of corrective vision wear are not receiving their eyeglass prescriptions after visiting their prescriber each year.

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b. Whether the Automatic-Release Provision is Still Necessary and Beneficial for Consumers

Having determined that prescriber compliance with the Rule's automatic-release provision is deficient, and that many eyeglass consumers do not receive their prescriptions, the Commission next considers the impact of this deficiency, and whether such failure remains an unfair act or practice in need of remedial action, as originally determined by the FTC when it formulated the Rule.

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Again, opinions on the need for, and benefit from, automatic prescription release, varied significantly in the comments received by the Commission. NAROC, for instance, opined that the automatic-release requirement—when complied with—provides a substantial benefit to consumers as it enables comparative shopping, and added there is “no evidence to support a conclusion that the automatic release provision is no longer needed; to the contrary, the substantial expansion of consumer choice in recent years is strong evidence that this requirement has helped consumers and that it is more necessary than ever.”

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In a subsequent comment, the organization added, “There is widespread agreement that the Commission should continue the `automatic-prescription-release requirement' for eyeglasses,” but evidence demonstrates that not all consumers are aware they should receive their prescription automatically, and some prescribers are not providing it.

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Wallace Lovejoy from NAROC opined during the workshop that, while some people have their mind made up before they go to the eye doctor, and want to get an exam and buy glasses at the same time and place, “there's a significant number of people who get an eye exam and wait to shop and go somewhere else. It's useful to have the prescription released and I would agree that the automatic release seems to make the most sense.”

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Some other commenters endorsed this view. 1-800 CONTACTS, for example, stated, “automatic prescription release is critical to promoting consumer choice and competition in the market for prescription eyewear,” and “prescribers are unlikely to comply with their automatic release obligations absent a credible threat of enforcement and fines. Prescribers have a strong financial incentive to withhold a prescription to discourage comparison shopping and pressure patients to purchase lenses inhouse.”

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One anonymous commenter submitted, “Being able to have a prescription in your hands as soon as your examination is done would be very beneficial to a lot of people for many reasons. This would allow people to shop for different resources for their lenses and find the best price for them. It shouldn't be a hassle for someone to get their prescription . . .”

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Likewise, Sara Brown, from the advocacy organization Prevent Blindness, stated during the workshop, “I think not having [automatic release] would make a major impact on patient access.”

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She noted that millions of Americans have difficulty affording eyewear, and not having information that makes it easier for them to comparison-shop would be detrimental.

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On the other hand, some commenters felt that, irrespective of whether prescribers automatically release prescriptions, prescribers no longer withhold prescriptions if directly asked for them. Dr. Arlan Aceto, a Connecticut Professor of Ophthalmic Design and Dispensing, for example, said during the workshop that he and his optician colleagues have not had a problem obtaining prescriptions from prescribers in instances where the patients failed to bring them,

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and panelist Dr. Artis Beatty, a North Carolina optometrist, commented that oftentimes patients are issued a prescription but fail to have it on hand when they need it.

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These comments suggest there may be less need for, and consequently less benefit from, the automatic-release requirement.

The most extensive criticism of the automatic-release requirement came from workshop panelist and NERA consultant Dr. Andrew Stivers,

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who submitted a survey and lengthy comment that challenged the underlying basis for the requirement, noting, “It's not just how much compliance, it's how impactful that compliance or lack of compliance is on consumers.”

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According to Dr. Stivers, the relevant issue is whether, and how much, consumers have their eyeglass-shopping options curtailed by failure of

prescribers to automatically provide patients with their prescriptions, since some consumers would not have shopped elsewhere even if they had received their prescriptions, and some consumers might have been offered their prescription and declined.

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Dr. Stivers argued that the Rule's automatic-release provision was meant to address a lack of competition resulting from market conditions that do not exist in today's “information rich, dynamic market,” and thus the Commission should reexamine whether automatic release still benefits consumers in light of two fundamental changes that have occurred in the market.

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First, said Dr. Stivers, mass merchandisers and wholesale clubs have “transformed” the eyeglass shopping experience, and second, internet search and shopping has created a new, competitive channel for eyewear.

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The original rule's finding of unfairness, according to Dr. Stivers, rested on a context of advertising restrictions [of eyeglass sellers], State restraints on trade, limited shopping options for consumers, and overt prescription-withholding behavior by prescribers, that rarely exists today.

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Therefore, he contended, the Commission's “determination of unfairness from 40 years ago cannot be presumed to apply today and thus there is no rationale or basis for new regulation in the prescription eyeglass market.”

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Furthermore, Dr. Stivers explained, “Today, consumers can choose to shop before getting an exam, which increases incentives to provide information and increases competition in ways that the Commission of 1978 could not imagine,”

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and this change has made automatic release less likely to generate substantial benefit. And absent such benefits, per Dr. Stivers, lack of compliance with automatic release cannot be the basis for a determination of unfairness, or the proposed changes to the Rule.

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As evidence of the altered market and changed consumer behavior, both Dr. Stivers and the American Optometric Association pointed to the NERA survey, which found, among other things: that consumers have numerous options for eyeglass purchases; that one in three eyeglass purchasers consider alternatives to where they ultimately purchase; that consumers purchase glasses from alternative channels such as retail chains and online stores more than 50% of the time; that consumers choose purchasing locations for a variety of reasons (including price, service, familiarity, location), with convenience valued over all others; and that eyeglass purchasers are more likely than contact lens users to know about and consider alternative purchasing channels.

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According to the American Optometric Association, these results demonstrate that consumers are aware of, and utilize, their eyeglass-purchasing options, and that there is a “well-functioning and competitive market for eyeglasses,

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thus calling into question the “underlying premise that more must be done to encourage competition and choice in the eyeglass market.”

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The AOA further quoted Dr. Stivers' NERA report for the premise that the survey results “do not support or uncover any systemic market failures requiring additional rulemaking that would benefit consumers.”

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2. Analysis of Evidence Regarding Failure To Release Prescriptions

Having considered the evidence in the record—including the written submissions and workshop comments, empirical surveys of prescription-release and consumer knowledge, ongoing and historical patterns of consumer complaints and anecdotal reports, and other relevant evidence submitted during the CLR review (and the Commission's determinations in that regard), along with the industry's long-documented history of failing to release prescriptions in order to capture consumer eyewear purchases in-house—in context of the intent, purpose, and history of the Eyeglass Rule, the Commission finds that, regardless of the increased information and availability of purchasing alternatives in today's eyeglass marketplace, it remains an unfair act or practice for prescribers to fail to release a prescription to consumers. The practice denies consumers the ability to effectively use the information available, and continues to result in substantial economic loss and lost opportunity costs due to an impaired ability to comparison-shop for eyeglasses. The Commission finds that such conduct remains pervasive, is likely to cause consumers substantial injury, is not outweighed by countervailing benefits that flow from such conduct, and cannot reasonably be avoided by a substantial number of consumers.

The Commission does not dispute that mass merchandisers, wholesale clubs, and internet search and shopping have dramatically altered the overall retail landscape for eyeglass shopping. But these changes relate primarily to aspects of eyeglass shopping that occur

once a consumer already has a prescription in hand.

The initial experience of having an eye exam and obtaining a prescription remains much the same as it was when the Rule was created in that a consumer still has to be examined by an optometrist or ophthalmologist in order to obtain a prescription with which to buy eyeglasses. While Dr. Stivers has suggested that consumer emphasis on convenience when deciding where to buy glasses suggests they “likely consider both where to get an exam and where to shop for glasses ahead of time for an efficient shopping experience,”

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the NERA survey does not reveal to what extent this pre-exam shopping occurs, and Dr. Stivers acknowledged that he was unaware of any survey evidence establishing that many consumers comparison-shop

before

choosing their eyecare provider.

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The Commission is not aware of any empirical evidence showing whether pre-exam shopping is prevalent, nor—even if it is—whether that means consumers no longer want or need a copy of their prescriptions. It also would not aid consumers who are hesitant to ask for their prescription, or feel pressured to buy glasses from their prescriber—whom they may view as a respected medical “authority figure”

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—even if consumers' pre-exam intention was to take their prescription and buy glasses elsewhere. Furthermore, even if consumers decide pre-examination that they want to buy glasses from their prescriber, and thus do not need a copy of their prescription, they could still be harmed by a prescriber's failure to release their prescription if, at a later date, those consumers want to purchase additional or replacement eyeglasses, and lack a copy of their prescription. In addition, as Dr. Michaels noted during the workshop, many consumers go in for an eye exam every year without any intention of buying glasses,

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only to learn during their exam that they now need vision correction, or that their vision correction has changed.

Dr. Stivers is correct in that not all consumers necessarily benefit from receiving a copy of their prescription. Some consumers prefer buying glasses from their prescriber for convenience, or trust the expertise of their prescriber's staff to help fit them with the most appropriate eyewear. Some consumers simply favor the prescriber's frame options. But in trying to calculate how much consumer eyeglass-shopping options are, or are not, curtailed by the failure to receive their prescriptions, the Commission faces a dilemma in that consumer decisions and preferences with respect to buying eyeglasses are impacted by the fact that so many consumers are not given a copy of their

prescription. Widespread lack of automatic prescription-release renders it difficult, if not impossible, to determine what percentage of consumers opted to buy glasses from their prescriber because they favored the prescriber's convenience, selection, and expertise, and what percentage opted to buy from their prescriber because they did not have a copy of their prescription, did not feel comfortable asking for one, or did not even know that they could. In sum, it is unlikely that consumers' current conduct and preferences regarding where they purchase eyeglasses can fully establish how much is or is not to be gained from improving compliance with the Rule's automatic-prescription-release requirement because current consumer conduct and preferences are colored (and perhaps unfairly influenced) by current prescriber non-compliance with automatic prescription release.

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Ultimately, it is the Commission's view that, regardless of the widespread availability of information and alternative opportunities to buy eyeglasses, not possessing a prescription continues to impede consumer options and comparison-shopping for eyeglasses. By many accounts, the Eyeglass Rule, and the removal of State restrictions, have played a major role in significantly altering and improving the information and alternatives available to eyeglass consumers.

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But possession of the prescription remains the key that unlocks the door to this altered and improved marketplace. As workshop panelist Lovejoy commented, “[t]he ability to advertise doesn't matter if you don't get a copy of your prescription.”

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The Commission noted this when promulgating the Eyeglass I Rule, declaring that the injury arising from failure to release prescriptions is clear in that consumers are denied “the ability to effectively use available information, and inhibit the functioning of the competitive market model,” and therefore, the failure to release prescriptions immediately after the eye examination is completed is, in and of itself, an unfair act or practice.

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This holds true irrespective of other changes and improvements in the eyeglass marketplace.

Furthermore, it remains evident that many consumers are still not fully knowledgeable about their unconditional right to their prescriptions, and thus their ability to avoid or self-remedy harm arising from not possessing their prescriptions. While prescribers have often asserted that consumers are well-aware of their purchasing options,

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the Commission continues to receive communications evidencing that some consumers do not even realize they are entitled to their prescriptions.

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As workshop panelist Brown noted, “there was a question that was [asked] earlier about why don't patients ask for this information? Because they don't know.”

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Indeed, some surveys have found that consumer awareness of prescription rights remains less than ideal. According to a 2015 survey—performed on behalf of 1-800 CONTACTS—49% of prescription eyeglass wearers are not aware that they have a right to receive their eyeglass prescription, and 51% are not aware that their eye exam provider cannot charge for their eyeglass prescription.

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Multiple consumer surveys reviewed during the Contact Lens Rule review reinforce this by showing that a high percentage of contact lens users (46 to 60%, according to submitted data) still do not realize they are entitled to receive their contact lens prescription,

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and it is probable that many of these consumers are also unaware they are entitled to their eyeglass prescription. The percentages of consumers unaware of their rights have been found to be even higher for traditionally underserved groups such as African Americans and Hispanics,

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and due to less English language proficiency, non-native speakers may also be less likely to speak up and request their prescription—even if they know they can—if it is not automatically provided by their prescriber. There are also significant numbers of consumers each year who are new to the need for corrective eyewear, and thus have little experience with eye examinations, including whether they should receive a copy of their prescription. Therefore, the Commission concludes that while the NERA survey may suggest that some percentage of consumers is now aware of their option to obtain eyeglasses from a source other than their prescriber, the number of consumers fully informed of their prescription rights, and of their ability to take their prescription and shop elsewhere, remains sub-optimal.

Furthermore, as noted previously, the Commission is also aware that some consumers know they have the right to their prescription but may feel pressure to purchase from their prescriber, or feel uncomfortable asking for their prescriptions since it signals to the prescriber that they plan to purchase eyewear at a different location.

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Consumers often like and respect their prescribers, and are hesitant to do something that might be perceived as disloyal.

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Other consumers may be reluctant to acknowledge to their prescriber that they are cost-conscious and have concerns about their ability to afford eyewear at the price charged by their prescriber.

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After considering all of the evidence, the Commission concludes that when prescribers do not release prescriptions, it still harms consumers and puts them at a disadvantage in the marketplace, and thus continues to require remedial regulation.

B. The Remedy for Failure To Release Prescriptions Remains the Automatic-Release Requirement

In fashioning a remedy for an unfair act or practice, the Commission has wide latitude, and need only show a “reasonable relation” between the unfair act or practice and the remedy.

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When, in the past, the Commission has considered how to remedy failure to release, it evaluated a variety of options, including, among other things, release-upon-request, offer-to-release, and increased signage and consumer education, and yet the Commission repeatedly determined that the most effective remedy is to require automatic release of prescriptions regardless of whether a consumer requests one following an examination. The Commission still finds this to be true and concludes that automatic release as a remedial measure continues to have a reasonable relationship to the unfair act or practice of withholding prescriptions. The Commission continues to find that automatic release remains the optimal remedy for prescribers' failure to release prescriptions because absent the requirement: (1) even more doctors would not always provide patients with their prescriptions, as demonstrated by surveys indicating that they often do not presently, even though required to do so; (2) large numbers of patients would not ask for their prescriptions due to a lack of awareness of their unconditional right to their prescription; (3) some patients would be reluctant to ask for their prescriptions (particularly underserved groups); and (4) release-upon-request would inappropriately place the burden on the consumer. Release-upon-request would also be difficult for the Commission to enforce because, absent documentary evidence, it would likely turn into a debate as to whether a patient did or did not ask for their prescription.

While the Commission concludes that automatic prescription release remains the best remedy for the unfair practice of failure to release, it is also evident from the record that the remedy has not fulfilled its potential. The remedy has been in effect for over forty years, and yet a significant number of consumers are still not receiving their

prescriptions. The Commission therefore turns next to examine ways to improve the automatic-release remedy via amendments and clarifications to the Rule.

C. Commission Determination To Update the Rule To Clarify Requirements for Prescription Release

One prescription-release issue that is periodically brought to the attention of the Commission relates to the timing of the Rule's required automatic prescription release—

i.e.,

at what point that release must occur during a patient's office visit to their prescriber. The Rule, as presently written, states that it must occur “immediately after” the eye examination is completed, but that a prescriber may withhold the prescription until the patient has paid for the examination if the prescriber also requires immediate payment from patients for whom the examination revealed that no ophthalmic goods were required.

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The words “immediately after,” however, have not previously been discussed or clarified in detail, and some non-prescribing eyewear sellers have raised concerns that prescribers who also sell eyewear have a tendency to lead patients into the prescriber-owned optical dispensaries and offer to sell them eyeglasses immediately following an examination and

before

providing their patients with their prescriptions.

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Some prescribers and optometric consultants even recommend such an approach as a way of increasing customer “capture rate.”

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When this occurs, the prescription copy is only released to the patient after they have already shopped for eyeglasses, when they are checking out and paying their total bill (a bill that would include the cost of the examination, as well as the cost for new glasses).

As noted during the Eyeglass Rule workshop, the Commission believes that prescribers holding onto a prescription until after they have already made an eyeglass sale runs contrary to both the letter and purpose of the Rule.

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The letter of the Rule is clear. The prescriber must provide the prescription “immediately after the eye examination is completed.”

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The policy of the Rule, as it relates to the timing of prescription release, is also clear in several ways. First, the regulatory history makes evident that two of the foundational purposes of the Rule have been to (a) separate the eye examination from the purchase of eyeglasses, and (b) ensure that consumers have possession of their ophthalmic prescriptions so they are able to comparison-shop for glasses.

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The singular fact that eyeglass prescribers sell what they prescribe

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(a practice that some members of Congress have called an “inherent conflict of interest”)

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already blurs the distinction between eye examination and the purchase of eyeglasses, and when a prescriber offers to sell consumers glasses before releasing their prescriptions, it blurs that distinction even further.

Additionally, as noted at the time the Commission first created the Rule, the prescription itself is “the means by which consumers can comparison shop.”

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Absent a prescription in hand, (whether that be physically in hand, or digitally uploaded to a patient portal and readily accessible to the consumer), consumers might not even realize they have an option to comparison-shop for their glasses. They may be confused, or misled, into thinking that the examination and purchase of eyeglasses are part of a unitary, or “total vision care” process, a once-common practice in the ophthalmic community in which the sale of eyeglasses was tied to the examination, and by scheduling an eye exam, a patient was essentially committing to purchase eyewear (if they needed it) from the same location at which they were examined.

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While there is nothing inherently wrong with consumers buying eyewear from the prescriber who conducted their refractive examination, and there may be benefits to it,

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the Eyeglass Rule was created because the Commission determined it was an unfair practice when consumers did not at least have the option to buy glasses from someone other than their prescriber. The Commission believes it is problematic if patients are confused about whether they have, or do not have, the option to separate the examination process from the commercial purchase of eyeglasses. And even if patients recognize that by coming for an examination they are not committing to buy glasses from their prescriber, they may feel pressure to do so, a pressure heightened by the fact that until they possess a copy of their prescription, they cannot shop at any other locations.

Lastly, the practice of not providing prescriptions until after the patient has selected eyeglasses can lead consumers to believe that they are receiving their prescription because it comes with the eyeglasses, or to believe that what they are paying for is their prescription copy, when, in fact, they are paying for their examination, and the prescription copy is free per the Rule. The Commission periodically receives complaints from consumers who believe they were charged for their prescription when, in actuality, consumers were charged for their examination, but the confusion arose because the prescriptions were only handed over after the consumers paid.

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Ultimately, of course, the consumer is free to buy eyeglasses from their prescriber. Many consumers prefer to do so,

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and the Commission has no interest in preventing this. But to fully realize the intent and purpose of the Rule, consumers must have the unfettered option to buy from wherever they choose, and must not be confused or misled about their unconditional prescription rights, and whether their examination is connected to the purchase of glasses. To achieve this, consumers must have the prescription in their possession—whether physically or digitally—as soon as the prescription is finalized and before they are offered eyeglasses for sale.

For this reason, the Commission is revising § 456.2 to clarify that the prescription must be provided after the refractive eye examination is completed “and before offering to sell the patient ophthalmic goods.” This does not mean that a patient is not permitted to walk through a prescriber's eyeglass dispensary, or browse available eyeglass frames, before receiving a copy of their prescription. Nor does it cancel the Rule provision that a prescriber may make consumers pay for their exam before releasing their prescriptions, so long as that prescriber would have required immediate payment from the patient had the examination revealed that no ophthalmic goods were required.

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But it does mean that if a prescriber (or the prescriber's staff) is ready and willing to sell that patient eyeglasses, the prescriber must release a copy of the prescription to the patient before moving forward with any aspect of the sale. If the prescription is released electronically (with the patient's consent), it must be uploaded to a patient portal or transmitted to the patient via email or text, and thus fully accessible to the patient before that patient is offered an opportunity to purchase eyewear. It also means that if the prescriber makes a medical determination to not write and release a prescription to a patient,

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or withholds a prescription pending payment by the patient for the examination, the prescriber may not offer to sell that patient eyeglasses at that time.

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The prescriber may only offer to sell the patient eyeglasses after the prescription is released.

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Furthermore, per the discussion above regarding automatic prescription release, the Commission still concludes—as it concluded multiple

times in the past—that the burden of ensuring prescriptions are released must rest on the prescriber and not the patient.

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And thus automatic release must occur regardless of whether or not the prescription is requested by the patient. This has always been the intent of the Rule—and is already reflected in the existing requirement that the patient's prescription must be provided “immediately” after the examination—but, unlike with the Contact Lens Rule, it has never been specifically stated in the Rule text. To ensure that is clear, and to bring the Eyeglass Rule prescription-release requirement into concordance with that of the Contact Lens Rule, thereby simplifying compliance, the Commission is further revising § 456.2 to clarify that the prescription must be provided “whether or not the prescription is requested by the patient.” This does not mean that a prescriber must force the prescription on a patient who does not want a copy. The patient is always free to refuse a copy, in which case the prescriber should merely note that in their files. But prescribers and their staff must at least attempt to give the patient a copy of the prescription, rather than merely offer to provide a copy, or just wait and see if the patient asks for it.

Neither of these clarifications alter the burden on prescribers, they merely make clearer what is already required by the Rule, and what should already be occurring in practice.

III. Final Rule Pertaining to Affirmative Consent to Digital Delivery of Eyeglass Prescriptions

A. Digital Delivery Option in the NPRM and the Basis for Such Amendment

As discussed above, § 456.2(a) of the Eyeglass Rule provides that it is an unfair act or practice for a prescriber to fail to provide to the patient one copy of the patient's prescription immediately after the eye examination is completed. The Rule, as currently codified, does not expressly permit electronic delivery of prescriptions as a means for automatic prescription release. In the NPRM, the Commission considered technological advances, such as the proliferation of patient portals, along with prescriber-to-patient communication via email or text, that could facilitate the transmission of the prescription to the patient once the eye exam is completed, and thereby enhance prescription portability.

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The Commission opined that permitting electronic delivery in certain circumstances could provide benefits to consumers, and proposed amending the Rule to permit such delivery after the prescriber obtains the patient's verifiable affirmative consent.

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To ensure that patients are able to make an informed choice about whether to agree to electronic delivery, the proposal required that the prescriber identify the particular delivery method to be used, such as portal, text, or email, and the prescription would need to be provided in a digital format that can be accessed, downloaded, and printed by the patient.

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This could enable patients to have easier access to and use of a prescription, reduce requests for additional copies and calls from sellers to verify a prescription, and potentially lower costs while providing flexibility for prescribers and patients. To aid Commission enforcement efforts to monitor compliance with the Rule, the Commission proposed that prescribers be required to keep a record or evidence of a patient's affirmative consent for a period of not less than three years.

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This proposed amendment to the Eyeglass Rule mirrored a change made to the CLR in 2020, allowing prescribers to satisfy the CLR's automatic-release requirement by providing the patient with a digital copy of his or her contact lens prescription in lieu of a paper copy, provided the prescriber first identified the specific method of delivery to be used and obtained the patient's verifiable affirmative consent to this method of delivery.

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In the CLR SNPRM, the Commission noted that providing patients with an electronic copy of their prescriptions could enable patients to share prescriptions more easily with sellers when purchasing eyewear, and this in turn could potentially reduce the number of patient and seller requests for verification or additional copies of the prescription. To enhance portability, the Commission noted that electronic delivery methods should allow patients to download, save, and print the prescription.

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B. Comments on the NPRM and Discussion at the Workshop Regarding the Proposal To Permit Digital Delivery of the Eyeglass Prescription With Patient's Affirmative Consent

In addition to seeking general comments on the benefits and burdens of this proposed change, the Commission invited public comment on whether prescribers would choose to satisfy the automatic-prescription-release requirement through electronic delivery if permitted by the Rule, and whether patient portals, emails, or text messages would be feasible methods for the provision of digital prescription copies. The Commission also asked what other technologies are available that could be implemented to improve prescription portability, and thereby increase benefits and decrease burdens related to prescription release.

1. Comments About the Benefits and Burdens of the Proposed Affirmative Consent to Digital Delivery Provision

The Commission received generally positive feedback on the proposed digital delivery provision, with commenters noting that it would allow the Rule to keep pace with technology and it would help patients understand their rights under the Rule.

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The AOA opined that this would be a “commonsense update” that would “ensure [ ] that the FTC's regulatory language is keeping pace with updates in technology.”

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NAROC suggested that the “impact of allowing a prescriber to release the [prescription] in digital form will be to increase patient understanding of their rights, because every instance of receipt of a digital copy of the prescription will require affirmative consent to such delivery and will help build an expectation on the part of consumers that they are entitled to the prescription.”

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Other commenters who objected generally to the burden of other proposed changes, including the proposed confirmation requirement, pointed to the widespread transition to electronic health records (“EHRs”) or electronic medical records (“EMRs”) and argued in favor of prescription availability via a portal as being wholly sufficient to address the FTC's concerns about prescription release, and ensure patient access to their prescription.

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Another commenter, an ophthalmic technician, expressed concerns over the added recordkeeping burden from the proposed confirmation requirement, noting that their practice already has a record of the prescription on file for the patient and that most EHRs track when prescriptions are printed out.

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Although having a prescription available on file upon request (either in a paper record or accessible through an online portal) would not satisfy the automatic-prescription-release requirement, the Commission considered the proliferation of patient portals and EHR systems in the NPRM, and discussed both the potential benefits available to consumers, prescribers, and sellers through the use of such systems, as well as the possible drawbacks. On the benefit side, a patient using a portal could have direct access to a current, exact copy of the eyeglass prescription, reducing the chance of errors caused by an inaccurate or expired prescription, and the need for follow-up corrections by prescribers.

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The use of health information

technologies, such as patient portals, could also reduce costs for prescribers, patients, and sellers by making it easier and more efficient for patients to obtain and share eyeglass prescriptions, and by reducing the number of requests placed on prescribers to verify prescription information or provide duplicate copies of prescriptions. In addition, it is likely that patient portals do not raise the same privacy concerns expressed by some prescribers about sharing patient prescription information with third parties because patient portals can enable the secure sharing of such information directly with the patients themselves, who may then provide the prescription to the third-party seller.

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The Commission is aware, however, of potential drawbacks in relying on electronic records exclusively for prescription delivery. In the recent CLR rulemaking, commenters expressed concerns that: (1) online portals are not widely used; (2) patients may not always be aware of the portal or may have difficulty accessing or printing documents online; and (3) some prescribers and patients prefer paper copies.

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Recent data shows that the number of prescribers offering patients access to their health information through an EHR system or patient portal has increased significantly. A survey from 2022 found that nearly 3 out of 5 U.S. adults reported they were offered and accessed their online medical record or patient portal, which was a 50% increase since 2020.

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Patients also increased their use of apps to access online medical records, and patients using apps to view their online medical records accessed them more frequently than those who used only a web-based method.

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Available information suggests, however, that disparities still exist in the availability and use of patient portals among some populations, including older patients.

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A variety of factors may influence the limited portal use in such populations, including lack of access to technology and personal preference, and some groups (including Black and Hispanic individuals) may be less likely to report being offered access to a portal in the first place, suggesting a need for improvement in provider communication and clinic practices.

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In addition, of those patients who access their online medical records through an app or web-based patient portal, relatively low numbers are downloading and transmitting their health information, which “suggests a need for further education of both individuals and providers on these features,” according to the Office of the National Coordinator for Health Information Technology.

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2. Comments in Favor of Allowing Prescribers to Choose Whether To Offer Digital Delivery of Prescriptions

A number of commenters supported making the decision to offer digital prescription delivery—either at all or using particular delivery methods—a voluntary one on the part of prescribers.

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For example, NAROC approved of not requiring prescribers to provide prescriptions electronically, but noted that some prescribers may already be complying with the CLR prescription-release requirement through digital prescription delivery and, for these prescribers, permitting compliance with the Eyeglass Rule in the same manner would create efficiencies for prescribers' offices.

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Some commenters also suggested that compliance with the automatic-release requirement is made easier by the digital delivery option due to the ease of emailing either the prescription itself or a link to a portal on which the prescription is available.

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One anonymous commenter questioned whether portals would need to be configured to require a patient signature whenever a patient accesses the portal to print a prescription.

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Workshop panelist Dr. Michael Repka, Medical Director for Governmental Affairs at the AAO, described an intricate process his office undertakes to attempt to obtain a signature of prescription-receipt from a patient who accesses their contact lens prescription via a portal.

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The Commission, however, notes that this represents a misunderstanding of the CLR's digital-prescription-delivery provision, which specifically removes the signature-requirement when prescriptions are digitally delivered, and likewise, confirmation signatures would not be required when prescriptions are delivered digitally under the amended Eyeglass Rule. Using a digital delivery method to comply with § 456.2 would relieve the prescriber of having to collect a signature from the patient confirming their receipt of the prescription.

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Under the new § 456.4(a)(1)(ii), prescribers using a digital delivery method would not need to request that the patient sign a separate statement confirming receipt of the prescription.

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Instead, prescribers would need merely to retain evidence that the prescription was sent, received, or made accessible, downloadable, and printable, which commenters have acknowledged EHRs generally are configured to do.

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Similarly, an emailed or texted prescription should create its own record of transmission, and therefore involve minimal burden to the prescriber.

Other commenters shared that the existence of electronic health records in a medical practice does not automatically result in a patient having access to their prescription on a portal,

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and that some prescribers may be using simplified websites to provide prescription delivery without giving a patient full access to all of their exam information, in order to make access simpler for patients.

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Some prescribers may be hesitant to offer EHR systems because of concerns about cost, functionality, and data security.

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For these reasons, the Commission believes it is important to allow prescribers the choice of whether to offer a digital delivery method to comply with the automatic-release requirement in the Eyeglass Rule, rather than mandating it.

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The final rule neither compels prescribers to offer prescription-release by an electronic method nor requires that patients accept their prescription by electronic method when offered by the prescriber.

3. Comments Regarding Giving Patients a True Choice as to How To Have Their Prescription Delivered

Some commenters expressed concerns that not all patients may benefit from electronic access to their prescription, both as a result of limitations in broadband capabilities and due to differences in patient needs and health literacy that might affect patients' ability to access their prescriptions online.

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Commenters asserted that patients must retain the ability to receive a paper copy of their prescription.

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The challenges in educating patients on how to access their prescription on a portal were also noted by Workshop panelist Dr. Stephen Montaquila, a Rhode Island optometrist, who acknowledged that some patients prefer a paper copy.

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Other commenters described their experience with patients frequently losing or forgetting their prescription when going to order glasses. The commenters pointed to the remedy of having the prescription available on the portal, or noted that the patient could request a duplicate copy of the prescription or the seller could call to verify a prescription with the prescriber, and argued that these solutions should resolve concerns over prescription access and portability.

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The Eyeglass Rule does not, however, require prescribers to respond to seller verification requests or provide duplicate copies of prescriptions, as is required by the CLR. The Commission also remains concerned about the

ongoing lack of understanding and limitations in patient access to portals or other health technology, and concludes that requiring all patients agree to digital delivery is not appropriate at this time.

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C. Additional Discussion and Commission Determination Regarding the Affirmative Consent to Digital Delivery

1. Final Rule Determination To Add Option for Digital Delivery of Eyeglass Prescriptions

The Commission agrees with the comments in favor of permitting, but not requiring, electronic delivery of the eyeglass prescription, provided consumers are informed about, and consent to, the delivery method. Based on its review of the record, the Commission is hereby modifying the Rule to require that prescribers provide patients with a copy of their prescription either (a) on paper or (b) after obtaining verifiable affirmative consent to digital delivery, in a digital format that can be accessed, downloaded, and printed by the patient. Obtaining such consent to digital delivery will require the prescriber to identify the specific method or methods of electronic delivery that will be used, and collect the patient's affirmative consent to the specified delivery method in a way that is verifiable,

i.e.,

can later be confirmed, such as through a signed consent form or electronic approval (as discussed below). Prescribers must then keep evidence of a patient's affirmative consent for a period of not less than three years. Patients who decline to consent, for any reason, must be given a paper copy of their prescription. Likewise prescribers who prefer to provide paper copies to their patients need not offer an electronic option.

Importantly, providing the option for digital delivery does not alter the prescriber's obligation to automatically provide the eyeglass prescription regardless of whether a patient requests it, but merely the method by which the patient will receive the prescription. It also does not impact the timing of prescription delivery. Whether the patient consents to digital delivery or opts for a paper copy of the prescription, prescribers must provide the prescription immediately after the eye examination is completed. As discussed above, it is critical that the patient be in receipt of their prescription before a prescriber offers to sell them eyeglasses, so as to ensure the separation of examination and dispensing under § 456.2, and to ensure that patients are able to freely comparison-shop for eyeglasses.

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Accordingly, if a patient consents to the prescriber emailing or texting the prescription, or placing it on a portal, this method of delivery must take place at the end of the examination, and before the prescriber or prescriber's staff attempts to sell the patient eyeglasses.

The digital delivery option includes a recordkeeping provision, but, as the Commission concluded in the CLR final rule, the burden of retaining a record of patient consent should be minimal, “since prescribers who opt for electronic delivery of prescriptions will, in all likelihood, obtain and/or store such consent electronically.”

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As detailed below, the Commission is modifying the proposed rule text to expressly recognize that consent to digital delivery can be obtained either on paper or in a digital format. In any case, obtaining and storing a record of patient consent should not take longer than obtaining and storing a patient's confirmation of prescription release,

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and prescribers who use digital delivery to provide the prescription would not need to request that the patient acknowledge receipt of the prescription by signing a separate confirmation statement. Finally, offering a prescription in a digital format would be an option for prescribers, but is not mandatory, so prescribers can choose not to offer electronic delivery of prescriptions if they find the recordkeeping provision overly burdensome.

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One related issue raised by some commenters is whether prescribers could obtain a patient's consent to digital delivery a single time rather than at every visit, and only need to obtain consent again if the prescriber changes their digital-delivery policy, a practice permitted by the Department of Health and Human Services with regard to its Notice of Privacy Practices signed-acknowledgement requirement.

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Dr. Montaquila, for one, noted that allowing prescribers to obtain consent just once, when the patient first visits a practice, would lessen the Rule's burden for prescribers and yet still allow for the patient to be educated, opt-in knowingly, and have the opportunity to withdraw consent at a later time.

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The Commission notes that the Rule, as proposed in the NPRM and hereby adopted, does not specify that the verifiable affirmative consent must be obtained at every appointment. Instead, it requires the prescriber to provide the prescription on paper or “in a digital format that can be accessed, downloaded, and printed by the patient, after obtaining verifiable affirmative consent, pursuant to § 456.3.” The Commission clarifies that if the prescriber identifies the digital method that will be used for prescription delivery and allows the patient to choose whether to consent to that delivery method (rather than making it the default), then allowing patients to sign an authorization just once would satisfy the Rule's requirements. But as noted by the commenters, if the prescriber changes their digital delivery policies (for example, by switching from email delivery of prescriptions to access on a portal), they would need to re-obtain the patient's digital delivery consent. Additionally, prescribers should allow a patient to revoke consent at any time.

Further, the Commission believes that prescribers could use a single document to obtain verifiable consent to digital delivery of both contact lens and eyeglass prescriptions so long as it is clear to consumers that they are consenting to digital delivery for both. Ensuring that patients are aware of where to locate their prescriptions, and how to access them, should be a priority for prescribers, so regular re-education on these points is appropriate.

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Furthermore, § 456.3(c) requires that prescribers maintain records or evidence of a patient's affirmative consent for a period of

not less than

three years. It is important to note that if a prescriber intends to provide digital delivery to a patient for more than three years following that patient's signed consent, they should not dispose of the consent record after three years. Rather, the prescriber should retain the patient's signed consent for as long as the prescriber relies on it to authorize digital delivery of the prescription, plus another three years.

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2. Final Rule Moves Requirement for Obtaining Patient's Verifiable Affirmative Consent for Digital Delivery to a New Section and Out of Definitions

In the NPRM, the Commission proposed adding the digital delivery provision to the Rule as a new definition of the phrase “provide to the patient one copy” in § 456.1.

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This definition would have stated both the option for the prescriber to offer the patient a digital copy of their prescription, and the requirements for obtaining verifiable affirmative consent to the digital delivery and maintaining a record or evidence of the patient's affirmative consent for a period of not less than three years. Adding this definition to the Rule would have mirrored the Commission's amendment of the CLR in 2020 to provide a similar

option for digital prescription delivery.

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Upon further consideration, the Commission has decided to move the digital delivery provision out of the definitions section and into § 456.2. By moving this language to § 456.2, the Commission seeks to ensure prescribers do not overlook the requirements for providing prescriptions digitally. Moving the digital delivery provision to this section may also make the requirement more noticeable and understandable to consumers. The FTC is also cognizant that the preferred drafting practice for regulations is to set out requirements in the body of the rule, rather than in the definitions.

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Accordingly, the Commission is amending § 456.2(a), “Separation of examination and dispensing,” to state that the automatic prescription release shall be provided on paper; or in a digital format that can be accessed, downloaded, and printed by the patient, after obtaining verifiable affirmative consent, pursuant to § 456.3. The Commission is then adding a new § 456.3 to the Rule titled, “Verifiable affirmative consent to providing the prescription in a digital format.”

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New § 456.3 sets out the remainder of the text proposed in the NPRM as § 456.1(h)(2). It requires that when a prescription copy is provided in a digital format, the prescriber shall inform the patient of the specific method(s) of electronic delivery that will be used; obtain, on paper or in a digital format, the patient's verifiable affirmative consent to receive a digital copy through the identified method or methods; and maintain records or evidence of a patient's affirmative consent for a period of not less than three years, as specified in the new § 456.3.

Since the digital delivery provision, as adopted herein as § 456.3, was clearly proposed as § 456.1(h)(2) in the NPRM, moving the requirement to a new section in the Rule complies with the rulemaking requirements of both the Administrative Procedure Act and the FTC Act, while ensuring that regulated entities and the general public do not overlook the requirements because they were included in the definitions.

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The Commission recognizes that the placement of the digital delivery provision in a new, dedicated section differs from the CLR, where it appears in the definitions. The requirements in each rule, however, are effectively the same. The Commission can amend the CLR during the next periodic rule review to mirror the Eyeglass Rule and, in the meantime, can provide clarity to prescribers through guidance materials.

3. Final Rule Adds Explicit Recognition of the Ability To Obtain Affirmative Consent on Paper or in a Digital Format

In this final rule, the Commission is amending the Rule to explicitly permit prescribers to obtain a patient's verifiable affirmative consent either “on paper or in a digital format.” This clarification comes in response to comments relating to permitting digital consent.

Participants at the workshop discussed that some EHR companies haven't updated their systems in light of the new CLR requirements to allow prescribers to collect signatures electronically, which would reduce the record-keeping burden.

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Nevertheless, commenters suggested that the Rule should expressly permit prescribers to obtain patient signatures digitally or on paper.

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For example, regarding the confirmation of prescription release, NAROC wrote, “[t]he Commission may want to specifically allow for the signature to be an electronic signature by means of either a handwritten signature input onto an electronic signature pad or a handwritten signature input on a display screen with a stylus device. . . . While it is not clear to us how many optometry or ophthalmology offices use electronic signatures today, this clarification may pave the way for more offices to adopt this method of collecting a signature, making the confirmation process more efficient and less reliant on paper receipts in the future.”

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Dr. Montaquila acknowledged that some practices are already using electronic methods to capture patient signatures required by the CLR.

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Throughout the process of updating the CLR to permit digital prescription delivery and require confirmation of prescription release, the Commission acknowledged that prescribers may obtain a patient's signature either on paper or digitally. In the NPRM for the Contact Lens Rule review, the Commission proposed, “[t]he acknowledgment form shall be in a format that allows either conventional or electronic signatures. Prescribers may maintain copies of the acknowledgment forms in paper or electronically.”

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In the SNPRM for the CLR, the Commission stated, “[t]he precise wording of such confirmations would be left to the prescriber's discretion, but for prescribers opting for (a), (b), or (c), a patient's written or electronic signature would always be required.”

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Similarly, when proposing changes to the Eyeglass Rule in its NPRM, the Commission noted the “recordkeeping burden could be reduced to the extent that prescribers have adopted electronic medical record systems, especially those where patient signatures can be recorded electronically and inputted automatically into the electronic record.”

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The Commission finds the Rule is improved by explicitly permitting prescribers to obtain a patient's verifiable affirmative consent either “on paper or in a digital format.” Accordingly, §§ 456.3 and 456.4, setting forth the requirement for obtaining a patient signature confirming prescription receipt, allow prescribers to meet the requirements of these provisions by obtaining the patients signature either “on paper or in a digital format.”

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This will resolve prescriber confusion regarding the need to print out digital forms and collect wet signatures that might then need to be scanned and stored electronically in an EHR system. Alleviating prescriber misunderstanding regarding signature collection should help reduce waste and facilitate faster, more efficient Rule compliance.

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4. Final Rule Clarifies That Digital Delivery Methods Identified in Affirmative Consent Request Must in Fact Be Used

The Commission recently sent cease and desist letters to prescribers of contact lens prescriptions and eyeglass prescriptions in response to consumer complaints that the prescribers did not release their prescriptions at the end of the contact lens fitting or eye examination, or otherwise violated the CLR or Eyeglass Rule.

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As discussed at the workshop, in subsequent communications with letter recipients, Commission staff obtained samples of forms some prescribers were using to comply with the CLR consent-to-digital-delivery and confirmation-of-prescription-release requirements. Staff noted, “[w]e've seen forms where there's not a separate signature about digital consent. We've also seen forms where the information is included in an intake form among a lot of other information that the patient may not see. And in some cases, the specific method of electronic delivery is not necessarily identified. It may say, `We will provide you with your prescription digitally either by text, email, or portal.' ”

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The Commission is concerned that patients cannot provide informed consent to digital delivery if prescribers do not identify the delivery method that will be used. Patients will not know where to locate their prescription if they are not told which delivery method the prescriber plans to use. This can result

in the patient effectively not receiving the prescription, as required by the Rule. Similarly, providing a disclosure about digital delivery as part of a long form containing unrelated information, such as privacy practices and payment policies, and then requesting one signature at the end of the form might not be an effective way of obtaining the “verifiable affirmative consent” required by the Rule. Dr. Beatty noted that decoupling information during intake related to patient consent may be appropriate to ensure patients are understanding and agreeing to digital delivery.

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In addition, providing a copy of the prescription electronically by default while notifying patients that they can request a paper copy if they want one undermines the automatic-prescription-release requirement by converting it to a release-upon-request model that the Commission has rejected.

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As an example, one of the sample forms shown at the workshop stated, “I acknowledge the [Prescription Access] policy and note I can (i) access my eyeglass and contact lens prescriptions digitally at [website redacted] or (ii) obtain a paper copy at any time as well.”

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This language essentially transforms it into a notice of digital delivery rather than a true patient consent to digital delivery. In satisfying the Eyeglass Rule's automatic-prescription-release requirement, the patient must be given an actual choice to select an identified electronic delivery method or to receive the prescription on paper automatically. Prescribers are free to also place prescriptions on a portal, but this action would not satisfy the requirements of § 456.2 if the patient did not opt-in to the digital delivery option.

To provide clarity to prescribers, the final rule, in § 456.3(a), states that the prescriber shall, “identify to the patient the specific method or methods of electronic delivery

that will

be used,” rather than “to be used,” as was proposed.

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The digital delivery method or methods the prescriber identifies to the patient when seeking consent should be the method the prescriber actually uses. It would not be appropriate, for example, for a consent form to state, “I authorize my eye doctor to provide me with a digital copy of my prescription via email, text, and/or the secure online patient portal at the completion of my contact lens fitting and/or refractive eye examination,” unless the prescriber did in fact deliver the prescription using all of the referenced methods.

IV. Final Rule Pertaining to Confirmation of Prescription Release

A. Proposed Confirmation Requirement in the NPRM and the Basis for Such Proposal

After considering the evidence discussed in sections I and II,

supra,

including comments submitted in response to the ANPR, the Commission proposed in the NPRM to amend the Rule to add a confirmation-of-prescription-release requirement. In so doing, the Commission stated its belief that such confirmation would increase the number of patients who receive their prescriptions, inform patients of the Rule and of their right to their prescriptions, reduce the number of seller requests to prescribers for eyeglass prescriptions, improve the Commission's ability to monitor overall compliance and target enforcement actions, reduce evidentiary issues, complaints and disputes between prescribers and consumers, and bring the Eyeglass Rule into congruence with the confirmation-of-prescription-release requirements of the Contact Lens Rule.

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As a result, in the NPRM, the Commission proposed a new § 456.3

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to require that upon completion of a refractive eye examination, and after providing a copy of the prescription, the prescriber shall do one of the following:

(i) Request that the patient acknowledge receipt of the prescription by signing a separate statement confirming receipt of the prescription;

(ii) Request that the patient sign a prescriber-retained copy of a prescription that contains a statement confirming receipt of the prescription;

(iii) Request that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming receipt of the prescription; or

(iv) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable.

Proposed § 456.3 further provided that if the prescriber elects to confirm prescription release via paragraphs (a)(i), (ii), or (iii), the prescriber may, but is not required to, use the statement, “My eye care professional provided me with a copy of my prescription at the completion of my examination” to satisfy the requirement. In the event the patient declines to sign a confirmation requested under paragraphs (a)(i), (ii), or (iii), the prescriber shall note the patient's refusal on the document and sign it. A prescriber shall maintain the records or evidence of confirmation for not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives. The prescription confirmation requirements shall not apply to prescribers who do not have a direct or indirect financial interest in the sale of eye wear, including, but not limited to, through an association, affiliation, or co-location with an optical dispenser.”

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The Commission then sought public comment on the benefits and burdens of its confirmation-of-prescription-release proposal.

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The Commission also invited comment on whether the proposed change would affect Rule compliance, the Commission's ability to enforce the Rule, or patient's understanding of their rights under the Rule.

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B. Comments on the NPRM and Discussion at the Workshop Regarding Confirmation of Prescription Release

1. Comments in Favor of Confirmation-of-Prescription-Release Proposal

The record contains numerous comments in support of the confirmation-of-prescription-release amendment, with these comments detailing the need for, and benefits of, the proposed amendment. Reasons given in support of the amendment include: that it will bring greater awareness of a consumer's right to their prescription, greater compliance with automatic prescription release,

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and a greater ability for the Commission to enforce the Rule; that the acknowledgment will serve as evidence of compliance for prescribers; and that benefits flow from having the Eyeglass Rule's confirmation requirement match that of the Contact Lens Rule. Other commenters generally support the Rule, but did not provide specific reasons for their support.

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NAROC, calling the confirmation proposal needed and simple,

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stated that it would result in greater compliance and wider consumer understanding of their rights.

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In addition, according to NAROC, the proposal would allow all sellers in the market for corrective eyeglasses to participate. Specifically, NAROC stated support for requiring confirmation since “evidence demonstrates that despite the many years that the [automatic prescription release] requirement has been in effect, not all consumers are aware that they should receive an eyeglass prescription without requesting it.”

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Consumer Action, likewise,

called the confirmation proposal “consumer-friendly” and discussed it as a way to remedy a lack of compliance, a lack of consumers awareness of their automatic right to a copy of a prescription, a lack of competition, and a reduced ability to shop around for lower prices.

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Other commenters reiterated that the confirmation proposal would increase compliance with automatic prescription release. The advocacy organization National Taxpayers Union supported requiring confirmation to “strengthen the process of providing consumers with a copy of their eyeglass prescription,” which will benefit consumers.

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1-800 CONTACTS stated the “confirmation proposal will bolster prescription portability, promoting consumer choice and competition in the evolving market for prescription eyewear.”

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Commenters specifically spoke to the proposed amendment's ability to assist the Commission in enforcing the Rule's automatic-release requirement. 1-800 CONTACTS stated its desire for greater enforcement of the Rule and expressed disappointment that the Commission has only issued warning letters since enacting a similar requirement for the Contact Lens Rule in 2021.

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NAROC commented that both the confirmation of prescription release and the three-year recordkeeping requirement will make the Rule easier for the FTC to enforce. The organization stated that prescribers have a responsibility to provide evidence that the patient received a copy of the eyeglass prescription at the end of the exam, and that confirmations of prescription release are helpful to prescribers to show their compliance in instances when patient complaints of non-compliance are brought before them.

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At the workshop, Joseph Neville of NAROC added that, if the FTC was going to regularly enforce the Rule, the prescriber needs proof they actually complied, and the acknowledgment will serve that purpose.

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NAROC likened the confirmation proposal to prescribers asking their patients to acknowledge receipt of privacy practices, to give consent to certain treatments or procedures, and to allow providers to share protected health information in certain situations.

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According to NAROC, such acknowledgments benefit the prescriber by averting disputes as to what the patient agreed.

At the workshop, Wallace Lovejoy opined that it is appropriate to encourage some sort of recordkeeping that the prescription was in fact delivered to the patient due to “the unique nature of the market and a significant amount of financial interest on the part of prescribing and dispensing optometrists”

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Indeed, NAROC commented that prescribers have a powerful incentive to improve the “capture rate” of in-office eyewear sales to their patients since they still make most of their revenue from selling the eyewear that they prescribe.

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NAROC also stated that the significant benefits of the proposed confirmation would exceed the minimal burdens. Its comment stated that the “amendments should not have significant or disproportionate impact on prescribers' costs” and that its member experience and observation indicates that “thousands of optometrists affiliated in co-location with NAROC member companies regularly comply with the current Eyeglass Rule and the Contact Lens Rule [which already contains a confirmation-of-prescription-release requirement] with little added cost or other burden on the eye care practice.”

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NAROC said it has not seen any credible evidence that the requirement is overly burdensome or will result in anything more than a trivial expense. In response to requests from their members for information as to whether the added effort of confirmations for contact lens prescriptions was a problem, they heard that compliance is occurring with little or no disruption or expense.

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Pete Sepp, the president of the National Taxpayers Union, said he supports the Rule and the confirmation proposal, but is very cognizant of regulatory burdens imposed on prescribers. He said the key question for him is whether the extra burden the confirmation brings is a problem, or alternatively, whether the problem may derive rather from the overall burden from all regulations imposed on prescribers.

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The National Taxpayers Union (NTU) suggested that the Commission may have underestimated the confirmation burden, particularly the 10-second estimate for how long it takes for consumers to read and sign the confirmation statement.

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It also stated it was likely the burden would have a disproportionate impact on smaller, less sophisticated, prescribers who lack economies of scale and equipment, and thus merely averaging the burden cost among all of the nation's eyecare prescribers was an “oversimplification.”

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According to NTU's estimate, a “modest optometry establishment” performing 3,000 examinations a year would—based on the Commission's NPRM estimates for time and labor—increase the paperwork burden by 167 hours and incur an additional labor compliance cost of $4,123, “not an inconsiderable burden for a small establishment.”

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Sepp of the NTU did suggest, however, that compliance with the confirmation-of-prescription-release proposal “might not be quite as burdensome” when comparing it to the overall regulatory burdens on prescribers, and that perhaps the real focus should be on reducing overall burdens that hamper small businesses.

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One factor worth noting for the confirmation proposal, according to NAROC, is that having a similar confirmation requirement for the Eyeglass Rule, as already codified in the Contact Lens Rule, should lessen the additional incremental burden of the proposed amendment to the Eyeglass Rule, since most contact lens wearers also receive eyeglass prescriptions and should get them at the same time.

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NAROC also stated that the similar requirement for the Eyeglass Rule should ease issues with compliance and staff training.

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2. Comments Against the Confirmation-of-Prescription-Release Proposal

Some commenters, largely prescribers and prescriber trade associations, were critical of the confirmation-of-prescription-release proposal, stating that existing strong compliance with the automatic-prescription-release requirement of the Eyeglass Rule makes the proposed confirmation requirement unnecessary, and that the confirmation proposal is burdensome.

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The American Optometric Association opposed the proposed confirmation requirement for a number of reasons. As noted above in the discussion regarding automatic-release compliance, the AOA asserts that the requirement is unnecessary because it disputes that there is any issue with prescription-release compliance.

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In addition, the AOA asserted that a confirmation requirement would not have a significant and meaningful impact on competition and choice and in support cited the (previously discussed) NERA survey for the propositions that: (1) three in five Americans do not believe that additional paperwork requirements in their doctor's offices would make them more aware of their rights; (2) nearly half indicated the amount of paperwork they currently do is overwhelming; (3) 41% indicated that the complexity of the paperwork is overwhelming; and (4) approximately 20% of those surveyed did not even remember the purpose of the paperwork they have to complete at a doctor's appointment.

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Based on these results, the AOA concluded that

“it is inaccurate to say that a new paperwork requirement for eyeglass prescriptions can lead to increased competition and choice.”

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Further, the AOA expressed concern that the confirmation requirement would have a disproportionate burden on small business, given the fact that many of its members have a small staff, high staff turnover, and face challenging economic pressures, including increased overhead and costs.

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In fact, according to AOA, the NERA survey data supports its position that the FTC “significantly underestimated” how long it takes to confirm prescription release.

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According to the AOA, a large percentage of its members report that it takes 30 seconds or more to obtain the patient's signed confirmation and “[e]ssentially, doctors of optometry have reported that the time burden is

at least

3 times the FTC's estimated burden.”

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(emphasis in original). The AOA requested that the Commission reconsider whether there is an urgent need at this time for the confirmation-of-prescription-release amendment.

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Individual prescribers share some of the same concerns voiced by the AOA. At least two commenters stated that the proposed confirmation is a burdensome solution to a problem that does not exist.

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A number of commenters, some of whom commented anonymously, stated that the confirmation is unnecessary, costly, intrusive, and would be time-consuming and take away from patient care.

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Optometrist Dr. David Durkee suggested that adding the burden of another confirmation requirement would be counterproductive and likely just lead to more prescriber non-compliance.

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At the workshop, Dr. Michaels stated that there is a lot of time, effort, and discussion required when prescribers ask their patients to sign confirmations.

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Dr. Montaquila explained at the workshop that for contact lens prescriptions, it takes his “very best staff about four minutes to complete the [confirmation and prescription release] process, from explaining why we're doing it to the patient, providing them with their prescription, making the copies, providing their prescription back to them, and ultimately storing it.”

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He stated that the office devotes about 1.5 full time employees to all of the office's compliance issues and that adding more rules [to the Eyeglass Rule] will only increase costs to the practice.

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Dr. Montaquila also noted that the burden is recurring (as opposed to a one-time expense) since each time prescribers provide a prescription, a confirmation will be needed.

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Dr. Masoudi questioned whether multiple confirmations are needed when multiple prescriptions are provided, and claimed that that would also increase the burden of compliance.

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The AAO also disagreed that the burden would be minimal, noting that it would particularly hit hard on small practices that may not utilize electronic health record systems.

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AAO further argued that, without better evidence of non-compliance, the confirmation-of-prescription-release amendment should not be imposed, and asked the Commission to identify alternative mechanisms to address actions of noncompliant prescribers.

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Dr. Repka also noted at the workshop that he has not seen a benefit for either the prescriber or the consumer in the contact lens space since enactment of the confirmation requirement in the Contact Lens Rule.

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Some commenters pointed to differences between the eyeglass and contact lens markets to support their position that the Eyeglass Rule should not contain the same confirmation requirement as exists in the Contact Lens Rule. Dr. Montaquila argued that there is a greater burden associated with the Eyeglass Rule proposal due to the greater volume of eyeglass wearers—165 million eyeglass wearers versus 45 million contact lens wearers.

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Dr. Repka pointed out that the average eyeglass wearer is much older than the average contact lens wearer and that the older population may be more easily concerned about multiple signature lines.

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3. Comments About the Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Eyeglasses

In the NPRM, the Commission proposed to exempt prescribers who do not have a direct or indirect financial interest in the sale of eyeglasses from the proposed signed confirmation-of-prescription-release requirement.

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Direct or indirect interest in the sale of eyeglasses would include, but not be limited to, an association, affiliation, or co-location with prescription-eyewear sellers.

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The Commission requested input on the question, “Aside from associations, affiliations, and co-locations with prescription-eyewear sellers, what other indirect financial interests exist in the sale of prescription eyewear that should disqualify a prescriber from the proposed exemption?”

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There were no written comments in response to the NPRM or workshop on this point.

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At the workshop, Joseph Neville floated the idea of applying the exemption more broadly. Specifically, he said that for the Contact Lens Rule, NAOO, the predecessor to NAROC, suggested that prescribers who were affiliated in a co-location situation should be exempt from the signed acknowledgment requirement.

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He explained that when an optical company leases space to a prescriber, the prescriber does not sell the eyeglasses, and thus, the exemption should apply. Yet, he acknowledged that the Commission previously rejected that position and in concluding his comments, he supported the Commission's proposal to limit the exemption to those who are solely involved in clinical and not connected in any way with sales.

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4. Comments About Alternatives to the Confirmation-of-Prescription-Release Proposal

As possible alternatives to the signed acknowledgement proposal, commenters at the ANPR stage recommended conspicuous signage regarding consumers' right to a copy of their prescription, or an eye care patients' bill of rights, notifying consumers of their rights under the Rule.

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Some commenters seemed to suggest that there is a greater need for the FTC or prescribers to educate consumers or to enforce the Rule as is, as opposed to amending the Rule to include a confirmation of prescription release.

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For instance, the AOA opposed the Commission's NPRM proposal, and asserted that the Commission should focus its energies on scrutinizing the sales of online retailers, and advising the public about “risks” arising from purchasing glasses online.

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Meanwhile optometrist David Durkee recommended that instead of adding the confirmation requirement, the Commission should increase enforcement through random audits, inspections, fines, and increased publicity about such penalties.

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C. Additional Discussion and Commission Determination Regarding the Confirmation-of-Prescription-Release Proposal

1. Final Rule Determination To Amend the Rule To Require Confirmation of Prescription Release

The Commission has carefully reviewed and analyzed all of the evidence in the record, including the 868 comments submitted in response to its ANPR, 27 comments submitted in response to its NPRM, the discussion at the 2023 Eyeglass Rule workshop, 20 comments after the workshop, and when appropriate, the record from the

Commission's recent review of the Contact Lens Rule. This record, in conjunction with the historical impetus for the Rule and the Commission's enforcement and oversight experience, has led to a Commission determination to amend the Rule to add a confirmation-of-prescription-release requirement.

The evidence demonstrates that the automatic-release requirement remains the optimal remedy for prescribers' continued failure to release prescriptions, and yet lack of compliance with the automatic-release provision hampers the effectiveness of this remedy.

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The evidence also demonstrates that consumers lack an awareness of their rights to a copy of their eyeglass prescription, and thus may be unable to remedy a prescriber's failure to release prescriptions on their own.

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Having determined that it would be beneficial to increase compliance with, and awareness of, the automatic-release provision, the Commission has determined that the best way to achieve this goal is to amend the Rule to add a new requirement to the existing automatic-release remedy. By modifying and improving the remedy for prescribers' failure to release a prescription, it will not only increase the number of patients who receive their prescriptions and learn of their right to possess their prescriptions, but will also: reduce the number of seller requests to prescribers for eyeglass prescriptions, improve the Commission's ability to monitor overall compliance and target enforcement actions, reduce evidentiary issues, complaints and disputes between prescribers and patients, and substantively bring the Eyeglass Rule into congruence with the Contact Lens Rule in terms of the confirmation-of-prescription-release requirement.

This remedy also solves the “evidentiary squabbles” issue as to whether a prescriber complied in a specific instance, or complies routinely with prescription release. As explained in the NPRM, the absence of documentation often makes it difficult in an enforcement investigation to determine whether, in any particular case, a prescriber provided a patient with a prescription. The lack of documentation also makes it difficult to determine how many times, or how frequently, a particular noncompliant prescriber has violated the Rule.

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In fact, due in part to the difficulty of ascertaining whether a prescriber violated the Rule, the Commission has only brought one enforcement action against an eyeglass prescriber for failure to comply with the automatic prescription release.

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The confirmation-of-prescription-release requirement will improve and simplify its ability to assess and verify compliance with the Rule's automatic prescription release requirement. It will also make it easier for prescribers to prove that they did, in fact, provide prescriptions to patients who claim otherwise.

a. Alternatives to Confirmation of Prescription Release Not Adopted

The Commission is not adopting the alternative remedies proposed by some commenters. First, as explained above, no new comments or evidence was submitted following the NPRM regarding the proposal to require conspicuous signage in prescribers' offices stating consumers' rights to their prescriptions, and, likewise, no new comments or evidence submitted with respect to a consumer Bill of Rights.

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Since the Commission had previously decided, for the reasons outlined in the NPRM,

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not to adopt these measures, the Commission has no reason to revisit and alter its decision.

For a number of reasons, the Commission also declines to adopt the proposal that the Commission focus on additional consumer education in lieu of adopting the signed confirmation of prescription release. First, relying on such an approach would improperly shift the burden of prescription-release compliance and enforcement to the consumer, an approach the Commission has repeatedly rejected in the past.

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Second, the Commission resolves that educating consumers at their appointment about their right to their prescription is more targeted and impactful than other methods of consumer education alone in which a consumer is not asked to read and provide a signature. Lastly, the AOA's suggestion in its NPRM comment to educate consumers about the potential risks from purchasing eyeglasses online would do nothing to increase prescription release. In fact, the suggestion appears unrelated to the issues under discussion in the NPRM or this final rule.

Although the Commission declines commenters' suggestions that it rely on greater consumer education in lieu of a signed confirmation requirement, as discussed in section IV.B.4,

supra,

the Commission agrees there is a need to bolster its existing guidance on the Eyeglass Rule, as an added measure to inform consumers of their rights, and businesses of their obligations, under the Rule.

As for the suggestion that the Commission increase enforcement of the existing automatic-release provision in lieu of adding a confirmation requirement, the Commission addressed this in the NPRM, noting that the Commission recognizes the need for increased enforcement, but that the absence of documentation often makes it difficult in an enforcement investigation to determine whether, in any particular case, a prescriber provided a patient with a prescription.

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The lack of documentation also makes it difficult to determine how many times, or how frequently, a particular noncompliant prescriber has violated the Rule. Instead, allegations and denials of non-compliance often become a matter of a patient's word against that of the prescriber, making violations difficult to prove.

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b. The Burdens of the Confirmation of Prescription Release Are Not Substantial

The evidentiary record does not establish that the burden of the confirmation-of-prescription-release requirement will have a substantial financial impact on prescribers. Prescribers already comply with a similar requirement for contact lens prescriptions, and it should require a minimum of additional time, effort, and training to include eyeglass prescriptions. Some prescribers may already be getting patient confirmations for eyeglass prescriptions, since it does not make much sense to obtain confirmations for contact lenses but not for eyeglasses, and the patient confirmation provides the prescriber with tangible proof that they complied with the existing prescription-release requirement. In its Paperwork Reduction Act (“PRA”) analysis, the Commission doubled the previously estimated time it takes for prescribers' offices to obtain a signed patient confirmation, and yet even doubled, it is still merely 20 seconds. In reality, it may even take less, and some industry estimates appear to be based on faulty presumptions.

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Furthermore, the ongoing transition to digital recordkeeping will continue to reduce the burden, both in terms of record preservation and obtaining patient signatures. The final rule's overall estimated financial burden for the confirmation-of-prescription-release requirement of $38,389,993 amounts by one estimate to approximately $629 in additional annual administrative costs per eye care provider.

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The Commission also does not find the AOA's paperwork survey, summarized in its comment, as compelling evidence for its position that “it is inaccurate to say that a new

paperwork requirement for eyeglass prescriptions can lead to increased competition and choice.”

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A review of appendix A attached to its comment shows that the following survey question was asked of 1,063 respondents: “Thinking about your experience, both virtual and in-person, with doctors in general, please select your level of agreement with the following statements.” The statements included in the survey were: (1) “I generally remember the purpose of the paperwork I complete at a doctor's appointment”; (2) “The amount of paperwork I have to complete at a doctor's appointment is overwhelming”; (3) “The complexity of the paperwork I have to complete at a doctor's appointment is overwhelming”; and (4) “Having to sign more paperwork at a doctor's appointment would make me more aware of my patient's rights.” The options provided to the respondents for each statement are: “Completely agree,” “Somewhat agree,” “Neutral,” “Somewhat disagree,” and “Completely disagree.”

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These questions, and the extent to which consumers agree or disagree with them, may reveal the unsurprising fact that most people do not appreciate doing “paperwork,” but do not display anything of import related to this rulemaking. By asking generalized questions about “paperwork”—a term with a negative connotation—and “patient's rights,” without explaining to respondents the context or what rights they are referring to, the survey loses its informational value. It does not reveal what consumers think about a confirmation-of-prescription-release requirement, about whether they would appreciate having a copy of their prescription, about whether they understand their right to their prescription, or even about their experiences with any particular documents provided to them by eye care prescribers.

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Aside from the fact that these survey questions are too vague and generalized to serve as a gauge as to the usefulness of a confirmation-of-prescription-release requirement, the survey questions may even indicate that some paperwork can serve a purpose. According to the survey, 62% of Americans respond that they generally remember the purpose of the paperwork they complete at a doctor's appointment, with another 19% remaining neutral on this question; and 40% agree with the statement, “having to sign more paperwork at a doctor's appointment would make me more aware of my patient rights,” with another 30% responding neutrally.

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While these percentages do not reveal anything about the confirmation-of-prescription-release requirement, they could, in fact, support the general position that many Americans do remember information from the paperwork they fill out at their doctors' offices, and that the paperwork can serve to make them somewhat more aware of their general rights. Of greater significance for this rulemaking, however, is the fact that the confirmation-of-prescription-release requirement is not solely intended to educate consumers about their rights. While that is one purpose, the requirement is also intended to remind prescribers' offices to provide patients with their prescriptions, and to create a mechanism for prescription-release verification and enforcement. Therefore, the Commission finds that the signed confirmation of prescription release (a form of “paperwork”) will increase prescriber compliance, and that will lead to increased competition that benefits consumers.

The Commission also carefully considered information and comments on the record that question the Commission's estimate of time for confirming prescription release, including the separately conducted AOA survey of its members submitted in support of its statement that the FTC “significantly underestimated” the length of time it would take for prescribers to confirm prescription release. As discussed more fully in the Paperwork Reduction Act section (section VIII of this SBP), the Commission has decided to increase the estimated time to obtain a patient confirmation signature.

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Although the Commission does not find the burdens of the confirmation of prescription release to be substantial, the Commission is sensitive to the concerns raised by the AOA and others regarding the burden on prescribers, many of whom are small businesses. In an attempt to minimize these burdens, the Rule provides prescribers with both digital and paper options for methods to comply,

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and provides one-sentence sample language that prescribers can use when providing paper copies of prescriptions should they wish to use it. As for concerns that the burden is ongoing since each time a prescriber provides a prescription a confirmation is needed, the Commission notes that many prescribers may offer and consumers may accept a digital delivery of the prescription, and as previously discussed, may not need to ask for affirmative consent to digital delivery for every new visit.

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As for paper copies of prescriptions, over time consumers should become more familiar with the request for their signature to confirm prescription receipt and thus, the staff time to handle possible questions or to otherwise comply with the confirmation of prescription release should decrease.

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The Rule also has an exemption for those without a direct or indirect financial interest in the sale of eyeglasses. Moreover, this amendment aligns with the prescription release related provisions of the Contact Lens Rule, thereby reducing the confusion and complexity that might arise for consumers and prescribers from having different confirmation-of-prescription-release requirements for contact lens and eyeglass prescriptions. In addition, the marginal cost of the amendment to the Eyeglass Rule should be relatively low because the CLR already requires prescribers to obtain confirmation of prescription release and to maintain records of such. Some prescribers likely have forms and systems in place already, which may need only minor adjustments to accommodate confirmations for eyeglass prescriptions.

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c. Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Eyeglasses

The Commission also adopts without modification proposed § 456.3(c), which provides an exemption to the confirmation-of-prescription-release requirements for prescribers who do not have a direct or indirect financial interest in the sale of eyeglasses.

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Direct or indirect financial interest in the sale of eyeglasses includes, but is not limited to, an association, affiliation, or co-location with prescription-eyewear sellers.

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The Contact Lens Rule contains a parallel exemption.

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The purpose of such an exemption is to reduce the burden on prescribers who do not sell lenses, and therefore, have no incentive to withhold prescriptions.

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Although Joseph Neville of NAROC questioned whether co-location arrangements should be considered as having an interest in the sale of eyeglasses, the Commission finds that co-location arrangements could create a financial incentive for prescribers to withhold a prescription, and thus, should be required to comply with the confirmation requirement. If a prescriber has uncertainty as to whether the exemption applies, they should err on the side of caution by complying with the confirmation-of-prescription-release requirement.

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Since there was no opposition to the proposal relating to the exemption, the Commission adopts § 456.3(c) as proposed.

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2. Comments About Options for Obtaining the Confirmation and Commission Determination

The Eyeglass Rule NPRM proposed in § 456.3(a) the same options to confirm prescription release of eyeglass prescriptions as the options available to confirm prescription release of contact lens prescriptions in the Contact Lens Rule. They consist of: (i) a signed statement confirming receipt of the prescription; (ii) a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the prescription; (iii) a prescriber-retained copy of the receipt for the examination containing a statement confirming receipt of the prescription; and (iv) if a digital copy of the prescription was provided to the patient, retain evidence that the prescription was sent, received, or made accessible, downloadable and printable.

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Workshop participants discussed these options in the context of the Contact Lens Rule in order to recommend for or against their inclusion in the Eyeglass Rule's confirmation requirement.

a. Comments at the Eyeglass Rule Workshop

At the workshop, Dr. Montaquila discussed the “range of approaches” prescribers use to comply with the CLR's confirmation-of-prescription-release requirements and provided concrete examples of the way some of the options are currently in use. He called option (a)(1)(i), the signed statement option, a flexible option currently in use. But, he stated that, for some offices that have electronic health records, offices must print the prescription from the electronic health records systems, request a signature, scan or retain the prescription with the acknowledgment, and store the acknowledgment.

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He provided an example of a template form that he said is in use by many offices.

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This form, entitled “Contact Lens Prescription Signed Acknowledgment Form” is recommended by the AOA to its members and is in its “Contact Lens Rule Compliance Toolkit.”

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The form contains six paragraphs, with the first stating, “Included below is important information to review prior to receiving your contact lens prescription.” The middle three paragraphs consist of advice, attributed to the Centers for Disease Control and the Food and Drug Administration, on healthy contact lens wearing habits, and include recommendations such as “Schedule a visit with your eye doctor at least once a year” and “Understand that eye infections that go untreated can lead to eye damage or even blindness,” among others. The fifth paragraph presents five bullet points listing common symptoms of an eye infection, such as “Irritated, red eyes,” “Light sensitivity,” and “Sudden blurry vision.” The last paragraph, directly above a patient signature and date line, states, “Sign below to acknowledge that you were provided with a copy of your contact lens prescription at the completion of your contact lens fitting.”

As for proposed § 456.3(a)(1)(ii), in which prescribers retain signed copies of contact lens prescriptions that contain a statement confirming receipt of the prescriptions, Dr. Montaquila stated that the AOA assists prescribers who use this option by providing carbon-copy prescription pads.

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With this method, the prescriber writes the prescription, the patient signs the confirmation statement on the prescription, and the patient and prescriber each retain a copy. Dr. Montaquila then implied that this paper option was less convenient or accurate because 88% of office-based physicians have transitioned to EHRs.

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According to Dr. Montaquila, some prescribers are handwriting prescriptions after generating a prescription in an electronic health record, and this duplication increases cost, time, and the possibility for errors.

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In support of his assertion about greater errors from handwritten prescriptions, he cited to a Weill Cornell Medical College study of drug prescriptions finding error rates in 30 per 100 written prescriptions versus seven per hundred in electronic prescriptions.

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He stated that some EHRs permit prescriptions containing statements of confirmation to be printed, but this creates a different problem because once it is signed by the patient, the office “needs to take that prescription back, copy and perhaps scan it and then retain that for three years.”

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Section 456.3(a)(1)(iii) of the NPRM Eyeglass Rule confirmation proposal (and existing Contact Lens Rule confirmation requirement) allows prescribers to retain a signed statement confirming prescription receipt on a copy of the examination payment receipt. According to a 2023 AOA survey of optometrists, about 15% of prescribers said they use this method,

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but Dr. Montaquila stated that he had not found that any of his colleagues had a payment system in place that would allow for the use of this method with respect to the confirmation of contact lens prescription release.

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Dr. Montaquila also addressed the digital release option, proposed § 456.3(a)(1)(iv), which allows a prescriber, with the patient's affirmative consent, to release the prescription digitally so long as they retain evidence that the prescription was sent, received, or made accessible, downloadable and printable. In discussing this option, he displayed a model consent form used by many practices for contact lens prescription release entitled “prescription access notice policy statement.” The model form states that access to prescriptions is available to patients digitally and that physical copies of prescriptions are available, and provides a place for a patient signature. He noted that the electronic prescription-release approach can take many forms depending on what's available to the practice, and that some forms default to the patient agreeing to receive the prescription digitally, with a paper version available upon request.

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b. Commission Determination Regarding Options for Obtaining the Confirmation

The final rule, § 456.4(a)(1), replaces the four options from the NPRM with two broader options in paragraphs (a)(1)(i) and (ii) that encompass the options proposed in the NPRM, but also ensure prescribers have flexibility and choice in how they obtain their confirmations. The first option, § 456.4(a)(1)(i), covering instances where prescribers provide a

paper copy

of the prescription, provides that the prescriber must request that the patient acknowledge receipt of the prescription by signing a separate statement confirming receipt of the prescription. Section 456.4(a)(1)(i) adopts the proposed § 456.3(a)(1)(i) with modifications so that it encompasses the proposed § 456.3(a)(1)(ii) (where a prescriber can retain a copy of a prescription that contains a signed statement confirming receipt of the prescription) and proposed § 456.3(a)(1)(iii) (where a prescriber can retain a signed copy of the sales receipt for the examination that contains a statement confirming receipt of the prescription). The NPRM's proposed § 456.3(a)(1)(ii) and (iii) are essentially examples of documents—prescriptions and sales receipts—that can contain separate statements confirming receipt of the prescription, and these methods of obtaining confirmation continue to be permitted under the final rule's broader option § 456.4(a)(1)(i).

The Commission adopts § 456.4(a), which requires that the statement confirming receipt be separate. Prescribers should provide a signature line that clearly and conspicuously applies to a statement of confirmation that the patient has received their

prescription. If instead it is part of a multi-paragraph form containing unrelated information, such as advice about contact lens wear and care habits or the symptoms of eye infections, which then requests a signature at the end of the form, it may not be a valid method to request confirmation of prescription release. While additional information supplied on the model form may be useful to patients, it can confuse patients as to what it is they are signing for, and add additional time to the confirmation obligation. Indeed, as discussed in this document's PRA analysis section, the use of a model template from AOA containing several additional paragraphs unrelated to the confirmation requirement may well contribute to some prescribers' claims that it takes more than 10 seconds to obtain a contact lens prescription confirmation from a patient.

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Section 456.4(a)(1)(ii) applies to instances where the prescriber provides a digital copy of the prescription to the patient and is, with one minor alteration,

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the same as the NPRM's proposed § 456.3(a)(1)(iv). If a prescriber provides the prescription digitally, after obtaining verifiable affirmative consent, the prescriber need not request the patient sign a separate statement confirming receipt. However, the prescriber does need to retain evidence that the prescription was sent, received, or made accessible, downloadable, and printable. In the final rule's § 456.4(a)(1)(ii), that evidence serves as the “confirmation of prescription release.”

The Commission recognizes that by altering its NPRM proposal in this manner, the options for obtaining confirmation of prescription release in the Eyeglass Rule will not precisely mirror the language of the options provided in the Contact Lens Rule, but these are differences in textual language, not the Rules' policy or effects. The obligations for prescribers with respect to when and how to offer a prescription, and how prescribers can obtain and store a confirmation of receipt, are essentially the same for contact lens and eyeglass prescriptions. For clarity purposes, the Commission may address the language differences in the CLR's next periodic rule review. For these reasons, the Commission adopts § 456.4(a) as s

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