Contact Lens Consumer Health Protection Act of 2016

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Contact Lens Consumer Health 
Protection Act of 2016''.

SEC. 2. IMPROVEMENT OF CONTACT LENS PRESCRIBER VERIFICATION PROCESS.

    (a) In General.--Section 4 of the Fairness to Contact Lens 
Consumers Act (15 U.S.C. 7603) is amended--
            (1) in subsection (c), by adding at the end the following:
            ``(7) A toll-free telephone number and email address for 
        prescribers to call or email with questions relating to a 
        verification request, as required under subsection (i).'';
            (2) in subsection (d)(3)--
                    (A) by striking ``, or a similar time as defined by 
                the Federal Trade Commission,'';
                    (B) by inserting ``(A)'' before ``The prescriber''; 
                and
                    (C) by adding at the end the following:
            ``(B) If a prescriber communicates a question or concern 
        about the accuracy of the prescription, or any other matter 
        relating to the verification of the prescription, to a seller 
        through the toll-free telephone service or dedicated email 
        address required under subsection (i) before such 8-business-
        hour period has ended, the prescription shall be considered 
        unverified until the seller obtains affirmative confirmation of 
        the accuracy of the prescription from the prescriber.'';
            (3) by redesignating subsections (e) through (g) as 
        subsections (f) through (h), respectively;
            (4) by amending subsection (f), as redesignated by 
        paragraph (3), to read as follows:
    ``(f) Invalid Prescriptions and Questions Concerning Accuracy.--
            ``(1) Invalid prescriptions.--If a prescriber informs a 
        seller before the deadline set forth in subparagraph (A) of 
        subsection (d)(3) that the contact lens prescription is 
        inaccurate, expired, or otherwise invalid--
                    ``(A) the seller shall not fill the prescription; 
                and
                    ``(B) the prescriber shall specify the basis for 
                the inaccuracy or invalidity of the prescription.
            ``(2) Questions concerning accuracy.--If a prescriber 
        communicates a question or concern about the accuracy of a 
        prescription as described in subsection (d)(3)(B) before the 
        deadline set forth in such subsection--
                    ``(A) the seller shall not fill the prescription; 
                and
                    ``(B) the prescriber shall provide the seller with 
                an accurate prescription.
            ``(3) Correction.--In any case, if the prescription 
        communicated by the seller to the prescriber is inaccurate, the 
        prescriber shall correct it.'';
            (5) by adding after subsection (d) the following:
    ``(e) Prescriber Preferred Method of Communication.--
            ``(1) In general.--A prescriber may provide written 
        notification to a seller requesting that all requests for 
        verification from that seller be communicated to that 
        prescriber by that prescriber's preferred method or methods of 
        communication, selected from among the methods of communication 
        offered by the seller pursuant to paragraph (2).
            ``(2) Methods offered.--Each seller shall offer a 
        prescriber methods for communication for selection as the 
        prescriber's preferred method or methods of communication under 
        paragraph (1). Such offer--
                    ``(A) shall include--
                            ``(i) live telephone;
                            ``(ii) facsimile; and
                            ``(iii) email; and
                    ``(B) may include such additional methods of 
                communication as the seller considers appropriate.
            ``(3) Requirement.--In a case in which a prescriber, 
        pursuant to paragraph (1), provides written notification to a 
        seller indicating a preferred method or methods of 
        communication as described in such paragraph, the seller may 
        only request verification from the prescriber through the 
        method or methods indicated.''; and
            (6) by inserting after subsection (h), as redesignated by 
        paragraph (3), the following:
    ``(i) Telephone Service and Dedicated Email Address.--
            ``(1) In general.--A seller of contact lenses who requests 
        verification of any contact lens prescription shall provide--
                    ``(A) a toll-free telephone service that is 
                operable during regular business hours and operated by 
                live persons; and
                    ``(B) a dedicated email address for the sole 
                purpose of responding to prescribers' questions and 
                concerns regarding verification requests.
            ``(2) Capacity.--Such toll-free telephone service shall 
        maintain a sufficient number of working telephone lines 
        operated by live persons to enable ready access by prescribers 
        to the service.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on the date that is 180 days after the date of the 
enactment of this Act.

SEC. 3. MODIFICATION OF PROHIBITION ON ALTERATION OF CONTACT LENS 
              PRESCRIPTIONS.

    (a) In General.--Subsection (f) of section 4 of the Fairness to 
Contact Lens Consumers Act (15 U.S.C. 7603) is amended to read as 
follows:
    ``(f) No Alteration.--
            ``(1) In general.--A seller may not alter a contact lens 
        prescription and when dispensing a contact lens prescription, 
        may only dispense such prescription exactly as written by the 
        prescriber.
            ``(2) Private labels.--In a case in which a private label 
        contact lens is included on the contact lens prescription and 
        the same contact lens is manufactured by the same company and 
        sold under multiple labels to individual providers, the seller 
        may fill the prescription with a contact lens of exactly the 
        same material, design, and power as manufactured by that 
        company under another label.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect on the date that is 180 days after the date of the 
enactment of this Act.

SEC. 4. REQUIREMENTS FOR IMPROVED RECORDKEEPING BY SELLERS OF CONTACT 
              LENSES.

    Section 4(b) of the Fairness to Contact Lens Consumers Act (15 
U.S.C. 7603(b)) is amended--
            (1) by striking ``A seller'' and inserting the following:
            ``(1) Communications generally.--A seller''; and
            (2) by adding at the end the following:
            ``(2) Prescriptions.--Each seller shall maintain a database 
        that includes, for each prescription received by a seller, the 
        following:
                    ``(A) The date on which the prescription was 
                issued.
                    ``(B) The specified expiration date of the 
                prescription.
            ``(3) Preferred methods of communication.--For each written 
        notification that a seller receives under subsection (e)(1), 
        the seller shall keep a copy of such notification for a period 
        of not less than 3 years.''.

SEC. 5. PROHIBITION ON REPRESENTATION IN ADVERTISING THAT PRESCRIPTIONS 
              FOR CONTACT LENSES MAY BE FILLED AFTER EXPIRATION DATE.

    Section 6 of the Fairness to Contact Lens Consumers Act (15 U.S.C. 
7605) is amended--
            (1) by striking ``that contact'' and inserting the 
        following: ``that--
            ``(1) contact'';
            (2) in paragraph (1), as designated by paragraph (1) of 
        this section, by striking the period at the end and inserting 
        ``; or''; and
            (3) by adding at the end the following:
            ``(2) a prescription for a contact lens may be filled after 
        the expiration date of the prescription.''.

SEC. 6. INCREASED PENALTIES FOR SELLERS OF CONTACT LENSES WHO VIOLATE 
              REQUIREMENTS RELATING TO PRESCRIBER VERIFICATION.

    (a) In General.--Subsection (b) of section 9 of the Fairness to 
Contact Lens Consumers Act (15 U.S.C. 7608) is amended by striking the 
period at the end and inserting ``, except that fines imposed for a 
violation of section 4 of this Act may be in an amount up to $40,000 
per violation.''.
    (b) Clarification of Applicability.--Such section is further 
amended by adding at the end the following new subsection:
    ``(c) Applicability.--This chapter shall apply to all sales of 
contact lenses in the United States and the sellers involved in such 
sales, notwithstanding where the seller is located.''.

SEC. 7. CONTACT LENS CONSUMER COMPLIANCE AND SAFETY STUDY.

    (a) Study Required.--The Secretary of Health and Human Services, 
acting through the Director of the Centers for Disease Control and 
Prevention, shall conduct a study to examine the adverse and 
potentially adverse effects on consumers of violations by sellers of 
the Fairness to Contact Lens Consumers Act (15 U.S.C. 7601 et seq.), as 
amended by section 2, particularly with respect to matters regarding 
prescription verification, business practices, and enforcement by the 
Federal Trade Commission of such Act.
    (b) Elements.--The study required by subsection (a) shall 
specifically address the following:
            (1) The overfilling of prescriptions with quantities of 
        lenses such that the normal expiration dates of the 
        prescriptions will be exceeded.
            (2) The dispensing of prescriptions that have expired or 
        are inaccurate.
            (3) The failure by a seller to allow prescribers to contact 
        the seller within 8 business hours to advise that a 
        prescription is inaccurate or expired.
            (4) The health risks to the consumer of receiving an 
        incorrect prescription from a seller, or issues with patient 
        access to the medically prescribed contact lenses.
            (5) The economic risks to the consumer of receiving an 
        incorrect prescription from a seller.
            (6) The improper advertising to consumers about what 
        constitutes a valid prescription or valid prescription 
        information, or advertising that no prescription is needed.
            (7) Such other matters regarding the effects on the health 
        of the consumers from violations of the verification or sales 
        requirements of the Fairness to Contact Lens Consumers Act (15 
        U.S.C. 7601 et seq.) as the Secretary considers appropriate.
    (c) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary shall submit to Congress and the Federal 
Trade Commission a report on the study required by subsection (a).

SEC. 8. MODIFICATION OF DEFINITIONS.

    (a) In General.--Section 11 of the Fairness to Contact Lens 
Consumers Act (15 U.S.C. 7610) is amended--
            (1) in paragraph (3), by amending subparagraph (E) to read 
        as follows:
                    ``(E) Power, material, manufacturer, or device 
                name.''; and
            (2) by adding at the end the following:
            ``(4) Business hour.--The term `business hour' means, with 
        respect to a prescriber, any hour during a business day within 
        the period beginning at 9:00 in the morning and ending at 5:00 
        in the evening in the time zone of the prescriber.
            ``(5) Business day.--The term `business day' means any day 
        other than Saturday and Sunday and other than a legal holiday 
        (within the meaning of section 7503 of the Internal Revenue 
        Code of 1986).''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on the date that is 180 days after the date of the 
enactment of this Act.

Summary: Contact Lens Consumer Health Protection Act of 2016 This bill amends the Fairness to Contact Lens Consumers Act to require contact lens sellers to provide a toll-free telephone number and email address that prescribers can use to ask questions about a seller's prescription verification request. Under current law, a prescription is considered verified if the prescriber fails to communicate with the seller within eight business hours after receiving the seller-provided verification information. The bill requires the prescription to be considered unverified until the seller obtains affirmative confirmation of the accuracy of the prescription from the prescriber in cases where a prescriber communicates a question or concern about the accuracy or verification of the prescription to a seller through the toll-free telephone service or email address before the end of that eight-hour period.  The bill removes the Federal Trade Commission's authority to adjust the eight-hour period.  If a prescriber communicates a question or concern about the accuracy of a prescription before the deadline: (1) the seller shall not fill the prescription, and (2) the prescriber shall provide the seller with an accurate prescription. Sellers must offer prescribers different communication methods that the prescribers may select as their preferred method for verification requests. The bill allows a seller to alter a prescription only if: (1) a private label contact lens is included on the prescription and the same contact lens is manufactured by the same company and sold under multiple labels to individual providers; and (2) the seller fills the prescription with a contact lens of exactly the same material, design, and power as manufactured by that company under another label. Sellers must maintain a database of the issuance and expiration dates of each prescription they receive. The bill prohibits advertisements representing that a contact lens prescription may be filled after the prescription expires. Sellers violating certain prescriber verification requirements are subject to increased penalties of up to $40,000 per violation. Such requirements apply to all contact lens sales in the United States, notwithstanding where the seller is located.  The Centers for Disease Control and Prevention must examine the potentially adverse effects of seller violations on consumers.