text: 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.
target: 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.
feat_title: Contact Lens Consumer Health Protection Act of 2016