Contact Lens Rule Modernization Act

Bill: 116-s-4613
Sponsor: full_name: Sen. Boozman, John [R-AR]
Introduced: 2020-09-17
Policy area: Commerce
Subjects: Consumer affairs

Health information and medical records

Health technology, devices, supplies

Hearing, speech, and vision care

Telephone and wireless communication
Latest action: action_date: 2020-09-17
text: Read twice and referred to the Committee on Commerce, Science, and Transportation.

Summaries:
action_date: 2020-09-17
action_desc: Introduced in Senate
text: <p><strong>Contact Lens Rule Modernization Act</strong></p> <p>This bill (1) requires prescribers of contact lenses to conspicuously post notice that the prescriber is required to provide a copy of the contact lens prescription to the patient, (2) prohibits prescribers from requiring patients to acknowledge a contact lens prescription release in writing or electronically, and (3) prohibits automated telephone calls to verify a prescription.</p>

tv_txt: II 116th CONGRESS 2d Session S. 4613 IN THE SENATE OF THE UNITED STATES September 17, 2020 Mr. Boozman (for himself, Mr. Wicker , Mr. Inhofe , and Mr. Paul ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To amend the Fairness to Contact Lens Consumers Act to prevent certain automated calls and to require notice of the availability of contact lens prescriptions to patients, and for other purposes.

1. Short title This Act may be cited as the Contact Lens Rule Modernization Act . 2. Findings Congress finds the following: (1) The Federal Trade Commission (FTC) has received over 9,000 comments since 2016 related to part 315 of title 16, Code of Federal Regulations (commonly known as the Contact Lens Rule ), including letters from over 100 Members of Congress. In addition, the Committee on Appropriations of the Senate and the Committee on Appropriations of the House of Representatives have included language 7 times since 2016 urging the FTC to consider patient safety concerns or regulatory burdens in its rulemaking. (2) The Food and Drug Administration (FDA) recorded over 1,075 contact lens-related corneal infections from 2005 to 2015, with 20 percent of those patients having permanent vision loss. (3) Over the last 20 years, the contact lens marketplace has grown more competitive and diversified, with many new and different types of sellers. As a result, automated phone calls as a means of passive verification of contact lens prescriptions have significantly increased since Congress passed the Fairness to Contact Lens Consumers Act (P.L. 108–164) in 2003, becoming the primary method of verification used by online sellers. (4) Outlining several concerns, the FTC in its Final Notice of Rulemaking, published in the Federal Register on August 17, 2020, stated that automated telephone calls are a commonly used method of verification. Moreover, these calls impose a cost on prescribers, and there are potential health risks to patients from incomplete and incomprehensible automated telephone requests. The FTC also acknowledged that it lacks enforcement capability related to automated calls, stating the Commission cannot reliably assess whether that call was compliant and further whether the seller has a pattern of non-compliant calls (and selling after such calls). . (5) The FTC has repeatedly acknowledged the ambiguity created by the lack of an explicit statutory ban on automated calls as a means of verification. (6) From 2011 to 2016, out of about 200,000,000 contact lens prescriptions written, the FTC received only 309 complaints, resulting in 45 letters to prescribers warning of potential Contact Lens Rule violations. (7) The FTC’s 2020 Final Contact Lens Rule addresses prescription release concerns by significantly increasing the paperwork burden on optometrists and ophthalmologists, requiring that eye care professionals keep a new record signed by the patient (or digitally agreed to) confirming the receipt of each of the 45,000,000 contact lens prescriptions written each year. (8) The vast majority of optometrists operate small businesses, with over 80 percent of practices having less than 10 employees. The paperwork burden in the FTC’s 2020 Final Contact Lens Rule is estimated to cost each practice between $10,000 and $18,000 a year. (9) The State of California requires prescribers to post a sign informing patients of their right to receive their prescription. 3. Amendments to the Fairness to Contact Lens Consumers Act (a) Patient notification Section 2(a) of the Fairness to Contact Lens Consumers Act ( 15 U.S.C. 7601(a) ) is amended— (1) in paragraph (1), by striking and ; (2) in paragraph (2), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (3) shall post a conspicuous notice that, upon the completion of a contact lens fitting, the prescriber is required to provide a copy of the contact lens prescription to the patient. . (b) Patient confirmation of receipt of contact lens prescription Section 2(b) of the Fairness to Contact Lens Consumers Act ( 15 U.S.C. 7601(b) ) is amended— (1) in paragraph (2), by striking or after the semicolon; (2) in paragraph (3), by striking the period at the end and inserting ; or ; and (3) by adding at the end the following: (4) require the patient to acknowledge any contact lens prescription release in writing or electronically. . (c) Prohibition on automated calls Section 4 of the Fairness to Contact Lens Consumers Act ( 15 U.S.C. 7603 ) is amended by striking subsection (g) and inserting the following: (g) Direct communication (1) In general As used in this section, the term direct communication includes communication by telephone, facsimile, or electronic mail. (2) Clarification Such term shall not include a telephone call made using an artificial or prerecorded voice message. . 4. Technical amendments Section 4(c)(6) of the Fairness to Contact Lens Consumers Act ( 15 U.S.C. 7603(c)(6) ) is amended by inserting and electronic mail address after telephone number .