Contact Lens Rule Modernization Act

II 116TH CONGRESS 2D SESSION S. 4613 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. IN THE SENATE OF THE UNITED STATES SEPTEMBER 17, 2020 Mr. BOOZMAN (for himself, Mr. WICKER, Mr. INHOFE, and Mr. PAUL) intro- duced the following bill; which was read twice and referred to the Com- mittee 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 pa- tients, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Contact Lens Rule 4 Modernization Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 18:05 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4613.IS S4613 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4613 IS (1) The Federal Trade Commission (FTC) has 1 received over 9,000 comments since 2016 related to 2 part 315 of title 16, Code of Federal Regulations 3 (commonly known as the ‘‘Contact Lens Rule’’), in- 4 cluding letters from over 100 Members of Congress. 5 In addition, the Committee on Appropriations of the 6 Senate and the Committee on Appropriations of the 7 House of Representatives have included language 7 8 times since 2016 urging the FTC to consider patient 9 safety concerns or regulatory burdens in its rule- 10 making. 11 (2) The Food and Drug Administration (FDA) 12 recorded over 1,075 contact lens-related corneal in- 13 fections from 2005 to 2015, with 20 percent of those 14 patients having permanent vision loss. 15 (3) Over the last 20 years, the contact lens 16 marketplace has grown more competitive and diver- 17 sified, with many new and different types of sellers. 18 As a result, automated phone calls as a means of 19 passive verification of contact lens prescriptions have 20 significantly increased since Congress passed the 21 Fairness to Contact Lens Consumers Act (P.L. 22 108–164) in 2003, becoming the primary method of 23 verification used by online sellers. 24 VerDate Sep 11 2014 18:05 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4613.IS S4613 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4613 IS (4) Outlining several concerns, the FTC in its 1 Final Notice of Rulemaking, published in the Fed- 2 eral Register on August 17, 2020, stated that ‘‘auto- 3 mated telephone calls are a commonly used method 4 of verification. Moreover, these calls impose a cost 5 on prescribers, and there are potential health risks 6 to patients from incomplete and incomprehensible 7 automated telephone requests.’’ The FTC also ac- 8 knowledged that it lacks enforcement capability re- 9 lated to automated calls, stating ‘‘the Commission 10 cannot reliably assess whether that call was compli- 11 ant and further whether the seller has a pattern of 12 non-compliant calls (and selling after such calls).’’. 13 (5) The FTC has repeatedly acknowledged the 14 ambiguity created by the lack of an explicit statu- 15 tory ban on automated calls as a means of 16 verification. 17 (6) From 2011 to 2016, out of about 18 200,000,000 contact lens prescriptions written, the 19 FTC received only 309 complaints, resulting in 45 20 letters to prescribers warning of potential Contact 21 Lens Rule violations. 22 (7) The FTC’s 2020 Final Contact Lens Rule 23 addresses prescription release concerns by signifi- 24 cantly increasing the paperwork burden on optom- 25 VerDate Sep 11 2014 18:05 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4613.IS S4613 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4613 IS etrists and ophthalmologists, requiring that eye care 1 professionals keep a new record signed by the pa- 2 tient (or digitally agreed to) confirming the receipt 3 of each of the 45,000,000 contact lens prescriptions 4 written each year. 5 (8) The vast majority of optometrists operate 6 small businesses, with over 80 percent of practices 7 having less than 10 employees. The paperwork bur- 8 den in the FTC’s 2020 Final Contact Lens Rule is 9 estimated to cost each practice between $10,000 and 10 $18,000 a year. 11 (9) The State of California requires prescribers 12 to post a sign informing patients of their right to re- 13 ceive their prescription. 14 SEC. 3. AMENDMENTS TO THE FAIRNESS TO CONTACT 15 LENS CONSUMERS ACT. 16 (a) PATIENT NOTIFICATION.—Section 2(a) of the 17 Fairness to Contact Lens Consumers Act (15 U.S.C. 18 7601(a)) is amended— 19 (1) in paragraph (1), by striking ‘‘and’’; 20 (2) in paragraph (2), by striking the period at 21 the end and inserting ‘‘; and’’; and 22 (3) by adding at the end the following: 23 ‘‘(3) shall post a conspicuous notice that, upon 24 the completion of a contact lens fitting, the pre- 25 VerDate Sep 11 2014 18:05 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4613.IS S4613 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4613 IS scriber is required to provide a copy of the contact 1 lens prescription to the patient.’’. 2 (b) PATIENT CONFIRMATION OF RECEIPT OF CON- 3 TACT LENS PRESCRIPTION.—Section 2(b) of the Fairness 4 to Contact Lens Consumers Act (15 U.S.C. 7601(b)) is 5 amended— 6 (1) in paragraph (2), by striking ‘‘or’’ after the 7 semicolon; 8 (2) in paragraph (3), by striking the period at 9 the end and inserting ‘‘; or’’; and 10 (3) by adding at the end the following: 11 ‘‘(4) require the patient to acknowledge any 12 contact lens prescription release in writing or elec- 13 tronically.’’. 14 (c) PROHIBITION ON AUTOMATED CALLS.—Section 4 15 of the Fairness to Contact Lens Consumers Act (15 16 U.S.C. 7603) is amended by striking subsection (g) and 17 inserting the following: 18 ‘‘(g) DIRECT COMMUNICATION.— 19 ‘‘(1) IN GENERAL.—As used in this section, the 20 term ‘direct communication’ includes communication 21 by telephone, facsimile, or electronic mail. 22 ‘‘(2) CLARIFICATION.—Such term shall not in- 23 clude a telephone call made using an artificial or 24 prerecorded voice message.’’. 25 VerDate Sep 11 2014 18:05 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4613.IS S4613 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4613 IS SEC. 4. TECHNICAL AMENDMENTS. 1 Section 4(c)(6) of the Fairness to Contact Lens Con- 2 sumers Act (15 U.S.C. 7603(c)(6)) is amended by insert- 3 ing ‘‘and electronic mail address’’ after ‘‘telephone num- 4 ber’’. 5 Æ VerDate Sep 11 2014 18:05 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S4613.IS S4613 pamtmann on DSKBC07HB2PROD with BILLS