IN THE MATTER OF: STATE OF FLORIDA DEPARTMENT OF LEGAL AFFAIRS OFFICE OF THE ATTORNEY GENERAL OPTUMRX HOLDINGS, LLC, a Delaware Limited Liability Company, AG Case No. L12-3-1015 Respondent. ---------------------------------------- I ASSURANCE OF VOLUNTARY COMPLIANCE PURSUANT TO the provisions of Chapter 501, Part II, Florida Statutes, the Florida Deceptive and Unfair Trade Practices Act, the STATE OF FLORIDA, DEPARTMENT OF LEGAL AFFAIRS, OFFICE OF THE ATTORNEY GENERAL, hereinafter referred to as the Department, caused an investigation to be made into the business practices of "hi Healthlnnovations" a division of OptumR:x, Inc., which is a California corporation that is a wholly-owned subsidiary of OptumRx Holdings, LLC. OptumRx Holdings, LLC has a principal business address of 2300 Main Street, Irvine, California 92614. For purposes of this AVC, the term "Respondent" shall refer to OptumR:x Holdings, LLC and the hi Healthinnovations division ofoptumrx, Inc. IT APPEARS THAT Respondent is prepared to enter into this Assurance of Voluntary Compliance, hereinafter A VC, without an admission that Respondent has violated the law and for the purpose of resolution of this matter with the Department, and the Department, by and through the undersigned Assistant Attorney General, and the undersigned Director of Consumer Protection, being in agreement, does in this matter accept this AVC in termination of this investigation, pursuant to Section 501.207(6), Florida Statutes, and by virtue of the authority vested in the Department by said statute. Initials
I. STIPULATED FACTS 1.1 Respondent is engaged in the business of selling hearing aids through internet marketing and solicitations to policyholders of certain health insurers. 1.2 At all times pertinent hereto, Respondent employed or affiliated with four audiologists who continue to hold valid licenses pursuant to Chapter 468, Part I, Florida Statutes in connection with the sale and distribution of hearing <;lids to Florida consumers. 1.3 Between on or about January 1, 2012 and March 28, 2012, Respondent used an online hearing test to diagnose hearing loss and recommend one of Respondent's hearing aids for purchase to Florida consumers. a. The online hearing test was self-administered by the consumer and not under direct supervision of any licensed professionals authorized to administer hearing tests in the State of Florida. b. The United States Food and Drug Administration (FDA) has determined that the online hearing test is a medical device that requires FDA pre-approval prior to being introduced into commerce. The requirement for pre-approval exists to protect the public health by ensuring that a medical device is safe and effective. Respondents had not received any approval or clearance from the FDA prior to introducing the online hearing test into commerce. c. On or about March 28, 2012, the FDA sent a letter to Respondent stating that Respondent should immediately cease marketing the online hearing test until Respondent submitted a new 51 O(k) application to be reviewed for clearance by the FDA. 1.4 Respondent no longer offers an online hearing test to diagnose hearing loss or market hearing aids. 1.5 The Department has investigated allegations that Respondent utilized the online 2 _v_1 1nitials
hearing test which the FDA claims is an adulterated and misbranded medical device in its marketing of hearing aids to Florida consumers. 1.6 Respondent and the Department desire to resolve all issues arising during the course of this investigation. 1.7 This A VC is based upon the stipulated facts set forth in Paragraphs 1.1 through 1.6 above. The Department shall not be estopped from taking further action in this matter should the facts described herein be shown to be incorrect in any material way, or the A VC not be complied with in full. II. COMPLIANCE TERMS 2.1 Respondent agrees to continue to refrain from offering an online hearing test to Florida consumers to diagnose hearing loss or market hearing aids. 2.2 Respondent shall contact all Florida consumers who used the online hearing test in connection with a hi Healthlnnovations hearing aid purchase and notify them of the terms of Paragraph 2.3 of this AVC. 2.3 Respondent shall provide refunds to any Florida consumers who used the online hearing test in connection with a hi Healthlnnovations hearing aid purchase if the consumer makes a written request and returns the hearing aids to Respondent before August 1, 2013. 2.4 Respondent shall provide documentation to the Department of all refunds made in accordance with this AVC before September 1, 2013. 2.5 Respondent and its representatives, agents, employees, successors, assigns or any other person, who acts under, by, through, or on behalf of Respondent, directly or indirectly, or through any corporate or other device, shall make its executives, and any employees, agents, or subcontractors involved in the process of approving of company sales and marketing practices, aware ofterms ofthis AVC. 3 \.:r Initials
2.6 If, subsequent to the effective date of this A VC, the laws or regulations of the United States, or the FDA otherwise explicitly permits an online hearing test of the type referred to in Section I of this A VC, then such conduct shall not constitute a violation of this AVC. Provided, however, if Respondent intends to engage in the expressly authorized conduct, Respondent shall notify the Department and the Florida Board of Speech-Language Pathology and Audiology within 60 business days prior to any change. 2.9 Respondent shall not affect any change in any form of doing business or organizational identity as a method of avoiding the terms of this A VC. 2.10 Nothing in this A VC shall be construed as a waiver of any private rights of any person or release of any private rights, causes of action, or remedies of any person against the Respondent. This A VC in no way limits the liability of the Respondent to consumers for any amounts paid that were not refunded or for any damages caused by Respondent's products. In addition, nothing herein shall be construed to limit or bar any other governmental entity from pursuing other available remedies against the Respondent for acts and practices addressed by this AVC.. III. STIPULATED PAYMENT 3.1 IT IS FURTHER AGREED by the parties that Respondent shall pay THIRTY THOUSAND DOLLARS ($30,000.00) to the Department for its investigative and attorney's fees and costs and associated with the matter resolved herein. Failure to comply with this A VC shall also subject Respondent to penalties as set forth in Paragraph 3.3 of this AVC. Time is of the essence in all payments pursuant to this agreement. 3.2 Payment shall be made pursuant to Paragraph 3.1 above by certified funds payable to "The Department of Legal Affairs Revolving Trust Fund" and submitted to the undersigned Assistant Attorney General with this A VC. The payment shall be deposited in the 4 Initials
Department of Legal Affairs' Revolving Trust Fund, in accordance with Section 501.2101 (1 ), Florida Statutes. 3.3 The Attorney General reserves the right to seek additional penalties pursuant to Florida Statutes, Chapter 501, Part II, for any future violation(s) of the terms contained within this agreement. The Attorney General reserves the right to seek additional investigative and attorney's fees and costs upon default, as defined herein, or upon any future noncompliance. IV. CHARITABLE CONTRIBUTION IT IS FURTHER AGREED by the parties that Respondent shall deliver the sum of FIFTEEN THOUSAND DOLLARS ($15,000.00) to the Florida School for the Deaf and the Blind, 207 North San Marco Ave., St. Augustine, Florida 32094, within ten ( 10) days of the execution of this AVC. V. BUSINESS RECORDS Respondent agrees to retain documents and other information reasonably sufficient to establish compliance with the provisions herein, and shall provide reasonable access to such documents and information to the Department upon request. VI. ACCEPTANCE IT IS HEREBY AGREED by the parties that this A VC shall become effective upon its acceptance by the Director of Consumer Protection, who may refuse to accept it at his discretion. The receipt of or deposit by the Department of any monies pursuant to this A VC does not constitute acceptance by said Department, and monies received will be returned if this AVC is not accepted. 5 Initials
IN WITNESS WHEREOF, Respondent has caused this A VC to be executed by an authorized representative, as a true act and deed, in the county and state listed below, as of the date affixed thereon. BY MY SIGNATURE I hereby affirm that I am acting in my capacity and within my authority as Chief Executive Officer of hi Healthlnnovations, and that by my signature I am binding Respondent to the terms and conditions of this A VC. HI HEALTHINNOVATIONS L~!~?r= ChiefExecutive Officer. State of M t.a,;\att f.t fu..., County of -+levt.mtpt.aa. BEFORE ME, an officer duly authorized to take acknowledgments in the State of H f.,v!atl.f(oiz:l, personally appeared LISA TSENG who acknowledged before me that she executed the foregoing instrument on behalf of OptumRx Holdings, LLC as the Chief Executive Officer of hi Healthlnnovations, for the purposes therein stated. Sworn to and subscribed before me this Itt-{;) day of JtJL11l.f.., 2013...., LYNN M. ZURNIEOEN Notary Public State of Minnesota My Commission Expires January 31, 2014 6 J1_1nitials
OFFICE OF THE ATTORNEY GENERAL RICHARD SCHIFFER Assistant Attorney General Florida Bar # 7 4418 Office ofthe Attorney General Consumer Protection Division 3507 E. Frontage Road, Suite 325 Tampa, Florida 33607 (813) 287-7950 Accepted this lj_ day of Jv._ t.. '2013. ' trector of Consumer Protection Florida Attorney General's Office PL-0 1 The Capitol Tallahassee, Florida 32399-1050 Telephone (850) 245-0410 Facsimile (850) 487-2564 7 Initials