Voluntary Resolution Agreement Between The United States Department of Health and Human Services, Office for Civil Rights (“HHS”) and UnitedHealthcare

1. RESOLUTION AGREEMENT

I. Recitals

The United States Department of Health and Human Services, Office for Civil Rights (“HHS”), which enforces the Federal standards that govern the privacy of individually identifiable health information (45 C.F.R. Part 160 and Subparts A and E of Part 164, the “Privacy Rule”), the Federal standards that govern the security of electronic individually identifiable health information (45 C.F.R. Part 160 and Subparts A and C of Part 164, the “Security Rule”), and the Federal standards for notification in the case of breach of unsecured protected health information (45 C.F.R. Part 160 and Subparts A and D of 45 C.F.R. Part 164, the “Breach Notification Rule”). HHS has the authority to conduct compliance reviews and investigations of complaints alleging violations of the Privacy, Security, and Breach Notification Rules (the “HIPAA Rules”) by covered entities and business associates, and covered entities and business associates must cooperate with HHS compliance reviews and investigations. See 45 C.F.R. §§ 160.306(c), 160.308, and 160.310(b).

HHS and UHIC shall together be referred to herein as the “Parties.”

HHS’s investigation of the complaint indicated that the following conduct occurred (“Covered Conduct”):

Parties. The Parties to this Resolution Agreement (“Agreement”) are:
1. UnitedHealthcare Insurance Company, in its capacity as insurer within UnitedHealthcare’s Employer & Individual business (“UHIC”), is a covered entity, as defined at 45 C.F.R §160.103, and therefore is required to comply with the HIPAA Rules. UHIC is a health insurer that provides insurance coverage to millions of individuals across the United States. UHIC is a wholly-owned subsidiary of UnitedHealth Group.
Factual Background and Covered Conduct. On March 25, 2021, OCR received a complaint alleging that UHIC did not respond to the complainant’s request for a copy of their medical record, which was received via mail at a post office box located in Utah. Upon becoming aware of the issue through the OCR complaint, UHIC immediately investigated and concluded the oversight had been a result of employee error. UHIC also promptly sent all requested records to the member.
1. UHIC failed to provide timely access to protected health information. See 45 C.F.R. § 164.524(a).
No Admission. This Agreement is not an admission of liability by UHIC.
No Concession. This Agreement is not a concession by HHS that UHIC is not in violation of the HIPAA Rules and not liable for civil money penalties.
Intention of Parties to Effect Resolution. This Agreement is intended to resolve HHS Transaction Number 21-419069 and any potential violations of the HIPAA Rules related to the Covered Conduct specified in paragraph I.2 of this Agreement. In consideration of the Parties’ interest in avoiding the uncertainty, burden, and expense of formal proceedings, the Parties agree to resolve this matter according to the Terms and Conditions below.

II. Terms and Conditions

Payment. HHS has agreed to accept, and UHIC has agreed to pay HHS, the amount of $80,000 (“Resolution Amount”). UHIC agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14 pursuant to written instructions provided by HHS.
Corrective Action Plan. UHIC has entered into and agrees to comply with the Corrective Action Plan (“CAP”), attached as Appendix A, which is incorporated into this Agreement by reference. If UHIC breaches the CAP and fails to cure the breach as set forth in the CAP, then UHIC will be in breach of this Agreement and HHS will not be subject to the Release set forth in paragraph II.8 of this Agreement.
Release by HHS. In consideration of and conditioned upon UHIC’s performance of its obligations under this Agreement, HHS releases UHIC from any actions it may have against UHIC under the HIPAA Rules arising out of or related to the Covered Conduct identified in paragraph I.2 of this Agreement. HHS does not release UHIC from, nor waive any rights, obligations, or causes of action other than those arising out of or related to the Covered Conduct and referred to in this paragraph. This release does not extend to actions that may be brought under Section 1177 of the Social Security Act, 42 U.S.C. § 1320d-6.
Agreement by Released Parties. UHIC shall not contest the validity of its obligation to pay, nor the amount of, the Resolution Amount or any other obligations agreed to under this Agreement. UHIC waives all procedural rights granted under Section 1128A of the Social Security Act (42 U.S.C. § 1320a- 7a) and 45 C.F.R. Part 160 Subpart E, and HHS claims collection regulations at 45 C.F.R. Part 30, including, but not limited to, notice, hearing, and appeal with respect to the Resolution Amount.
Binding on Successors. This Agreement is binding on UHIC and its successors, heirs, transferees, and assigns.
Costs. Each Party to this Agreement shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.
No Additional Releases. This Agreement is intended to be for the benefit of the Parties only, and by this instrument, the Parties do not release any claims against or by any other person or entity.
Effect of Agreement. This Agreement constitutes the complete agreement between the Parties. All material representations, understandings, and promises of the Parties are contained in this Agreement. Any modifications to this Agreement shall be set forth in writing and signed by all Parties.
Execution of Agreement and Effective Date. The Agreement shall become effective (e., final and binding) upon the date of signing of this Agreement and the CAP by the last signatory (“Effective Date”).
Tolling of Statute of Limitations. Pursuant to 42 U.S.C. § 1320a-7a(c)(1), a civil money penalty (“CMP”) must be imposed within six (6) years from the date of the occurrence of the violation. To ensure that this six (6)-year period does not expire during the term of this Agreement, UHIC agrees that the time between the Effective Date of this Agreement (as set forth in paragraph II.14) and the date the Agreement may be terminated by reason of UHIC’s breach, plus one-year thereafter, will not be included in calculating the six (6) year statute of limitations applicable to the violations which are the subject of this Agreement. UHIC waives and will not plead any statute of limitations, laches, or similar defenses to any administrative action relating to the Covered Conduct identified in paragraph I.2 that is filed by HHS within the time period set forth above, except to the extent that such defenses would have been available had an administrative action been filed on the Effective Date of this Agreement.
Disclosure. HHS places no restriction on the publication of the Agreement. In addition, HHS may be required to disclose material related to this Agreement to any person upon request consistent with the applicable provisions of the Freedom of Information Act, 5 U.S.C. § 552, and its implementing regulations, 45 C.F.R. Part 5.
Execution in Counterparts. This Agreement may be executed in counterparts, each of which constitutes an original, and all of which shall constitute one and the same agreement.
Authorizations. The individual(s) signing this Agreement on behalf of UHIC represents and warrants that they are authorized to execute this Agreement and bind UHIC, as set forth in paragraph I.1.B. The individual(s) signing this Agreement on behalf of HHS represent and warrant that they are signing this Agreement in their official capacities and that they are authorized to execute this Agreement.

Signatures

The individuals signing represent that they are authorized to execute this Agreement and legally bind the parties to this Agreement.

For UnitedHealthcare Insurance Company

_______________________________________
Date: August 4, 2023
Daniel Kueter, CEO, UHC E&I

Date: August 7, 2023
Blake Berquist, CFO, UHC E&I

Date: August 7, 2023
Daniel Mulligan, CFO, UHC E&I

For the U.S. Department of Health and Human Services

_______________________________________
Date: August 8, 2023

Linda C. Colón, Regional Manager
Eastern and Caribbean Region
Office for Civil Rights

Appendix A

CORRECTIVE ACTION PLAN

BETWEEN THE

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

AND

UHIC

I.Preamble

UHIC hereby enters into this Corrective Action Plan (“CAP”) with the United States Department of Health and Human Services, Office for Civil Rights (“HHS”). Contemporaneously with this CAP, UHIC is entering into a Resolution Agreement (“Agreement”) with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. UHIC enters into this CAP as part of consideration for the release set forth in paragraph II.8 of the Agreement. Capitalized terms without definition in this CAP shall have the same meaning assigned to them under the Agreement.

II. Contact Persons and Submissions

Contact Persons
UHIC has identified the following individual as its authorized representative and contact person regarding the implementation of this CAP and for receipt and submission of notifications and reports:

Richard Ramsay
Vice President, Chief Compliance Officer, Employer & Individual UnitedHealthcare
701 Pennsylvania Ave, NW, Suite 600
Washington, DC 20004
202.383.6405 (Direct Dial)
703.626.3493 (Cell)
Rick_Ramsay@uhc.com

HHS has identified the following individual as its authorized representative and contact person with whom UHIC is to report information regarding the implementation of this CAP:

Linda C. Colón, Regional Manager
Eastern and Caribbean Region
Office for Civil Rights
U.S. Department of Health and Human Services
26 Federal Plaza
New York, New York 10278
Telephone (212) 264-4136
Linda.Colon@hhs.gov

UHIC and HHS agree to promptly notify each other of any changes in the contact person or the other information provided above.
Proof of Submissions. Unless otherwise specified, all notifications and reports required by this CAP may be made by any means, including certified mail, overnight mail, electronic mail, or hand delivery, provided that there is proof that such notification was received. For purposes of this requirement, internal facsimile confirmation sheets do not constitute proof of receipt.

III. Effective Date and Term of CAP

The Effective Date for this CAP shall be calculated in accordance with paragraph II.14 of the Agreement (“Effective Date”). The period for compliance (“Compliance Term”) with the obligations assumed by UHIC under this CAP shall begin on the Effective Date of this CAP and end one (1) year from the Effective Date unless HHS has notified UHIC under Section VIII hereof of its determination that UHIC has breached this CAP. In the event HHS notifies UHIC under Section VIII hereof, the Compliance Term shall not end until HHS notifies UHIC that HHS has determined that the breach has been cured. After the Compliance Term ends, UHIC shall still be obligated to: (a) submit the final Annual Report as required by Section VI; and (b) comply with the document retention requirement in Section VII. Nothing in this CAP is intended to eliminate or modify UHIC’s obligation to comply with the document retention requirements in 45 C.F.R. § 164.316(b) and 45 C.F.R. § 164.530(j).

IV. Time

In computing any period of time prescribed or allowed by this CAP, all days referred to shall be calendar days. The day of the act, event, or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of the next day which is not one of the aforementioned days.

V. Corrective Action Obligations

UHIC agrees to the following:

Review and Revise Policies and Procedures for Individual Access to PHI
1. Within thirty (30) calendar days of the Effective Date, UHIC shall review, and to the extent necessary, revise the policies and procedures related to the right of access to protected health information (PHI) to be consistent with 45 C.F.R. § 164.524. At a minimum, the Policies and Procedures shall include measures to address the following Privacy Rule provisions:
  1. Right of Access – 45 C.F.R. § 164.524(a)(1)
  2. Timely Action by the Covered Entity - 45 C.F.R. § 164.524(b)(2)
  3. Form of access requested, including form and format - 45 C.F.R. § 164.524(c)(2)
  4. Method for calculating reasonable, cost-based fees - 45 C.F.R. § 164.524(c)(4)
2. HHS shall review and, if necessary, recommend changes to the aforementioned Policies and Procedures. Upon receiving recommended changes from HHS, UHIC shall have thirty (30) calendar days to provide revised Policies and Procedures for HHS’s approval. This process shall continue until HHS approves such Policies and Procedures.
3. Within thirty (30) days after receiving HHS’s final approval of any revisions to such Policies and Procedures, UHIC shall implement and distribute the Policies and Procedures to all appropriate workforce members.
Distribution and Updating of Policies and Procedures
1. UHIC shall require, at the time of distribution of the Policies and Procedures, a signed written or electronic initial compliance certification from all members of the workforce to whom UHIC distributed the Policies and Procedures in accordance with Section V.A.3., stating that the workforce members have read, understand, and shall abide by such Policies and Procedures.
Privacy Training on Individual Access to PHI
1. Within sixty (60) calendar days of the Effective Date, UHIC shall provide workforce training materials regarding the individual’s right of access to PHI consistent with 45 C.F.R. § 164.524 to HHS for review and approval.
2. Within thirty (30) calendar days of HHS’s approval, and annually while under the Term of this CAP, UHIC shall provide training to all appropriate workforce members at its facilities on the Privacy Rule requirements concerning the individual’s right of access to PHI.
3. Each workforce member who is required to attend privacy training shall certify in electronic or written form, that he or she has received the training. The training certification shall specify the date that the training was received. All course materials shall be retained in compliance with Section VII.
Access Request Status Requirements
1. Within ninety (90) calendar days of HHS’s approval of the Policies and Procedures required by Section V.A.1, and every ninety (90) days thereafter while under the Term of this CAP, UHIC shall submit to HHS a list of written requests for access to PHI received by UHIC via mail at the regional mail operations post office box in Utah listed below, including the date UHIC received the request, the date UHIC fulfilled the request, the format requested, the format provided, the number of pages (if provided in paper format), and the fee charged (if any), excluding postage.
  P.O. Box 30555
  Salt Lake City, UT 84130-0555
2. If UHIC denied any request for access, in whole or in part, UHIC shall submit to HHS all documentation consistent with 45 C.F.R. § 164.524(d).
Reportable Events
1. During the Compliance Term, UHIC shall, upon receiving information that a workforce member that handles requests covered in Section V(D) may have failed to comply with the Policies and Procedures described in Section V.A.1, promptly investigate this matter. If UHIC determines, after review and investigation, that a member of such workforce has failed to comply with the Policies and Procedures, UHIC shall report such events to HHS in writing within thirty (30) calendar days. Such violations shall be known as Reportable Events. The report to HHS shall include the following:
  1. A complete description of the event, including the relevant facts, the persons involved, and the applicable provision(s) of the Policies and Procedures implicated; and
  2. A description of the actions taken and any further steps UHIC plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including the application of appropriate sanctions against workforce members who failed to comply with the Policies and Procedures.
2. If no Reportable Events occur during the Compliance Term, UHIC shall so inform HHS in the Implementation Report as specified in Section VI below.

VI. Implementation Report and Annual Reports

Implementation Report. Within one hundred twenty (120) days after HHS approves the Policies and Procedures required by Section V.A.1. above, UHIC shall submit a written report to HHS summarizing the status of its implementation with the requirements of this CAP. This report, known as the “Implementation Report,” shall include:
1. An attestation signed by an owner or officer of UHIC attesting that the Policies and Procedures approved by HHS pursuant to Section V.A. are being implemented, have been distributed to all appropriate members of the workforce, and that UHIC has obtained all of the compliance certifications required by Sections V.B.1 and V.B.2.;
2. An attestation signed by an owner or officer of UHIC attesting that all appropriate members of the workforce have completed the initial training required by this CAP and have executed the training certifications required by Section V.C.3.; and
3. An attestation signed by an owner or officer of UHIC stating that he or she has reviewed the Implementation Report, has made a reasonable inquiry regarding its content, and believes that, upon such inquiry, the information is accurate and truthful.
Annual Reports. The one (1)-year period beginning on the Effective Date and each subsequent one (1) year period during the course of the Compliance Term shall be known as a “Reporting Period.” Within sixty (60) calendar days after the close of each corresponding Reporting Period, UHIC shall submit a report to HHS regarding UHIC’s compliance with this CAP for each corresponding Reporting Period no later than sixty (60) days after the end of each corresponding Reporting Period (the “Annual Report”). The Annual Report shall include:
1. An attestation signed by an owner or officer of UHIC attesting that all appropriate workforce members have completed the training required by Section V.C.2 during the Reporting Period;
2. An attestation signed by an owner or officer of UHIC attesting that any revision(s) to the Policies and Procedures required by Section V.A. were finalized and adopted within thirty (30) calendar days of HHS’s approval of the revision(s), which shall include a statement affirming that UHIC distributed the revised Policies and Procedures to all appropriate members of UHIC’s workforce within thirty (30) calendar days of HHS’s approval of the revision(s);
3. A summary of Reportable Events (defined in Section V.E.), if any, the status of any corrective and preventable action(s) relating to all such Reportable Events, or an attestation signed by an officer or director of UHIC stating that no Reportable Events occurred during the Compliance Term;
4. An attestation signed by an owner or officer of UHIC attesting that he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content, and believes that, upon such inquiry, the information is accurate and truthful.

VII. Document Retention

UHIC shall maintain for inspection and copying, and shall provide to HHS, upon request, all documents and records relating to compliance with this CAP for six (6) years from the Effective Date.

VIII. Breach Provisions

UHIC is expected to fully and timely comply with all provisions contained in this CAP.

Timely Written Requests for Extensions. UHIC may, in advance of any due date set forth in this CAP, submit a timely written request for an extension of time to perform any act required by this CAP. A “timely written request” is defined as a request in writing received by HHS at least five (5) calendar days prior to the date such an act is required or due to be performed.
Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by UHIC constitutes a breach of the Agreement. Upon a determination by HHS that UHIC has breached this CAP, HHS may notify UHIC of: (1) UHIC’s breach; and (2) HHS’s intent to impose a civil money penalty (CMP), pursuant to 45 C.F.R. Part 160, or other remedies, for the Covered Conduct set forth in paragraph I.2 of the Agreement and for any other conduct that constitutes a violation of the HIPAA Privacy, Security, and Breach Notification Rules (“Notice of Breach and Intent to Impose CMP”).
UHIC’s Response. UHIC shall have thirty (30) calendar days from the date of receipt of the Notice of Breach and Intent to Impose CMP to demonstrate to HHS’s satisfaction that:
1. UHIC is in compliance with the obligations of the CAP that HHS cited as the basis for the breach;
2. The alleged breach has been cured; or
3. The alleged breach cannot be cured within the thirty (30)-day period, but: (a) UHIC has begun to take action to cure the breach; (b) UHIC is pursuing such action with due diligence; and (c) UHIC has provided to HHS a reasonable timetable for curing the breach.
Imposition of CMP. If at the conclusion of the thirty (30)-day period, UHIC fails to meet the requirements of Section VIII.C of this CAP to HHS’s satisfaction, HHS may proceed with the imposition of the CMP against UHIC pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph I.2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify UHIC in writing of its determination to proceed with the imposition of the CMP pursuant to 45 C.F.R. Part 160.

IX. Signatures

The individuals signing represent that they are authorized to execute this Agreement and legally bind the parties to this Agreement.

For UnitedHealthcare Insurance Company

_______________________________________
Date: August 4, 2023
Daniel Kueter
CEO, UHC E&I

Date: August 7, 2023
Blake Berquist
CFO, UHC E&I

Date: August 7, 2023
Daniel Mulligan
CFO, UHC E&I

For the U.S. Department of Health and Human Services

_______________________________________
Date: August 8, 2023
Linda C. Colón, Regional Manager
Eastern and Caribbean Region
Office for Civil Rights

Voluntary Resolution Agreement Between The United States Department of Health and Human Services, Office for Civil Rights (“HHS”) and UnitedHealthcare Insurance Company

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