I. Recitals
- Parties. The Parties to this Resolution Agreement (“Agreement”) are:
- 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).
- Memorial Hermann Health System (the “Covered Entity,” or “MHHS”), which is a covered entity, as defined at 45 C.F.R. § 160.103, and is therefore required to comply with the HIPAA Rules. The Covered Entity is a not-for-profit health system in Southeast Texas, consisting of 17 hospitals, including Memorial Hermann Katy Hospital. HHS and the Covered Entity shall together be referred to herein as the “Parties.”
- Factual Background and Covered Conduct. On August 31, 2020, OCR received a complaint alleging that the Covered Entity has violated the Federal Standards for Privacy of Individually Identifiable Health Information (45 C.F.R. Parts 160 and 164, Subparts A and E, the Privacy Rule). Specifically, the Complainant – a patient of the Covered Entity – alleged to have made, from June 2019 to January 2020, multiple requests (five (5) in total) to MHHS’ Billing Department for a copy of her complete medical and billing records, and that the Covered Entity subsequently failed to take timely and compliant action upon said requests. Based on the foregoing, OCR initiated a formal investigation of the Covered Entity’s compliance with 45 C.F.R. § 164.524 – setting forth the standard governing an individual’s right of access to his / her protected health information (“PHI”).
OCR’s investigation yielded a determination that the Complainant made an initial, written request for access to, at a minimum, an itemized billing statement to the Covered Entity on July 3, 2019, which was acknowledged to have been received thereby on July 10, 2019, and that the Covered Entity did not comply with said request, in full, until March 26, 2021. The resulting findings support the legal conclusion that the Covered Entity violated 45 C.F.R. § 164.524(b)(2) by failing to provide the Complainant with timely access to a copy of her itemized billing statement for a total of 564 days. - No Admission. This Agreement is not an admission of liability by the Covered Entity.
- No Concession. This Agreement is not a concession by HHS that the Covered Entity 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 OCR Transaction Number 20-396202 and any 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 further investigation and 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 the Covered Entity has agreed to pay HHS, the amount of $ 240,000 (“Resolution Amount”). The Covered Entity agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14 by automated clearinghouse transaction pursuant to written instructions to be provided by HHS.
- Corrective Action Plan. The Covered Entity 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 the Covered Entity breaches the CAP, and fails to cure the breach as set forth in the CAP, then the Covered Entity 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 the Covered Entity’s performance of its obligations under this Agreement, HHS releases the Covered Entity from any actions it may have against the Covered Entity 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 the Covered Entity 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 Party. The Covered Entity 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. The Covered Entity 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 the Covered Entity 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 (i.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-year period does not expire during the term of this Agreement, the Covered Entity agrees that the time between the Effective Date of this Agreement (as set forth in Paragraph 14) and the date the Agreement may be terminated by reason of the Covered Entity’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. The Covered Entity 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.
- 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 the Covered Entity represent and warrant that they are authorized by the Covered Entity to execute this Agreement. 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.
For The Covered Entity
/s/ 5/3/2022
________________________________ ___________________
David L. Callender, M.D. Date
President and Chief Executive Officer
Memorial Hermann Health System
For the United States Department of Health and Human Services
/s/ 5/3/2022
_____________________ _______________________
Marisa M. Smith, Ph.D. Date
Regional Manager
Office for Civil Rights
Southwest Region
Appendix A
Corrective Action Plan Between the United States Department of Health and Human Services and Memorial Hermann Health System
I. Preamble
Memorial Hermann Health System (referred to herein as the “Covered Entity”) 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, the Covered Entity is entering into a Resolution Agreement (“Agreement”) with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. The Covered Entity enters into this CAP as part of the consideration for the release set forth in paragraph II.8 of the Agreement.
II. Contact Persons and Submissions
A. Contact Persons.
The Covered Entity 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:
Carol Paret
Sr. Vice President
Chief Community Health and Privacy Officer
Memorial Hermann Health System
909 Frostwood Dr., Ste. 2.205
Houston, TX 77024
Carol.Paret@memorialhermann.org
HHS has identified the following individual as its authorized representative and contact person with whom The Covered Entity is to report information regarding the implementation of this CAP:
Marisa M. Smith, Ph.D.
Regional Manager
Office for Civil Rights, Southwest Region
U.S. Department of Health and Human Services
1301 Young Street, Suite 106-1130
Dallas, TX 75202
Voice Phone (214) 767-6973
Fax: (214) 767-0432
marisa.smith@hhs.gov
The Covered Entity and HHS agree to promptly notify each other of any changes in the contact persons or the other information provided above.
B. 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, 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 the Covered Entity under this CAP shall begin on the Effective Date of this CAP and end two (2) years from the Effective Date, unless HHS has notified the Covered Entity under section VIII hereof of its determination that the Covered Entity has breached this CAP. In the event of such a notification by HHS under section VIII hereof, the Compliance Term shall not end until HHS notifies the Covered Entity that it has determined that the breach has been cured. After the Compliance Term ends, the Covered Entity 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.
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
The Covered Entity agrees to the following:
A. Revision of Internal Policies and Procedures Governing the Individual Right of Patient Access to PHI
- Within thirty (30) calendar days of the Effective Date, the Covered Entity shall revise its controlling internal policies and procedures governing the individual right of patient access to PHI (see 45 C.F.R. § 164.524), so as to expressly establish, delineate, and implement a mechanism by which the Covered Entity will be able to reliably track its receipt and processing of written requests for access to medical information and records under 45 C.F.R. § 164.524 submitted to its Billing Department.
- HHS shall review and, if necessary, recommend changes to the aforementioned policies and procedures. Upon receiving recommended changes from HHS, the Covered Entity shall have thirty (30) calendar days to provide revised policies and procedures to HHS. The Covered Entity shall make its policies and procedures available for review and comment until it has received final approval from HHS.
B. Training
- Within thirty (30) calendar days of HHS’s approval of the Covered Entity’s revised policies and procedures regarding the individual right of access to PHI, the Covered Entity shall develop training materials regarding these policies and procedures – consistent with 45 C.F.R. §§ 164.524 and 164.530(b) – to HHS for review.
- HHS shall review and, if necessary, recommend changes to the aforementioned training materials. Upon receiving recommended changes from HHS, the Covered Entity shall have thirty (30) calendar days to provide the revised training materials to HHS. The Covered Entity shall make its training materials available for review and comment until it has received final approval from HHS.
- Within ninety (90) calendar days of HHS’s approval of the training materials, and annually while under the Term of this CAP, the Covered Entity shall provide training to its Billing Department workforce members on its revised policies and procedures regarding the individual right of access to PHI.
C. Access Request Status Requirements
- Within ninety (90) calendar days of receipt of HHS’s approval of the policies and procedures required by section V.A.1, and every ninety (90) calendar days thereafter while the under the Term of this CAP, the Covered Entity shall submit to HHS a list of requests for access to medical information and records, in respect to the Covered Entity’s obligations under 45 C.F.R. §§ 164.502(g) and 164.524, received by the Covered Entity’s Billing Department, including the date request received, date request completed, format requested, format provided, number of pages (if provided in paper format), and cost, excluding postage.
- If the Covered Entity denied any request for access, in whole or in part, the Covered Entity shall submit to HHS all documentation consistent with 45 C.F.R. § 164.524(d).
D. Reportable Events
- During the Compliance Term, the Covered Entity shall, upon receiving information that a Billing Department workforce member may have failed to comply with its revised access policies and procedures, promptly investigate such matters. If the Covered Entity determines, after review and investigation, that a member of its workforce has failed to comply with these policies and procedures, the Covered Entity shall notify HHS in writing within thirty (30) calendar days. Such violations shall be known as Reportable Events. The report to HHS shall include the following information:
- A complete description of the event, including the relevant facts, the persons involved, and the provision(s) of the policies and procedures implicated; and
- A description of the actions taken and any further steps the Covered Entity plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including application of appropriate sanctions against workforce members who failed to comply with its Privacy Rule policies and procedures.
VI. Implementation Report and Annual Reports
A. Implementation Report
- Within one hundred twenty (120) calendar days after the receipt of HHS’s final approval of the policies and procedures required by section V.A.1, the Covered Entity shall submit a written report to HHS summarizing the status of its implementation of the requirements of this CAP. This report, known as the “Implementation Report,” shall include:
- An attestation signed by an owner or officer of the Covered Entity attesting that the policies and procedures approved by HHS in section V.A. are being implemented;
- An attestation signed by an officer or director of the Covered Entity attesting that the Covered Entity distributed the policies and procedures required by section V.A.1 to all members of the Covered Entity’s Billing Department’s workforce within sixty (60) calendar days of HHS’s approval of the policies and procedures or to all new Billing Department workforce members within fifteen (15) calendar days;
- An attestation signed by an owner or officer of the Covered Entity attesting that its Billing Department workforce members have completed the initial training required by section V.B.3;
- An attestation signed by an owner or officer of the Covered Entity 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.
B. Annual Reports.
- The one (1) year period after 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, the Covered Entity shall submit a report to HHS regarding the Covered Entity’s compliance with this CAP for each corresponding Reporting Period (“Annual Report”). This annual report shall include:
- An attestation signed by an officer or director of the Covered Entity attesting that the policies and procedures required by section V.A.1 have been implemented;
- An attestation signed by an owner or officer of the Covered Entity attesting that all members of the Billing Department’s workforce have completed the training required by section V.B.3 during the Reporting Period;
- A summary of Reportable Events (defined in V.D.), if any, the status of any corrective and preventative action(s) relating to all such Reportable Events, or an attestation signed by an officer or director of the Covered Entity stating that no Reportable Events occurred during the Compliance Term; and
- An attestation signed by an owner or office of the Covered Entity 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
The Covered Entity 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
The Covered Entity is expected to fully and timely comply with all provisions contained in this CAP.
A. Timely Written Requests for Extensions. The Covered Entity 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.
B. Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by the Covered Entity constitutes a breach of the Agreement. Upon a determination by HHS that the Covered Entity has breached this CAP, HHS may notify the Covered Entity of: (1) the Covered Entity’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”).
C. The Covered Entity Response. The Covered Entity 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:
- The Covered Entity is in compliance with the obligations of the CAP that HHS cited as the basis for the breach;
- the alleged breach has been cured; or
- the alleged breach cannot be cured within the 30-day period, but that: (a) the Covered Entity has begun to take action to cure the breach; (b) the Covered Entity is pursuing such action with due diligence; and (c) the Covered Entity has provided to HHS a reasonable timetable for curing the breach.
D. Imposition of CMP. If at the conclusion of the 30-day period, the Covered Entity 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 the Covered Entity pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph 2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify the Covered Entity in writing of its determination to proceed with the imposition of the CMP.
For The Covered Entity
/s/ 5/3/2022
______________________________ ___________________
David L. Callender, M.D. Date
President and Chief Executive Officer
Memorial Hermann Health System
For the United States Department of Health and Human Services
/s/ 5/3/2022
______________________________ ___________________
Marisa M. Smith, Ph.D. Date
Regional Manager
Office for Civil Rights
Southwest Region
