Lafourche Medical Group, LLC Resolution Agreement and Corrective Action Plan

Resolution Agreement

I. Recitals

Parties The Parties to this Resolution Agreement (“Agreement”) are:
1. 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 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).
2. Lafourche Medical Group, LLC (“LMG”), which is a covered entity, as defined at 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules. LMG is a medical group with two urgent care facilities in the state of Louisiana. LMG consists of five health care providers specializing in emergency medicine, occupational medicine, laboratory testing, and specialty services. LMG provides services to communities of South Louisiana, mainly to residents of Lafourche Parish and the surrounding areas. HHS and LMG shall together be referred to herein as the “Parties.”

Factual Background and Covered Conduct. On May 28, 2021, HHS received a breach notification report filed by LMG as required by 45 C.F.R. § 164.408. According to the report, on March 30, 2021, LMG learned that an unauthorized individual obtained access to one of its owners’ email accounts through a phishing attack. LMG determined that the email account contained patients’ protected health information (PHI). As LMG was unable to identify the specific patients affected, LMG notified all of its patients - approximately 34,862 individuals, of the incident. On January 13, 2022, HHS notified LMG of its investigation into LMG’s compliance with the applicable Federal Standards for Privacy of Individually Identifiable Health Information and/or the Security Standards for the Protection of Electronic Protected Health Information (45 C.F.R. Parts 160 and 164, Subparts A, C, and E, the Privacy and Security Rules), and the Breach Notification Rule (45 F.R. Parts 160 and 164, Subpart D).

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

LMG never conducted a Security Rule risk analysis prior to the 2021 security See 45 C.F.R. § 164.308(a)(1)(ii)(A).
LMG never implemented procedures to regularly review records of information system activity prior to the security See 45 C.F.R. § 164.308(a)(1)(ii)(D).

No Admission. This Agreement is not an admission of liability by
No Concession. This Agreement is not a concession by HHS that LMG is not in violation of the HIPAA Rules and not liable for civil money penalties (“CMPs”).
Intention of Parties to Effect Resolution. This Agreement is intended to resolve OCR Transaction Number 21-428483 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

II. Terms and Conditions

Payment. HHS has agreed to accept, and LMG has agreed to pay HHS, the amount of $480,000 (“Resolution Amount”). LMG agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph 14 by automated clearing house transaction pursuant to written instructions to be provided by HHS.
Corrective Action Plan. LMG has entered into and agrees to comply with the Corrective Action Plan (“CAP”), attached as Appendix A, which is incorporated into this Agreement by If LMG breaches the CAP and fails to cure the breach as set forth in the CAP, then LMG 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 LMG’s performance of its obligations under this Agreement, HHS releases LMG from any actions it may have against LMG 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 LMG 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 S.C. § 1320d-6.
Agreement by Released Party. LMG 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 LMG 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 LMG 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
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
Effect of Agreement. This Agreement constitutes the complete agreement between the 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 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, LMG 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 LMG’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. LMG 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 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. This Agreement and information related to this Agreement may be made public by either
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
Authorizations. The individual(s) signing this Agreement on behalf of LMG represent and warrant that they are authorized by LMG to execute this 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 Lafourche Medical Group, LLC

/s/

Adam Arcement, MD, FAAEM
Owner
Lafourche Medical Group, LLC

11/03/2023

Date

For the United States Department of Health and Human Services

/s/

Marisa M. Smith, Ph.D.
Regional Manager
Office for Civil Rights, Southwest Region

11/03/2023

Date

Appendix A

Corrective Action Plan
Between the
U.S. Department of Health and Human Services
and
Lafourche Medical Group, LLC

Preamble
Lafourche Medical Group, LLC (“LMG”) 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, LMG is entering into a Resolution Agreement (“Agreement”) with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. LMG enters into this CAP as part of the consideration for the release set forth in paragraph II.8 of the Agreement.
Contact Persons and Submissions
1. Contact Persons.
  LMG 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:
  
  Adam Arcement, MD, Owner
  Lafourche Medical Group, LLC
  13100 River Road, Suite 100
  Destrehan, LA 70047
  Voice Phone (985) 235-0010
  
  HHS has identified the following individual as its authorized representative and contact person with whom LMG 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
  
  LMG and HHS agree to promptly notify each other of any changes in the contact persons or the other information provided above.
2. 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.
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 LMG 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 LMG under section VIII hereof of its determination that LMG 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 LMG that it has determined that the breach has been cured. After the Compliance Term ends, LMG 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 LMG’s obligation to comply with the document retention requirements in 45 C.F.R. §§ 164.316(b) and 164.530(j).
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.
Corrective Action Obligations
LMG agrees to the following:
1. Security Management Process
  1. LMG shall create, document and implement security measures sufficient to reduce risks and vulnerabilities to ePHI, identified in its December 2022 Security Risk Assessment, to a reasonable and appropriate level (“Risk Management Plan”). This Risk Management Plan shall be forwarded to HHS for review and approval within sixty (60) calendar days of the Effective Date. HHS shall approve, or, if necessary, require revisions to LMG's Risk Management Plan.
  2. Upon receiving HHS' notice of required revisions, if any, LMG shall have thirty (30) calendar days to revise the Risk Management Plan accordingly and forward to HHS for review and approval. This process shall continue until HHS approves the Risk Management Plan.
  3. LMG shall annually conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by LMG, including any affiliates that are owned, controlled, or managed by LMG, and document the security measures LMG implemented or is implementing to sufficiently reduce the identified risks and vulnerabilities to a reasonable and appropriate level. See 45 C.F.R § 164.308(a)(1)(ii)(A) and § 164.308(a)(1)(ii)(B). Subsequent risk analyses and corresponding risk management plans shall be submitted for review by HHS in the same manner as described in this section until the conclusion of the CAP. LMG may submit any risk analysis performed in 2023 or that is currently underway for consideration by HHS for compliance with this provision, along with the corresponding risk management plan.
2. Policies and Procedures
  1. LMG shall develop, maintain, and revise, as necessary, its written policies and procedures ("policies and procedures") to comply with the Federal standards that govern the privacy and security of individually identifiable health information (45 C.F.R. Parts 160 and 164, Subpart E of 45 C.F.R. Part 164) to address any threats and vulnerabilities to the ePHI identified in the risk analysis and risk management plan required by Section V.A.
  2. LMG shall develop, maintain, and revise, as necessary, its written policies and procedures to address Information System Activity Review 45 C.F.R § 164.308(a)(1)(ii)(D). Such policies and procedures shall include a process(es) for the regular review of all records of information system activity collected by LMG and processes for evaluating when the collection of new or different records needs to be included in the review. The policies and procedures should also identify what systems are being included in the review and a 14-day frequency to conduct such reviews.
  3. Within thirty (30) calendar days following HHS’ approval of LMG’s Risk Management Plan, LMG shall provide such policies and procedures, consistent with Section V.B.1 and V.B.2 above, to HHS for review and approval. Upon receiving any required revisions to such policies and procedures from HHS, LMG shall have thirty (30) calendar days to revise the policies and procedures accordingly and provide the revised policies and procedures to HHS for review and approval. This process shall continue until HHS approves such policies and procedures.
3. Distribution and Updating of Policies and Procedures
  1. LMG shall distribute the policies and procedures identified in Section V.B to members of its workforce responsible for implementation and enforcement of those policies within thirty (30) calendar days of HHS' approval of such policies and to new members of its workforce responsible for implementation and enforcement of those policies within fifteen (15) calendar days of the beginning of service.
  2. LMG shall require, at the time of distribution of the policies and procedures, a signed written or electronic initial compliance certification from all members of its workforce identified in Section V.C.1, stating that the workforce members have read, understand, and shall abide by such policies and procedures.
  3. LMG shall assess, update, and revise, as necessary, the policies and procedures at least annually. LMG shall provide the revised policies and procedures to HHS for review and approval. Within thirty (30) calendar days of receipt of any approved substantive revisions by HHS, LMG shall distribute such revised policies and procedures to its workforce identified in Section V.C.1 and shall require new compliance certifications.
  4. LMG shall not provide any member of its workforce identified in Section V.C.1 with access to PHI if that workforce member has not signed or provided the written or electronic certification required by paragraphs 2 and 3 of this section.
4. Reportable Events
  1. During the Compliance Term, LMG shall, upon learning that a workforce member likely failed to comply with its policies and procedures described in Section V.B.l and 2, promptly investigate this matter. If LMG, after review and investigation, determines that a member of its workforce has failed to comply with its policies and procedures, LMG shall report such events to HHS as provided in Section VI.B.1.c on a quarterly basis. Such violations shall be known as Reportable Events. The report to HHSshall include the following:
    1. A complete description of the event, including the relevant facts, the persons involved, and the applicable provision(s) of LMG's Privacy, Security, and Breach Notification policies and procedures; and
    2. A description of the actions taken and any further steps LMG plans to take to address the matter, to mitigate any harm, and to prevent it from recurring, including application of any appropriate sanctions against workforce members who failed to comply with its Privacy, Security, and Breach Notification policies and procedures.
    3. If no Reportable Events occur during the Compliance Term, LMG shall so inform HHS in the Annual Report(s) as specified in Section VI below.
5. Training
  1. LMG shall provide HHS with training materials on the privacy and security of protected health information (PHI) to all members of its workforce who have access to PHI, including specific training related to the policies and procedures required in Section V.B as necessary and appropriate for workforce members to perform their job duties, within thirty (30) calendar days of receiving HHS’ final approval of policies and procedures described in Section V.B.
  2. Upon receiving notice from HHS specifying any required changes, LMG shall make the required changes and provide revised training materials to HHS within thirty (30) calendar days.
  3. Upon receiving approval from HHS of the training materials, LMG shall provide training for each workforce member who has access to PHI within thirty (30) calendar days of HHS’ approval and annually thereafter. LMG shall also provide such training to each new member of its workforce within thirty (30) calendar days of their beginning of service.
  4. Each workforce member who is required to attend training shall certify, in electronic or written form, that he or she has received the training. The training certification shall specify the date training was received. All course materials shall be retained in compliance with Section VII.
  5. LMG shall review the training at least annually, and, where appropriate, update the training to reflect changes in Federal law or HHS guidance, any issues discovered during audits or reviews, or any other relevant developments.
Implementation Report, and Annual Reports
1. Implementation Report
  1. Within one hundred twenty (120) calendar days after the receipt of HHS’ approval of the policies and procedures required by section V.B.1, LMG 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:
    1. An attestation signed by an owner or officer of LMG attesting that the policies and procedures approved by HHS in Section V.B are being implemented;
    2. An attestation signed by an owner or officer of LMG attesting that all members of the workforce have completed the initial training required by Section V.E;
    3. An attestation signed by an owner or officer of LMG 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.
2. Annual Reports.
  1. 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, LMG shall submit a report to HHS regarding LMG’s compliance with this CAP for each corresponding Reporting Period (“Annual Report”). The Annual Report shall include:
    1. An attestation signed by an owner or officer of LMG attesting that all members of the workforce have completed the training required by section V.E during the Reporting Period;
    2. An attestation signed by an officer or director of LMG attesting that any revision(s) to the policies and procedures required by Section V.B were finalized and adopted within thirty (30) calendar days of HHS’ approval of the revision(s), which shall include a statement affirming that LMG distributed the revised policies and procedures to all appropriate members of LMG’s workforce within sixty (60) calendar days of HHS’ approval of the revision(s);
    3. A summary of Reportable Events (defined in Section 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 LMG stating that no Reportable Events occurred during the Compliance Term.
    4. An attestation signed by an owner or officer of LMG 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.
Document Retention
LMG 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.
Requests for Extensions and Breach Provisions
1. Timely Written Requests for Extensions. LMG 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. This requirement may be waived by HHS only.
2. Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by LMG constitutes a breach of the Agreement. Upon a determination by HHS that LMG has breached this CAP, HHS may notify LMG of: (1) LMG’s breach; and (2) HHS’ intent to impose a 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”).
3. LMG’s Response. LMG 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’ satisfaction that:
  1. LMG 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 30-day period, but that: (a) LMG has begun to take action to cure the breach; (b) LMG is pursuing such action with due diligence; and (c) LMG has provided to HHS a reasonable timetable for curing the breach.
4. Imposition of CMP. If at the conclusion of the 30-day period, LMG fails to meet the requirements of this CAP to HHS’ satisfaction, HHS may proceed with the imposition of the CMP against LMG pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph 1.2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify LMG in writing of its determination to proceed with the imposition of the CMP.

For Lafourche Medical Group, LLC

/s/

Adam Arcement, MD, FAAEM
Owner

11/03/2023

Date

For the United States Department of Health and Human Services

/s/

Marisa M. Smith, Ph.D.
Regional Manager
Office for Civil Rights
Southwest Region

11/03/2023

Date

Lafourche Medical Group, LLC Resolution Agreement and Corrective Action Plan

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