Manasa Health Center LLC Resolution Agreement and Corrective Action Plan | HHS.gov
Manasa Health Center LLC Resolution Agreement and Corrective Action Plan
Resolution Agreement
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)
Manasa Health Center, LLC (Manasa) is a practice located in Kendall Park, New Jersey that provides adult and child psychiatric services. Manasa is a covered entity, as defined at 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules.
HHS and Manasa shall together be referred to herein as the “Parties.”
Factual Background and Covered Conduct. On November 18, 2020, HHS notified Manasa of HHS’ investigation regarding Manasa’s noncompliance with the HIPAA Privacy Rule.
HHS’s investigation indicated that the following conduct occurred (“Covered Conduct”):
Manasa impermissibly disclosed the PHI of four (4) patients in response to their negative reviews posted on Google Reviews. See 45 C.F.R. § 164.502(a).
Manasa failed to implement policies and procedures with respect to PHI that are designed to comply with the standards, implementation specifications, or other requirements of the Privacy and Breach Notification Rules in violation of 45 C.F.R. § 164.530(i)
No Admission. This Agreement is not an admission of liability by Manasa.
No Concession. This Agreement is not a concession by HHS that Manasa 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 TN 20-380176 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 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, andManasa has agreed to pay HHS, the amount of $30,000 (“Resolution Amount”). Manasa 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. Manasa 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 Manasa breaches the CAP, and fails to cure the breach as set forth in the CAP, then Manasa 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 Manasa’s performance of its obligations under this Agreement, HHS releases Manasa from any actions it may have against Manasa 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 Manasa 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. Manasa 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. Manasa 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 Manasa 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 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, Manasa agrees that the time between the Effective Date of this Agreement and the date the Agreement may be terminated by reason of Manasa’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. Manasa 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 Manasa represents and warrants that they are authorized to execute this Agreement and bind Manasa, 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.
For Manasa Health Center, LLC
/s/
Dr. Nidagalle Gowda, Owner
3/27/2023
Date
For the United States Department of Health and Human Services
/s/
Linda C. Colón, Regional Manager
Eastern and Caribbean Region
Office for Civil Rights
3/28/2023
Date
Appendix A
Corrective Action Plan
Between the
U.S. Department of Health and Human Services
and
Manasa Health Center, LLC
I. Preamble
Manasa Health Center, LLC (hereinafter known as “Manasa”) 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, Manasa is entering into the Agreement with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. Manasa enters into this CAP as part of the 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
Manasa 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:
TBD
XXXXXX
XXXXXX
XXXXXX
Voice Phone: (xxx) xxx-xxxx
HHS has identified the following individual as its authorized representative and contact person with whom Manasa 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, Suite 3312
New York, New York 10278
Voice Phone (212) 264-4136
Manasa 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 Manasa 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 Manasa under section VIII hereof of its determination that Manasa 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 Manasa that it has determined that the breach has been cured. After the Compliance Term ends, Manasa 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
Manasa agrees to the following:
Policies and Procedures
Manasa shall develop, maintain, and revise its written privacy policies and procedures (“Policies and Procedures”) to comply with the Federal standards that govern the privacy of individually identifiable health information. (45 C.F.R. Parts 160 and 164, Subpart E of 45 C.F.R. Part 164). Manasa’s Policies and Procedures shall include, but not be limited to, the minimum content set forth in Section V.B.
Within ninety (90) days following the Effective Date of the Agreement, Manasa shall provide such Policies and Procedures, consistent with Section V.A.1. above, to HHS for review and approval. Upon receiving any required changes to such Policies and Procedures from HHS, Manasa shall have thirty (30) 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.
Manasa shall implement the Policies and Procedures and distribute them to all workforce members within thirty (30) days after receiving HHS’s final approval of any revisions to the Policies and Procedures described in Sections V.A.1 and V.B.
Manasa shall assess, update, and revise, as necessary, the Policies and Procedures at least annually. Manasa shall provide the revised Policies and Procedures to HHS for review and approval. Within thirty (30) days of HHS’s approval of any substantive revisions, Manasa shall distribute such revised Policies and Procedures to all members of the workforce, and shall require new compliance certifications
Minimum Content of the Policies and Procedures
At a minimum, the Policies and Procedures shall include measures to address the following Privacy Rule provisions:
Policies and Procedures that specifically address permissible and impermissible uses and disclosures of PHI and appropriate administrative, technical, and physical safeguards to protect the privacy of PHI. (Uses and disclosures of protected health information – 45 C.F.R. § 164.502 and Safeguards 45 C.F.R. § 164.530(c))
A revision to Manasa’s authorization form to comply with the requirements of the Privacy Rule, including a description of how the individual may revoke the authorization and a statement regarding the covered entity’s ability or inability to condition treatment, payment, enrollment, or eligibility for benefits on the authorization. (Authorizations – 45 C.F.R. § 164.508).
A revision to Manasa’s Notice of Privacy Practices to comply with the requirements of the Privacy Rule, including a description of the uses and disclosures of PHI for which Manasa is required to obtain an individual’s authorization (e.g., posting on Manasa’s website, social media pages and/or other public platforms). (Notice of Privacy Practices – 45 C.F.R. § 164.520(b)).
Identification of personnel or representatives whom workforce members, agents, or business associates may contact in the event of any inquiry or concern regarding compliance with HIPAA in relation to these activities. (Personnel Designations – 45 C.F.R. § 164.530(a))
Internal reporting procedures which will require all workforce members to report to the designated person or office at the earliest possible time any potential violations of the Privacy, Security or Breach Notification Rules or of Manasa’s privacy and security policies and procedures. Such reporting procedures shall require Manasa to promptly investigate and address all received reports in a timely manner. (Complaints to the Covered Entity – 45 C.F.R. § 164.530(d) and Mitigation – 45 C.F.R. § 164.530(f))
Application and documentation of appropriate sanctions (which may include retraining or other instructive corrective action, depending on the circumstances) against members of Manasa’s workforce who fail to comply with the Privacy, Security or Breach Notification Rules or Manasa’s privacy and security policies and procedures. This content shall include a description of the sanctions; a timeframe in which Manasa will apply and document sanctions for violations of the HIPAA Rules or of Manasa’s privacy, security or breach policies or procedures; the manner in which Manasa will document the sanctions; and where Manasa will store or retain such documentation (e.g., personnel file). (Sanctions – 45 C.F.R. § 164.530(e))
Reportable Events
During the Compliance Term, Manasa shall, upon learning that a workforce member likely failed to comply with its Policies and Procedures described in Section V.A.1, promptly investigate this matter. If Manasa, after review and investigation, determines that a member of its workforce has failed to comply with its Policies and Procedures, Manasa shall report such events to HHS as provided in Section VI.B.4. Such violations shall be known as Reportable Events. The report to HHS shall include the following:
A complete description of the event, including the relevant facts, the persons involved, and the applicable provision(s) of Manasa’s Privacy, Security, and Breach Notification Policies and Procedures; and
A description of the actions taken and any further steps Manasa 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 its Privacy, Security, and Breach Notification Policies and Procedures.
If no Reportable Events occur during the Compliance term, Manasa shall so inform HHS in the Implementation Report as specified in Section VI below.
Training
All members of Manasa’s workforce, including owners and managers, shall receive training on Manasa’s policies and procedures to comply with the Privacy and Security Rules, including the specific items referenced in Section V.C. within 30 days of the implementation of the policies and procedures, or within 30 days of when they become a member of the workforce of Manasa.
Manasa shall provide HHS with training materials for all members of the workforce and management that have access to PHI to include specific training related to its new Policies and Procedures described under Sections V.A.1 and V.B. above, within sixty (60) days after HHS approves Manasa’s Policies and Procedures per Section V.A.2 above.
Each workforce member shall certify, in electronic or written form, that he or she has received and understands the required training. The training certification shall specify the date training was received. All course materials shall be retained in compliance with Section VII.
Manasa shall review the privacy 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, and any other relevant developments.
Manasa shall not provide access to PHI to any member of its workforce if that workforce member has not signed or provided the written or electronic certification required by paragraph V.D.3.
Issuance of Breach Notifications
Within 30 calendar days of the Effective Date, Manasa shall issue breach notices to all individuals, or the individuals’ personal representatives, whose PHI was disclosed by the Covered Entity on Google Reviews or any other internet platform without a valid authorization. See 45 C.F.R. § 164.404.
Within 30 calendar days of the Effective Date, Manasa shall submit to HHS, through HHS’ breach portal, breach reports regarding the individuals in V.E.1. See 45 C.F.R. § 164.408.
VI. Implementation Report and Annual Reports
Implementation Report. Within one hundred twenty (120) calendar days after the receipt of HHS’s approval of the policies and procedures required by section V.A.1, Manasa 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 Manasa attesting that the policies and procedures approved by HHS in section V.A are being implemented;
A copy of all training materials used for the training required by this CAP, a description of the training, including a summary of the topics covered, the length of the session(s) and a schedule of when the training session(s) were held;
An attestation signed by Manasa attesting that all members of the workforce, including owners and managers, have completed the initial training required by this CAP and have executed the training certifications required by Section V.D.3.; and
An attestation signed by an owner or officer of Manasa 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 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, Manasa shall submit a report to HHS regarding Manasa’s compliance with this CAP for each corresponding Reporting Period (“Annual Report”).
An attestation signed by an officer or owner of Manasa 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 Manasa distributed the revised policies and procedures to all appropriate members of Manasa’s workforce within thirty (30) calendar days of HHS’s approval of the revision(s);
An attestation signed by an owner or officer of Manasa attesting that all members of the workforce have completed the training required by section V.D. during the Reporting Period;
An attestation signed by an owner or officer of Manasa attesting that it is obtaining and maintaining written training certifications from all persons that require training that they received training pursuant to the requirements set forth in this CAP;
A summary of Reportable Events (defined in V.C.), if any, the status of any corrective and preventative action(s) relating to all such Reportable Events, or an attestation signed by Manasa stating that no Reportable Events occurred during the Compliance Term; and
An attestation signed by Manasa attesting that it 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
Manasa 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
Manasa is expected to fully and timely comply with all provisions contained in this CAP.
Timely Written Requests for Extensions. Manasa 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 Manasa constitutes a breach of the Agreement. Upon a determination by HHS that Manasa has breached this CAP, HHS may notify Manasa of: (1) Manasa’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”).
Manasa’s Response. Manasa 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:
Manasa 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) Manasa has begun to take action to cure the breach; (b) Manasa is pursuing such action with due diligence; and (c) Manasa has provided to HHS a reasonable timetable for curing the breach.
Imposition of CMP. If at the conclusion of the 30-day period, Manasa 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 Manasa 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 Manasa in writing of its determination to proceed with the imposition of the CMP pursuant to 45 C.F.R. Part 160.
For Manasa Health Center, LLC
/s/
Dr. Nidagalle Gowda, Owner
3/27/2023
Date
For the United States Department of Health and Human Services
/s/
Linda C. Colón, Regional Manager
Eastern and Caribbean Region, Office for Civil Rights
3/28/2023
Date
Resolution Agreement
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)
Manasa Health Center, LLC (Manasa) is a practice located in Kendall Park, New Jersey that provides adult and child psychiatric services. Manasa is a covered entity, as defined at 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules.
HHS and Manasa shall together be referred to herein as the “Parties.”
Factual Background and Covered Conduct. On November 18, 2020, HHS notified Manasa of HHS’ investigation regarding Manasa’s noncompliance with the HIPAA Privacy Rule.
HHS’s investigation indicated that the following conduct occurred (“Covered Conduct”):
Manasa impermissibly disclosed the PHI of four (4) patients in response to their negative reviews posted on Google Reviews. See 45 C.F.R. § 164.502(a).
Manasa failed to implement policies and procedures with respect to PHI that are designed to comply with the standards, implementation specifications, or other requirements of the Privacy and Breach Notification Rules in violation of 45 C.F.R. § 164.530(i)
No Admission. This Agreement is not an admission of liability by Manasa.
No Concession. This Agreement is not a concession by HHS that Manasa 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 TN 20-380176 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 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, andManasa has agreed to pay HHS, the amount of $30,000 (“Resolution Amount”). Manasa 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. Manasa 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 Manasa breaches the CAP, and fails to cure the breach as set forth in the CAP, then Manasa 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 Manasa’s performance of its obligations under this Agreement, HHS releases Manasa from any actions it may have against Manasa 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 Manasa 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. Manasa 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. Manasa 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 Manasa 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 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, Manasa agrees that the time between the Effective Date of this Agreement and the date the Agreement may be terminated by reason of Manasa’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. Manasa 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 Manasa represents and warrants that they are authorized to execute this Agreement and bind Manasa, 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.
For Manasa Health Center, LLC
/s/
Dr. Nidagalle Gowda, Owner
3/27/2023
Date
For the United States Department of Health and Human Services
/s/
Linda C. Colón, Regional Manager
Eastern and Caribbean Region
Office for Civil Rights
3/28/2023
Date
Appendix A
Corrective Action Plan
Between the
U.S. Department of Health and Human Services
and
Manasa Health Center, LLC
I. Preamble
Manasa Health Center, LLC (hereinafter known as “Manasa”) 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, Manasa is entering into the Agreement with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. Manasa enters into this CAP as part of the 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
Manasa 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:
TBD
XXXXXX
XXXXXX
XXXXXX
Voice Phone: (xxx) xxx-xxxx
HHS has identified the following individual as its authorized representative and contact person with whom Manasa 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, Suite 3312
New York, New York 10278
Voice Phone (212) 264-4136
Manasa 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 Manasa 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 Manasa under section VIII hereof of its determination that Manasa 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 Manasa that it has determined that the breach has been cured. After the Compliance Term ends, Manasa 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
Manasa agrees to the following:
Policies and Procedures
Manasa shall develop, maintain, and revise its written privacy policies and procedures (“Policies and Procedures”) to comply with the Federal standards that govern the privacy of individually identifiable health information. (45 C.F.R. Parts 160 and 164, Subpart E of 45 C.F.R. Part 164). Manasa’s Policies and Procedures shall include, but not be limited to, the minimum content set forth in Section V.B.
Within ninety (90) days following the Effective Date of the Agreement, Manasa shall provide such Policies and Procedures, consistent with Section V.A.1. above, to HHS for review and approval. Upon receiving any required changes to such Policies and Procedures from HHS, Manasa shall have thirty (30) 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.
Manasa shall implement the Policies and Procedures and distribute them to all workforce members within thirty (30) days after receiving HHS’s final approval of any revisions to the Policies and Procedures described in Sections V.A.1 and V.B.
Manasa shall assess, update, and revise, as necessary, the Policies and Procedures at least annually. Manasa shall provide the revised Policies and Procedures to HHS for review and approval. Within thirty (30) days of HHS’s approval of any substantive revisions, Manasa shall distribute such revised Policies and Procedures to all members of the workforce, and shall require new compliance certifications
Minimum Content of the Policies and Procedures
At a minimum, the Policies and Procedures shall include measures to address the following Privacy Rule provisions:
Policies and Procedures that specifically address permissible and impermissible uses and disclosures of PHI and appropriate administrative, technical, and physical safeguards to protect the privacy of PHI. (Uses and disclosures of protected health information – 45 C.F.R. § 164.502 and Safeguards 45 C.F.R. § 164.530(c))
A revision to Manasa’s authorization form to comply with the requirements of the Privacy Rule, including a description of how the individual may revoke the authorization and a statement regarding the covered entity’s ability or inability to condition treatment, payment, enrollment, or eligibility for benefits on the authorization. (Authorizations – 45 C.F.R. § 164.508).
A revision to Manasa’s Notice of Privacy Practices to comply with the requirements of the Privacy Rule, including a description of the uses and disclosures of PHI for which Manasa is required to obtain an individual’s authorization (e.g., posting on Manasa’s website, social media pages and/or other public platforms). (Notice of Privacy Practices – 45 C.F.R. § 164.520(b)).
Identification of personnel or representatives whom workforce members, agents, or business associates may contact in the event of any inquiry or concern regarding compliance with HIPAA in relation to these activities. (Personnel Designations – 45 C.F.R. § 164.530(a))
Internal reporting procedures which will require all workforce members to report to the designated person or office at the earliest possible time any potential violations of the Privacy, Security or Breach Notification Rules or of Manasa’s privacy and security policies and procedures. Such reporting procedures shall require Manasa to promptly investigate and address all received reports in a timely manner. (Complaints to the Covered Entity – 45 C.F.R. § 164.530(d) and Mitigation – 45 C.F.R. § 164.530(f))
Application and documentation of appropriate sanctions (which may include retraining or other instructive corrective action, depending on the circumstances) against members of Manasa’s workforce who fail to comply with the Privacy, Security or Breach Notification Rules or Manasa’s privacy and security policies and procedures. This content shall include a description of the sanctions; a timeframe in which Manasa will apply and document sanctions for violations of the HIPAA Rules or of Manasa’s privacy, security or breach policies or procedures; the manner in which Manasa will document the sanctions; and where Manasa will store or retain such documentation (e.g., personnel file). (Sanctions – 45 C.F.R. § 164.530(e))
Reportable Events
During the Compliance Term, Manasa shall, upon learning that a workforce member likely failed to comply with its Policies and Procedures described in Section V.A.1, promptly investigate this matter. If Manasa, after review and investigation, determines that a member of its workforce has failed to comply with its Policies and Procedures, Manasa shall report such events to HHS as provided in Section VI.B.4. Such violations shall be known as Reportable Events. The report to HHS shall include the following:
A complete description of the event, including the relevant facts, the persons involved, and the applicable provision(s) of Manasa’s Privacy, Security, and Breach Notification Policies and Procedures; and
A description of the actions taken and any further steps Manasa 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 its Privacy, Security, and Breach Notification Policies and Procedures.
If no Reportable Events occur during the Compliance term, Manasa shall so inform HHS in the Implementation Report as specified in Section VI below.
Training
All members of Manasa’s workforce, including owners and managers, shall receive training on Manasa’s policies and procedures to comply with the Privacy and Security Rules, including the specific items referenced in Section V.C. within 30 days of the implementation of the policies and procedures, or within 30 days of when they become a member of the workforce of Manasa.
Manasa shall provide HHS with training materials for all members of the workforce and management that have access to PHI to include specific training related to its new Policies and Procedures described under Sections V.A.1 and V.B. above, within sixty (60) days after HHS approves Manasa’s Policies and Procedures per Section V.A.2 above.
Each workforce member shall certify, in electronic or written form, that he or she has received and understands the required training. The training certification shall specify the date training was received. All course materials shall be retained in compliance with Section VII.
Manasa shall review the privacy 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, and any other relevant developments.
Manasa shall not provide access to PHI to any member of its workforce if that workforce member has not signed or provided the written or electronic certification required by paragraph V.D.3.
Issuance of Breach Notifications
Within 30 calendar days of the Effective Date, Manasa shall issue breach notices to all individuals, or the individuals’ personal representatives, whose PHI was disclosed by the Covered Entity on Google Reviews or any other internet platform without a valid authorization. See 45 C.F.R. § 164.404.
Within 30 calendar days of the Effective Date, Manasa shall submit to HHS, through HHS’ breach portal, breach reports regarding the individuals in V.E.1. See 45 C.F.R. § 164.408.
VI. Implementation Report and Annual Reports
Implementation Report. Within one hundred twenty (120) calendar days after the receipt of HHS’s approval of the policies and procedures required by section V.A.1, Manasa 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 Manasa attesting that the policies and procedures approved by HHS in section V.A are being implemented;
A copy of all training materials used for the training required by this CAP, a description of the training, including a summary of the topics covered, the length of the session(s) and a schedule of when the training session(s) were held;
An attestation signed by Manasa attesting that all members of the workforce, including owners and managers, have completed the initial training required by this CAP and have executed the training certifications required by Section V.D.3.; and
An attestation signed by an owner or officer of Manasa 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 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, Manasa shall submit a report to HHS regarding Manasa’s compliance with this CAP for each corresponding Reporting Period (“Annual Report”).
An attestation signed by an officer or owner of Manasa 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 Manasa distributed the revised policies and procedures to all appropriate members of Manasa’s workforce within thirty (30) calendar days of HHS’s approval of the revision(s);
An attestation signed by an owner or officer of Manasa attesting that all members of the workforce have completed the training required by section V.D. during the Reporting Period;
An attestation signed by an owner or officer of Manasa attesting that it is obtaining and maintaining written training certifications from all persons that require training that they received training pursuant to the requirements set forth in this CAP;
A summary of Reportable Events (defined in V.C.), if any, the status of any corrective and preventative action(s) relating to all such Reportable Events, or an attestation signed by Manasa stating that no Reportable Events occurred during the Compliance Term; and
An attestation signed by Manasa attesting that it 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
Manasa 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
Manasa is expected to fully and timely comply with all provisions contained in this CAP.
Timely Written Requests for Extensions. Manasa 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 Manasa constitutes a breach of the Agreement. Upon a determination by HHS that Manasa has breached this CAP, HHS may notify Manasa of: (1) Manasa’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”).
Manasa’s Response. Manasa 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:
Manasa 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) Manasa has begun to take action to cure the breach; (b) Manasa is pursuing such action with due diligence; and (c) Manasa has provided to HHS a reasonable timetable for curing the breach.
Imposition of CMP. If at the conclusion of the 30-day period, Manasa 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 Manasa 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 Manasa in writing of its determination to proceed with the imposition of the CMP pursuant to 45 C.F.R. Part 160.
For Manasa Health Center, LLC
/s/
Dr. Nidagalle Gowda, Owner
3/27/2023
Date
For the United States Department of Health and Human Services
/s/
Linda C. Colón, Regional Manager
Eastern and Caribbean Region, Office for Civil Rights
3/28/2023
Date
