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                              MelroseWakefield Healthcare (MWH) Resolution Agreement and Corrective Action Plan


    

    

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MelroseWakefield Healthcare (MWH) Resolution Agreement and Corrective Action Plan








  
  
    

  
      





**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).
		MelroseWakefield Healthcare, Inc. ("MelroseWakefield"), which 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 MelroseWakefield shall together be referred to herein as the "Parties."
	**Factual Background and Covered Conduct.**
	On July 20, 2020, HHS received a complaint against MelroseWakefield from an individual ("Complainant") alleging that she requested the protected health information (PHI) of her mother from MelroseWakefield and had been denied access to the requested records.
	HHS' investigation revealed that, on June 12, 2020, the Complainant made a valid access request for her mother's PHI, having attached documentation verifying that she was her mother's personal representative. The complainant was not provided access to the records on the mistaken basis that the durable power of attorney did not allow for the provision of such medical records. Upon receiving notification of OCR's investigation, MelroseWakefield reviewed the power of attorney documentation anew and determined that the complainant should have received access to the records based on her initial request. The complainant was provided access on October 20, 2020.
	HHS' investigation indicated that the following covered conduct occurred ("Covered Conduct"):
	MelroseWakefield failed to provide access to protected health information about the individual in a designated record set (*see*45 C.F.R. § 164.524).
	**No Admission**.  This Agreement is not an admission of liability by MelroseWakefield.
	**No Concession**.  This Agreement is not a concession by HHS that MelroseWakefield 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 01-20-388889 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 MelroseWakefield has agreed to pay HHS, the amount of $55,000 ("Resolution Amount"). MelroseWakefield agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14 pursuant to written instructions to be provided by HHS.
	**Corrective Action Plan**.  MelroseWakefield 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 MelroseWakefield breaches the CAP, and fails to cure the breach as set forth in the CAP, then MelroseWakefield 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 MelroseWakefield's performance of its obligations under this Agreement, HHS releases MelroseWakefield from any actions it may have against MelroseWakefield 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 MelroseWakefield 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**.  MelroseWakefield 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.  MelroseWakefield 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 MelroseWakefield 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 (6) year period does not expire during the term of this Agreement, MelroseWakefield agrees that the time between the Effective Date of this Agreement and the date the Agreement may be terminated by reason of MelroseWakefield'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.  MelroseWakefield 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 MelroseWakefield represent and warrant that they are authorized by MelroseWakefield 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 MelroseWakefield Healthcare, Inc. (MelroseWakefield)**

/s/

Charles R. Whipple, Esq.
General Counsel
MelroseWakefield Healthcare Inc.

Date: 5/11/2022

**For Department of Health and Human Services**

/s/

Susan M. Pezzullo Rhodes
Regional Manager
Office for Civil Rights

Date: 5/11/2022

**Appendix A**

**CORRECTIVE ACTION PLAN BETWEEN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND MELROSEWAKEFIELD HEALTHCARE, Inc.**

**I.  Preamble**

MelroseWakefield Healthcare, Inc. ("MelroseWakefield") 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, MelroseWakefield is entering into a Resolution Agreement ("Agreement") with HHS, and this CAP is incorporated by reference into the Resolution Agreement as Appendix A.  MelroseWakefield enters into this CAP as part of consideration for the release set forth in paragraph II.8 of the Agreement.

**II.  Contact Persons and Submissions**

**Contact Persons**MelroseWakefield 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:

Michael McAuliffe
Senior Director, Data Integrity & Privacy
170 Governors Avenue
Medford, MA 02155

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

Susan M. Pezzullo Rhodes
Office for Civil Rights, New England Region
U.S. Department of Health and Human Services
JFK Federal Building, Room 1875
Boston, MA  02203
Telephone:  617-565-1347
Facsimile:  617-565-3809

MelroseWakefield and HHS agree to promptly notify each other of any changes in the contact persons 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, 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 MelroseWakefield under this CAP shall begin on the Effective Date of this CAP and end one (1) year from the Effective Date unless HHS has notified MelroseWakefield under section VIII hereof of its determination that MelroseWakefield 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 MelroseWakefield that it has determined that the breach has been cured.  After the Compliance Term ends, MelroseWakefield shall still be obligated to submit the final Annual Report as required by section VI and 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**

MelroseWakefield agrees to the following:

**Policies and Procedures**

	MelroseWakefield shall develop, maintain, and revise, as necessary, its written policies and procedures to comply with 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").  MelroseWakefield's policies and procedures shall include, but not be limited to, the minimum content set forth in section V.C.
		MelroseWakefield shall provide such policies and procedures, consistent with paragraph 1 above, to HHS within sixty (60) days of the Effective Date for review and approval.  Upon receiving any recommended changes to such policies and procedures from HHS, MelroseWakefield shall have thirty (30) days to revise such policies and procedures accordingly and provide the revised policies and procedures to HHS for review and approval.
		MelroseWakefield shall implement such policies and procedures within thirty (30) days of receipt of HHS' approval.
	**Distribution and Updating of Policies and Procedures**
	MelroseWakefield shall distribute the policies and procedures identified in section V.A. to all workforce members whose job duties include receiving and fulfilling record access requests or supervising those who have such duties within thirty (30) days of HHS approval of such policies and to new members of the workforce within thirty (30) days of their beginning of service.
		MelroseWakefield shall require, at the time of distribution of such policies and procedures, a signed written or electronic initial compliance certification from all members of the workforce*,* stating that the workforce members have read, understand, and shall abide by such policies and procedures.
		MelroseWakefield shall assess, update, and revise, as necessary, the policies and procedures at least annually. MelroseWakefield shall provide such revised policies and procedures to HHS for review and approval.
	**Minimum Content of the Policies and Procedures**
	The Policies and Procedures shall include, but not be limited to:
	Obligations under 45 C.F.R. § 164.524 to ensure accurate and timely responses to requests from individuals or their personal representatives for access to inspect or obtain a copy of protected health information (PHI) about the individual.
		Protocols reasonably designed to verify the identity and authority of a personal representative for the purposes of a request for access to PHI, including provision describing what documentation, if any, is necessary to provide with the access request. Revise instructions or access request(s) forms consistent with the revised protocols.
		Upon receiving approval from HHS of any revised training protocol and materials, MelroseWakefield shall provide training on any revised training materials as set forth in the OCR-approved protocol
		Application of appropriate sanctions against MelroseWakefield workforce members who fail to comply with policies and procedures provided for in subparagraphs (1) and (2) above.
	**Reportable Events.**
	During the Compliance Term, MelroseWakefield shall promptly investigate upon receiving information that a workforce member may have failed to comply with the policies and procedures described in Section V.A.1., related to requests for access to PHI. If MelroseWakefield determines, after review and investigation, that a member of its workforce has failed to comply with these policies and procedures, MelroseWakefield shall notify HHS in writing within thirty (30) days and in the Annual Report, as set forth in Section VI.B.4. Such violations shall be known as Reportable Events. The report 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 MelroseWakefield 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.
	**Training**
	MelroseWakefield shall provide HHS with training materials per section V.C. above for all members of the workforce within sixty (60) days of the approval of its policies and procedures per section V.A.
		Upon receiving notice from HHS specifying any required changes, MelroseWakefield shall make the required changes and provide the revised training materials to HHS within thirty (30) days.
		Upon receiving approval from HHS of any revised training materials, MelroseWakefield shall provide training on any revised training materials for each workforce member whose primary job function relate to requests for access within sixty (60) days of HHS approval and annually thereafter. MelroseWakefield shall also provide such training to each new member of the workforce whose primary job function relate to requests for access within thirty (30) days of their beginning of service.
		Each workforce member who is required to attend the 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.
		MelroseWakefield shall review the training and shall continue to provide 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.**VI. Implementation Report and Annual Reports**

**Implementation Report***.*
	Within one hundred and twenty (120) days after the receipt of HHS' approval of the policies and procedures required by section V.A.1, MelroseWakefield shall submit a written report to HHS and the Monitor 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 MelroseWakefield attesting that the Policies and Procedures are being implemented, have been distributed to all appropriate members of the workforce, and that MelroseWakefield has obtained all of the compliance certifications required by sections V.B.2. and V.B.3.;
		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 an owner or officer of MelroseWakefield attesting that all members of the workforce, whose primary job function relate to requests for access, have completed the initial training required by this CAP and have executed the training certifications required by section V.E.4.;
		An attestation signed by an owner or officer of MelroseWakefield 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 shall be known as a "Reporting Period." Within sixty (60) days after the close of the Reporting Period, MelroseWakefield shall submit a report or reports to HHS regarding MelroseWakefield's compliance with this CAP for the Reporting Period ("Annual Report"). The Annual Report shall include:
	A schedule, topic outline, and copies of the training materials for the training programs attended in accordance with this CAP during the Reporting Period that is the subject of the report;
		An attestation signed by an owner or officer of MelroseWakefield attesting that it is obtaining and maintaining written or electronic training certifications from all persons that require training that they received training pursuant to the requirements set forth in this CAP;
		An attestation signed by an officer or director of MelroseWakefield attesting that any revision(s) to the Policies and Procedures required by section V were finalized and adopted within thirty (30) days of HHS' approval of the revision(s), which shall include a statement affirming that MelroseWakefield distributed the revised Policies and Procedures to all appropriate members of MelroseWakefield's workforce within sixty (60) days of HHS' approval of the revision(s); and
		A summary of Reportable Events (defined in section V.D.) identified during the Reporting Period and the status of any corrective and preventative action relating to all such Reportable Events, or an attestation signed by an officer or director of MelroseWakefield stating that no Reportable Events occurred during the Compliance Term;
		An attestation signed by an owner or officer of MelroseWakefield 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**

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

**VIII.  Breach Provisions**

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

**Timely Written Requests for Extensions.**  MelroseWakefield 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) 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 MelroseWakefield constitutes a breach of the Agreement.  Upon a determination by HHS that MelroseWakefield has breached this CAP, HHS may notify MelroseWakefield of: (1) MelroseWakefield's breach; and (2) HHS' 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 any other conduct that constitutes a violation of the HIPAA Privacy, Security, or Breach Notification Rules ("Notice of Breach and Intent to Impose CMP").
	**MelroseWakefield's Response**.  MelroseWakefield shall have 30 days from the date of receipt of the Notice of Breach and Intent to Impose CMP to demonstrate to HHS' satisfaction that:
	MelroseWakefield 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 thirty (30) day period, but that: (a) MelroseWakefield has begun to take action to cure the breach; (b) MelroseWakefield is pursuing such action with due diligence; and (c) MelroseWakefield has provided to HHS a reasonable timetable for curing the breach.
	**Imposition of CMP**.  If at the conclusion of the thirty (30) day period, MelroseWakefield fails to meet the requirements of section VIII.C. of this CAP to HHS' satisfaction, HHS may proceed with the imposition of a CMP against MelroseWakefield 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 MelroseWakefield in writing of its determination to proceed with the imposition of a CMP pursuant to 45 C.F.R. §§ 160.312(a)(3)(i) and (ii).**For MelroseWakefield Healthcare, Inc. (MelroseWakefield)**

/s/

Charles R. Whipple, Esq.
General Counsel
MelroseWakefield Healthcare, Inc.

Date: 5/11/2022

**For Department of Health and Human Services**

/s/

Susan M. Pezzullo Rhodes
Regional Manager, New England Region
Office for Civil Rights

Date: 5/11/2022

                    
  


Content created by Office for Civil Rights (OCR) Content last reviewed June 13, 2023Back to top
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