OCR Settles Thirteenth Investigation in to HIPAA Right of Access
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RESOLUTION AGREEMENT
I. Recitals
1. Parties. The Parties to this Resolution Agreement (“Agreement”) are:
A. 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).
B. Peter Wrobel, M.D., P.C. dba Elite Primary Care (“Covered Entity”), which meets the
definition of “covered entity” under 45 C.F.R. § 160.103 and therefore is required to comply with the
HIPAA Rules.
C. HHS and the Covered Entity shall together be referred to herein as the “Parties.”
2. Factual Background and Covered Conduct
On April 22, 2019, OCR received a Records Access complaint from the Complainant against the
Covered Entity. On May 2, 2019, OCR provided technical assistance to the Covered Entity
regarding the Privacy Rule's access provision, and advised the Covered Entity to review the facts
of the Complainant’s request for access and provide the requested access swiftly if the request met
the requirements of the Privacy Rule. Subsequently, the Complainant made a written access
request for his medical records, which the Covered Entity received on June 5, 2019. On October
9, 2019, OCR received a second complaint from the Complainant, alleging that the Covered Entity
continued to deny his Right of Access. On November 21, 2019, the Covered Entity sent the
Complainant’s medical records to the Complainant’s new healthcare provider. The Covered Entity
provided the Complainant with his medical records on May 8, 2020. HHS’ investigation indicated
that the following conduct occurred (“Covered Conduct”):
The Covered Entity failed to timely respond to the Complainant’s access request. See 45 C.F.R. §
164.524.
3. No Admission. This Agreement is not an admission of liability by the Covered Entity.
4. No Concession. This Agreement is not a concession by HHS that the Covered Entity is
not in violation of the HIPAA Rules and not liable for civil money penalties.
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5. Intention of Parties to Effect Resolution. This Agreement is intended to resolve HHS
Transaction Number: 04-20-360277 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
6. Payment. HHS has agreed to accept, and the Covered Entity has agreed to pay HHS, the
amount of $36,000 (“Resolution Amount”). The Covered Entity agrees to pay the
Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14
by automated clearing house transaction pursuant to written instructions to be provided by
HHS.
7. Corrective Action Plan. The Covered Entity has entered into and agrees to comply with the
Corrective Action Plan (“CAP”), attached as Appendix A, which is incorporated into this
Agreement by reference. If the Covered Entity breaches the CAP, and fails to cure the
breach as set forth in the CAP, then the Covered Entity will be in breach of this Agreement
and HHS will not be subject to the Release set forth in paragraph II.8 of this Agreement.
8. Release by HHS. In consideration of and conditioned upon the Covered Entity’s
performance of its obligations under this Agreement, HHS releases the Covered Entity
from any actions it may have against the Covered Entity under the HIPAA Rules arising
out of or related to the Covered Conduct identified in paragraph I.2 of this Agreement.
HHS does not release the Covered Entity from, nor waive any rights, obligations, or causes
of action other than those arising out of or related to the Covered Conduct and referred to
in this paragraph. This release does not extend to actions that may be brought under section
1177 of the Social Security Act, 42 U.S.C. § 1320d-6.
9. Agreement by Released Parties. The Covered Entity shall not contest the validity of its
obligation to pay, nor the amount of, the Resolution Amount or any other obligations
agreed to under this Agreement. The Covered Entity waive 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.
10. Binding on Successors. This Agreement is binding on the Covered Entity and its
successors, heirs, transferees, and assigns.
11. 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.
12. 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.
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13. 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.
14. 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).
15. 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, the Covered Entity agrees that the time between the Effective Date of this
Agreement and the date the Agreement may be terminated by reason of the Covered
Entity’s breach, plus one-year thereafter, will not be included in calculating the six (6) year
statute of limitations applicable to the violations which are the subject of this Agreement.
The Covered Entity waives and will not plead any statute of limitations, laches, or similar
defenses to any administrative action relating to the Covered Conduct identified in
paragraph I.2 that is filed by HHS within the time period set forth above, except to the
extent that such defenses would have been available had an administrative action been filed
on the Effective Date of this Agreement.
16. Disclosure. HHS places no restriction on the publication of the Agreement. In addition,
HHS may be required to disclose material related to this Agreement to any person upon
request consistent with the applicable provisions of the Freedom of Information Act, 5
U.S.C. § 552, and its implementing regulations, 45 C.F.R. Part 5.
17. 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.
18. Authorizations. The individual(s) signing this Agreement on behalf of the Covered Entity
represents and warrants that they are authorized to execute this Agreement and bind the
Covered Entity, 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.
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For Peter Wrobel, M.D., P.C.
/s/ 12/16/2020
____________________________ ____________
Dr. Peter Wrobel, Owner-Physician Date
Peter Wrobel, M.D., P.C.
1720 Reynolds St.
Waycross, GA 31501
For U.S. Department of Health and Human Services
/s/ 12/17/2020
____________________________ _____________
Barbara Stampul Date
Acting Regional Manager, Southeast Region
Office for Civil Rights
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Appendix A
CORRECTIVE ACTION PLAN
BETWEEN THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
Peter Wrobel, M.D., P.C.
I. Preamble
Peter Wrobel, M.D., P.C. dba Elite Primary Care (“Covered Entity”) hereby enters into
this Corrective Action Plan (“CAP”) with the United States Department of Health and Human
Services, Office for Civil Rights (“HHS”). Contemporaneously with this CAP, the Covered Entity
is entering into the Agreement with HHS, and this CAP is incorporated by reference into the
Agreement as Appendix A. The Covered Entity enters into this CAP as part of 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
A. Contact Persons
The contact person for the Covered Entity regarding the implementation of this CAP and
for receipt and submission of notifications and reports (“the Covered Entity Contact”) is:
Dr. Peter Wrobel, Owner-Physician
Peter Wrobel, M.D., P.C.
1720 Reynolds St.
Waycross, GA 31501
(912) 283-1359
HHS has identified the following individual as its authorized representative and contact
person with whom the Covered Entity is to report information regarding the implementation of
this CAP:
Ms. Barbara Stampul, Acting Regional Manager
Office for Civil Rights, Southeast Region
Department of Health and Human Services
Sam Nunn Federal Building, Suite 16T70
61 Forsyth Street, S.W.
Atlanta, GA 30303
[email protected]
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Telephone: 404-562-2799
Facsimile: 404-562-7881
The Covered Entity and HHS agree to promptly notify each other of any changes in the contact
person or the other information provided above.
B. Proof of Submissions. Unless otherwise specified, all notifications and reports
required by this CAP may be made by anymeans, 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 the Covered Entity under this CAP shall begin on the Effective Date of this
CAP and end two (2) years from the Effective Date, unless HHS has notified the Covered Entity
under Section VIII hereof of its determination that the Covered Entity breached this CAP. In the
event of such a notification by HHS under Section VIII hereof, the Compliance Term shall not end
until HHS notifies the Covered Entity that it has determined that the breach has been cured. After
the Compliance Term ends, the Covered Entity shall still be obligated to: (a)submit the final Annual
Report as required by section VI; and (b) comply with the document retention requirement in
section VII. Nothing in this CAP isintended to eliminate or modify the Covered Entity’s obligation
to comply with the document retention requirements in 45 C.F.R. §§ 164.316(b) and 164.530(j).
IV. Time
In computing any period of time prescribed or allowed by this CAP, all days referred to
shall be calendar days. The day of the act, event, or default from which the designated period of
time begins to run shall not be included. The last day of the period so computed shall be included,
unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of
the next day which is not one of the aforementioned days.
V. Corrective Action Obligations
The Covered Entity agrees to the following:
A. Policies and Procedures
1. The Covered Entity 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”). The Covered Entity’s policies and procedures shall address, but not be limited
to, the Covered Conduct specified in paragraph I.2 of the Agreement.
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2. The Covered Entity 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, the
Covered Entity 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.
3. The Covered Entity shall implement such policies and procedures within thirty (30)
days of receipt of HHS’ approval.
B. Distribution and Updating of Policies and Procedures
1. The Covered Entity shall distribute the policies and procedures identified in section
V.A. to all members of the workforce 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.
2. The Covered Entity 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.
3. The Covered Entity shall assess, update, and revise, as necessary, the policies and
procedures at least annually or as needed. The Covered Entity shall provide such revised policies
and procedures to HHS for review and approval. Within thirty (30) days of the effective date of
any approved substantive revisions, the Covered Entity shall distribute such revised policies and
procedures to all members of its workforce and shall require new compliance certifications.
C. Minimum Content of Policies and Procedures
The Policies and Procedures shall include, but not be limited to:
1. Review and update as necessary the Covered Entity’s Designated Record Set Policy
contained within its Right of Access to PHI policy to ensure comprehensive responses to requests
for records.
2. Protocols for training all the Covered Entity’s workforce members that are involved
in receiving or fulfilling access requests as necessary and appropriate to ensure compliance with
the policies and procedures provided for in section V.A. above.
3. Application of appropriate sanctions against the Covered Entity workforce
members who fail to comply with policies and procedures provided for in subparagraph (1) above.
4. Review and update as necessary the Covered Entity’s Designated Record Set Policy
contained within its Right of Access to PHI policy to ensure the provision of a standard method
for requesting access for personal representatives versus individuals with whom the Covered
Entity is authorized to share PHI.
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D. Training
1. The Covered Entity shall provide HHS with training materials per section V.D.
above for all members of the workforce within sixty (60) days of the approval of its policies and
procedures per section V.A.
2. Upon receiving notice from HHS specifying any required changes, the Covered
Entity shall make the required changes and provide revised training materials to HHS within thirty
(30) days.
3. Upon receiving approval from HHS, the Covered Entity shall provide training for
each workforce member within sixty (60) days of HHS approval and at least every twelve (12)
months thereafter. The Covered Entity shall also provide such training to each new member of
the workforce within thirty (30) 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. The Covered Entity 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, and any other relevant developments.
E. Reportable Events
During the Compliance Term, the Covered Entity shall, upon receiving information that
a workforce member may have failed to comply with its access policies and procedures or a
business associate may have failed to comply with the provision of access requirements in its
business associate agreement with the Covered Entity, promptly investigate this matter. If the
Covered Entity determines, after review and investigation, that a member of its workforce has
failed to comply with these policies and procedures or a business associate has filed to comply
with the provision of access requirements in its business associate agreement, the Covered Entity
shall notify HHS in writing within thirty (30) days. Such violations shall be known as Reportable
Events. The report to shall include the following information:
1. A complete description of the event, including the relevant facts, the persons
involved, and the provision(s) of the policies and procedures implicated; and
2. A description of the actions taken and any further steps the Covered Entity plans to
take to address the matter to mitigate any harm, and to prevent it from recurring, including
application of appropriate sanctions against workforce members who failed to comply with its
Privacy Rule policies and procedures.
VI. Implementation Report and Annual Reports
A. Implementation Report.
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Within 120 days after the receipt of HHS’ approval of the policies and procedures
required by section V.A.1, the Covered Entity shall submit a written report to HHS summarizing
the status of its implementation of the requirements of this CAP. This report, known as the
“Implementation Report,” shall include:
1. An attestation signed by an owner or officer of the Covered Entity attesting that
the Policies and Procedures are being implemented, have been distributed to all appropriate
members of the workforce and that the Covered Entity has obtained all of the compliance
certifications required by section V.B.2. and V.B.3.;
2. 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;
3. An attestation signed by an owner or officer of the Covered Entity attesting that
all members of the workforce have completed the initial training required by this CAP and have
executed the training certifications required by section V.D.4.;
4. An attestation signed by an owner or officer of the Covered Entity stating that
he or she has reviewed the Implementation Report, has made a reasonable inquiry regarding its
content and believes that, upon such inquiry, the information is accurate and truthful.
F. 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) days after the close of each corresponding Reporting Period, the Covered Entity
shall submit a report or reports to HHS regarding the Covered Entity’s compliance with this CAP
for each corresponding Reporting Period (“Annual Report”). The Annual Report shall include:
1. A copy of the schedule, topic outline, and training materials for the training
programs provided during the Reporting Period that is the subject of the Annual Report;
2. An attestation signed by an officer or director of the Covered Entity attesting
that it is obtaining and maintaining written or electronic training certifications from all persons
who are required to attend training under this CAP;
3. An attestation signed by an officer or director of the Covered Entity 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 the Covered Entity distributed the revised Policies and Procedures to
all appropriate members of the Covered Entity’s workforce within sixty (60) days of HHS’
approval of the revision(s); and
4. A summary of Reportable Events (defined in section VII), if any, the status of
any corrective and preventative action(s) relating to all such Reportable Events, or an attestation
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signed by an officer or director of the Covered Entity stating that no Reportable Events occurred
during the Compliance Term.
5. An attestation signed by an owner or officer of the Covered Entity attesting that
he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and
believes that, upon such inquiry, the information is accurate and truthful.
VII. Document Retention
The Covered Entity shall maintain for inspection and copying, and shall provide to HHS,
upon request, all documents and records relating to compliance with this CAP for six (6) years
from the Effective Date.
VIII. Breach Provisions
The Covered Entity is expected to fully and timely comply with all provisions contained
in this CAP.
A. Timely Written Requests for Extensions. The Covered Entity may, in advance
of any due date set forth in this CAP, submit a timely written request for an
extension of time to perform any act required by this CAP. A “timely written
request” is defined as a request in writing received by HHS at least five (5)
days prior to the date such an act is required or due to be performed. This
requirement may be waived by HHS only.
B. Notice of Breach of this CAP and Intent to Impose CMP. The Parties agree
that a breach of this CAP by the Covered Entity constitutes a breach of the
Agreement. Upon a determination by HHS that the Covered Entity has breached
this CAP, HHS may notify the Covered Entity Contact of: (1) the Covered
Entity’s breach; and (2) HHS’ intent to impose a CMP pursuant to 45 C.F.R. Part
160, 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”).
C. The Covered Entity’s Response. If the Covered Entity is named in a Notice of
Breach and Intent to Impose CMP, the Covered Entity shall have thirty (30) days
from the date of receipt of the Notice of Breach and Intent to Impose CMP to
demonstrate to HHS’ satisfaction that:
1. The Covered Entity is in compliance with the obligations of the CAP
that HHS cited as the basis for the breach;
1. The alleged breach has been cured; or
2. The alleged breach cannot be cured within the thirty (30) day period,
but that the Covered Entity: (a) has begun to take action to cure the
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breach; (b) is pursuing such action with due diligence; and (c) has
provided to HHS a reasonable timetable for curing the breach.
D. Imposition of CMP. If at the conclusion of the thirty (30) day period, the
Covered Entity fails to meet the requirements of section IX.C. of this CAP to
HHS’ satisfaction, HHS may proceed with the imposition of a CMP against the
Covered Entity pursuant to the rights and obligations set forth in 45 C.F.R. Part
160 for any violations of the HIPAA Rules applicable to 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 the Covered Entity
Contact 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 Peter Wrobel, M.D., P.C.
/s/ 12/16/2020
___________________________ ________________________
Dr. Peter Wrobel, Owner-Physician Date
Peter Wrobel, M.D., P.C.
For U.S. Department of Health and Human Services
/s/ 12/17/2020
___________________________ ________________________
Barbara Stampul Date
Acting Regional Manager, Southeast Region
Office for Civil Rights
RESOLUTION AGREEMENT
I. Recitals
1. Parties. The Parties to this Resolution Agreement (“Agreement”) are:
A. 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).
B. Peter Wrobel, M.D., P.C. dba Elite Primary Care (“Covered Entity”), which meets the
definition of “covered entity” under 45 C.F.R. § 160.103 and therefore is required to comply with the
HIPAA Rules.
C. HHS and the Covered Entity shall together be referred to herein as the “Parties.”
2. Factual Background and Covered Conduct
On April 22, 2019, OCR received a Records Access complaint from the Complainant against the
Covered Entity. On May 2, 2019, OCR provided technical assistance to the Covered Entity
regarding the Privacy Rule's access provision, and advised the Covered Entity to review the facts
of the Complainant’s request for access and provide the requested access swiftly if the request met
the requirements of the Privacy Rule. Subsequently, the Complainant made a written access
request for his medical records, which the Covered Entity received on June 5, 2019. On October
9, 2019, OCR received a second complaint from the Complainant, alleging that the Covered Entity
continued to deny his Right of Access. On November 21, 2019, the Covered Entity sent the
Complainant’s medical records to the Complainant’s new healthcare provider. The Covered Entity
provided the Complainant with his medical records on May 8, 2020. HHS’ investigation indicated
that the following conduct occurred (“Covered Conduct”):
The Covered Entity failed to timely respond to the Complainant’s access request. See 45 C.F.R. §
164.524.
3. No Admission. This Agreement is not an admission of liability by the Covered Entity.
4. No Concession. This Agreement is not a concession by HHS that the Covered Entity is
not in violation of the HIPAA Rules and not liable for civil money penalties.
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5. Intention of Parties to Effect Resolution. This Agreement is intended to resolve HHS
Transaction Number: 04-20-360277 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
6. Payment. HHS has agreed to accept, and the Covered Entity has agreed to pay HHS, the
amount of $36,000 (“Resolution Amount”). The Covered Entity agrees to pay the
Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14
by automated clearing house transaction pursuant to written instructions to be provided by
HHS.
7. Corrective Action Plan. The Covered Entity has entered into and agrees to comply with the
Corrective Action Plan (“CAP”), attached as Appendix A, which is incorporated into this
Agreement by reference. If the Covered Entity breaches the CAP, and fails to cure the
breach as set forth in the CAP, then the Covered Entity will be in breach of this Agreement
and HHS will not be subject to the Release set forth in paragraph II.8 of this Agreement.
8. Release by HHS. In consideration of and conditioned upon the Covered Entity’s
performance of its obligations under this Agreement, HHS releases the Covered Entity
from any actions it may have against the Covered Entity under the HIPAA Rules arising
out of or related to the Covered Conduct identified in paragraph I.2 of this Agreement.
HHS does not release the Covered Entity from, nor waive any rights, obligations, or causes
of action other than those arising out of or related to the Covered Conduct and referred to
in this paragraph. This release does not extend to actions that may be brought under section
1177 of the Social Security Act, 42 U.S.C. § 1320d-6.
9. Agreement by Released Parties. The Covered Entity shall not contest the validity of its
obligation to pay, nor the amount of, the Resolution Amount or any other obligations
agreed to under this Agreement. The Covered Entity waive 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.
10. Binding on Successors. This Agreement is binding on the Covered Entity and its
successors, heirs, transferees, and assigns.
11. 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.
12. 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.
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13. 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.
14. 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).
15. 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, the Covered Entity agrees that the time between the Effective Date of this
Agreement and the date the Agreement may be terminated by reason of the Covered
Entity’s breach, plus one-year thereafter, will not be included in calculating the six (6) year
statute of limitations applicable to the violations which are the subject of this Agreement.
The Covered Entity waives and will not plead any statute of limitations, laches, or similar
defenses to any administrative action relating to the Covered Conduct identified in
paragraph I.2 that is filed by HHS within the time period set forth above, except to the
extent that such defenses would have been available had an administrative action been filed
on the Effective Date of this Agreement.
16. Disclosure. HHS places no restriction on the publication of the Agreement. In addition,
HHS may be required to disclose material related to this Agreement to any person upon
request consistent with the applicable provisions of the Freedom of Information Act, 5
U.S.C. § 552, and its implementing regulations, 45 C.F.R. Part 5.
17. 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.
18. Authorizations. The individual(s) signing this Agreement on behalf of the Covered Entity
represents and warrants that they are authorized to execute this Agreement and bind the
Covered Entity, 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.
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For Peter Wrobel, M.D., P.C.
/s/ 12/16/2020
____________________________ ____________
Dr. Peter Wrobel, Owner-Physician Date
Peter Wrobel, M.D., P.C.
1720 Reynolds St.
Waycross, GA 31501
For U.S. Department of Health and Human Services
/s/ 12/17/2020
____________________________ _____________
Barbara Stampul Date
Acting Regional Manager, Southeast Region
Office for Civil Rights
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Appendix A
CORRECTIVE ACTION PLAN
BETWEEN THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
Peter Wrobel, M.D., P.C.
I. Preamble
Peter Wrobel, M.D., P.C. dba Elite Primary Care (“Covered Entity”) hereby enters into
this Corrective Action Plan (“CAP”) with the United States Department of Health and Human
Services, Office for Civil Rights (“HHS”). Contemporaneously with this CAP, the Covered Entity
is entering into the Agreement with HHS, and this CAP is incorporated by reference into the
Agreement as Appendix A. The Covered Entity enters into this CAP as part of 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
A. Contact Persons
The contact person for the Covered Entity regarding the implementation of this CAP and
for receipt and submission of notifications and reports (“the Covered Entity Contact”) is:
Dr. Peter Wrobel, Owner-Physician
Peter Wrobel, M.D., P.C.
1720 Reynolds St.
Waycross, GA 31501
(912) 283-1359
HHS has identified the following individual as its authorized representative and contact
person with whom the Covered Entity is to report information regarding the implementation of
this CAP:
Ms. Barbara Stampul, Acting Regional Manager
Office for Civil Rights, Southeast Region
Department of Health and Human Services
Sam Nunn Federal Building, Suite 16T70
61 Forsyth Street, S.W.
Atlanta, GA 30303
[email protected]
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Telephone: 404-562-2799
Facsimile: 404-562-7881
The Covered Entity and HHS agree to promptly notify each other of any changes in the contact
person or the other information provided above.
B. Proof of Submissions. Unless otherwise specified, all notifications and reports
required by this CAP may be made by anymeans, 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 the Covered Entity under this CAP shall begin on the Effective Date of this
CAP and end two (2) years from the Effective Date, unless HHS has notified the Covered Entity
under Section VIII hereof of its determination that the Covered Entity breached this CAP. In the
event of such a notification by HHS under Section VIII hereof, the Compliance Term shall not end
until HHS notifies the Covered Entity that it has determined that the breach has been cured. After
the Compliance Term ends, the Covered Entity shall still be obligated to: (a)submit the final Annual
Report as required by section VI; and (b) comply with the document retention requirement in
section VII. Nothing in this CAP isintended to eliminate or modify the Covered Entity’s obligation
to comply with the document retention requirements in 45 C.F.R. §§ 164.316(b) and 164.530(j).
IV. Time
In computing any period of time prescribed or allowed by this CAP, all days referred to
shall be calendar days. The day of the act, event, or default from which the designated period of
time begins to run shall not be included. The last day of the period so computed shall be included,
unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of
the next day which is not one of the aforementioned days.
V. Corrective Action Obligations
The Covered Entity agrees to the following:
A. Policies and Procedures
1. The Covered Entity 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”). The Covered Entity’s policies and procedures shall address, but not be limited
to, the Covered Conduct specified in paragraph I.2 of the Agreement.
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2. The Covered Entity 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, the
Covered Entity 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.
3. The Covered Entity shall implement such policies and procedures within thirty (30)
days of receipt of HHS’ approval.
B. Distribution and Updating of Policies and Procedures
1. The Covered Entity shall distribute the policies and procedures identified in section
V.A. to all members of the workforce 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.
2. The Covered Entity 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.
3. The Covered Entity shall assess, update, and revise, as necessary, the policies and
procedures at least annually or as needed. The Covered Entity shall provide such revised policies
and procedures to HHS for review and approval. Within thirty (30) days of the effective date of
any approved substantive revisions, the Covered Entity shall distribute such revised policies and
procedures to all members of its workforce and shall require new compliance certifications.
C. Minimum Content of Policies and Procedures
The Policies and Procedures shall include, but not be limited to:
1. Review and update as necessary the Covered Entity’s Designated Record Set Policy
contained within its Right of Access to PHI policy to ensure comprehensive responses to requests
for records.
2. Protocols for training all the Covered Entity’s workforce members that are involved
in receiving or fulfilling access requests as necessary and appropriate to ensure compliance with
the policies and procedures provided for in section V.A. above.
3. Application of appropriate sanctions against the Covered Entity workforce
members who fail to comply with policies and procedures provided for in subparagraph (1) above.
4. Review and update as necessary the Covered Entity’s Designated Record Set Policy
contained within its Right of Access to PHI policy to ensure the provision of a standard method
for requesting access for personal representatives versus individuals with whom the Covered
Entity is authorized to share PHI.
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D. Training
1. The Covered Entity shall provide HHS with training materials per section V.D.
above for all members of the workforce within sixty (60) days of the approval of its policies and
procedures per section V.A.
2. Upon receiving notice from HHS specifying any required changes, the Covered
Entity shall make the required changes and provide revised training materials to HHS within thirty
(30) days.
3. Upon receiving approval from HHS, the Covered Entity shall provide training for
each workforce member within sixty (60) days of HHS approval and at least every twelve (12)
months thereafter. The Covered Entity shall also provide such training to each new member of
the workforce within thirty (30) 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. The Covered Entity 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, and any other relevant developments.
E. Reportable Events
During the Compliance Term, the Covered Entity shall, upon receiving information that
a workforce member may have failed to comply with its access policies and procedures or a
business associate may have failed to comply with the provision of access requirements in its
business associate agreement with the Covered Entity, promptly investigate this matter. If the
Covered Entity determines, after review and investigation, that a member of its workforce has
failed to comply with these policies and procedures or a business associate has filed to comply
with the provision of access requirements in its business associate agreement, the Covered Entity
shall notify HHS in writing within thirty (30) days. Such violations shall be known as Reportable
Events. The report to shall include the following information:
1. A complete description of the event, including the relevant facts, the persons
involved, and the provision(s) of the policies and procedures implicated; and
2. A description of the actions taken and any further steps the Covered Entity plans to
take to address the matter to mitigate any harm, and to prevent it from recurring, including
application of appropriate sanctions against workforce members who failed to comply with its
Privacy Rule policies and procedures.
VI. Implementation Report and Annual Reports
A. Implementation Report.
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Within 120 days after the receipt of HHS’ approval of the policies and procedures
required by section V.A.1, the Covered Entity shall submit a written report to HHS summarizing
the status of its implementation of the requirements of this CAP. This report, known as the
“Implementation Report,” shall include:
1. An attestation signed by an owner or officer of the Covered Entity attesting that
the Policies and Procedures are being implemented, have been distributed to all appropriate
members of the workforce and that the Covered Entity has obtained all of the compliance
certifications required by section V.B.2. and V.B.3.;
2. 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;
3. An attestation signed by an owner or officer of the Covered Entity attesting that
all members of the workforce have completed the initial training required by this CAP and have
executed the training certifications required by section V.D.4.;
4. An attestation signed by an owner or officer of the Covered Entity stating that
he or she has reviewed the Implementation Report, has made a reasonable inquiry regarding its
content and believes that, upon such inquiry, the information is accurate and truthful.
F. 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) days after the close of each corresponding Reporting Period, the Covered Entity
shall submit a report or reports to HHS regarding the Covered Entity’s compliance with this CAP
for each corresponding Reporting Period (“Annual Report”). The Annual Report shall include:
1. A copy of the schedule, topic outline, and training materials for the training
programs provided during the Reporting Period that is the subject of the Annual Report;
2. An attestation signed by an officer or director of the Covered Entity attesting
that it is obtaining and maintaining written or electronic training certifications from all persons
who are required to attend training under this CAP;
3. An attestation signed by an officer or director of the Covered Entity 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 the Covered Entity distributed the revised Policies and Procedures to
all appropriate members of the Covered Entity’s workforce within sixty (60) days of HHS’
approval of the revision(s); and
4. A summary of Reportable Events (defined in section VII), if any, the status of
any corrective and preventative action(s) relating to all such Reportable Events, or an attestation
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signed by an officer or director of the Covered Entity stating that no Reportable Events occurred
during the Compliance Term.
5. An attestation signed by an owner or officer of the Covered Entity attesting that
he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and
believes that, upon such inquiry, the information is accurate and truthful.
VII. Document Retention
The Covered Entity shall maintain for inspection and copying, and shall provide to HHS,
upon request, all documents and records relating to compliance with this CAP for six (6) years
from the Effective Date.
VIII. Breach Provisions
The Covered Entity is expected to fully and timely comply with all provisions contained
in this CAP.
A. Timely Written Requests for Extensions. The Covered Entity may, in advance
of any due date set forth in this CAP, submit a timely written request for an
extension of time to perform any act required by this CAP. A “timely written
request” is defined as a request in writing received by HHS at least five (5)
days prior to the date such an act is required or due to be performed. This
requirement may be waived by HHS only.
B. Notice of Breach of this CAP and Intent to Impose CMP. The Parties agree
that a breach of this CAP by the Covered Entity constitutes a breach of the
Agreement. Upon a determination by HHS that the Covered Entity has breached
this CAP, HHS may notify the Covered Entity Contact of: (1) the Covered
Entity’s breach; and (2) HHS’ intent to impose a CMP pursuant to 45 C.F.R. Part
160, 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”).
C. The Covered Entity’s Response. If the Covered Entity is named in a Notice of
Breach and Intent to Impose CMP, the Covered Entity shall have thirty (30) days
from the date of receipt of the Notice of Breach and Intent to Impose CMP to
demonstrate to HHS’ satisfaction that:
1. The Covered Entity is in compliance with the obligations of the CAP
that HHS cited as the basis for the breach;
1. The alleged breach has been cured; or
2. The alleged breach cannot be cured within the thirty (30) day period,
but that the Covered Entity: (a) has begun to take action to cure the
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breach; (b) is pursuing such action with due diligence; and (c) has
provided to HHS a reasonable timetable for curing the breach.
D. Imposition of CMP. If at the conclusion of the thirty (30) day period, the
Covered Entity fails to meet the requirements of section IX.C. of this CAP to
HHS’ satisfaction, HHS may proceed with the imposition of a CMP against the
Covered Entity pursuant to the rights and obligations set forth in 45 C.F.R. Part
160 for any violations of the HIPAA Rules applicable to 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 the Covered Entity
Contact 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 Peter Wrobel, M.D., P.C.
/s/ 12/16/2020
___________________________ ________________________
Dr. Peter Wrobel, Owner-Physician Date
Peter Wrobel, M.D., P.C.
For U.S. Department of Health and Human Services
/s/ 12/17/2020
___________________________ ________________________
Barbara Stampul Date
Acting Regional Manager, Southeast Region
Office for Civil Rights
