Exhibit 2 to Schedule E HIPAA BAA.docx

DOCX document 48 KB Posted

Attached to
Behavioral Health and Substance Use Disorder Benefits Admin
Solicitation number
RFP 171 260000002410 2
Issued by
Michigan

About this file

This document is a HIPAA Business Associate Agreement (BAA) between the State of Michigan State Health Plan (Covered Entity) and a contractor to be named (Business Associate) for RFP No. 260000002410. The agreement establishes the terms and conditions under which the Business Associate will collect, receive, and handle Protected Health Information (PHI) on behalf of the State Health Plan in compliance with the Health Insurance Portability and Accountability Act of 1996 and applicable HIPAA Rules (45 CFR Parts 160 and 164). The contract covers behavioral health and substance use disorder benefits administration services and remains in effect until terminated or replaced with a new compliant agreement.

The Business Associate must implement comprehensive written information privacy and security programs that protect the confidentiality, integrity, and availability of PHI; report any unauthorized use, disclosure, or security incidents within five calendar days; ensure subcontractors execute substantially similar BAA provisions; maintain PHI for six years from creation or last use; and cooperate with the Covered Entity's inspections of facilities, systems, and records within thirty days of written request. The Covered Entity retains all ownership rights to PHI and may terminate the agreement for material breach if the Business Associate fails to cure non-performance within thirty days of written notice. Upon termination, the Business Associate must return or destroy PHI as directed and continue protecting any retained information. The agreement includes provisions for data aggregation, de-identification, limited data sets for research and public health purposes, and automatic amendments to maintain compliance with future HIPAA regulatory changes. Designated representatives and notice procedures are identified, with notices to be delivered by hand or certified mail deemed effective upon delivery or the third business day after mailing.

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EXHIBIT 2 to Schedule E – HIPAA BAA RFP No. 260000002410

HIPAA BUSINESS ASSOCIATE AGREEMENT

The parties to this Business Associate Agreement (“Agreement”) are the State of Michigan State Health Plan (“Covered Entity”) and [Insert Contractor Name] (“Business Associate”).

RECITALS

A.Under this Agreement, Business Associate will collect or receive certain information on the Covered Entity’s behalf, some of which may constitute Protected Health Information (“PHI”). In consideration of the receipt of PHI, Business Associate agrees to protect the privacy and security of the information as set forth in this Agreement.
B.Covered Entity and Business Associate intend to protect the privacy and provide for the security of PHI collected or received by Business Associate under the Agreement in compliance with the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and the HIPAA Rules, as amended.
C.The HIPAA Rules require the Covered Entity to enter into an agreement containing specific requirements with Business Associate before Business Associate’s receipt of PHI.

AGREEMENT

1.Definitions.
a.The following terms used in this Agreement have the same meaning as those terms in the HIPAA Rules: Breach; Data Aggregation; Designated Record Set; Disclosure; Health Care Obligations; Individual; Minimum Necessary; Notice of Privacy Practices; Protected Health Information; Required by Law; Secretary; Security Incident; Security Measures, Subcontractor; Unsecured Protected Health Information, and Use.
b.“Business Associate” has the same meaning as the term “business associate” at 45 CFR 160.103, and as used in this agreement refers to [Insert Contractor Name].
c.“Covered Entity” has the same meaning as the term “covered entity” at 45 CFR 160.103 and regarding this Agreement means the State of Michigan State Health Plan.
d.“HIPAA Rules” means the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.
2.Obligations of Business Associate.

Business Associate agrees to:

a. use and disclose PHI only as permitted or required by HIPAA and this Agreement or as required by law.

b. implement and use appropriate safeguards and comply with Subpart C of 45 CFR 164 regarding electronic protected health information, to prevent use or disclosure of PHI other than as provided in this Agreement. Business Associate must maintain, and provide a copy to the Covered Entity within 10 days of a request from the Covered Entity, a comprehensive written information privacy and security program that includes security measures that reasonably and appropriately protect the confidentiality, integrity, and availability of PHI relative to the size and complexity of Business Associate’s operations and the nature and the scope of its activities.

c.report to the Covered Entity within five (5) calendar days of any use or disclosure of PHI not provided for by the Agreement of which it becomes aware, including breaches of Unsecured Protected Health Information as required by 45 CFR 164.410, and any Security Incident of which it becomes aware. If Business Associate is responsible for any unauthorized use or disclosure of PHI, it must promptly act as required by applicable federal and State laws and regulations. Covered Entity and Business Associate will cooperate in investigating whether a breach has occurred, to decide how to provide breach notifications to individuals, the federal Health and Human Services’ Office for Civil Rights, and potentially the media.
d.ensure, according to 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, that any subcontractors that create, receive, maintain, or transmit PHI on behalf of Business Associate agree to the same restrictions, conditions, and requirements that apply to Business Associate regarding such information. Each subcontractor must sign an agreement with Business Associate containing substantially the same provisions as this Agreement. Business Associate must implement and maintain sanctions against subcontractors that violate such restrictions and conditions and must mitigate the effects of any such violation.
e.make available PHI in a Designated Record Set to the Covered Entity within ten (10) days of a request from the Covered Entity to satisfy the Covered Entity’s obligations under 45 CFR 164.524.
f.within ten (10) days of a request from the Covered Entity, amend PHI in a Designated Record Set under, 45 CFR § 164.526. If any individual requests an amendment of PHI directly from Business Associate or its agents or subcontractors, Business Associate must notify the Covered Entity in writing within five (5) days of the request and amend the information within ten (10) days of the request. Any denial of amendment of PHI maintained by Business Associate or its agents or subcontractors is the responsibility of Business Associate.
g.maintain, and within ten (10) days of a request from the Covered Entity make available, the information required to provide an accounting of disclosures to enable the Covered Entity to fulfill its obligations under 45 CFR § 164.528. Business Associate is not required to provide an accounting to the Covered Entity of disclosures: (i) to carry out treatment, payment or health care operations, as set forth in 45 CFR § 164.506; (ii) to individuals of PHI about them as set forth in 45 CFR § 164.502; (iii) under an authorization as provided in 45 CFR § 164.508; (iv) to persons involved in the individual’s care or other notification purposes as set forth in 45 CFR § 164.510; (v) for national security or intelligence purposes as set forth in 45 CFR § 164.512(k)(2); (vi) to correctional institutions or law enforcement officials as set forth in 45 CFR § 164.512(k)(5); (vii) as part of a limited data set according to 45 CFR 164.514(e); or (viii) that occurred before the compliance date for the Covered Entity. Business Associate agrees to implement a process that allows for an accounting to be collected and maintained by Business Associate and its agents or subcontractors for at least six (6) years before the request, but not before the compliance date of the Privacy Rule. At a minimum, such information must include: (i) the date of disclosure; (ii) the name of the entity or person who received PHI and, if known, the address of the entity or person; (iii) a brief description of PHI disclosed; and (iv) a brief statement of purpose of the disclosure that reasonably informs the individual of the basis for the disclosure or a copy of the written request for disclosure. If the request for an accounting is delivered directly to Business Associate or its agents or subcontractors, Business Associate must, within ten (10) days of the receipt of the request, forward it to the Covered Entity in writing.
h.to the extent Business Associate is to carry out one or more of the Covered Entity’s obligations under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to the Covered Entity when performing those obligations.
i.make its internal practices, books, and records relating to Business Associate’s use and disclosure of Covered Entity’s PHI available to the Secretary for purposes of determining compliance with the HIPAA Rules. Business Associate must concurrently provide to the Covered Entity a copy of any PHI that Business Associate provides to the Secretary.
j.retain all PHI throughout the term of the Agreement and for a period of six (6) years from the date of creation or the date when it last was in effect, whichever is later, or as required by law. This obligation survives the termination of the Agreement.
k.implement policies and procedures for the final disposition of PHI and the hardware and equipment on which it is stored, including but not limited to, removal of PHI before re-use.
l.within thirty (30) days of a written request by the Covered Entity, Business Associate and its agents or subcontractors must allow the Covered Entity to conduct a reasonable inspection of the facilities, systems, books, records, agreements, policies and procedures relating to the use or disclosure of PHI under this Agreement. Business Associate and the Covered Entity will mutually agree in advance upon the scope, timing and location of such an inspection. Covered Entity and Business Associate will execute a nondisclosure agreement, if requested by the other party. The fact that the Covered Entity inspects, or fails to inspect, or has the right to inspect, Business Associate’s facilities, systems, books, records, agreements, policies and procedures does not relieve Business Associate of its responsibility to comply with this Agreement. Covered Entity’s (i) failure to detect or (ii) detection, but failure to notify Business Associate or require Business Associate’s remediation of any unsatisfactory practices, does not constitute acceptance of such practice or a waiver of the Covered Entity’s enforcement rights under this Agreement.
3.Permitted Uses and Disclosures by the Business Associate.
a.Business Associate may use or disclose PHI:

(1) for the proper management and administration of Business Associate or to carry out its legal responsibilities; provided, however, either (A) the disclosures are required by law, or (B) Business Associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached;

(2) as required by law;

(3) for Data Aggregation services relating to the health care operations of the Covered Entity;

(4) to de-identify, consistent with 45 CFR 164.514(a) – (c), PHI it receives from the Covered Entity. If Business Associates de-identifies the PHI it receives from the Covered Entity, Business Associate may use the de-identified information for any purpose not prohibited by the HIPAA Rules; and

(5) In conformance with the provisions and requirements set forth in HIPAA, Business Associate may use PHI to create De-Identified Health Information and Limited Data Sets containing the minimum necessary amount of PHI reasonably needed for Research, Public Health or Health Care Operations activities; and

(6) may use and disclose a Limited Data Set for Research, Public Health or Health Care Operations purposes. Business Associate may make such use and disclosure of the Limited Data Set after any cancellation, termination, expiration, or other conclusion of the underlying agreement between Business Associate and Covered Entity.

b.Business Associate agrees to make uses and disclosures and requests for PHI consistent with the Covered Entity’s minimum necessary policies and procedures.
c.Business Associate may not use or disclose PHI in a manner that would violate Subpart E of 45 CFR Part 164 if done by the Covered Entity except for the specific uses and disclosures described above in 3(a)(i) and (iii).
4.Covered Entity’s Obligations

Covered Entity agrees to:

a. use its Security Measures to reasonably and appropriately maintain and ensure the confidentiality, integrity, and availability of PHI transmitted to Business Associate under this Agreement until the PHI is received by Business Associate.

b. provide Business Associate with a copy of its Notice of Privacy Practices and must notify Business Associate of any limitations in the Notice of Privacy Practices of the Covered Entity under 45 CFR 164.520 to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

c. notify Business Associate of any changes in, or revocation of, the permission by an individual to use or disclose the individual’s PHI to the extent that such changes may affect Business Associate’s use or disclosure of PHI.

d. notify Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522 to the extent that such restriction may affect Business Associate’s use or disclosure of PHI.

e. Covered Entity shall ensure that the data it transmits, or direct another entity to transmit, to Business Associate, is timely, complete, minimum necessary and accurate, contains no social security numbers.

5.Term. This Agreement continues in effect until terminated or is replaced with a new agreement between the parties containing provisions meeting the requirements of the HIPAA Rules, whichever first occurs.
6.Termination.
a.Material Breach. In addition to any other provisions in the Agreement regarding breach, a breach by Business Associate of any provision of this Agreement, as determined by the Covered Entity, constitutes a material breach of the Agreement and provides grounds for Covered Entity to terminate this Agreement for cause.

Termination for cause is subject to 6.b:

(1)Default. If Business Associate refuses or fails to timely perform any of the provisions of this Agreement, the Covered Entity may notify Business Associate in writing of the non-performance, and if not corrected within 30 days, Covered Entity may immediately terminate the Agreement. Business Associate must continue performance of the Agreement to the extent it is not terminated.
(2)Business Associate’s Duties. Notwithstanding termination of the Agreement, and subject to any directions from the Covered Entity, Business Associate must protect and preserve property in the possession of Business Associate in which the Covered Entity has an interest.
(3)Erroneous Termination for Default. If Covered Entity terminates this Agreement under Section 6(a) and after such termination it is determined, for any reason, that Business Associate was not in default, then such termination will be treated as a termination for convenience, and the rights and obligations of the parties will be the same as if the Agreement had been terminated for convenience.
b.Reasonable Steps to Cure Breach. If the Covered Entity knows of a pattern of activity or practice of Business Associate that constitutes a material breach or violation of Business Associate’s obligations under the provisions of this Agreement or another arrangement and does not terminate this Agreement under Section 6(a), then Covered Entity must notify Business Associate of the pattern of activity or practice. Business Associate must then take reasonable steps to cure such breach or end such violation, as applicable. If the Business Associate’s efforts to cure such breach or end such violation are unsuccessful, Covered Entity may either (i) terminate this Agreement, if feasible or (ii) report Business Associate’s breach or violation to the Secretary.
c.Effect of Termination. After termination of this Agreement for any reason, Business Associate, with respect to PHI it received from the Covered Entity, or PHI created, maintained, or received by Business Associate on behalf of the Covered Entity, must:

(1) retain only that PHI which is necessary for Business Associate to continue its proper management and administration or to carry out its legal responsibilities;

(2) return to Covered Entity (or, if agreed to by the Covered Entity in writing, destroy) the remaining PHI that Business Associate still maintains in any form;

(3) continue to use appropriate safeguards and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information to prevent use or disclosure of the PHI, other than as provided for in this Section, for as long as Business Associate retains the PHI;

(4) not use or disclose the PHI retained by Business Associate other than for the purposes for which such PHI was retained and subject to the same conditions set out at Section 3(a)(1) which applied before termination; and

(5) return to Covered Entity (or, if agreed to by Covered Entity in writing, destroy) the PHI retained by Business Associate when it is no longer needed by Business Associate for its proper management and administration or to carry out its legal responsibilities.

7.No Waiver of Immunity. The parties do not intend to waive any of the immunities, rights, benefits, protection, or other provisions of the Michigan Governmental Immunity Act, MCL 691.1401, et seq., the Federal Tort Claims Act, 28 U.S.C. 2671 et seq., or the common law.
8.Data Ownership. Business Associate has no ownership rights in the PHI. Covered Entity retains all ownership rights of the PHI.
9.Disclaimer. Covered Entity does not warrant or represent that compliance by Business Associate with this Agreement, HIPAA, or the HIPAA Rules will be adequate or satisfactory for Business Associate’s own purposes. Business Associate is solely responsible for all decisions made by Business Associate regarding the safeguarding of PHI.
10.Certification. If Covered Entity determines an examination is necessary to comply with Covered Entity’s legal obligations under HIPAA relating to certification of its security practices, Covered Entity or its authorized agents or contractors may, at Covered Entity’s expense, examine Business Associate’s facilities, systems, procedures and records as may be necessary for such agents or contractors to certify to Covered Entity the extent to which Business Associate’s security safeguards comply with HIPAA, the HIPAA Rules or this Agreement.
11.Amendment. Upon the compliance date of any final regulation or amendment to final regulations with respect to PHI, Standard Transactions, the security of electronic PHI, or other aspects of HIPAA applicable to this Agreement or to the ASC, this Agreement will automatically amend such that the obligations imposed on Covered Entity and Business Associate remain in compliance with such regulations.
12.Assistance in Litigation or Administrative Proceedings. Business Associate must make itself, and any subcontractors, employees or agents assisting Business Associate in the performance of its obligations under this Agreement, available to Covered Entity at no cost to Covered Entity to testify as witnesses, or otherwise, if litigation or administrative proceedings are commenced against Covered Entity, its directors, officers or employees, departments, agencies, or divisions based upon a claimed violation of HIPAA or the HIPAA Rules or other laws relating to Business Associate’s or its subcontractors’ use or disclosure of PHI under this Agreement, except where Business Associate or its subcontractor, employee or agent is a named adverse party.
13.No Third-Party Beneficiaries. Nothing express or implied in this Agreement is intended to confer upon any person other than the Covered Entity, Business Associate, and their respective successors or assigns, any rights, remedies, obligations or liabilities whatsoever.
14.Interpretation and Order of Precedence. Any ambiguity in this Agreement must be interpreted to permit compliance with the HIPAA Rules. In the event of any conflict between the mandatory provisions of the HIPAA Regulations and the HITECH Act and the provisions of this Agreement, the HIPAA Regulations and the HITECH Act shall control. Where the provisions of this Agreement differ from those mandated by the HIPAA Rules, but are nonetheless permitted by the HIPAA Rules, the provisions of this Agreement control.
15.Effective Date. This Agreement is effective upon receipt of the last approval necessary and the affixing of the last signature required.
16.Survival of Certain Agreement Terms. Notwithstanding any contrary provision in this Agreement, Business Associate’s obligations under Section 6(c) and record retention laws (“Effect of Termination”) and Section 13 (“No Third Party Beneficiaries”) survive termination of this Agreement and are enforceable by Covered Entity.
17.Representatives and Notice.
a.Representatives. The individuals listed below are designated as the parties’ respective representatives for purposes of this Agreement. Either party may from time to time designate in writing new or substitute representatives.
b.Notices. All required notices must be in writing and must be hand delivered or given by certified or registered mail to the representatives at the addresses set forth below.

Covered Entity Representative:

Bethany C. Beauchine Bureau of Benefits Administration Director Michigan Civil Service Commission P.O. Box 30002 Lansing, MI 48909 517-284-0086 beauchineb@michigan.gov with copy to:

Mary Ostrowski Category Specialist, Services

DTMB CPS

525 W Allegan St Lansing, MI 48933

(517) 249-0438 ostrowskim@michigan.gov Business Associate Representative:

Name:

Title:

Department:

Address:

Phone:

Email:

Any notice given to a party under this Agreement shall be deemed effective, if addressed to such party, upon: (i) delivery, if hand delivered; or (ii) the third Business Day after being sent by certified or registered mail.

Covered Entity State of Michigan State Health Plan Business Associate [Insert Contractor Name]

By: _______________________________

Date: _____________________________

By: ________________________________

Date: _______________________________

Print Name: _______________________

Print Name: _______________________

Title: _____________________________

Title: ______________________________

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