Minnesota Legislature
HF 3279
1st Committee Engrossment - 86th Legislature (2009 - 2010) Posted on 03/19/2013 07:29pm
KEY: stricken = removed, old language.
underscored = added, new language.
1.2relating to health; amending provisions for electronic health record technology;
1.3providing for administrative penalties; appropriating money;amending
1.4Minnesota Statutes 2009 Supplement, section 62J.495, subdivisions 1a, 3;
1.5proposing coding for new law in Minnesota Statutes, chapter 62J.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. Minnesota Statutes 2009 Supplement, section 62J.495, subdivision 1a,
1.8is amended to read:
1.9 Subd. 1a. Definitions. (a) "Certified electronic health record technology" means an
1.10electronic health record that is certified pursuant to section 3001(c)(5) of the HITECH
1.11Act to meet the standards and implementation specifications adopted under section 3004
1.12as applicable.
1.13(b) "Commissioner" means the commissioner of health.
1.14(c) "Pharmaceutical electronic data intermediary" means any entity that provides
1.15the infrastructure to connect computer systems or other electronic devices utilized
1.16by prescribing practitioners with those used by pharmacies, health plans, third-party
1.17administrators, and pharmacy benefit managers in order to facilitate the secure
1.18transmission of electronic prescriptions, refill authorization requests, communications,
1.19and other prescription-related information between such entities.
1.20(d) "HITECH Act" means the Health Information Technology for Economic and
1.21Clinical Health Act in division A, title XIII and division B, title IV of the American
1.22Recovery and Reinvestment Act of 2009, including federal regulations adopted under
1.23that act.
1.24(e) "Interoperable electronic health record" means an electronic health record that
1.25securely exchanges health information with another electronic health record system that
2.1meets requirements specified in subdivision 3, and national requirements for certification
2.2under the HITECH Act.
2.3(f) "Qualified electronic health record" means an electronic record of health-related
2.4information on an individual that includes patient demographic and clinical health
2.5information and has the capacity to:
2.6(1) provide clinical decision support;
2.7(2) support physician order entry;
2.8(3) capture and query information relevant to health care quality; and
2.9(4) exchange electronic health information with, and integrate such information
2.10from, other sources.
2.11 Sec. 2. Minnesota Statutes 2009 Supplement, section 62J.495, subdivision 3, is
2.12amended to read:
2.13 Subd. 3. Interoperable electronic health record requirements. To meet the
2.14requirements of subdivision 1, hospitals and health care providers must meet the following
2.15criteria when implementing an interoperable electronic health records system within their
2.16hospital system or clinical practice setting.
2.17(a) The electronic health record must be a qualified electronic health record.
2.18 (b) The electronic health record must be certified by the Office of the National
2.19Coordinator pursuant to the HITECH Act. This criterion only applies to hospitals and
2.20health care providersonly if a certified electronic health record product for the provider's
2.21particular practice setting is available. This criterion shall be considered met if a hospital
2.22or health care provider is using an electronic health records system that has been certified
2.23within the last three years, even if a more current version of the system has been certified
2.24within the three-year period.
2.25(c) The electronic health record must meet the standards established according to
2.26section 3004 of the HITECH Act as applicable.
2.27(d) The electronic health record must have the ability to generate information on
2.28clinical quality measures and other measures reported under sections 4101, 4102, and
2.294201 of the HITECH Act.
2.30(e) The electronic health record system must be connected to a state-certified
2.31health information organization either directly or through a connection facilitated by a
2.32state-certified health data intermediary as defined in section 62J.498.
2.33(e) (f) A health care provider who is a prescriber or dispenser of legend drugs must
2.34have an electronic health record system that meets the requirements of section62J.497 .
3.1 Sec. 3. [62J.498] HEALTH INFORMATION EXCHANGE.
3.2 Subdivision 1. Definitions. The following definitions apply to sections 62J.498 to
3.362J.4982:
3.4(a) "Clinical transaction" means any meaningful use transaction that is not covered
3.5by section 62J.536.
3.6(b) "Commissioner" means the commissioner of health.
3.7(c) "Direct health information exchange" means the electronic transmission of
3.8health-related information through a direct connection between the electronic health
3.9record systems of health care providers without the use of a health data intermediary.
3.10(d) "Health care provider" or "provider" means a health care provider or provider as
3.11defined in section 62J.03, subdivision 8.
3.12(e) "Health data intermediary" means an entity that provides the infrastructure to
3.13connect computer systems or other electronic devices used by health care providers,
3.14laboratories, pharmacies, health plans, third-party administrators, or pharmacy benefit
3.15managers to facilitate the secure transmission of health information, including
3.16pharmaceutical electronic data intermediaries as defined in section 62J.495. This does not
3.17include health care providers engaged in direct health information exchange.
3.18(f) "Health information exchange" means the electronic transmission of
3.19health-related information between organizations according to nationally recognized
3.20standards.
3.21(g) "Health information exchange service provider" means a health data intermediary
3.22or health information organization that has been issued a certificate of authority by the
3.23commissioner under section 62J.4981.
3.24(h) "Health information organization" means an organization that oversees, governs,
3.25and facilitates the exchange of health-related information among organizations according
3.26to nationally recognized standards.
3.27(i) "HITECH Act" means the Health Information Technology for Economic and
3.28Clinical Health Act as defined in section 62J.495.
3.29(j) "Major participating entity" means:
3.30(1) a participating entity that receives compensation for services that is greater
3.31than 30 percent of the health information organization's gross annual revenues from the
3.32health information exchange service provider;
3.33(2) a participating entity providing administrative, financial, or management services
3.34to the health information organization, if the total payment for all services provided by the
3.35participating entity exceeds three percent of the gross revenue of the health information
3.36organization; and
4.1(3) a participating entity that nominates or appoints 30 percent or more of the board
4.2of directors of the health information organization.
4.3(k) "Meaningful use" means use of certified electronic health record technology that
4.4includes e-prescribing, and is connected in a manner that provides for the electronic
4.5exchange of health information and used for the submission of clinical quality measures
4.6as established by the Center for Medicare and Medicaid Services and the Minnesota
4.7Department of Human Services pursuant to sections 4101, 4102, and 4201 of the HITECH
4.8Act.
4.9(l) "Meaningful use transaction" means an electronic transaction that a health care
4.10provider must exchange to receive Medicare or Medicaid incentives or avoid Medicare
4.11penalties pursuant to sections 4101, 4102, and 4201 of the HITECH Act.
4.12(m) "Participating entity" means any of the following persons, health care providers,
4.13companies, or other organizations with which a health information organization or health
4.14data intermediary has contracts or other agreements for the provision of health information
4.15exchange service providers:
4.16(1) a health care facility licensed under sections 144.50 to 144.56, a nursing home
4.17licensed under sections 144A.02 to 144A.10, and any other health care facility otherwise
4.18licensed under the laws of this state or registered with the commissioner;
4.19(2) a health care provider, and any other health care professional otherwise licensed
4.20under the laws of this state or registered with the commissioner;
4.21(3) a group, professional corporation, or other organization that provides the
4.22services of individuals or entities identified in clause (2), including but not limited to a
4.23medical clinic, a medical group, a home health care agency, an urgent care center, and
4.24an emergent care center;
4.25(4) a health plan as defined in section 62A.011, subdivision 3; and
4.26(5) a state agency as defined in section 13.02, subdivision 17.
4.27(n) "Reciprocal agreement" means an arrangement in which two or more health
4.28information exchange service providers agree to share in-kind services and resources to
4.29allow for the pass-through of meaningful use transactions.
4.30(o) "State-certified health data intermediary" means a health data intermediary that:
4.31(1) provides a subset of the meaningful use transaction capabilities necessary for
4.32hospitals and providers to achieve meaningful use of electronic health records;
4.33(2) is not exclusively engaged in the exchange of meaningful use transactions
4.34covered by section 62J.536; and
4.35(3) has been issued a certificate of authority to operate in Minnesota.
5.1(p) "State-certified health information organization" means a nonprofit health
5.2information organization that provides transaction capabilities necessary to fully support
5.3clinical transactions required for meaningful use of electronic health records that has been
5.4issued a certificate of authority to operate in Minnesota.
5.5 Subd. 2. Health information exchange oversight. (a) The commissioner shall
5.6protect the public interest on matters pertaining to health information exchange. The
5.7commissioner shall:
5.8(1) review and act on applications from health data intermediaries and health
5.9information organizations for certificates of authority to operate in Minnesota;
5.10(2) provide ongoing monitoring to ensure compliance with criteria established under
5.11sections 62J.498 to 62J.4982;
5.12(3) respond to public complaints related to health information exchange services;
5.13(4) take enforcement actions as necessary, including the imposition of fines,
5.14suspension, or revocation of certificates of authority as outlined in section 62J.4982;
5.15(5) provide a biannual report on the status of health information exchange services
5.16that includes but is not limited to:
5.17(i) recommendations on actions necessary to ensure that health information exchange
5.18services are adequate to meet the needs of Minnesota citizens and providers statewide;
5.19(ii) recommendations on enforcement actions to ensure that health information
5.20exchange service providers act in the public interest without causing disruption in health
5.21information exchange services;
5.22(iii) recommendations on updates to criteria for obtaining certificates of authority
5.23under this section; and
5.24(iv) recommendations on standard operating procedures for health information
5.25exchange, including but not limited to the management of consumer preferences;
5.26(6) other duties necessary to protect the public interest.
5.27(b) As part of the application review process for certification under paragraph (a),
5.28prior to issuing a certificate of authority, the commissioner shall:
5.29(1) hold public hearings that provide an adequate opportunity for participating
5.30entities and consumers to provide feedback and recommendations on the application under
5.31consideration. The commissioner shall make all portions of the application classified
5.32as public data available to the public at least ten days in advance of the hearing. The
5.33applicant shall participate in the hearing by presenting an overview of their application
5.34and responding to questions from interested parties;
5.35(2) make available all feedback and recommendations from the hearing available to
5.36the public prior to issuing a certificate of authority; and
6.1(3) consult with hospitals, physicians, and other professionals eligible to receive
6.2meaningful use incentive payments or subject to penalties as established in the HITECH
6.3Act, and their respective statewide associations, prior to issuing a certificate of authority.
6.4(c)(1) When the commissioner is actively considering a suspension or revocation of
6.5a certificate of authority as described in section 62J.4982, subdivision 3, all investigatory
6.6data that are collected, created, or maintained related to the suspension or revocation
6.7are classified as confidential data on individuals and as protected nonpublic data in the
6.8case of data not on individuals.
6.9(2) The commissioner may disclose data classified as protected nonpublic or
6.10confidential under this paragraph if disclosing the data will protect the health or safety of
6.11patients.
6.12(d) After the commissioner makes a final determination regarding a suspension or
6.13revocation of a certificate of authority, all minutes, orders for hearing, findings of fact,
6.14conclusions of law, and the specification of the final disciplinary action, are classified
6.15as public data.
6.16 Sec. 4. [62J.4981] CERTIFICATE OF AUTHORITY TO PROVIDE HEALTH
6.17INFORMATION EXCHANGE SERVICES.
6.18 Subdivision 1. Authority to require organizations to apply. The commissioner
6.19shall require an entity providing health information exchange services to apply for a
6.20certificate of authority under this section. An applicant may continue to operate until
6.21the commissioner acts on the application. If the application is denied, the applicant is
6.22considered a health information organization whose certificate of authority has been
6.23revoked under section 62J.4982, subdivision 2, paragraph (d).
6.24 Subd. 2. Certificate of authority for health data intermediaries. (a) A health
6.25data intermediary that provides health information exchange services for the transmission
6.26of one or more clinical transactions necessary for hospitals, providers, or eligible
6.27professionals to achieve meaningful use must be registered with the state and comply with
6.28requirements established in this section.
6.29(b) Notwithstanding any law to the contrary, any corporation organized to do so
6.30may apply to the commissioner for a certificate of authority to establish and operate as
6.31a health data intermediary in compliance with this section. No person shall establish or
6.32operate a health data intermediary in this state, nor sell or offer to sell, or solicit offers
6.33to purchase or receive advance or periodic consideration in conjunction with a health
6.34data intermediary contract unless the organization has a certificate of authority or has an
6.35application under active consideration under this section.
7.1(c) In issuing the certificate of authority, the commissioner shall determine whether
7.2the applicant for the certificate of authority has demonstrated that the applicant meets
7.3the following minimum criteria:
7.4(1) interoperate with at least one state-certified health information organization;
7.5(2) provide an option for Minnesota entities to connect to their services through at
7.6least one state-certified health information organization;
7.7(3) have a record locator service as defined in section 144.291, subdivision 2,
7.8paragraph (i), that is compliant with the requirements of section 144.293, subdivision 8,
7.9when conducting meaningful use transactions; and
7.10(4) hold reciprocal agreements with at least one state-certified health information
7.11organization to enable access to record locator services to find patient data, and for the
7.12transmission and receipt of meaningful use transactions consistent with the format and
7.13content required by national standards established by Centers for Medicare and Medicaid
7.14Services. Reciprocal agreements must meet the requirements established in subdivision 5.
7.15 Subd. 3. Certificate of authority for health information organizations.
7.16(a) A health information organization that provides all electronic capabilities for the
7.17transmission of clinical transactions necessary for meaningful use of electronic health
7.18records must obtain a certificate of authority from the commissioner and demonstrate
7.19compliance with the criteria in paragraph (c).
7.20(b) Notwithstanding any law to the contrary, a nonprofit corporation organized to do
7.21so may apply for a certificate of authority to establish and operate a health information
7.22organization under this section. No person shall establish or operate a health information
7.23organization in this state, nor sell or offer to sell, or solicit offers to purchase or receive
7.24advance or periodic consideration in conjunction with a health information organization
7.25or health information contract unless the organization has a certificate of authority under
7.26this section.
7.27(c) In issuing the certificate of authority, the commissioner shall determine whether
7.28the applicant for the certificate of authority has demonstrated that the applicant meets
7.29the following minimum criteria:
7.30(1) the entity is a legally established, nonprofit organization;
7.31(2) appropriate insurance, including liability insurance, for the operation of the
7.32health information organization is in place and sufficient to protect the interest of the
7.33public and participating entities;
7.34(3) strategic and operational plans clearly address how the organization will expand
7.35technical capacity of the health information organization to support providers in achieving
7.36meaningful use of electronic health records over time;
8.1(4) the entity addresses the parameters to be used with participating entities and
8.2other health information organizations for meaningful use transactions, compliance with
8.3Minnesota law, and interstate health information exchange in trust agreements;
8.4(5) the entity's board of directors is comprised of members that broadly represent the
8.5health information organization's participating entities and consumers;
8.6(6) the entity maintains a professional staff responsible to the board of directors with
8.7the capacity to ensure accountability to the organization's mission;
8.8(7) the organization is compliant with criteria established under the Health
8.9Information Exchange Accreditation Program of the Electronic Healthcare Network
8.10Accreditation Commission (EHNAC) or equivalent criteria established by the
8.11commissioner;
8.12(8) the entity maintains a record locator service as defined in section 144.291,
8.13subdivision 2, paragraph (i), that is compliant with the requirements of section 144.293,
8.14subdivision 8, when conducting meaningful use transactions;
8.15(9) the organization demonstrates interoperability with all other state-certified health
8.16information organizations using nationally recognized standards;
8.17(10) the organization demonstrates compliance with all privacy and security
8.18requirements required by state and federal law; and
8.19(11) the organization uses financial policies and procedures consistent with generally
8.20accepted accounting principles and has an independent audit of the organization's
8.21financials on an annual basis.
8.22(d) Health information organizations that have obtained a certificate of authority
8.23must:
8.24(1) meet the requirements established for connecting to the Nationwide Health
8.25Information Network (NHIN) within the federally mandated timeline or within a time
8.26frame established by the commissioner and published in the State Register. If the state
8.27timeline for implementation varies from the federal timeline, the State Register notice
8.28shall include an explanation for the variation;
8.29(2) annually submit strategic and operational plans for review by the commissioner
8.30that address:
8.31(i) increasing adoption rates to include a sufficient number of participating entities to
8.32achieve financial sustainability; and
8.33(ii) progress in achieving objectives included in previously submitted strategic
8.34and operational plans across the following domains: business and technical operations,
8.35technical infrastructure, legal and policy issues, finance, and organizational governance;
8.36(3) develop and maintain a business plan that addresses:
9.1(i) plans for ensuring the necessary capacity to support meaningful use transactions;
9.2(ii) approach for attaining financial sustainability, including public and private
9.3financing strategies, and rate structures;
9.4(iii) rates of adoption, utilization, and transaction volume, and mechanisms to
9.5support health information exchange; and
9.6(iv) an explanation of methods employed to address the needs of community clinics,
9.7critical access hospitals, and free clinics in accessing health information exchange services;
9.8(4) annually submit a rate plan outlining fee structures for health information
9.9exchange services for approval by the commissioner. The commissioner shall approve the
9.10rate plan if it:
9.11(i) distributes costs equitably among users of health information services;
9.12(ii) provides predictable costs for participating entities;
9.13(iii) covers all costs associated with conducting the full range of meaningful use
9.14clinical transactions, including access to health information retrieved through other
9.15state-certified health information exchange service providers; and
9.16(iv) provides for a predictable revenue stream for the health information organization
9.17and generates sufficient resources to maintain operating costs and develop technical
9.18infrastructure necessary to serve the public interest;
9.19(5) enter into reciprocal agreements with all other state-certified health information
9.20organizations to enable access to record locator services to find patient data, and
9.21transmission and receipt of meaningful use transactions consistent with the format and
9.22content required by national standards established by Centers for Medicare and Medicaid
9.23Services. Reciprocal agreements must meet the requirements in subdivision 5; and
9.24(6) comply with additional requirements for the certification or recertification of
9.25health information organizations that may be established by the commissioner.
9.26 Subd. 4. Application for certificate of authority for health information exchange
9.27service providers. (a) Each application for a certificate of authority shall be in a form
9.28prescribed by the commissioner and verified by an officer or authorized representative of
9.29the applicant. Each application shall include the following:
9.30(1) a copy of the basic organizational document, if any, of the applicant and of
9.31each major participating entity, such as the articles of incorporation, or other applicable
9.32documents, and all amendments to it;
9.33(2) a list of the names, addresses, and official positions of the following:
9.34(i) all members of the board of directors, and the principal officers and, if applicable,
9.35shareholders of the applicant organization; and
10.1(ii) all members of the board of directors, and the principal officers of each major
10.2participating entity and, if applicable, each shareholder beneficially owning more than ten
10.3percent of any voting stock of the major participating entity;
10.4(3) the name and address of each participating entity and the agreed-upon duration
10.5of each contract or agreement if applicable;
10.6(4) a copy of each standard agreement or contract intended to bind the participating
10.7entities and the health information organization. Contractual provisions shall be consistent
10.8with the purposes of this section, in regard to the services to be performed under the
10.9standard agreement or contract, the manner in which payment for services is determined,
10.10the nature and extent of responsibilities to be retained by the health information
10.11organization, and contractual termination provisions;
10.12(5) a copy of each contract intended to bind major participating entities and the
10.13health information organization. Contract information filed with the commissioner under
10.14this section shall be nonpublic as defined in section 13.02, subdivision 9;
10.15(6) a statement generally describing the health information organization, its health
10.16information exchange contracts, facilities, and personnel, including a statement describing
10.17the manner in which the applicant proposes to provide participants with comprehensive
10.18health information exchange services;
10.19(7) financial statements showing the applicant's assets, liabilities, and sources
10.20of financial support, including a copy of the applicant's most recent certified financial
10.21statement;
10.22(8) strategic and operational plans that specifically address how the organization
10.23will expand technical capacity of the health information organization to support providers
10.24in achieving meaningful use of electronic health records over time, a description of
10.25the proposed method of marketing the services, a schedule of proposed charges, and a
10.26financial plan that includes a three-year projection of the expenses and income and other
10.27sources of future capital;
10.28(9) a statement reasonably describing the geographic area or areas to be served and
10.29the type or types of participants to be served;
10.30(10) a description of the complaint procedures to be used as required under this
10.31section;
10.32(11) a description of the mechanism by which participating entities will have an
10.33opportunity to participate in matters of policy and operation;
10.34(12) a copy of any pertinent agreements between the health information organization
10.35and insurers, including liability insurers, demonstrating coverage is in place;
11.1(13) a copy of the conflict of interest policy that applies to all members of the board
11.2of directors and the principal officers of the health information organization; and
11.3(14) other information as the commissioner may reasonably require to be provided.
11.4(b) Thirty days after the receipt of the application for a certificate of authority,
11.5the commissioner shall determine whether or not the application submitted meets the
11.6requirements for completion in paragraph (a), and notify the applicant of any further
11.7information required for the application to be processed.
11.8(c) Ninety days after the receipt of a complete application for a certificate of
11.9authority, the commissioner shall issue a certificate of authority to the applicant if the
11.10commissioner determines that the applicant meets the minimum criteria requirements
11.11of subdivision 2 for health data intermediaries or subdivision 3 for health information
11.12organizations. If the commissioner determines that the applicant is not qualified, the
11.13commissioner shall notify the applicant and specify the reasons for disqualification.
11.14(d) Upon being granted a certificate of authority to operate as a health information
11.15organization, the organization must operate in compliance with the provisions of this
11.16section. Noncompliance may result in the imposition of a fine or the suspension or
11.17revocation of the certificate of authority according to section 62J.4982.
11.18 Subd. 5. Reciprocal agreements between health information exchange entities.
11.19(a) Reciprocal agreements between two health information organizations or between a
11.20health information organization and a health data intermediary must include a fair and
11.21equitable model for charges between the entities that:
11.22(1) does not impede the secure transmission of transactions necessary to achieve
11.23meaningful use;
11.24(2) does not charge a fee for the exchange of meaningful use transactions transmitted
11.25according to nationally recognized standards where no additional value-added service
11.26is rendered to the sending or receiving health information organization or health data
11.27intermediary either directly or on behalf of the client;
11.28(3) is consistent with fair market value and proportionately reflects the value-added
11.29services accessed as a result of the agreement; and
11.30(4) prevents health care stakeholders from being charged multiple times for the
11.31same service.
11.32(b) Reciprocal agreements must include comparable quality of service standards that
11.33ensure equitable levels of services.
11.34(c) Reciprocal agreements are subject to review and approval by the commissioner.
12.1(d) Nothing in this section precludes a state-certified health information organization
12.2or state-certified health data intermediary from entering into contractual agreements for
12.3the provision of value-added services beyond meaningful use.
12.4(e) The commissioner of human services or health, when providing access to data or
12.5services through a certified health information organization, must offer the same data or
12.6services directly through any certified health information organization at the same pricing,
12.7if the health information organization pays for all connection costs to the state data or
12.8service. For all external connectivity to the respective agencies through existing or future
12.9information exchange implementations, the respective agency shall establish the required
12.10connectivity methods as well as protocol standards to be utilized.
12.11 Subd. 6. State participation in health information exchange. A state agency
12.12that connects to a health information exchange service provider for the purpose of
12.13exchanging meaningful use transactions must ensure that the contracted health information
12.14exchange service provider has reciprocal agreements in place as required by this section.
12.15The reciprocal agreements must provide equal access to information supplied by the
12.16agency and necessary for meaningful use by the participating entities of the other health
12.17information service providers.
12.18 Sec. 5. [62J.4982] ENFORCEMENT AUTHORITY; COMPLIANCE.
12.19 Subdivision 1. Penalties and enforcement. (a) The commissioner may, for any
12.20violation of statute or rule applicable to a health information exchange service provider,
12.21levy an administrative penalty in an amount up to $25,000 for each violation. In
12.22determining the level of an administrative penalty, the commissioner shall consider the
12.23following factors:
12.24(1) the number of participating entities affected by the violation;
12.25(2) the effect of the violation on participating entities' access to health information
12.26exchange services;
12.27(3) if only one participating entity is affected, the effect of the violation on the
12.28patients of that entity;
12.29(4) whether the violation is an isolated incident or part of a pattern of violations;
12.30(5) the economic benefits derived by the health information organization or a health
12.31data intermediary by virtue of the violation;
12.32(6) whether the violation hindered or facilitated an individual's ability to obtain
12.33health care;
12.34(7) whether the violation was intentional;
13.1(8) whether the violation was beyond the direct control of the health information
13.2exchange service provider;
13.3(9) any history of prior compliance with the provisions of this section, including
13.4violations;
13.5(10) whether and to what extent the health information exchange service provider
13.6attempted to correct previous violations;
13.7(11) how the health information exchange service provider responded to technical
13.8assistance from the commissioner provided in the context of a compliance effort; and
13.9(12) the financial condition of the health information exchange service provider
13.10including, but not limited to, whether the health information exchange service provider
13.11had financial difficulties that affected its ability to comply or whether the imposition of an
13.12administrative monetary penalty would jeopardize the ability of the health information
13.13exchange service provider to continue to deliver health information exchange services.
13.14Reasonable notice in writing to the health information exchange service provider
13.15shall be given of the intent to levy the penalty and the reasons for them. A health
13.16information exchange service provider may have 15 days within which to contest whether
13.17the finding of facts constitute a violation of sections 62J.4981 and 62J.4982, according to
13.18the contested case and judicial review provisions of sections 14.57 to 14.69.
13.19(b) If the commissioner has reason to believe that a violation of section 62J.4981 or
13.2062J.4982 has occurred or is likely, the commissioner may confer with the persons involved
13.21before commencing action under subdivision 2. The commissioner may notify the health
13.22information exchange service provider and the representatives, or other persons who
13.23appear to be involved in the suspected violation, to arrange a voluntary conference with
13.24the alleged violators or their authorized representatives. The purpose of the conference is
13.25to attempt to learn the facts about the suspected violation and, if it appears that a violation
13.26has occurred or is threatened, to find a way to correct or prevent it. The conference is
13.27not governed by any formal procedural requirements, and may be conducted as the
13.28commissioner considers appropriate.
13.29(c) The commissioner may issue an order directing a health information exchange
13.30service provider or a representative of a health information exchange service provider to
13.31cease and desist from engaging in any act or practice in violation of sections 62J.4981
13.32and 62J.4982.
13.33(d) Within 20 days after service of the order to cease and desist, a health information
13.34exchange service provider may contest whether the finding of facts constitutes a violation
13.35of sections 62J.4981 and 62J.4982 according to the contested case and judicial review
13.36provisions of sections 14.57 to 14.69.
14.1(e) In the event of noncompliance with a cease and desist order issued under this
14.2subdivision, the commissioner may institute a proceeding to obtain injunctive relief or
14.3other appropriate relief in Ramsey County District Court.
14.4 Subd. 2. Suspension or revocation of certificates of authority. (a) The
14.5commissioner may suspend or revoke a certificate of authority issued to a health
14.6data intermediary or health information organization under section 62J.4981 if the
14.7commissioner finds that:
14.8(1) the health information exchange service provider is operating significantly
14.9in contravention of its basic organizational document, or in a manner contrary to that
14.10described in and reasonably inferred from any other information submitted under section
14.1162J.4981, unless amendments to the submissions have been filed with and approved by
14.12the commissioner;
14.13(2) the health information exchange service provider is unable to fulfill its
14.14obligations to furnish comprehensive health information exchange services as required
14.15under its health information exchange contract;
14.16(3) the health information exchange service provider is no longer financially solvent
14.17or may not reasonably be expected to meet its obligations to participating entities;
14.18(4) the health information exchange service provider has failed to implement the
14.19complaint system in a manner designed to reasonably resolve valid complaints;
14.20(5) the health information exchange service provider, or any person acting with its
14.21sanction, has advertised or merchandised its services in an untrue, misleading, deceptive,
14.22or unfair manner;
14.23(6) the continued operation of the health information exchange service provider
14.24would be hazardous to its participating entities or the patients served by the participating
14.25entities; or
14.26(7) the health information exchange service provider has otherwise failed to
14.27substantially comply with section 62J.4981 or with any other statute or administrative
14.28rule applicable to health information exchange service providers, or has submitted false
14.29information in any report required under sections 62J.498 to 62J.4982.
14.30(b) A certificate of authority shall be suspended or revoked only after meeting the
14.31requirements of subdivision 3.
14.32(c) If the certificate of authority of a health information exchange service provider is
14.33suspended, the health information exchange service provider shall not, during the period
14.34of suspension, enroll any additional participating entities, and shall not engage in any
14.35advertising or solicitation.
15.1(d) If the certificate of authority of a health information exchange service provider is
15.2revoked, the organization shall proceed, immediately following the effective date of the
15.3order of revocation, to wind up its affairs, and shall conduct no further business except as
15.4necessary to the orderly conclusion of the affairs of the organization. The organization
15.5shall engage in no further advertising or solicitation. The commissioner may, by written
15.6order, permit further operation of the organization as the commissioner finds to be in the
15.7best interest of participating entities, to the end that participating entities will be given the
15.8greatest practical opportunity to access continuing health information exchange services.
15.9 Subd. 3. Denial, suspension, and revocation; administrative procedures. (a)
15.10When the commissioner has cause to believe that grounds for the denial, suspension,
15.11or revocation of a certificate of authority exists, the commissioner shall notify the
15.12health information exchange service provider in writing stating the grounds for denial,
15.13suspension, or revocation and setting a time within 20 days for a hearing on the matter.
15.14(b) After a hearing before the commissioner at which the health information
15.15exchange service provider may respond to the grounds for denial, suspension, or
15.16revocation, or upon the failure of the health information exchange service provider to
15.17appear at the hearing, the commissioner shall take action as deemed necessary and shall
15.18issue written findings that shall be mailed to the health information exchange service
15.19provider.
15.20(c) If suspension, revocation, or an administrative penalty is proposed according
15.21to this section, the commissioner must deliver, or send by certified mail with return
15.22receipt requested, to the health information exchange service provider written notice of
15.23the commissioner's intent to impose a penalty. This notice of proposed determination
15.24must include:
15.25(1) a reference to the statutory basis for the penalty;
15.26(2) a description of the findings of fact regarding the violations with respect to
15.27which the penalty is proposed;
15.28(3) the nature and/or amount of the proposed penalty;
15.29(4) any circumstances described in subdivision 1, paragraph (a), that were considered
15.30in determining the amount of the proposed penalty;
15.31(5) instructions for responding to the notice, including a statement of the health
15.32information exchange service provider's right to a contested case proceeding and a
15.33statement that failure to request a contested case proceeding within 30 calendar days
15.34permits the imposition of the proposed penalty; and
15.35(6) the address to which the contested case proceeding request must be sent.
16.1 Subd. 4. Coordination. (a) The commissioner shall, to the extent possible, seek
16.2the advice of the Minnesota e-Health Advisory Committee, in the review and update of
16.3criteria for the certification and recertification of health information exchange service
16.4providers when implementing sections 62J.498 to 62J.4982.
16.5(b) By January 1, 2011, the commissioner shall report to the governor and the chairs
16.6of the senate and house of representatives committees having jurisdiction over health
16.7information policy issues on the status of health information exchange in Minnesota, and
16.8provide recommendations on further action necessary to facilitate the secure electronic
16.9movement of health information among health providers that will enable Minnesota
16.10providers and hospitals to meet meaningful use exchange requirements.
16.11 Subd. 5. Fees and monetary penalties. (a) Every health information exchange
16.12service provider subject to sections 62J.4981 and 62J.4982 shall be assessed fees as
16.13follows:
16.14(1) filing an application for certificate of authority to operate as a health information
16.15organization, $10,500;
16.16(2) filing an application for certificate of authority to operate as a health data
16.17intermediary, $7,000;
16.18(3) annual health information organization certificate fee, $14,000;
16.19(4) annual health data intermediary certificate fee, $7,000; and
16.20(5) fees for other filings, as specified by rule.
16.21(b) Administrative monetary penalties imposed under this subdivision shall be
16.22deposited into a revolving fund and are appropriated to the commissioner for the purposes
16.23of sections 62J.498 to 62J.4982.
16.24 Sec. 6. APPLICATION PROCESS FOR HEALTH INFORMATION
16.25EXCHANGE.
16.26To the extent that the commissioner of health applies for additional federal funding
16.27to support the commissioner's responsibilities of developing and maintaining state level
16.28health information exchange under section 3013 of the HITECH Act, the commissioner of
16.29health shall ensure that applications are made through an open process that provides health
16.30information exchange service providers equal opportunity to receive funding.
16.31 Sec. 7. APPROPRIATION; HEALTH INFORMATION EXCHANGE
16.32OVERSIGHT.
16.33$104,000 in fiscal year 2011 is appropriated from the state government special
16.34revenue fund to the commissioner of health for the duties required under sections 62J.498
17.1to 62J.4982. Base funding shall be $97,000 in fiscal year 2012 and $97,000 in fiscal
17.2year 2013.
1.3providing for administrative penalties; appropriating money;amending
1.4Minnesota Statutes 2009 Supplement, section 62J.495, subdivisions 1a, 3;
1.5proposing coding for new law in Minnesota Statutes, chapter 62J.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. Minnesota Statutes 2009 Supplement, section 62J.495, subdivision 1a,
1.8is amended to read:
1.9 Subd. 1a. Definitions. (a) "Certified electronic health record technology" means an
1.10electronic health record that is certified pursuant to section 3001(c)(5) of the HITECH
1.11Act to meet the standards and implementation specifications adopted under section 3004
1.12as applicable.
1.13(b) "Commissioner" means the commissioner of health.
1.14(c) "Pharmaceutical electronic data intermediary" means any entity that provides
1.15the infrastructure to connect computer systems or other electronic devices utilized
1.16by prescribing practitioners with those used by pharmacies, health plans, third-party
1.17administrators, and pharmacy benefit managers in order to facilitate the secure
1.18transmission of electronic prescriptions, refill authorization requests, communications,
1.19and other prescription-related information between such entities.
1.20(d) "HITECH Act" means the Health Information Technology for Economic and
1.21Clinical Health Act in division A, title XIII and division B, title IV of the American
1.22Recovery and Reinvestment Act of 2009, including federal regulations adopted under
1.23that act.
1.24(e) "Interoperable electronic health record" means an electronic health record that
1.25securely exchanges health information with another electronic health record system that
2.1meets requirements specified in subdivision 3, and national requirements for certification
2.2under the HITECH Act.
2.3(f) "Qualified electronic health record" means an electronic record of health-related
2.4information on an individual that includes patient demographic and clinical health
2.5information and has the capacity to:
2.6(1) provide clinical decision support;
2.7(2) support physician order entry;
2.8(3) capture and query information relevant to health care quality; and
2.9(4) exchange electronic health information with, and integrate such information
2.10from, other sources.
2.11 Sec. 2. Minnesota Statutes 2009 Supplement, section 62J.495, subdivision 3, is
2.12amended to read:
2.13 Subd. 3. Interoperable electronic health record requirements. To meet the
2.14requirements of subdivision 1, hospitals and health care providers must meet the following
2.15criteria when implementing an interoperable electronic health records system within their
2.16hospital system or clinical practice setting.
2.17(a) The electronic health record must be a qualified electronic health record.
2.18 (b) The electronic health record must be certified by the Office of the National
2.19Coordinator pursuant to the HITECH Act. This criterion only applies to hospitals and
2.20health care providers
2.21particular practice setting is available. This criterion shall be considered met if a hospital
2.22or health care provider is using an electronic health records system that has been certified
2.23within the last three years, even if a more current version of the system has been certified
2.24within the three-year period.
2.25(c) The electronic health record must meet the standards established according to
2.26section 3004 of the HITECH Act as applicable.
2.27(d) The electronic health record must have the ability to generate information on
2.28clinical quality measures and other measures reported under sections 4101, 4102, and
2.294201 of the HITECH Act.
2.30(e) The electronic health record system must be connected to a state-certified
2.31health information organization either directly or through a connection facilitated by a
2.32state-certified health data intermediary as defined in section 62J.498.
2.33
2.34have an electronic health record system that meets the requirements of section
3.1 Sec. 3. [62J.498] HEALTH INFORMATION EXCHANGE.
3.2 Subdivision 1. Definitions. The following definitions apply to sections 62J.498 to
3.362J.4982:
3.4(a) "Clinical transaction" means any meaningful use transaction that is not covered
3.5by section 62J.536.
3.6(b) "Commissioner" means the commissioner of health.
3.7(c) "Direct health information exchange" means the electronic transmission of
3.8health-related information through a direct connection between the electronic health
3.9record systems of health care providers without the use of a health data intermediary.
3.10(d) "Health care provider" or "provider" means a health care provider or provider as
3.11defined in section 62J.03, subdivision 8.
3.12(e) "Health data intermediary" means an entity that provides the infrastructure to
3.13connect computer systems or other electronic devices used by health care providers,
3.14laboratories, pharmacies, health plans, third-party administrators, or pharmacy benefit
3.15managers to facilitate the secure transmission of health information, including
3.16pharmaceutical electronic data intermediaries as defined in section 62J.495. This does not
3.17include health care providers engaged in direct health information exchange.
3.18(f) "Health information exchange" means the electronic transmission of
3.19health-related information between organizations according to nationally recognized
3.20standards.
3.21(g) "Health information exchange service provider" means a health data intermediary
3.22or health information organization that has been issued a certificate of authority by the
3.23commissioner under section 62J.4981.
3.24(h) "Health information organization" means an organization that oversees, governs,
3.25and facilitates the exchange of health-related information among organizations according
3.26to nationally recognized standards.
3.27(i) "HITECH Act" means the Health Information Technology for Economic and
3.28Clinical Health Act as defined in section 62J.495.
3.29(j) "Major participating entity" means:
3.30(1) a participating entity that receives compensation for services that is greater
3.31than 30 percent of the health information organization's gross annual revenues from the
3.32health information exchange service provider;
3.33(2) a participating entity providing administrative, financial, or management services
3.34to the health information organization, if the total payment for all services provided by the
3.35participating entity exceeds three percent of the gross revenue of the health information
3.36organization; and
4.1(3) a participating entity that nominates or appoints 30 percent or more of the board
4.2of directors of the health information organization.
4.3(k) "Meaningful use" means use of certified electronic health record technology that
4.4includes e-prescribing, and is connected in a manner that provides for the electronic
4.5exchange of health information and used for the submission of clinical quality measures
4.6as established by the Center for Medicare and Medicaid Services and the Minnesota
4.7Department of Human Services pursuant to sections 4101, 4102, and 4201 of the HITECH
4.8Act.
4.9(l) "Meaningful use transaction" means an electronic transaction that a health care
4.10provider must exchange to receive Medicare or Medicaid incentives or avoid Medicare
4.11penalties pursuant to sections 4101, 4102, and 4201 of the HITECH Act.
4.12(m) "Participating entity" means any of the following persons, health care providers,
4.13companies, or other organizations with which a health information organization or health
4.14data intermediary has contracts or other agreements for the provision of health information
4.15exchange service providers:
4.16(1) a health care facility licensed under sections 144.50 to 144.56, a nursing home
4.17licensed under sections 144A.02 to 144A.10, and any other health care facility otherwise
4.18licensed under the laws of this state or registered with the commissioner;
4.19(2) a health care provider, and any other health care professional otherwise licensed
4.20under the laws of this state or registered with the commissioner;
4.21(3) a group, professional corporation, or other organization that provides the
4.22services of individuals or entities identified in clause (2), including but not limited to a
4.23medical clinic, a medical group, a home health care agency, an urgent care center, and
4.24an emergent care center;
4.25(4) a health plan as defined in section 62A.011, subdivision 3; and
4.26(5) a state agency as defined in section 13.02, subdivision 17.
4.27(n) "Reciprocal agreement" means an arrangement in which two or more health
4.28information exchange service providers agree to share in-kind services and resources to
4.29allow for the pass-through of meaningful use transactions.
4.30(o) "State-certified health data intermediary" means a health data intermediary that:
4.31(1) provides a subset of the meaningful use transaction capabilities necessary for
4.32hospitals and providers to achieve meaningful use of electronic health records;
4.33(2) is not exclusively engaged in the exchange of meaningful use transactions
4.34covered by section 62J.536; and
4.35(3) has been issued a certificate of authority to operate in Minnesota.
5.1(p) "State-certified health information organization" means a nonprofit health
5.2information organization that provides transaction capabilities necessary to fully support
5.3clinical transactions required for meaningful use of electronic health records that has been
5.4issued a certificate of authority to operate in Minnesota.
5.5 Subd. 2. Health information exchange oversight. (a) The commissioner shall
5.6protect the public interest on matters pertaining to health information exchange. The
5.7commissioner shall:
5.8(1) review and act on applications from health data intermediaries and health
5.9information organizations for certificates of authority to operate in Minnesota;
5.10(2) provide ongoing monitoring to ensure compliance with criteria established under
5.11sections 62J.498 to 62J.4982;
5.12(3) respond to public complaints related to health information exchange services;
5.13(4) take enforcement actions as necessary, including the imposition of fines,
5.14suspension, or revocation of certificates of authority as outlined in section 62J.4982;
5.15(5) provide a biannual report on the status of health information exchange services
5.16that includes but is not limited to:
5.17(i) recommendations on actions necessary to ensure that health information exchange
5.18services are adequate to meet the needs of Minnesota citizens and providers statewide;
5.19(ii) recommendations on enforcement actions to ensure that health information
5.20exchange service providers act in the public interest without causing disruption in health
5.21information exchange services;
5.22(iii) recommendations on updates to criteria for obtaining certificates of authority
5.23under this section; and
5.24(iv) recommendations on standard operating procedures for health information
5.25exchange, including but not limited to the management of consumer preferences;
5.26(6) other duties necessary to protect the public interest.
5.27(b) As part of the application review process for certification under paragraph (a),
5.28prior to issuing a certificate of authority, the commissioner shall:
5.29(1) hold public hearings that provide an adequate opportunity for participating
5.30entities and consumers to provide feedback and recommendations on the application under
5.31consideration. The commissioner shall make all portions of the application classified
5.32as public data available to the public at least ten days in advance of the hearing. The
5.33applicant shall participate in the hearing by presenting an overview of their application
5.34and responding to questions from interested parties;
5.35(2) make available all feedback and recommendations from the hearing available to
5.36the public prior to issuing a certificate of authority; and
6.1(3) consult with hospitals, physicians, and other professionals eligible to receive
6.2meaningful use incentive payments or subject to penalties as established in the HITECH
6.3Act, and their respective statewide associations, prior to issuing a certificate of authority.
6.4(c)(1) When the commissioner is actively considering a suspension or revocation of
6.5a certificate of authority as described in section 62J.4982, subdivision 3, all investigatory
6.6data that are collected, created, or maintained related to the suspension or revocation
6.7are classified as confidential data on individuals and as protected nonpublic data in the
6.8case of data not on individuals.
6.9(2) The commissioner may disclose data classified as protected nonpublic or
6.10confidential under this paragraph if disclosing the data will protect the health or safety of
6.11patients.
6.12(d) After the commissioner makes a final determination regarding a suspension or
6.13revocation of a certificate of authority, all minutes, orders for hearing, findings of fact,
6.14conclusions of law, and the specification of the final disciplinary action, are classified
6.15as public data.
6.16 Sec. 4. [62J.4981] CERTIFICATE OF AUTHORITY TO PROVIDE HEALTH
6.17INFORMATION EXCHANGE SERVICES.
6.18 Subdivision 1. Authority to require organizations to apply. The commissioner
6.19shall require an entity providing health information exchange services to apply for a
6.20certificate of authority under this section. An applicant may continue to operate until
6.21the commissioner acts on the application. If the application is denied, the applicant is
6.22considered a health information organization whose certificate of authority has been
6.23revoked under section 62J.4982, subdivision 2, paragraph (d).
6.24 Subd. 2. Certificate of authority for health data intermediaries. (a) A health
6.25data intermediary that provides health information exchange services for the transmission
6.26of one or more clinical transactions necessary for hospitals, providers, or eligible
6.27professionals to achieve meaningful use must be registered with the state and comply with
6.28requirements established in this section.
6.29(b) Notwithstanding any law to the contrary, any corporation organized to do so
6.30may apply to the commissioner for a certificate of authority to establish and operate as
6.31a health data intermediary in compliance with this section. No person shall establish or
6.32operate a health data intermediary in this state, nor sell or offer to sell, or solicit offers
6.33to purchase or receive advance or periodic consideration in conjunction with a health
6.34data intermediary contract unless the organization has a certificate of authority or has an
6.35application under active consideration under this section.
7.1(c) In issuing the certificate of authority, the commissioner shall determine whether
7.2the applicant for the certificate of authority has demonstrated that the applicant meets
7.3the following minimum criteria:
7.4(1) interoperate with at least one state-certified health information organization;
7.5(2) provide an option for Minnesota entities to connect to their services through at
7.6least one state-certified health information organization;
7.7(3) have a record locator service as defined in section 144.291, subdivision 2,
7.8paragraph (i), that is compliant with the requirements of section 144.293, subdivision 8,
7.9when conducting meaningful use transactions; and
7.10(4) hold reciprocal agreements with at least one state-certified health information
7.11organization to enable access to record locator services to find patient data, and for the
7.12transmission and receipt of meaningful use transactions consistent with the format and
7.13content required by national standards established by Centers for Medicare and Medicaid
7.14Services. Reciprocal agreements must meet the requirements established in subdivision 5.
7.15 Subd. 3. Certificate of authority for health information organizations.
7.16(a) A health information organization that provides all electronic capabilities for the
7.17transmission of clinical transactions necessary for meaningful use of electronic health
7.18records must obtain a certificate of authority from the commissioner and demonstrate
7.19compliance with the criteria in paragraph (c).
7.20(b) Notwithstanding any law to the contrary, a nonprofit corporation organized to do
7.21so may apply for a certificate of authority to establish and operate a health information
7.22organization under this section. No person shall establish or operate a health information
7.23organization in this state, nor sell or offer to sell, or solicit offers to purchase or receive
7.24advance or periodic consideration in conjunction with a health information organization
7.25or health information contract unless the organization has a certificate of authority under
7.26this section.
7.27(c) In issuing the certificate of authority, the commissioner shall determine whether
7.28the applicant for the certificate of authority has demonstrated that the applicant meets
7.29the following minimum criteria:
7.30(1) the entity is a legally established, nonprofit organization;
7.31(2) appropriate insurance, including liability insurance, for the operation of the
7.32health information organization is in place and sufficient to protect the interest of the
7.33public and participating entities;
7.34(3) strategic and operational plans clearly address how the organization will expand
7.35technical capacity of the health information organization to support providers in achieving
7.36meaningful use of electronic health records over time;
8.1(4) the entity addresses the parameters to be used with participating entities and
8.2other health information organizations for meaningful use transactions, compliance with
8.3Minnesota law, and interstate health information exchange in trust agreements;
8.4(5) the entity's board of directors is comprised of members that broadly represent the
8.5health information organization's participating entities and consumers;
8.6(6) the entity maintains a professional staff responsible to the board of directors with
8.7the capacity to ensure accountability to the organization's mission;
8.8(7) the organization is compliant with criteria established under the Health
8.9Information Exchange Accreditation Program of the Electronic Healthcare Network
8.10Accreditation Commission (EHNAC) or equivalent criteria established by the
8.11commissioner;
8.12(8) the entity maintains a record locator service as defined in section 144.291,
8.13subdivision 2, paragraph (i), that is compliant with the requirements of section 144.293,
8.14subdivision 8, when conducting meaningful use transactions;
8.15(9) the organization demonstrates interoperability with all other state-certified health
8.16information organizations using nationally recognized standards;
8.17(10) the organization demonstrates compliance with all privacy and security
8.18requirements required by state and federal law; and
8.19(11) the organization uses financial policies and procedures consistent with generally
8.20accepted accounting principles and has an independent audit of the organization's
8.21financials on an annual basis.
8.22(d) Health information organizations that have obtained a certificate of authority
8.23must:
8.24(1) meet the requirements established for connecting to the Nationwide Health
8.25Information Network (NHIN) within the federally mandated timeline or within a time
8.26frame established by the commissioner and published in the State Register. If the state
8.27timeline for implementation varies from the federal timeline, the State Register notice
8.28shall include an explanation for the variation;
8.29(2) annually submit strategic and operational plans for review by the commissioner
8.30that address:
8.31(i) increasing adoption rates to include a sufficient number of participating entities to
8.32achieve financial sustainability; and
8.33(ii) progress in achieving objectives included in previously submitted strategic
8.34and operational plans across the following domains: business and technical operations,
8.35technical infrastructure, legal and policy issues, finance, and organizational governance;
8.36(3) develop and maintain a business plan that addresses:
9.1(i) plans for ensuring the necessary capacity to support meaningful use transactions;
9.2(ii) approach for attaining financial sustainability, including public and private
9.3financing strategies, and rate structures;
9.4(iii) rates of adoption, utilization, and transaction volume, and mechanisms to
9.5support health information exchange; and
9.6(iv) an explanation of methods employed to address the needs of community clinics,
9.7critical access hospitals, and free clinics in accessing health information exchange services;
9.8(4) annually submit a rate plan outlining fee structures for health information
9.9exchange services for approval by the commissioner. The commissioner shall approve the
9.10rate plan if it:
9.11(i) distributes costs equitably among users of health information services;
9.12(ii) provides predictable costs for participating entities;
9.13(iii) covers all costs associated with conducting the full range of meaningful use
9.14clinical transactions, including access to health information retrieved through other
9.15state-certified health information exchange service providers; and
9.16(iv) provides for a predictable revenue stream for the health information organization
9.17and generates sufficient resources to maintain operating costs and develop technical
9.18infrastructure necessary to serve the public interest;
9.19(5) enter into reciprocal agreements with all other state-certified health information
9.20organizations to enable access to record locator services to find patient data, and
9.21transmission and receipt of meaningful use transactions consistent with the format and
9.22content required by national standards established by Centers for Medicare and Medicaid
9.23Services. Reciprocal agreements must meet the requirements in subdivision 5; and
9.24(6) comply with additional requirements for the certification or recertification of
9.25health information organizations that may be established by the commissioner.
9.26 Subd. 4. Application for certificate of authority for health information exchange
9.27service providers. (a) Each application for a certificate of authority shall be in a form
9.28prescribed by the commissioner and verified by an officer or authorized representative of
9.29the applicant. Each application shall include the following:
9.30(1) a copy of the basic organizational document, if any, of the applicant and of
9.31each major participating entity, such as the articles of incorporation, or other applicable
9.32documents, and all amendments to it;
9.33(2) a list of the names, addresses, and official positions of the following:
9.34(i) all members of the board of directors, and the principal officers and, if applicable,
9.35shareholders of the applicant organization; and
10.1(ii) all members of the board of directors, and the principal officers of each major
10.2participating entity and, if applicable, each shareholder beneficially owning more than ten
10.3percent of any voting stock of the major participating entity;
10.4(3) the name and address of each participating entity and the agreed-upon duration
10.5of each contract or agreement if applicable;
10.6(4) a copy of each standard agreement or contract intended to bind the participating
10.7entities and the health information organization. Contractual provisions shall be consistent
10.8with the purposes of this section, in regard to the services to be performed under the
10.9standard agreement or contract, the manner in which payment for services is determined,
10.10the nature and extent of responsibilities to be retained by the health information
10.11organization, and contractual termination provisions;
10.12(5) a copy of each contract intended to bind major participating entities and the
10.13health information organization. Contract information filed with the commissioner under
10.14this section shall be nonpublic as defined in section 13.02, subdivision 9;
10.15(6) a statement generally describing the health information organization, its health
10.16information exchange contracts, facilities, and personnel, including a statement describing
10.17the manner in which the applicant proposes to provide participants with comprehensive
10.18health information exchange services;
10.19(7) financial statements showing the applicant's assets, liabilities, and sources
10.20of financial support, including a copy of the applicant's most recent certified financial
10.21statement;
10.22(8) strategic and operational plans that specifically address how the organization
10.23will expand technical capacity of the health information organization to support providers
10.24in achieving meaningful use of electronic health records over time, a description of
10.25the proposed method of marketing the services, a schedule of proposed charges, and a
10.26financial plan that includes a three-year projection of the expenses and income and other
10.27sources of future capital;
10.28(9) a statement reasonably describing the geographic area or areas to be served and
10.29the type or types of participants to be served;
10.30(10) a description of the complaint procedures to be used as required under this
10.31section;
10.32(11) a description of the mechanism by which participating entities will have an
10.33opportunity to participate in matters of policy and operation;
10.34(12) a copy of any pertinent agreements between the health information organization
10.35and insurers, including liability insurers, demonstrating coverage is in place;
11.1(13) a copy of the conflict of interest policy that applies to all members of the board
11.2of directors and the principal officers of the health information organization; and
11.3(14) other information as the commissioner may reasonably require to be provided.
11.4(b) Thirty days after the receipt of the application for a certificate of authority,
11.5the commissioner shall determine whether or not the application submitted meets the
11.6requirements for completion in paragraph (a), and notify the applicant of any further
11.7information required for the application to be processed.
11.8(c) Ninety days after the receipt of a complete application for a certificate of
11.9authority, the commissioner shall issue a certificate of authority to the applicant if the
11.10commissioner determines that the applicant meets the minimum criteria requirements
11.11of subdivision 2 for health data intermediaries or subdivision 3 for health information
11.12organizations. If the commissioner determines that the applicant is not qualified, the
11.13commissioner shall notify the applicant and specify the reasons for disqualification.
11.14(d) Upon being granted a certificate of authority to operate as a health information
11.15organization, the organization must operate in compliance with the provisions of this
11.16section. Noncompliance may result in the imposition of a fine or the suspension or
11.17revocation of the certificate of authority according to section 62J.4982.
11.18 Subd. 5. Reciprocal agreements between health information exchange entities.
11.19(a) Reciprocal agreements between two health information organizations or between a
11.20health information organization and a health data intermediary must include a fair and
11.21equitable model for charges between the entities that:
11.22(1) does not impede the secure transmission of transactions necessary to achieve
11.23meaningful use;
11.24(2) does not charge a fee for the exchange of meaningful use transactions transmitted
11.25according to nationally recognized standards where no additional value-added service
11.26is rendered to the sending or receiving health information organization or health data
11.27intermediary either directly or on behalf of the client;
11.28(3) is consistent with fair market value and proportionately reflects the value-added
11.29services accessed as a result of the agreement; and
11.30(4) prevents health care stakeholders from being charged multiple times for the
11.31same service.
11.32(b) Reciprocal agreements must include comparable quality of service standards that
11.33ensure equitable levels of services.
11.34(c) Reciprocal agreements are subject to review and approval by the commissioner.
12.1(d) Nothing in this section precludes a state-certified health information organization
12.2or state-certified health data intermediary from entering into contractual agreements for
12.3the provision of value-added services beyond meaningful use.
12.4(e) The commissioner of human services or health, when providing access to data or
12.5services through a certified health information organization, must offer the same data or
12.6services directly through any certified health information organization at the same pricing,
12.7if the health information organization pays for all connection costs to the state data or
12.8service. For all external connectivity to the respective agencies through existing or future
12.9information exchange implementations, the respective agency shall establish the required
12.10connectivity methods as well as protocol standards to be utilized.
12.11 Subd. 6. State participation in health information exchange. A state agency
12.12that connects to a health information exchange service provider for the purpose of
12.13exchanging meaningful use transactions must ensure that the contracted health information
12.14exchange service provider has reciprocal agreements in place as required by this section.
12.15The reciprocal agreements must provide equal access to information supplied by the
12.16agency and necessary for meaningful use by the participating entities of the other health
12.17information service providers.
12.18 Sec. 5. [62J.4982] ENFORCEMENT AUTHORITY; COMPLIANCE.
12.19 Subdivision 1. Penalties and enforcement. (a) The commissioner may, for any
12.20violation of statute or rule applicable to a health information exchange service provider,
12.21levy an administrative penalty in an amount up to $25,000 for each violation. In
12.22determining the level of an administrative penalty, the commissioner shall consider the
12.23following factors:
12.24(1) the number of participating entities affected by the violation;
12.25(2) the effect of the violation on participating entities' access to health information
12.26exchange services;
12.27(3) if only one participating entity is affected, the effect of the violation on the
12.28patients of that entity;
12.29(4) whether the violation is an isolated incident or part of a pattern of violations;
12.30(5) the economic benefits derived by the health information organization or a health
12.31data intermediary by virtue of the violation;
12.32(6) whether the violation hindered or facilitated an individual's ability to obtain
12.33health care;
12.34(7) whether the violation was intentional;
13.1(8) whether the violation was beyond the direct control of the health information
13.2exchange service provider;
13.3(9) any history of prior compliance with the provisions of this section, including
13.4violations;
13.5(10) whether and to what extent the health information exchange service provider
13.6attempted to correct previous violations;
13.7(11) how the health information exchange service provider responded to technical
13.8assistance from the commissioner provided in the context of a compliance effort; and
13.9(12) the financial condition of the health information exchange service provider
13.10including, but not limited to, whether the health information exchange service provider
13.11had financial difficulties that affected its ability to comply or whether the imposition of an
13.12administrative monetary penalty would jeopardize the ability of the health information
13.13exchange service provider to continue to deliver health information exchange services.
13.14Reasonable notice in writing to the health information exchange service provider
13.15shall be given of the intent to levy the penalty and the reasons for them. A health
13.16information exchange service provider may have 15 days within which to contest whether
13.17the finding of facts constitute a violation of sections 62J.4981 and 62J.4982, according to
13.18the contested case and judicial review provisions of sections 14.57 to 14.69.
13.19(b) If the commissioner has reason to believe that a violation of section 62J.4981 or
13.2062J.4982 has occurred or is likely, the commissioner may confer with the persons involved
13.21before commencing action under subdivision 2. The commissioner may notify the health
13.22information exchange service provider and the representatives, or other persons who
13.23appear to be involved in the suspected violation, to arrange a voluntary conference with
13.24the alleged violators or their authorized representatives. The purpose of the conference is
13.25to attempt to learn the facts about the suspected violation and, if it appears that a violation
13.26has occurred or is threatened, to find a way to correct or prevent it. The conference is
13.27not governed by any formal procedural requirements, and may be conducted as the
13.28commissioner considers appropriate.
13.29(c) The commissioner may issue an order directing a health information exchange
13.30service provider or a representative of a health information exchange service provider to
13.31cease and desist from engaging in any act or practice in violation of sections 62J.4981
13.32and 62J.4982.
13.33(d) Within 20 days after service of the order to cease and desist, a health information
13.34exchange service provider may contest whether the finding of facts constitutes a violation
13.35of sections 62J.4981 and 62J.4982 according to the contested case and judicial review
13.36provisions of sections 14.57 to 14.69.
14.1(e) In the event of noncompliance with a cease and desist order issued under this
14.2subdivision, the commissioner may institute a proceeding to obtain injunctive relief or
14.3other appropriate relief in Ramsey County District Court.
14.4 Subd. 2. Suspension or revocation of certificates of authority. (a) The
14.5commissioner may suspend or revoke a certificate of authority issued to a health
14.6data intermediary or health information organization under section 62J.4981 if the
14.7commissioner finds that:
14.8(1) the health information exchange service provider is operating significantly
14.9in contravention of its basic organizational document, or in a manner contrary to that
14.10described in and reasonably inferred from any other information submitted under section
14.1162J.4981, unless amendments to the submissions have been filed with and approved by
14.12the commissioner;
14.13(2) the health information exchange service provider is unable to fulfill its
14.14obligations to furnish comprehensive health information exchange services as required
14.15under its health information exchange contract;
14.16(3) the health information exchange service provider is no longer financially solvent
14.17or may not reasonably be expected to meet its obligations to participating entities;
14.18(4) the health information exchange service provider has failed to implement the
14.19complaint system in a manner designed to reasonably resolve valid complaints;
14.20(5) the health information exchange service provider, or any person acting with its
14.21sanction, has advertised or merchandised its services in an untrue, misleading, deceptive,
14.22or unfair manner;
14.23(6) the continued operation of the health information exchange service provider
14.24would be hazardous to its participating entities or the patients served by the participating
14.25entities; or
14.26(7) the health information exchange service provider has otherwise failed to
14.27substantially comply with section 62J.4981 or with any other statute or administrative
14.28rule applicable to health information exchange service providers, or has submitted false
14.29information in any report required under sections 62J.498 to 62J.4982.
14.30(b) A certificate of authority shall be suspended or revoked only after meeting the
14.31requirements of subdivision 3.
14.32(c) If the certificate of authority of a health information exchange service provider is
14.33suspended, the health information exchange service provider shall not, during the period
14.34of suspension, enroll any additional participating entities, and shall not engage in any
14.35advertising or solicitation.
15.1(d) If the certificate of authority of a health information exchange service provider is
15.2revoked, the organization shall proceed, immediately following the effective date of the
15.3order of revocation, to wind up its affairs, and shall conduct no further business except as
15.4necessary to the orderly conclusion of the affairs of the organization. The organization
15.5shall engage in no further advertising or solicitation. The commissioner may, by written
15.6order, permit further operation of the organization as the commissioner finds to be in the
15.7best interest of participating entities, to the end that participating entities will be given the
15.8greatest practical opportunity to access continuing health information exchange services.
15.9 Subd. 3. Denial, suspension, and revocation; administrative procedures. (a)
15.10When the commissioner has cause to believe that grounds for the denial, suspension,
15.11or revocation of a certificate of authority exists, the commissioner shall notify the
15.12health information exchange service provider in writing stating the grounds for denial,
15.13suspension, or revocation and setting a time within 20 days for a hearing on the matter.
15.14(b) After a hearing before the commissioner at which the health information
15.15exchange service provider may respond to the grounds for denial, suspension, or
15.16revocation, or upon the failure of the health information exchange service provider to
15.17appear at the hearing, the commissioner shall take action as deemed necessary and shall
15.18issue written findings that shall be mailed to the health information exchange service
15.19provider.
15.20(c) If suspension, revocation, or an administrative penalty is proposed according
15.21to this section, the commissioner must deliver, or send by certified mail with return
15.22receipt requested, to the health information exchange service provider written notice of
15.23the commissioner's intent to impose a penalty. This notice of proposed determination
15.24must include:
15.25(1) a reference to the statutory basis for the penalty;
15.26(2) a description of the findings of fact regarding the violations with respect to
15.27which the penalty is proposed;
15.28(3) the nature and/or amount of the proposed penalty;
15.29(4) any circumstances described in subdivision 1, paragraph (a), that were considered
15.30in determining the amount of the proposed penalty;
15.31(5) instructions for responding to the notice, including a statement of the health
15.32information exchange service provider's right to a contested case proceeding and a
15.33statement that failure to request a contested case proceeding within 30 calendar days
15.34permits the imposition of the proposed penalty; and
15.35(6) the address to which the contested case proceeding request must be sent.
16.1 Subd. 4. Coordination. (a) The commissioner shall, to the extent possible, seek
16.2the advice of the Minnesota e-Health Advisory Committee, in the review and update of
16.3criteria for the certification and recertification of health information exchange service
16.4providers when implementing sections 62J.498 to 62J.4982.
16.5(b) By January 1, 2011, the commissioner shall report to the governor and the chairs
16.6of the senate and house of representatives committees having jurisdiction over health
16.7information policy issues on the status of health information exchange in Minnesota, and
16.8provide recommendations on further action necessary to facilitate the secure electronic
16.9movement of health information among health providers that will enable Minnesota
16.10providers and hospitals to meet meaningful use exchange requirements.
16.11 Subd. 5. Fees and monetary penalties. (a) Every health information exchange
16.12service provider subject to sections 62J.4981 and 62J.4982 shall be assessed fees as
16.13follows:
16.14(1) filing an application for certificate of authority to operate as a health information
16.15organization, $10,500;
16.16(2) filing an application for certificate of authority to operate as a health data
16.17intermediary, $7,000;
16.18(3) annual health information organization certificate fee, $14,000;
16.19(4) annual health data intermediary certificate fee, $7,000; and
16.20(5) fees for other filings, as specified by rule.
16.21(b) Administrative monetary penalties imposed under this subdivision shall be
16.22deposited into a revolving fund and are appropriated to the commissioner for the purposes
16.23of sections 62J.498 to 62J.4982.
16.24 Sec. 6. APPLICATION PROCESS FOR HEALTH INFORMATION
16.25EXCHANGE.
16.26To the extent that the commissioner of health applies for additional federal funding
16.27to support the commissioner's responsibilities of developing and maintaining state level
16.28health information exchange under section 3013 of the HITECH Act, the commissioner of
16.29health shall ensure that applications are made through an open process that provides health
16.30information exchange service providers equal opportunity to receive funding.
16.31 Sec. 7. APPROPRIATION; HEALTH INFORMATION EXCHANGE
16.32OVERSIGHT.
16.33$104,000 in fiscal year 2011 is appropriated from the state government special
16.34revenue fund to the commissioner of health for the duties required under sections 62J.498
17.1to 62J.4982. Base funding shall be $97,000 in fiscal year 2012 and $97,000 in fiscal
17.2year 2013.