This chapter applies to the State designation of management service organizations. Only a management service organization that is awarded State Designation status by the Maryland Health Care Commission pursuant to this chapter may represent itself as a State-Designated management service organization. In this chapter, the following terms have the meanings indicated. Terms Defined. “Commission” or “MHCC” means the Maryland Health Care Commission. “Electronic health record” or “EHR” means a complete electronic record system that: Contains health-related information on one or more individuals; and Is certified by an authorized testing and certification body designated by the Office of the National Coordinator for Health Information Technology. “Entity” means an individual, trust or estate, general or limited partnership, joint stock company, unincorporated association or society, municipal or other corporation, incorporated association, limited liability partnership, limited liability company, the State, an agency or political subdivision of the State, a court, and any other governmental body. “Executive Director” means the Executive Director of the Commission. “Management service organization” or “MSO” means an entity that provides technology and consultative services to health care providers, and makes available one or more hosted electronic health records systems and other health information technology solutions. “MSO State Designation certificate” means a certificate provided to the MSO by the Commission that documents award of State Designation. “MSO State Designation criteria” means the standards published by the Commission on its website and by notice in the Maryland Register that an MSO must meet to qualify for State Designation. “State Designation” or “State-Designated” means the status awarded by the Commission to an MSO that has met the MSO State Designation criteria required under this chapter. Application. An entity seeking MSO State Designation shall submit an application in a form and manner specified by the Commission. The application shall be signed by an individual authorized by the entity submitting the application. Requirements for State Designation. An applicant for MSO State Designation shall: Demonstrate that it meets all MSO State Designation criteria in effect at the date of application; Affirm that the applicant, a related entity, or a person or entity that is a principal, owner, operator, or part of management of the entity has never: Pleaded guilty to, been convicted of, or received probation before judgment or similar diversionary disposition for a crime related to the operation of an MSO or for a crime involving fraud, dishonesty, or false dealing; or Been found in violation of State or federal laws or regulations governing the operation of an MSO; Provide all required documentation; Timely provide additional information requested by the Commission as needed to complete the application; and Agree to comply with the requirements of this chapter. Review of Applications. Commission staff shall review an application to determine compliance with the State Designation criteria. The Executive Director may approve or deny an application for State Designation, as follows: The Executive Director shall award State Designation to an MSO that meets the requirements set forth in this chapter; and If the Executive Director determines that an application should be denied, the Executive Director shall, within 30 days of receipt of a complete application, notify the applicant in writing of the decision, and include the reasons for denial. Duration of State Designation. State Designation is valid for 2 years from the date of issuance of an MSO State Designation certificate, unless suspended or revoked by the Commission. An MSO awarded State Designation shall accept the designation in writing and agree to the comply with the requirements of this chapter. An application for renewal of State Designation shall: Be made at least 30 days before the expiration of the State Designation in a form and manner specified by the Commission; and Demonstrate compliance with the MSO State Designation criteria in effect at the date of application for renewal. Commission staff shall review a renewal application to determine compliance with the State Designation criteria. The Executive Director may approve or deny an application for renewal. The Executive Director shall renew the State Designation of each MSO that meets the requirements set forth in this chapter. If the Executive Director determines that a renewal application should be denied, the Executive Director shall, within 30 days of receipt of a complete application for renewal, notify the applicant in writing of the decision, supported by reasons for denial. An MSO whose initial or renewal application was denied may seek Commission review of the denial. A written request for Commission review of the denial of an application shall:. Be filed within 20 days of the receipt of the denial; State with particularity the grounds and factual basis for the applicant’s disagreement with the denial; and Be supported by relevant documentation and affidavits. The Commission may determine whether or not to affirm the denial of the application or approve the application: After considering the written filing by the MSO and any response by Commission staff; or After hearing oral arguments on the written filings by the MSO and staff. State Designation issued pursuant to this chapter may not be sold, assigned, leased, or transferred in any way. At least 60 days before the closure, sale, lease, assignment, or transfer of all or part of a State-Designated MSO to any person or entity that was not identified as an owner of the MSO at the time of the most recent certification by the Commission, the State-Designated MSO shall notify the Commission of the impending closure, sale, lease, assignment, or transfer of the State-Designated MSO and timely provide information required or requested by the Commission. If all or part of a State-Designated MSO is closed, sold, leased, assigned, or transferred in any person or entity that was not identified as an owner of the MSO at the time of the most recent certification by the Commission, the Commission shall review current State Designation status pursuant to the renewal requirements set forth in Regulation .04 of this chapter. Commission staff may, on its own initiative or in response to information provided to the Commission, investigate any State-Designated MSO or applicant for State Designation. Following an investigation, the Executive Director may issue a notice of proposed action, which may include the following: A time-limited opportunity to correct deficiencies identified by the investigation; Suspension of the State Designation of an MSO for a definite period of time after which, depending upon the circumstances of the case and completion of appropriate corrective actions, the MSO may seek reinstatement of its State Designation; or Revocation of State Designation. An MSO that receives a notice of proposed action from the Executive Director may request an opportunity to show cause why the proposed action should not be implemented. A written request to show cause shall be filed with the Commission within 20 days of the issuance of the notice of proposed action and shall: State with particularity the grounds and factual basis for the applicant’s disagreement with the denial; Include each fact upon which the person relies to show cause why the proposed action should not be taken; and Be supported by relevant documentation and affidavits. The Commission may determine whether or not to impose the proposed action or a different action: After considering the written show cause filing by the MSO and any response by Commission staff; or After hearing oral arguments on the written filings by the MSO and staff. Health-General Article, §§4-302, 19-103(c)(2)(i) and (ii), 19-109(a)(1), 19-135(a), (b), and (d), and 19-143(h), Annotated Code of Maryland Effective date: November 15, 2010 (37:23 Md. R. 1610) Regulations .01 — .11 repealed and new Regulations .01 — .08 adopted effective August 18, 2014 (41:16 Md. R. 946)