This regulation establishes standards for providers using Data Management systems. Definitions. In this regulation, the following terms have the meanings indicated. Terms Defined. “Data management system” means a health information technology solution used by the Maryland Department of Health (Department), its agents, providers, and Program participants that stores provider or participant protected health information (PHI) or personally identifiable information (PII) and related business processes. “Electronic visit verification (EVV)” means an electronic service entry method used to record service details, including but not limited to service type, provider and participant information, date of service, service delivery location, and beginning and ending times of service that meets the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines. Electronic visit verification (EVV) services means services that are: Covered Medicaid services, according to the respective authority, including but not limited to the Medicaid State Plan, a Medicaid waiver program, or regulations; and Required to be electronically recorded in the Department’s EVV system or approved financial management and counseling services contractors’ EVV solutions pursuant to 42 U.S.C. §1396b(l) and other State and federal laws, regulations, or guidance except in circumstances when the services, provided under the agency, traditional, or self-directed delivery model, are provided by a live-in caregiver or worker and exempted by the Department, or otherwise exempted by the Department and the participant elects to forego the electronic process. “Financial management and counseling services (FMCS) contractors” means agencies that provide financial management and counseling services to support individuals who choose the self-direction delivery model. “Live-in caregiver” means a paid personal caregiver who permanently, or for an extended period of time approved by the Department, resides in the same residence as the Medicaid participant for whom they are providing services and supports. “Preauthorized” means approved by the Department or its designee before services are rendered. “Worker” means an individual, who may be referred to as a caregiver, who is employed by or contracts with a provider or self-directing participant. Requirements for Using Data Management Systems. Providers shall: Register and credential all system users in the manner specified by the Department with valid and accurate information; Properly train all workers registered as system users on proper protocols for conducting system activities, including: Accurate entry of information into the system; Proper use of hardware and equipment required to use the system; EVV, including but not limited to recording and modifying billing entries, participant and provider information, or other records, in accordance with the policies and procedures issued by the Department, unless otherwise exempted by the Department; and Protection of protected health information in compliance with State and federal law, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA); Comply with the laws and regulations concerning the privacy and security of protected health information under State and federal law, including HIPAA; and Ensure that any provider-owned systems and devices responsible for sending, retrieving, or storing data from a State-operated data management system comply with all Department, State and federal regulations, policies, and procedures regarding information technology privacy and security. Requirements for EVV Use. Agency providers and workers shall use the EVV method and data management system approved by the Department, unless otherwise exempted by the Department, to: Meet the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines; and Submit claims. The Department shall reimburse for EVV services if the service is: Electronically recorded through the EVV method and data management system approved by the Department in accordance with Department regulations, policies, and procedures; Recorded using a manual or alternate electronic timekeeping process and data management system approved by the Department in accordance with Department regulations, policies, and procedures when the live-in caregiver exemption is applicable and elected; Preauthorized in the manner designated by the Department for the service type; Directly provided to the participant in-person, unless otherwise authorized by the Department; and Delivered in accordance with all applicable Department regulations, policies, and procedures for the service type. The Program does not cover services, even those exempted from EVV, provided: During periods of participant ineligibility; During time periods that overlap with the worker’s time period for the same or another participant unless otherwise authorized by the appropriate program authority for the service type; or During time periods that overlap with the same or another worker’s time period for the same participant unless otherwise authorized by the appropriate program authority for the service type.