This chapter sets forth the requirements for certification of drug and alcohol treatment programs. In this subtitle, the following terms have the meanings indicated. Terms Defined. “Addiction Severity Index” means a standardized method for the assessment of adults regarding addictions severity and patient need. “Administration” means the Alcohol and Drug Abuse Administration within the Maryland Department of Health. “Administrator” means the program director of an alcohol or drug abuse facility or a health care facility. “Admission” means the documented acceptance of an applicant into a program. “Adolescent” means an individual 12 — 17 years old. “Alcohol abuse” means a disease that is characterized by a pattern of pathological use of alcohol with repeated attempts to control its use, and with significant negative consequences in at least one of the following areas of life: medical, legal, financial, or psychosocial. “Alcohol dependence” means a disease characterized by: Alcohol abuse; and Physical symptoms of withdrawal or tolerance. “American Society of Addiction Medicine Patient Placement Criteria” means an instrument designed to indicate patient placement guidelines for admission, continued stay, and discharge. “Assessment” means the process of ascertaining the treatment needs of the patient regarding addiction and other social issues. “Caseload” means the number of patients for whom a drug and alcohol counselor has the responsibility for providing clinical services and case management. “Case management” means the process of coordinating and monitoring the services provided to a patient both within the program and in conjunction with other providers. “Certification” means the approval issued to a program by the Administration to provide services under this subtitle. “Child” means an individual younger than 12 years old. “Clinical director” means the individual who is responsible for the therapeutic and rehabilitative aspects and direction of a program. “Clinical staff” means the individuals employed by or associated with a program who provide treatment, care, or rehabilitation to program patients or patients' families. “Clinical supervisor” means the individual responsible for providing supervision to alcohol and drug clinical staff as clinically appropriate. “Continuous quality review” means objective and systematic monitoring and evaluation of the quality and appropriateness of patient care, the purpose of which is the improvement of that care, prevention of problems, and resolution of problems. “Controlled dangerous substance” means any drug, substance, or immediate precursor in Schedules I — V under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. Correctional Facility. “Correctional facility” means an institution overseen by the State or one of the 24 subdivisions where individuals are incarcerated. “Correctional facility” includes a jail, detention center, prison, or correctional halfway house. “Credentialing” means a process of review to determine the professional level at which an employee may practice. “Crisis intervention training” means training of staff to respond adequately to emergency situations, including: Medical emergencies; Emotional and psychological crises; and Emergencies arising from environmental circumstances such as fires, floods, terrorism, and other disasters. Critical Incident. “Critical incident” means a life, safety, or health threat involving the staff or patients participating in a program. “Critical incident” includes, but is not limited to, death or physical or sexual assault. “Critical incident report” means the documentation of a critical incident. “Department” means the Maryland Department of Health. “Detoxification” means the process of withdrawing addictive psychoactive substances from the body in a safe and effective manner. “Director” means the Director of the Administration. “Discharge plan” means a written description of specific goals and objectives to assist the patient upon leaving treatment. Dispense. “Dispense” means to deliver a controlled dangerous substance or other drug to the ultimate user by a practitioner pursuant to a lawful order of the practitioner. “Dispense” includes prescribing, administering, packaging, labeling or compounding necessary to prepare the substance for delivery. “Documentation” means written or recorded information that is dated. “Drug” means: A controlled dangerous substance that is regulated under the Maryland Controlled Dangerous Substances Act; A prescription medication; or A chemical substance when used for unintended and harmful purposes. “Drug abuse” means a disease which is characterized by a pattern of pathological use of a drug with repeated attempts to control its use, and with significant negative consequences in at least one of the following areas of life: medical, legal, financial, or psychosocial. “Drug dependence” means a disease characterized by: Drug abuse; and Physical symptoms of withdrawal or tolerance. “Family” means an individual's immediate relatives or significant others. “Family counseling” means a distinct discipline that utilizes accepted family system theories and intervention techniques. “Governing body” means the organizational structure that is responsible for establishing policy, maintaining quality care, and providing management and planning for the program. “Individualized treatment plan” means a written plan of action that is developed and modified to address a patient's specific service needs. “Intermediate care facility” means a facility that provides a planned regimen of 24-hour professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. “Maintenance” means medically supervised continuation of the administration of methadone, LAAM, or other drugs approved by the Administration. “Medical director” means a physician who oversees the medical practice of a program. “Methadone” means a synthetic opioid. “Nurse” means an individual who is licensed by the State Board of Nursing to practice registered nursing or licensed practical nursing as defined in Health Occupations Article, §8-101, Annotated Code of Maryland. “Nurse practitioner” means a registered nurse who is certified as a nurse practitioner as defined in Health Occupations Article, §8-508, Annotated Code of Maryland. “Office of Health Care Quality” means the office under the Department that oversees certification and inspection of programs for the Administration. “Patient” means an individual who is admitted into a program. “Physician” means any person authorized by law to practice medicine in this State under Health Occupations Article, §14-101, Annotated Code of Maryland. “Physician assistant” means an individual licensed to act as an assistant to a licensed physician in Maryland, as defined in Health Occupations Article, §15-101, Annotated Code of Maryland. “Possess” means the exercise of actual or constructive dominion or control over a controlled dangerous substance. “Prevention program” means the Early Intervention Level 0.5 level of treatment as described in COMAR 10.47.02.03. “Privileging” means the process of review to determine the duties a volunteer or employee may perform. “Problem Oriented Screening Instrument for Teenagers” means a standardized method of screening to determine whether or not an adolescent may have alcohol or other drug abuse or dependence or both and will need further evaluation. Program. “Program” means any organization or individual that provides treatment, care, or rehabilitation for individuals who show the effects of drug abuse or alcohol abuse, and represents or advertises itself as an alcohol or other drug abuse treatment program. “Program” includes a: Program or facility that is owned or operated by the State or any of its political subdivisions; and Detoxification facility as defined in Health-General Article, §8-101(g), Annotated Code of Maryland. “Progress note” means an objective documentation of the patient's progress in relation to specific treatment goals and objectives. “Screening” means the utilization of a valid tool or instrument approved by the Administration to determine whether or not an individual may have alcohol or other drug abuse or dependence or both and will need further evaluation. “Secretary” means the Secretary of Health. “Self-help group” means a voluntary fellowship or group that supports patients in recovery from alcohol and other drug abuse or dependence. “Therapeutic agent” means an intervention that is used to effect positive change. “Treatment plan goal” means an intended resolution of a patient's clinical condition or problem that is completed within a specific amount of time and will contribute to the completion of treatment in a program. “Treatment plan objective” means a behaviorally measurable symptom or social, legal, or family change that results in a stepwise achievement of a treatment goal. “Utilization review” means a systematic assessment of the appropriateness of patient admissions, continuation in treatment, and referral to specific treatment services within a program. “Variance” means an alternate method of meeting the intent of a regulation under this subtitle. “Waiting list” means a list of individuals who are appropriate for services from a program but for whom a treatment slot is not available for 4 or more weeks for outpatient programs, or 2 or more weeks for residential programs. “Waiver” means the exemption from compliance with a regulation under this subtitle. The program shall: Have a governing body legally responsible for overseeing the management and operation of the program and for ensuring compliance with applicable laws and regulations by: Approving the program's: Mission; Goals; Policies and procedures; Budget; and Program service plan; Adopting written bylaws; Overseeing the operation of the program, according to the stated purposes of the program; Ensuring proper management of the program by developing a job description for the administrator, and hiring, supervising, and providing for periodic performance evaluation of the administrator; and Ensuring sound fiscal operation; Implement fiscal policies and procedure which include: The maintenance of fiscal records according to generally accepted accounting principles in Article 19, §28A, Annotated Code of Maryland, and COMAR 10.02.01 and 10.04.04; Appropriate fire, casualty, liability, unemployment, and workers' compensation insurance; In the event of fiscal instability, immediately notifying the Office of Health Care Quality; Maintaining and posting a list of services and associated charges; and Maintaining an annual program budget reflecting anticipated expenditures and sources of income; Implement personnel policies and procedures that include: Personnel policies and procedures that promote the objectives of the program; Personnel policies that include: The qualifications required for each position; An employee assistance policy and procedure; A policy to prevent discrimination prohibited by Article 49B, Annotated Code of Maryland, and federal law; A policy designed to prevent sexual harassment of staff and patients and appropriately manage complaints of sexual harassment; A staff grievance procedure; A mechanism for assuring annual employee tuberculosis testing; Before employment, applying for national and State criminal history records checks; As part of the employment or volunteer application process, requiring the applicant to complete and sign a sworn statement or written affirmation disclosing the existence of a criminal conviction, probation before judgment disposition, not criminally responsible disposition, or pending charges without a final disposition; Requiring the employee to comply with §A(3)(b)(viii) of this regulation annually; and Providing information to the employee so the employee may determine whether he or she needs testing or vaccination or both for hepatitis; Maintaining a personnel file, in accordance with State and federal confidentiality requirements, for each employee, contractual staff, intern, or volunteer, that includes the individual’s: Written application or resume including, name, home address, current telephone number, educational and training background, and employment history; Emergency contact information; Copies of required credentials; Current job title and description; Current wage and salary information; Annual performance evaluation; Contracts, if applicable; Results of a criminal background check; Results of tuberculosis tests; and Documentation of attendance at continuing education courses or other training; and Not permitting any individual with a documented history of physical, mental, or sexual abuse or neglect of adolescents or children to work with children and adolescents; Manage the program by: Implementing a policy and procedure manual that contains: An all hazards emergency protocol plan, approved by the Administration and updated at the time of recertification, that includes the name of the contact person for access to medical and clinical records, the written agreement or agreements with another facility to provide services in case of an emergency, notification procedures for the State Methadone Authority, program staff, and patients, a policy regarding patient access to emergency mental health services necessitated by a hazardous event, and a policy assuring that correctional levels of care comply with the institution’s all hazards emergency plan; The program's mission and goals; A description of the organizational structure of the program; Identification of the duties of the administrator and, if applicable, the medical director or clinical director; Admission, transition, discharge, and termination procedures; Procedures governing patient rights and grievances; If applicable, a procedure for storing, handling, prescribing, dispensing, administering, and disposing of medications; Procedures for assisting program enrollees with access to entitlements, insurance benefits, and reimbursements for which the individual is eligible, if the program provides case management services; and Procedures for staff orientation, supervision, training, and education that include, but are not limited to, ethics and State and federal laws regarding confidentiality including, but not limited to, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, 42 CFR Part 2, The Health Insurance Portability Assurance and Accountability Act (HIPAA), and 45 CFR Parts 160 and 164; and Implementing a program service plan, approved by the Administration, that is based on the levels of treatment to be provided as defined in COMAR 10.47.02.03 — .11 and describes how the program shall comply with the regulatory requirements, is updated annually, and includes: A description of medical staff, if required by the level of treatment; A description of the program's scope that includes target populations and other program characteristics; Staff positions, their job descriptions, and educational and clinical training requirements, including an organizational chart detailing lines of authority and responsibility; A list of services to be delivered, including the types of medication and controlled dangerous substances to be prescribed, the types of group sessions, including education, the types of individual sessions and a complete family services plan; Names of clinical supervisors and the number of alcohol and drug counselors supervised; Types of services that are available by referral; and Planning protocol for transfer or discharge of patients; Implement a continuous quality review process that includes: Designated teams responsible for implementation; An ongoing procedure for utilization review; A plan to identify problems and initiate actions to correct deviations from the program’s established standards, which includes: Data collection; Current information regarding efficient and effective service delivery; Indicators relevant to the needs of the population served; and Ongoing internal review of the program, including monitoring for effectiveness of changes incorporated; and An opportunity for all staff to participate on the teams described in §E of this regulation; and Report critical incidents to the Administration within 5 business days of the incident; Limit an individual’s role on the governing body to being a nonvoting member if the individual has an immediate family member who: Is employed by the program; Consults on behalf of the program; Owns the program; or Sits on an advisory committee for the program; and Refuse to allow an individual to serve on the program’s governing body if the individual receives any monetary benefit from the program. The program may not allow: An immediate family member of an employee of an organization to serve as a voting member of the governing body, board of directors, or advisory committee; or An individual who is compensated for providing goods or services to the program to serve on the governing body, board of directors, or advisory committee. Admission. The program: Shall upon request for admission: Establish an interview date that falls within 10 working days of the individual's initial contact; Refer or recommend another program to the individual; or Place the individual on a waiting list; Shall have a detailed description of patient placement criteria for admission to the program, including: Eligibility criteria, using guidelines such as the American Society of Addiction Medicine Patient Placement Criteria or other guidelines approved by the Administration; and Procedures for admission; Shall include in its admission procedures: An intake process; An emergency intake process, including a procedure to refer individuals who are not suitable for its program to a more suitable program; A procedure for developing and maintaining a waiting list; and A fee schedule; and May not admit a patient unless the individual meets the admission criteria of the American Society of Addiction Medicine Patient Placement Criteria or other guidelines approved by the Administration. Assessment. A program shall prepare a comprehensive assessment for each patient, unless the patient is being readmitted to the same program or admitted to a different program within 30 days of the patient's last discharge, or has received an assessment by a licensed or certified clinician or program within 30 days, in which case the program may update the prior assessment. The comprehensive assessment shall assess the following areas: Physical health; Employment or financial support; Drug and alcohol; Treatment history; Legal; Family and social; Educational; and Mental health. Programs shall use the Addiction Severity Index as the standardized assessment instrument for adults, or an equivalent assessment instrument chosen by the Administration. Programs shall use the Problem Oriented Screening Instrument for Teenagers as the standardized screening instrument for adolescents, or an equivalent screening instrument chosen by the Administration. The initial physical health assessment shall meet the requirements of the appropriate level of treatment. Treatment Plans. A program shall develop a written treatment plan, with the participation of the patient, based on the comprehensive assessment and patient placement criteria, that shall set forth: The patient's individualized needs, including: Socialization; Alcohol and drug abuse or dependence; Psychological; Vocational; Educational; Physical health; Legal; and Family; and Individualized interventions, including: Long-range and short-range treatment plan goals and objectives; Strategy for implementation of treatment plan goals and objectives; Target dates for completion of treatment plan goals and objectives; A schedule of clinical services including individual, group, and, if appropriate, family counseling; Criteria for successful completion of treatment; Referrals to ancillary services, if needed; and Referrals to self-help groups, if recommended. If the alcohol and other drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall: Determine the reason for a delay in development of a treatment plan; Document the reason in the patient's record; and Direct an appropriate clinical staff person to develop a treatment plan within 7 working days of the clinical director's or clinical supervisor's documentation of the delay. The length of stay in the program shall be based on the patient's level of illness severity and response to treatment. Infectious Disease Education. Within the first 30 days of treatment, a program shall ensure and document in the patient record that human immunodeficiency virus, hepatitis, sexually transmitted diseases, and tuberculosis education was completed, including: Risk assessment; Risk reduction; and If appropriate, referral for counseling and testing. Family Involvement and Utilization of Self-Help Groups. A program may provide education and support services to a patient's family directly or through referrals to appropriate community agencies. A program shall: Develop procedures for obtaining an assessment of the treatment needs of the patient's family; Provide access or referral to family counseling; Describe how family members are involved in the patient's recovery process; and Develop procedures to encourage ongoing active participation by the patient and the patient's family in self-help groups and support activities. Referrals. Referral documentation shall include the: Reason for referral; Name of the individual; Referring program; Receiving program; and Final disposition of referral. Discharge. A program shall complete a written discharge summary. The discharge summary shall include: The reason for admission; The reason for discharge; The individual's address; A summary of services delivered, including frequency and duration of services, and progress made; If appropriate, the diagnosis and prognosis at the time of discharge; Current medications, if applicable; Continuing service recommendations and summary of transition process; and The extent of the individual's involvement in the discharge plan. The discharge summary shall be completed within 30 days of the patient's discharge from the program. In the event of a patient's transfer from the program to another program, the discharging program shall complete a written transfer summary. The transfer summary shall include: The reason for admission; The reason for discharge; The individual's address; The diagnosis and prognosis at the time of discharge; and Current medications, if applicable. The transfer summary shall be completed at the time of the patient's discharge from the program. Child and Adolescent Services. A parent or guardian of a child or adolescent, with the child or adolescent's consent, may apply on behalf of the child or adolescent for admission to a certified program. A program exclusively for children and adolescents shall: Maintain written treatment protocols providing for the needs of adolescents and children, emphasizing the use of family interventions; Provide for the educational needs of adolescents in compliance with local, State, and federal laws and regulations; Comply with criminal background requirements for all staff; and Meet any other requirements requested by the Administration. A program that admits children and adolescents: May not admit a child or adolescent into treatment unless the treatment plan indicates that the program is appropriate for the child or adolescent; Shall provide separate social, residential, dietary, and recreational activities for the child or adolescent, if appropriate; Shall obtain informed consent from the child or adolescent, or the parents or guardians for the child or adolescent, to be admitted to the program; Shall comply with criminal background requirements for all staff; and Shall meet any other requirements requested by the Administration. A program that does not admit children and adolescents shall: Identify in its program service plan the elements of the program that make treatment, care, and rehabilitation for children or adolescents contraindicated; and Meet any other requirements requested by the Administration. Programs that provide services to adults and permit the adult's children or adolescents to be present at the program shall verify that the children and adolescents: Receive proper supervision; Are appropriately enrolled in education services; and Have access to appropriate health care. Medication Control and Staff Requirements. A program shall develop and implement a written policy and procedure governing the use of controlled dangerous substances and other drugs used by the program. The policies shall include: A list of controlled dangerous substances and other drugs administered, dispensed, or stored at the program; Procedures to account for and secure the drugs from time of order until dispensing; Computer security and accountability, if applicable; Other policy and procedures required by the Administration; and Procedures for all Level III programs to hold securely all take-home opioid therapy medication for patients who are on opioid maintenance therapy. A program shall dispense medications to the patient according to the instructions, supervision, and directions of the licensed physician. If staff observes an adverse reaction to medication, the program immediately shall contact a licensed physician or emergency medical service to ensure the patient receives treatment. Medication Errors. For a medication error regarding administration, dispensing, documentation, inventory, or storage, an appropriate clinical staff person shall complete a report at the time of the incident. The report shall be filed and brought to the immediate attention of the: Administrator; and Medical director, if a medical director is employed by the program. Programs shall report the diversion of any controlled substance to the Administration as soon as the diversion is discovered. Life Safety Requirements. A program shall: Have a facility free from fire hazards and have: Adequate smoke detectors; Working and updated fire extinguishers; A written fire evacuation plan; and A current fire inspection certification; Comply with applicable federal, State, and local sanitation, building, fire codes, and zoning requirements; Maintain documentation of legally required periodic evacuation drills, if applicable; and Within the first 30 days of employment, provide staff training in emergency evacuation procedures. Special Accommodations. A program shall have protocols, which may include referral agreements with other programs, that provide for admission and treatment of individuals with: Limited English proficiency or hearing and speaking disabilities; and Physical and mental disabilities. Residential Treatment Programs. A program shall have: Nurses' stations, if appropriate; A dining room; Bathrooms; Telephones; A living room; Space for privacy for visits; Space for leisure time activities; Offices for both administrative and counseling personnel; and Sleeping quarters that: Do not allow for more than six patients to share the sleeping quarters, except for therapeutic communities that use dormitory style sleeping areas; Provide adolescents and adults with separate sleeping quarters; Provide privacy for patients; Provide beds that: Are at least 3 feet apart; Are located more than 18 inches away from radiators and registers; Are at least 36 inches wide, and not rollaway-type beds, cots, or folding beds; Have mattresses that are clean, in good repair, and the same size as the bed frame; and Have at least two sets of sheets; Have at least two dresser drawers and an enclosed space for hanging clothes; and Have a mirror and window coverings in good repair; A method for safely storing a patient's valuables; and A written plan for providing temporary shelter for patients if a facility becomes uninhabitable. Dietary Services. If meals are provided, a program shall: Comply with applicable local, State, and federal laws; Have a written plan describing the organization and delivery of dietary services; and Require a dietitian licensed under the Health Occupations Article, §5-101, Annotated Code of Maryland, to develop and implement the dietary service plan. Infection Control — Universal Precautions. A program shall observe universal precautions as required under COMAR 10.07.02.21-1. Administrator. A program shall have an administrator. Qualifications. The administrator shall: Possess a working knowledge of all applicable State and federal laws; Possess a working knowledge of program management skills; Be employed as an administrator before October 1, 2002; or Have at a minimum: A bachelor's degree from an accredited educational institution; and At least 5 years of documented experience in human services, 2 years of which include providing administrative or clinical supervision. Duties. The administrator shall ensure that the program complies with all applicable State and federal laws. Clinical Director. A program may have a clinical director. The clinical director functions under the administrative supervision of the administrator. Qualifications. The clinical director shall have at a minimum: A master's degree in counseling or a related discipline regulated under the Health Occupations Article, Annotated Code of Maryland, and certification or licensure as an alcohol and drug counselor by the Board of Professional Counselors and Therapists; or Approval to supervise by the Board of Professional Counselors and Therapists. Clinical Supervisor. A program shall have a clinical supervisor. Qualifications. The clinical supervisor shall: Be employed as a clinical supervisor before October 1, 2002; or Have at a minimum: A master's degree in counseling or a related discipline regulated under the Health Occupations Article, Annotated Code of Maryland, and certification or licensure as an alcohol and drug counselor by the Board of Professional Counselors and Therapists; or Approval to supervise by the Board of Professional Counselors and Therapists. Duties. A clinical supervisor may carry a caseload at the discretion of the administrator. Clinical Staff. Qualifications. All staff employed as alcohol and drug counselors shall, at a minimum be: Licensed or certified as an alcohol and drug counselors by the Board of Professional Counselors and Therapists; Approved by the Board of Professional Counselors and Therapists; or Licensed, certified, or permitted under the Health Occupations Article, Annotated Code of Maryland to provide substance abuse treatment. Credentials. The administrator shall ensure that program staff, including students, interns, and volunteers, are credentialed and appropriately privileged. Policies and Procedures. All clinical staff, including the administrator, clinical director, and clinical supervisor, shall review the program's policies and procedures and shall sign a statement saying that they reviewed and understood the policies and procedures. Patient Rights. A program shall: Treat each patient with consideration, respect, and full recognition of the patient's human dignity and individuality; Provide treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; Prevent physical or mental abuse by the program staff; Provide an atmosphere free from discrimination; Not allow use of any physical restraints; Ensure privacy and confidentiality; and Allow the patient the right to refuse participation in any experimental research unless the research complies with 45 CFR Part 46. A program shall post in a conspicuous area and provide to each patient a statement of patients' rights. Grievance Procedures. A program shall: Have a grievance procedure approved by the Administration; Provide the patient upon admission a description of grievance policy and procedure that includes the: Patient's right to grieve program decisions including but not limited to: Discharge; and Change in status; Steps of the grievance process; and Levels to which the grievance may be taken; Take no retaliation against a patient who presents a grievance; and Inform each patient if revisions are made to the grievance policy and the nature and extent of the revisions. Nondiscrimination. A program may not discriminate in the provision of services on the basis of race, creed, color, age, gender, sexual orientation, national origin, marital status, disabilities, and any other classification prohibited under State or federal law including: Americans with Disabilities Act, 28 CFR 35; and Fair Housing Act, 42 U.S.C. §3604. Program Records. A program shall either manually or electronically maintain a record for each patient that includes, but is not limited to: A patient identifier, which may be a name, number, or an identifying code; Intake information, including the patient's name, date of admission, summary of medical examinations, allergies to medication, and laboratory reports; Assessments, individualized treatment plans, progress notes, and consent to disclose information if needed; Documentation of each program contact with the patient; Critical incident reports documented on the day of the incident; and A discharge summary. A program shall maintain Medicaid patient records for at least 6 years following discharge, and all other patient records for at least 3 years as required by Health-General Article, §4-403, Annotated Code of Maryland, and shall: Maintain, transfer, and destroy all records in a manner consistent with the medical records confidentiality and disclosure requirements of: Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; Health-General Article, §4-403, Annotated Code of Maryland; 42 CFR Part 2; The Health Insurance Portability and Accountability Act (HIPAA); and 45 CFR Parts 160 and 164; Locate all records so that they are convenient and available to designated staff; and Provide a designated staff member responsible for appropriate records control, including storage, security, and indexing records. Management Information System. The program shall: Participate in the Administration's management information system; Comply with reporting requirements as required by the Department; and Complete and submit the driving while intoxicated data collection form chosen by the Administration for those arrested for driving while intoxicated or driving under the influence. Electronic Records. Electronic records shall be maintained according to requirements set forth in this regulation. A companion hard copy file shall be maintained at the program and shall contain the following: Informed consent to treatment signed by the patient; Any requests for or releases of information shared with other entities signed by the patient; Any treatment plan or treatment plan update signed by the patient; and Any program agreements or patient/counselor behavioral contracts signed by the patient. The Administration shall annually evaluate all publicly funded substance abuse treatment programs certified under this subtitle, using federal outcomes measures or other subsequently adopted federal standards, to determine the extent that individuals who have received treatment under these programs have: Been successfully retained in the treatment program; Been successfully discharged from the treatment program; Reduced their substance use; Successfully attained, maintained, or increased their employment; Demonstrated a decrease in engaging in criminal activity; and Successfully established or maintained stable living arrangements. All publicly funded programs shall fully comply with the Administration’s reporting requirements completing all data fields required within the Administration’s management information system as directed. A program shall coordinate patient care with other community service providers to ensure that the widest range of appropriate services are available to patients. Referral Agreements. A program shall establish referral agreements with other human service agencies as required by COMAR 10.47.02. The program shall make the referral agreements available to the Administration for review. A program shall have referral agreements with other programs for individuals with disabilities whom the program may be unable to accommodate. Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland Effective date: April 8, 1985 (12:7 Md. R. 703) Regulations .26H, .30L, and .31K amended effective June 17, 1985 (12:12 Md. R. 1165) Regulations .01—.33, Certification of Alcoholism and Alcohol Abuse Facilities, repealed and new Regulations .01—.09, Requirements, adopted effective June 10, 2002 (29:11 Md. R. 882) Regulation .02B amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .03 amended effective December 12, 2013 (40:24 Md. R. 2017) Regulation .04 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .05A amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .06A, D amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .07A amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .08-1 adopted effective December 12, 2013 (40:24 Md. R. 2017) This chapter sets forth additional requirements that a program shall meet to be certified to offer a particular level of treatment. The program shall meet the requirements of COMAR 10.47.01 and 10.47.03. In this chapter, terms have the meanings stated in COMAR 10.47.01.02. Prevention Program Description. The prevention program shall treat patients who are, for a known reason, at risk for developing alcohol or other drug abuse or dependence but for whom there is not yet sufficient information to document alcohol or other drug abuse or dependence. Patients who are appropriate for this level of treatment shall meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level 0.5, or its equivalent as approved by the Administration. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. Program services include: Assessments as described in COMAR 10.47.01.04 within 2 weeks of admission; An individualized treatment plan as described in COMAR 10.47.01.04, completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 90 days; Group or individual counseling, or both, as clinically indicated; Family counseling, as clinically indicated; Alcohol and drug education; and Referral for further assessment or to another level of treatment, as clinically indicated. Documentation. The clinical staff providing the service shall write a patient progress note after each counseling session and shall place the note in the patient's record. Referral Services. The prevention program shall offer the following services or maintain a listing of agency referral agreements for the following services: Mental health services; Social services; and Substance abuse treatment programs. Program Description. The program shall provide outpatient evaluation and treatment to patients who require services for less than 9 hours weekly for adults and 6 hours weekly for adolescents. Patients who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level I, or its equivalent as approved by the Administration; and Have a physical and emotional status that allows them to function in their usual environment. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. The adult patient to alcohol and drug counselor ratio may not exceed 30 adult patients weekly to one full-time alcohol and drug counselor. The child and adolescent patient to alcohol and drug counselor ratio may not exceed 25 adolescent patients weekly to one full-time alcohol and drug counselor. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 2 weeks of admission; An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 90 days; Case management services; Group or individual counseling sessions; Family services that shall include an assessment for family treatment needs and, as clinically appropriate: Alcohol and drug education; and Family counseling. Documentation. The clinical staff providing the service shall write a patient progress note after each counseling session and shall place the note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Medical examinations; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Substance abuse treatment programs; Legal assistance; and Social services. Program Description. A program shall provide structured outpatient evaluation and treatment to patients who require programming: From 9 to 20 hours weekly for adult intensive outpatient services; From 6 to 20 hours weekly for adolescent intensive outpatient services, based on the adolescents' developmental and clinical needs; and From 20 to 35 hours weekly for adult and adolescent partial hospitalization services. Patients who are appropriate for this level of treatment shall meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for either Level II.1 or Level II.5, or its equivalent as approved by the Administration. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. The patient to alcohol and drug counselor ratio may not exceed 15 patients to one full-time alcohol and drug counselor. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 1 week of admission; An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 5 working days of the comprehensive assessment and updated every 30 days; Case management services; At least one group counseling session a week; At least one individual session every 2 weeks; Family services, which may include an assessment for family needs and, as clinically appropriate: Alcohol and drug education; and Family counseling. Documentation. A designated clinical staff person shall: Write a patient progress note at the end of each week that services are provided; and Place the progress note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Medical services with medical consultations available: Within 24 hours of a request for service by telephone for intensive outpatient services; Within 72 hours of a request for service in person for intensive outpatient services; Within 8 hours of a request for service by telephone for partial hospitalization services; and Within 48 hours of a request for service in person for partial hospitalization services; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services with psychiatric consultations available: Within 24 hours of a request for service by telephone for intensive outpatient services; Within 72 hours of a request for service in person for intensive outpatient services; Within 8 hours of a request for service by telephone for partial hospitalization services; and Within 48 hours of a request for service in person for partial hospitalization services; Substance abuse treatment programs; Legal assistance; and Social services. Program Description. Clinically managed low intensity treatment programs shall offer treatment services at least 5 hours a week directed toward preventing relapse, applying recovery skills, promoting personal responsibility, and reintegration. Patients who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.1, or its equivalent as approved by the Administration; and Be capable of self-care but not ready to return to family or independent living. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. A clinically managed low intensity treatment program shall employ: One individual as clinical supervisor who may also be the program's administrator; Another individual as house manager; At least one staff member to be on duty at all times; and At least one staff member who is certified in cardiopulmonary resuscitation, and who has been trained in crisis intervention to be on duty between 11 p.m. and 7 a.m. The patient to alcohol and drug counselor ratio may not exceed 15 patients to one full-time alcohol and drug counselor. Staff may not dispense medications. Program Services. A clinically managed low intensity treatment program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 2 weeks of admission; An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 60 days; Periodic group counseling that focuses on relapse prevention; Case management services; Individual counseling, at least monthly; and Leisure and recreational activities. Documentation. The clinical staff providing the service shall write a patient progress note after each counseling session and shall place the note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Physical examinations as determined by medical condition, within a reasonable time; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services, which shall include: Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and Services appropriate to the severity and urgency of the patient's mental condition; Legal assistance; Substance abuse treatment programs; Social services; Family services; and Education. Program Description. A clinically managed medium intensity treatment program provides a structured environment in combination with medium intensity treatment and ancillary services to support and promote recovery. Patients who are appropriate for this level of treatment: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.3, or its equivalent as approved by the Administration; Are chronic alcohol or other drug dependent individuals; Do not need skilled nursing care; May have a history of multiple admissions to alcohol or drug abuse or dependence programs as defined in COMAR 10.47.01; May have physical and mental disabilities as a result of prolonged alcohol or other drug use; and Have been identified as individuals for whom a controlled environment and supportive therapy are necessary for an indefinite period of time. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. The patient to alcohol and drug counselor ratio may not exceed 15 patients to one full-time alcohol and drug counselor. At least one staff member certified in cardiopulmonary resuscitation and trained in crisis intervention shall be on duty between 11 p.m. and 7 a.m. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 1 week of admission; An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 3 working days of the comprehensive assessment and updated every 30 days; Alcohol and drug education; Individual counseling; Leisure and recreation counseling; and Assistance with vocational issues. Documentation. A designated clinical staff shall write a patient progress note at the end of each week services are provided and place the progress note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Physical examinations as determined by medical condition, within a reasonable time; Medical care; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services, which shall include, as appropriate to the severity and urgency of the patient's mental condition: Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and At least one of the following services: Services available by telephone within 8 hours of a request; or Services available onsite or closely coordinated off-site within 24 hours of a request; Substance abuse treatment programs; Legal assistance; Family services; and Social services. Program Description. A clinically managed high intensity residential program shall: Provide a highly structured environment in combination with moderate to high intensity treatment and ancillary services to support and promote recovery; and Be characterized by its reliance on the treatment community as a therapeutic agent. Patients who are appropriate for this level of treatment meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.5, or its equivalent as approved by the Administration. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. A program shall have sufficient physician, physician assistant, or nurse practitioner services to: Provide initial diagnostic work-up; Provide identification of medical and surgical problems for referral; and Handle medical emergencies when necessary. The patient to alcohol and drug counselor ratio may not exceed 15 patients for one full-time alcohol and drug counselor. At least one staff member certified in cardiopulmonary resuscitation and trained in crisis intervention shall be on duty between 11 p.m. and 7 a.m. Program Services. A program shall provide the following services: A preliminary medical assessment within 36 hours of the patient's admission; A physical examination by a medical doctor, physician assistant, or nurse practitioner within the first week of the patient's admission; An assessment as described in COMAR 10.47.01.04 within 2 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 2 working days of the comprehensive assessment with a treatment plan update every 30 days; Monitoring of medication, as necessary; and A minimum of 36 hours of therapeutic activities a week, including but not limited to: At least weekly individual counseling; Group counseling; Alcohol and drug education; Career counseling; Nutrition education; and Family services. Documentation. A designated clinical staff shall write a patient progress note at the end of each week services are provided and place the progress note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Medical care; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services, which shall include, as appropriate to the severity and urgency of the patient's mental condition: Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and At least one of the following services: Services available by telephone within 8 hours of a request; or Services available on-site or closely coordinated off-site within 24 hours of a request; Substance abuse treatment programs; Legal assistance; and Social services. Program Description. A medically monitored intensive inpatient treatment program shall: Offer a planned regimen of 24-hour professionally directed evaluation, care, and treatment in an inpatient setting; Act as an Intermediate Care Facility Type C/D; and Meet the certification requirements for detoxification services as described in COMAR 10.47.02.10E. Patients who are appropriate for this level of treatment: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.7, or its equivalent as approved by the Administration; and Require 24-hour monitoring and care for subacute biomedical and emotional or behavioral conditions severe enough to warrant inpatient treatment. Staffing. A program shall have: Appropriately credentialed staff as described in COMAR 10.47.01.06; Staffing which allows for detoxification and can provide services necessary for treatment of coexisting medical, emotional, or behavioral problems that could interfere with recovery; A patient to alcohol and drug counselor ratio not exceeding eight patients for one full-time alcohol and drug counselor; On-site physician, physician assistant, or nurse practitioner coverage available to provide initial assessment and documented referral for care, and to monitor progress in treatment; A physician on call 24 hours a day; Nursing services, between 7 a.m. and 11 p.m., 7 days a week, including: 8 hours a day, 5 days a week coverage by a registered nurse; and The remainder of coverage by a licensed practical nurse; and At least two employees on duty between the hours of 11 p.m. and 7 a.m., 7 days a week, trained in crisis management and cardiopulmonary resuscitation. Program Services. A program shall provide: An assessment as described in COMAR 10.47.01.04 within 2 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04C completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment with a treatment plan update completed every 7 days; A minimum of 36 hours of therapeutic activities a week including, but not limited to: A minimum of one weekly individual counseling session; Group counseling; Alcohol and drug education; Nutrition education; Weekly family sessions; and Case management. Medically Monitored Services. Nursing Services. Services shall include: An assessment at the time of the patient's admission, including a mental health focused assessment: Approved by the registered nurse and program physician; Completed by qualified staff; and Overseen by a registered nurse for patients admitted with any prescribed medication; and Medication monitoring conducted by: The registered nurse or overseen by the registered nurse in conjunction with the program's physician; and Qualified nursing staff for patients who are admitted on or are prescribed any medications. Physician, Physician Assistant, or Nurse Practitioner Services. A physician, physician assistant, or nurse practitioner shall: Assess a patient within 24 hours of admission; and Continue to assess the patient as is medically necessary after the first 24 hours of admission. A physician, physician assistant, or nurse practitioner shall conduct a physical examination of a patient within 96 hours of admission to the program. A physician or physician assistant shall assess a patient undergoing detoxification within 24 hours of admission or earlier if it is medically necessary to conduct the assessment in less than 24 hours. A physician or physician assistant shall provide on-site monitoring and further evaluation of patients undergoing detoxification on a daily basis, if medically necessary. A physician or physician assistant shall be available by telephone at all times to consult about patients undergoing detoxification. Documentation. A designated clinical staff shall write a patient progress note at the end of each day services are provided and place the progress note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Substance abuse treatment programs; Legal assistance; and Social services. Description of Services. A detoxification program shall provide services to an intoxicated patient by: Monitoring the decreasing amount of psychoactive substances in the body; Managing the withdrawal symptoms; and Motivating the individual to participate in an appropriate treatment program for alcohol or other drug dependence. A detoxification program shall: Avoid potentially harmful consequences of withdrawal from alcohol and drug dependence as medically possible; Provide a space to house and observe patients suffering from withdrawal symptoms; Ease physical discomfort during the withdrawal process; and Facilitate transition to a treatment continuum of care which may include: Ongoing alcohol or drug treatment in a residential or outpatient treatment program; Referral to mental health treatment; and Referral to self-help recovery programming. Level I-D Ambulatory Detoxification Without Extended On-Site Monitoring. Description of Services. Ambulatory detoxification without extended on-site monitoring services offers evaluation, detoxification, and referral under medical supervision to patients who require services in an office setting or healthcare, correctional, or addictions treatment facility. This program may be certified as a separate program or be combined with a Level I outpatient program. Patients who are appropriate for this level of treatment meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria, or its equivalent as approved by the Alcohol and Drug Abuse Administration. Staffing. A program shall employ: Appropriately credentialed staff as described in COMAR 10.47.01.06; A licensed physician; and A registered nurse. To perform the program's services, a program shall also employ sufficient licensed health care professionals, which may include: Physician assistants; Nurse practitioners; Registered nurses; or Licensed practical nurses. Services. Detoxification services shall include: A physical examination by a medical doctor, physician assistant, or nurse practitioner within a reasonable time frame; An assessment as described in COMAR 10.47.01.04; An individualized treatment plan as described in COMAR 10.47.01.04; Administration and monitoring of medication, including administration and monitoring of psychotropic medication by qualified nursing staff, as necessary; Monitoring of vital signs; Discharge or transfer planning as described in COMAR 10.47.01.04; and A mental health focused assessment for patients taking or prescribed psychotropic medication: Approved by the registered nurse and the program physician; and Overseen by the registered nurse. Documentation. The clinical staff providing services shall: Write a patient progress note after each counseling session; and Place the note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Medical, psychological, and psychiatric consultation; Laboratory services; Transportation services; and Substance abuse/dependence and mental health treatment programs. Emergency Services. A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services. The agreement shall include: An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care; Cooperative arrangements that specifically assign responsibility to provide transportation; The manner in which hospital on-call coverage is provided; A mechanism to provide psychiatric evaluation, if necessary; A prescreening protocol for patients referred to the ambulatory detoxification program from the hospital; and A written protocol for the transfer of a patient to continued treatment. Level II-D Ambulatory Detoxification with Extended On-Site Monitoring. Description of Services. An ambulatory detoxification with extended on-site monitoring services shall: Offer evaluation, detoxification, and referral under medical supervision to patients who require services in an office setting, healthcare, correctional, or addictions treatment facility; and Be certified as a separate program or be combined with intensive outpatient or partial hospitalization treatment. Patients who are appropriate for this level of treatment meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for either Level II.1 or Level II.5, or its equivalent as approved by the Administration. Staffing. A program shall employ: Appropriately credentialed staff as described in COMAR 10.47.01.06; A licensed physician, physician assistant, or a licensed nurse practitioner; and Additional medical staff which shall be a: Licensed physician's assistant; Registered nurse; or Licensed practical nurse. Services. Detoxification services shall include: A physical examination by a medical doctor, physician assistant, or nurse practitioner within 24 hours of admission; An assessment as described in COMAR 10.47.01.04; An individualized treatment plan as described in COMAR 10.47.01.04; Administering and monitoring of medication, as necessary; Monitoring of vital signs; and Discharge or transfer planning as described in COMAR 10.47.01.04. Documentation. The clinical staff person providing the service shall: Write a patient progress note after each counseling session; and Place the note in the patient's record. Referral Services. The program shall offer or maintain a listing of agency referral agreements for the following services: Medical, psychological, and psychiatric consultation; Laboratory services; Transportation services; and Substance abuse/dependence and mental health treatment programs. Emergency Services. A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services. This agreement shall include: An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care; Cooperative arrangements that specifically assign responsibility to provide transportation; The manner in which hospital on-call coverage is provided; A mechanism to provide psychiatric evaluation, if necessary; A prescreening protocol for patients referred to the ambulatory detoxification program from the hospital; and A written protocol for the transfer of a patient to continued treatment. Level III.2-D Clinically Managed Residential Detoxification. Description of Services. Clinically managed residential detoxification services are provided for patients whose intoxication or withdrawal signs and symptoms are sufficiently severe to require 24-hour structure and support and may be offered at Level III.3 or Level III.5 programs. Patients who are appropriate for this level of treatment: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria, or its equivalent as approved by the Administration; and Are intoxicated, show moderate withdrawal signs and symptoms, or evidence that withdrawal is imminent. Staffing. A program: Shall employ appropriately credentialed staff as described in COMAR 10.47.01.06; May not have a patient to alcohol and drug counselor ratio that exceeds eight patients to one full-time alcohol and drug counselor if counseling services are available; Shall have a physician, physician assistant, or nurse practitioner available 24 hours a day; Shall provide licensed nursing services between 7 a.m. and 11 p.m. daily as follows: A registered nurse shall provide at least 8 hours of coverage a day 5 days a week; and The remainder of coverage may be provided by either a licensed practical nurse or a registered nurse; and Shall have at least two employees trained in crisis management and cardiopulmonary resuscitation on duty between the hours of 11 p.m. and 7 a.m., 7 days a week. Program Services. A program shall provide the following services: Nursing assessment upon admission; Physical examination by a medical doctor, physician assistant, or nurse practitioner within 24 hours of admission if clinically indicated; Assessment as described in COMAR 10.47.01.04; Individualized treatment plan appropriate to a short term detoxification treatment regimen; Discharge or transfer planning as described in COMAR 10.47.01.04; Monitoring of vital signs as clinically indicated; Administering of medication, as necessary; and Adjunct services, which may include: Basic alcohol or other drug education; Family services; and Motivational counseling. Documentation. Designated clinical staff shall: Write a patient progress note at the end of each day services are provided; and Place the progress note in the patient's record. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: Medical, psychological, and psychiatric consultation; Laboratory services; Transportation services; and Substance abuse or dependence and mental health treatment programs. Emergency Services. A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services. The agreement shall include: An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care; Cooperative arrangements that specifically assign responsibility to provide transportation; The manner in which hospital on-call coverage is provided; A mechanism to provide psychiatric evaluation, if necessary; A prescreening protocol for patients referred to the inpatient detoxification program from the hospital; and A written protocol for the transfer of a patient to continued treatment. Patients Treated with Opioid Maintenance Medication. A detoxification facility is not limited in the number of admissions for detoxification of patients who are treated with opioid maintenance medication. A detoxification facility is not limited in the total number of doses of opioid maintenance medication that it will accept from patients who: Attend the detoxification program; and Require opioid maintenance medication for opioid detoxification or detoxification for substances other than opioids. Level III.7-D Medically Monitored Inpatient Detoxification. Description of Services. Medically monitored inpatient detoxification services offer 24-hour medically supervised evaluation and withdrawal management by medical professionals at an inpatient facility and may be offered with therapeutic community or medically monitored intensive inpatient treatment. This is an Intermediate Care Facility/C. Patients who are appropriate for this level of treatment: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria, or its equivalent as approved by the Administration, for this level of treatment; and Are intoxicated, show physical signs of withdrawal, or both. Staffing. A program: Shall employ appropriately credentialed staff as described in COMAR 10.47.01.06; May not have a patient to alcohol and drug counselor ratio that exceeds eight patients to one full-time alcohol and drug counselor if counseling services are available; Shall have on-site physician, physician assistant, or nurse practitioner coverage available to provide initial assessment and documented referral for care, and to monitor progress in treatment; Shall have a physician, physician assistant, or nurse practitioner on call 24 hours a day; and Shall have nursing services during all hours of service, including at least 8 hours of service provided by a licensed registered nurse. Program Services. A program shall provide the following services: Nursing assessment upon admission; Physical examination by a medical doctor, physician assistant, or nurse practitioner within 24 hours of admission; An assessment as described in COMAR 10.47.01.04; Individualized treatment plan appropriate to a short term detoxification treatment regimen; Discharge or transfer planning as described in COMAR 10.47.01.04; Monitoring of vital signs; Administering of medication, as necessary; and Adjunct services, which may include: Basic alcohol and drug education; Family services; and Motivational counseling. Documentation. Designated clinical staff shall write a patient progress note at the end of each day services are provided and place the progress note in the patient's record. Referral Services. The program shall offer or have available through referral the following: Medical, psychological, and psychiatric consultation; Laboratory services; Transportation services; and Substance abuse or dependence and mental health treatment programs. A program shall have a written agreement with a nearby hospital to provide necessary emergency medical support services. This agreement shall include: An emergency protocol describing the manner in which patients are referred to the hospital and provided appropriate care; Cooperative arrangements that specifically assign responsibility to provide transportation; The manner in which hospital on-call coverage is provided; A mechanism to provide psychiatric evaluation, if necessary; A prescreening protocol for patients referred to the inpatient detoxification program from the hospital; and A written protocol for the transfer of a patient to continued treatment. Patients Treated with Opioid Maintenance Medication. A detoxification facility is not limited in the number of admissions for detoxification of patients who are treated with opioid maintenance medication. A detoxification facility is not limited in the total number of doses of opioid maintenance medication that it will accept from patients who: Attend the detoxification program; and Require opioid maintenance medication for opioid detoxification or detoxification for substances other than opioids Program Description. Opioid maintenance therapy: Uses pharmacological interventions, including full and partial opiate agonist treatment medications, to provide treatment, support, and recovery to opioid-addicted patients; Is a separate service that is certified and offered by a program as described in COMAR 10.47.02.03 — .11; Complies with the requirements under this regulation; and Can be provided in correctional facility based programs. The program shall comply with federal regulation 42 CFR 8. Staffing. The patient to alcohol and drug counselor ratio may not exceed 50 patients to one full-time counselor. Medical Director. The program shall have a medical director who is a physician and who: Has 3 years documented experience providing services to persons who are addicted to alcohol or other drugs, including at least 1 year of experience in the treatment of opioid addiction with opioid maintenance therapy; Meets at least one of the following criteria: Has been continuously employed as the medical director for opioid maintenance therapy programs from or before August 1, 2002; Is certified in addiction medicine by the American Society of Addiction Medicine; Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.; or Is certified in added qualifications in addiction medicine by the appropriate specialty boards of the American Osteopathic Association; and Takes an active part in interdisciplinary team meetings, not less than every 2 weeks. A program unable to hire a medical director who meets the criteria set forth in §C(2) of this chapter may hire an interim medical director under the following conditions: The program shall submit a training plan for the interim medical director to the Administration for approval; The plan shall address a means for achieving minimal competencies and proficiencies until the interim medical director meets qualifications set forth in §C(1) of this chapter; and The interim medical director shall meet the qualifications within 48 months of being hired. An opioid maintenance therapy program shall: Have hours that meet the needs of the patients; Establish an answering system when the program is closed which provides direct contact or call back by a staff member capable of addressing emergency patient issues; and Complete an individualized treatment plan which is described in COMAR 10.47.01.04 as follows: Completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment; Updated every 90 days for the first year of treatment; and After completion of 1 year of continuous treatment and if the patient meets the requirements for unsupervised or take home use set forth in CFR 42 §8.12(i), the individualized treatment plan may be updated every 180 days and signed by the alcohol and drug counselor and patient. Random Drug Testing. The program shall: Conduct random drug testing on each patient at least monthly, in accordance with State law; Conduct random drug testing at a minimum for the following substances: Benzodiazepines; Marijuana; Cocaine; Opiates; Alcohol; and Methadone; Ensure that positive screens are validated using federally approved, State-certified laboratories; If appropriate, use temperature sensitive cups in place of direct observation; and Develop procedures, approved by the Administration, that mandate clinical intervention if a patient's drug test result indicates substance use. Dosage. The program shall: Maintain patients with a dose adequate to alleviate all withdrawal symptoms; Employ dose increases and behavior therapy before mandatory detoxification for patients continuing to use drugs; Establish patient dosing on an individual need; Provide flexible dosage tapering at patient request; and Develop a detoxification schedule at least 21 days long with daily dosage reductions less than 5 percent of the original total dose, regardless of the patient's ability to pay. Opioid maintenance programs shall arrange for transportation of medication to and from the following levels of care: Residential treatment at Levels III.3, III.5, and III.7, as described in Regulations .07 — .09 of this chapter; Detoxification services at Level III.2-D and III.7-D, as described in Regulation .10 of this chapter; or Residential treatment at Level III.1, when the patient cannot obtain or transport his or her own take-home opioid maintenance medication because of developmental or physical disabilities or because the patient does not have access to transportation. Opioid maintenance programs may transfer care of a patient to a closer opioid maintenance program when the patient is also being treated at a residential program or for detoxification services in a different county or jurisdiction. Programs may administratively detoxify or transfer a patient only if the: Patient's behavior on program premises is abusive, violent, or illegal; Patient fails to pay fees and has been informed in writing and counseled as to responsibility and possible sanctions including detoxification; Patient misses 3 consecutive medication days, and the program physician after a reevaluation has determined that administrative detoxification is warranted; or Clinical staff documents therapeutic reasons for detoxification, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions. Criteria for Take-Home Privileges. Before the patient may take home any dose the patient shall: Meet the criteria set within 42 CFR Part 8; and Provide the program with a working lock box for the take-home medication. Referral Services. Programs shall: Provide referral services as required by the level of treatment under which the program is certified; and Maintain a listing of agency referral agreements for the services. Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland Effective date: November 4, 1985 (12:22 Md. R. 2107) Regulations .01—.11, DWI Program Protocols, repealed and new Regulations .01—.11, Specific Program Requirements, adopted effective June 10, 2002 (29:11 Md. R. 882) Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .04 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .05 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .06 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .07 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .09 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .10 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .11 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .11D amended effective December 12, 2013 (40:24 Md. R. 2017) This chapter sets forth: Additional requirements that a program shall meet to be certified to offer the correctional levels of care; and Requirement exemptions for a program certified as a correctional level of care, which shall meet the requirements of COMAR 10.47.01 and 10.47.04. Correctional levels are exempt from the following requirements of COMAR 10.47.01: COMAR 10.47.01.03C(2)(h), if the correctional facility's requirements are more stringent; COMAR 10.47.01.04A(1)(a) and (b); COMAR 10.47.01.04E(2); COMAR 10.47.01.07A(1)(e); and COMAR 10.47.01.09. In this chapter, terms have the meanings stated in COMAR 10.47.01.02. Program Description. The program shall provide evaluation and treatment to patients who require services for less than 9 hours weekly in a correctional facility. Inmates receiving treatment may be housed throughout the correctional facility. Inmates who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level I, or its equivalent as approved by the Administration, for the 30 days before incarceration; and Have a physical and emotional status that allows the inmate to function in the inmate's usual environment. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 30 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 90 days in accordance with the following: The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall: Determine the reason for a delay in development of a treatment plan; Document the reason in the patient's record; and Direct an appropriate clinical staff person to develop a treatment plan within 7 working days of the clinical director or clinical supervisor's documentation of the delay; Case management services; and Group or individual counseling sessions. Documentation. The clinical staff person providing the service shall: Write a patient progress note after each counseling session; and Place the note in the patient's record. Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution: Medical examinations; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Substance abuse treatment programs; Legal assistance; and Social services. Program Description. A program shall provide structured evaluation and treatment to patients who require services from 9 to 20 hours weekly in a correctional facility. Inmates receiving treatment may be housed throughout the institution. Inmates who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level II.1, or its equivalent as approved by the Administration, for the 30 days before incarceration; and Have a physical and emotional status that allows the inmate to function in the inmate's usual environment. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 30 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 30 days in accordance with the following: The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall: Determine the reason for a delay in development of a treatment plan; Document the reason in the patient's record; and Direct an appropriate clinical staff person to develop a treatment plan within 3 working days of the clinical director's or clinical supervisor's documentation of the delay; Case management services; At least one group counseling session a week; and At least one individual session every 2 weeks. Documentation. A designated clinical staff person shall: Write a patient progress note at the end of each week that services are provided; and Place the progress note in the patient's record. Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution: Medical services; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Substance abuse treatment programs; Legal assistance; and Social services. Program Description. A program shall provide structured evaluation and treatment to patients who require programming from 20 to 35 hours weekly in a correctional facility. Inmates receiving treatment may be housed together in a separate unit. Inmates who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level II.5, or its equivalent as approved by the Administration, for the 30 days before incarceration; and Have a physical and emotional status that allows the inmate to function in the inmate's usual environment. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 30 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 30 days in accordance with the following: The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall: Determine the reason for a delay in development of a treatment plan; Document the reason in the patient's record; and Direct an appropriate clinical staff person to develop a treatment plan within 3 working days of the clinical director's or clinical supervisor's documentation of the delay; Case management services; At least one group counseling session a week; and At least one individual session every 2 weeks. Documentation. A designated clinical staff person shall: Write a patient progress note at the end of each week that services are provided; and Place the progress note in the patient's record. Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution: Medical services; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Substance abuse treatment programs; Legal assistance; and Social services. Program Description. A program shall offer treatment services at least 5 hours a week directed toward preventing relapse, applying recovery skills, promoting personal responsibility, and reintegration into the community. Inmates receiving this level of treatment shall be housed: Together in a prerelease center or a correctional halfway house; and Separately from inmates not receiving this level of treatment. Inmates who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.1, or its equivalent as approved by the Administration, for the 30 days before incarceration; and Be capable of self care but not ready to return to independent living. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. A correctional Level III.1 program shall employ: One individual as clinical supervisor, who may also be the program's administrator; and At least one staff member to be on duty at all times. Staff may not dispense medications. Program Services. A correctional Level III.1 program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 30 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update completed every 60 days in accordance with the following: The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall: Determine the reason for a delay in development of a treatment plan; Document the reason in the patient's record; and Direct an appropriate clinical staff person to develop a treatment plan within 7 working days of the clinical director's or clinical supervisor's documentation of the delay; Periodic group counseling that focuses on relapse prevention; Case management services; Individual counseling, at least monthly; and Leisure and recreational activities. Documentation. The clinical staff person providing the service shall: Write a patient progress note after each counseling session; and Place the note in the patient's record. Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution: Medical examinations; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Legal assistance; Substance abuse treatment programs; Social services; and Education. Program Description. A correctional Level III.5 program: Shall provide a highly structured environment in combination with moderate to high intensity treatment and ancillary services to support and promote recovery; Shall be characterized by its reliance on the treatment community as a therapeutic agent; and May not allow a structure whereby inmates have authority over one another. Inmates who are appropriate for this level of treatment shall: Meet the current edition of the American Society of Addiction Medicine Patient Placement Criteria for Level III.5, or its equivalent as approved by the Administration, for the 30 days before incarceration; and Be housed separately from inmates not receiving this level of treatment. Staffing. Services shall be provided by appropriately credentialed staff as described in COMAR 10.47.01.06. A program shall have sufficient medical services to: Provide initial diagnostic work-up; Provide identification of medical and surgical problems for referral; and Handle medical emergencies when necessary. Program Services. A program shall provide the following services: An assessment as described in COMAR 10.47.01.04 within 2 days of admission; An individualized treatment plan as described in COMAR 10.47.01.04 with a treatment plan update every 30 days in accordance with the following: The alcohol and drug counselor and patient shall complete and sign the initial treatment plan within 10 working days of the comprehensive assessment; or If the alcohol and drug counselor is unable to develop a treatment plan within the required time, the clinical director or the clinical supervisor shall: Determine the reason for a delay in development of a treatment plan; Document the reason in the patient's record; and Direct an appropriate clinical staff person to develop a treatment plan within 2 working days of the clinical director's or clinical supervisor's documentation of the delay; and A minimum of 36 hours of therapeutic activities a week, including but not limited to: One individual counseling session a week; Group counseling; Alcohol and drug education; Career counseling; and Nutrition education. Documentation. A designated clinical staff person shall write a patient progress note at the end of each week that services are provided and place the progress note in the patient's record. Referral Services. At the time of the patient's release from the institution, the program shall have available through referral the following: Medical care; Services through the Division of Rehabilitation Services; Vocational assistance; Mental health services; Substance abuse treatment programs; Legal assistance; and Social services. Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland Effective date: COMAR 10.47.03, Certification Requirements, recodified to be COMAR 10.47.04 and new chapter, Specific Program Requirements for Correctional Levels of Care, adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898) This chapter sets forth additional requirements that a program shall meet to be certified to offer a particular level of treatment. The program shall meet the requirements of COMAR 10.47.01 and this chapter. In this chapter, terms have the meanings stated in COMAR 10.47.01.02. In addition to terms referenced under §A of this regulation, in this chapter the following terms have the meanings indicated. Terms Defined. “Deficiency” means a failure to meet a regulation or its intent. “Plan of correction” means the program's proposed response to findings of noncompliance identified by the Office of Health Care Quality or the Administration. “Sale” means the transfer of a majority interest of ownership. All programs and prevention programs shall be certified by the Department before program services and prevention program services may be provided in the State. The following are exempt from certification under this chapter: A health professional licensed under the Health Occupations Article who is treating patients within the scope of the professional's practice and who does not advertise the practice as an alcohol abuse or drug abuse program; Alcoholics Anonymous, Narcotics Anonymous, transitional housing programs, or other similar organizations, if the organization holds meetings or provides support services to help individuals who show the effects of drug abuse or alcohol abuse; An employees' assistance program of a business entity; and A hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland, accredited by the Joint Commission on Accreditation of Health Care Organizations with a separately accredited alcohol and drug abuse program. All programs offering drug and alcohol treatment, care, and rehabilitation are required to be certified except as in §A of this regulation. Each level of service offered by a program requires a certification. A separate certification is required for each physical site regardless of the service. A certification is valid only for the program to which it is issued and is not subject to voluntary or involuntary sale, assignment, or transfer. Upon sale, transfer, assignment, lease, or relocation, the program shall obtain a new certification. Initial Certification. After receipt of the completed written or electronic application provided by the Administration and after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant an initial certification. The initial certification is valid for a period in the discretion of the Administration, not to exceed 6 months. Provisional Certification. After a program has been in operation for 4 months, after inspection by the Office of Health Care Quality, and, if there are deficiencies which are not life threatening, the Administration, with the program's consent, may grant a provisional certification to permit the program to correct its deficiencies as set forth in its plan of correction. If upon review of a written or electronic renewal application provided by the Administration, the Office of Health Care Quality finds deficiencies which are not life threatening, the Administration may grant a provisional certification to permit the program to correct the deficiencies as set forth in the plan of correction. A provisional certification is valid for a period in the discretion of the Administration, not to exceed 6 months, and may be issued once. General Certification. After a program has been in operation for 4 months, after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant the program a general certification. A general certification is valid for 2 years from date of issue. Surrender of Certification. A program shall surrender its certificate to the Administration on: Revocation of the program's certification by the Administration; Sale of the program; Transfer of the program; Assignment of the program; Lease of the program; Relocation of the program; or Voluntary decision to close the program. Application. An applicant for certification of a program or renewal of certification shall submit to the Office of Health Care Quality: A completed application on a written or electronic form approved by the Administration; Documentation of: The program service plan; Satisfactory fire, safety, and health inspection reports; and Compliance with COMAR 10.47.01 and the applicable specific program requirements under COMAR 10.47.02; A request for a variance or a waiver of a regulation; and An application fee of $700 with initial application and at recertification, if the program provides opioid maintenance therapy as described in COMAR 10.47.02.11. Incomplete Application or Information. After reviewing the application, if the Office of Health Care Quality or the Administration finds it needs more information, the Office of Health Care Quality or the Administration shall request the information in writing. The application shall remain open for 6 months after the information is requested. If the program does not provide the requested information, the Office of Health Care Quality shall close the application. Initial Site Visit and Written Report. On receipt of a completed application under this regulation and the required documentation, the Office of Health Care Quality shall conduct a site visit and issue a written report. If deficiencies are found, the Office of Health Care Quality shall require the program to submit a written plan of correction within 15 working days. Deficiencies in a New Program. If a new program with deficiencies: Fails to submit a plan of correction, the Office of Health Care Quality shall considered the application withdrawn; or Submits a plan of correction that the Office of Health Care Quality believes: Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program initial certification; or Does not correct the deficiencies, the Office of Health Care Quality may issue a denial or permit the program to submit an additional plan of correction. Deficiencies in a Program Being Renewed. If a renewal program with deficiencies: Fails to submit a plan of correction, the Office of Health Care Quality may recommend disciplinary action; or Submits a plan of correction which the Office of Health Care Quality believes: Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program general certification; Does not immediately correct the deficiencies but which brings the program into compliance within 4 months, the Office of Health Care Quality may recommend a provisional certification; or Cannot bring the program into compliance within 4 months, the Office of Health Care Quality may recommend disciplinary action, or request another plan of correction. No Deficiencies. If no deficiencies are found, the Office of Health Care Quality shall: For new applicants, recommend an initial certification; and For renewal applicants, recommend general certification. Site Visit and Written Report After Issuing Initial or Provisional Certificate. Within 4 months after the issuance of an initial certification or provisional certification, the Office of Health Care Quality shall conduct a site visit and submit a written report. Deficiencies in a Program with Initial Certification. If deficiencies are found, the Office of Health Care Quality shall require the program to submit a plan of correction within 15 days. If the program: Fails to submit a plan of correction, the Office of Health Care Quality may recommend disciplinary action; or Submits a plan of correction which the Office of Health Care Quality believes: Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program general certification; Does not immediately correct the deficiencies but which brings the program into compliance within 4 months, the Office of Health Care Quality may recommend a provisional certification; or Cannot bring the program into compliance within 4 months, the Office of Health Care Quality may recommend disciplinary action, or request another plan of correction. Deficiencies in a Program with Provisional Certification. The Office of Health Care Quality shall: For good cause, permit the program to submit a plan of correction within 15 days and follow §C(1) of this regulation; or Recommend disciplinary action. No Deficiencies. If no deficiencies are found, the Office of Health Care Quality shall recommend a general certification. In considering a renewal application, the Administration may accept accreditation of the program by an accreditation organization approved in accordance with Health-General Article, §19-2302(a) and (b), Annotated Code of Maryland, in lieu of the site visit and written report by the Office of Health Care Quality that is otherwise required by this regulation. Upon written request by the program, the Director shall issue a written decision which may: Grant a variance or waiver from a regulation if the: Variance or waiver would not endanger the life or safety of a patient in a program; or Intent of the regulation to which a variance or waiver is sought meets the alternative proposed by the program; or Deny the variance or waiver. The Director may grant a variance or waiver that: Remains in effect for as long as the program continues to comply with the conditions under which the variance or waiver is granted; or Is time limited. The program is responsible for maintaining a copy of the decision in its certification file. A program shall be open at all reasonable times for announced and unannounced inspections or investigations by the Administration or its designees. A program shall be open at all reasonable times for announced and unannounced inspections or investigations by the Office of Health Care Quality. If an applicant or program fails to comply with the applicable State and federal laws, rules, or regulations, the Director may: Deny approval to the applicant; or Take disciplinary action, such as: Placing the program on probation; Suspending or revoking the certification of the program; or Imposing intermediate sanctions on the program. For purposes of §A of this regulation, intermediate sanctions include: A directed plan of correction, if the program is directed to take a specific action by a certain date; A mandatory staffing pattern that is stricter than that required under the appropriate level of care required under COMAR 10.47.02, if the Administration defines for the program the level of individual supervision; Mandatory training, if the Administration identifies deficient areas in which training is needed; Patient relocation, if the Administration reserves the right to relocate a patient to another program in order to protect the health and safety of the patient; Expansion ban, if the Administration retains the authority to prohibit the program from obtaining additional sites, admitting individuals, or providing additional services at the site; Imposition of an intensive monitoring protocol by the Administration; or Imposition of a temporary site monitor, if the Administration maintains an ongoing physical presence for the purpose of providing assistance and evaluating the extent of the program's corrective actions. If the Director proposes to deny approval to an applicant or to take disciplinary action against a program, the Director shall give written notice to the governing body or the health officer and the administrator of the program. In the written notice under §C of this regulation, the Director shall include: The statutory and regulatory authority upon which the proposed action is based; The facts supporting the alleged violation of law; and The applicant's or program's right to a hearing before final action under §F of this regulation. Summary Suspension. Under the State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a predeprivation hearing, the Director may summarily order the suspension of a certification if the Administration finds that the public health, safety, or welfare imperatively requires emergency action. The Director shall notify the program in writing of the suspension, findings, and reasons that support the findings, and, if appropriate, the opportunity for a predeprivation hearing. The notice shall include: The proposed order for summary suspension which includes: The statutory and regulatory authority upon which the order is based; The facts supporting the alleged violations of law; The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals; and The program's right to appeal the summary suspension, if executed by the Director; and A show cause notice providing an opportunity for the program to show cause as to why an order under §C(1) of this regulation should not be issued. The Director may suspend an approval without prior notice and the opportunity to be heard if: The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension; Notice of an opportunity to be heard before the action is not feasible; and The Administration provides the program with a post-deprivation hearing opportunity within 15 working days of the suspension. The Administration shall: Notify the individuals being served by the program and, if appropriate, their families or proponents, regarding the summary suspension; and Assist the individuals in finding alternative services if the approval is summarily suspended. Procedures for Hearings. If the Director proposes to deny an approval or take disciplinary action against a program, the Director shall give the program written notice according to §D of this regulation. Within 10 working days of receipt of the notice, the governing body or health officer may file a written request for a hearing with the Office of Administrative Hearings and send copies of the request to the: Director; and Administrative prosecutor. If the governing body or the health officer does not file a request for a hearing within 10 working days of receipt of the notification, the: Program waives its right to request a hearing; and Director may implement the proposed action. If a timely request for a hearing has been received, the Office of Administrative Hearings shall: Notify the Director, the governing body or health officer, and administrative prosecutor of the date, time, and location of the hearing; and In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director. After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Director shall issue a final decision and send notice to the governing body or the health officer. A program may appeal any final decision from a contested case by following the provisions of Health-General Article, §2-207, Annotated Code of Maryland, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. In addition to disposing of a case by a hearing, the Director may dispose of a contested case by: Stipulation; Settlement; Consent order; Default; Withdrawal; Summary disposition; or Dismissal. Health-General Article, §§7.5-205, 8-401 — 8-405, and 19-308, Annotated Code of Maryland Effective date: June 10, 2002 (29:11 Md. R. 882) Chapter recodified from COMAR 10.47.03 to 10.47.04 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .01 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .04A, B amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .04D adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .05A, B amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .05E adopted effective November 24, 2014 (41:23 Md. R. 1374) Regulation .07 recodified to be Regulation .08 and new Regulation .07 adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) This chapter sets forth additional requirements that a program shall meet as a private or public education program for individuals convicted under Transportation Article, §21-902, Annotated Code of Maryland, and ordered to attend an education program. In this chapter, terms have the meanings set forth in COMAR 10.47.01.02. The applicant shall complete an application on a form approved by the Administration and submit the application and documentation to indicate the applicant is in compliance with the requirements of this chapter. After the Administration receives the application the Administration shall: Return the application if it is incomplete; or Arrange a site visit. After the site visit, the Administration shall Grant approval; Grant approval with conditions; or Deny approval. The program shall: Comply with COMAR 10.47.01 and 10.47.02.03; At minimum, offer six weekly 2-hour sessions for a total of 12 hours; Have instructors approved by the Administration who are: Instructors before October 1, 2002; or At a minimum, certified as a Certified Supervised Counselor-Alcohol and Drug, as defined by Health Occupations Article, Title 17, Annotated Code of Maryland; Ensure that staff is appropriately credentialed and privileged to teach the curriculum; Teach the Administration's curriculum or an equivalent curriculum approved by the Administration, which covers: Scope of drinking-driver problem; Drinking driver patterns and characteristics; The pharmacology of substance abuse; The process of addiction to drugs and alcohol; The relationship of substance use to crime, health, family, and other social problems; and Treatment resources; and Report to the court or probation agent as specified by the court order. If an applicant or Program fails to comply with the applicable State and federal laws, rules, or regulations, the Director may: Deny approval to the applicant; or Take disciplinary action, such as: Placing the program on probation; Suspending or revoking the certification of the program; or Imposing intermediate sanctions on the program. For purposes of §A of this regulation, intermediate sanctions include: A directed plan of correction, if the program is directed to take a specific action by a certain date; A mandatory staffing pattern that is stricter than that required under the appropriate level of care in these regulations, if the Administration defines for the program the level of individual supervision; Mandatory training, if the Administration identifies deficient areas in which training is needed; Expansion ban, if the Administration retains the authority to prohibit the program from obtaining additional sites, admitting individuals, or providing additional services at the site; Imposition of an intensive monitoring protocol by the Administration; or Imposition of a temporary site monitor, if the Administration maintains an ongoing physical presence for the purpose of providing assistance and evaluating the extent of the program's corrective actions. If the Director proposes to deny approval to an applicant or to take disciplinary action against a program, the Director shall give written notice to the health officer or executive director of the program. In the written notice under §C of this regulation, the Director shall include: The statutory and regulatory authority upon which the proposed action is based; The facts supporting the alleged violation of law; and The applicant's or program's right to a hearing before final action under §F of this regulation. Summary Suspension. Under the State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a predeprivation hearing, the Director may summarily order the suspension of the approval if the Administration finds that the public health, safety, or welfare imperatively requires emergency action. The Director shall notify the program in writing of the suspension, findings, and reasons that support the findings, and, if appropriate, the opportunity for a predeprivation hearing. The notice shall include: The proposed order for summary suspension which includes: The statutory and regulatory authority upon which the order is based; The facts supporting the alleged violations of law; The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals; and The program's right to appeal the summary suspension, if executed by the Director; and A show cause notice providing an opportunity for the program to show cause as to why the order may not be issued if the public health, safety, and welfare permits. The Director may suspend approval without prior notice and the opportunity to be heard if: The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension; Notice of an opportunity to be heard before the action is not feasible; and The Administration provides the program with a post-deprivation hearing opportunity within 15 working days of the suspension. Procedures for Hearings. If the Director proposes to deny an approval or take disciplinary action against a program, the Director shall give the program written notice according to §C of this regulation. Within 10 working days of receipt of the notice, the executive director or health officer may file a written request for a hearing with the Office of Administrative Hearings and send copies of the request to the: Director; and Administrative prosecutor. If the executive director or health officer does not file a request for a hearing within 10 working days of receipt of the notification, the: Program waives its right to request a hearing; and Director may implement the proposed action. If a timely request for a hearing has been received, the Office of Administrative Hearings shall: Notify the Director, the executive director or health officer, and administrative prosecutor of the date, time, and location of the hearing; and In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director. After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Director shall issue a final decision and send notice to the governing body or the health officer. A program may appeal any final decision from a contested case by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. In addition to disposing of a case by a hearing, the Director may dispose of a contested case by: Stipulation; Settlement; Consent order; Default; Withdrawal; Summary disposition; or Dismissal. Health-General Article, §§8-401 — 8-405 and 19-308, Annotated Code of Maryland Effective date: June 10, 2002 (29:11 Md. R. 882) Chapter recodified from COMAR 10.47.04 to 10.47.05 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .01 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .04 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .05 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898) This chapter specifies the requirements for applying for funding from the Substance Abuse Treatment Outcomes Partnership Fund. This chapter establishes time lines and procedures for requests for partnership funding, guidelines that require programs to bill third-party insurers, and fund management including, but not limited to, authorization of distribution of money. In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Eligible functions” means: Transportation to and from treatment services; Treatment, prevention, or coordination staff; Data sharing services among counties and other appropriate treatment providers; Education or outreach programs and materials; In-community emergency behavioral health services or crisis stabilization units; or Behavioral health programs in schools. “Eligible population” means: Mothers of drug-addicted infants; Parents of children in need of assistance; Hospital emergency room admittees; Needy families receiving temporary cash assistance; Foster care children and parents; Children in after-school programs and their parents, including children and parents in programs supported by the Maryland After-School Opportunity Fund; Adolescents; Parents subject to arrearages in child support payments; Drug offenders under the supervision of the Division of Parole and Probation; Pretrial correctional inmates; Prerelease correctional inmates; The general inmate population within county-managed correctional facilities; Parents of children entering out-of-home placements or at risk of entering out-of-home placements; or Drug offenders under the supervision of the problem solving courts. “Jurisdiction” means Baltimore City or one of the 23 counties in Maryland. “Partnership funding” means money granted from the Substance Abuse Treatment Outcomes Partnership Fund. “Proposal” means a plan under this chapter to provide new or expanded substance abuse treatment services. “Request for partnership funding” means: A proposal, submitted by the governing bodies of one or more jurisdictions, to provide substance-related disorder treatment services to one or more eligible populations; or To provide funding for eligible functions within the requesting jurisdiction or jurisdictions. “Task Force” means the Task Force to Study Increasing the Availability of Substance Abuse Programs. Requests for partnership funding may be submitted to the Department by: The governing body of a jurisdiction or its designee; or The governing bodies of more than one jurisdiction or their designee. Proposals shall include the following: Identification of one or more eligible populations per jurisdiction; Eligible functions that will be funded under the plan; A description of the plan to provide substance-related disorder services; Identification of local providers able to provide these services; A plan to reach the eligible populations using relevant means of contact; Performance and outcome indicators to evaluate the program effectiveness including a description of the expected schedule and methods for measuring performance and outcome; A plan to bill third-party insurers; A prepared annual expenditure plan which reflects all anticipated income including partnership funding, local, third party, and cash revenue to the partnership program; and A statement of the local cash match or local in-kind match, including but not limited to provision of space, staff, or services, that the applicant intends to commit to the effort. Time Line. Requests for partnership funding shall be received by the Department by April 1 for the following fiscal year. The Department shall consider the following: Performance and outcome indicators specified; The degree to which the proposal may reduce the need for other State or local public services or programs intended for the populations targeted by the proposal; The extent to which the proposal incorporates the use of excess or otherwise available medical-related facilities, including vacant hospital beds; How the proposal fits into a balanced approach to the State’s variety of substance-related disorder needs and populations that serve different geographic areas of the State with partnership funding; The extent to which the proposal is part of or consistent with a regional strategy for substance-related disorder treatment programs affecting adjoining jurisdictions; and Other factors consistent with Health-General Article, §8-6C-04, Annotated Code of Maryland. The Department may specify in a request for proposals the types of treatment services that are eligible for funding awards. The Department may award partnership funding that results in a county being responsible for less than 1/2 of the cost of the approved partnership funding after considering: The financial hardship of the participating county; Prior and current contributions of funds for substance abuse treatment programs made by the participating county; and Other relevant considerations considered appropriate by the Department. A participating jurisdiction shall use partnership funding only to supplement levels of spending by the participating jurisdiction on drug treatment programs. A participating jurisdiction may not use partnership funding to supplant spending by the participating jurisdiction on drug treatment programs. A participating jurisdiction may use partnership funding to continue or expand funding for eligible functions if the participating jurisdiction began spending funds on eligible functions after October 1, 2010. Health-General Article, §§8-6C-01 — 8-6C-04, Annotated Code of Maryland Effective date: Regulations .01—.04 adopted as an emergency provision effective January 30, 2001 (28:3 Md. R. 203); adopted permanently effective April 30, 2001 (28:8 Md. R. 762) Chapter recodified from COMAR 10.47.03 to 10.47.05 effective June 10, 2002 (29:11 Md. R. 882) Chapter recodified from 10.47.05 to 10.47.06 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898) Regulation .02B amended effective August 15, 2016 (43:16 Md. R. 901) Regulation .03 amended effective August 15, 2016 (43:16 Md. R. 901) Regulation .04D adopted effective August 15, 2016 (43:16 Md. R. 901) This chapter sets forth the requirements for monitoring the prescribing and dispensing of controlled dangerous substances under the Prescription Drug Monitoring Program. In this chapter, the following terms have the meanings indicated. Terms Defined. “Authorized user” means a licensed prescriber, a prescriber delegate, a licensed pharmacist, a pharmacist delegate, or a licensed health care practitioner registered with another state’s prescription drug monitoring program. “Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. “Dispense” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland, but does not include: Directly administering a monitored prescription drug to a patient; or Giving a patient prescription drug samples in accordance with Health Occupations Article, §12-102(d), Annotated Code of Maryland. Dispenser. “Dispenser” means person authorized by law to dispense a monitored prescription drug to a patient or a patient’s agent in the State, including a nonresident pharmacy so authorized. “Dispenser” does not include: A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital; An opioid treatment services program; A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services; A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; or A pharmacy issued a waiver from reporting dispensing of monitored prescription drugs to hospice inpatients under Regulation .03G of this chapter. “Existing bona fide individual investigation” means an active and good faith investigation of an identified prescriber, dispenser, or patient for possible violations falling under the jurisdiction of the requesting governmental unit or agency. “Existing bona fide investigation” means an active and good faith investigation of identified prescribers, dispensers, or patients for possible violations falling under the jurisdiction of the requesting governmental unit or agency. “Licensed health care practitioner” means an individual who is: Licensed, certified, or registered under Health Occupations Article, Annotated Code of Maryland, or the laws of the practitioner’s respective state, as appropriate, to provide health care services; and Authorized by a prescriber or pharmacist to access prescription monitoring data in connection with the medical care of a patient to whom the prescriber prescribes or the pharmacist dispenses a monitored prescription drug. “Licensing entity” means an entity authorized under Health Occupations Article, Annotated Code of Maryland, to license, regulate, or discipline a prescriber or pharmacist. “Medical director” means an individual who is: A prescriber; and Employed by or under contract with a health care facility and serves as that facility’s chief medical officer or in an equivalent role. Monitored Prescription Drug. “Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. “Monitored prescription drug” does not include naloxone medication. “Naloxone medication” means an opioid antagonist approved by the federal Food and Drug Administration for the reversal of an opioid overdose. “Naloxone medication data” means the information required to be submitted to the Program when dispensing naloxone medication “Office” means the Office of Controlled Substances Administration in the Department. “Opioid treatment services program” means a program that: Is certified by the State under Health-General Article, §8-401, Annotated Code of Maryland or licensed by the State under Health-General Article, §7.5-401, Annotated Code of Maryland; Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence; Complies with: The Code of Federal Regulations 42, Part 8; COMAR 10.47.02.11; and Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the State Division of Drug Control; and Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the Federal Center for Substance Abuse Treatment. “Patient” means: An individual for whom a prescriber has prescribed or is considering prescribing a monitored prescription drug; or An individual for whom a pharmacist has dispensed or is considering dispensing a monitored prescription drug. “Pharmacist” means an individual who is licensed under Health-Occupations Article, Title 12, Annotated Code of Maryland, to dispense a monitored prescription drug. “Pharmacist delegate” means an individual who is: Authorized by a registered pharmacist to request or access prescription monitoring data; and Employed by or under contract with the same professional practice as the registered pharmacist. “Prescriber” means a practitioner: Lawfully authorized to prescribe a monitored prescription drug; or Legally authorized to prescribe a monitored prescription drug under an institutional DEA registration; “Prescriber delegate” means an individual who is: Authorized by a registered prescriber to request or access prescription monitoring data; and Employed by or under contract with the same professional practice as the registered prescriber. “Prescription drug” has the meaning stated in Health-General Article, §21-201, Annotated Code of Maryland. “Prescription monitoring data” means the information submitted to the program for a monitored prescription drug. “Program” means the Prescription Drug Monitoring Program established under Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland. “Registered” means a person registered with the Program to request or access prescription monitoring data for clinical use. “Rehabilitation program under a health occupations board” means a group, committee, or program recognized by a licensing entity that provides assistance to a licensed health care practitioner in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other physical, emotional, or mental condition. “Technical Advisory Committee” means the Technical Advisory Committee established by Health-General Article, §21-2A-07, Annotated Code of Maryland. “Zero report” means an electronic report submitted by a dispenser to the Program to confirm that no monitored prescription drugs were dispensed during the reporting time frame. For each monitored prescription drug and naloxone medication dispensed, the dispenser shall report data elements required by American Society for Automation in Pharmacy (ASAP) standards in addition to the following: Identifying information for the prescription issued and drug dispensed, including: Prescription number; Date prescription was issued; Date prescription was filled; Whether the prescription was new or a refill; Number of refills ordered; Sources of payment; National Drug Code for dispensed drug; Metric quantity of drug dispensed and units; Days’ supply of drug dispensed; and Date prescription was sold; Identifying information for the patient or animal owner or handler, as appropriate, including: Last name; First name; Date of birth; Gender; (text unchanged) Address, including residential house or building number, apartment number, street name, state, and zip code; A patient identification number, which may include: A state-issued driver’s license or identification card number; An insurance or third-party payer identification number; A passport identification number; An employer-issued identification card number; A student identification card number; A United States Permanent Resident Card identification number; or A patient or customer identification number generated by the dispenser’s record management system; ID qualifier; and Species indication; First and Last name for the prescriber, including: For prescription monitoring data, a valid Drug Enforcement Administration registration number; or For naloxone medication data, a valid National Provider Identifier; Identifying information for the dispenser, including a valid Drug Enforcement Administration registration number; and Additional data elements consistent with the standards established by the ASAP. Reporting Deadline. A dispenser shall report prescription monitoring data and naloxone medication data to the Department to include zero reports at least once every 24 hours and in accordance with procedures developed by the Department and approved by the Advisory Board on Prescription Drug Monitoring. A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser’s ability to report prescription monitoring data or naloxone medication data electronically shall: Notify the Department, by a communications method approved by the Department, within 24 hours of discovery of the technical failure; and Submit a report for each monitored prescription drug and naloxone medication dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting. Waiver from Reporting Deadline. At the Secretary’s discretion, a dispenser may be granted a waiver from §B of this regulation, provided that the dispenser’s waiver request: Is submitted on a form or in a method approved by the Department; Is particular to a unique problem, incident or other issue that prevents the dispenser from meeting the reporting deadline; and Describes in detail and includes any available documentation of the specific circumstances that prevent the dispenser from meeting the reporting deadline. A dispenser that receives a waiver shall comply with all the terms and conditions enumerated therein, including any new reporting deadline required. Means of Data Submission and Data Format. Prescription monitoring data shall be transmitted to the Department or its agent: In accordance with any procedures and guidelines established or approved by the Department, including by use of an encrypted electronic transmission method or a secure electronic reporting form; and In a format or utilizing a data standard approved by the Department. Reporting of Incomplete or Inaccurate Data. Data not accepted by the Department or its agent due to inaccuracy or incompleteness shall be corrected and resubmitted to the Department no later than 3 business days after receiving notification from the Department of receipt of incomplete or inaccurate data. Reporting Exemptions. The following shall be exempt from reporting prescription monitoring data to the Program: A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital; An opioid treatment service program; A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services; A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and Dispensing to hospice inpatients, provided that the dispensing pharmacy has applied for and been granted a waiver by the Department pursuant to §G of this regulation. Waiver for Dispensing to Hospice Inpatients. On a form or in a manner approved by the Department, a pharmacy may apply to the Department to be granted a waiver from reporting prescription monitoring data or naloxone medication data for dispensing of monitored prescription drugs to hospice inpatients, provided that: The pharmacy demonstrates, through written application, live demonstration, or any other method required by the Department, how it will distinguish dispensing to hospice inpatients from all other dispensing of monitored prescription drugs required to be reported to the Program; and The pharmacy agrees that it will be subject to unannounced, on-site inspections by the Department to verify its reporting of prescription monitoring data and naloxone medication data on customers that are not hospice inpatients. A waiver granted to a pharmacy under this regulation shall remain in effect for 2 years. The Program shall review prescription monitoring data and naloxone medication data for indications of possible: Misuse or abuse of a monitored prescription drug; and Violations of law or possible breaches of professional standards by a prescriber or a dispenser. In determining whether its review indicates a possible violation of law or possible breach of professional standards by a prescriber or dispenser, the Program shall take into account to the extent practicable the particular specialty, circumstances, patient type, and location of the prescriber or dispenser. Registration of a Prescriber, a Prescriber Delegate, a Pharmacist, a Pharmacist Delegate, or a Licensed Health Care Practitioner to Request Prescription Monitoring Data. A prescriber, a prescriber delegate, a pharmacist, a pharmacist delegate, or a licensed health care practitioner shall register with the Department or its agent, in a manner specified by the Department, in order to request disclosure of or otherwise access prescription monitoring data. The Department or its agent shall: Establish procedures to authenticate a prescriber, a dispenser, or an authorized licensed health care practitioner in accordance with Health-General Article, §21-2A-06(b)(1)—(2), Annotated Code of Maryland; and Issue credentials to a prescriber, a prescriber delegate, a pharmacist, or a pharmacist delegate that can be used to request disclosure of or otherwise access prescription monitoring data electronically. If the credentials issued to a registrant are lost, stolen, or otherwise compromised, the registrant shall notify the Department or its agent, by a method approved by the Department, as soon as reasonably possible. A prescriber or pharmacist who authorizes the registration of a licensed health care practitioner, prescriber delegate, or pharmacist delegate to request disclosure of or otherwise access prescription monitoring data shall: Make every reasonable effort, including regularly reviewing and auditing any available logs of system access and use, to ensure the prescriber delegate or pharmacist delegate is requesting disclosure of, redisclosing, or otherwise accessing prescription monitoring data in clear compliance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records; Immediately notify the Department or its agent, by a method approved by the Department, as well as the licensing entity responsible for licensing, certifying, or registering the prescriber delegate, or pharmacist delegate, if applicable, if the prescriber or pharmacist believes that the confidentiality of prescription monitoring data or the security of the Program has been compromised by that individual; and Immediately notify the Department or its agent, by a method approved by the Department, of any requested change in the registration status of a licensed health care practitioner, prescriber delegate, or pharmacist delegate, including if that individual is no longer employed by or practicing under the authority of the prescriber or pharmacist. Disclosure of Prescription Monitoring Data to a Prescriber, a Prescriber Delegate, a Pharmacist, or a Pharmacist Delegate. Upon request from a prescriber or a licensed health care practitioner or a prescriber delegate authorized by a prescriber, the Program shall disclose patient-specific prescription monitoring data provided that the request is made solely for the purpose of the medical care or treatment of the patient about whom prescription monitoring data is being requested. Upon request from a prescriber, the Program may provide a report containing prescription monitoring data on all monitored prescription drugs dispensed pursuant to the prescriber’s prescriptions, provided that the request is submitted on a form or in a manner approved by the Department. Upon request from a pharmacist or a licensed health care practitioner or pharmacist delegate authorized by a pharmacist, the Program shall disclose patient-specific prescription monitoring data provided that the request is made pursuant to a pharmacist’s responsibility to perform due diligence and exercise professional judgment when presented with a prescription to dispense a monitored prescription drug for use by the patient about whom prescription monitoring data is being requested. The Department or its agent shall make available the electronic means by which a prescriber, a pharmacist, a prescriber delegate, or a pharmacist delegate may request disclosure of or otherwise access patient-specific prescription monitoring data. If the Program’s review of prescription monitoring data under Regulation .04 of this chapter indicates possible misuse or abuse of a monitored prescription drug, possible violation of law, or possible breach of professional standards by a prescriber or dispenser, the Program shall: Report the possible misuse or abuse, possible violation of law, or possible breach of professional standards to the prescriber or dispenser of the monitored prescription drug in a manner and form determined by the Program; and Provide education to the prescriber or dispenser. Disclosure of Prescription Monitoring Data to a Federal, State, or Local Law Enforcement Agency. The Program shall disclose prescription monitoring data to a federal, State, or local law enforcement agency, for the purpose of furthering an existing bona fide individual investigation, on receipt of a subpoena that: Includes information sufficient to identify the unique prescriber, dispenser, or patient about whom prescription monitoring data is requested; Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; Includes an agency case number or other identifier sufficient to identify an existing bona fide individual investigation; and Bears the name, title, and signature of the official under whose authority the subpoena is issued. Disclosure of Prescription Monitoring Data to a Licensing Entity. The Program shall disclose prescription monitoring data to a licensing entity upon receipt of an administrative subpoena. The licensing entity shall include in the administrative subpoena: Information sufficient to identify the unique prescriber, dispenser, or patient about whom prescription monitoring data is requested; The time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; A case number or other identifier sufficient to identify an existing bona fide individual investigation; and The name, title, and original signature of the official under whose authority the subpoena is issued. Disclosure of Prescription Monitoring Data to a Rehabilitation Program under a Health Occupations Board. The Program shall disclose prescription monitoring data to a rehabilitation program under a health occupations board upon receipt of an administrative subpoena that: Includes information sufficient to identify the unique licensed health care practitioner about whom prescription monitoring data is requested; Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; and Bears the name, title and original signature of the official under whose authority the subpoena is issued. Disclosure of Prescription Monitoring Data to a Patient or a Patient’s Authorized Representative. Upon request, the Program shall disclose to a patient 18 years old or older prescription monitoring data about the patient provided that the request is submitted to the Program: On a completed form approved by the Department that contains a notarized signature of the requester; or In any other manner approved by the Department. Upon request, the Program shall disclose patient-specific prescription monitoring data to a patient’s authorized representative who is 18 years old or older, including the parent or legal guardian of a minor, an individual with power of attorney, the personal representative of a decedent’s estate, or any other person duly authorized by State law to request or otherwise access medical records on behalf of a patient, provided that the request shall be submitted to the Program: In person and accompanied by: A completed form approved by the Department; Valid photo identification issued by a government agency of any jurisdiction of the United States verifying that the patient’s authorized representative is 18 years old or older; and An original copy of any form or documentation required by State law or regulation to verify the authority of the representative to request or otherwise access the medical records of a patient on their behalf; or In any other manner approved by the Department. If a patient, a patient’s authorized representative, or a patient’s prescriber believes that prescription monitoring data relating to the patient’s prescription history is incorrect, the patient, authorized representative, or prescriber may request that the Program correct the data provided that the request: Is submitted to the Program in writing and on a form or in a manner approved by the Department; and Includes documentation, which may include but not be limited to, a copy of the original prescription and a signed, notarized statement from the prescriber or dispenser that demonstrates which of the specific data elements reported to the Program under Regulation .03A of this chapter are incorrect. Upon determination by the Secretary that prescription monitoring data specific to a patient’s prescription history is incorrect, the Program shall issue a corrected prescription history report to the patient or the patient’s authorized representative. Disclosure of Prescription Monitoring Data to the Office of the Attorney General. The Program shall disclose prescription monitoring data to the Office of the Attorney General, for the purpose of furthering an existing bona fide investigation, on receipt of a subpoena that: Includes information sufficient to identify the prescribers, dispensers, or patients about whom prescription monitoring data is requested; Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; Includes an agency case number or other identifier sufficient to identify an existing bona fide investigation; and Bears the name, title, and signature of the official under whose authority the subpoena is issued. Disclosure of Prescription Monitoring Data to an Authorized User of Another State’s Prescription Drug Monitoring Program or of any Other Authorized Agency. Upon request, the Program shall disclose prescription monitoring data to an authorized user of another state’s prescription drug monitoring program or an authorized user with any other authorized local, state, territorial, or federal agency in connection with the provision of medical care, provided that the request: Is submitted in a manner approved by the Department; Is under the authority of the authorized administrator of that state’s program or authorized agency; Includes an attestation that prescription monitoring data will only be used or redisclosed in a manner consistent with the provisions of Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .08D of this chapter; and Relates to a patient to whom the authorized user anticipates providing, is providing, or has provided medical care. The Program may develop and implement interoperability with another state’s prescription drug monitoring program or authorized agency to facilitate the automated exchange of prescription monitoring data provided that a written agreement has been established with the other state’s program or authorized agency specifying that the information technology employed will: Only disclose prescription monitoring data to authorized users in a manner consistent with the provisions of Health-General Article, §21-2A-06, Annotated Code of Maryland, and this regulation; and Operate in accordance with all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records. Disclosure of Prescription Monitoring Data to Units of the Department. Upon request, the Program may disclose prescription monitoring data to the Maryland Medical Assistance Program, the Office of the Inspector General of the Department, the Office of Health Care Quality, and the Office, provided that the request: Includes information sufficient to identify the unique individual about whom prescription monitoring data is requested; Specifies the time frame for which prescription monitoring data is requested, including the day, month and year the report is to begin and end; Includes a case number or other identifier sufficient to identify an existing bona fide individual investigation; and Is approved by the Secretary. Disclosure of Prescription Monitoring Data to a Medical Director of a Health Care Facility. The Program may disclose prescription monitoring data to the medical director of a health care facility, as defined in Health-General Article, §19-114, Annotated Code of Maryland, or the medical director’s designee for the purpose of providing health care practitioners employed or contractually employed at the health care facility access to the prescription monitoring data in connection with the provision of medical care or the dispensing of a monitored prescription drug to an individual who receives health care at the health care facility and on whom a medical record is maintained at the health care facility, provided that the health care facility: Is licensed by the Department of Health or is operated by the federal government or a federally recognized Indian tribe; Has an active participation agreement with the State’s Health Information Exchange; Operates in accordance with all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records; and Can provide an audit trail of the facility’s staff access to the prescription monitoring data to the Department upon request. Disclosure of Prescription Monitoring Data to the Office of the Chief Medical Examiner. Upon request from the Office of Chief Medical Examiner, the Program shall disclose decedent-specific prescription monitoring data, provided that the request is made solely for the purpose of carrying out duties authorized under Health-General Article, §5-309, Annotated Code of Maryland. The Program shall determine the electronic means by which the Office of the Chief Medical Examiner may request disclosure of or otherwise access decedent-specific prescription monitoring data. Disclosure of Prescription Monitoring Data to Case Review Entities. Upon request, the Program may disclose prescription monitoring data to the following case review entities for the purposes of furthering an existing bona fide individual case review: The State Child Fatality Review Team or a local child fatality review team as defined in Health-General Article, §5-701, Annotated Code of Maryland, upon request from the chair of the State or local team; A local drug overdose fatality review team as described in Health-General Article, §5-902, Annotated Code of Maryland, upon request from the chair of the local team; The Maternal Mortality Review Program, as defined in Health-General Article, §13-1203, Annotated Code of Maryland, on request from the Program; and A medical review committee described in Health Occupations Article, §1-401(b)(3), Annotated Code of Maryland, upon request from the committee. The request shall: Include information sufficient to identify the unique individual about whom prescription monitoring data is requested; Specify the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; Include a case number or other identifier sufficient to identify an existing bona fide individual case review; and Be approved by the Secretary. Disclosure of Prescription Monitoring Data for Research, Analysis, Education, and Public Reporting. The Program may disclose prescription monitoring data for research, analysis, education, and public reporting: In response to requests determined by the Department to be consistent with institutional review board protocols and human subjects research protections; Upon approval by the Department of a written proposal or abstract explaining the purpose and scope of the research, analysis, education, and public reporting; and After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual. The Secretary may waive the requirement of §M(1)(b) of this regulation for requests from units of the Department. Technical Advisory Committee Review. Before the Program discloses prescription monitoring data under §§C—E, H, and I of this regulation, the Technical Advisory Committee may: Review the request for disclosure; and Within 10 business days of submission of the request to the Technical Advisory Committee for review, submit to the Program, in written form, clinical guidance and interpretation of the prescription monitoring data requested to: Assist the Secretary’s decision on how to respond to a judicial subpoena, administrative subpoena, or other request; and Be made available for use by the recipient of prescription monitoring data should the request for disclosure be authorized. Notwithstanding §N(1) of this regulation, the Program may disclose prescription monitoring data to the authorized administrator of another state’s prescription drug monitoring program or authorized agency for disclosure to an authorized user in a manner consistent with §H of this regulation. Before the Program discloses prescription monitoring data to a prescriber or dispenser under §B(5) of this regulation, the Technical Advisory Committee: For indications of possible misuse or abuse, may provide clinical guidance and interpretation of the prescription monitoring data that indicates possible misuse or abuse; and For indications of possible violations of law or breach of professional standards, shall provide clinical guidance regarding the method used and advise whether the method identifies possible violations of law or breach of professional standards. If the Technical Advisory Committee has not provided clinical guidance and interpretation in accordance with §N(1) or (3) of this regulation within 10 business days of submission of the request or data to the Technical Advisory Committee for review, the Program may proceed as if the Technical Advisory Committee does not have clinical guidance or interpretation to provide regarding the request, data, or method at issue. Before making a referral to the Office in accordance with Regulation .05O of this chapter, the Program shall provide to the Technical Advisory Committee notice and an opportunity to make recommendations within 10 business days on the referral. If the Technical Advisory Committee has not provided recommendations within 10 business days under §N(5) of this regulation, the Program may proceed as if the Technical Advisory Committee does not have clinical guidance or interpretation to provide. The Department shall establish procedures, which may include but not be limited to secure electronic messaging, for the timely disclosure of prescription monitoring data to the Technical Advisory Committee and the receipt of responses from the Technical Advisory Committee to ensure that the review process is conducted with all possible expediency. For all purposes, including but not limited to confidentiality, security, redisclosure, and admissibility as evidence, Program reports based on evaluation of prescription monitoring data and that contain individual identifying information shall be considered as one and the same with the prescription monitoring data. Disclosure of Prescription Monitoring Data to the Office. The Program may disclose prescription monitoring data and make a referral to the Office about a possible violation of law or possible breach of professional standards by a prescriber or dispenser as identified under Regulation .04 of this chapter, if the Program: Determines the: Outreach and education provided was inadequate to address the possible breach or violation; or Outreach and education would be inadequate to address the possible violations of law or a possible breach of professional standards; Provides notice and an opportunity to the Technical Advisory Committee to make recommendations within 10 business days regarding interpretation of the prescription monitoring data; Provides the recommendations, if any, of the Technical Advisory Committee to the Office; and Notifies the prescriber or the dispenser that the prescription monitoring data will be provided to the Office for further investigation. Disclosure of Naloxone Medication Data for Public Health Surveillance, Research, Analysis, Education, and Public Reporting. The Program shall disclose naloxone medication data for research, analysis, education, and public reporting: Upon approval by the Department of a written proposal or abstract explaining the purpose and scope of the research, analysis, education, and public reporting; and After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual. The Secretary may waive the requirement of §A(1) of this regulation for requests from units of the Department. The Program may disclose de-identified naloxone medication data for public health surveillance purposes. The Program may not disclose identifiable naloxone medication data to any entity, including but not limited to prescribers or dispensers. Pharmacists. Any pharmacist who intends to request prescription monitoring data from the Program may post a sign that can be easily viewed by the public at the place where the prescription is delivered to the pharmacist. The sign shall disclose to the public that the pharmacist may access prescription monitoring data on a patient for whom a prescription for a monitored prescription drug is presented. In lieu of posting a sign, the pharmacist may provide such notice in written material provided to the patient. Prescriber. Any prescriber who intends to request prescription monitoring data from the Program may post a sign that can be easily viewed by the public that discloses to the public that the prescriber may access prescription monitoring data on a patient. In lieu of posting a sign, the prescriber may provide such notice in written material provided to the patient. Prescription monitoring data and naloxone medication data are confidential, privileged, not subject to discovery, subpoena, or other means of legal compulsion in civil litigation, and are not public records. The Program shall ensure that confidential or privileged patient information be kept confidential and that records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .04 of this chapter, does not disclose the identity of the person protected. The Program shall periodically conduct an audit review of prescription monitoring data and naloxone medication data and disclosure requests to ensure compliance with §B of this regulation. Civil Penalties. A dispenser who knowingly fails to submit prescription monitoring data or naloxone medication data to the Program as required by Regulation .03 of this chapter shall be subject to a civil penalty not exceeding $500 for each failure to submit required information. Criminal Penalties. A person who knowingly discloses, uses, obtains, or attempts to obtain by fraud or deceit prescription monitoring data or naloxone medication data in violation of in Health-General Article, §21-2A, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both. Administrative Sanctions. A prescriber or pharmacist who knowingly discloses or uses prescription monitoring data or naloxone medication data in violation of Health-General Article, §21-2A, Annotated Code of Maryland shall be subject to disciplinary action by the appropriate licensing entity. The Program shall make available the information technology necessary for dispensers to report prescription monitoring data and naloxone medication data to the Program. The Program may not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program. A prescriber or pharmacist, when acting in good faith, is not subject to liability or disciplinary action arising solely from: Requesting or receiving prescription monitoring data from the Program; or Acting, or failing to act, on the basis of prescription monitoring data provided by the Program. Redisclosure of Prescription Monitoring Data. Prescription monitoring data received under Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .05 of this chapter may be redisclosed only: In a manner consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §1320d et seq., as amended, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records; or For entities to which the Program has disclosed data, in furtherance of an existing, bona fide, individual investigation to another agency cooperating with or providing support to the original data. The release of prescription monitoring data by a prescriber or pharmacist to a licensed health care professional solely for treatment purposes in a manner otherwise consistent with State and federal law is not a violation of Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland. Redisclosure of Naloxone Medication Data. Naloxone medication data received under Health-General Article, §21-2A-6.1, Annotated Code of Maryland, and Regulation .05-1 of this chapter may be redisclosed only in a manner consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §1320d et seq., as amended, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records. The Program shall retain prescription monitoring data and naloxone medication data for 5 years from the date of receipt. A member of the Technical Advisory Committee: Shall serve for a term of 3 years from the date of appointment; and May be reappointed at the discretion of the Secretary. Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland Effective date: January 7, 2013 (39:26 Md. R. 1665) Regulation .04H amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .08D amended effective October 28, 2013 (40:21 Md. R. 1775) Chapter revised effective June 8, 2015 (42:11 Md. R.725) Regulation .02B amended effective October 8, 2018 (45:20 Md. R. 918); May 18, 2020 (47:10 Md. R. 519); July 20, 2023 (50:8 Md. R. 338) Regulation .03 amended effective July 20, 2023 (50:8 Md. R. 338) Regulation .03B, F amended effective October 8, 2018 (45:20 Md. R. 918) Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .04A amended effective July 20, 2023 (50:8 Md. R. 338) Regulation .05 amended effective February 29, 2016 (43:4 Md. R. 332); October 8, 2018 (45:20 Md. R. 918); May 18, 2020 (47:10 Md. R. 519) Regulation .05D, F amended effective July 20, 2023 (50:8 Md. R. 338) Regulation .05-1 adopted effective July 20, 2023 (50:8 Md. R. 338) Regulation .06A amended effective October 8, 2018 (45:20 Md. R. 918) Regulation .07A, C amended effective July 20, 2023 (50:8 Md. R. 338) Regulation .08 amended effective July 20, 2023 (50:8 Md. R. 338) Regulation .08C amended effective October 8, 2018 (45:20 Md. R. 918) Regulation .09 amended effective July 20, 2023 (50:8 Md. R. 338) Regulation .09C—E amended effective October 8, 2018 (45:20 Md. R. 918) This chapter sets forth the requirements for the Overdose Response Program administered by the Department for the purpose of providing a means of training individuals to administer naloxone to an individual experiencing, or believed to be experiencing, opioid overdose to help prevent a fatality when medical services are not immediately available. In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Education and training program” means educational instruction in opioid overdose recognition and response and the administration of naloxone. “Emergency medical services” means the Statewide comprehensive system of emergency medical care. “Health care provider” means an individual licensed or certified under Health Occupations Article, Annotated Code of Maryland, or Education Article, §13-516, Annotated Code of Maryland, to provide health care services; “Naloxone” means an opioid antagonist medication used to counter the effects of an opioid overdose. “Pharmacist” means an individual licensed to practice pharmacy in Maryland under Health Occupations Article, Title 12, Annotated Code of Maryland. “Private or Public Entity” means a health care provider, local health department, community-based organization, substance use disorder treatment organization, or other person that addresses medical or social issues related to drug addiction. “Standing order” means a written instruction for the prescribing and dispensing of naloxone in accordance with Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland. Application for Authorization. A private or public entity that seeks to conduct education and training programs under Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland, shall submit to the Department: A completed application form containing all identifying information for the private or public entity that is required by the Department, including: Entity name; Type of entity based on categories supplied by the Department; Entity address; Entity telephone number; Entity email address; Name of Entity Director; Name of Training Program Director; and Any additional information as requested by the Department; For a public or private entity intending to provide naloxone: A copy of a written agreement between a health care provider with prescribing authority and the private or public entity for the prescribing and dispensing of naloxone; Identifying information for the health care provider with prescribing authority including: Name; Title; Address; Phone number; Email address; and State license number; and If applicable, a copy of the entity’s dispensing protocols for naloxone; A description of ancillary topics to be covered in addition to the core educational training curriculum provided by the Department pursuant to Regulation .04A(2) of this chapter, and copies of any training materials to be used during instruction; Any other information required by the Department; and Any fee required by the Department. Approval of Applications. Upon approval of an application for authorization, the Department shall issue to the private or public entity a form that includes: The name of the private or public entity and its director; A statement that the private or public entity is authorized by the Department to conduct education and training programs; A serial number; The date of the approval of the authorization; and The date of the expiration of the authorization. Term of Authorization. An authorization under this chapter shall be valid for 2 years. Notification of Significant Change of Information. An authorized private or public entity shall notify the Department in writing of any significant change in the information that was submitted in the application for authorization under §A(1)—(5) of this chapter within 30 days of such change. Authorization Renewal. An authorized private or public entity may apply to the Department for renewal of its authorization to conduct education and training programs. An authorized private or public entity shall submit to the Department a completed renewal application form, along with any fee required by the Department, on a schedule set by the Department. The Department may request additional information from the private or public entity as necessary to render a decision on the renewal application. If the Department finds, after review of the application for authorization renewal, that the private or public entity is in compliance with the requirements for initial authorization set forth in this chapter, the Department shall issue a renewal authorization form to the private or public entity that includes the information set forth in §B of this regulation. An authorization renewal under this chapter shall be valid for 2 years. Expiration without Renewal. The Department may require a private or public entity whose authorization has expired without renewal to reapply for initial authorization as required under §A of this regulation. Maintenance of Records. The Department shall maintain a record of each authorized private or public entity, including all information submitted by the private or public entity in the initial application for authorization and any additional information provided in an application for authorization renewal. A private or public entity authorized by the Department: Shall offer an education and training program on opioid overdose recognition and response; and May provide access to naloxone. Education and training shall include a core curriculum provided by the Department. The core curriculum shall include: Education on recognizing the symptoms and signs of an opioid overdose; Training on responding to an opioid overdose; The proper use and administration of naloxone; Proper rescue breathing technique; The importance of contacting emergency medical services; The care of an individual after the administration of naloxone; and Any other topic required by the Department. The Department may approve multiple core curricula: For use in training specific populations; For delivery in specific settings; or Based on other relevant factors. Education and training may include any other relevant topic at the discretion of the authorized private or public entity conducting the education and training. A private or public entity authorized by the Department under this chapter may offer a training program online. An individual of any age may receive from any health care provider with prescribing authority a prescription for naloxone and the necessary supplies for the administration of naloxone. An individual for whom naloxone is prescribed and dispensed in accordance with this chapter may: Possess prescribed naloxone and the necessary supplies for the administration of naloxone; and In an emergency situation when medical services are not immediately available, administer naloxone to an individual experiencing or believed by the individual to be experiencing an opioid overdose. An individual who, in accordance with Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland, and this regulation, is administering naloxone to an individual experiencing, or believed by the individual to be experiencing an opioid overdose, may not be considered to be practicing: Medicine for the purposes of Health Occupations Article, Title 14, Annotated Code of Maryland; or Registered nursing for the purposes of Health Occupations Article, Title 8, Annotated Code of Maryland. An individual may report information on the administration of naloxone by the individual, overdose reversals, and other program outcomes to: The private and public entity that provided training; The Maryland Poison Center; The Department; or Any other entity identified by the Department. A healthcare provider with prescribing authority may prescribe and dispense naloxone to an individual of any age who: Is believed by the health care provider to be at risk of experiencing an opioid overdose; or Is in a position to assist an individual at risk of experiencing an opioid overdose. A health care provider with prescribing authority may prescribe and dispense naloxone by issuing a standing order if the health care provider: Is employed by the department or a local health department; or Has a written agreement with an authorized private or public entity under Health-General Article, §13-3104, Annotated Code of Maryland. A health care provider with prescribing authority who issues a standing order may delegate the dispensing of naloxone to an employee or a volunteer of an authorized private or public entity in accordance with a written agreement under Health-General Article, §13-3104, Annotated Code of Maryland. A health care provider who has dispensing authority also may dispense naloxone to any individual of any age in accordance with a standing order issued by a health care provider in accordance with Health-General Article, §13-3106, Annotated Code of Maryland. If the Department determines that a private or public entity has failed to comply with the requirements of this chapter, the Department may initiate one or more of the following actions against the private or public entity: Denial of an initial application for authorization; Denial of an application for authorization renewal; Suspension of the authorization of the private or public entity; or Revocation of authorization of the private or public entity. Notification to Applicant or Private or Public Entity. The Department shall notify an applicant or private or public entity in writing of the denial of initial application for authorization, denial of application for authorization renewal, suspension of authorization, or revocation of authorization. The written notice shall include: The reason for the action taken; The effective date of the action; The procedure for appeal of the decision to deny an initial application for, or to suspend, revoke, or not renew the authorization of, a private or public entity; and Notification that the private or public entity may file an appeal of the Department’s decision and that any such appeal shall be filed within 10 days of receipt of the notice. Summary Suspension. Under State Government Article, §10-226(c), Annotated Code of Maryland, the Department may summarily suspend the authorization of a private or public entity if the Department finds that the public health, safety, or welfare imperatively requires emergency action. From the time of receipt of the notice of summary suspension, the private or public entity may not: Conduct an education and training program; or Provide access to naloxone. Reinstatement of Authorization after Suspension. The Department may lift the suspension and reinstate authorization of a private or public entity if: The private or public entity submits in writing to the Department a request for the reinstatement that documents how the conditions leading to the suspension have been remedied or corrected; and The Department verifies that the conditions leading to the suspension have been remedied or corrected. Application after Revocation. After authorization of a private or public entity has been revoked for a period of 12 months, the former authorized entity may reapply for authorization approval pursuant to the process set forth in Regulation .03 of this chapter. A private or public entity may request a hearing on an action taken by the Department pursuant to Regulation .07 of this chapter as allowed by: COMAR 10.01.03; State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and Health-General Article, Title 2, Subtitle 2, Annotated Code of Maryland. The Department shall maintain the following records: Information on private or public entities authorized by the Department, including: Names of entities and directors; Addresses of entities; Serial numbers of the initial authorizations; Initial authorization dates; and Dates of authorization renewals; and Information on private or public entities whose authorization has been suspended or revoked, including: Names of entities and directors; Addresses of entities; Serial numbers of the initial authorizations; Effective dates of suspensions or revocations; Reasons for suspensions or revocations; and If applicable, dates on which the approvals for authorization were reinstated. If providing naloxone, a private or public entity authorized by the Department shall maintain records for each individual who has been provided naloxone, including: Full name of individual; Name of prescriber; Name and address of dispenser; Date of dispensing; and Type and dosage of naloxone dispensed. Reporting Information to the Department. A private or public entity authorized by the Department shall report to the Department: Information on program operations, including: Number of individuals who have completed education and training programs; For private or public entities authorized by the Department that provide naloxone directly or by means of a voucher for redemption at a pharmacy: Form of naloxone dispensed; Number of initial doses of naloxone dispensed; and Number of naloxone refills dispensed; and Number and location of naloxone administrations and overdose reversals to the extent this information is reported to the private or public entity authorized by the Department; Demographic information on individuals who participated in an education and training program, including aggregate number of individuals by: Sex; Ethnicity; Race; Age; and The specific reason to receive education and training; and Any other information required by the Department. Information under §C of this regulation shall be reported by the private or public entity authorized by the Department on a monthly basis in a format specified by the Department. Waiver of Fees. The Department may waive any fee required under this chapter. Discipline of a Health Care Provider. A health care provider who prescribes or dispenses naloxone to an individual in good faith, may not be subject to any disciplinary action under Health Occupations Article, Annotated Code of Maryland, solely for the act of prescribing or dispensing naloxone to the individual. A cause of action may not arise against any health care provider with prescribing authority, or pharmacist for any act or omission when prescribing or dispensing naloxone and the necessary paraphernalia for the administration of naloxone to an individual in good faith under Health General Article, §13-3108, Annotated Code of Maryland. An individual who administers naloxone to an individual who is or in good faith is believed to be experiencing an opioid overdose shall have immunity from liability under Courts and Judicial Proceedings Article, §§5–603 and 5–629, Annotated Code of Maryland. Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland Effective date: March 3, 2014 (41:4 Md. R. 301) Regulation .02B amended effective April 13, 2015 (42:7 Md. R. 570) Regulation .03A, D amended effective April 13, 2015 (42:7 Md. R. 570) Regulation .04A amended effective April 13, 2015 (42:7 Md. R. 570) Regulation .05 amended effective April 13, 2015 (42:7 Md. R. 570) Regulation .08C amended effective April 13, 2015 (42:7 Md. R. 570) Regulation .10B, C amended effective April 13, 2015 (42:7 Md. R. 570) Regulation .10D adopted effective April 13, 2015 (42:7 Md. R. 570) Chapter revised effective September 12, 2016 (43:18 Md. R. 1017) Chapter revised effective October 7, 2019 (46:20 Md. R. 845)