Maryland Administrative Code

.03 Requests for Partnership Funding and Criteria for Awarding Funding. A. Requests for partnership funding may be submitted to the Department by: (1) The governing body of a jurisdiction or its designee; or (2) The governing bodies of more than one jurisdiction or their designee…

.04 Fiscal Responsibility by Jurisdiction. A. 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: (1) The financial hardship of the participating county; (2) P…

.01 Scope. This chapter sets forth the requirements for monitoring the prescribing and dispensing of controlled dangerous substances under the Prescription Drug Monitoring Program.

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Authorized user” means a licensed prescriber, a prescriber delegate, a licensed pharmacist, a pharmacist delegate, or a licensed health care practitioner registered with a…

.03 Dispenser Reporting. A. 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: (1) Identifying information for the …

.04 Review of Prescription Monitoring Data. A. The Program shall review prescription monitoring data and naloxone medication data for indications of possible: (1) Misuse or abuse of a monitored prescription drug; and (2) Violations of law or possible breaches of professional stan…

.05 Disclosure of Prescription Monitoring Data. A. Registration of a Prescriber, a Prescriber Delegate, a Pharmacist, a Pharmacist Delegate, or a Licensed Health Care Practitioner to Request Prescription Monitoring Data. (1) A prescriber, a prescriber delegate, a pharmacist, a ph…

.05-1 Disclosure of Naloxone Medication Data. Disclosure of Naloxone Medication Data for Public Health Surveillance, Research, Analysis, Education, and Public Reporting. A. The Program shall disclose naloxone medication data for research, analysis, education, and public reporting…

.06 Notice to Patients. A. Pharmacists. (1) 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. (2) The sign shall disclose …

.07 Confidentiality. A. 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. B. The Program shall ensure that confidential or…

.08 Penalties and Sanctions. A. 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…

.09 General Provisions. A. The Program shall make available the information technology necessary for dispensers to report prescription monitoring data and naloxone medication data to the Program. B. The Program may not impose any fees or other assessments on prescribers or dispen…

.01 Scope. 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 …

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Education and training program” means educational instruction in opioid overdose recognition and response and the…

.03 Authorization of a Private or Public Entity. A. 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: (1)…

.04 Education and Training Programs. A. A private or public entity authorized by the Department: (1) Shall offer an education and training program on opioid overdose recognition and response; and (2) May provide access to naloxone. B. Education and training shall include a core c…

.05 Naloxone Use. A. 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. B. An individual for whom naloxone is prescribed and dispensed in accordan…

.06 Naloxone Prescribing and Dispensing. A. A healthcare provider with prescribing authority may prescribe and dispense naloxone to an individual of any age who: (1) Is believed by the health care provider to be at risk of experiencing an opioid overdose; or (2) Is in a position …

.07 Denial, Suspension, and Revocation of Authorization of a Private or Public Entity. A. 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 agai…

.08 Appeals. 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: A. COMAR 10.01.03; B. State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and C. Health-General Art…

.09 Record Maintenance and Reporting. A. The Department shall maintain the following records: (1) Information on private or public entities authorized by the Department, including: (a) Names of entities and directors; (b) Addresses of entities; (c) Serial numbers of the initial a…

.10 General Provisions. A. Waiver of Fees. The Department may waive any fee required under this chapter. B. 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 act…

.01 Scope. This chapter: A. Defines the emergency medical treatment and the limitations on this treatment paid for by the Department for the victims of child abuse and neglect; B. Defines provider license requirements and conditions for participation, payment, and reimbursement p…

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Abuse” means: (a) The physical or mental injury of a child by any parent or other person who has permanent or temporary care or custody or responsibility for supervision o…

.03 License Requirements. A. A doctor of medicine shall be licensed and legally authorized to practice medicine and surgery in Maryland. B. A hospital shall be licensed by the Department as a hospital, pursuant to Hospital and Related Institutions subtitle, Health-General Article…

.04 Conditions for Participation. A. To be reimbursed by the Program, the provider shall: (1) Accept payment by the Program as payment in full for the services rendered to an eligible child and make no additional charge to any person for covered services; (2) Agree that if the Pr…

.05 Covered Services. The Program covers emergency medical treatment rendered to children who are alleged victims of abuse or neglect. This treatment includes: A. Medical or surgical care rendered by a physician or health care institution; and B. Diagnostic tests.

.06 Limitations. The Program does not cover the following: A. Nonemergency outpatient treatment; B. Periodic nonemergency health care; C. Services which are investigational or experimental; or D. Services related to the assessment and treatment of mental injury.

.07 Payment Procedures. A. The provider shall submit the request for payment on the appropriate Medical Assistance Program invoice form. B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by…

.08 Recovery and Reimbursement. A. The child's parent or guardian is liable to the Maryland Department of Health for all payments made on behalf of the child by this Program. B. The child's parent or guardian shall take any steps necessary to secure health benefits available for …

.09 Appeal Procedures. A. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to State Government Article, Title 10, Subtitle 2, and Health-General Article, §§2-201—2-207, Annotated Code of Maryland. B. Appeals sh…

.10 Funding Availability. Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Anatomy Board. (2) “Cadaveric specimens” means requested body parts, organs, or tissues taken from a cadaver. (3) “In-State commercial programs” mea…

.02 Reimbursement Claim Fees. A. The Board shall: (1) Release an unclaimed body under its control to a relative or friend; and (2) Be reimbursed for expenses incurred for transportation, storage, preparation, cremation, and supplies and materials used. B. The Board may, at its di…

.03 Cadaver and Cadaveric Specimen Fees. A. The Board shall review costs of services provided to the State's medical-dental member school programs every 2 years. B. Cost Analysis. The Board shall: (1) Perform a cost analysis of expenditures and experienced program services based …

.01 Purpose. The intent of this chapter is to protect the public and individual health by requiring that all tissue banks operating or providing services in Maryland operate under qualified supervision, reliable procedures, and appropriate quality assurance.

.02 Scope. This chapter does not apply to a tissue bank operated: A. By the federal government; or B. Solely for research and teaching purposes, if human tissue and tissue products from the research or teaching are not transplanted, transfused, or used within or upon a human.

.03 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adverse outcome” means an undesirable effect or untoward complication in a recipient as a result of or reasonably related to a transfusion or transplantation of cells, tis…

.04 Incorporation by Reference. A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) Standards for Tissue Banking (American Association of Tissue Banks, 14th Edition), Sections C, D, E, F, G, H, J, K, L, and M1-8 only; (2) Stan…

.05 Responsibilities of the OHCQ. — Repealed.

.06 Permitting Procedure. A. Application. An application is not complete until the OHCQ has received the completed permit application and all required documents. B. Initial Inspection. The OHCQ shall inspect or have an inspection conducted by an accreditation organization for eac…

.07 Accredited Tissue Bank and Accrediting Organization. A. Accredited Tissue Bank — Determination. The Secretary may accept as compliance with the inspection requirements of this chapter a tissue bank accredited by an organization approved by the Secretary, as set forth in §C of…

.08 Inspection by OHCQ. A. Open for Inspection. A permit holder shall allow an on-site inspection by the OHCQ, or any designee by OHCQ, at any time during the tissue bank's regular hours of operation, to evaluate the tissue bank's compliance with the applicable requirements, cond…

.09 Tissue Bank Standards — General. A. Applicable Laws. A tissue bank shall comply with all requirements and standards in this chapter as well as with other applicable federal, State, and local laws, regulations, and rules. B. Governing Body. Unless provided by the institution o…

.10 Tissue Bank Standards — Personnel. A. General Requirements. A tissue bank shall employ a technical director, medical director, and sufficient staff to: (1) Provide accurate and reliable services; (2) Meet all operational needs; and (3) Meet all statutory and regulatory requir…

.11 Tissue Bank Standards — Testing to Minimize Disease Transmission. A. Required Testing. (1) General — All Donors. A permit holder shall ensure that a prospective donor of tissue, including both leukocyte-rich and leukocyte-poor cell and tissue, intended to be used as an allogr…

.12 Tissue Bank Standards — Technical. In addition to the requirements and standards in this chapter, a tissue bank shall meet and comply, where applicable, with the following technical requirements and standards: A. Records management, in the manner prescribed in Section C of St…