§ 24A — Electronic monitoring of the prescribing and dispensing of controlled substances and certain additional drugs

Massachusetts § 24A

• Jurisdiction: Massachusetts
• Part I: ADMINISTRATION OF THE GOVERNMENT
• Title XV: REGULATION OF TRADE
• Ch. 94C: CONTROLLED SUBSTANCES ACT

Text

Section 24A. (a)(1) The department shall establish and maintain an electronic system to monitor the prescribing and dispensing of all schedule II to V, inclusive, controlled substances and certain additional drugs by all professionals licensed to prescribe or dispense such substances. For the purposes of this section, ''additional drugs'' shall mean substances determined by the department to carry a bona fide potential for abuse.(2) The department shall enter into reciprocal agreements with other states that have compatible prescription drug monitoring programs to share prescription drug monitoring information among the states.(b) The requirements of this section shall not apply to the dispensing of controlled substances to inpatients in a hospital.(c) For the purposes of monitoring the prescribing and dispensing of all schedule II to V, inclusive, controlled substances and additional drugs, as authorized in subsection (a), the department shall promulgate regulations including, but not limited to, (1) a requirement that each pharmacy that delivers a schedule II to V, inclusive, controlled substance or a substance classified as an additional drug by the department to the ultimate user shall submit to the department, by electronic means, information regarding each prescription dispensed for a drug included under subsection (a); and (2) a requirement that each pharmacy collects and reports, for each prescription dispensed for a drug under subsection (a), a customer identification number and other information associated with the customer identification number, as specified by the department. Each pharmacy shall submit the information in accordance with transmission methods and frequency requirements promulgated by the department; provided, however, that the information shall be submitted at least once every 24 hours. The department may issue a waiver to a pharmacy that is unable to submit prescription information by electronic means. The waiver shall permit the pharmacy to submit prescription information by other means promulgated by the department; provided, however, that all information required in this section is submitted in this alternative format.The department shall promulgate rules and regulations relative to the use of the prescription monitoring program by registered participants. The regulations shall include the requirement that prior to issuance, participants shall utilize the prescription monitoring program each time a prescription for a narcotic drug that is contained in schedule II or III, or a prescription for a benzodiazepine, is issued. The department may require participants to utilize the prescription monitoring program prior to the issuance of any schedule IV or V prescription drug, that is commonly misused and may lead to physical or psychological dependence or that causes patients with a history of substance dependence to experience significant addictive symptoms. The regulations shall specify the circumstances under which such narcotics or benzodiazepines may be prescribed without first utilizing the prescription monitoring program. The regulations may also specify the circumstances under which support staff may use the prescription monitoring program on behalf of a registered participant. When promulgating the rules and regulations, the department shall also require that pharmacists be trained in the use of the prescription monitoring program as part of the continuing education requirements mandated for licensure by the board of registration in pharmacy, under section 24A of chapter 112. The department shall also study the feasibility and value of expanding the prescription monitoring program to include schedule VI prescription drugs.(d) Prescription information submitted to the department under this section shall be confidential and exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 and chapter 66. The department shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted and maintained is not disclosed to persons except as provided for in this chapter.(e) The department shall review the prescription and dispensing monitoring information. If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the department shall notify the appropriate law enforcement or professional licensing, certification or regulatory agency or entity and provide prescription information required for an investigation.(f) The department shall, upon request, provide data from the prescription monitoring program to the following:—(1) persons authorized to prescribe or dispense controlled substances, for the purpose of providing medical or pharmaceutical care for their patients;(2) individuals who request their own prescription monitoring information in accordance with procedures established under chapter 66A;(3) persons authorized to act on behalf of state boards and regulatory agencies that supervise or regulate a profession that may prescribe controlled substances; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation;(4) local, state and federal law enforcement or prosecutorial officials working with the executive office of public safety and security engaged in the administration, investigation or enforcement of the laws governing prescription drugs; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation and accompanied by a probable cause warrant issued pursuant to chapter 276;(5) personnel of the executive office of health and human services regarding Medicaid program recipients; provided, however that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation;(6) personnel of: (A) the United States attorney or a federal agency; provided, however, that the data request is made pursuant to clause (4) or federal law; (B) the office of the attorney general provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug related investigation and accompanied by a probable cause warrant issued pursuant to chapter 276 or a civil investigative demand; or (C) a district attorney's office; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug related investigation and accompanied by a probable cause warrant issued pursuant to chapter 276;(7) personnel of the Medicaid fraud control unit within the office of the attorney general; provided, however, that the data request is made in connection with a bona fide specific controlled substance or additional drug related investigation of a practitioner, pharmacist, pharmacy, person required to be a registered participant by this chapter or any other provider subject to the jurisdiction of a Medicaid fraud control unit under federal law, including, but not limited to, 42 U.S.C. section 1396b, et. seq.; and provided further, that, notwithstanding clauses (4) and (6), the department shall provide the data requested pursuant to this clause without a probable cause warrant issued pursuant to chapter 276 or a civil investigative demand; or(8) personnel within the office of a district attorney; provided, however, that the data request is made in connection with a bona fide investigation into the cause and manner of death of an individual suspected of a drug overdose; provided further, that data provided pursuant to this clause is limited to the prescription information of the individual suspected of the drug overdose; and provided further, that, notwithstanding clauses (4) and (6), the department shall provide the data requested pursuant to this clause without a probable cause warrant issued pursuant to chapter 276.(g) The department may provide data from the prescription monitoring program to practitioners in accordance with this section; provided, however, that practitioners shall be able to access the data directly through a secure electronic medical record or other similar secure software or information system that enables automated query and retrieval of prescription monitoring program data to a practitioner. This data may be used only for the purpose of diagnosis, treatment or coordinating care of the practitioner's patient, unless otherwise permitted by this section. Any such secure software or information system shall identify the registered participant on whose behalf the prescription monitoring program was accessed. The department may enter into data use agreements to allow summary prescription monitoring program data to be securely retained in the patient's medical record as a clinical note associated with a clinical encounter; provided, however, that prescription monitoring program data shall not be retained separately from said clinical note; and provided further, that no such agreement shall allow for prescription monitoring program data to be used for purposes inconsistent with this section.(h) The department may provide de-identified information to a public or private entity for statistical research or educational purposes.(i) The department may contract with another agency or with a private vendor, as necessary, to ensure the effective operation of the prescription monitoring program. A contractor shall be bound to comply with the provisions regarding confidentiality of prescription information in this section.(j) The department shall promulgate rules and regulations setting forth the procedures and methods for implementing this section.(k) The department shall submit an annual report on the effectiveness of the prescription monitoring program with the clerks of the house and senate, the chairs of the joint committee on public health, the chairs of the joint committee on health care financing and the chairs of the joint committee on public safety and homeland security.(l) Upon receiving a report of an overdose-related death from the chief medical examiner, under section 16 of chapter 38, or a report of examination or treatment of a person with injuries resulting from an opiate, illegal or illicit drug overdose, under section 12A of chapter 112, the department shall review the prescription monitoring program to determine if a notification should be made under subsection (e).(m) The department may enter into agreements to permit health care facilities to integrate secure software or information systems into their electronic medical records for the purpose of using prescription monitoring program data to perform data analysis, compilation, or visualization, for purposes of diagnosis, treatment or coordinating care of the practitioner's patient. Any such secure software or information system shall comply with requirements established by the department to ensure the security and confidentiality of any data transferred.