105 Mass. Reg. 700.012

Current through Register 1523, June 7, 2024

Section 700.012 - Prescription Monitoring Program

(A)Pharmacy Reporting Requirements.

(1) The reporting requirement of 105 CMR 700.012 applies to every pharmacy registered with the Commissioner that dispenses a controlled substance pursuant to a prescription in Schedules II through V, or a controlled substance classified by the Department as an additional drug as outlined in 105 CMR 700.012, and to any pharmacy in another state, commonwealth, district or territory that delivers such a controlled substance to a person in Massachusetts. Such a pharmacy shall, in accordance with standards established by the Commissioner, transmit to the Department or its agent the pharmacy identifier, customer identification number and associated information as specified in the PMP Dispensing Guide issued by the Commissioner.

(2)105 CMR 700.012 shall not apply to the dispensing pursuant to a medication order of a controlled substance to an inpatient in a hospital.

(3) A pharmacy that dispenses a controlled substance subject to the requirements in 105 CMR 700.012 must require that a customer identifier is presented whenever a controlled substance in Schedules II through V, or an additional drug is dispensed. The pharmacy may dispense a controlled substance in Schedules II through V or an additional drug without reviewing the customer identifier if the pharmacy has reason to believe that the failure to dispense the controlled substance or additional drug would result in a serious hardship for the ultimate user or agent of the ultimate user, and documents the reason; and the ultimate user or agent of the ultimate user prints their name and address on the reverse side of the prescription and signs their name thereto, or in the case of an electronic prescription, provides an electronic signature; and the pharmacy provides to the Department those informational fields required by the Department.

(4) The Commissioner may waive or modify the requirements in 105 CMR 700.012(A) for a pharmacy to report customer information as specified by the Commissioner.

(5) The information required by 105 CMR 700.012 shall be transmitted to the Department or its agent in accordance with any procedures established by the Commissioner by the end of the next business day and shall include data for all controlled substances dispensed since the previous transmission or report or as otherwise specified in guidelines of the Department, by use of encrypted electronic device or electronic transmission method in a format approved by the Commissioner.

(6) If a pharmacy is not able to submit dispensing information by electronic means, the Commissioner may issue a waiver to authorize another means of transmission, provided that all information required in accordance with 105 CMR 700.012(A) is submitted in this alternate format.

(B)Prescription Monitoring Program Medical Review Group.

(1) The Commissioner may establish the Prescription Monitoring Program Medical Review Group to advise the Department in the evaluation of prescription information and clinical aspects of the implementation of 105 CMR 700.012.

(2) Members of the Medical Review Group shall be licensed health care practitioners and pharmacists and, to the extent feasible, at least one member shall be licensed in the same discipline as the practitioner whose records are under review. Practitioners serving on the Medical Review Group must have a valid Controlled Substances Registration for Schedules II through VI pursuant to M.G.L. c. 94C, § 7.

(C)Privacy, Confidentiality and Disclosure.

(1) Except where otherwise provided by judicial order, statute or regulation including, but not limited to 105 CMR 700.012(C)(2), the information collected or generated pursuant to 105 CMR 700.012 shall be kept confidential by the Department.

(2) The Department shall, upon request and to the extent made feasible by 105 CMR 700.012, provide data collected pursuant to 105 CMR 700.012 to:

(a) a practitioner for the purpose of providing medical or pharmaceutical care to a patient or to review their own prescribing history for the purpose of practice improvement; further, a supervising practitioner may review the prescribing history of any practitioner they supervise as required by law, for the purpose of practice improvement;

(b) a person authorized to act on behalf of an entity designated by M.G.L. c. 94C, § 24A, provided the request is in connection with a bona fide specific controlled substance or additional drug-related investigation; meets all applicable requirements of M.G.L. c. 94C, § 24A(f); and such requesting entity is:

1. a state board or regulatory agency that supervises or regulates a profession that may prescribe or dispense controlled substances;

2. a local, state or federal law enforcement agency or prosecutorial office working with the Executive Office of Public Safety engaged in the administration, investigation or enforcement of criminal law governing controlled substances;

3. the Executive Office of Health and Human Services, acting with regard to a MassHealth program recipient;

4. the United States Attorney;

5. the Office of the Attorney General; or

6. the office of a District Attorney.

(c) a duly authorized representative of a health department or other agency in another state, commonwealth, district, territory or country that maintains prescription information in a data system with privacy, security and other disclosure requirements consistent with those established in the Commonwealth, in accordance with a valid, written reciprocal data sharing agreement establishing the terms and conditions for exchange of data; and (d) an individual or the individual's parent or legal guardian, who requests the individual's own prescription monitoring information in accordance with procedures established under M.G.L. c. 66A and other applicable statute or regulation of the Commonwealth.

(3) PMP data provided to prescribers pursuant to 105 CMR 700.012(C)(2)(a) may be accessed directly through the MassPAT, or through a secure electronic medical record or other secure electronic system which complies with 21 CFR 1311, Subpart C, and other federal regulations applicable to the safety and security of healthcare information and prescriptive practice, as authorized in a written agreement with the Department pursuant to 105 CMR 700.012(E)(1) and in accordance with Departmental guidance. Such agreement may allow the creation and maintenance of a summary or description of patient-specific data collected pursuant to 105 CMR 700.012 in that patient's electronic medical record as a clinical note associated with a specific clinical encounter; provided however, that such data may be used only for the purpose of diagnosis, treatment or coordinating care, and shall not be retained separately from said clinical note.

(4) A request for information collected pursuant to 105 CMR 700.012 shall be in writing or, if applicable, transmitted electronically pursuant to 105 CMR 700.012(E) and shall be made in accordance with procedures established by the Commissioner to ensure compliance with the requirements of 105 CMR 700.012(C) and (D).

(5) The Commissioner may initiate disclosure of data on a patient or research subject collected pursuant to 105 CMR 700.012 to an individual authorized and registered to prescribe or dispense controlled substances in any or all of the Schedules II through V, and Schedule VI if applicable, pursuant to 105 CMR 700.000, provided that:

(a) The authorized individual has prescribed or dispensed such a controlled substance to the patient or research subject;

(b) The Commissioner has determined that the patient or research subject is receiving a controlled substance or additional drug from more than one source and in quantities that they determine to be harmful to the health of the patient or research subject or that disclosure is otherwise necessary to prevent the unlawful diversion of a controlled substance; and

(c) Such disclosure shall not require or direct the authorized individual to take action that they believe to be contrary to the patient's or research subject's best interests.

(6)

(a) The Department shall review the prescription monitoring information collected pursuant to 105 CMR 700.012. 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 monitoring information required for an investigation.

(b) Disclosure at the initiation of the Commissioner pursuant to 105 CMR 700.012(C)(4) and (5) shall be in conformance with any protocols established by the Commissioner, who may consult with the Medical Review Group when such consultation is provided on Commissioner initiated disclosure, the Medical Review Group shall review the content and application of the protocols, make recommendations to the Commissioner for effective use of such protocols and as needed review specific instances of Commissioner initiated disclosure. If undertaking such review, the Medical Review Group may be provided upon request with such pertinent information as needed.

(7) The Commissioner may provide de-identified data to a public or private entity for statistical research or educational purposes.

(8) The Commissioner may determine that a drug is an "additional drug" for purposes of 105 CMR 700.012, because it carries a bona fide potential for abuse based on factors including, but not limited to, the following:

(a) A risk of addiction exists when used alone or in combination with a Schedule II through IV drug;

(b) The drug is known to be used recreationally;

(c) The drug is known to be regularly diverted for misuse; or

(d) The drug has been known to contribute to overdose or be regularly present in the bloodstream of individuals who have experienced overdose.

Upon making such a determination, the Commissioner shall notify all dispensers that they must begin to report the dispensing of such additional drug pursuant to prescription as directed in 105 CMR 700.012(A).

(9) Data collected or generated pursuant to 105 CMR 700.012(A) shall not be a public record and shall not be disclosed to anyone other than those persons specifically authorized under 105 CMR 700.012(C).

(D)Security Protections.

(1) Any disclosure or transmission of personally identifying information collected pursuant to 105 CMR 700.012 shall be in accordance with Department security requirements for such disclosure and transmission, including requirements for technical non-repudiation, confidentiality, and authentication, as those terms are defined in 105 CMR 721.000: Standards for Prescription Safety and Security. Such protections shall include the establishment of a record of each request and transmission.

(2) A person authorized to receive information pursuant to 105 CMR 700.012(C) shall promptly notify the Department of any potential violation of confidentiality or use of the data in a manner contrary to 105 CMR 700.012 or applicable professional standards.

(E)Electronic Transmission of Prescription Monitoring Program Information.

(1) The Department may establish means for secure electronic transmission of prescription monitoring program information to facilitate disclosure of such information authorized pursuant to 105 CMR 700.012.

(2) The Department may allow an authorized individual listed in 105 CMR 700.012(C)(2)(a) through (c), or a designee of such individual as approved by the Commissioner, to use the secure electronic transmission system established pursuant to 105 CMR 700.012(E)(1) in accordance with security protocols established by the Commissioner.

(3) Use of the secure electronic transmission system shall be limited to the uses authorized by 105 CMR 700.012.

(4) An authorized end user of the secure electronic transmission system must agree and attest to terms and conditions of use established by the Commissioner.

(5) Failure of an end user to comply with 105 CMR 700.012 may result in revocation of the end user's authorization to use the secure electronic transmission system and may subject the end user to further sanction pursuant to 105 CMR 700.012(J) or other state law.

(6) The Department may enter into data use agreements with healthcare facilities permitting healthcare facilities to integrate secure software or other information systems with their electronic medical record for the purpose of performing compilation, data analysis or visualization of data collected pursuant to 105 CMR 700.012(A). Such data use agreements must comply with Department guidelines including security protocols and terms and conditions of use established by the Commissioner, and 105 CMR 721.000: Standards for Prescription Format and Security in Massachusetts. Notwithstanding 105 CMR 700.012(E)(3), use of prescription monitoring data received and retained pursuant to 105 CMR 700.012(E) shall be limited to performing data analysis, compilation, or visualization for the purposes of diagnosis, treatment or coordinating care of the practitioner's patient.

(F)Automatic Authorization to Utilize the Prescription Monitoring Program.

(1) Every practitioner except a veterinarian will automatically, in a manner and form determined by the Department, be granted authority to utilize the prescription monitoring program, as established pursuant to 105 CMR 700.012(E).

(2) If the licensure or registration of a practitioner is suspended, the Department shall suspend he practitioner's access to the prescription monitoring program.

(3) If the licensure or registration of a practitioner is voided or terminated, the Department shall terminate the practitioner's access to the prescription monitoring program.

(G)Requirement to Utilize the Prescription Monitoring Program.

(1) A practitioner must utilize the prescription monitoring program:

(a) prior to prescribing a Schedule IV or V controlled substance, as designated in guidance issued by the Department pursuant to M.G.L. c. 94C, § 24A(c), and

(b) prior to prescribing any opoid in Schedule II or III or a benzodiazepine.

(2) A practitioner is not required to utilize the prescription monitoring program prior to prescribing any controlled substances, only in the following circumstances:

(a) A practitioner providing medical, dental, podiatric, pharmaceutical, or nursing care to hospice patients;

(b) An instance in which emergency care is required and in the professional opinion of the prescriber utilization of the prescription monitoring program is likely to result in patient harm;

(c) An instance in which it is not reasonably possible to utilize the prescription monitoring program, including when the system is not operational due to temporary technological or electrical failure;

(d) A practitioner granted a waiver pursuant to 105 CMR 700.012(I); and

(e) Other exceptions as defined in guidance issued by the Department.

(H)Waiver of Requirement to Utilize the Prescription Monitoring Program.

(1) The Department may temporarily waive the requirements established in 105 CMR 700.012(G)(1) and (2) for a participant who submits a request, in a manner and form determined by the Department, if the Department determines that a waiver is appropriate based on the criteria listed in 105 CMR 700.012(H)(2).

(2) A request for a waiver of the requirements in 105 CMR 700.012(G)(1) and (2) shall include a description of the following:

(a) The participant's history of compliance with laws and regulations related to controlled substances;

(b) A substantial hardship created by a natural disaster or other emergency beyond the control of the participant;

(c) Technological limitations not reasonably within control of the participant; or

(d) Temporary technological limitations within the control of the participant that will be rectified within six months.

(I)Delegate Sub-accounts.

(1) A primary account holder may authorize support staff as delegates to use the prescription monitoring program on behalf of the participant when the participant submits a request to create delegate sub-accounts in a manner and form determined by the Department. An individual eligible to be a primary account holder may not be a delegate.

(2) A primary account holder submitting a request to establish delegate sub-accounts must provide, upon request by the Department, the hospital's, clinic's, medical office's or pharmacy's written policies and procedures regarding the management and security of prescription monitoring data and reports.

(3) A request for delegate sub-accounts must include an attestation that the primary account holder will:

(a) Ensure that delegates comply with the prescription monitoring program Sub-account User Terms and Conditions;

(b) Monitor delegate use of the prescription monitoring program and inform the Department when a delegate has violated the Sub-account User Terms and Conditions or is no longer authorized by the participant to be a delegate within one business day; and

(c) Take reasonable steps to ensure that the delegate is sufficiently competent in the use of the prescription monitoring program.

(4) The primary account holder is responsible for all delegate use of the prescription monitoring program and may be referred to the appropriate licensing authority if delegate use is inconsistent with the Sub-account User Terms and Conditions.

(J)Suspension of Authorization to Utilize the Prescription Monitoring Program.

(1) If the Department learns, by means of system audit, complaint, or other mechanism, that a participant has, or may have, utilized the prescription monitoring program in a manner that is inconsistent with the terms and conditions for its use, the Department:

(a) May immediately restrict the participant's electronic access to the prescription monitoring program system; and

(b) Shall contact the participant to investigate the potential violation.

(2) If the Department determines after investigation that the participant did not utilize the prescription monitoring program in a manner that is inconsistent with the terms and conditions for its use, the Department shall immediately reinstate the participant's electronic access to the prescription monitoring program system, if such access has been restricted.

(3) If the Department determines after investigation that the participant did utilize the prescription monitoring program in a manner that is inconsistent with the terms and conditions for its use, the Department may, depending on the severity of the violation, take one or more of the following actions:

(a) Issue a warning letter to the participant;

(b) Require the participant to undergo training on the appropriate use of the prescription monitoring program;

(c) Temporarily suspend the participant's access to the prescription monitoring program;

(d) Share information with the appropriate board of registration; and

(e) Take action pursuant to 105 CMR 700.115.

(4) If the Department takes action under 105 CMR 700.012(J)(3), the participant may contest the Department's action, in writing, and request further review.