14- 118 C.M.R. ch. 11, § 7 - Access to Prescription Monitoring Information

1. By patients

A. A patient, or a patients' authorized representative, may obtain a report listing all prescription monitoring information that pertains to the patient.

B. A patient or a patient's authorized representative seeking access to prescription monitoring information described above must submit a written request for information in person at the office of the Monitor, or at any other place specified by the Monitor or the Office. The written request shall be in a format established by the Office or the Monitor and shall contain at least, but not limited to, the following elements:

1) the patient's name and the full name of the patient's authorized representative, if applicable;

2) the patient's date of birth;

3) the patient's address, and the complete physical address of the patient's authorized representative, if applicable;

4) the patient's telephone number, if any, and the telephone number of the authorized representative, if applicable; and

5) the time period for which information is being requested.

C. The patient or the patient's authorized representative must produce valid photographic identification prior to obtaining access to the information described above. The patient or the patient's authorized representative must allow photocopying of the identification.

D. Prior to obtaining access to the information described above, authorized representatives must produce either an official attested copy of the judicial order granting them authority to gain access to the health care records of the patient; or in the case of parents of a minor child, a certified copy of the Birth Certificate of the minor child or other official documents establishing legal guardianship; or in the case of persons holding power of attorney, the original document establishing the power of attorney. The patient's authorized representative must allow photocopying of the documents described above. The Office or the Monitor may verify the patient authorization by any reasonable means prior to providing the information to the authorized representative.

2. By dispensers

A. A dispenser, a licensed pharmacy technician authorized by a supervising pharmacist, or a staff member of a dispenser who is authorized by the dispenser on duty may obtain any prescription monitoring information insofar as the information relates to a customer of the dispenser seeking to have a prescription filled. The information shall be provided in a format established by the Office, which may include, but is not limited to, delivery by electronic means, facsimile transmission, or telephonic communication.

B. A dispenser who seeks access to the information described above must register as a data requester in a manner specified by the Monitor or the Office. The Office or Monitor shall issue credentials to authorized dispensers. Dispensers may use these credentials to access the online database and submit requests. If the credentials issued by the Office are lost, missing, or the security of the credentials is compromised, the dispenser shall cause the Office or Monitor to be notified by telephone and in writing as soon as reasonably possible. Information regarding more than one customer may be submitted in a single request. Requests shall be in a format established by the Office or the Monitor and shall contain at least, but not limited to, the following elements for each customer:

1) The name and date of birth of the customer; and

2) The time period for which information is being requested.

C. The Office or the Monitor shall take reasonable steps to verify each registration, such as, but not limited to, making a telephone call to the dispenser or to an agent of the dispenser at a telephone number known to belong to the dispenser's place of business.

3. By prescribers

A. A prescriber, or any staff member duly authorized by a prescriber and the Office, or any staff member of a licensed hospital who is authorized by the chief medical officer of the hospital, or staff members of a group practice of prescribers who are authorized by a designated group practice leader, insofar as the information relates to a patient receiving care from that group practice, may obtain any prescription monitoring information insofar as the information relates to a patient under the prescriber's care, or patient receiving care in the hospital's emergency department or receiving inpatient services or surgical services from the hospital. The information shall be provided in a format established by the Office, which may include, but is not limited to delivery by electronic means, facsimile transmission, or telephonic communication.

B. A prescriber, or any staff member duly authorized by a prescriber and the Office, who seeks access to the information described above must register as a data requester in a manner specified by the Monitor or the Office. The Office or Monitor shall issue credentials to authorized prescribers or their designees. Data requesters may use these credentials to access the online database and submit requests. If the credentials issued by the Office are lost, missing, or the security of the credentials is compromised, the data requester shall cause the Office or Monitor to be notified by telephone and in writing as soon as reasonably possible. Requests shall be in a format established by the Office or the Monitor and shall contain at least, but not limited to, the following elements for each patient:

1) The name and date of birth of the patient; or the individual seeking care for and/or owner of an animal for whom a drug is issued or dispensed; and

2) The time period for which information is being requested.

C. The Office or the Monitor shall take reasonable steps to verify each registration, such as, but not limited to, making a telephone call to the prescriber and licensed health care practitioners duly authorized by prescribers, or to an agent of the prescriber at a telephone number known to belong to the prescriber's place of business.

4. By executive director, board investigator, or person authorized to discharge equivalent functions of a licensing board.

A. An executive director, board investigator, or person authorized to discharge equivalent functions of a licensing board with jurisdiction over a dispenser or prescriber may obtain any prescription monitoring information as required for an investigation, with reasonable cause. The information shall be provided in a format established by the Office, which may include, but is not limited to delivery by electronic means, facsimile transmission, or telephonic communication.

B. An executive director, board investigator, or person authorized to discharge equivalent functions of a licensing board with jurisdiction over a dispenser or prescriber who seeks access to prescription monitoring information described above must submit a request via mail, facsimile, or secure electronic transmission, to a location specified by the Monitor or the Office. The request shall contain identifying information regarding the licensee or patient and the time period for which the information is being requested. The data requester shall certify that each request is related to an investigation involving misuse of a Schedule II, III, or IV drug and provide a case number or other assurance that the request is related to the board representative's official duties.

5. By personnel of any vendor or contractor engaged by the Office

A. Personnel of any vendor or contractor engaged by the Office may obtain any prescription monitoring information insofar as the information is necessary for establishing and maintaining the program's electronic system.

B. The Office, the monitor, and program vendors or contractors engaged by the Office, shall purge all prescription monitoring information more than six years old.

6. By the units within the Department of Health and Human Services that administer the MaineCare program

A. Subject to the requirements of 22 M.R.S.A. §7250(4)(F), the authorized representative of those units of the Department of Health and Human Services which oversee, administer, or otherwise supervise MaineCare programs which determine eligibility for and use of prescription drugs, and the appropriate utilization of prescription drugs, may obtain any prescription monitoring information insofar as the information is necessary for the purposes of managing the care of MaineCare members, monitoring the purchase of controlled substances by MaineCare members, and avoiding duplicate dispensing of controlled substances to MaineCare members.

B. The person or persons authorized pursuant to Section 7(6)(A) must submit a request via mail, facsimile, or secure electronic transmission, to a location specified by the Monitor or the Office. The request shall contain surname, first name, and date of birth of the member and the time period for which the information is being requested. An intervention approach shall be undertaken with MaineCare members who are determined to be accessing controlled substances in a quantity or with a frequency beyond the norm for persons with similar medical conditions or diagnoses and the intervention approach shall not include terminating the member from MaineCare services.

7. By the Office of the Chief Medical Examiner

A. The Chief Medical Examiner or a designee may obtain any prescription monitoring information as required for an investigation or inquiry into the cause, manner and circumstances of death in a medical examiner case. The information shall be provided in a format established by the Office of Substance Abuse, which may include, but is not limited to delivery by electronic means, facsimile transmission, or telephonic communication.

B. The Chief Medical Examiner or a designee must submit a request via mail, facsimile, or secure electronic transmission, to a location specified by the Monitor or the Office. The request shall contain the surname, first name, and date of birth of the decedent and the time period for which the information is being requested.

8. By Other States and Canadian Provinces

The Department may provide prescription monitoring information to and receive prescription monitoring information from another state or a Canadian province that has prescription monitoring information provisions consistent with this regulation and that has entered into a prescription monitoring information sharing agreement with the Department.

The Department may enter into a prescription monitoring information agreement with another state or a Canadian province to establish the terms and conditions of prescription monitoring information sharing and interoperability of information systems and to carry out the purposes of this rule.

For purposes of this rule, "another state" means any state other than Maine and any territory or possession of the United States, but does not include a foreign country.

Notes

14- 118 C.M.R. ch. 11, § 7