ARC 8423C

ARC 8423C

Proposing rulemaking related to Iowa prescription monitoring program
and providing an opportunity for public comment

A Regulatory Analysis for this rulemaking was published in the Iowa Administrative Bulletin on August 7, 2024. A public hearing was held on the following date(s):

●August 29, 2024

Any persons who intend to attend a public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs.

ITEM 1.Adopt the following new481—Chapter 556:

CHAPTER 556

IOWA PRESCRIPTION MONITORING PROGRAM

481—556.1(124,155A) Definitions. The definitions found in 481—Chapter 550 are incorporated by reference into these rules.

481—556.2(124) PMP advisory committee.

556.2(1) Membership. The members of the PMP advisory committee will include prescribing practitioners as identified in Iowa Code section 124.555(1) as amended on by 2024 Iowa Acts, Senate File 2385, and may include a multidisciplinary coalition of authorized users who routinely interact with the PMP and one member of the public who is not eligible to register with the PMP.

556.2(2) Term of appointment. Committee members will be appointed by the board for a three-year term and may be reappointed by the board for no more than two additional terms. Each term will expire on June 30 of the third year of the term.

556.2(3) Quorum. A quorum will be a majority of the appointed members.

556.2(4) Termination of appointment. A committee member who is no longer eligible or able to serve on the committee will submit a written resignation to the board. A committee member who fails to attend three consecutive regular committee meetings is deemed to have resigned.

481—556.3(124) Registration.

556.3(1) Registration. Authorized access to PMP information pursuant to Iowa Code section 124.553 will be available only to registered users, except as provided herein.

556.3(2) Registration not needed. Individuals seeking their own individual prescription records need not register with the PMP.

556.3(3) Practitioner’s delegates. A practitioner may authorize an adequate number of credentialed health care professionals not exceeding 30 to access PMP information. The practitioner is responsible for the PMP information access of the delegates.

481—556.4(124) Reporting requirements.

556.4(1) Reportable data. The following will be reported to the PMP in accordance with Iowa Code sections 124.551, 124.552, and 124.554(1)“g”:

a.Controlled substances dispensed to a patient for self-administration.

b.Opioid antagonists dispensed or administered by a practitioner, including:

(1)To an emergency department patient, and

(2)To a patient upon discharge from a hospital, correctional facility or care facility.

c.If the pharmacy did not dispense or administer any reportable prescriptions during a reporting period, a zero report.

556.4(2) Required data elements.

a.In addition to the information required in Iowa Code section 124.552(1), the following elements will be reported:

(1)Form of transmission of prescription origin.

(2)Refill number.

(3)Number of refills authorized.

b.In an exceptional circumstance, a practitioner may request an extension of time for transmitting program information.

556.4(3) Exemptions—practitioners. The following are exempt from reporting controlled substances:

a.A licensed veterinarian in the normal course of professional practice.

b.A DEA-registered narcotic treatment program that is subject to the recordkeeping provisions of 21 CFR §1304.24 as amended on June 28, 2021.

556.4(4) Board notification. A pharmacy that does not engage in any reportable dispensing or administration will notify the board at the time of licensure.

556.4(5) Submission format. Data will be transmitted via the PMP’s current version of data upload or electronic submission.

556.4(6) Submission errors. Upon notification of a potential error in program information, the reporting practitioner will promptly correct the error.

481—556.5(124) Security.

556.5(1) Board. The board will collect, store, and disseminate program information using technology that utilizes encryption as defined in Iowa Code section 715C.1.

556.5(2) Integrated systems. A practitioner, pharmacy, or health care system utilizing an integrated system to connect its electronic health record or data processing system with the PMP will:

a.Ensure the maintenance of user access logs for four years from the date of access, including the identification of the practitioner for which a delegate accessed program information.

b.Ensure the maintenance of adequate security to prevent unauthorized access, disclosure, or theft of program information.

c.Notify the board within 72 hours of any breach in the electronic health record or data processing system that may have included program information.

481—556.6(124) Access to and reporting of PMP information.

556.6(1) Patient requests. An individual patient or a patient’s authorized representative may request the individual’s own program information via submission of a completed PMP patient request form via personal, mail, or commercial delivery. A patient’s authorized representative includes an individual with medical power of attorney for the patient, the patient’s attorney, an executor of the patient’s estate, or the patient’s next of kin as defined in Iowa Code section 523A.102.

556.6(2) Authorized user requests. An individual authorized to receive program information may request program information pursuant to and in accordance with Iowa Code section 124.553 via the program platform, which request will include verification of the requestor’s authorization to receive the information.

556.6(3) Statistical data. The board or its designee may provide summary, statistical, or aggregate data to public or private entities for statistical, public research, public policy, or educational purposes.

556.6(4) Prescriber activity reports. At least annually, the board will electronically issue to each prescriber whose prescribed controlled substances were reported to the program during the preceding reporting period an activity report in accordance with Iowa Code section 124.554(3)“a.”

556.6(5) Proactive notifications. When a patient meets or exceeds the criteria and thresholds determined by the board and the advisory committee, the board will issue a notification to a practitioner that the patient may be at risk of abusing or misusing a controlled substance and suggest review of the patient’s program information.

These rules are intended to implement Iowa Code chapter 124, subchapter VI.