Amended Notice of Intended Action

Iowa prescription monitoring program, ch 556

Untitled document

ARC 8979C

INSPECTIONS AND APPEALS DEPARTMENT[481]

Amended Notice of Intended Action

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

The Department of Inspections, Appeals, and Licensing hereby proposes to adopt new Chapter 556, “Iowa Prescription Monitoring Program,” Iowa Administrative Code.

Legal Authority for Rulemaking

This rulemaking is proposed under the authority provided in Iowa Code chapter 124.

State or Federal Law Implemented

This rulemaking implements, in whole or in part, Iowa Code chapter 124.

Purpose and Summary

The purpose of this proposed rulemaking is to establish the functional requirements for the Iowa Prescription Monitoring Program (PMP) Advisory Committee (Committee), requirements for practitioners to register for the PMP, reporting requirements, PMP security, and requirements for access to and reporting of PMP information.

Reason for Amendment of Notice of Intended Action

Notice of Intended Action for this rulemaking was published in the Iowa Administrative Bulletin on November 27, 2024, as ARC 8423C. No public comments were received.

While the Board of Pharmacy did not receive any public comments relating to this rulemaking, modifications were made to provide clarity and eliminate potential confusion since the rulemaking relates to the qualification of practitioner delegates seeking PMP registration and access to patient prescription history. One additional change was made to remove a reference to 2024 Iowa Acts, Senate File 2385, since that legislation has been codified in the 2025 Iowa Code.

Fiscal Impact

This rulemaking has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rulemaking, no impact on jobs has been found.

Waivers

Any person who believes that the application of the discretionary provisions of this rulemaking would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 481—Chapter 6.

Public Comment

Any interested person may submit written comments concerning this proposed rulemaking, which must be received by the Board no later than 4:30 p.m. on March 25, 2025. Comments should be directed to:

Sue Mears
Department of Inspections, Appeals, and Licensing
6200 Park Avenue, Suite 100
Des Moines, Iowa 50321
Email: sue.mears@dia.iowa.gov

Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oral presentation regarding this rulemaking may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rulemaking at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

The following rulemaking action is proposed:

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) 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, who are directly involved in the care of the patient 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 patient’s own prescription history report 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.

Open For Comments

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Official Document

  • Iowa prescription monitoring program, ch 556
  • Published on 3/5/2025
  • 68 Views , 0 Comments
  • Amended Notice of Intended Action

The official published PDF of this document is available from the Iowa General Assembly’s Administrative Rules page.

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View the Iowa Administrative Bulletin for 3/5/2025.

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Related Notices

Administrative Rule References

The following administrative rule references were added to this document. You may click a reference to view related notices.

Rule 481-556.1 Rule 481-556.2 Rule 481-556.3 Rule 481-556.4 Rule 481-556.5 Rule 481-556.6
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