CR 24-033 Rule Text

STATE OF WISCONSIN

CONTROLLED SUBSTANCES BOARD

IN THE MATTER OF RULEMAKING   :   PROPOSED ORDER OF THE

PROCEEDINGS BEFORE THE     :   CONTROLLED SUBSTANCES

CONTROLLED SUBSTANCES BOARD   :   BOARD

            :   ADOPTING RULES

            :   (CLEARINGHOUSE RULE )

PROPOSED ORDER

An order of the Controlled Substances Board to amend CSB 4.11 (2) (a) and (c), relating to monitored prescription drug history reports.

Analysis prepared by the Department of Safety and Professional Services.

ANALYSIS

Statutes interpreted: s. 961.385 (2) (c), Stats.

Statutory authority: s. 961.385 (2) (c), Stats.

Explanation of agency authority:

961.385 (2) (c) states that the board shall establish by rule and have the prescription drug monitoring program “specify the persons whom a record may be disclosed and the circumstances under which the disclosure may occur. Except as otherwise provided under this section, the rule promulgated under this paragraph shall comply with s. 146.82.”

Related statute or rule: None.

Plain language analysis: Wisconsin Administrative Code Chapter CSB 4 currently outlines requirements for methods of obtaining monitored prescription drug history reports. Patients are allowed to request their own history reports either in person at the Department of Safety and Professional Services or via a mailed request on a form provided by the Board. A person authorized by the patient may only request copies of those same reports in person. Without making changes under the proposed rule, a person authorized by the patient will continue to only be able to make such requests in person at the Department.

Summary of, and comparison with, existing or proposed federal regulation: None.

Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A

Comparison with rules in adjacent states:

Illinois: The Illinois Prescription Monitoring Program allows patients access to their personal prescription history based on a validation process established by administrative rules [720 Illinois Compiled Statutes Chapter 570 Section 318 (m)]. The administrative rules governing patient access to their prescription history require that the patient, parent, or guardian complete a notarized request for a personal information report of a patient’s prescription history, and submit it by mail to the Illinois Prescription Monitoring Program [Illinois Administrative Coder Title 77 Chapter X Subchapter e Part 2050 Section 2080.190 (a)].

Iowa: The Iowa Prescription Monitoring Program allows patients or a patient’s agent to request that individual patient’s own prescription history report by submitting a request form. Request forms may be submitted in-person with a government issued photo identification or via mail if the request form is notarized and sent with a certified copy of the patient’s government issued identification. A patient’s agent may sign the request form in lieu of the patient if a copy the legal document establishing the agency relationship is provided. The patient’s agent must also present a government issued identification for in-person requests or a certified copy of a government issued identification for mailed requests. [657 Iowa Administrative Code Chapter 37 Section 37.16 (7)].

Michigan: The administrative rules that govern the Michigan Automated Prescription System, the states electronic system for monitoring schedule II to V controlled substances, does not specify whether a report of a patient’s prescription history can be disclosed, nor how a report may be obtained by a patient. [Michigan Administrative Rules R 338.3162b].

Minnesota: The Minnesota Prescription Monitoring Program allows a patient who has been prescribed a controlled substance to access the program’s database to obtain information on users who have access to that patient’s data records. A patient may submit a request for this information on a notarized form from the Minnesota State Board of Pharmacy’s website.[Minnesota Statutes Chapter 152 Section 152.126 Subdivision 11].

Summary of factual data and analytical methodologies: The Board reviewed Wisconsin Administrative Code Chapter CSB 4 and made updates as needed.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

The proposed rule was posted for a period of 14 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. No comments were received.

Fiscal Estimate and Economic Impact Analysis:

The Fiscal Estimate and Economic Impact Analysis is attached.

Effect on small business:

These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at [e-mail], or by calling [phone].

Agency contact person:

Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail]. Comments must be received on or before the public hearing, held on May 10, 2024, to be included in the record of rule-making proceedings.