CR 24-013 Rule Text

STATE OF WISCONSIN

CONTROLLED SUBSTANCES BOARD

IN THE MATTER OF RULEMAKING   :   ORDER OF THE

PROCEEDINGS BEFORE THE     :   CONTROLLED SUBSTANCES

CONTROLLED SUBSTANCES BOARD   :   BOARD

            :   ADOPTING RULES

            :   (CLEARINGHOUSE RULE 24-013)

ORDER

An order of the Controlled Substances Board to create CSB 4.02 (12s), 4.04 (2) (bm) and (im), and 4.097 (1) (i), and amend CSB 4.04 (2) (b) and (i), 4.05 (1) (b) (Note), 4.06 (3) (b) (Note), 4.07 (2) (Note), and 4.08 (1) (b) (Note), and repeal CSB 4.08 (4), relating to national provider identifier requirement.

Analysis prepared by the Department of Safety and Professional Services.

ANALYSIS

Statutes interpreted: ss. 961.385 (2) (b) and (7s), Stats.

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

Explanation of agency authority:

961.385 (2) (b) states that the board shall establish by rule and have the prescription drug monitoring program “Identify specific data elements to be contained in a record documenting the dispensing of a monitored prescription drug, including the method of payment and, subject to sub. (2m), the name recorded under s. 450.44 (1b) (bm). In identifying specific data elements, the board shall consider data elements identified by similar programs in other states and shall ensure, to the extent possible, that records generated by the program are easily shared with other states.”

Related statute or rule: None.

Plain language analysis:

_Hlk164158082 The objective of the proposed rule is to add the National Provider Identifier (NPI) for all dispensing and prescribing Prescription Drug Monitoring Program (PDMP) records by creating CSB 4.02 (12s), 4.04 (2) (bm) and (im). Sections CSB 4.04 (2) (b) and (i) were also updated to reflect that a DEA number is only required if applicable. The Board also repealed the exemption requirement under CSB 4.08 (4) that allowed dispensers to be exempt from reporting Gabapentin prescribing if they do not have a DEA number. Section CSB 4.097 (1) (i) was created to reflect that access to the PDMP can be restricted for failure to provide any of the data from CSB 4.04 (2) when required. Updates were also made to the mailing address for the Department in ss CSB 4.05 (1) (b) (Note), 4.06 (3) (b) (Note), 4.07 (2) (Note), and 4.08 (1) (b) (Note).

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: No comments were received.

Comparison with rules in adjacent states:

Illinois: The Illinois Prescription Monitoring Program does not require an NPI number to be reported [720 Illinois Compiled Statutes Chapter 570 Section 316].

Iowa: The Iowa Prescription Monitoring Program does not require an NPI number to be reported [657 Iowa Administrative Code Chapter 37 Section 12].

Michigan: The Michigan Automated Prescription System, the states electronic system for monitoring schedule II to V controlled substances, does not require an NPI number to be reported [Michigan Administrative Rules R 338.3162b].

Minnesota: The Minnesota Prescription Monitoring Program requires the NPI number of the prescriber and the NPI number of the dispenser to be reported for all controlled substances dispensed in the state [Minnesota Statutes Chapter 152 Section 152.126 Subdivision 4].

Summary of factual data and analytical methodologies:

The Board reviewed Wisconsin Administrative Code Chapter CSB 4 in consultation with Wisconsin Prescription Drug Monitoring Program staff to determine where the NPI number requirement can be added and if updates to other sections in the chapter were needed.

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

The proposed rules were 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; email at [e-mail].

TEXT OF RULE

Section 1. CSB 4.02 (12s) is created to read:

CSB 4.02 (12s) “NPI number” means national provider identifier number, the unique number issued by the National Plan and Provider Enumeration System of the federal Centers for Medicare and Medicaid Services used in the U.S. to identify each health care provider.

Section 2. CSB 4.04 (2) (b) is amended to read:

  CSB 4.04 (2) (b) The dispenser’s DEA registration number, if applicable.

Section 3. CSB 4.04 (2) (bm) is created to read:

  CSB 4.04 (2) (bm) Beginning December 1, 2025, the dispenser’s NPI number.

Section 4. CSB 4.04 (2) (i) is amended to read:

  CSB 4.04 (2) (i) The practitioner’s DEA registration number, if applicable.

Section 5. CSB 4.04 (2) (im) is created to read:

  CSB 4.04 (2) (im) Beginning December 1, 2025, the prescriber’s NPI number.

Section 6. CSB 4.05 (1) (b) (Note), 4.06 (3) (b) (Note), 4.07 (2) (Note), and 4.08 (1) (b) (Note) are amended to read:

CSB 4.05 (1) (b) (Note) The guide for dispensers which specifies the data standards in version 4 release 2 of the ASAP implementation guide for prescription monitoring programs and other electronic formats identified by the board may be obtained online at https://pdmp.wi.gov or obtained at no charge from the Department of Safety and Professional Services, 1400 East Washington Avenue4822 Madison Yards Way, P.O. Box 8366, Madison, WI 5370853705.

CSB 4.06 (3) (b) (Note) The application for an emergency waiver may be obtained online at www.dsps.wi.gov or obtained at no charge from the Department of Safety and Professional Services, 1400 East Washington Avenue4822 Madison Yards Way, P.O. Box 8366, Madison, WI 5370853705.

CSB 4.07 (2) (Note) The written notice to the board may be submitted through an account with the board, sent by electronic mail or sent by U.S. mail to the Department of Safety and Professional Services 1400 East Washington Avenue,4822 Madison Yards Way, P.O. Box 8366, Madison, WI 5370853705.

CSB 4.08 (1) (b) (Note) The application for an exemption may be obtained online at www.dsps.wi.gov or at no charge from the Department of Safety and Professional Services 1400 East Washington Avenue,4822 Madison Yards Way, P.O. Box 8366, Madison, WI 5370853705. A dispenser who is already exempt can renew his or her exemption as part of the licensure renewal process.