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Section 38 repeals the separate provision that is unnecessary due to the update in section 37.
Section 39 creates a requirement for the board to develop and maintain PDMP to facilitate the submission of dispensing data, creation of monitored prescription drug history reports about patients, practitioners and dispensers and access to the monitored prescription drug history reports, prescribing metrics reports and audit trails.
Section 40 creates the description of audit trails which includes logs of dispensing data, persons who have access to the PDMP, prescription monitoring programs in other states which shares data, pharmacies and hospitals which are determined to have the equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person accesses PDMP, monitored prescription drug history reports and PDMP data disclosed pursuant to CSB 4.11 and requests for PDMP data or monitored prescription drug history reports even when no information was disclosed.
Section 41 repeals the separate provisions regarding logs which must be maintained due to the creation of section 40.
Section 42 updates terminology.
Section 43 creates provision regarding the operation of the analytics platform.
Section 44 updates terminology from PDMP information to monitored prescription drug history reports, audit trails and PDMP data.
Section 45 creates the requirement for preparing monitored prescription drug history reports, audit trails and PDMP data for the board to review in determining whether suspicious or critically dangerous conduct or practices took place.
Section 46 updates terminology regarding the confidentiality of PDMP records. It clarifies that a person who discloses PDMP data may be referred for discipline or prosecution.
Section 47 updates terminology from information to monitored prescription drug history reports and data.
Section 48 amends the information being reviewed and disclosed by the board when determining suspicious or critically dangerous conduct to include dispensing data, monitored prescription drug history reports, and PDMP data.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
Illinois: Illinois requires reporting to the drug monitoring program within one day. Illinois does not require mandatory use of the drug monitoring program. Illinois does not provide access to mental health, substance abuse professionals or law enforcement.
Iowa: Iowa requires reporting to the drug monitoring program within one week. Iowa does not require mandatory use of the drug monitoring program. Iowa does not provide access to mental health, substance abuse professionals or law enforcement.
Michigan: Michigan requires reporting to the drug monitoring program within one day if reporting online and within one week if reporting by mail. Michigan does not require mandatory use of the drug monitoring program. Michigan does not provide access to mental health, substance abuse professionals or law enforcement.
Minnesota: Minnesota requires reporting to the drug monitoring program within one day. Minnesota does require mandatory use of the drug monitoring program. Minnesota does provide access to mental health and substance abuse professionals. Minnesota does not provide access to law enforcement.
Summary of factual data and analytical methodologies:
This rule updates terminology and requirements resulting from 2015 Wisconsin Acts 266, 267 and 268.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
Any economic impact is a result of the statutory requirement created by 2015 Wisconsin Acts 266, 267 and 268.
Fiscal Estimate and Economic Impact Analysis:
There is no fiscal impact.
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 Kirsten.Reader@wisconsin.gov, or by calling (608) 267-2435.
Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov.
Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received at or before the public hearing to be held on May 12, 2017 to be included in the record of rule-making proceedings.
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TEXT OF RULE
Section 1. CSB 4.01 is amended to read:
CSB 4.01Authority and scope. The rules in this chapter are adopted under authority in ss. 227.11 (2) (a) and 961.385, Stats., for the purpose of creating a prescription drug monitoring program to collect and maintain disclose information relating to the prescribing and dispensing of monitored prescription drugs.
Section 2. CSB 4.02 (1) and (2) are amended to read:
CSB 4.02 (1)“Access” means to have the ability to view PDMP information through an account established with the board monitored prescription drug history reports, audit trails, and PDMP data as authorized by s. CSB 4.09.
(2)“Administer” has the meaning given in s. 450.01 (1) 961.385 (1) (a), Stats.
Section 3. CSB 4.02 (2m), (3s), (4m) and (5m) are created to read:
CSB 4.02 (2m) “Agent” has the meaning given in s. 961.385 (1) (ab), Stats.
(3s) “Audit trail” means the log that contains information about each time the PDMP system discloses PDMP data, monitored prescription drug history reports, and prescribing metrics reports.
(4m)Business day” has the meaning given in s. 961.385 (1) (ad), Stats.
(5m)Deliver” or “delivery” has the meaning in s. 961.385 (1) (ae), Stats.
Section 4. CSB 4.02 (7) is amended to read:
CSB 4.02 (7)“Dispense” has the meaning given in s. 450.01 (7) 961.385 (1) (af), Stats.
Section 5. CSB 4.02 (11c) and (11n) are created to read:
CSB 4.02 (11c) “Healthcare Professional” means a pharmacist, practitioner, registered nurse licensed under s. 441.06, Stats., substance abuse counselor, as defined in s. 440.88 (1) (b), or individual authorized under s. 457.02 (5m) to treat alcohol or substance dependency or abuse as a specialty.
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