Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
This rule was posted for economic comments and none 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 Eric.Esser@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at Sharon.Henes@wisconsin.gov. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. CSB 4.02 (4) is amended to read:
CSB 4.02 (4) “Board” has the meaning given in s. 450.01 (2), Stats. means the Controlled Substances Board. Section 2. CSB 4.03 (3) is repealed.
Section 3. CSB 4.08 (1) is amended to read:
CSB 4.08 (1) The board shall exempt a dispenser from compiling and submitting dispensing data and from submitting a zero report as required under this chapter until the dispenser is required to renew his or her its license, or until the dispenser dispenses a monitored prescription drug, if the dispenser satisfies all of the following conditions:
Section 4. CSB 4.10 (1) (c) is amended to read:
CSB 4.10 (1) (c) The denial, suspension, revocation or other restriction or limitation imposed on the dispenser’s, dispenser pharmacist’s, pharmacist delegate’s, practitioner’s, or practitioner delegate’s account pursuant to s. CSB 18.09 (3). Section 5. CSB 4.10 (2) (a) is amended to read:
CSB 4.10 (2) (a) The dispenser’s, dispenser pharmacist’s, pharmacist delegate’s, practitioner’s, or practitioner delegate’s name and address, including street address, city, state and ZIP code.
Section 6. CSB 4.11 (1) is amended to read:
CSB 4.11 (1) The board shall disclose PDMP information dispensing data about a patient to the patient if he or she does all of the following:
Section 7. CSB 4.11 (1) (b) is amended to read:
CSB 4.11 (1) (b) Makes a request for the PDMP information dispensing data on a form provided by the board.
Section 8. CSB 4.11 (2) is amended to read:
CSB 4.11 (2) The board shall disclose PDMP information dispensing data about a patient to a person authorized by the patient if the person authorized by the patient does all of the following:
Section 9. CSB 4.11 (2) (c) is amended to read:
CSB 4.11 (2) (c) Makes a request for the PDMP information dispensing data on a form provided by the board.
Section 10. CSB 4.11 (7) is amended to read:
CSB 4.11 (7) The board shall disclose the minimum amount of PDMP information dispensing data necessary to a prisoner’s health care provider, the medical staff of a prison or jail in which a prisoner is confined, the receiving institution intake staff at a prison or jail to which a prisoner is being transferred or a person designated by a jailer to maintain prisoner medical records or designated staff of the department of corrections in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following: Section 11. CSB 4.11 (7) (c) is amended to read:
CSB 4.11 (7) (c) Makes a request for the PDMP information dispensing data through its account with the board.
Section 12. CSB 4.11 (8) is amended to read:
CSB 4.11 (8) The board shall disclose the minimum amount of PDMP information dispensing data necessary to a coroner, deputy coroner, medical examiner, or medical examiner’s assistant following the death of a patient in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following: Section 13. CSB 4.11 (8) (c) is amended to read:
CSB 4.11 (8) (c) Makes a request for the PDMP information dispensing data through its account with the board.
Section 14. CSB 4.15 is created to read:
CSB 4.15 Disclosure of suspicious or critically dangerous conduct or practices.
(1) The board may review PDMP information to determine whether circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacist, pharmacy, practitioner, or patient.
(2) The board may include any of the following factors when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacist or pharmacy:
(a) The pharmacist or pharmacy’s monitored prescription drug dispensing practices deviate from accepted pharmacist or pharmacy practices.
(b) There are unusual patterns in the payment methodology used by patients to whom monitored prescription drugs are dispensed by the pharmacist or pharmacy.
(c) The history of actions taken against the pharmacist or pharmacy by other state agencies, agencies of another state, or law enforcement.
(d) The type and number of monitored prescription drugs dispensed by the pharmacist or at the pharmacy.
(e) The pharmacist or pharmacy has dispensed forged prescription orders for a monitored prescription drug.
(f) The distance patients travel to have monitored prescription drugs dispensed at the pharmacy.
(g) The number of patients dispensed monitored prescription drugs at the pharmacy or by the pharmacist who satisfy any of the criteria identified in sub. (4).
(3) The board may include any of the following factors when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a practitioner:
(a) The practitioner’s monitored prescription drug prescribing practices deviate from accepted prescribing practices.
(b) The practitioner prescribes potentially dangerous combinations of monitored prescription drugs to the same patient.
