Chapter CSB 4

CSB 4.06 CSB 4.06 Frequency of submissions.

CSB 4.06(1) (1) A dispenser shall submit dispensing data to the PDMP no later than 11:59 p.m. of the next business day after the monitored prescription drug is dispensed.

CSB 4.06(2) (2) If a dispenser does not dispense a monitored prescription drug on a business day, the dispenser shall submit no later than 11:59 p.m. of the next business day a zero report to the PDMP that accounts for each business day on which the dispenser did not dispense a monitored prescription drug.

CSB 4.06(3) (3) If a dispenser is not able to submit dispensing data zero report before 11:59 p.m. of the next business day as required by subs. (1) or (2), the board may grant an emergency waiver to a dispenser who satisfies all of the following conditions:

CSB 4.06(3)(a) (a) The dispenser is not able to submit dispensing data or a zero report because of circumstances beyond its control.

CSB 4.06(3)(b) (b) The dispenser files with the board a written application for an emergency waiver on a form provided by the board prior to the required submission of dispensing data or zero report.

CSB 4.06 Note 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 Avenue, P.O. Box 8366, Madison, WI 53708.

CSB 4.06(4) (4) Unless otherwise specified by the board, an emergency waiver granted under sub. (3) shall only be effective for 7 days.

CSB 4.06(5) (5) The board may refer a dispenser and dispenser delegate that fail to submit dispensing data or a zero report as required by subs. (1) and (2), or be granted an emergency waiver under sub. (3), or a dispenser and a dispenser delegate that submit false information to the PDMP to the appropriate licensing or regulatory board for discipline.

CSB 4.06 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 13-065: am. (1), (2), (3) (intro.), r. (4) to (6), (9), renum. (7) to (4) and am., renum. (8) to (5) Register February 2014 No. 698, eff. 3-1-14; CR 14-003: am. (2), (5) Register August 2014 No. 704, eff. 9-1-14; EmR1706: emerg. am. (1), (2), (3), (5), eff. 4-1-17; CR 17-028: am. (1), (2), (3), (5) Register December 2017 No. 744, eff. 1-1-18.

CSB 4.07 CSB 4.07 Correction of dispensing data.

CSB 4.07(1) (1) A dispenser shall electronically correct dispensing data in the PDMP system within 5 business days of discovering an omission, error, or inaccuracy in previously submitted dispensing data.

CSB 4.07(2) (2) The board may refer a dispenser and dispenser delegate that fail to correct dispensing data as required by sub. (1) to the appropriate licensing or regulatory board for discipline.

CSB 4.07 Note 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, P.O. Box 8366, Madison, WI 53708.

CSB 4.07 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. Register August 2014 No. 704, eff. 9-1-14; EmR1706: emerg. r. and recr. eff. 4-1-17; CR 17-028: r. and recr. Register December 2017 No. 744, eff. 1-1-18.

CSB 4.08 CSB 4.08 Exemptions from compiling and submitting dispensing data.

CSB 4.08(1) (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 its license, or until the dispenser dispenses a monitored prescription drug, if the dispenser satisfies all of the following conditions:

CSB 4.08(1)(a) (a) The dispenser provides evidence sufficient to the board that the dispenser does not dispense monitored prescription drugs.

CSB 4.08(1)(b) (b) The dispenser files with the board a written request for exemption on a form provided by the board.

CSB 4.08 Note 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, P.O. Box 8366, Madison, WI 53708. A dispenser who is already exempt can renew his or her exemption as part of the licensure renewal process.

CSB 4.08(2) (2) A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is administered directly to a patient.

CSB 4.08(2m) (2m) A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is compounded, packaged, or labeled in preparation for delivery but is not delivered.

CSB 4.08(3) (3) A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is a substance listed in the schedule in s. 961.22, Stats., and is not a narcotic drug, as defined in s. 961.01 (15), Stats., and is dispensed pursuant to a prescription order for a number of doses that is intended to last the patient 7 days or less.

CSB 4.08(4) (4) A dispenser who is not otherwise required to have a DEA registration number is not required to compile or submit dispensing data when dispensing Gabapentin.

CSB 4.08 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (1) (a), cr. (3) Register August 2014 No. 704, eff. 9-1-14; CR 15-101: am. (1) Register June 2016 No. 726, eff. 7-1-16; EmR1706: emerg. cr. (2m), eff. 4-1-17; CR 17-028: cr. (2m) Register December 2017 No. 744, eff. 1-1-18; CR 20-080: cr. (4) Register August 2021 No. 788, eff. 9-1-21.

CSB 4.09 CSB 4.09 Access to monitored prescription drug history reports and PDMP data about a patient.

CSB 4.09(1) (1) Healthcare professionals may access monitored prescription drug history reports about a patient for any of the following reasons:

CSB 4.09(1)(a) (a) The healthcare professional is directly treating or rendering assistance to the patient.

CSB 4.09(1)(b) (b) The healthcare professional is being consulted regarding the health of the patient by an individual who is directly treating or rendering assistance to the patient.

CSB 4.09(1)(c) (c) Scientific research purposes if all of the following requirements are met:

CSB 4.09(1)(c)1. 1. The patient is a direct patient of the healthcare professional.

CSB 4.09(1)(c)2. 2. The healthcare professional has obtained informed consent from the patient to access monitored prescription drug history reports for scientific research purposes.

CSB 4.09(1)(d) (d) Purposes of conducting an overdose fatality review.

CSB 4.09(2) (2) Pharmacist delegates and practitioner delegates may access monitored prescription drug history reports about a patient for any of the following reasons:

CSB 4.09(2)(a) (a) A pharmacist or practitioner who is directly treating or rendering assistance to the patient has delegated the task of obtaining monitored prescription drug history reports about the patient to the pharmacist delegate or practitioner delegate.

CSB 4.09(2)(b) (b) A pharmacist or practitioner who is being consulted regarding the health of the patient by an individual who is directly treating or rendering assistance to the patient has delegated the task of obtaining monitored prescription drug history reports about the patient to the pharmacist delegate or practitioner delegate.

CSB 4.09(3) (3) Healthcare professionals, pharmacist delegates, and practitioner delegates may only disclose a monitored prescription drug history report about a patient obtained pursuant to sub. (1) or (2) in the following situations:

CSB 4.09(3)(a) (a) To the patient as part of treating or rendering assistance to the patient.

CSB 4.09(3)(b) (b) To another healthcare professional or a medical coordinator for consultation about the health of the patient or as part of treating or rendering assistance to the patient.

CSB 4.09(3)(c) (c) To the pharmacist or practitioner who is directly treating or rendering assistance to the patient.

CSB 4.09(3)(d) (d) To a law enforcement agency as required by s. 146.82, Stats.

CSB 4.09(4) (4) To obtain access to monitored prescription drug history reports as authorized in subs. (1) and (2), healthcare professionals, pharmacist delegates, and practitioner delegates shall do one of the following:

CSB 4.09(4)(a) (a) Create an account with the PDMP system.

CSB 4.09(4)(b) (b) Create an account with a prescription monitoring program operated by a relevant agency in another jurisdiction with which the board exchanges monitored prescription drug history reports or PDMP data pursuant to s. CSB 4.14.

CSB 4.09(4)(c) (c) Create an account with a pharmacy or other entity at which pharmacists dispense or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports or that is connected to and lawfully obtains data from the state-designated entity under ch. 153, Stats.

CSB 4.09(4)(d) (d) Create an account with a hospital or other entity at which practitioners prescribe, dispense, or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports or that is connected to and lawfully obtains data from the state-designated entity under ch. 153, Stats.

CSB 4.09 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (1), renum. (2) to (2) (intro.) and am., cr. (2) (a) to (d), am. (3) Register August 2014 No. 704, eff. 9-1-14; corrections in (1), (2) (b), (3) (a) Register September 2015 No. 717; EmR1706: emerg. r. and recr., eff. 4-1-17; CR 17-028: r. and recr. Register December 2017 No. 744, eff. 4-1-17; s. 35.17 corrections in (3) (intro.), (4) (intro.), Register December 2017 No. 744; CR 19-156: cr. (1) (c), (d) Register August 2020 No. 776, eff. 9-1-20.

CSB 4.093 CSB 4.093 Monitored prescription drug history reports and audit trails about healthcare professionals.

CSB 4.093(1) (1) Healthcare professionals may access audit trails about themselves and their practitioner delegates or pharmacist delegates.

CSB 4.093(2) (2) A practitioner may access the audit trails accessible to healthcare professionals and a prescribing metrics report about themself.

CSB 4.093(2m) (2m) Department staff who are charged with investigating dispensers, dispenser delegates, pharmacists, pharmacist delegates, practitioners, and practitioner delegates may access the audit trails related to s. CSB 4.12 (3) (f) and (g).

CSB 4.093(3) (3) Medical coordinators may access prescribing metrics reports and audit trails about a healthcare professional whom the medical coordinator coordinates, directs, or supervises or for whom the medical coordinator establishes standard operating procedures that contain no personally identifiable information about a patient if the medical coordinator is conducting any of the following activities:

CSB 4.093(3)(a) (a) Evaluating the job performance of the healthcare professional.

CSB 4.093(3)(b) (b) Performing quality assessment and improvement activities, including outcomes evaluation or development of clinical guidelines for the healthcare professional.

CSB 4.093(4) (4) To obtain access to prescribing metrics reports and audit trails as authorized in subs. (1) and (2), healthcare professionals, pharmacist delegates, and practitioner delegates shall create an account with the PDMP system.

CSB 4.093(5) (5) To obtain access to prescribing metrics reports, and audit trails about a healthcare professional, a medical coordinator shall create an account with the PDMP system.

CSB 4.093 History History: EmR1706: emerg. cr. eff. 4-1-17; CR 17-028: cr. Register December 2017 No. 744, eff. 4-1-17; s. 35.17 correction in (4), Register December 2017 No. 744; CR 19-156: cr. (2m) Register August 2020 No. 776, eff. 9-1-20.

CSB 4.097 CSB 4.097 Deny, suspend, revoke or otherwise restrict or limit access.

CSB 4.097(1) (1) The board may deny, suspend, revoke, or otherwise restrict or limit a healthcare professional’s, pharmacist delegate’s, practitioner delegate’s, or medical coordinator’s access to monitored prescription drug history reports, prescribing metrics reports, PDMP data, and audit tails for any of the following reasons:

CSB 4.097(1)(a) (a) The healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator is suspected of attempting to access, accessing, or disclosing a monitored prescription drug history report, prescribing metrics report, PDMP data, or audit trail in violation of s. 146.82 or 961.385, Stats., this chapter, or other state or federal laws or regulations relating to the privacy of patient health care records.

CSB 4.097(1)(b) (b) The healthcare professional is no longer licensed in this state or in another state and recognized by this state as a person to whom the board may grant access pursuant to s. CSB 4.09 or 4.093.

CSB 4.097(1)(c) (c) The board, or other licensing board, or regulatory agency takes adverse action against the healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator.

CSB 4.097(1)(d) (d) A licensing board or equivalent regulatory agency in another jurisdiction takes adverse action against the healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator.

CSB 4.097(1)(e) (e) The federal department of justice, drug enforcement administration takes adverse action against the healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator.

CSB 4.097(1)(f) (f) The healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator is convicted of a crime substantially related to the prescribing, administering, or dispensing of a monitored prescription drug.

CSB 4.097(1)(g) (g) The pharmacist delegate or practitioner delegate is no longer delegated the task of accessing monitored prescription drug history reports.

CSB 4.097(1)(h) (h) The medical coordinator no longer coordinates, directs, supervises, or establishes standard operating procedures for a healthcare professional.

CSB 4.097(2) (2) The board may temporarily suspend access to monitored prescription drug history reports, prescribing metrics reports, PDMP data, and audit trails upon discovering circumstances that indicate a healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator has performed any of the actions identified in sub. (1) (a).

CSB 4.097 History History: EmR1706: emerg. cr., eff. 4-1-17; CR 17-028: cr. Register December 2017 No. 744, eff. 1-1-18.

CSB 4.10 CSB 4.10 Requests for review.

CSB 4.10(1) (1) A dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator may request that the board review any of the following:

CSB 4.10(1)(b) (b) The denial of an emergency waiver requested pursuant to s. CSB 4.06 (3).

CSB 4.10(1)(c) (c) The denial, suspension, revocation or other restriction or limitation imposed on the healthcare professional’s, pharmacist delegate’s, practitioner delegate’s, or medical coordinator’s account pursuant to s. CSB 4.097.

CSB 4.10(2) (2) To request a review, the dispenser, health care professional, pharmacist delegate, practitioner delegate, or medical coordinator shall file a written request with the board within 20 days after the mailing of the notice of the action in sub. (1). The request shall be in writing and include all of the following:

CSB 4.10(2)(a) (a) The dispenser’s, healthcare professional’s, pharmacist delegate’s, practitioner delegate’s, or medical coordinator’s name and address, including street address, city, state and ZIP code.

CSB 4.10(2)(b) (b) The citation to the specific statute or rule on which the request is based.

CSB 4.10(3) (3) The board shall conduct the review at its next regularly scheduled meeting and notify the dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator of the time and place of the review.

CSB 4.10(4) (4) No discovery is permitted.

CSB 4.10(5) (5) The board shall preside over the review. The review shall be recorded by audio tape unless otherwise specified by the board.

CSB 4.10(6) (6) The board shall provide the dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator with an opportunity to submit written documentation, make a personal appearance before the board and present a statement. The board may establish a time limit for making a presentation. Unless otherwise determined by the board, the time for making a personal appearance shall be 20 minutes.

CSB 4.10(7) (7) If the dispenser, healthcare professional, pharmacist delegate, practitioner delegate, or medical coordinator fails to appear for a review, or withdraws the request for a review, the board may note the failure to appear in the minutes and affirm its original decision without further action.

CSB 4.10 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction in (1) (b) made under s. 13.92 (4) (b) 7., Stats., Register February 2014 No. 698; CR 14-003: am. (1) (intro.), (2) (intro.), (b), (3), (6), (7) Register August 2014 No. 704, eff. 9-1-14; correction in (1) (a) to (c) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; CR 15-101: am. (1) (c), (2) (a) Register June 2016 No. 726, eff. 7-1-16; s. 35.17 correction in (1) (c), Register June 2016 No. 726; EmR1706: emerg. am. (1) (intro.), r. (1) (a), am. (1) (c), (2) (intro.), (a), (3), (6), (7), eff. 4-1-17; CR 17-028: am. (1) (intro.), r. (1) (a), am. (1) (c), (2) (intro.), (a), (3), (6), (7) Register December 2017 No. 744, eff. 1-1-18; correction in (1) (c) made under s. 13.92 (4) (b) 7., Stats., December 2017 No. 744.

CSB 4.105 CSB 4.105 Practitioners’ requirement to review monitored prescription drug history reports.

CSB 4.105(1) (1) A practitioner, or a practitioner delegate assisting the practitioner in accordance with the standards of practice for the practitioner’s profession, shall review the monitored prescription drug history report about a patient before the practitioner issues a prescription order for the patient unless any of the following conditions are met:

CSB 4.105(1)(a) (a) The patient is receiving hospice care, as defined in s. 50.94 (1) (a).

CSB 4.105(1)(b) (b) The prescription order is for a number of doses that is intended to last the patient 3 days or less and is not subject to refill.

CSB 4.105(1)(c) (c) The monitored prescription drug is lawfully administered to the patient.

CSB 4.105(1)(d) (d) The practitioner is unable to review the patient’s monitored prescription drug history reports before issuing a prescription order for the patient due to an emergency.

CSB 4.105(1)(e) (e) The practitioner is unable to review the patient’s records under their program because the PDMP system is not operational or due to other technological failure that the practitioner reports to the board.