Michigan: The Michigan Board of Dentistry is charged with the licensing and practice requirements of dentists; these rules include dentists training on various methods of sedation and proper handling of waste. No rules currently list training and verification forms for the training of unlicensed individuals. [Public Health Code: Act 368 of 1978, Part 166, Dentistry].
Minnesota: Under the Minnesota Board of Dentistry, “…dentists employing, assisting, or enabling in any manner an unlicensed person to practice dentistry…" as found in Minnesota Statutes, section 150A.08, subdivision 1, is in violation of the state code. A brief review of the code did not reveal that a licensee has the authority to train an unlicensed individual, nor is there a means to report such training to the board. [Chapter 3100, Dentists, Hygienists, and Assistants].
Summary of factual data and analytical methodologies
The Board, in reviewing their rules in response to Executive Order 61, recognized that in practice, no form has been approved by the Board or required to be submitted to the Board for each circumstance of training an unlicensed person.
The proposed provisions are expected to reflect current practice.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis
The Dentistry Examining Board in reviewing their rules in response to Executive Order 61 found that neither the Board nor the industry was in conformance to the rule, which was deemed unnecessary.
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
greg.gasper@wisconsin.gov, or by calling (608) 266-8608.
Fiscal Estimate and Economic Impact Analysis
The Fiscal Estimate and Economic Impact Analysis is attached.
Initial Regulatory Flexibility Analysis or Summary
This rule change will not have an effect on small business.
Agency Contact Person
Jean MacCubbin, Program Manager
Department of Safety and Professional Services, Division of Policy Development
1400 East Washington Avenue, Room 151
P.O. Box 8935
Madison, WI 53708-8935
Telephone: (608) 266-0955
Telecommunications: contact at 711
STATE OF WISCONSIN
DEPARTMENT OF ADMINISTRATION
DOA-2049 (R03/2012)
|
Division of Executive Budget and Finance
101 East Wilson Street, 10th Floor
P.O. Box 7864
Madison, WI 53707-7864
FAX: (608) 267-0372
|
ADMINISTRATIVE RULES
Fiscal Estimate & Economic Impact Analysis
|
1. Type of Estimate and Analysis
|
X Original
⍽ Updated
⍽ Corrected
|
2. Administrative Rule Chapter, Title and Number
|
Ch. DE 12, Delegation of Functions to Unlicensed Persons
|
3. Subject
|
Training of Unlicensed Persons and Deletion of Required Form(s)
|
4. Fund Sources Affected
|
5. Chapter 20, Stats. Appropriations Affected
|
⍽ GPR
⍽ FED X PRO ⍽ PRS
⍽ SEG ⍽ SEG-S
|
s. 20.165 (1) (g), Stats.
|
6. Fiscal Effect of Implementing the Rule
|
X No Fiscal Effect
⍽ Indeterminate
|
⍽ Increase Existing Revenues
⍽ Decrease Existing Revenues
|
⍽ Increase Costs
⍽ Could Absorb Within Agency's Budget
⍽ Decrease Cost
|
7. The Rule Will Impact the Following (Check All That Apply)
|
⍽ State's Economy
⍽ Local Government Units
|
⍽ Specific Businesses/Sectors
⍽ Public Utility Rate Payers
⍽ Small Businesses (if checked, complete Attachment A)
|
8. Would Implementation and Compliance Costs Be Greater Than $20 million?
⍽ Yes
X No
|
9. Policy Problem Addressed by the Rule
|
Chapter DE 12, delegation of functions to unlicensed persons, has not been revised since 1991. The Dentistry Examining Board requests to repeal the requirements for the submittal of a form to verify a dentist's training and delegation of any remediable dental procedure to an unlicensed person.
|
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
|
Licensed dentists.
|
11. Identify the local governmental units that participated in the development of this EIA.
|
None known.
|
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
|
The proposed rule would have no affect on Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole. The major impact would be the deletion of a process not currently followed while maintaining both the delegation responsibilities with the licensed dentist and reporting of violations by dentists and dental hygienists.
|
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
|
Rules will be contemporary and reflect current practice in the industry.
|
14. Long Range Implications of Implementing the Rule
|
Licensed dentists will continue to be responsible for training unlicensed persons in practices and functions, but so communicating to the board will not be practice.
|
15. Compare With Approaches Being Used by Federal Government
|
An Internet-based search of the U.S. Code or the Code of Federal Register did not reveal any current or proposed rules relating to dentists training unlicensed individuals or any forms recording such training.
|
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
|
Illinois: The rules for Illinois Department of Financial & Professional Regulation for dentistry has no mention of a licensed dentist providing such training be required to apply or report such activity to the Division of Professional Regulation. Iowa: The rules for the Iowa Dental Board have no reference to training of unlicensed individuals or forms so required. Michigan: Under the Michigan Board of Dentistry, there are no rules currently listing training and verification forms for unlicensed individuals. Minnesota: Under the Minnesota Board of Dentistry rules, a review did not reveal that a licensee has the authority to train an unlicensed individual, nor is there a means to report such training to the Board.
|
17. Contact Name
|
18. Contact Phone Number
|
Jean MacCubbin
|
608.266.0955
|
This document can be made available in alternate formats to individuals with disabilities upon request.
Notice of Hearing
Safety and Professional Services —
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b),
450.02 (3) (a), and
961.31, Stats., and interpreting ss.
450.11 (2) and
961.38, Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal s.
Phar 7.08 (1) (Note) and amend ss.
Phar 8.05 (4),
8.07 (2), and
8.09 (1),
(2),
(3), and
(4), relating to electronic prescriptions.
Hearing Information
Date: Wednesday, October 30, 2013
Time: 9:05 a.m.
Locations: 1400 East Washington Ave.
Room 121
Madison, WI
Appearances at the Hearing
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions, and arguments in writing as well. Facts, opinions, and arguments may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.
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 Development, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, WI 53708-8935, or by email to
sharon.henes@wisconsin.gov. Comments must be received at or before the public hearing to be held on
October 30, 2013, to be included in the record of rule-making proceedings.
Copies of Rule
Analysis Prepared by the Department
Statutes interpreted
Statutory authority
Explanation of agency authority
Section
15.08 (5) (b), Stats., allows each examining board to “promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Section
450.02 (3) (a), Stats., authorizes the Board to promulgate rules “[r]elating to the
…distribution and dispensing of prescription drugs."
Section
961.31, Stats., authorizes the Board to promulgate rules relating to the manufacture, distribution, and dispensing of controlled substances within the state.
Related statute or rule
Plain language analysis
2011 Wisconsin Act 159 amended s.
961.38, Stats. to allow electronic prescriptions for schedule II controlled substances. This rule updates the Pharmacy Examining Board rules accordingly.
Section 1 repeals the note following s.
Phar 7.08 (1) which stated that prescription orders for schedule II controlled substances may not be transmitted electronically except in emergency.
Section 2 amends s.
Phar 8.05 (4) to indicate that a prescription containing a controlled substance can only be dispensed pursuant to a written hard copy or electronic order signed by the prescribing practitioner.
Section 3 amends s.
Phar 8.07 (2) to indicate the notation of the partial quantity provided is written on the hard copy of the prescription or the electronic order. The word “emergency" is moved to solely modify oral prescription.
Sections 4, 5, and 7 amend s.
Phar 8.09 (1),
(2), and
(4) to remove electronic from the emergency prescriptions and to reflect the provisions relate solely to oral authorizations in an emergency situation.
Section 6 amends s.
Phar 8.09 (3) to remove the reference to electronic in this emergency prescription provision. It also removes the reference to the “practitioner's phone number as listed in the telephone directory" to reflect current technologies may be used rather than the outdated method of looking phone numbers up in a telephone directory.
Summary of, and comparison with, existing or proposed federal regulation
21 CFR §1311 allows electronic prescriptions for controlled substances.
Comparison with rules in adjacent states
Illinois: Per Ill. Admin. Code Title 68, s. 1330.760, electronically transmitted prescriptions for controlled substances may be dispensed only as provided by federal law.
Iowa: Per Iowa Admin. Code 657 to 8.19, electronic prescriptions may be accepted for controlled substances.
Michigan: Per Mich. Admin. Code s.
333.7333, electronic prescriptions of controlled substances are allowed, if not prohibited by federal law.
Minnesota: Per Minnesota Rules 6800.3000 Subp. 3, electronic prescriptions are allowed if they conform to the rules of the federal Drug Enforcement Administration.
Summary of factual data and analytical methodologies
The methodology used was to update the rule to reflect the changes to the statutes as a result of
2011 Wisconsin Act 159.
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 for 14 days and none were received. This rule updates the code to reflect the statutory change to allow for electronic prescriptions and will not have an economic impact.
Fiscal Estimate and Economic Impact Analysis
The Fiscal Estimate and Economic Impact Analysis is attached.
Initial Regulatory Flexibility Analysis or Summary
There is no effect on small business as defined under s.
227.114 (1), Stats.
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 8935
Madison, WI 53708
Telephone: 608-261-2377
Email:
sharon.henes@wisconsin.gov
STATE OF WISCONSIN
DEPARTMENT OF ADMINISTRATION
DOA-2049 (R03/2012)
|
Division of Executive Budget and Finance
101 East Wilson Street, 10th Floor
P.O. Box 7864
Madison, WI 53707-7864
FAX: (608) 267-0372
|
ADMINISTRATIVE RULES
Fiscal Estimate & Economic Impact Analysis
|
1. Type of Estimate and Analysis
|
X Original
⍽ Updated
⍽ Corrected
|
2. Administrative Rule Chapter, Title and Number
|
Chapters Phar 7, 8
|
3. Subject
|
Allowing electronic prescriptions for controlled substances schedule II.
|
4. Fund Sources Affected
|
5. Chapter 20, Stats. Appropriations Affected
|
⍽ GPR
⍽ FED X PRO ⍽ PRS
⍽ SEG ⍽ SEG-S
|
|
6. Fiscal Effect of Implementing the Rule
|
X No Fiscal Effect
⍽ Indeterminate
|
⍽ Increase Existing Revenues
⍽ Decrease Existing Revenues
|
⍽ Increase Costs
⍽ Could Absorb Within Agency's Budget
⍽ Decrease Cost
|
7. The Rule Will Impact the Following (Check All That Apply)
|
⍽ State's Economy
⍽ Local Government Units
|
⍽ Specific Businesses/Sectors
⍽ Public Utility Rate Payers
⍽ Small Businesses (if checked, complete Attachment A)
|
8. Would Implementation and Compliance Costs Be Greater Than $20 million?
⍽ Yes
X No
|
9. Policy Problem Addressed by the Rule
|
2011 Wisconsin Act 159 amended § 961.38, Stats. to allow electronic prescriptions for schedule II controlled substances. This rule updates the Pharmacy Examining Board rules accordingly.
|
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
|
This rule was posted for 14 days for economic comments and none were received.
|
11. Identify the local governmental units that participated in the development of this EIA.
|
None. This rule does not affect local governments.
|
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
|
This rule will not have an economic or fiscal impact on specific businesses, business sectors, public utility rate payers, local governmental units or the state's economy as a whole. This rule updates the code to reflect the statutory change to allow for electronic prescriptions.
|
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
|
The benefit of implementing the rule would allow a pharmacy/pharmacist to use modern technology in a manner that efficiently meets patient needs by allowing electronic prescriptions for schedule II controlled substances and allowing oral prescriptions to be reduced to an electronic record while maintaining public safety. This rule updates the code to reflect the revision in statute created by 2011 Act 159 to allow for electronic prescriptions to schedule II controlled substances.
|
14. Long Range Implications of Implementing the Rule
|
The long range implication is to increase public safety by cutting down on dispensing errors or patients misplacing their written prescription orders by allowing electronic prescriptions, rather than only written prescription orders.
|
15. Compare With Approaches Being Used by Federal Government
|
The federal government allows for electronic prescriptions for schedule II controlled substances.
|
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
|
Our four neighboring states allow for electronic prescriptions for scheduled II controlled substances, if not prohibited by federal law.
|
17. Contact Name
|
18. Contact Phone Number
|
Sharon Henes, Administrative Rules Coordinator
|
(608) 261-2377
|
This document can be made available in alternate formats to individuals with disabilities upon request.
Notice of Hearing
Safety and Professional Services —
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b) and
450.02 (3), Stats., and interpreting ss.
450.01 (7) and
450.02 (3), Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal s.
Phar 7.04 (1) (e) 2. (Note) and amend s.
Phar 7.04 (1) (e) 2., relating to return or exchange of health items.
Hearing Information
Date: Wednesday, October 30, 2013
Time: 9:00 a.m.
Locations: 1400 East Washington Ave.
Room 121
Madison, WI
Appearances at the Hearing
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions, and arguments in writing as well. Facts, opinions, and arguments may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.
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 Development, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, WI 53708-8935, or by email to
sharon.henes@wisconsin.gov. Comments must be received at or before the public hearing to be held on
October 30, 2013, to be included in the record of rule-making proceedings.
Copies of Rule
