CR_14-040 Revises Chapter Med 18, relating to physicians and informed consent.

Sections 15.085 (5) (b) , 227.11 (2) (a) , and 460.04 (2) (a) , Stats.

Explanation of agency authority

Pursuant to ss. 15.085 (5) (b) and 227.11 (2) (a) , Stats., the Massage Therapy and Bodywork Therapy Affiliated Credentialing Board (Board) is generally empowered by the legislature to promulgate rules that will provide guidance within the profession and rules that interpret the statutes it enforces or administers. Section 460.04 (2) (a) , Stats., specifically empowers the Board to draft rules regarding the professional conduct of licensees practicing massage therapy or bodywork therapy. This proposed rule seeks to carry out this mandate by revising the rules related to unprofessional conduct.

Related statute or rule

None.

Plain language analysis

The passage of 2009 Wisconsin Act 355 transformed the Massage Therapy and Bodywork Council into the Massage Therapy and Bodywork Therapy Affiliated Credentialing Board (Board). The Act granted the newly formed Board rule-making authority. Pursuant to that authority, the Board reviewed its unprofessional conduct rules and decided the rules were outdated and needed updating. The modernization of the rules will not result in a significant policy change but rather a further clarification of the ethical goals of the profession.

SECTION 1. Creates a section identifying the authority to promulgate the proposed rules.

SECTION 2. Renumbers s. MTBT 5.02 .

SECTION 3. Modernizes the definition of unprofessional conduct for massage therapist and bodywork therapists.

SECTION 4. Creates a provision regarding auditing continuing education requirements.

Summary of, and comparison with, existing or proposed federal regulation

None.

Comparison with rules in adjacent states

Illinois: The grounds for unprofessional conduct for Illinois licensed massage therapists and bodywork therapists are governed by statute, ILL . Comp. Stat. 225/57. The rules are similar to current Wisconsin unprofessional conduct rules in that they are comprehensive ranging from prohibitions against false advertising to inability to practice with reasonable judgment and skill

Iowa: The Iowa Administrative Code sets forth the grounds for discipline of massage therapists in 645 IAC 134.2. The rules are similar to Wisconsin in that they cover a variety of topics; however the Iowa rules focus primarily on fraudulent behavior such as fraud in procuring a license, untruthful or improbable statements in advertising, and acceptance of any fee by fraud.

Michigan: Prohibited conduct of massage therapists as set forth in Michigan Administrative Code R 338.723, is limited to eight prohibitions. The prohibitions focus primarily on exceeding the boundaries of a professional relationship with clients such as taking on a professional role when a personal, scientific, legal, financial, or other relationship impairs the exercise of professional discretion or being involved in a dual relationship with a current or former client.

Minnesota: In Minnesota massage therapy and bodywork therapy are identified as complementary and alternative health care practices, Minn. Stat. §146A.01. Those who conduct alternative health care practices are regulated by statute, Minn. Stat. §146A.08. The statute identifies prohibited conduct covering a variety of topics including: prohibition against sexual contact with clients, adjudication as mentally incompetent and fraudulent billing practices.

Summary of factual data and analytical methodologies

The Board reviewed its current unprofessional conduct rules and decided that the rules needed to be updated to conform to current practice within the profession. No other factual data or analytical methodologies were used. The Board ensures the accuracy, integrity, objectivity, and consistency of data were used in preparing the proposed rule and related analysis.

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

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].

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis are below.

Agency Contact Person

Shawn Leatherwood, 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 [phone]; email at Shancethea.Leatherwood@ 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: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
MTBT 5
3. Subject
Unprofessional Conduct
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   ⍽ 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
The Massage Therapy and Bodywork Therapy Board (Board) recently reviewed its unprofessional conduct rules and determined that the rules were outdated. The Board decided to modernize the rules by making the language consistent with current practice within the profession. The promulgation of the proposed rules will not result in a significant policy change but rather a further clarification of the ethical goals of the profession.
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.
The rule was posted on the Department of Safety and Professional Service's website for 14 days in order to solicit comments from businesses, associations representing businesses, local governmental units and individuals that may be affected by the rule. No comments were received.
11. Identify the local governmental units that participated in the development of this EIA.
No local governmental units participated in the development of this EIA.
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 proposed rule will not have a significant impact on specific businesses, business sectors, public utility rate payers, local governmental units or the state's economy as a whole.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
Updating the unprofessional conduct rules will provide greater guidance on ethical issues facing licensed massage therapists and bodywork therapists.
14. Long Range Implications of Implementing the Rule
Consistent application of the proposed rule will act as a deterrent to unethical conduct amongst licensed massage therapists and bodywork therapists.
15. Compare With Approaches Being Used by Federal Government
None.
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
Illinois: The grounds for unprofessional conduct for Illinois licensed massage therapists and bodywork therapists are governed by statute, ILL . Comp. Stat. 225/57, and not rule as in Wisconsin . The rules are similar to current Wisconsin unprofessional conduct rules in that they are comprehensive ranging from prohibitions against false advertising to inability to practice with reasonable judgment and skill. Iowa: The Iowa Administrative Code sets forth the grounds for discipline of massage therapists in 645 IAC 134.2. The rules are similar to Wisconsin in that they cover a variety of topics; however the Iowa rules focus primarily on fraudulent behavior such as fraud in procuring a license, untruthful or improbable statements in advertising, and acceptance of any fee by fraud. Michigan: Prohibited conduct of massage therapists as set forth in Michigan Administrative Code R 338.723, is limited to eight prohibitions. The prohibitions focus primarily on exceeding the boundaries of a professional relationship with clients such as taking on a professional role when a personal, scientific, legal, financial, or other relationship impairs the exercise of professional discretion or being involved in a dual relationship with a current or former client. Minnesota: In Minnesota massage therapy and bodywork therapy are identified as complementary and alternative health care practices, Minn. Stat. §146A.01. Those who conduct alternative health care practices are regulated by statute, Minn. Stat. §146A.08. The statute identifies prohibited conduct covering a variety of topics including: prohibition against sexual contact with clients, adjudication as mentally incompetent and fraudulent billing practices
17. Contact Name				18. Contact Phone Number
Shawn Leatherwood				608-261-4438

This document can be made available in alternate formats to individuals with disabilities upon request.

Notice of Hearings

Safety and Professional Services —
Medical Examining Board

CR 14-040

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Medical Examining Board in ss. 15.08 (5) (b) , 227.11 (2) (a) , and 448.40 (2) (a) , Wis. Stats., and 2013 Wisconsin Act 111 , and interpreting s. 448.30 , Wis. Stats., the Medical Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend sections Med 18.02 (3) , 18.04 (3) and (5) , and 18.05 ; to repeal and recreate section Med 18.03 (title); and to create section Med 18.04 (6) , relating to physicians and informed consent.

Hearing Information

Date:   Wednesday, August 20, 2014
Time:   8:30 a.m.
Location:   1400 East Washington Avenue
  (enter at 55 North Dickinson Street)
  Room 121A
  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 argument in writing as well. Facts, opinions, and argument 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 8366, 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 Shawn Leatherwood, Administrative Rules Coordinator Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8935, or by email to [e-mail] . Comments must be received at or before the public hearing to be held on August 20, 2014 , to be included in the record of rule-making proceedings.

Copies of Rule

Copies of this proposed rule are available upon request to Shawn Leatherwood, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, P.O. Box 8366, Madison, Wisconsin 53708, by email at [e-mail] or on our website at http://dsps.wi.gov/Default.aspx?Page=44e541e8-abdd- 49da-8fde-046713617e9e .

Analysis Prepared by the Department of Safety and Professional Services

Statutes interpreted

Section 448.30 , Stats.

Statutory authority

Sections 15.08 (5) (b) , 227.11 (2) (a) , and 448.40 (2) (a) , Stats., 2013 Wisconsin Act 111 .

Explanation of agency authority

Examining boards are authorized by s. 15.08 (5) (b) , Stats., to promulgate rules that will provide guidance within their profession. Section 227.11 (2) (a) , Stats., grants authority to boards to promulgate rules interpreting the statutes it enforces or administers as long as the proposed rule does not exceed proper interpretation of the statute. This proposed rule will interpret s. 448.30 , Stats., which sets forth the guidelines physicians must follow in order to properly inform their patients regarding alternate modes of treatment. Section 448.40 (2) (a) , Stats., grants express authority from the legislature to the Medical Examining Board to draft rules regarding informed consent.

Related statute or rule

None.

Plain language analysis

Recent legislation, 2013 Wisconsin Act 111 , significantly impacted s. 448.30 , Stats., and Wis. Admin Code ch. Med 18 . Before the Act, physicians had a duty to inform their patients, under s. 448.30 , Stats., of all alternate viable medical modes of treatment and about the benefits and risks of those treatments. After the passage of Act 111, physicians are required to inform their patients of reasonable alternate medical modes of treatment. The latter standard is not as broad as the former standard and in fact lessens the burden on physicians.

Another major change is the reasonable physician standard has replaced the reasonable patient standard. The reasonable physician standard requires doctors to disclose only the information that a reasonable physician in the same or similar medical specialty would know and disclose under the circumstances. The reasonable patient standard requires a physician to disclose information necessary for a reasonable person to make an intelligent decision with respect to the choices of treatment. The reasonable physician standard is a more objective approach and is the standard to which Wisconsin physicians must now adhere.

Summary of, and comparison with, existing or proposed federal regulation

Several federal agencies, including but not limited to the Food and Drug Administration, have rules protecting human subjects participating in investigative trials. Investigators are required to obtain informed consent of each person that will participate in experimental studies, 21 CFR 50.20 , including experiments involving drugs for human use found in 21 CFR 312.60 . Obtaining informed consent from participants in the investigatory research is not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

Comparison with rules in adjacent states

Illinois: Illinois does not have a comparable statute or rule.

Iowa: Iowa statutes create a presumption that informed consent was given if it is documented in writing. "A consent in writing to any medical or surgical procedure or course of procedure in patient care which meets the requirements of this section shall create a presumption that informed consent was given." Iowa Code § 147.137 .

Michigan: Michigan's statute has comparable language which is directed towards physicians who are treating breast cancer patients. Physicians are required to inform patients verbally and in writing about alternative modes of treatment of cancer. The statute sets forth the reasonable physician standards. "A physician's duty to inform a patient under this section does not require disclosure of information beyond what a reasonably well-qualified physician licensed under this article would know." MCLS § 333.17013 (6) .

Minnesota: Minnesota does not have comparable statute or rule.

Summary of factual data and analytical methodologies

No factual data was required for the rule-making in this proposal, due to the changes being necessitated by the passage of 2013 Wisconsin Act 111 . For that reason, no factual data or analytical methodologies were used in the preparation of these proposed rules.

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

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].

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis are below.

Initial Regulatory Flexibility Analysis or Summary

N/A

Agency Contact Person

Shawn Leatherwood, 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 [phone]; email at Shancethea.Leatherwood@ 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: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
Med 18
3. Subject
Informed consent
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   ⍽ 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
This proposed rule is a result of recent legislation. 2013 Wisconsin Act 111changed the standard regarding doctors informing patients of their health care options by removing the reasonable patient standard and replacing it with the reasonable physician standard. The reasonable physician standard requires doctors to disclose only the information that a reasonable physician in the same or similar medical specialty would know and disclose under the circumstances. As a result of the legislation doctors must obtain informed consent from their patients by advising them of reasonable alternate medical modes of treatment and the benefits and risks of those treatments in a manner consistent with the reasonable physician standard. The proposed rule will update Wis. Admin. Code s. Med 18 to reflect these changes.
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.
The Rule was posted on the Department and Professional Services website for 14 days in order to solicit comments from businesses, associations representing of Safety businesses, local governmental units and individuals that may be affected by the rule. No comments were received.
11. Identify the local governmental units that participated in the development of this EIA.
No local governmental units participated in the development of this EIA.
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 proposed rule will not have a significant impact on specific businesses, business sectors, public utility rate payers, local governmental units or the state's economy as a whole.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
Physicians will advise their patients their patients in a manner of alternate modes of treatment in a manner that is consistent with current law. There is no alternative to implementing the proposed rule due to the changes being necessitated by passage of legislation.
14. Long Range Implications of Implementing the Rule
Physicians consistently advising patients of reasonable alternate medical modes of treatment will result in physicians upholding their duty to inform patients in accordance with s. 448.30, Stats.
15. Compare With Approaches Being Used by Federal Government
Several federal agencies, including but not limited to the Food and Drug Administration, have rules protecting human subjects participating in investigative trials. Investigators are required to obtain informed consent of each person that will participate in experimental studies, 21 CFR 50.20, including experiments involving drugs for human use found in 21 CFR 312.60. Obtaining informed consent from participants in the investigatory research is not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
Illinois: Illinois does not have a comparable statute or rule. Iowa: Iowa statutes create a presumption that informed consent was given if it is documented in writing. "A consent in writing to any medical or surgical procedure or course of procedure in patient care which meets the requirements of this section shall create a presumption that informed consent was given." Iowa Code § 147.137. Michigan: Michigan's statute has comparable language which is directed towards physicians who are treating breast cancer patients. Physicians are required to inform patients verbally and in writing about alternative modes of treatment of cancer. The statute sets forth the reasonable physician standards. "A physician's duty to inform a patient under this section does not require disclosure of information beyond what a reasonably well-qualified physician licensed under this article would know." MCLS §333.17013 (6). Minnesota: Minnesota does not have comparable statute or rule.
17. Contact Name				18. Contact Phone Number
Shawn Leatherwood				608-261-4438

This document can be made available in alternate formats to individuals with disabilities upon request.