Wisconsin Legislature: Text

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 Tom.Engels@wisconsin.gov, or by calling (608) 266-8608.

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 608-261-4438; 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: (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
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

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