STATE OF WISCONSIN
MEDICAL EXAMINING BOARD
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IN THE MATTER OF RULEMAKING
:
ORDER OF THE
PROCEEDINGS BEFORE THE
:
MEDICAL EXAMINING BOARD
MEDICAL EXAMINING BOARD
:
ADOPTING RULES
:
(CLEARINGHOUSE RULE 14-040)
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ORDER
An order of the Medical Examining Board to amend Med 18.02 (3), 18.04 (3) and (5) and 18.05; to repeal and recreate chapter Med 18 (title) Med 18.03 (title); and to create Med 18.04 (6), relating to physicians and informed consent.
Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Statutes interpreted:
Statutory authority:
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 s. 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
experiment
al 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 b
y 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 report:
The rule was posted for public comment on the economic impact of the proposed rule, including how this proposed rule may affect businesses, local government units, and individuals, for a period of 14 days. No comments were received relating to the economic impact of the rule.
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 c
alling (608) 267-2435
.
Agency contact person
:
Katie
Paff
,
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) 261-4472
; email at
Kathleen.Paff@wisconsin.gov
.
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TEXT OF RULE
SECTION 1. Chapter Med 18 (title) is repealed and recreated to read:
CHAPTER MED 18 (title)
INFORMED CONSENT
SECTION 2.
Med 18.02 (3) is amended to read:
Med 18.
02
(3)
“ Viable”
as
u
s
ed in s.
448.30
, Stats., to modify the term “medical modes of treatment
”
means
modes of
treatment
“
Modes of treatment
”
means treatment, including diagnostic procedure
s,
generally considered by the medical profession to be within the scope of current,
acceptable standard
s
of care
.
SECTION 3. Med 18.03 is repealed and recreated to read:
Med 18.03
(title)
Informed
c
onsent
.
Any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments. The reasonable physician standard is the standard for inform
ing a patient
. The reasonable physician standard requires disclosure only of information that a reasonable physician in the same or a similar medical specialty would know and disclose under the circumstances.
SECTION 4. Med 18.04 (3) and (5) are amended to read:
Med 18.04 (3)
A physician is not required to communicate any mode of treatment
which is not
viable
a reasonable
alternate
mode of treatment
or
which is experimental.
Med 18.04 (5)
A physician may simplify or omit communication of
viable
reasonable alternate
modes of treatment if the communication would unduly confuse or frighten a patient or if a patient refuses to receive the communication.
SECTION 5. Med 18.04 (6) is created to read:
Med 18.04 (6)
A physician is not required to communicate
i
nformation about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient
.
SECTION 6. Med 18.05 is amended to read:
Med 18.0
5
Recordkeeping.
A physician shall indicate on a patient's medical record he or she has communicated to the patient
reasonable
alternate
viable
modes of treatment
.
Section 7. Effective Date.
The rules adopted in this order shall take effect on the first day of the month following publication in the
Wisconsin
Administrative Register, pursuant to s.
227.22 (2) (intro.)
, Stats.
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(END OF TEXT OF RULE)
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