May 5, 2005, Introduced by Senators GEORGE, SWITALSKI, CHERRY, OLSHOVE, JACOBS, HAMMERSTROM, GILBERT, CROPSEY, PATTERSON, PRUSI, BRATER, BARCIA, SCHAUER and STAMAS and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 16221, 17020, and 17520 (MCL 333.16221,
333.17020, and 333.17520), section 16221 as amended by 2004 PA 214
and sections 17020 and 17520 as added by 2000 PA 29, and by adding
sections 17020a, 17520a, and 20170a.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 16221. The department may investigate activities related
to the practice of a health profession by a licensee, a registrant,
or an applicant for licensure or registration. The department may
hold hearings, administer oaths, and order relevant testimony to be
taken and shall report its findings to the appropriate disciplinary
subcommittee. The disciplinary subcommittee shall proceed under
section 16226 if it finds that 1 or more of the following grounds
exist:
(a) A violation of general duty, consisting of negligence or
failure to exercise due care, including negligent delegation to or
supervision of employees or other individuals, whether or not
injury results, or any conduct, practice, or condition that
impairs, or may impair, the ability to safely and skillfully
practice the health profession.
(b) Personal disqualifications, consisting of 1 or more of the
following:
(i) Incompetence.
(ii) Subject to sections 16165 to 16170a, substance abuse as
defined in section 6107.
(iii) Mental or physical inability reasonably related to and
adversely affecting the licensee's ability to practice in a safe
and competent manner.
(iv) Declaration of mental incompetence by a court of competent
jurisdiction.
(v) Conviction of a misdemeanor punishable by imprisonment for
a maximum term of 2 years; a misdemeanor involving the illegal
delivery, possession, or use of a controlled substance; or a
felony. A certified copy of the court record is conclusive evidence
of the conviction.
(vi) Lack of good moral character.
(vii) Conviction of a criminal offense under sections 520b to
520g of the Michigan penal code, 1931 PA 328, MCL 750.520b to
750.520g. A certified copy of the court record is conclusive
evidence of the conviction.
(viii) Conviction of a violation of section 492a of the Michigan
penal code, 1931 PA 328, MCL 750.492a. A certified copy of the
court record is conclusive evidence of the conviction.
(ix) Conviction of a misdemeanor or felony involving fraud in
obtaining or attempting to obtain fees related to the practice of a
health profession. A certified copy of the court record is
conclusive evidence of the conviction.
(x) Final adverse administrative action by a licensure,
registration, disciplinary, or certification board involving the
holder of, or an applicant for, a license or registration regulated
by another state or a territory of the United States, by the United
States military, by the federal government, or by another country.
A certified copy of the record of the board is conclusive evidence
of the final action.
(xi) Conviction of a misdemeanor that is reasonably related to
or that adversely affects the licensee's ability to practice in a
safe and competent manner. A certified copy of the court record is
conclusive evidence of the conviction.
(xii) Conviction of a violation of section 430 of the Michigan
penal code, 1931 PA 328, MCL 750.430. A certified copy of the court
record is conclusive evidence of the conviction.
(c) Prohibited acts, consisting of 1 or more of the following:
(i) Fraud or deceit in obtaining or renewing a license or
registration.
(ii) Permitting the license or registration to be used by an
unauthorized person.
(iii) Practice outside the scope of a license.
(iv) Obtaining, possessing, or attempting to obtain or possess
a controlled substance as defined in section 7104 or a drug as
defined in section 7105 without lawful authority; or selling,
prescribing, giving away, or administering drugs for other than
lawful diagnostic or therapeutic purposes.
(d) Unethical business practices, consisting of 1 or more of
the following:
(i) False or misleading advertising.
(ii) Dividing fees for referral of patients or accepting
kickbacks on medical or surgical services, appliances, or
medications purchased by or in behalf of patients.
(iii) Fraud or deceit in obtaining or attempting to obtain third
party reimbursement.
(e) Unprofessional conduct, consisting of 1 or more of the
following:
(i) Misrepresentation to a consumer or patient or in obtaining
or attempting to obtain third party reimbursement in the course of
professional practice.
(ii) Betrayal of a professional confidence.
(iii) Promotion for personal gain of an unnecessary drug,
device, treatment, procedure, or service.
(iv) Either of the following:
(A) A requirement by a licensee other than a physician that an
individual purchase or secure a drug, device, treatment, procedure,
or service from another person, place, facility, or business in
which the licensee has a financial interest.
(B) A referral by a physician for a designated health service
that violates section 1877 of part D of title XVIII of the social
security act, 42 USC 1395nn, or a regulation promulgated under that
section. Section 1877 of part D of title XVIII of the social
security act, 42 USC 1395nn, and the regulations promulgated under
that section, as they exist on June 3, 2002, are incorporated by
reference for purposes of this subparagraph. A disciplinary
subcommittee shall apply section 1877 of part D of title XVIII of
the social security act, 42 USC 1395nn, and the regulations
promulgated under that section regardless of the source of payment
for the designated health service referred and rendered. If section
1877 of part D of title XVIII of the social security act, 42 USC
1395nn, or a regulation promulgated under that section is revised
after June 3, 2002, the department shall officially take notice of
the revision. Within 30 days after taking notice of the revision,
the department shall decide whether or not the revision pertains to
referral by physicians for designated health services and continues
to protect the public from inappropriate referrals by physicians.
If the department decides that the revision does both of those
things, the department may promulgate rules to incorporate the
revision by reference. If the department does promulgate rules to
incorporate the revision by reference, the department shall not
make any changes to the revision. As used in this subparagraph,
"designated health service" means that term as defined in section
1877 of part D of title XVIII of the social security act, 42 USC
1395nn, and the regulations promulgated under that section and
"physician" means that term as defined in sections 17001 and 17501.
(v) For a physician who makes referrals pursuant to section
1877 of part D of title XVIII of the social security act, 42 USC
1395nn, or a regulation promulgated under that section, refusing to
accept a reasonable proportion of patients eligible for medicaid
and refusing to accept payment from medicaid or medicare as payment
in full for a treatment, procedure, or service for which the
physician refers the individual and in which the physician has a
financial interest. A physician who owns all or part of a facility
in which he or she provides surgical services is not subject to
this subparagraph if a referred surgical procedure he or she
performs in the facility is not reimbursed at a minimum of the
appropriate medicaid or medicare outpatient fee schedule, including
the combined technical and professional components.
(f)
Beginning June 3, 2003, the department of consumer and
industry
services shall prepare the first of 3 annual reports on
the effect of this amendatory act on access to care for the
uninsured and medicaid patients. The department shall report on the
number of referrals by licensees of uninsured and medicaid patients
to purchase or secure a drug, device, treatment, procedure, or
service from another person, place, facility, or business in which
the licensee has a financial interest.
(g) Failure to report a change of name or mailing address
within 30 days after the change occurs.
(h) A violation, or aiding or abetting in a violation, of this
article or of a rule promulgated under this article.
(i) Failure to comply with a subpoena issued pursuant to this
part, failure to respond to a complaint issued under this article
or article 7, failure to appear at a compliance conference or an
administrative hearing, or failure to report under section 16222 or
16223.
(j) Failure to pay an installment of an assessment levied
pursuant to the insurance code of 1956, 1956 PA 218, MCL 500.100 to
500.8302, within 60 days after notice by the appropriate board.
(k) A violation of section 17013 or 17513.
(l) Failure to meet 1 or more of the requirements for licensure
or registration under section 16174.
(m) A violation of section 17015 or 17515.
(n) A violation of section 17016 or 17516.
(o) Failure to comply with section 9206(3).
(p) A violation of section 5654 or 5655.
(q) A violation of section 16274.
(r)
A violation of section 17020, or 17020a,
17520, or
17520a.
(s) A violation of the medical records access act, 2004 PA 47,
MCL 333.26261 to 333.26271.
(t) A violation of section 17764(2).
Sec. 17020. (1) Except as otherwise provided for a test
performed under section 5431 and except as otherwise provided by
law,
beginning upon the expiration of 6 months after the effective
date
of the amendatory act that added this section September 15,
2000, a physician or an individual to whom the physician has
delegated authority to perform a selected act, task, or function
under section 16215 shall not order a presymptomatic or predictive
genetic test without first obtaining the written, informed consent
of the test subject, pursuant to this section.
(2) For purposes of subsection (1), written, informed consent
consists of a signed writing executed by the test subject or the
legally authorized representative of the test subject that confirms
that the physician or the individual acting under the delegatory
authority of the physician has explained, and the test subject or
the legally authorized representative of the test subject
understands, at a minimum, all of the following:
(a) The nature and purpose of the presymptomatic or predictive
genetic test.
(b) The effectiveness and limitations of the presymptomatic or
predictive genetic test.
(c) The implications of taking the presymptomatic or
predictive genetic test, including, but not limited to, the medical
risks and benefits.
(d) The future uses of the sample taken from the test subject
in order to conduct the presymptomatic or predictive genetic test
and the information obtained from the presymptomatic or predictive
genetic test.
(e) The meaning of the presymptomatic or predictive genetic
test results and the procedure for providing notice of the results
to the test subject.
(f) Who will have access to the sample taken from the test
subject in order to conduct the presymptomatic or predictive
genetic test and the information obtained from the presymptomatic
or predictive genetic test, and the test subject's right to
confidential treatment of the sample and the information.
(3) Within
6 months after the effective date of the
amendatory
act that added this section Before
September 15, 2000,
the department of community health, in consultation with the
Michigan board of medicine, the Michigan board of osteopathic
medicine and surgery, at least 1 physician who is board certified
by the American board of medical genetics, and appropriate
professional organizations, shall develop and distribute a model
informed consent form for purposes of this section that
practitioners may adopt. The department of community health shall
include in the model form at least all of the information required
under subsection (2). The department of community health shall
distribute the model form to physicians and other individuals
subject to this section upon request and at no charge. The
department of community health shall review the model form at least
annually for 5 years after the first model form is distributed, and
shall revise the model form if necessary to make the form reflect
the latest developments in medical genetics.
(4) The department of community health, in consultation with
the entities described in subsection (3), may also develop and
distribute a pamphlet that provides further explanation of the
information included in the model informed consent form.
(5) If a test subject or his or her legally authorized
representative signs a copy of the model informed consent form
developed and distributed under subsection (3), the physician or
individual acting under the delegatory authority of the physician
shall give the test subject a copy of the signed informed consent
form and shall include the original signed informed consent form in
the test subject's medical record.
(6) If a test subject or his or her legally authorized
representative signs a copy of the model informed consent form
developed and distributed under subsection (3), the test subject is
barred from subsequently bringing a civil action for damages
against the physician, or an individual to whom the physician
delegated the authority to perform a selected act, task, or
function under section 16215, who ordered the presymptomatic or
predictive genetic test, based on failure to obtain informed
consent for the presymptomatic or predictive genetic test.
(7) 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.
(8) Except as otherwise provided in subsection (9), as used in
this section and section 17020a:
(a) "Genetic information" means information about a gene, gene
product, or inherited characteristic which information is derived
from a genetic test.
(b) "Genetic test" means the analysis of human DNA, RNA,
chromosomes, and those proteins and metabolites used to detect
heritable or somatic disease-related genotypes or karyotypes for
clinical purposes. A genetic test must be generally accepted in the
scientific and medical communities as being specifically
determinative for the presence, absence, or mutation of a gene or
chromosome in order to qualify under this definition. Genetic test
does not include a routine physical examination or a routine
analysis, including, but not limited to, a chemical analysis, of
body fluids, unless conducted specifically to determine the
presence, absence, or mutation of a gene or chromosome.
(c) "Predictive genetic test" means a genetic test performed
for the purpose of predicting the future probability that the test
subject will develop a genetically related disease or disability.
(d) "Presymptomatic genetic test" means a genetic test
performed before the onset of clinical symptoms or indications of
disease.
(9) For purposes of subsection (8)(b), the term "genetic test"
does not include a procedure performed as a component of biomedical
research that is conducted pursuant to federal common rule under 21
C.F.R.
CFR parts 50 and 56 and 45 C.F.R. CFR part
46.
Sec. 17020a. (1) The fact that a presymptomatic or predictive
genetic test has been ordered and conducted under section 17020 and
the results of that test are privileged and confidential. Except as
otherwise provided by law, a person shall not disclose that a test
has been ordered or conducted or the results of that test without
first obtaining written authorization from the test subject or his
or her legally authorized representative as provided under this
section.
(2) For purposes of subsection (1), written authorization
shall be on a form that is separate from any other written,
informed consent form required under section 17020, shall identify
to whom the information is to be disclosed, and shall include the
following notice:
NOTICE OF RIGHTS WITH REGARD TO
GENETIC TESTING AND INFORMATION
Michigan law restricts requests by h ealth insurers, nonprofit
health care corporations, health maintenance organizations, and
employers for individuals to submit to genetic testing, to disclose
genetic information, or to disclose whether genetic testing has
been conducted or the results of that genetic testing. Individuals
who have questions about their rights may seek legal advice.
(3) For purposes of subsection (1), a general consent or
authorization given for the release of medical records or other
information does not constitute written authorization for
disclosure under this section. A separate written authorization
shall be obtained for each person to whom the information is to be
disclosed. If the test subject or his or her legally authorized
representative provides written authorization under this section,
the person shall do each of the following:
(a) Provide the test subject with a copy of the signed written
authorization.
(b) Maintain the original signed written authorization in the
test subject's medical record.
(c) Provide the test subject and the person to whom the
information is being disclosed with the following notice:
RESTRICTIONS ON FURTHER DISCLOSURE OF
GENETIC TESTING AND INFORMATION
This information is privileged and confidential. This information
is being provided to you in accordance with Michigan law and shall
not be further disclosed without a separate written authorization
from the test subject or his or her legally authorized
representative. A general consent or authorization for the release
of medical records or other information is not sufficient to
authorize the disclosure of genetic testing and information.
(4) If a test subject consents to the performance of a genetic
test for the sole purpose of assisting in the recovery or
identification of human remains from a disaster or assisting in the
identification of living or deceased missing persons by matching
forensic DNA profiles in the event of an emergency or disaster,
those results as well as the DNA profiles shall only be disclosed
and used for those identification purposes, are not public records,
are not subject to court subpoena, and are not discoverable in a
legal proceeding. Consent provided for testing and DNA profiling
under this subsection is not consent for secondary research
utilizing those results or DNA profiles or any other use except for
the identification of living or deceased missing persons.
Sec. 17520. (1) Except as otherwise provided for a test
performed under section 5431 and except as otherwise provided by
law,
beginning upon the expiration of 6 months after the effective
date
of the amendatory act that added this section September 15,
2000, a physician or an individual to whom the physician has
delegated authority to perform a selected act, task, or function
under section 16215 shall not order a presymptomatic or predictive
genetic test without first obtaining the written, informed consent
of the test subject, pursuant to this section.
(2) For purposes of subsection (1), written, informed consent
consists of a signed writing executed by the test subject or the
legally authorized representative of the test subject that confirms
that the physician or the individual acting under the delegatory
authority of the physician has explained, and the test subject or
the legally authorized representative of the test subject
understands, at a minimum, all of the following:
(a) The nature and purpose of the presymptomatic or predictive
genetic test.
(b) The effectiveness and limitations of the presymptomatic or
predictive genetic test.
(c) The implications of taking the presymptomatic or
predictive genetic test, including, but not limited to, the medical
risks and benefits.
(d) The future uses of the sample taken from the test subject
in order to conduct the presymptomatic or predictive genetic test
and the information obtained from the presymptomatic or predictive
genetic test.
(e) The meaning of the presymptomatic or predictive genetic
test results and the procedure for providing notice of the results
to the test subject.
(f) Who will have access to the sample taken from the test
subject in order to conduct the presymptomatic or predictive
genetic test and the information obtained from the presymptomatic
or predictive genetic test, and the test subject's right to
confidential treatment of the sample and the information.
(3) Within
6 months after the effective date of the
amendatory
act that added this section Before
September 15, 2000,
the department of community health, in consultation with the
Michigan board of medicine, the Michigan board of osteopathic
medicine and surgery, at least 1 physician who is board certified
by the American board of medical genetics, and appropriate
professional organizations, shall develop and distribute a model
informed consent form for purposes of this section that
practitioners may adopt. The department of community health shall
include in the model form at least all of the information required
under subsection (2). The department of community health shall
distribute the model form to physicians and other individuals
subject to this section upon request and at no charge. The
department of community health shall review the model form at least
annually for 5 years after the first model form is distributed, and
shall revise the model form if necessary to make the form reflect
the latest developments in medical genetics.
(4) The department of community health, in consultation with
the entities described in subsection (3), may also develop and
distribute a pamphlet that provides further explanation of the
information included in the model informed consent form.
(5) If a test subject or his or her legally authorized
representative signs a copy of the model informed consent form
developed and distributed under subsection (3), the physician or
individual acting under the delegatory authority of the physician
shall give the test subject a copy of the signed informed consent
form and shall include the original signed informed consent form in
the test subject's medical record.
(6) If a test subject or his or her legally authorized
representative signs a copy of the model informed consent form
developed and distributed under subsection (3), the test subject is
barred from subsequently bringing a civil action for damages
against the physician, or an individual to whom the physician
delegated the authority to perform a selected act, task, or
function under section 16215, who ordered the presymptomatic or
predictive genetic test, based on failure to obtain informed
consent for the presymptomatic or predictive genetic test.
(7) 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.
(8) Except as otherwise provided in subsection (9), as used in
this section and section 17520a:
(a) "Genetic information" means information about a gene, gene
product, or inherited characteristic which information is derived
from a genetic test.
(b) "Genetic test" means the analysis of human DNA, RNA,
chromosomes, and those proteins and metabolites used to detect
heritable or somatic disease-related genotypes or karyotypes for
clinical purposes. A genetic test must be generally accepted in the
scientific and medical communities as being specifically
determinative for the presence, absence, or mutation of a gene or
chromosome in order to qualify under this definition. Genetic test
does not include a routine physical examination or a routine
analysis, including, but not limited to, a chemical analysis, of
body fluids, unless conducted specifically to determine the
presence, absence, or mutation of a gene or chromosome.
(c) "Predictive genetic test" means a genetic test performed
for the purpose of predicting the future probability that the test
subject will develop a genetically related disease or disability.
(d) "Presymptomatic genetic test" means a genetic test
performed before the onset of clinical symptoms or indications of
disease.
(9) For purposes of subsection (8)(b), the term "genetic test"
does not include a procedure performed as a component of biomedical
research that is conducted pursuant to federal common rule under 21
C.F.R.
CFR parts 50 and 56 and 45 C.F.R. CFR part
46.
Sec. 17520a. (1) The fact that a presymptomatic or predictive
genetic test has been ordered and conducted under section 17520 and
the results of that test are privileged and confidential. Except as
otherwise provided by law, a person shall not disclose that a test
has been ordered or conducted or the results of that test without
first obtaining written authorization from the test subject or his
or her legally authorized representative as provided under this
section.
(2) For purposes of subsection (1), written authorization
shall be on a form that is separate from any other written,
informed consent form required under section 17520, shall identify
to whom the information is to be disclosed, and shall include the
following notice:
NOTICE OF RIGHTS WITH REGARD TO
GENETIC TESTING AND INFORMATION
Michigan law restricts requests by health insurers, nonprofit
health care corporations, health maintenance organizations, and
employers for individuals to submit to genetic testing, to disclose
genetic information, or to disclose whether genetic testing has
been conducted or the results of that genetic testing. Individuals
who have questions about their rights may seek legal advice.
(3) For purposes of subsection (1), a general consent or
authorization given for the release of medical records or other
information does not constitute written authorization for
disclosure under this section. A separate written authorization
shall be obtained for each person to whom the information is to be
disclosed. If the test subject or his or her legally authorized
representative provides written authorization under this section,
the person shall do each of the following:
(a) Provide the test subject with a copy of the signed written
authorization.
(b) Maintain the original signed written authorization in the
test subject's medical record.
(c) Provide the test subject and the person to whom the
information is being disclosed with the following notice:
RESTRICTIONS ON FURTHER DISCLOSURE OF
GENETIC TESTING AND INFORMATION
This information is privileged and confidential. This information
is being provided to you in accordance with Michigan law and shall
not be further disclosed without a separate written authorization
from the test subject or his or her legally authorized
representative. A general consent or authorization for the release
of medical records or other information is not sufficient to
authorize the disclosure of genetic testing and information.
(4) If a test subject consents to the performance of a genetic
test for the sole purpose of assisting in the recovery or
identification of human remains from a disaster or assisting in the
identification of living or deceased missing persons by matching
DNA profiles in the event of an emergency or disaster, those
results as well as the DNA profiles shall only be disclosed and
used for those identification purposes, are not public records, are
not subject to court subpoena, and are not discoverable in a legal
proceeding. Consent provided for testing and DNA profiling under
this subsection is not consent for secondary research utilizing
those results or DNA profiles or any other use except for the
identification of living or deceased missing persons.
Sec. 20170a. (1) All reports, records, and data pertaining to
genetic testing or other genetic information are privileged and
confidential. Except as otherwise provided by law, a health
facility or agency shall not disclose to anyone, other than the
physician or the individual to whom the physician delegated
authority under section 16215, the test results of a presymptomatic
or predictive genetic test or the fact that such a test was ordered
without first obtaining written authorization from the test subject
or his or her legally authorized representative as required under
section 17020a or 17520a.
(2) If the test subject or the legally authorized
representative agrees to the disclosure of information relating to
his or her genetics or the presymptomatic or predictive genetic
testing, or both, to someone other than the physician or the
individual to whom the physician delegated the authority to order
such testing, he or she shall provide the health facility or agency
with the requisite written authorization.
(3) If the test subject or his or her legally authorized
representative provides written authorization for disclosure under
this section, the health facility or agency shall do each of the
following:
(a) Provide the test subject with a copy of the signed
written authorization.
(b) Maintain the original signed written authorization in the
test subject's medical record.
(c) Provide the test subject and the person to whom the
information is being disclosed with the following notice:
RESTRICTIONS ON FURTHER DISCLOSURE OF
GENETIC TESTING AND INFORMATION
This information is privileged and confidential. This information
is being provided to you in accordance with Michigan law and shall
not be further disclosed without a separate written authorization
from the test subject or his or her legally authorized
representative. A general consent or authorization for the release
of medical records or other information is not sufficient to
authorize the disclosure of genetic testing and information.
(4) If a test subject consents to the performance of a genetic
test for the sole purpose of assisting in the recovery or
identification of human remains from a disaster or assisting in the
identification of living or deceased missing persons by matching
DNA profiles in the event of an emergency or disaster, those
results as well as the DNA profiles shall only be disclosed and
used for those identification purposes, are not public records, are
not subject to court subpoena, and are not discoverable in a legal
proceeding. Consent provided for testing and DNA profiling under
this subsection is not consent for secondary research utilizing
those results or DNA profiles or any other use except for the
identification of living or deceased missing persons.
(5) Except as otherwise provided in subsection (6), as used in
this section:
(a) "Genetic information" means information about a gene, gene
product, or inherited characteristic which information is derived
from a genetic test.
(b) "Genetic test" means the analysis of human DNA, RNA,
chromosomes, and those proteins and metabolites used to detect
heritable or somatic disease-related genotypes or karyotypes for
clinical purposes. A genetic test must be generally accepted in the
scientific and medical communities as being specifically
determinative for the presence, absence, or mutation of a gene or
chromosome in order to qualify under this definition. Genetic test
does not include a routine physical examination or a routine
analysis, including, but not limited to, a chemical analysis, of
body fluids, unless conducted specifically to determine the
presence, absence, or mutation of a gene or chromosome.
(c) "Predictive genetic test" means a genetic test performed
for the purpose of predicting the future probability that the test
subject will develop a genetically related disease or disability.
(d) "Presymptomatic genetic test" means a genetic test
performed before the onset of clinical symptoms or indications of
disease.
(6) For purposes of subsection (5)(b), the term "genetic test"
does not include a procedure performed as a component of biomedical
research that is conducted pursuant to federal common rule under 21
CFR parts 50 and 56 and 45 CFR part 46.