SB-0467, As Passed Senate, April 27, 2006

 

 

 

 

 

 

 

 

 

 

 

 

SUBSTITUTE FOR

 

SENATE BILL NO. 467

 

 

 

 

 

 

 

 

 

 

 

 

      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:

 

 1        Sec. 16221. The department may investigate activities

 

 2  related to the practice of a health profession by a licensee, a

 

 3  registrant, or an applicant for licensure or registration. The

 

 4  department may hold hearings, administer oaths, and order

 

 5  relevant testimony to be taken and shall report its findings to

 

 6  the appropriate disciplinary subcommittee. The disciplinary

 


 1  subcommittee shall proceed under section 16226 if it finds that 1

 

 2  or more of the following grounds exist:

 

 3        (a) A violation of general duty, consisting of negligence or

 

 4  failure to exercise due care, including negligent delegation to

 

 5  or supervision of employees or other individuals, whether or not

 

 6  injury results, or any conduct, practice, or condition that

 

 7  impairs, or may impair, the ability to safely and skillfully

 

 8  practice the health profession.

 

 9        (b) Personal disqualifications, consisting of 1 or more of

 

10  the following:

 

11        (i) Incompetence.

 

12        (ii) Subject to sections 16165 to 16170a, substance abuse as

 

13  defined in section 6107.

 

14        (iii) Mental or physical inability reasonably related to and

 

15  adversely affecting the licensee's ability to practice in a safe

 

16  and competent manner.

 

17        (iv) Declaration of mental incompetence by a court of

 

18  competent jurisdiction.

 

19        (v) Conviction of a misdemeanor punishable by imprisonment

 

20  for a maximum term of 2 years; a misdemeanor involving the

 

21  illegal delivery, possession, or use of a controlled substance;

 

22  or a felony. A certified copy of the court record is conclusive

 

23  evidence of the conviction.

 

24        (vi) Lack of good moral character.

 

25        (vii) Conviction of a criminal offense under sections 520b to

 

26  520g of the Michigan penal code, 1931 PA 328, MCL 750.520b to

 

27  750.520g. A certified copy of the court record is conclusive

 


 1  evidence of the conviction.

 

 2        (viii) Conviction of a violation of section 492a of the

 

 3  Michigan penal code, 1931 PA 328, MCL 750.492a. A certified copy

 

 4  of the court record is conclusive evidence of the conviction.

 

 5        (ix) Conviction of a misdemeanor or felony involving fraud in

 

 6  obtaining or attempting to obtain fees related to the practice of

 

 7  a health profession. A certified copy of the court record is

 

 8  conclusive evidence of the conviction.

 

 9        (x) Final adverse administrative action by a licensure,

 

10  registration, disciplinary, or certification board involving the

 

11  holder of, or an applicant for, a license or registration

 

12  regulated by another state or a territory of the United States,

 

13  by the United States military, by the federal government, or by

 

14  another country. A certified copy of the record of the board is

 

15  conclusive evidence of the final action.

 

16        (xi) Conviction of a misdemeanor that is reasonably related

 

17  to or that adversely affects the licensee's ability to practice

 

18  in a safe and competent manner. A certified copy of the court

 

19  record is conclusive evidence of the conviction.

 

20        (xii) Conviction of a violation of section 430 of the

 

21  Michigan penal code, 1931 PA 328, MCL 750.430. A certified copy

 

22  of the court record is conclusive evidence of the conviction.

 

23        (c) Prohibited acts, consisting of 1 or more of the

 

24  following:

 

25        (i) Fraud or deceit in obtaining or renewing a license or

 

26  registration.

 

27        (ii) Permitting the license or registration to be used by an

 


 1  unauthorized person.

 

 2        (iii) Practice outside the scope of a license.

 

 3        (iv) Obtaining, possessing, or attempting to obtain or

 

 4  possess a controlled substance as defined in section 7104 or a

 

 5  drug as defined in section 7105 without lawful authority; or

 

 6  selling, prescribing, giving away, or administering drugs for

 

 7  other than lawful diagnostic or therapeutic purposes.

 

 8        (d) Unethical business practices, consisting of 1 or more of

 

 9  the following:

 

10        (i) False or misleading advertising.

 

11        (ii) Dividing fees for referral of patients or accepting

 

12  kickbacks on medical or surgical services, appliances, or

 

13  medications purchased by or in behalf of patients.

 

14        (iii) Fraud or deceit in obtaining or attempting to obtain

 

15  third party reimbursement.

 

16        (e) Unprofessional conduct, consisting of 1 or more of the

 

17  following:

 

18        (i) Misrepresentation to a consumer or patient or in

 

19  obtaining or attempting to obtain third party reimbursement in

 

20  the course of professional practice.

 

21        (ii) Betrayal of a professional confidence.

 

22        (iii) Promotion for personal gain of an unnecessary drug,

 

23  device, treatment, procedure, or service.

 

24        (iv) Either of the following:

 

25        (A) A requirement by a licensee other than a physician that

 

26  an individual purchase or secure a drug, device, treatment,

 

27  procedure, or service from another person, place, facility, or

 


 1  business in which the licensee has a financial interest.

 

 2        (B) A referral by a physician for a designated health

 

 3  service that violates section 1877 of part D of title XVIII of

 

 4  the social security act, 42 USC 1395nn, or a regulation

 

 5  promulgated under that section. Section 1877 of part D of title

 

 6  XVIII of the social security act, 42 USC 1395nn, and the

 

 7  regulations promulgated under that section, as they exist on June

 

 8  3, 2002, are incorporated by reference for purposes of this

 

 9  subparagraph. A disciplinary subcommittee shall apply section

 

10  1877 of part D of title XVIII of the social security act, 42 USC

 

11  1395nn, and the regulations promulgated under that section

 

12  regardless of the source of payment for the designated health

 

13  service referred and rendered. If section 1877 of part D of title

 

14  XVIII of the social security act, 42 USC 1395nn, or a regulation

 

15  promulgated under that section is revised after June 3, 2002, the

 

16  department shall officially take notice of the revision. Within

 

17  30 days after taking notice of the revision, the department shall

 

18  decide whether or not the revision pertains to referral by

 

19  physicians for designated health services and continues to

 

20  protect the public from inappropriate referrals by physicians. If

 

21  the department decides that the revision does both of those

 

22  things, the department may promulgate rules to incorporate the

 

23  revision by reference. If the department does promulgate rules to

 

24  incorporate the revision by reference, the department shall not

 

25  make any changes to the revision. As used in this subparagraph,

 

26  "designated health service" means that term as defined in section

 

27  1877 of part D of title XVIII of the social security act, 42 USC

 


 1  1395nn, and the regulations promulgated under that section and

 

 2  "physician" means that term as defined in sections 17001 and

 

 3  17501.

 

 4        (v) For a physician who makes referrals pursuant to section

 

 5  1877 of part D of title XVIII of the social security act, 42 USC

 

 6  1395nn, or a regulation promulgated under that section, refusing

 

 7  to accept a reasonable proportion of patients eligible for

 

 8  medicaid and refusing to accept payment from medicaid or medicare

 

 9  as payment in full for a treatment, procedure, or service for

 

10  which the physician refers the individual and in which the

 

11  physician has a financial interest. A physician who owns all or

 

12  part of a facility in which he or she provides surgical services

 

13  is not subject to this subparagraph if a referred surgical

 

14  procedure he or she performs in the facility is not reimbursed at

 

15  a minimum of the appropriate medicaid or medicare outpatient fee

 

16  schedule, including the combined technical and professional

 

17  components.

 

18        (f) Beginning June 3, 2003, the department  of consumer and

 

19  industry services  shall prepare the first of 3 annual reports on

 

20  the effect of this amendatory act on access to care for the

 

21  uninsured and medicaid patients. The department shall report on

 

22  the number of referrals by licensees of uninsured and medicaid

 

23  patients to purchase or secure a drug, device, treatment,

 

24  procedure, or service from another person, place, facility, or

 

25  business in which the licensee has a financial interest.

 

26        (g) Failure to report a change of name or mailing address

 

27  within 30 days after the change occurs.

 


 1        (h) A violation, or aiding or abetting in a violation, of

 

 2  this article or of a rule promulgated under this article.

 

 3        (i) Failure to comply with a subpoena issued pursuant to

 

 4  this part, failure to respond to a complaint issued under this

 

 5  article or article 7, failure to appear at a compliance

 

 6  conference or an administrative hearing, or failure to report

 

 7  under section 16222 or 16223.

 

 8        (j) Failure to pay an installment of an assessment levied

 

 9  pursuant to the insurance code of 1956, 1956 PA 218, MCL 500.100

 

10  to 500.8302, within 60 days after notice by the appropriate

 

11  board.

 

12        (k) A violation of section 17013 or 17513.

 

13        (l) Failure to meet 1 or more of the requirements for

 

14  licensure or registration under section 16174.

 

15        (m) A violation of section 17015 or 17515.

 

16        (n) A violation of section 17016 or 17516.

 

17        (o) Failure to comply with section 9206(3).

 

18        (p) A violation of section 5654 or 5655.

 

19        (q) A violation of section 16274.

 

20        (r) A violation of section 17020,  or  17020a, 17520, or

 

21  17520a.

 

22        (s) A violation of the medical records access act, 2004 PA

 

23  47, MCL 333.26261 to 333.26271.

 

24        (t) A violation of section 17764(2).

 

25        Sec. 17020. (1) Except as otherwise provided for a test

 

26  performed under section 5431 and except as otherwise provided by

 

27  law, beginning  upon the expiration of 6 months after the

 


 1  effective date of the amendatory act that added this section  

 

 2  September 15, 2000, a physician or an individual to whom the

 

 3  physician has delegated authority to perform a selected act,

 

 4  task, or function under section 16215 shall not order a

 

 5  presymptomatic or predictive genetic test without first obtaining

 

 6  the written, informed consent of the test subject, pursuant to

 

 7  this section.

 

 8        (2) For purposes of subsection (1), written, informed

 

 9  consent consists of a signed writing executed by the test subject

 

10  or the legally authorized representative of the test subject that

 

11  confirms that the physician or the individual acting under the

 

12  delegatory authority of the physician has explained, and the test

 

13  subject or the legally authorized representative of the test

 

14  subject understands, at a minimum, all of the following:

 

15        (a) The nature and purpose of the presymptomatic or

 

16  predictive genetic test.

 

17        (b) The effectiveness and limitations of the presymptomatic

 

18  or predictive genetic test.

 

19        (c) The implications of taking the presymptomatic or

 

20  predictive genetic test, including, but not limited to, the

 

21  medical risks and benefits.

 

22        (d) The future uses of the sample taken from the test

 

23  subject in order to conduct the presymptomatic or predictive

 

24  genetic test and the information obtained from the presymptomatic

 

25  or predictive genetic test.

 

26        (e) The meaning of the presymptomatic or predictive genetic

 

27  test results and the procedure for providing notice of the

 


 1  results to the test subject.

 

 2        (f) Who will have access to the sample taken from the test

 

 3  subject in order to conduct the presymptomatic or predictive

 

 4  genetic test and the information obtained from the presymptomatic

 

 5  or predictive genetic test, and the test subject's right to

 

 6  confidential treatment of the sample and the information.

 

 7        (3)  Within 6 months after the effective date of the

 

 8  amendatory act that added this section  Before September 15,

 

 9  2000, the department of community health, in consultation with

 

10  the Michigan board of medicine, the Michigan board of osteopathic

 

11  medicine and surgery, at least 1 physician who is board certified

 

12  by the American board of medical genetics, and appropriate

 

13  professional organizations, shall develop and distribute a model

 

14  informed consent form for purposes of this section that

 

15  practitioners may adopt. The department of community health shall

 

16  include in the model form at least all of the information

 

17  required under subsection (2). The department of community health

 

18  shall distribute the model form to physicians and other

 

19  individuals subject to this section upon request and at no

 

20  charge. The department of community health shall review the model

 

21  form at least annually for 5 years after the first model form is

 

22  distributed, and shall revise the model form if necessary to make

 

23  the form reflect the latest developments in medical genetics.

 

24        (4) The department of community health, in consultation with

 

25  the entities described in subsection (3), may also develop and

 

26  distribute a pamphlet that provides further explanation of the

 

27  information included in the model informed consent form.

 


 1        (5) If a test subject or his or her legally authorized

 

 2  representative signs a copy of the model informed consent form

 

 3  developed and distributed under subsection (3), the physician or

 

 4  individual acting under the delegatory authority of the physician

 

 5  shall give the test subject a copy of the signed informed consent

 

 6  form and shall include the original signed informed consent form

 

 7  in the test subject's medical record.

 

 8        (6) If a test subject or his or her legally authorized

 

 9  representative signs a copy of the model informed consent form

 

10  developed and distributed under subsection (3), the test subject

 

11  is barred from subsequently bringing a civil action for damages

 

12  against the physician, or an individual to whom the physician

 

13  delegated the authority to perform a selected act, task, or

 

14  function under section 16215, who ordered the presymptomatic or

 

15  predictive genetic test, based on failure to obtain informed

 

16  consent for the presymptomatic or predictive genetic test.

 

17        (7) A physician's duty to inform a patient under this

 

18  section does not require disclosure of information beyond what a

 

19  reasonably well-qualified physician licensed under this article

 

20  would know.

 

21        (8) Except as otherwise provided in subsection (9), as used

 

22  in this section and section 17020a:

 

23        (a) "Genetic information" means information about a gene,

 

24  gene product, or inherited characteristic which information is

 

25  derived from a genetic test.

 

26        (b) "Genetic test" means the analysis of human DNA, RNA,

 

27  chromosomes, and those proteins and metabolites used to detect

 


 1  heritable or somatic disease-related genotypes or karyotypes for

 

 2  clinical purposes. A genetic test must be generally accepted in

 

 3  the scientific and medical communities as being specifically

 

 4  determinative for the presence, absence, or mutation of a gene or

 

 5  chromosome in order to qualify under this definition. Genetic

 

 6  test does not include a routine physical examination or a routine

 

 7  analysis, including, but not limited to, a chemical analysis, of

 

 8  body fluids, unless conducted specifically to determine the

 

 9  presence, absence, or mutation of a gene or chromosome.

 

10        (c) "Predictive genetic test" means a genetic test performed

 

11  for the purpose of predicting the future probability that the

 

12  test subject will develop a genetically related disease or

 

13  disability.

 

14        (d) "Presymptomatic genetic test" means a genetic test

 

15  performed before the onset of clinical symptoms or indications of

 

16  disease.

 

17        (9) For purposes of subsection (8)(b), the term "genetic

 

18  test" does not include a procedure performed as a component of

 

19  biomedical research that is conducted pursuant to federal common

 

20  rule under 21 C.F.R.  CFR parts 50 and 56 and 45  C.F.R.  CFR

 

21  part 46.

 

22        Sec. 17020a. (1) The fact that a presymptomatic or

 

23  predictive genetic test has been ordered and conducted under

 

24  section 17020 and the results of that test are privileged and

 

25  confidential. Except as otherwise provided by law, a person shall

 

26  not disclose that a test has been ordered or conducted or the

 

27  results of that test for purposes other than treatment, payment,

 


 1  or health care operations as provided under the health insurance

 

 2  portability and accountability act of 1996, Public Law 104-191,

 

 3  and regulations promulgated under that act, 45 CFR parts 160 and

 

 4  164, without first obtaining written authorization from the test

 

 5  subject or his or her legally authorized representative as

 

 6  provided under this section.

 

 7        (2) For purposes of subsection (1), written authorization

 

 8  shall be on a form that identifies to whom the information is to

 

 9  be disclosed and includes the following notice:

 

 

10 NOTICE OF RIGHTS WITH REGARD TO

11 GENETIC TESTING AND INFORMATION

 

 

12  Michigan law restricts requests by health insurers, nonprofit

 

13  health care corporations, health maintenance organizations, and

 

14  employers for individuals to submit to genetic testing, to

 

15  disclose genetic information, or to disclose whether genetic

 

16  testing has been conducted or the results of that genetic

 

17  testing. Individuals who have questions about their rights may

 

18  seek legal advice.

 

19        (3) For purposes of subsection (1), a general consent or

 

20  authorization given for the release of medical records or other

 

21  medical information does not constitute written authorization for

 

22  disclosure under this section. The informed consent form required

 

23  under section 17020 for the performance of genetic testing shall

 

24  satisfy the written authorization requirements for disclosure

 

25  under this section if that informed consent form identifies to

 

26  whom the genetic information is being provided, includes the


 

 1  notice described under subsection (2), and requires a separate

 

 2  signature for disclosure than the signature required for the

 

 3  performance of the genetic testing. If the test subject or his or

 

 4  her legally authorized representative provides written

 

 5  authorization under this section, the person shall do each of the

 

 6  following:

 

 7        (a) Provide the test subject with a copy of the signed

 

 8  written authorization.

 

 9        (b) Maintain the original signed written authorization in

 

10  the test subject's medical record.

 

11        (c) Provide the test subject and the person to whom the

 

12  information is being disclosed with the following notice:

 

 

13 RESTRICTIONS ON FURTHER DISCLOSURE OF

14 GENETIC TESTING AND INFORMATION

 

 

15  This information is privileged and confidential. This information

 

16  is being provided to you in accordance with Michigan law and

 

17  shall not be further disclosed without a separate written

 

18  authorization from the test subject or his or her legally

 

19  authorized representative.  A general consent or authorization

 

20  for the release of medical records or other information is not

 

21  sufficient to authorize the disclosure of genetic testing and

 

22  information.

 

23        (4) If a test subject consents to the performance of a

 

24  genetic test for the sole purpose of assisting in the recovery or

 

25  identification of human remains from a disaster or assisting in

 


 1  the identification of living or deceased missing persons by

 

 2  matching forensic DNA profiles in the event of an emergency or

 

 3  disaster, those results as well as the DNA profiles shall only be

 

 4  disclosed and used for those identification purposes, are not

 

 5  public records, are not subject to court subpoena, and are not

 

 6  discoverable in a legal proceeding. Consent provided for testing

 

 7  and DNA profiling under this subsection is not consent for

 

 8  secondary research utilizing those results or DNA profiles or any

 

 9  other use except for the identification of living or deceased

 

10  missing persons.

 

11        Sec. 17520. (1) Except as otherwise provided for a test

 

12  performed under section 5431 and except as otherwise provided by

 

13  law, beginning  upon the expiration of 6 months after the

 

14  effective date of the amendatory act that added this section  

 

15  September 15, 2000, a physician or an individual to whom the

 

16  physician has delegated authority to perform a selected act,

 

17  task, or function under section 16215 shall not order a

 

18  presymptomatic or predictive genetic test without first obtaining

 

19  the written, informed consent of the test subject, pursuant to

 

20  this section.

 

21        (2) For purposes of subsection (1), written, informed

 

22  consent consists of a signed writing executed by the test subject

 

23  or the legally authorized representative of the test subject that

 

24  confirms that the physician or the individual acting under the

 

25  delegatory authority of the physician has explained, and the test

 

26  subject or the legally authorized representative of the test

 

27  subject understands, at a minimum, all of the following:

 


 1        (a) The nature and purpose of the presymptomatic or

 

 2  predictive genetic test.

 

 3        (b) The effectiveness and limitations of the presymptomatic

 

 4  or predictive genetic test.

 

 5        (c) The implications of taking the presymptomatic or

 

 6  predictive genetic test, including, but not limited to, the

 

 7  medical risks and benefits.

 

 8        (d) The future uses of the sample taken from the test

 

 9  subject in order to conduct the presymptomatic or predictive

 

10  genetic test and the information obtained from the presymptomatic

 

11  or predictive genetic test.

 

12        (e) The meaning of the presymptomatic or predictive genetic

 

13  test results and the procedure for providing notice of the

 

14  results to the test subject.

 

15        (f) Who will have access to the sample taken from the test

 

16  subject in order to conduct the presymptomatic or predictive

 

17  genetic test and the information obtained from the presymptomatic

 

18  or predictive genetic test, and the test subject's right to

 

19  confidential treatment of the sample and the information.

 

20        (3)  Within 6 months after the effective date of the

 

21  amendatory act that added this section  Before September 15,

 

22  2000, the department of community health, in consultation with

 

23  the Michigan board of medicine, the Michigan board of osteopathic

 

24  medicine and surgery, at least 1 physician who is board certified

 

25  by the American board of medical genetics, and appropriate

 

26  professional organizations, shall develop and distribute a model

 

27  informed consent form for purposes of this section that

 


 1  practitioners may adopt. The department of community health shall

 

 2  include in the model form at least all of the information

 

 3  required under subsection (2). The department of community health

 

 4  shall distribute the model form to physicians and other

 

 5  individuals subject to this section upon request and at no

 

 6  charge. The department of community health shall review the model

 

 7  form at least annually for 5 years after the first model form is

 

 8  distributed, and shall revise the model form if necessary to make

 

 9  the form reflect the latest developments in medical genetics.

 

10        (4) The department of community health, in consultation with

 

11  the entities described in subsection (3), may also develop and

 

12  distribute a pamphlet that provides further explanation of the

 

13  information included in the model informed consent form.

 

14        (5) If a test subject or his or her legally authorized

 

15  representative signs a copy of the model informed consent form

 

16  developed and distributed under subsection (3), the physician or

 

17  individual acting under the delegatory authority of the physician

 

18  shall give the test subject a copy of the signed informed consent

 

19  form and shall include the original signed informed consent form

 

20  in the test subject's medical record.

 

21        (6) If a test subject or his or her legally authorized

 

22  representative signs a copy of the model informed consent form

 

23  developed and distributed under subsection (3), the test subject

 

24  is barred from subsequently bringing a civil action for damages

 

25  against the physician, or an individual to whom the physician

 

26  delegated the authority to perform a selected act, task, or

 

27  function under section 16215, who ordered the presymptomatic or

 


 1  predictive genetic test, based on failure to obtain informed

 

 2  consent for the presymptomatic or predictive genetic test.

 

 3        (7) A physician's duty to inform a patient under this

 

 4  section does not require disclosure of information beyond what a

 

 5  reasonably well-qualified physician licensed under this article

 

 6  would know.

 

 7        (8) Except as otherwise provided in subsection (9), as used

 

 8  in this section and section 17520a:

 

 9        (a) "Genetic information" means information about a gene,

 

10  gene product, or inherited characteristic which information is

 

11  derived from a genetic test.

 

12        (b) "Genetic test" means the analysis of human DNA, RNA,

 

13  chromosomes, and those proteins and metabolites used to detect

 

14  heritable or somatic disease-related genotypes or karyotypes for

 

15  clinical purposes. A genetic test must be generally accepted in

 

16  the scientific and medical communities as being specifically

 

17  determinative for the presence, absence, or mutation of a gene or

 

18  chromosome in order to qualify under this definition. Genetic

 

19  test does not include a routine physical examination or a routine

 

20  analysis, including, but not limited to, a chemical analysis, of

 

21  body fluids, unless conducted specifically to determine the

 

22  presence, absence, or mutation of a gene or chromosome.

 

23        (c) "Predictive genetic test" means a genetic test performed

 

24  for the purpose of predicting the future probability that the

 

25  test subject will develop a genetically related disease or

 

26  disability.

 

27        (d) "Presymptomatic genetic test" means a genetic test

 


 1  performed before the onset of clinical symptoms or indications of

 

 2  disease.

 

 3        (9) For purposes of subsection (8)(b), the term "genetic

 

 4  test" does not include a procedure performed as a component of

 

 5  biomedical research that is conducted pursuant to federal common

 

 6  rule under 21 C.F.R.  CFR parts 50 and 56 and 45  C.F.R.  CFR

 

 7  part 46.

 

 8        Sec. 17520a. (1) The fact that a presymptomatic or

 

 9  predictive genetic test has been ordered and conducted under

 

10  section 17520 and the results of that test are privileged and

 

11  confidential. Except as otherwise provided by law, a person shall

 

12  not disclose that a test has been ordered or conducted or the

 

13  results of that test for purposes other than treatment, payment,

 

14  or health care operations as provided under the health insurance

 

15  portability and accountability act of 1996, Public Law 104-191,

 

16  and regulations promulgated under that act, 45 CFR parts 160 and

 

17  164, without first obtaining written authorization from the test

 

18  subject or his or her legally authorized representative as

 

19  provided under this section.

 

20        (2) For purposes of subsection (1), written authorization

 

21  shall be on a form that identifies to whom the information is to

 

22  be disclosed and includes the following notice:

 

 

23 NOTICE OF RIGHTS WITH REGARD TO

24 GENETIC TESTING AND INFORMATION

 

 

25  Michigan law restricts requests by health insurers, nonprofit

 

26  health care corporations, health maintenance organizations, and


 

 1  employers for individuals to submit to genetic testing, to

 

 2  disclose genetic information, or to disclose whether genetic

 

 3  testing has been conducted or the results of that genetic

 

 4  testing. Individuals who have questions about their rights may

 

 5  seek legal advice.

 

 6        (3) For purposes of subsection (1), a general consent or

 

 7  authorization given for the release of medical records or other

 

 8  medical information does not constitute written authorization for

 

 9  disclosure under this section. The informed consent form required

 

10  under section 17020 for the performance of genetic testing shall

 

11  satisfy the written authorization requirements for disclosure

 

12  under this section if that informed consent form identifies to

 

13  whom the genetic information is being provided, includes the

 

14  notice described under subsection (2), and requires a separate

 

15  signature for disclosure than the signature required for the

 

16  performance of the genetic testing. If the test subject or his or

 

17  her legally authorized representative provides written

 

18  authorization under this section, the person shall do each of the

 

19  following:

 

20        (a) Provide the test subject with a copy of the signed

 

21  written authorization.

 

22        (b) Maintain the original signed written authorization in

 

23  the test subject's medical record.

 

24        (c) Provide the test subject and the person to whom the

 

25  information is being disclosed with the following notice:

 

 

26 RESTRICTIONS ON FURTHER DISCLOSURE OF


1  GENETIC TESTING AND INFORMATION

 

 

 2  This information is privileged and confidential. This information

 

 3  is being provided to you in accordance with Michigan law and

 

 4  shall not be further disclosed without a separate written

 

 5  authorization from the test subject or his or her legally

 

 6  authorized representative. A general consent or authorization for

 

 7  the release of medical records or other information is not

 

 8  sufficient to authorize the disclosure of genetic testing and

 

 9  information.

 

10        (4) If a test subject consents to the performance of a

 

11  genetic test for the sole purpose of assisting in the recovery or

 

12  identification of human remains from a disaster or assisting in

 

13  the identification of living or deceased missing persons by

 

14  matching DNA profiles in the event of an emergency or disaster,

 

15  those results as well as the DNA profiles shall only be disclosed

 

16  and used for those identification purposes, are not public

 

17  records, are not subject to court subpoena, and are not

 

18  discoverable in a legal proceeding. Consent provided for testing

 

19  and DNA profiling under this subsection is not consent for

 

20  secondary research utilizing those results or DNA profiles or any

 

21  other use except for the identification of living or deceased

 

22  missing persons.

 

23        Sec. 20170a. (1) All reports, records, and data pertaining

 

24  to genetic testing or other genetic information are privileged

 

25  and confidential. Except as otherwise provided by law, a health

 

26  facility or agency shall not disclose the test results of a

 


 1  presymptomatic or predictive genetic test or the fact that such a

 

 2  test was ordered for purposes other than treatment, payment, or

 

 3  health care operations as provided under the health insurance

 

 4  portability and accountability act of 1996, Public Law 104-191,

 

 5  and regulations promulgated under that act, 45 CFR parts 160 and

 

 6  164, without first obtaining written authorization from the test

 

 7  subject or his or her legally authorized representative as

 

 8  required under section 17020a or 17520a.

 

 9        (2) If the test subject or the legally authorized

 

10  representative agrees to the disclosure of information relating

 

11  to his or her genetics or the presymptomatic or predictive

 

12  genetic testing, or both, he or she shall provide the health

 

13  facility or agency with the requisite written authorization.

 

14        (3) If the test subject or his or her legally authorized

 

15  representative provides written authorization for disclosure

 

16  under this section, the health facility or agency shall do each

 

17  of the following:

 

18        (a) Provide the test subject with a copy of the signed

 

19  written authorization.

 

20        (b) Maintain the original signed written authorization in

 

21  the test subject's medical record.

 

22        (c) Provide the test subject and the person to whom the

 

23  information is being disclosed with the following notice:

 

 

24 RESTRICTIONS ON FURTHER DISCLOSURE OF

25 GENETIC TESTING AND INFORMATION

 

 

26  This information is privileged and confidential. This information


 

 1  is being provided to you in accordance with Michigan law and

 

 2  shall not be further disclosed without a separate written

 

 3  authorization from the test subject or his or her legally

 

 4  authorized representative. A general consent or authorization for

 

 5  the release of medical records or other information is not

 

 6  sufficient to authorize the disclosure of genetic testing and

 

 7  information.

 

 8        (4) If a test subject consents to the performance of a

 

 9  genetic test for the sole purpose of assisting in the recovery or

 

10  identification of human remains from a disaster or assisting in

 

11  the identification of living or deceased missing persons by

 

12  matching DNA profiles in the event of an emergency or disaster,

 

13  those results as well as the DNA profiles shall only be disclosed

 

14  and used for those identification purposes, are not public

 

15  records, are not subject to court subpoena, and are not

 

16  discoverable in a legal proceeding. Consent provided for testing

 

17  and DNA profiling under this subsection is not consent for

 

18  secondary research utilizing those results or DNA profiles or any

 

19  other use except for the identification of living or deceased

 

20  missing persons.

 

21        (5) Except as otherwise provided in subsection (6), as used

 

22  in this section:

 

23        (a) "Genetic information" means information about a gene,

 

24  gene product, or inherited characteristic which information is

 

25  derived from a genetic test.

 

26        (b) "Genetic test" means the analysis of human DNA, RNA,

 

27  chromosomes, and those proteins and metabolites used to detect


 

 1  heritable or somatic disease-related genotypes or karyotypes for

 

 2  clinical purposes. A genetic test must be generally accepted in

 

 3  the scientific and medical communities as being specifically

 

 4  determinative for the presence, absence, or mutation of a gene or

 

 5  chromosome in order to qualify under this definition. Genetic

 

 6  test does not include a routine physical examination or a routine

 

 7  analysis, including, but not limited to, a chemical analysis, of

 

 8  body fluids, unless conducted specifically to determine the

 

 9  presence, absence, or mutation of a gene or chromosome.

 

10        (c) "Predictive genetic test" means a genetic test performed

 

11  for the purpose of predicting the future probability that the

 

12  test subject will develop a genetically related disease or

 

13  disability.

 

14        (d) "Presymptomatic genetic test" means a genetic test

 

15  performed before the onset of clinical symptoms or indications of

 

16  disease.

 

17        (6) For purposes of subsection (5)(b), the term "genetic

 

18  test" does not include a procedure performed as a component of

 

19  biomedical research that is conducted pursuant to federal common

 

20  rule under 21 CFR parts 50 and 56 and 45 CFR part 46.