1.1                          A bill for an act 
  1.2             relating to health; modifying newborn screenings; 
  1.3             amending Minnesota Statutes 2002, sections 144.125; 
  1.4             144.128; proposing coding for new law in Minnesota 
  1.5             Statutes, chapter 144. 
  1.6   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.7      Section 1.  Minnesota Statutes 2002, section 144.125, is 
  1.8   amended to read: 
  1.9      144.125 [TESTS OF INFANTS FOR INBORN METABOLIC ERRORS 
  1.10  HERITABLE AND CONGENITAL DISORDERS.] 
  1.11     Subdivision 1.  [DUTY TO PERFORM TESTING.] It is the duty 
  1.12  of (1) the administrative officer or other person in charge of 
  1.13  each institution caring for infants 28 days or less of age, (2) 
  1.14  the person required in pursuance of the provisions of section 
  1.15  144.215, to register the birth of a child, or (3) the nurse 
  1.16  midwife or midwife in attendance at the birth, to arrange to 
  1.17  have administered to every infant or child in its care tests for 
  1.18  inborn errors of metabolism in accordance with heritable and 
  1.19  congenital disorders according to subdivision 2 and rules 
  1.20  prescribed by the state commissioner of health.  In determining 
  1.21  which tests must be administered, the commissioner shall take 
  1.22  into consideration the adequacy of laboratory methods to detect 
  1.23  the inborn metabolic error, the ability to treat or prevent 
  1.24  medical conditions caused by the inborn metabolic error, and the 
  1.25  severity of the medical conditions caused by the inborn 
  2.1   metabolic error.  Testing and the recording and reporting of 
  2.2   test results shall be performed at the times and in the manner 
  2.3   prescribed by the commissioner of health.  The commissioner 
  2.4   shall charge laboratory service fees so that the total of fees 
  2.5   collected will approximate the costs of conducting the tests and 
  2.6   implementing and maintaining a system to follow-up infants with 
  2.7   inborn metabolic errors heritable or congenital disorders.  The 
  2.8   laboratory service fee is $61 per specimen.  Costs associated 
  2.9   with capital expenditures and the development of new procedures 
  2.10  may be prorated over a three-year period when calculating the 
  2.11  amount of the fees. 
  2.12     Subd. 2.  [DETERMINATION OF TESTS TO BE ADMINISTERED.] The 
  2.13  commissioner shall periodically revise the list of tests to be 
  2.14  administered for determining the presence of a heritable or 
  2.15  congenital disorder.  Revisions to the list shall reflect 
  2.16  advances in medical science, new and improved testing methods, 
  2.17  or other factors that will improve the public health.  In 
  2.18  determining whether a test must be administered, the 
  2.19  commissioner shall take into consideration the adequacy of 
  2.20  laboratory methods to detect the heritable or congenital 
  2.21  disorder, the ability to treat or prevent medical conditions 
  2.22  caused by the heritable or congenital disorder, and the severity 
  2.23  of the medical conditions caused by the heritable or congenital 
  2.24  disorder.  The list of tests to be performed may be revised if 
  2.25  the changes are recommended by the advisory committee 
  2.26  established under section 144.1255, approved by the 
  2.27  commissioner, and published in the State Register.  The revision 
  2.28  is exempt from the rulemaking requirements in chapter 14 and 
  2.29  sections 14.385 and 14.386 do not apply.  
  2.30     Subd. 3.  [OBJECTION OF PARENTS TO TEST.] If the parents of 
  2.31  an infant object in writing to testing for heritable and 
  2.32  congenital disorders as being in conflict with their religious 
  2.33  tenets and practice, the objection shall be recorded on a form 
  2.34  that is signed by a parent or legal guardian and made part of 
  2.35  the infant's medical record.  A written objection exempts an 
  2.36  infant from the requirements of this section and section 144.128.
  3.1      Sec. 2.  [144.1255] [ADVISORY COMMITTEE ON HERITABLE AND 
  3.2   CONGENITAL DISORDERS.] 
  3.3      Subdivision 1.  [CREATION AND MEMBERSHIP.] (a) By July 1, 
  3.4   2003, the commissioner of health shall appoint an advisory 
  3.5   committee to provide advice and recommendations to the 
  3.6   commissioner concerning tests and treatments for heritable and 
  3.7   congenital disorders found in newborn children.  Membership of 
  3.8   the committee shall include, but not be limited to, at least one 
  3.9   member from each of the following representative groups:  
  3.10     (1) parents and other consumers; 
  3.11     (2) primary care providers; 
  3.12     (3) clinicians and researchers specializing in newborn 
  3.13  diseases and disorders; 
  3.14     (4) genetic counselors; 
  3.15     (5) birth hospital representatives; 
  3.16     (6) newborn screening laboratory professionals; 
  3.17     (7) nutritionists; and 
  3.18     (8) other experts as needed representing related fields 
  3.19  such as emerging technologies and health insurance. 
  3.20     (b) The terms and removal of members are governed by 
  3.21  section 15.059.  Members shall not receive per diems but shall 
  3.22  be compensated for expenses.  Notwithstanding section 15.059, 
  3.23  subdivision 5, the advisory committee does not expire. 
  3.24     Subd. 2.  [FUNCTION AND OBJECTIVES.] The committee's 
  3.25  activities include, but are not limited to:  
  3.26     (1) collection of information on the efficacy and 
  3.27  reliability of various tests for heritable and congenital 
  3.28  disorders; 
  3.29     (2) collection of information on the availability and 
  3.30  efficacy of treatments for heritable and congenital disorders; 
  3.31     (3) collection of information on the severity of medical 
  3.32  conditions caused by heritable and congenital disorders; 
  3.33     (4) discussion and assessment of the benefits of performing 
  3.34  tests for heritable or congenital disorders as compared to the 
  3.35  costs, treatment limitations, or other potential disadvantages 
  3.36  of requiring the tests; 
  4.1      (5) discussion and assessment of ethical considerations 
  4.2   surrounding the testing, treatment, and handling of data and 
  4.3   specimens generated by the testing requirements of sections 
  4.4   144.125 to 144.128; and 
  4.5      (6) providing advice and recommendations to the 
  4.6   commissioner concerning tests and treatments for heritable and 
  4.7   congenital disorders found in newborn children. 
  4.8      <b>[EFFECTIVE DATE.]</b> This section is effective the day 
  4.9   following final enactment. 
  4.10     Sec. 3.  Minnesota Statutes 2002, section 144.128, is 
  4.11  amended to read: 
  4.12     144.128 [TREATMENT FOR POSITIVE DIAGNOSIS, REGISTRY OF 
  4.13  CASES COMMISSIONER'S DUTIES.] 
  4.14     The commissioner shall: 
  4.15     (1) make arrangements referrals for the necessary treatment 
  4.16  of diagnosed cases of hemoglobinopathy, phenylketonuria, and 
  4.17  other inborn errors of metabolism heritable or congenital 
  4.18  disorders when treatment is indicated and the family is 
  4.19  uninsured and, because of a lack of available income, is unable 
  4.20  to pay the cost of the treatment; 
  4.21     (2) maintain a registry of the cases of hemoglobinopathy, 
  4.22  phenylketonuria, and other inborn errors of metabolism heritable 
  4.23  and congenital disorders detected by the screening program for 
  4.24  the purpose of follow-up services; and 
  4.25     (3) adopt rules to carry out section 144.126 and this 
  4.26  section sections 144.125 to 144.128.