SF 1212

2nd Unofficial Engrossment - 87th Legislature (2011 - 2012)

Posted on 05/07/2012 03:45 p.m.

1.1A bill for an act 1.2relating to health; changing provisions of newborn screening program; adding 1.3surviving adult children of a deceased patient to the definition of patient for 1.4purpose of health records; regulating public health use of certain genetic 1.5information; requiring certain medical assistance notices be in plain language; 1.6requiring a request for information relating to mandated health benefits; requiring 1.7reports;amending Minnesota Statutes 2010, sections 13.386, by adding a 1.8subdivision; 144.125, subdivision 3, by adding subdivisions; 144.128; 144.291, 1.9subdivision 2, as amended; 256B.05, by adding a subdivision. 1.10BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 1.11    Section 1. Minnesota Statutes 2010, section 13.386, is amended by adding a 1.12subdivision to read: 1.13     new text begin Subd. 4. new text end new text begin Public health exception. new text end new text begin Notwithstanding subdivisions 1 to 3, the new text end 1.14 new text begin commissioner of health may collect, store, use, and disseminate any genetic information, new text end 1.15 new text begin which includes biological information or specimens, to the extent required or permitted by new text end 1.16 new text begin any statute or rule that exists as of the effective date of this subdivision. This subdivision new text end 1.17 new text begin does not apply to newborn screening activities conducted under sections 144.125 to new text end 1.18 new text begin 144.128. new text end 1.19 new text begin This subdivision expires July 1, 2013. new text end 1.20 new text begin EFFECTIVE DATE. new text end new text begin This section is effective the day following final enactment. new text end 1.21    Sec. 2. Minnesota Statutes 2010, section 144.125, subdivision 3, is amended to read: 1.22    Subd. 3. Objection of parents to test new text begin Information provided to parents new text end . Persons 1.23with a duty to perform testing under subdivision 1 shall advise parents of infants (1) that 1.24the blood or tissue samples used to perform testing thereunder as well as the results of 1.25such testing may be retained by the Department of Health, (2) the benefit of retaining the 2.1blood or tissue sample, and (3) that the following options are available to them with 2.2respect to the testing: (i) to decline to have the tests, or (ii) to elect to have the tests but to 2.3require that all blood samples and records of test results be destroyed within 24 months 2.4of the testing. If the parents of an infant object in writing to testing for heritable and 2.5congenital disorders or elect to require that blood samples and test results be destroyed, 2.6the objection or election shall be recorded on a form that is signed by a parent or legal 2.7guardian and made part of the infant's medical record. A written objection exempts an 2.8infant from the requirements of this section and section . new text begin (a) The department shall new text end 2.9 new text begin make information and forms available to health care providers who provide prenatal care new text end 2.10 new text begin describing the newborn screening program and the provisions of this section to be used in new text end 2.11 new text begin a discussion with expectant parents and parents of newborns. The department shall make new text end 2.12 new text begin information and forms about newborn screening available to the persons with a duty new text end 2.13 new text begin to perform testing under this section and to expectant parents and parents of newborns new text end 2.14 new text begin using electronic and other means. new text end 2.15 new text begin (b) Prior to collecting a sample, persons with a duty to perform testing under new text end 2.16 new text begin subdivision 1 must: new text end 2.17 new text begin (1) provide parents or legal guardians of infants with a document that provides new text end 2.18 new text begin the following information: new text end 2.19 new text begin (i) the benefits of newborn screening; new text end 2.20 new text begin (ii) that the blood sample will be used to test for heritable and congenital disorders, new text end 2.21 new text begin as determined under subdivision 2; new text end 2.22 new text begin (iii) the data that will be collected as part of the testing; new text end 2.23 new text begin (iv) the standard retention periods for blood samples and test results as provided in new text end 2.24 new text begin subdivision 6; new text end 2.25 new text begin (v) that blood samples and test results will be used for program operations during the new text end 2.26 new text begin standard retention period in accordance with subdivision 5; new text end 2.27 new text begin (vi) the Department of Health's Web site address where more information and forms new text end 2.28 new text begin may be obtained; and new text end 2.29 new text begin (vii) that parents have a right to elect not to have newborn screening performed and new text end 2.30 new text begin a right to secure private testing; new text end 2.31 new text begin (2) upon request, provide parents or legal guardians of infants with forms necessary new text end 2.32 new text begin to request that the infant not have blood collected for testing; and new text end 2.33 new text begin (3) record in the infant's medical record that a parent or legal guardian of the new text end 2.34 new text begin infant has received the information provided pursuant to this subdivision and has had new text end 2.35 new text begin an opportunity to ask questions. new text end 3.1 new text begin (c) Nothing in this section prohibits a parent or legal guardian of an infant from new text end 3.2 new text begin having newborn screening performed by a private entity. new text end 3.3    Sec. 3. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 3.4to read: 3.5     new text begin Subd. 4. new text end new text begin Parental options. new text end new text begin (a) The parent or legal guardian of an infant otherwise new text end 3.6 new text begin subject to testing under this section may elect not to have newborn screening performed. new text end 3.7 new text begin (b) If a parent or legal guardian elects not to have newborn screening performed, new text end 3.8 new text begin then the election shall be recorded on a form that is signed by the parent or legal guardian. new text end 3.9 new text begin The signed form shall be made part of the infant's medical record and a copy shall be new text end 3.10 new text begin provided to the Department of Health. When a parent or legal guardian elects not to new text end 3.11 new text begin have newborn screening performed, the person with the duty to perform testing under new text end 3.12 new text begin subdivision 1 must follow that election. A written election to decline testing exempts new text end 3.13 new text begin persons with a duty to perform testing and the Department of Health from the requirements new text end 3.14 new text begin of this section and section 144.128. new text end 3.15    Sec. 4. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 3.16to read: 3.17     new text begin Subd. 5. new text end new text begin Newborn screening program operations. new text end new text begin (a) "Newborn screening new text end 3.18 new text begin program operations" means actions, testing, and procedures directly related to the new text end 3.19 new text begin operation of the newborn screening program, limited to the following: new text end 3.20 new text begin (1) confirmatory testing; new text end 3.21 new text begin (2) laboratory quality control assurance and improvement; new text end 3.22 new text begin (3) calibration of equipment; new text end 3.23 new text begin (4) evaluating and improving the accuracy of newborn screening tests for conditions new text end 3.24 new text begin approved for screening in Minnesota; new text end 3.25 new text begin (5) validation of equipment and screening methods; and new text end 3.26 new text begin (6) continuity of operations to ensure testing can continue as required by Minnesota new text end 3.27 new text begin law in the event of an emergency. new text end 3.28 new text begin (b) No research, public health studies, or development of new newborn screening new text end 3.29 new text begin tests shall be conducted under this subdivision. new text end 3.30    Sec. 5. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 3.31to read: 3.32     new text begin Subd. 6. new text end new text begin Standard retention period for samples and test results. new text end new text begin The standard new text end 3.33 new text begin retention period for blood samples with a negative test result is up to 71 days from the date new text end 4.1 new text begin of receipt of the sample. The standard retention period for blood samples with a positive new text end 4.2 new text begin test result is up to 24 months from the date of receipt of the sample. The standard retention new text end 4.3 new text begin period for all test results is up to 24 months from the last date of reporting. Blood samples new text end 4.4 new text begin with a negative test result will be destroyed within one week of the 71-day retention new text end 4.5 new text begin period. Blood samples with a positive test result will be destroyed within one week of new text end 4.6 new text begin the 24-month retention period. All test results will be destroyed within one month of new text end 4.7 new text begin the 24-month retention period. During the standard retention period, the Department of new text end 4.8 new text begin Health may use blood samples and test results for newborn screening program operations new text end 4.9 new text begin in accordance with subdivision 5. new text end 4.10    Sec. 6. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 4.11to read: 4.12     new text begin Subd. 7. new text end new text begin Parental options for extended storage and use. new text end new text begin (a) The parent or legal new text end 4.13 new text begin guardian of an infant otherwise subject to testing under this section may authorize that new text end 4.14 new text begin the infant's blood sample and test results be retained and used by the Department of new text end 4.15 new text begin Health beyond the standard retention periods provided in subdivision 6 or the purposes new text end 4.16 new text begin described in subdivision 9. new text end 4.17 new text begin (b) The Department of Health must provide a consent form, with an attached new text end 4.18 new text begin Tennessen warning pursuant to section 13.04, subdivision 2. The consent form must new text end 4.19 new text begin provide the following: new text end 4.20 new text begin (1) information as to the personal identification and use of samples and test results new text end 4.21 new text begin for studies, including studies used to develop new tests; new text end 4.22 new text begin (2) information as to the personal identification and use of samples and test results new text end 4.23 new text begin for public health studies or research not related to newborn screening; new text end 4.24 new text begin (3) information that explains that the Department of Health will not store a blood new text end 4.25 new text begin sample or test result for longer than 18 years from an infant's birth date; new text end 4.26 new text begin (4) information that explains that, upon approval by the Department of Health's new text end 4.27 new text begin Institutional Review Board, blood samples and test results may be shared with external new text end 4.28 new text begin parties for public health studies or research; new text end 4.29 new text begin (5) information that explains that blood samples contain various components, new text end 4.30 new text begin including deoxyribonucleic acid (DNA); and new text end 4.31 new text begin (6) the benefits and risks associated with the department's storage of a child's blood new text end 4.32 new text begin sample and test results. new text end 4.33    Sec. 7. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 4.34to read: 5.1     new text begin Subd. 8. new text end new text begin Extended storage and use of samples and test results. new text end new text begin When authorized new text end 5.2 new text begin in writing by a parent or legal guardian under subdivision 7, the Department of Health new text end 5.3 new text begin may store blood samples and test results for a time period not to exceed 18 years from new text end 5.4 new text begin the infant's birth date, and may use the blood samples and test results in accordance with new text end 5.5 new text begin subdivision 9. new text end 5.6    Sec. 8. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 5.7to read: 5.8     new text begin Subd. 9. new text end new text begin Written informed consent for other use of samples and test results. new text end 5.9 new text begin With the written, informed consent of a parent or legal guardian, the Department of Health new text end 5.10 new text begin may: new text end 5.11 new text begin (1) use blood samples and test results for studies related to newborn screening, new text end 5.12 new text begin including studies used to develop new tests; and new text end 5.13 new text begin (2) use blood samples and test results for public health studies or research not related new text end 5.14 new text begin to newborn screening, and upon approval by the Department of Health's Institutional new text end 5.15 new text begin Review Board, share samples and test results with external parties for public health new text end 5.16 new text begin studies or research. new text end 5.17    Sec. 9. Minnesota Statutes 2010, section 144.125, is amended by adding a subdivision 5.18to read: 5.19     new text begin Subd. 10. new text end new text begin Revoking consent for storage and use. new text end new text begin A parent or legal guardian new text end 5.20 new text begin may revoke approval for extended storage or use of blood samples or test results at any new text end 5.21 new text begin time by providing a signed and dated form requesting destruction of the blood samples new text end 5.22 new text begin or test results. The Department of Health shall make necessary forms available on the new text end 5.23 new text begin department's Web site. Blood samples must be destroyed within one week of receipt of a new text end 5.24 new text begin request or within one week of the standard retention period for blood samples provided new text end 5.25 new text begin in subdivision 6, whichever is later. Test results must be destroyed within one month of new text end 5.26 new text begin receipt of a request or within one month of the standard retention period for test results new text end 5.27 new text begin provided in subdivision 6, whichever is later. new text end 5.28    Sec. 10. Minnesota Statutes 2010, section 144.128, is amended to read: 5.29144.128 COMMISSIONER'S DUTIES. 5.30 new text begin (a) new text end The commissioner shall: 5.31(1) notify the physicians of newborns tested of the results of the tests performed; 5.32(2) make referrals for the necessary treatment of diagnosed cases of heritable and 5.33congenital disorders when treatment is indicated; 6.1(3) maintain a registry of the cases of heritable and congenital disorders detected by 6.2the screening program for the purpose of follow-up services; 6.3(4) prepare a separate form for use by parents or by adults who were tested as minors 6.4to direct that blood samples and new text begin or new text end test results be destroyed; 6.5(5) comply with a destruction request within 45 days after receiving it new text begin as described new text end 6.6 new text begin in section 144.125 new text end ; 6.7(6) notify individuals who request destruction of samples and test results that the 6.8samples and test results have been destroyed new text begin and the date of destruction new text end ; and 6.9(7) adopt rules to carry out sections 144.125 to 144.128. 6.10 new text begin (b) Nothing in sections 144.125 to 144.128 shall exempt the commissioner from new text end 6.11 new text begin the requirements of the Genetic Privacy Act in section 13.386 or from the penalties for a new text end 6.12 new text begin violation of the Genetic Privacy Act as provided in chapter 13. new text end 6.13    Sec. 11. Minnesota Statutes 2010, section 144.291, subdivision 2, as amended by Laws 6.142012, chapter 187, article 1, section 21, is amended to read: 6.15    Subd. 2. Definitions. For the purposes of sections 144.291 to 144.298, the following 6.16terms have the meanings given. 6.17    (a) "Group purchaser" has the meaning given in section 62J.03, subdivision 6. 6.18    (b) "Health information exchange" means a legal arrangement between health care 6.19providers and group purchasers to enable and oversee the business and legal issues 6.20involved in the electronic exchange of health records between the entities for the delivery 6.21of patient care. 6.22    (c) "Health record" means any information, whether oral or recorded in any form or 6.23medium, that relates to the past, present, or future physical or mental health or condition of 6.24a patient; the provision of health care to a patient; or the past, present, or future payment 6.25for the provision of health care to a patient. 6.26    (d) "Identifying information" means the patient's name, address, date of birth, 6.27gender, parent's or guardian's name regardless of the age of the patient, and other 6.28nonclinical data which can be used to uniquely identify a patient. 6.29    (e) "Individually identifiable form" means a form in which the patient is or can be 6.30identified as the subject of the health records. 6.31    (f) "Medical emergency" means medically necessary care which is immediately 6.32needed to preserve life, prevent serious impairment to bodily functions, organs, or parts, 6.33or prevent placing the physical or mental health of the patient in serious jeopardy. 6.34    (g) "Patient" means new text begin : new text end 7.1 new text begin (1) new text end a natural person who has received health care services from a provider for 7.2treatment or examination of a medical, psychiatric, or mental condition, new text begin ; new text end 7.3 new text begin (2) new text end the surviving spouse new text begin , surviving adult children, new text end and parents of a deceased patient, 7.4or new text begin unless the authority of a surviving adult child has been limited by the principal in the new text end 7.5 new text begin principal's health care directive; new text end 7.6 new text begin (3) new text end a person the patient appoints in writing as a representative, including a health 7.7care agent acting according to chapter 145C, unless the authority of the agent has been 7.8limited by the principal in the principal's health care directive. new text begin ; and new text end 7.9 new text begin (4) new text end except for minors who have received health care services under sections 144.341 7.10to 144.347, in the case of a minor, patient includes a parent or guardian, or a person acting 7.11as a parent or guardian in the absence of a parent or guardian. 7.12    (h) "Provider" means: 7.13    (1) any person who furnishes health care services and is regulated to furnish the 7.14services under chapter 147, 147A, 147B, 147C, 147D, 148, 148B, 148C, 148D, 150A, 7.15151, 153, or 153A; 7.16    (2) a home care provider licensed under section 144A.46; 7.17    (3) a health care facility licensed under this chapter or chapter 144A; and 7.18    (4) a physician assistant registered under chapter 147A. 7.19    (i) "Record locator service" means an electronic index of patient identifying 7.20information that directs providers in a health information exchange to the location of 7.21patient health records held by providers and group purchasers. 7.22    (j) "Related health care entity" means an affiliate, as defined in section 144.6521, 7.23subdivision 3 , paragraph (b), of the provider releasing the health records. 7.24 new text begin EFFECTIVE DATE. new text end new text begin This section is effective August 1, 2012, and applies for new text end 7.25 new text begin persons who become deceased on or after that date. new text end 7.26    Sec. 12. Minnesota Statutes 2010, section 256B.05, is amended by adding a 7.27subdivision to read: 7.28     new text begin Subd. 6. new text end new text begin Notice from lead agency. new text end new text begin The notice of the reduction, suspension, denial, new text end 7.29 new text begin or termination of services under section 256B.0659, 256B.0915, 256B.092, or 256B.49, new text end 7.30 new text begin from the lead agency to the applicant or recipient must be made in plain language. new text end 7.31 new text begin EFFECTIVE DATE. new text end new text begin This section is effective for all notices dated on or after new text end 7.32 new text begin January 1, 2013. new text end 7.33    Sec. 13. new text begin REPORTS FROM THE COMMISSIONER OF HEALTH. new text end 8.1 new text begin By January 15, 2013, the commissioner of health must publish and submit to the new text end 8.2 new text begin chairs and ranking minority members of the legislative committees with jurisdiction over new text end 8.3 new text begin health and data privacy proposed legislation to authorize the commissioner of health new text end 8.4 new text begin to collect, store, use, and disseminate genetic information, which includes biological new text end 8.5 new text begin information or specimens, for existing activities at the Department of Health where the new text end 8.6 new text begin commissioner of health determines express authorization is not already provided in law. new text end 8.7    Sec. 14. new text begin NOTIFICATION FROM COMMISSIONER OF HEALTH. new text end 8.8 new text begin After destruction of the test results created pursuant to the newborn screening new text end 8.9 new text begin program that were retained for more than two years prior to November 16, 2011, and after new text end 8.10 new text begin destruction of all blood samples collected pursuant to the newborn screening program that new text end 8.11 new text begin were retained prior to November 16, 2011, the commissioner of health must notify the new text end 8.12 new text begin public through a general announcement and must submit a letter of notification to the new text end 8.13 new text begin chairs and ranking minority members of the legislative committees with jurisdiction new text end 8.14 new text begin over health and human services. new text end 8.15    Sec. 15. new text begin REQUEST FOR INFORMATION; EVALUATION OF MANDATED new text end 8.16 new text begin HEALTH BENEFITS. new text end 8.17 new text begin The commissioner of commerce shall issue a request for information regarding the new text end 8.18 new text begin cost and feasibility of a comprehensive evaluation of mandated health benefits required by new text end 8.19 new text begin a Minnesota statute or rule as of June 1, 2012. The commissioner shall issue a written new text end 8.20 new text begin report on the results of the request for information to the chairs and ranking minority new text end 8.21 new text begin members of the legislative committees with jurisdiction over health and human services new text end 8.22 new text begin and commerce no later than December 15, 2012. Any such evaluation must include new text end 8.23 new text begin the analysis, data, and information described in Minnesota Statutes, section 62J.26, new text end 8.24 new text begin subdivision 2, paragraph (b), clauses (1) through (6). For purposes of this section, a new text end 8.25 new text begin "mandated health benefit" means a statutory or administrative requirement that a health new text end 8.26 new text begin plan do the following: new text end 8.27 new text begin (1) provide coverage or increase the amount of coverage for the treatment of a new text end 8.28 new text begin particular disease, condition, or other health care need; new text end 8.29 new text begin (2) provide coverage or increase the amount of coverage of a particular type of new text end 8.30 new text begin health care treatment or service, or of equipment, supplies, or drugs used in connection new text end 8.31 new text begin with a health care treatment or service; or new text end 8.32 new text begin (3) provide coverage for care delivered by a specific type of provider. new text end 8.33 new text begin EFFECTIVE DATE. new text end new text begin This section is effective the day following final enactment. new text end 9.1    Sec. 16. new text begin EFFECTIVE DATE. new text end 9.2 new text begin (a) Sections 2 and 6 to 9 are effective August 1, 2012. new text end 9.3 new text begin (b) Sections 3 to 5 are effective the day following final enactment and apply to blood new text end 9.4 new text begin samples collected and test results created on or after that date. new text end 9.5 new text begin (c) Nothing in sections 2 to 10 affect or limit pending legal actions with respect to new text end 9.6 new text begin transactions, occurrences, or events that occurred prior to November 16, 2011. new text end