House File 2539 - Introduced HOUSE FILE 2539 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO HSB 690) (COMPANION TO SF 2345 BY COMMITTEE ON HUMAN RESOURCES) A BILL FOR An Act relating to the newborn screening. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 6177HV (3) 89 pf/rh

H.F. 2539 Section 1. Section 136A.2, Code 2022, is amended by adding 1 the following new subsection: 2 NEW SUBSECTION . 1A. “Congenital and inherited disorders 3 advisory committee” or “advisory committee” means the congenital 4 and inherited disorders advisory committee created in this 5 chapter. 6 Sec. 2. NEW SECTION . 136A.3A Congenital and inherited 7 disorders advisory committee established —— process for addition 8 of conditions to newborn screening. 9 1. A congenital and inherited disorders advisory committee 10 is established to assist the center for congenital and 11 inherited disorders and the department in the development of 12 programs that ensure the availability and access to quality 13 genetic and genomic health care services for all Iowans. 14 2. The members of the advisory committee shall be appointed 15 by the director and shall include persons with relevant 16 expertise and interest including parent representatives. 17 3. The advisory committee shall assist the center for 18 congenital and inherited disorders and the department in 19 designating the conditions to be included in the newborn 20 screening and in regularly evaluating the effectiveness and 21 appropriateness of the newborn screening. 22 4. a. Beginning July 1, 2022, the advisory committee shall 23 ensure that all conditions included in the federal recommended 24 uniform screening panel as of January 1, 2022, are included in 25 the newborn screening. 26 b. Within twelve months of the addition of a new condition 27 to the federal recommended uniform screening panel, the 28 advisory committee shall consider and make a recommendation 29 to the department regarding inclusion of the new condition in 30 the newborn screening, including the current newborn screening 31 capacity to screen for the new condition and the resources 32 necessary to screen for the new condition going forward. 33 If the advisory committee recommends inclusion of a new 34 condition, the department shall include the new condition in 35 -1- LSB 6177HV (3) 89 pf/rh 1/ 5

H.F. 2539 the newborn screening within eighteen months of receipt of the 1 recommendation. 2 5. The department shall submit a status report to the 3 general assembly, annually, by December 31, regarding all of 4 the following: 5 a. The current conditions included in the newborn screening. 6 b. Any new conditions currently under consideration or 7 recommended by the advisory committee for inclusion in the 8 newborn screening. 9 c. Any new conditions considered but not recommended by the 10 advisory committee in the prior twelve-month period and the 11 reason for not recommending any such conditions. 12 d. Any departmental request for additional program capacity 13 or resources necessitated by the inclusion of a recommended new 14 condition in the newborn screening. 15 e. Any delay and the reason for the delay by the advisory 16 committee in complying with the specified twelve-month time 17 frame in considering or recommending the inclusion of a new 18 condition in the newborn screening to the department. 19 f. Any delay and the reason for the delay by the department 20 in complying with the specified eighteen-month time frame in 21 including a new condition in the newborn screening following 22 receipt of a recommendation from the advisory committee 23 recommending the inclusion of such condition. 24 6. The state hygienic laboratory shall establish the 25 newborn screening fee schedule in a manner sufficient to 26 support the newborn screening system of care including 27 laboratory screening costs, short-term and long-term follow-up 28 program costs, the newborn screening developmental fund, and 29 the cost of the department’s newborn screening data system. 30 Sec. 3. Section 136A.5, Code 2022, is amended to read as 31 follows: 32 136A.5 Newborn metabolic screening. 33 1. All newborns born in this state shall be screened for 34 congenital and inherited disorders in accordance with rules 35 -2- LSB 6177HV (3) 89 pf/rh 2/ 5

H.F. 2539 adopted by the department. 1 2. An attending health care provider shall ensure that every 2 newborn under the provider’s care is screened for congenital 3 and inherited disorders in accordance with rules adopted by the 4 department. 5 3. This section does not apply if a parent objects to 6 the screening. If a parent objects to the screening of a 7 newborn, the attending health care provider shall document the 8 refusal in the newborn’s medical record and shall obtain a 9 written refusal from the parent and report the refusal to the 10 department as provided by rule of the department. 11 Sec. 4. Section 136A.5A, subsections 1 and 4, Code 2022, are 12 amended to read as follows: 13 1. Each newborn born in this state shall receive a critical 14 congenital heart disease screening by pulse oximetry or other 15 means as determined by rule, in conjunction with the metabolic 16 newborn screening required pursuant to section 136A.5 . 17 4. Notwithstanding any provision to the contrary, the 18 results of each newborn’s critical congenital heart disease 19 screening shall only be reported in a manner consistent with 20 the reporting of the results of metabolic newborn screenings 21 pursuant to section 136A.5 if funding is available for 22 implementation of the reporting requirement. 23 EXPLANATION 24 The inclusion of this explanation does not constitute agreement with 25 the explanation’s substance by the members of the general assembly. 26 This bill relates to newborn screenings. 27 The bill establishes, in Code, the congenital and inherited 28 disorders advisory committee (advisory committee), which 29 currently is established in administrative rules. The bill 30 provides, as is provided in administrative rules, that the 31 advisory committee is established to assist the center for 32 congenital and inherited disorders (center) and the department 33 of public health (DPH) in matters relating to genetic 34 and genomic health care services for all Iowans, that the 35 -3- LSB 6177HV (3) 89 pf/rh 3/ 5

H.F. 2539 members of the advisory committee shall be appointed by the 1 director of public health, that the members shall include 2 persons with relevant expertise and interest including parent 3 representatives, and that one of the duties of the advisory 4 committee is to assist the center and DPH in designating the 5 conditions to be included in the newborn screening and in 6 regularly evaluating the effectiveness and appropriateness of 7 the newborn screening. 8 The bill specifically requires that beginning July 1, 9 2022, the advisory committee shall ensure that all conditions 10 included in the federal recommended uniform screening panel as 11 of January 1, 2022, are included in the newborn screening. The 12 bill requires that within 12 months of the addition of a new 13 condition to the federal recommended uniform screening panel, 14 the advisory committee shall consider and make a recommendation 15 to DPH regarding inclusion of the new condition in the newborn 16 screening, including current newborn screening capacity to 17 screen for the new condition and the resources necessary to 18 screen for the new condition going forward. If the advisory 19 committee recommends inclusion of a new condition, DPH shall 20 ensure that the new condition is included in the newborn 21 screening within 18 months of receipt of the recommendation. 22 The bill requires DPH to submit an annual status report to 23 the general assembly by December 31, regarding the current 24 conditions included in the newborn screening, any new 25 conditions currently under consideration or recommended by the 26 advisory committee for inclusion in the newborn screening, any 27 new conditions considered but not recommended by the advisory 28 committee in the prior 12-month period and the reason for not 29 recommending any such conditions, any departmental request for 30 additional newborn screening program capacity or resources 31 necessitated by the inclusion of a recommended new condition 32 in the newborn screening, and any delay and the reason for 33 the delay by the advisory committee or DPH in complying with 34 the specified time frames for considering and recommending or 35 -4- LSB 6177HV (3) 89 pf/rh 4/ 5

H.F. 2539 adding a new condition to the newborn screening. 1 The bill requires the state hygienic laboratory to establish 2 the newborn screening fee schedule in a manner sufficient to 3 support the newborn screening system of care. 4 The bill also changes references to “newborn metabolic 5 screening” or “metabolic newborn screening” to “newborn 6 screening”. 7 -5- LSB 6177HV (3) 89 pf/rh 5/ 5