Plain language analysis
As provided in s. 253.13 (1), Stats. (2011-12), ch. DHS 115 specifies the congenital and metabolic orders for which newborns must be screened by means of a blood sample shortly after birth and tested by the Wisconsin State Laboratory of Hygiene (WSLH). 2013 Wisconsin Act 135 modified s. 253.13 (1) Stats., relating to infant blood tests to provide that the required screening may be performed by methods in addition to blood testing. Under the proposed rules the department revises ch. DHS 115 to conform the rules to s. 253.13 (1), Stats. The proposed rules add critical congenital heart disease (CCHD) and organic acidemias (OA) as conditions for which newborns must be tested. CCHD is usually described as those congenital cardiac malformations in which surgical or catheter-based therapy is necessary within the first months of life, and is screened for by use of pulse oximetry. In September 2010, the U.S. Department of Health and Human Services, Discretionary Advisory Committee on Heritable Disorders in Newborns and Children added CCHD to its Recommended Uniform Screening Panel Core Conditions. To date, 35 states have added CCHD screening to their newborn screening panel.
OA is a group of inherited disorders that lead to an abnormal buildup of particular acids known as organic acids in the body for which the WSLH currently tests newborns. Though the criteria under s. DHS 115.06 were met for OA to be added to the list of congenital and metabolic disorders for which WSLH must test blood samples, the disorders were inadvertently omitted from subsequent revisions of s. DHS 115.04. The department promulgated emergency rules effective July 3, 2014, to add CCHD and OA to the list of conditions for which newborns must be screened.
Currently, the conditions listed in s. DHS 115.04, are coded using the International Classification of Diseases, 9th Revision (ICD-9 CM). The U.S. Department of Health and Human Services requires health care providers, health plans, and health care clearinghouses to transition to the International Classification of Diseases, 10th Revision (ICD-10 CM) effective October 1, 2015. To ensure consistency among health care providers and to facilitate the transition in this order, the proposed rule lists the ICD-10 CM codes for the CCHD and OA conditions proposed, and the conditions already listed in s. DHS 115.04. The transition to the ICD-10 CM codes in the proposed rule will occur on October 1, 2015. Summary of, and comparison with, existing or proposed federal regulations
There appears to be no existing or proposed federal regulations that address the activities to be regulated by the proposed rules.
Comparison with rules in adjacent states
Illinois, Iowa, Michigan, and Minnesota state law require that newborns be screened for congenital and metabolic disorders, including CCHD and organic acidemias.
Illinois:
Illinois does not list in administrative rules, the congenital or metabolic disorders for which infants are screened.
Iowa:
Iowa does not list in administrative rules, the congenital or inherited disorders for which infants are screened.
Michigan:
Michigan does not list in administrative rules, the congenital or metabolic disorders for which infants are screened.
Minnesota:
Minnesota does not list in administrative rules, the congenital or metabolic disorders for which infants are screened.
Summary of factual data and analytical methodologies
The DHS Secretary’s Advisory Committee on Newborn Screening (Committee) recommended to the department, and the department concurred with the recommendation to add CCHD to the list of congenital and metabolic disorders for which newborns must be screened.
The WSLH tests newborns for OA, a group of inherited disorders that lead to an abnormal buildup of particular acids, known as organic acids, in the body. Though OA was determined to have met the criteria under s. DHS 115.06 for being added to the list of congenital and metabolic disorders for which WSLH must test the blood samples of newborns, the conditions were inadvertently omitted from the list of conditions in s. DHS 115.04 during subsequent revisions of the rule section. Analysis and supporting documents used to determine effect on small business
The department proposes to revise ch. DHS 115 to conform the rules to s. 253.13 (1), Stats., as revised under 2013 Wisconsin Act 135 so that the required newborn screening may be performed by methods in addition to blood testing. The department also proposes to add CCHD and OA to the list of congenital and metabolic disorders for which newborns must be tested. Section 253.13 (1), Stats., requires attending physicians, nurse-midwives, and certified midwives to cause every infant born in Wisconsin to be screened for the congenital and metabolic disorders specified by the department by rule. To comply with s. 253.13 (1), Stats., hospitals, stand-alone birth centers, physicians, nurse-midwives, certified midwives, and other entities (purchasers) purchase newborn screening sample collection cards for $109 from the WSLH for use when obtaining the newborn’s blood sample for testing. The addition of CCHD and OA to the list of congenital and metabolic disorders under s. DHS 115.04 for which newborns must be tested does not increase the current fee or impose any additional fees to purchasers of newborn screening sample collection cards. Costs to providers for screening for CCHD are indeterminate. Pulse oximetry is the recognized screening method for CCHD. The cost of a reliable hand held device, with a reusable probe, costs about $500, with probe wraps costing about $.60 each. Administering the pulse oximetry testing on newborns averages about three minutes per baby and is usually conducted by nurses. Some of the costs to providers for screening for CCHD have been mitigated through the Wisconsin SHINE Project (Screening Hearts in Newborns), a pilot project of the University of Wisconsin School of Medicine and Public Health, the Medical College of Wisconsin, the department, and the WSLH, which works to create a safety net for all babies born in Wisconsin by educating healthcare providers, improving access to screening and diagnostic technology, and creating a statewide CCHD screening and data collection system. The Wisconsin SHINE project has supplied pulse oximeters to hospitals and midwives who did not have them.
The inclusion of OA in the list of disorders for which newborns must be tested will not impose any additional costs to providers because the WSLH currently tests newborns for OA including propionic acidemia, methylmalonic acidemia, and related organic acidemias.
Effect on small business
Based on the foregoing analysis, the proposed rules are anticipated to have little or no economic impact on businesses.
Agency contact person
Susan Uttech, Department of Health Services, Bureau Director, Community Health Promotion, susan.uttech@wi.gov 608-267-3561 Statement on quality of agency data
The department relied on the following information for the rules and analysis:
1. The Centers for Disease Control (CDC)
2. The United States Department of Health and Human Services Discretionary Advisory Committee on Heritable Disorders in Newborns and Children
3. The Wisconsin Newborn Screening Program – Condition Nomination Form
4. The Wisconsin SHINE Project
5. Ng, B. and Hokanson, J. (2010), Missed Congenital Heart Disease in Neonates. Congenital Heart Disease, 5: 292–296. doi: 10.1111/j.1747-0803.2010.00418.x
6. Beissel, D. J., Goetz, E. M. and Hokanson, J. S. (2012), Pulse Oximetry Screening in Wisconsin. Congenital Heart Disease, 7: 460–465. doi: 10.1111/j.1747-0803.2012.00651.x
Place where comments are to be submitted and deadline for submission
Comments may be submitted to the agency contact person that is listed above until the deadline given in the upcoming notice of public hearing. The deadline for submitting comments and the notice of public hearing will be posted on the Wisconsin Administrative Rules Website at http://adminrules.wisconsin.gov after the hearing is scheduled. RULE TEXT
SECTION 1. DHS 115.01 and 115.02 are amended to read:
DHS 115.01 Authority and purpose. This chapter is promulgated under the authority of ss. 253.13 (1), and 227.11 (2), Stats., to specify the congenital and metabolic disorders for which newborn infants are to be screened by means of a sample of blood taken from an infant shortly after birth and tests performed on that sample by the state laboratory of hygieneand tested. DHS 115.02 Applicability. This chapter applies to the attending physician licensed under ch. 448, Stats., nurse-midwife certified under s. 441.15, Stats., or other attendant at the birth of an infant born in Wisconsin, to the infant and the infant's parents or guardian, and to the state laboratory which carries out tests on the sample of blood taken from the infant. SECTION 2. DHS 115.03 (3) is repealed and recreated to read:
DHS 115.03 (3) “ICD-10-CM” means the International Classification of Diseases, 10th Revision, Clinical Modification.
SECTION 3. DHS 115.04 (intro.) is amended to read:
DHS 115.04 Congenital and metabolic disorders. Blood samples taken from newborns as required underPursuant to s. 253.13 (1), Stats., each newborn shall be tested by the state laboratory for all of the following conditions: SECTION 4. DHS 115.04 (1) is renumbered DHS 115.04 (1) (a) and amended to read:
DHS 115.04 (1) (a) Phenylketonuria (PKU), ICD-9-CM 270.1ICD-10-CM-E70.0.
SECTION 5. DHS 115.04 (1) (b) is created to read:
DHS 115.04 (1) (b) Hyperphenylalaninemia, ICD-10-CM-E70.1
SECTION 6. DHS 115.04 (2) and (3) are amended to read:
