Chapter DHS 115

DHS 115.04(1)(b) (b) Hyperphenylalaninemia, ICD-10-CM-E70.1.

DHS 115.04(2) (2) Galactosemia, ICD-10-CM-E74.21.

DHS 115.04(3) (3) Congenital hypothyroidism, ICD-10-CM-E03.1.

DHS 115.04(4) (4) Hemoglobinopathies, including all of the following:

DHS 115.04(4)(a) (a) Sickle cell disease, ICD-10-CM-D57.1.

DHS 115.04(4)(b) (b) Hemoglobin S-beta Thalassemia, ICD-10-CM-D57.40.

DHS 115.04(4)(c) (c) Hemoglobin SC disease, ICD-10-CM-D57.20.

DHS 115.04(4)(d) (d) Hemoglobin disease other, ICD-10-CM-D58.2.

DHS 115.04(5) (5) Biotinidase deficiency, ICD-10-CM-D81.810.

DHS 115.04(6) (6) Congenital adrenal hyperplasia, ICD-10-CM-E25.0.

DHS 115.04(7) (7) Cystic fibrosis, ICD-10-CM-E84.9.

DHS 115.04(8) (8) Fatty acid oxidation disorders, including all of the following:

DHS 115.04(8)(a) (a) Medium-chain acyl-CoA dehydrogenase deficiency, ICD-10-CM-E71.311.

DHS 115.04(8)(b) (b) Long-chain L-3-Hydroxy acyl-CoA dehydrogenase deficiency, ICD-10-CM-E71.318.

DHS 115.04(8)(c) (c) Very long-chain acyl-CoA dehydrogenase deficiency, ICD-10-CM-E71.310.

DHS 115.04(8)(cm) (cm) Carnitine palmitoyltransferase IA deficiency, ICD-10-CM-E71.318.

DHS 115.04(8)(d) (d) Carnitine palmitoyltransferase II deficiency, ICD-10-CM-E71.318.

DHS 115.04(8)(e) (e) Carnitine-acylcarnitine translocase deficiency, ICD-10-CM-E71.318.

DHS 115.04(8)(f) (f) Glutaric acidemia type II, ICD-10-CM-E71.313.

DHS 115.04(8)(g) (g) 2, 4-Dienoyl-CoA reductase deficiency, ICD-10-CM-E71.318.

DHS 115.04(8)(h) (h) Carnitine uptake defect, ICD-10-CM-E71.41.

DHS 115.04(8)(i) (i) Medium/short-chain hydroxy CoA dehydrogenase deficiency, ICD-10-CM-E71.318.

DHS 115.04(8)(j) (j) Medium-chain ketoacyl-CoA thiolase deficiency, ICD-10-CM-E71.318.

DHS 115.04(9) (9) Maple Syrup Urine Disease, ICD-10-CM-E71.0.

DHS 115.04(10) (10) Homocystinuria, ICD-10-CM-E72.11.

DHS 115.04(11) (11) Tyrosinemia types I, II, and III, ICD-10-CM-E70.21.

DHS 115.04(12) (12) Citrullinemia types I and II, ICD-10-CM-E72.23.

DHS 115.04(13) (13) Argininosuccinic acidura, ICD-10-CM-E72.22.

DHS 115.04(14) (14) Severe Combined Immunodeficiency and related conditions of immunodeficiency, ICD-10-CM-D81.9.

DHS 115.04(15) (15) Organic acidemias, including all of the following:

DHS 115.04(15)(a) (a) Glutaric acidemia type I, ICD-10-CM-E72.3.

DHS 115.04(15)(b) (b) Propionic acidemia, ICD-10-CM-E71.121.

DHS 115.04(15)(c) (c) Methylmalonic acidemia (CBL A, B, C, D; MUT), ICD-10-CM-E71.120.

DHS 115.04(15)(d) (d) Isovaleric acidemia, ICD-10-CM-E71.110.

DHS 115.04(15)(e) (e) 3-Methylcrotony1-CoA carboxylase deficiency, ICD-10-CM-E71.19.

DHS 115.04(15)(f) (f) Multiple carboxylase deficiency, ICD-10-CM-D81.818.

DHS 115.04(15)(g) (g) 3-Methylglutaconic aciduria, ICD-10-CM-E71.111.

DHS 115.04(15)(h) (h) beta-Ketothiolase deficiency, ICD-10-CM-E71.19.

DHS 115.04(15)(i) (i) 2-Methyl-3-hydroxbutyric aciduria, ICD-10-CM-
E71.19.

DHS 115.04(15)(j) (j) 3-Hydroxy-3-methylglutaric aciduria, ICD-10-CM-
E71.118.

DHS 115.04(15m) (15m) Spinal muscular atrophy, ICD-10-CM-G12.9.

DHS 115.04(16) (16) Critical congenital heart disease, including all of the following:

DHS 115.04(16)(a) (a)

DHS 115.04(16)(a)1. 1. Coarctation of the aorta, ICD-10-CM-Q25.1.

DHS 115.04(16)(a)2. 2. Atresia of aorta, ICD-10-CM-Q25.2.

DHS 115.04(16)(a)3. 3. Stenosis of aorta, ICD-10-CM-Q25.3.

DHS 115.04(16)(b) (b)

DHS 115.04(16)(b)1. 1. Double outlet right ventricle, ICD-10-CM-Q20.1.

DHS 115.04(16)(b)2. 2. Double outlet left ventricle, ICD-10-CM-Q20.2.

DHS 115.04(16)(c) (c) Ebstein’s anomaly, ICD-10-CM-Q22.5.

DHS 115.04(16)(d) (d)

DHS 115.04(16)(d)1. 1. Hypoplastic left heart syndrome ICD-10-CM-Q23.4.

DHS 115.04(16)(d)2. 2. Congenital mitral stenosis or atresia, ICD-10-CM-Q23.2.

DHS 115.04(16)(e) (e)

DHS 115.04(16)(e)1. 1. Interrupted aortic arch, ICD-10-CM-Q25.4.

DHS 115.04(16)(e)2. 2. Atresia of aorta, ICD-10-CM-Q25.2.

DHS 115.04(16)(e)3. 3. Stenosis of aorta, ICD-10-CM-Q25.3.

DHS 115.04(16)(f) (f)

DHS 115.04(16)(f)1. 1. Pulmonary valve atresia, ICD-10-CM-Q22.0.

DHS 115.04(16)(f)2. 2. Other congenital malformations of the pulmonary valve, ICD-10-CM-Q22.3.

DHS 115.04(16)(f)3. 3. Atresia of pulmonary artery, ICD-10-CM-Q25.5.

DHS 115.04(16)(g) (g) Single ventricle heart disease variants other than HLHS, including all of the following:

DHS 115.04(16)(g)1. 1. Hypoplastic right heart syndrome, ICD-10-CM-Q22.6.

DHS 115.04(16)(g)2. 2. Other congenital malformations of the tricuspid valve ICD-10-CM-Q22.8.

DHS 115.04(16)(g)3. 3. Congenital malformations of the tricuspid valve unspecified, ICD-10-CM-Q22.9.

DHS 115.04(16)(g)4. 4. Double inlet ventricle, ICD-10-CM-Q20.4.

DHS 115.04(16)(h) (h) Tetralogy of fallot, ICD-10-CM-Q21.3.

DHS 115.04(16)(i) (i)

DHS 115.04(16)(i)1. 1. Total anomalous pulmonary venous return, ICD-10-CM-Q26.2.

DHS 115.04(16)(i)2. 2. Anomalous pulmonary venous connection, unspecified, ICD-10-CM-Q26.4.

DHS 115.04(16)(i)3. 3. Partial anomalous pulmonary venous connection, ICD-10-CM-Q26.3.

DHS 115.04(16)(j) (j) Transposition of the great vessels, ICD-10-CM-Q20.3.

DHS 115.04(16)(k) (k) Tricuspid atresia and stenosis, ICD-10-CM-Q22.4.

DHS 115.04(16)(L) (L) Truncus arteriosus, ICD-10-CM-Q20.0.

DHS 115.04(17) (17) Pompe Disease, ICD-10-CM-E74.02.

DHS 115.04 History History: Cr. Register, May, 1993, No. 449, eff. 6-1-93; emerg. am. (5) and (6), cr. (7), eff. 1-31-95; correction in (intro.) made under s. 13.93 (2m) (b) 7., Stats., Register, July, 1995, No. 475; am. (5) and (6), cr. (7), Register, July, 1995, No. 475, eff. 8-1-95; am. (intro.) and (1) to (6), cr. (8), Register, December, 1999, No. 528, eff. 1-1-00; emerg. cr. (9) to (13), eff. 10-12-02; CR 02-136: cr. (9) to (13) Register March 2003 No. 567, eff. 4-1-03; emerg. cr. (14), eff. 1-1-08; CR 08-005: cr. (14) Register June 2008 No. 630, eff. 7-1-08; CR 14-074: am. (intro.), cr. (15), (16) Register July 2015 No. 715, eff. 8-1-15, and renum. (1) to (1) (a) and am., cr. (1) (b), am. (2), (3), r. and recr. (4), am. (5) to (7), r. and recr. (8), am. (9) to (14), r. and recr. (15), am. (16) Register July 2015 No. 715, eff. 10-1-15; correction in (15) (g) made under s. 35.17, Stats., Register September 2015 No. 717; EmR1920: emerg. am. (title), (intro.), cr. (8) (cm), (15m), eff. 10-15-19; CR 19-064: am. (title), (intro.), cr. (8) (cm), (15m) Register December 2019 No. 768, eff. 1-1-20; EmR2131: emerg. cr. (17), eff. 1-10-22; CR 21-051: cr. (17) Register May 2022 No. 797, eff. 6-1-22.

DHS 115.05 DHS 115.05 Laboratory tests.

DHS 115.05(1) (1) Procedures. The state laboratory shall establish procedures, with the approval of the department, for obtaining blood specimens for the testing required under s. 253.13 (1), Stats., and this chapter, performing tests and reporting results of tests performed to the infant’s physician and the department as required under s. 253.13 (4), Stats.

DHS 115.05(2) (2) Additional tests for research and evaluation purposes. The department may direct the state laboratory to perform other tests on specimens for research and evaluation purposes related to congenital and metabolic disorders or laboratory procedures. In directing that additional testing be performed, the department shall ensure that all applicable laws relating to protection of human subjects of research are observed.

DHS 115.05 History History: Cr. Register, May, 1993, No. 449, eff. 6-1-93; corrections in (1) made under s. 13.93 (2m) (b) 7., Stats., Register, July, 1995, No. 475; CR 12-025: cr. (3) Register May 2013 No. 689, eff. 6-1-13; CR 14-074: (3) renum. to 115.055 and am. Register July 2015 No. 715, eff. 8-1-15.

DHS 115.055 DHS 115.055 Fees. The newborn screening sample collection card fee for testing a newborn under s. 253.13 (1), Stats., and this chapter shall be $109 to cover the costs of testing and to fund follow-up services and other activities under s. 253.13 (2), Stats.

DHS 115.055 History History: CR 14-074: renum. from 115.05 (3) and am. Register July 2015 No. 715, eff. 8-1-15.

DHS 115.06 DHS 115.06 Criteria for adding or deleting conditions. In determining which disorders are to be added or deleted from s. DHS 115.04, the department shall seek the advice and guidance of medical consultants, staff of the state laboratory and other persons who have expertise and experience in dealing with congenital and metabolic disorders. Criteria to be considered in adding or deleting disorders shall include all of the following:

DHS 115.06(1) (1) Characteristics of the specific disorder, including disease incidence, morbidity and mortality.

DHS 115.06(2) (2) The availability of effective therapy and potential for successful treatment.

DHS 115.06(3) (3) Characteristics of the test, including sensitivity, specificity, feasibility for mass screening and cost.

DHS 115.06(4) (4) The availability of mechanisms for determining the effectiveness of test procedures.

DHS 115.06(5) (5) Characteristics of the screening program, including the ability to collect and analyze specimens reliably and promptly, the ability to report test results quickly and accurately and the existence of adequate follow-up and management programs.

DHS 115.06(6) (6) The expected benefits to children and society in relation to the risks and costs associated with testing for the specific condition.