The Department relied on the following information for the rules and analysis:
— The Wisconsin Newborn Screening Program DHS Newborn Screening program paper, and WSLH Surcharge Report 2022. These documents summarize that WSLH costs for the NBS Program include: the costs of purchasing, storing, and distributing the collection cards; laboratory equipment, consumables, and staff salaries to perform the testing; short term follow-up of all non-normal results reported by the laboratory; and education activities for health care providers regarding newborn screening issues such as specimen collection and reporting of test results. The cost of NBS laboratory operations consistently increases due to program expansion, enhancements and inflation. The paper reports that the WSLH typically experiences an inflation rate of 3% annually, and addition and implementation of new conditions to the panel also increases costs due to a variety of reasons such as additional equipment, staff time to run additional tests, and new test set up.
— DHS NBS program reports, which indicate that costs to the department are based on the number of participants in NBS, diagnostic and counseling services (i.e. clinical assessment, nutritional and genetic counseling); special dietary treatment (i.e. coordinating payment of specialty formula and vitamins); consulting with experts (i.e. hosting and coordinating the newborn screening advisory group meetings) and management and supplies for hearing screening and Critical Congenital Heart Disease (CCHD) screening. Heart and hearing screening are run by DHS staff and contracted agencies, while the blood screening is run by DHS staff and contracted agencies along with the WSLH. These reports also indicate that each child with a positive screening result gets a confirmatory test in a specialty center and receives the necessary dietary treatment for life; thus, as children live longer and the cumulative number of patients increases, the overall cost of the program rises. The report also finds that the costs for formula and other food products have risen as much as 20% annually, and the total number of the patient population served by the NBS program nearly doubled from fiscal year 2009 to 2022.
Analysis and supporting documents used to determine effect on small business
According to the WSLH Surcharge Report, the number of newborn screening sample cards purchased in SFY 2022 was 59,737. In FY 2024, 2025, and 2026 it is estimated that there will be approximately 55,000 blood cards purchased annually by hospitals and midwives. Hospitals do not meet the definition of a “small business” under s. 227.114 (1), Stats., but midwives do. Midwives purchase approximately 3% of the estimated 55,000 cards, or 1,650 cards in total. The number of cards may fluctuate slightly in future years depending on factors such as the number of births or cards purchased each year. The $28 fee increase as a result of the proposed rules may have a moderate economic impact on midwives. Midwives’ small businesses are affected by an increase in the blood collection card fee as they purchase cards out of pocket for their patients. (2023 Memorandum of Understanding Fee-exempt Newborn Screening Blood Collection Cards). The total annual amount estimated for all midwives as a result of the proposed rule is approximately $46,200—which is 3% of increased cost for 55,000 cards as a result of the proposed rule. Purchasers of newborn screening sample collection cards may seek reimbursement of the costs of the newborn screening sample cards and any related costs incurred from private insurers, Medicaid, parents of newborns, or the NBS Program for eligible parents.
The department published a solicitation in the Administrative Register, requesting comments on the economic impact of the proposed rule, from December 18, 2023 to January 17, 2024.
Effect on small business
The fee increase in the proposed rule may have a moderate economic impact on small business. All other changes in the proposed rule will not have an effect on small businesses.
Agency contact person
Tami Horzewski MS, CHES
Newborn Screening Program Coordinator
Bureau of Community Health Promotion, Division of Public Health
Wisconsin Department of Health Services
Statement on quality of agency data
The data used by the department to prepare these proposed rules and analysis comply with s. 227.14 (2m), Stats. Place where comments are to be submitted and deadline for submission
RULE TEXT
SECTION 1. DHS 115.04 (8) (b) and (13) amended to read:
DHS 115.04 (8) (b) Long−chain L−3−Hydroxy acyl−CoA dehydrogenase deficiency, trifunctional protein deficiency, ICD−10−CM−E71.318.
DHS 115.04 (13) Argininosuccinic acidura aciduria, ICD-10-CM-E72.22.
SECTION 2. DHS 115.04 (13m) is created to read:
DHS 115.04 (13m) Hypermethioninemia (MET) ICD-10-CM- E72.19.
SECTION 3. DHS 115.04 (15) (c), (e), and (i) are amended to read:
DHS 115.04 (15) (c) Methylmalonic acidemia (CBL A, B, C, D; MUT) (cobalamin disorders) and methylmalonyl-CoA mutase deficiency, ICD−10−CM−E71.120.
DHS 115.04 (15) (e) 3-Methylcrotony1-CoA carboxylase deficiency 2-Methyl-3-hydroxybutyric aciduria, ICD-10-CM-E71.19
DHS 115.04 (15) (i) 2-Methyl-3-hydroxbutyric aciduria 3-Methylcrotonyl-CoA carboxylase deficiency, ICD-10-CM-E71.19.
SECTION 4. DHS 115.04 (17) is repealed and recreated to read:
DHS 115.04 (17) Lysosomal disorders, including all of the following:
a) Pompe Disease ICD−10−CM−E74.02
b) Mucopolysaccharidosis I ICD-10-CM-E76.0
SECTION 5. DHS 115.04 (18) is created to read:
DHS 115.04 (18) X-Linked Adrenoleukodystrophy (X-ALD), ICD-10-CM-E71.52
SECTION 6. DHS 115.055 is renumbered DHS 115.055 (2) and amended to read:
DHS 115.055 (2) Calculation of fees. The newborn screening sample collection card fee for testing a newborn under s. 253.13 (1), Stats., and this chapter shall be $109 $223 as of [LRB to insert effective date of rule] to cover the costs of testing and to fund follow−up services and other activities under s. 253.13 (2), Stats. Thereafter, the fee charged under this section shall be adjusted by the department on July 1 of each odd numbered year based on the average of the three most recently published Medicare economic indexes. SECTION 7. DHS 115.055 (1) is created to read:
DHS 115.055 (1) Definition. In this section, “Medicare economic index” means the price index authorized under 42 USC 1395u (b) (3), and computed and published in accordance with 42 CFR 405.504 (d). SECTION 8. EFFECTIVE DATE. This rule takes effect on the first day of the month following publication in the Wisconsin Administrative Register as provided in s. 227.22 (2) (intro.), Stats.
