FINAL REGULATORY FLEXIBILITY ANALYSIS AND
SUMMARY OF LEGISLATIVE STANDING COMMITTEE COMMENTS
June 18, 2025
Department of Health Services
DHS 115, relating to the screening of newborns for congenital disorders
Final Regulatory Flexibility Analysis or Summary:
As stated in sections 9 and 11 of the fiscal estimate and economic impact analysis, the Department estimates that 55,000 newborn screening (“NBS”) sample collection cards will be purchased in fiscal year 2026, and increasing the card fee from $195 (as currently required under s. 253.13 (2), Stats.) to $223 in the proposed rule would result in additional costs of $1,540,000. The need to increase the fee to $223 was calculated using the following data: •• NBS program reports, which summarize the costs to the department. Those costs are based on the number of participants who are in the program, 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 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 including the Wisconsin State Lab of Hygiene (“WSLH”). 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 indicated that the costs for formula and other food products that constitute special dietary treatment 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. •• The WSLH’s surcharge report, which summarizes the WSLH’s costs for testing, which includes all of the following costs: 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 increased costs of specimen transport, program expansion, enhancements and inflation. Reports indicated 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. As explained in Section 1. of Attachment A to the fiscal estimate and economic impact analysis, the majority of the newborn screening cards are purchased by hospitals, which do not meet the definition of a “small business” under s. 227.114(1). The WSLH’s surcharged report indicated that approximately 3% of the total number of cards purchased annually are purchased by midwives, who likely meet the definition of a small business under the statute. Accordingly, the Department estimates $46,200 in total increased costs to all midwifery businesses in Wisconsin. No issues were raised by small businesses when the department solicited input on the economic impact of the proposed rule under s. 227.137(3), Stats., or during the public hearing and comment period for the proposed rule under ss. 227.16 to 227.18, Stats. The department did not implement any of the methods listed under s. 227.114(2), Stats., to reduce costs for small businesses because s. 253.13 (1) requires testing for every infant born in a hospital or maternity home, and the department must charge a fee for each test card purchased to cover the cost of testing, necessary diagnostic services, special dietary treatment follow-up counseling for the patient and their family, periodic evaluation of infant screening programs, and the cost of administering the hearing screening program under s. 253.115, Stats. These fees are critical to ensuring the NBS program remains solvent and continues to provide critical services to individuals screened into the program. The department attempted to supplement NBS program costs through appropriated funds via the biennial budget process for fiscal years 2024 and 2025, but no funds were appropriated, and the department concluded that the only remaining option was to move forward with increasing the fee in rule in accordance with s. 253.13 (2), Stats. Finally, the department did not implement any of the methods listed under s. 227.114(1) because midwives who purchase NBS sample collection cards may seek reimbursement for the card fee and any related costs from private insurers, Medicaid, parents of newborns, or, for eligible parents, from the NBS program. Comments of Legislative Committees:
The final proposed rule that was submitted for legislative review under s. 227.19 originally included an additional provision that would permit biennial increases to the fee based on the three-year average of the Medicare Economic Index (“MEI”) only if program costs for the preceding biennium exceeded the costs of testing, follow-up services, and other activities under s. 253.12 (2), Stats. The Assembly Committee on Health, Aging, and Long-Term Care and the Senate Committee on Health held a combined public hearing on the proposed rule on March 12, 2025. During that hearing, several committee members raised questions about the proposal to permit biennial increases based on the MEI. Each committee met in executive session on March 20, 2025, and requested that the department consider modifying the proposed rule. The department agreed to consider modifications and submitted a modified proposed rule order that sought only to increase the fee to $223 and excluded any biennial increases to the fee. Neither standing committee took any action on the modified rule, nor did the Joint Committee for Review of Administrative Rules.
