DHS 115.06 Criteria for adding and 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: (1) Characteristics of the specific disorder, including disease incidence, morbidity and mortality.
(2) The availability of effective therapy and potential for successful treatment.
(3) Characteristics of the test, including sensitivity, specificity, feasibility for mass screening and cost.
(4) The availability of mechanisms for determining the effectiveness of test procedures.
(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.
(6) The expected benefits to children and society in relation to the risks and costs associated with testing for the specific condition.
In addition, as a part of the nomination review process, the department seeks the advice and guidance of medical consultants and experts via the NBS Umbrella Committee and SACNBS. The SACNBS forwards recommendations for adding or deleting conditions to the newborn screening panel to the Secretary. Prior to the committee’s recommendation and report submission to the Secretary of DHS, the following criteria are reviewed:
1) Mandated testing should be limited to conditions that cause serious health risks in childhood that are unlikely to be detected and prevented in the absence of newborn screening.
2) For each condition, there should be information about the incidence, morbidity and mortality, and the natural history of the disorder.
3) Conditions identified by newborn screening should be linked with interventions that have been shown in well-designed studies to be safe and effective in preventing serious health consequences.
4) The interventions should be reasonably available to affected newborns.
5) Appropriate follow-up should be available for newborns who have a false positive newborn screen.
6) The characteristics of mandated tests in the newborn population should be known, including specificity, sensitivity, and predictive value or other convincing medical evidence (experience, natural history, or literature).
7) If a new sample collection system is needed to add a disorder, reliability and timeliness of sample collection must be demonstrated.
8) Before a test is added to the panel, the details of reporting, follow-up, and management must be completely delineated, including development of standard instructions, identification of consultants, and identification of appropriate referral centers throughout the state/region.
9) Recommendations and decisions should include consideration of the costs of the screening test, confirmatory testing, accompanying treatment, counseling, and the consequences of false positives. The mechanism of funding those costs should be identified. Expertise in economic factors should be available to those responsible for recommendations and decisions.
6.
Estimates of the amount of time that state employees will spend to develop the rule and other necessary resourcesThe department estimates that it will take approximately 160 hours to develop the proposed rules. This includes time required for research and analysis, creating the advisory committee list, and coordinating meetings, rule drafting, preparing any related documents, holding a public hearing, and communicating with affected persons and groups.
7.
Description of all of the entities that may be affected by the rule, including any local governmental units, businesses, economic sectors, or public utility ratepayers who may reasonably be anticipated to be affected by the rule
purchasers of the newborn screening blood collection cards
the Wisconsin State Laboratory of Hygiene
The Newborn Screening Program
Newborns and parents of newborns will benefit from early diagnosis through newborn screening and follow up treatment
The Wisconsin State Laboratory of Hygiene will provide ongoing testing for additional conditions and the WI Newborn Screening Program will have additional newborn screening conditions to follow up and report on
Expert consultants in the newborn screening field and health care providers will have a slight increase in patient care for those diagnosed through newborn screening8.
Summary and preliminary comparison of any existing or proposed federal regulation that is intended to address the activities to be regulated by the ruleThere do not appear to be any existing or proposed federal regulations that address the activities of this rule.
9.
Anticipated economic impact, locally or statewideThe proposed rule may have a moderate economic impact. An increase to the Newborn Screening card fee is needed by the Wisconsin State Laboratory of Hygiene to cover screening and testing costs and for the department to cover the provision of diagnostic and counseling services, special dietary treatment, and periodic evaluation of infant screening programs, costs of consulting with experts, and an integrated data system and program operation costs.
In FY 24, 25, and 26 it is estimated that there will be approximately 52,000 blood cards annually. Based on current fees, this is an annual projected revenue of $5,668,000 and with the proposed increased a projected annual revenue of $11,596,000. This will cover increased costs experienced by both WSLH and the Department.
Tami Horzewski, MS, CHES
Newborn Screening Program Coordinator - Senior Outreach Specialist
Bureau of Community Health Promotion,
608-266-8904
