Agency Contact Person
Betty Kalscheur, Wisconsin Department of Commerce, Bureau of Local Development, 201 West Washington Avenue, Madison, WI 53703; telephone: 608-267-6904; E-Mail:
Betty.Kalscheur@wisconsin.gov.
Environmental Analysis
NOTICE IS HEREBY GIVEN that the Department has considered the environmental impact of the proposed rules. In accordance with chapter Comm 1, the proposed rules are a Type III action. A Type III action normally does not have the potential to cause significant environmental effects and normally does not involve unresolved conflicts in the use of available resources. The Department has reviewed these rules and finds no reason to believe that any unusual conditions exist. At this time, the Department has issued this notice to serve as a finding of no significant impact.
Initial Regulatory Flexibility Analysis
The rules are not expected to impose any significant costs on small businesses. The rules provide a potential cost benefit to small businesses engaged in the disposal of abandoned manufactured homes.
Types of small businesses that will be affected by the rules
Any nonprofit organization that chooses to apply for grant funding under the rules.
Reporting, bookkeeping and other procedures required for compliance with the rules
Applicants for becoming funded must submit an application that demonstrates their capacity to complete their proposed activities, their technical expertise with manufactured housing, and their performance in other housing programs.
Types of professional skills necessary for compliance with the rules
No new professional skills would be needed for compliance with these rules.
Will the rules have a significant economic impact on small businesses?
No.
Small business regulatory coordinator
The small business regulatory coordinator for the Department of Commerce is Carol Dunn, who may be contacted at telephone (608) 267-0297, or by e-mail at
cdunn@commerce.state.wi.us.
Fiscal Estimate
Summary
Although the proposed rules would newly result in review of documentation relating to awarding grants to nonprofit organizations for rehabilitation and recycling of manufactured housing, the number of these reviews is expected to be too small to result in significant changes in the Department's costs for administering its housing assistance programs. Therefore, the proposed rules are not expected to have any significant fiscal effect on the Department.
The proposed rules are not expected to impose any significant costs on the private sector, because the rules address only voluntary submittal of documentation relating to grants for rehabilitation and recycling of manufactured housing.
State fiscal effect
None
Local fiscal effect
None
Long-range fiscal implications
None
Notice of Hearing
Health and Family Services
NOTICE IS HEREBY GIVEN that pursuant to ss.
253.13 (1) and
227.11 (2), Stats., and interpreting s.
253.13, Stats., the Wisconsin Department of Health and Family Services will hold a public hearing on emergency rules, and permanent rules creating s.
HFS 115.04 (14), relating to screening newborns for Severe Combined Immunodeficiency and related conditions of immunodeficiency (SCID) at the date, time, and location listed below. The Department's emergency rules became effective on January 1, 2008.
Hearing Information
Date and Time
|
Location
|
March 6, 2008
10 am to 12 pm.
|
Dept. of Health and Family
Services
1 W. Wilson Street, Rm. B139
Madison, Wisconsin
|
The hearing site is fully accessible to people with disabilities. If you are hearing impaired, do not speak English or have circumstances that might make communication at a hearing difficult; you require an interpreter or a non-English large print or taped version of the proposed rules, contact the person at the address or telephone number given below at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.
Copy of Rules
A copy of the full text of the rules and the fiscal estimate can be obtained at no charge from the Wis. Administrative Rules website at
http://adminrules.wisconsin.gov or by contacting the person listed below.
Submission of Written Comments
Written comments may be submitted at the public hearing or submitted to the contact person listed below. Comments may also be made using the Wisconsin Administrative Rule website at
http://adminrules.wisconsin.gov.
The deadline for submitting comments to the Department is 4:30 p.m. on March 13, 2008.
Agency Contact Person
Alexandria M. Meyer, MS, CGC
Genetic & Newborn Screening Coordinator
Division of Public Health
1 West Wilson Street, Room 233
Madison, WI 53701
Phone: 608-267-7148
Analysis Prepared by the Department of Health and Family Services
Statute interpreted
Statutory authority
Explanation of agency authority
Section
253.13 (1), Stats., stipulates that every infant born in Wisconsin to be subjected to blood tests for congenital and metabolic disorders, as specified in rules promulgated by the department. Section
227.11 (2), Stats., grants each agency rule-making authority, provided it conforms to expressly provided guidelines.
Plain language analysis
The Department in an emergency order effective January 1, 2008, added Severe Combined Immunodeficiency
(SCID) and related conditions of immunodeficiency to the list of congenital and metabolic disorders and types of disorders for which newborns are required to be screened, except when objected to for religious reasons, under s.
HFS 115.04. The early identification of particular congenital and metabolic disorders that are harmful or fatal to persons with the disorders is critical to mitigating the negative effects of such disorders. Persons with SCID are extremely vulnerable to infections, to the degree that the condition is universally fatal without treatment within the first year of life. With an estimated prevalence of 1 in 66,000, and a Wisconsin annual birth rate around 71,000, the failure to screen for SCID could result in the death of 1-2 infants in the state every year.
This proposed permanent rule is intended to replace the emergency rule currently in effect.
When SCID and related conditions of immunodeficiency are permanently added to the list of disorders under s.
HFS 115.04, follow-up and management will be conducted by specialists and primary care physicians. Families of infants will receive intensive counseling and be fully apprised of treatment options and availability. The Wisconsin Congenital Disorders Program is responsible for coordinating the activities of managing specialists, but will not provide direct patient care.
All newborn screening tests are currently paid for by user-generated fees. The State Laboratory of Hygiene charges hospitals $69.50 for each newborn screening sample collection card. Hospitals in turn charge parents for newborn screening, which is typically included in the labor and delivery bill and covered by the mother's insurance. A grant from the Jeffrey Modell Foundation, which is matched by the Children's Hospital of Wisconsin and the Medical College of Wisconsin, will fund the cost of testing for SCID through 2008. For the years 2009, 2010, and 2011, the Wisconsin State Laboratory of Hygiene and Division of Public Health will actively seek additional grant funding in order to continue screening for SCID and related conditions of immunodeficiency, at no cost to the state. If grant funding is not available, the fee for the newborn screening sample card will need to be increased by January 1, 2009. The annual cost of screening an estimated 71,000 births in Wisconsin for SCID and related conditions of immunodeficiency will be approximately $387,000. This increased cost will raise fees by $5.50 per child, for a total screening fee of $75.00 per child screened.
In the absence of this screening, babies who are undiagnosed or diagnosed late with SCID typically cost $1-2 million each to treat (this figure is based on audited costs from Children's Hospital of Wisconsin, the facility which treats children with SCID, but without benefit of early diagnosis). Babies with SCID, diagnosed in the first week of life can be cured by bone marrow transplantation (estimate 75-95% cure rate) at a charge of $170,000/discharge (2005 J Peds, McGhee et.al.) In treating infants with SCID, the state would not assume responsibility for the bone marrow transplantation, since the Congenital Disorders Program historically pays only for initial follow-up visits and confirmatory testing. It is expected that the savings to Medicaid may be substantial for each eligible affected child receiving early diagnosis.
Comparison with federal regulations
There are no current federal regulations concerning newborn screening, nor are there any that specifically address screening newborn infants for the condition known as SCID.
Comparison with rules in adjacent states
Illinois: Illinois currently has no rule or statute addressing newborn screening for SCID.
Iowa: Iowa currently has no rule or statute addressing newborn screening for SCID.
Michigan: Michigan currently has no rule or statute addressing newborn screening for SCID.
Minnesota: Minnesota currently has no rule or statute addressing newborn screening for SCID.
Summary of factual data and analytical methodologies
In determining whether to add or delete SCID and related conditions of immunodeficiency to the list of disorders under s.
HFS 115.04, the Department sought advice from the Wisconsin Newborn Screening Umbrella Advisory Group (Advisory Group). The Department and the Advisory Group considered the following criteria under s.
HFS 115.06:
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 the testing for the specific condition.
In consideration of these criteria, the Advisory Group recommended the Department add the condition known as and related conditions of immunodeficiency to the 13 disorders and types of disorders currently screened for under s.
HFS 115.04.
Initial Regulatory Flexibility Analysis
The rule change will not affect small business as “small business" is defined in s.
227.114 (1) (a), Stats., as small businesses are not involved in the process of screening newborns for congenital and metabolic disorders.
Small business regulatory coordinator
Rosie Greer
608-266-1279
Fiscal Estimate
Summary
Wisconsin Statute 253.13 requires that every infant born be subjected to blood tests for congenital and metabolic disorders; however, parents may refuse to have their infants screened for religious reasons. The Wisconsin Newborn Screening Umbrella Advisory Group recommended to the Department the addition of Severe Combined Immunodeficiency (SCID) and related conditions of immunodeficiency to the screening panel. Infants with SCID are extremely vulnerable to infections, to the degree that the condition is universally fatal if not detected and treated within the first year of life.
The Department of Health and Family Services works closely with the Wisconsin State Laboratory of Hygiene to implement the program.
The rule change would add SCID and related conditions of immunodeficiency to the 13 disorders and disorder types currently screened for under HFS 115.04. All newborn screening tests are currently paid for by user-generated fees. The State Laboratory of Hygiene charges hospitals $69.50 for each newborn screening sample collection card. Hospitals in turn charge parents for newborn screening, which is typically included in the labor and delivery bill and covered by the mother's insurance. A grant from the Jeffrey Modell Foundation, which is matched by the Children's Hospital of Wisconsin/Medical College of Wisconsin, will fund the cost of testing for SCID through 2008. For subsequent years, the Wisconsin State Laboratory of Hygiene and Division of Public Health will actively seek additional grant funding in order to continue screening for SCID and related conditions of immunodeficiency at no cost to the state.
If grant funding is not available, the fee for the newborn screening sample card will need to be increased by January 1, 2009. The annual cost of screening an estimated 71,000 births in Wisconsin for SCID will be approximately $387,000. This increased cost will raise fees by $5.50 per child, for a total screening fee of $75.00 per child screened. In the absence of this screening, babies who are undiagnosed or diagnosed late with SCID typically cost $1-2 million each to treat (this figure is based on audited costs from Children's Hospital of Wisconsin, the facility which treats children with SCID, but without benefit of early diagnosis). Babies diagnosed in the first week of life can be cured by bone marrow transplantation (at least 75% cure rate) at a charge of $170,000/discharge (2005 J Peds, McGhee et.al.). Typically, the cost of this treatment for infants with SCID is paid by the infant's health insurance or Medicaid and is not a cost to the Congenital Disorders Program, which pays only for initial follow-up visits and confirmatory testing. It is expected that the savings to Medicaid may be substantial for each eligible affected child receiving early diagnosis.
Local fiscal effect
None
