Scope Statements
Health and Family Services
Subject
The proposed rules amend ch.
HFS 115, relating to screening of newborns for congenital and metabolic disorders.
Policy Analysis
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. Therefore, Wisconsin Statute 253.13 requires that every infant born be subjected to blood tests for congenital and metabolic disorders, as specified in administrative rules promulgated by the Department; however, parents may refuse to have their infants screened for religious reasons. The Department has issued ch.
HFS 115, Screening of Newborns for Congenital and Metabolic Disorders, to administer this statutory requirement. Currently, s.
HFS 115.04 lists 13 congenital and metabolic disorders and types of disorders, for a total of 47 different disorders, for which the state hygiene laboratory must test newborn blood samples.
In determining whether to add or delete disorders from the list under s.
HFS 115.04, s.
HFS 115.06 directs the Department to seek the advice of persons with expertise and experience concerning congenital and metabolic disorders. For this purpose, the Department has established the Wisconsin Newborn Screening Umbrella Advisory Group. Section
HFS 115.06 also lists 6 criteria on which the Department must base its decision to add or delete disorders from s.
HFS 115.04. These criteria are as follows:
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 Wisconsin Newborn Screening Advisory Umbrella Advisory Group has recently recommended the Department add the condition known as Severe Combined Immunodeficiency (SCID) and related conditions of immunodeficiency to the 13 disorders and types of disorders currently screened for and listed in s.
HFS 115.04. 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.
When SCID and related conditions of immunodeficiency are permanently added to those disorders and types of disorders listed in s.
HFS 115.04, follow-up and management will be conducted by both 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 will be responsible for coordinating the activities of the managing specialists, but will not provide direct patient care.
This rule change would add SCID and related conditions of immunodeficiency to the 13 disorders and disorder types currently screened for under s.
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. The cost of adding SCID to the newborn screening panel will be supported by grant funds through 2008 at least. In years 2009, 2010, 2011 and 2012, 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. However, such outside funding is not guaranteed. Thus, perhaps as early as January 1, 2009, the cost of the newborn screening sample card will need to be increased. The increase is currently estimated to be $5.52, which would result in a new total cost of approximately $75.00 per child screened. The annual cost of screening for SCID in Wisconsin, based on the additional $5.50 per child, would be approximately $387,000 when grant funding is completed and user-generated fees begin covering costs (anticipated sometime between 1/1/09 and 1/31/13). 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 and related conditions of immunodeficiency, 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.
The Advisory Group also recommended the Department begin screening newborns for SCID and related conditions of immunodeficiency as soon as possible. Before the screening can begin, the Department needs to add these conditions to the list in s.
HFS 115.04. Therefore, it is proposed to put an emergency rule in effect first, to be followed by an identical proposed permanent rule to replace the emergency rule.
Statutory Authority
Entities Affected by the Rule
Wisconsin State Lab of Hygiene, hospitals, primary care physicians/pediatricians, families of infants born in the state of Wisconsin.
Comparison with Federal Regulations
There are no current federal regulations concerning newborn screening, nor are there any which specifically address screening newborn infants for the condition known as SCID.
Estimate of Time Needed to Develop the Rule
40-45 hours
Insurance
Subject
The rules affect ch.
Ins 3, relating to long-term care plans including the long-term care partnership program and affecting small business.
Objective of the Rule
To update the current administrative rule which was last revised in 2001 to comply with the National Association of Insurance Commissioners (NAIC) Model Act. Additionally, amendments are needed to comply with the requirements of the Center for Medicare and Medicaid Services (CMS) related to the Long-term Care Partnership program.
Policy Analysis
The current administrative rule was last revised in 2001 and is not fully compliant with the NAIC Model Act. Potential modifications to the long-term care rule include expanded reporting requirements, standards for marketing, suitability of products, and format changes to outlines of coverage. Additionally, modifications will be necessary in order to comply with
2007 Wis. Act 20 that created s.
601.415 (8), Stats. Modifications may include requirements related to the approval of training programs in compliance with the statute.
Statutory Authority
Entities Affected by the Rule
Insurers offering long-term care insurance products including the long-term care partnership program policies and insurance intermediaries that sell these products to consumers.
Comparison with Federal Regulations
The Office is unaware of any proposed or existing federal regulation that is intended to address the activities to be regulated by this proposed rule.
Estimate of Time Needed to Develop the Rule
200 hours and no other resources are necessary.
Natural Resources
Subject
The Bureau of Wildlife Management recommends promulgating administrative rules that modify sections of chapters NR 1, 8, 10, 12, 15, 16, 17, and 19. These rule changes related to hunting, trapping, captive wild animals, dog training, nuisance animal removal and license issuance are minor and unlikely to be controversial. The intent of these rule changes is to correct drafting errors, provide clarification to existing rules, simplify regulations, and update administrative code language and references. Specifically, these rules will expand the types of licenses which may be issued through the automated license system, update deer shooting permit language to be consistent with statutes, and correct and update deer hunting rule language. This rule also updates bear hunting zones, fur tagging regulations, the description of the Horicon Marsh Fur Farm, and corrects drafting errors and oversights related to dog training. Finally, this rule will clarify that tanning furs does not require a taxidermy license.
Policy Analysis
Every year the department promulgates a rule order that contains changes that are considered to be minor and non-controversial. This package, known as the annual housekeeping order, helps to correct inaccuracies and clarify existing regulations. Policy issues affected by this rule are ones which have already been addressed decided by previous rulemaking.
Statutory Authority
Entities Affected by the Rule
Groups and individuals who are likely to be interested in the outcome of these rule changes include hunters, trappers, dog trainers, license agents, and people who tan raw furs. However, because of the corrective and non-controversial nature of these changes no groups will be significantly impacted.
Comparison with Federal Regulations
Federal regulations allow states to manage the wildlife resources located within their boundaries provided they do not conflict with regulations established in the Federal Register. None of these rule changes violate or conflict with the provisions established in the Federal Code of Regulations.
Estimate of Time Needed to Develop the Rule
150 hours.
Agency Contact Person
Natural Resources
Subject
