The Department intends to promulgate the proposed rule order without a public hearing, pursuant to s. 227.16 (2) (e), Stats. The Office of the Secretary is primarily responsible for the promulgation of the rule order.
Contact Information
If you have questions regarding this rule, you may contact:
Mark Wipperfurth
Income, Sales, and Excise Tax Division
Telephone (608) 266-8253
Revenue
Rule Submittal Date
Notice is hereby given, pursuant to s. 227.14 (4m), Stats., that on June 14, 1999 the Wisconsin Department of Revenue submitted a proposed rule order to the Wisconsin Legislative Council Rules Clearinghouse.
Analysis
The proposed rule order amends s. Tax 11.66, relating to telecommunications services.
Agency Procedure for Promulgation
The Department intends to promulgate the proposed rule order without a public hearing, pursuant to s. 227.16 (2) (e), Stats. The Office of the Secretary is primarily responsible for the promulgation of the rule order.
Contact Information
If you have questions regarding this rule, you may contact:
Mark Wipperfurth
Income, Sales, and Excise Tax Division
Telephone (608) 266-8253
N o t i c e S e c t i o n
Notice of Hearing
Health & Family Services
(Health, Chs. HFS 110-)
Notice is hereby given that, pursuant to ss. 253.13 (1) and 227.11 (2) (a), Stats., the Department of Health and Family Services will hold a public hearing to consider the amendment of s. HFS 115.04 (intro.) and (1) to (7) and 115.06, Wis. Adm. Code, and the creation of s. HFS 115.04 (8), Wis. Adm. Code, relating to screening of newborn children for congenital and metabolic disorders.
Hearing Information
July 14, 1999 2nd Floor Conference Room
Wednesday State Laboratory of Hygiene
Beginning at 10 a.m. 2601 Agriculture Dr.(intersects with
Pflaum Rd. a few blocks east of
Hwy. 51)
MADISON, WI
The hearing site is fully accessible to people with disabilities.
Analysis Prepared by the Department of Health and Family Services
The Department of Health and Family Services administers the Newborn Screening Program under s. 253.13, Stats. Under that program a sample of blood is drawn from nearly every newborn infant in the state before a child is discharged from the hospital, if the child was born in a hospital, or within one week of birth, if the child was born elsewhere, and tests are conducted by the State Laboratory of Hygiene on each blood sample to detect any of the congenital or metabolic disorders specified in ch. HFS 115, the Department's rules for the program. The conditions for which testing is done were specified by statute before November 1, 1992. Since then, s. 253.13 (1), Stats., has directed the Department to specify those conditions by rule.
The Department adds to or deletes from the rules conditions for testing of blood samples on the advice of the Newborn Screening Advisory Group made up of medical consultants, State Laboratory of Hygiene staff and other persons with expertise and experience in dealing with congenital and metabolic disorders, and in accordance with 6 criteria listed in s. HFS 115.06. The criteria include the availability of effective therapy for the condition and potential for successful treatment, the availabilty of mechanisms for determining the effectiveness of test procedures, and the expected benefits to children and society in relation to the risks and costs of the testing.
The Newborn Screening Advisory Group has unanimously supported the recommendation of Department staff to add at this time Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCAD) and 13 other fatty oxidation and branched chain amino acid disorders as a new condition for which testing of blood samples drawn from newborns is conducted. It is estimated that through this testing 15 to 20 babies a year in Wisconsin will be identified as having one of the disorders. Morbidity and mortality are high for persons with the condition if treatment is not begun before the onset of clinical symptoms. Prompt initiation of treatment results in nearly 100% survival and normal development. Treatment is simple (diet supplementation and regulation) and inexpensive. The screening technology has only recently been developed.
This rulemaking order adds MCAD and the other 13 fatty acid oxidation and branched chain amino acid disorders as a new condition to the list of conditions in s, HFS 115.04 for which blood samples taken from newborns will be tested. The order also converts the lists found in ss. HFS 115.04 and 115.06 to a new form required by revised drafting standards.
Text of Rules
SECTION 1. HFS 115.04 (intro.) and (1) to (7) are amended to read:
HFS 115.04 Congenital and metabolic disorders. Blood samples taken from newborns as required under s. 253.13 (1), Stats., shall be tested by the state laboratory for all of the following conditions:
(1) Phenylketonuria (PKU), ICD-9-CM 270.1;.
(2) Galactosemia, ICD-9-CM 271.1;.
(3) Congenital hypothyroidism, ICD-9-CM 243;
.
(4) Sickle cell disease and related hemoglobin abnormalities, ICD-9-CM 282.6;.
(5) Biotinidase deficiency, ICD-9-CM 266.9;.
(6) Congenital adrenal hyperplasia, ICD-9-CM 255.2; and.
(7) Cystic fibrosis, ICD-9-CM 277.0.
SECTION 2. HFS 115.04 (8) is created to read:
HFS 115.04 (8) Medium chain acyl-coenzyme A dehydrogenase deficiency (MCAD) and related disorders of lipid metabolism, ICD-9-CM 272.9.
SECTION 3. HFS 115.06 is amended to read:
HFS 115.06 Criteria for adding or deleting conditions. In determining which disorders are to be added or deleted from s. HFS 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 abililty 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; and
.
(6) The expected benefits to children and society in relation to the risks and costs associated with testing for the specific condition.
Contact Person
To find out more about the hearing, write or phone:
Michael Pfrang
Division of Public Health
1414 E. Washington Avenue
Room 251
Madison, Wisconsin 53703
(608) 266-7550
if you are hearing impaired,
phone 1-800-947-3529
If you are hearing or visually impaired, do not speak English, or have other personal circumstances which might make communication at the hearing difficult and if you, therefore, require an interpreter or a non-English, large-print or taped version of the hearing document, contact the person at the address or phone number above. A person requesting a non-English or sign language interpreter should make that request at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.
Written comments on the proposed rules received at the above address no later than July 21, 1999 will be given the same consideration as testimony presented at a hearing.
Fiscal Estimate
Under s. 253.13, Stats., a blood sample is required to be taken from each newborn infant in the state and that one blood sample is currently tested to determine if the child has one of seven different congenital or metabolic disorders, including phenylketenuria (PKU) and cystic fibrosis, listed in the Department's rules at HFS 115.04. Very few children are found to have one of the listed conditions but, for those who do, effective therapy is available and the potential for successful treatment is high if treatment is begun early. This order adds a new condition to the list of congenital and metabolic disorders for which testing of blood samples is done.
Addition of the new condition to s. HFS 115.04 will increase State Laboratory of Hygiene costs, that is, the laboratory costs of the Newborn Screening Program, by about $275,000 a year or $4.00 per newborn screened. The annual cost for follow-up treatment, which is funded by a Department surcharge added to the laboratory costs, is estimated at about $105,000 or about $1.50 per newborn screened. The cost of providing screening and treatment for the seven current disorders is borne by parents of newborns through a screening charge which is part of the delivery cost for an infant born in Wisconsin, and this cost will be increased by about $5.50 by the rule addition. For most parents this is an expense covered by third party payers whose policies cover the cost of labor and delivery.
This rule change will not affect the expenditures or revenues of state government or local governments. Local governments are not involved with the administration of the Newborn Screening Program and are not affected by the Program. Program administration costs will increase for the State Laboratory of Hygiene and the Department but those costs will be fully covered by the increased newborn screening fee paid by parents or third party payers on behalf of parents.
Initial Regulatory Flexibility Analysis
This change to ch. HFS 115 will not affect small businesses as “small business" is defined in s. 227.114 (1) (a), Stats. The addition of another condition for which a blood sample is screened will affect the State Laboratory of Hygiene, the Department (for follow-up treatment), newborn children identified as having the particular condition (they will benefit from follow-up treatment) and their parents, and all parents of newborn children or their third-party payers for the additional cost (about $5.50) of a delivery. No third-party payer is likely to be a small business, and in any case would likely absorb or pass-on increased costs to parents.
Notice of Proposed Rule
Medical Examining Board
