1. A statutory or nonstatutory provision containing a statement or declaration of legislative intent, purpose, findings, or policy does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
2. A statutory provision describing the agency's general powers or duties does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
3. A statutory provision containing a specific standard, requirement, or threshold does not confer on the agency the authority to promulgate, enforce, or administer a rule that contains a standard, requirement, or threshold that is more restrictive than the standard, requirement, or threshold contained in the statutory provision.
Section 253.13 (1) and (4) (b) reads: (1)
Tests; requirements. The attending physician or nurse licensed under s.
441.15 shall cause every infant born in each hospital or maternity home, prior to its discharge therefrom, to be subjected to tests for congenital and metabolic disorders, as specified in rules promulgated by the department. If the infant is born elsewhere than in a hospital or maternity home, the attending physician, nurse licensed under s.
441.15, or birth attendant who attended the birth shall cause the infant, within one week of birth, to be subjected to these tests.
(4) (b) The department may require reporting in connection with the tests performed under this section for use in statistical data compilation and for evaluation of infant screening programs.
Related statute or rule
See the “Statute interpreted" section.
Plain language analysis
As provided in s.
253.13 (1), Stats. (2011-12), ch.
DHS 115 specifies the congenital and metabolic orders for which newborns must be screened by means of a blood sample shortly after birth and tested by the WSLH.
2013 Wisconsin Act 135 modified s.
253.13 (1), Stats., relating to infant blood tests to provide that the required screening may be performed by methods in addition to blood testing. Under this emergency order the department revises ch.
DHS 115 to conform the rules to s.
253.13, Stats.
The emergency order adds CCHD and OA as conditions for which newborns must be tested. CCHD is usually described as those congenital cardiac malformations in which surgical or catheter-based therapy is necessary within the first months of life, and is screened for by use of pulse oximetry. In September 2010, the federal Department of Health and Human Services' Discretionary Advisory Committee on Heritable Disorders in Newborns and Children added CCHD to its Recommended Uniform Screening Panel Core Conditions. To date, 35 states have added CCHD screening to their newborn screening panel.
OA is
a group of inherited disorders that lead to an abnormal buildup of particular acids known as organic acids in the body for which the WSLH currently tests newborns. Though the criteria under s.
DHS 115.06 was met for OA to be added to the list of congenital and metabolic disorders for which WSLH must test blood samples, the disorders were inadvertently omitted from subsequent revisions of s.
DHS 115.04.
The department intends to promulgate corresponding permanent rules to replace these emergency rules, except that the department intends to also propose, as permitted under s.
253.13 (4), Stats., reporting requirements in the proposed permanent rules.
Summary of, and comparison with, existing or proposed federal regulations
There appears to be no existing or proposed federal regulations that address the activities to be regulated by the emergency rules.
Comparison with rules in adjacent states
For the past ten years Illinois, Iowa, Michigan, and Minnesota have mandated that newborns be screened for organic acidemias to include propionic acidemia and methylmalonic acidemia as part of their state's newborn screening program. Also, each of these four states require by law that newborns be screened for CCHD using pulse oximetry screening and provide reports on all pulse oximetry results if sufficient funds are available to do so. Only Iowa has an administrative rule for CCHD.
Illinois:
Illinois 410 ILCS 240/1.10 (b) “The Department shall require that screening tests for critical congenital heart disease be performed at birthing hospitals and birth centers in accordance with a testing protocol adopted by the Department, by rule, in line with current standards of care, such as pulse oximetry screening…" 77 Ill. Adm. Code 661.10 Responsibility for Screening explains that a Genetic and Metabolic Diseases Advisory Committee will recommend to the Department when an additional disorder should be added to the screening panel. Implementation of the Department's determination is subject to that determination's adoption by rule. This process is similar to Wisconsin's procedure for adding a disorder.
Iowa:
Iowa Code s. 136A.5A requires that each Iowa newborn “shall receive a critical congenital heart disease screening by pulse oximetry or other means as determined by rule, in conjunction with the metabolic screening required pursuant to section 136A.5A." Section 136.5A was added as part of 2013 Act, Ch.
140 Section 91 and Section 92 to address critical congenital heart disease screening; however the administrative rule is not yet written. Administrative Code 641 IAC 4.3 (1) states that CCHD will be included in the state's newborn screening panel as included in the recommended uniform screening panel as approved by the United States Secretary of Health and Human Services."
Michigan:
Under Michigan statute, MCLS, s.
333.5431 (1) (i) refers to CCHD generally as “other treatable but otherwise disabling conditions as designated by the department." The Michigan Department of Community Health website lists all (55) of the disorders included in their screening panel which includes CCHD.
Minnesota:
Minn. Stats. s.
144.1251 (1) (a) requires testing and reporting as follows “each licensed hospital or state licensed birthing center or facility that provides maternity and newborn care services shall provide screening for congenital heart disease to all newborns prior to discharge using pulse oximetry screening." The Minnesota Department of Health's procedure for implementation includes: communicating CCHD screening protocol requirements; providing information to hospitals; providing training; establishing the mechanism for required data collection; coordinating implementation of universal standardized screening; and acting as a resources for providers which is similar to Wisconsin's approach.
Summary of factual data and analytical methodologies
The Secretary's Advisory Committee on Newborn Screening (Committee) recommended to the department, and the department concurred with the recommendation to add CCHD to the list of congenital or metabolic disorders for which newborns must be screened.
The WSLH tests newborns OA, a group of inherited disorders that lead to an abnormal buildup of particular acids, known as organic acids, in the body. Though OA was determined to have met the criteria under s.
DHS 115.06 for being added to the list of congenital and metabolic disorders for which WSLH must test the blood samples of newborns, the conditions were inadvertently omitted from the list of conditions in s.
DHS 115.04 during subsequent revisions.
Analysis and supporting documents used to determine effect on small business
The department under this emergency order revises ch.
DHS 115 to conform the rules to s.
253.13, Stats., as revised under
2013 Wisconsin Act 135 so that the required newborn screening may be performed by methods in addition to blood testing. Also under this emergency order, the department adds CCHD and OA to the list of congenital and metabolic disorders for which newborns must be tested. Section
253.13 (1), Stats., requires attending physicians, nurse-midwives, and certified midwives to cause every infant born in Wisconsin to be screened for the congenital and metabolic disorders specified by the department by rule. To comply with s.
253.13 (1), Stats., hospitals, stand-alone birth centers, physicians, nurse-midwives, certified midwives, and other entities (purchasers) purchase newborn screening sample collection cards for $109 from the WSLH for use when obtaining the newborn's blood sample for testing. The addition of CCHD and OA to the list of congenital and metabolic disorders under s.
DHS 115.04 for which newborns must be tested does not increase the current fee or impose any additional fees to purchasers of newborn screening sample collection cards.
Costs to providers for screening for CCHD is indeterminate. Pulse oximetry is the recognized screening method for CCHD. The cost of a reliable hand held device, with a reusable probe, costs about $500, with probe wraps costing about $.60 each. Administering the pulse oximetry testing on newborns averages about three minutes per baby and it is usually conducted by nurses. Some of the costs to providers for screening for CCHD have been mitigated through the Wisconsin SHINE Project (Screening Hearts in Newborns), a pilot project through the University of Wisconsin School of Medicine and Public Health, the Medical College of Wisconsin, the department, and the WSLH , which works to create a safety net for all babies born in Wisconsin by educating healthcare providers, improving access to screening and diagnostic technology, and creating a statewide CCHD screening and data collection system. The Wisconsin SHINE project has supplied pulse oximeters to hospitals and midwives who did not have them.
The inclusion of OA in the list of disorders for which newborns must be tested will not impose any additional costs to providers because the WSLH currently tests newborns for OA including propionic acidemia, methylmalonic acidemia, and related organic acidemias.
Effect on Small Business
Based on the foregoing analysis, the emergency rules are anticipated to have little or no economic impact on businesses.
Agency Contact Person
Susan Uttech, Department of Health Services, Bureau Director, Community Health Promotion,
susan.uttech@wi.gov 608-267-3561
Statement on Quality of Agency Data
The department relied on the following information for the rules and analysis:
US Secretary of Health and Human Services, Secretary's Advisory Committee on Heritable Disorders in Newborns and Children
Wisconsin Newborn Screening Program — Condition Nomination Form
Ng B, Hokanson J. Missed congenital heart disease in neonates. Congenit Heart Dis. 2010;5:292-6.
Bissel DlJl Goetz EM, Hokanson J.S> Pulse Oximetry for Congenital Heart Disease in Wisconsin. Congenit Heart Dis. 2011; 6:521-2
Initial Regulatory Flexibility Analysis
The rules affect hospitals, stand-alone birth centers, physicians, nurse-midwives, certified midwives, and other entities that are required by s.
253.13 (1), Stats., to test newborns for congenital and metabolic disorders. The rules do not impose any reporting, bookkeeping, or other procedures for compliance with the rules, nor do the rules require any professional skill beyond those used in the respective medical professions to comply with the rules.
Rosie Greer
(608) 266-1279
Fiscal Estimate—Economic Impact Analysis
The Fiscal Estimate—Economic Impact Analysis follows this hearing notice.
Agency Contact Person
Susan Uttech, Department of Health Services, 1 W. Wilson Street, Room 218, Madison, WI, 53701, (608) 267-3561,
susan.uttech@wi.gov.
STATE OF WISCONSIN
DEPARTMENT OF ADMINISTRATION
DOA-2049 (R03/2012)
|
Division of Executive Budget and Finance
101 East Wilson Street, 10th Floor
P.O. Box 7864
Madison, WI 53707-7864
FAX: (608) 267-0372
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ADMINISTRATIVE RULES
Fiscal Estimate & Economic Impact Analysis
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1. Type of Estimate and Analysis
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X Original
⍽ Updated
⍽ Corrected
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2. Administrative Rule Chapter, Title and Number
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DHS 115, Screening of Newborns for Congenital and Metabolic Disorders
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3. Subject
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Newborn screening for congenital and metabolic disorders (to add Critical Congenital Heart Disease (CCHD) and Organic Acidemia (OA) as conditions for which newborns must be tested)
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4. Fund Sources Affected
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5. Chapter 20, Stats. Appropriations Affected
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⍽ GPR
⍽ FED
⍽ PRO
⍽ PRS
⍽ SEG
⍽ SEG-S
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6. Fiscal Effect of Implementing the Rule
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X No Fiscal Effect
⍽ Indeterminate
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⍽ Increase Existing Revenues
⍽ Decrease Existing Revenues
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⍽ Increase Costs
⍽ Could Absorb Within Agency's Budget
⍽ Decrease Cost
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7. The Rule Will Impact the Following (Check All That Apply)
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⍽ State's Economy
⍽ Local Government Units
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⍽ Specific Businesses/Sectors
⍽ Public Utility Rate Payers
⍽ Small Businesses (if checked, complete Attachment A)
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8. Would Implementation and Compliance Costs Be Greater Than $20 million?
⍽ Yes X No
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9. Policy Problem Addressed by the Rule
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As provided in s. 253.13 (1), Stats. (2011-12), ch. DHS 115 specifies the congenital and metabolic orders for which newborns must be screened by means of a blood sample shortly after birth and tested by the Wisconsin State Laboratory of Hygiene (WSLH). 2013 Wisconsin Act 135 modified s. 253.13 (1) Stats., relating to infant blood tests to provide that the required screening may be performed by methods in addition to blood testing. Under the emergency order, the department revises ch. DHS 115 to conform the rules to s. 253.13, Stats., and adds CCHD and OA as conditions for which newborns must be tested.
CCHD is usually described as those congenital cardiac malformations in which surgical or catheter-based therapy is necessary within the first months of life, and is screened for by use of pulse oximetry. In September 2010, the federal Department of Health and Human Services' Discretionary Advisory Committee on Heritable Disorders in Newborns and Children added CCHD to its Recommended Uniform Screening Panel Core Conditions. To date, 35 states have added CCHD screening to their newborn screening panel.
Adding OA as a condition for testing corrects an inadvertent omission from the list of congenital and metabolic disorders. OA is a group of inherited disorders that lead to an abnormal buildup of particular acids known as organic acids in the body for which the WSLH currently tests newborns. Though OA met the criteria under s. DHS 115.06 for being added to the list of congenital and metabolic disorders for which WSLH must test blood samples, the disorders were not included in subsequent revisions of s. DHS 115.04.
The department does not anticipate that the revisions to ch. DHS 115 will have a fiscal impact on the department or local government.
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10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
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Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
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11. Identify the local governmental units that participated in the development of this EIA.
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Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
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12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
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Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
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13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
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Section 253.13 (1), Stats., requires that every infant born in each hospital or maternity home, prior to its discharge, be tested for congenital and metabolic disorders, as specified in rules promulgated by the department. Therefore, there are no reasonable alternatives to the proposed rulemaking.
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14. Long Range Implications of Implementing the Rule
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Indeterminate
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15. Compare With Approaches Being Used by Federal Government
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Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
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16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
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Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
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17. Contact Name
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18. Contact Phone Number
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Susan Uttech
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608-267-3561
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This document can be made available in alternate formats to individuals with disabilities upon request.
Notice of Hearings
Insurance
NOTICE IS HEREBY GIVEN that pursuant to the authority granted under s.
601.41 (3), Stats., and the procedures set forth in under ss.
227.18 and
227.24, Stats., OCI will hold a public hearing to consider the emergency rule issued on June 18, 2014 and the adoption of the attached proposed rulemaking order affecting sections
Ins 17.01 (3) and
17.28 (3) (c) and
(6), relating to Injured Patients and Families Compensation Fund annual fund and mediation panel fees for the fiscal year beginning July 1, 2014, and affecting small business.
Hearing Information
Date: Tuesday, August 12, 2014
Time: 1:30 p.m., or as soon thereafter as the
matter may be reached
Location: Office of the Commissioner of Insurance
Room 227
125 South Webster St., 2nd Floor
Madison, WI
Submission of Written Comments
Written comments can be mailed to:
Julie E. Walsh
Legal Unit — OCI Rule Comment for Rule Ins 1728
Office of the Commissioner of Insurance
PO Box 7873
Madison WI 53707-7873
Written comments can be hand delivered to:
Julie E. Walsh
Legal Unit — OCI Rule Comment for Rule Ins 1728
Office of the Commissioner of Insurance
125 South Webster St, 2nd Floor
Madison WI 53703-3474
Comments can be emailed to:
Julie E. Walsh
The deadline for submitting comments is 4:00 p.m. on August 22, 2014.
Copies of the Rule and Fiscal Estimate
A copy of the full text of the proposed rule changes, analysis and fiscal estimate may be obtained from the OCI internet Web site at
http://oci.wi.gov/ocirules.htm or by contacting Inger Williams, Public Information and Communications, OCI, at
inger.williams@wisconsin.gov, (608) 264-8110, 125 South Webster Street — 2
nd Floor, Madison WI or PO Box 7873, Madison WI 53707-7873.
Summary of Proposed Rule and Fiscal Estimate
For a summary of the rule see the analysis contained in the attached proposed rulemaking order. There will be no state or local government fiscal effect. The full text of the proposed changes, a summary of the changes and the fiscal estimate are attached to this Notice of Hearing.
Initial Regulatory Flexibility Analysis
This rule does not impose any additional requirements on small businesses.
Notice is hereby further given that pursuant to s.
227.114, Stats., the proposed rule may have an effect on small businesses. The initial regulatory flexibility analysis is as follows:
a. Types of small businesses affected:
Small businesses that employ physicians or other health care professionals participating in the fund.
b. Description of reporting and bookkeeping procedures required:
None beyond those currently required.
c. Description of professional skills required:
