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)
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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:
None beyond those currently required.
Oci Small Business Regulatory Coordinator
The OCI small business coordinator is Louie Cornelius and may be reached at phone number (608) 264-8113 or by email at
Louie.Cornelius@wisconsin.gov.
Proposed Order Amending, Repealing, and Recreating a Rule
The Commissioner of Insurance proposes an order to amend s.
Ins 17.01 (3), and to repeal and recreate s.
Ins 17.28 (6), Wis. Admin. Code, relating to the Injured Patients and Families Compensation Fund annual fund and mediation panel fees, for the fiscal year beginning July 1, 2014 and affecting small business.
The statement of scope for this rule SS: 147-13, was approved by the Governor on November 18, 2013, published in
Register No. 695, on November 30, 2013, and approved by the Commissioner on May 8, 2014.
Analysis Prepared by the Office of the Commissioner Of Insurance (OCI)
Statutes interpreted:
Statutory authority
Explanation of OCI's authority to promulgate the proposed rule
The injured patients and families compensation fund (“fund"), was established by and operated under Ch.
655, Stats. The commissioner of insurance with approval of the board of governors (“board") is required to annually set the fees for the fund and the medical mediation panel by administrative rule. The proposed fees comply with the limitation delineated in s.
655.27 (3) (br), Stats. Section
655.004, Stats., provides that the director of state courts and the commissioner may promulgate rules necessary to enable them to perform their responsibilities under this chapter. Pursuant to s.
655.27 (3) (b), Stats., the commissioner, after approval by the board, shall by rule set the fees to the fund and s.
655.61, Stats., requires the board, by rule, to set the fees charged to health care providers at a level sufficient to provide the necessary revenue to fund the medical mediation panels. Further, s.
601.41 (3), Stats., provides that the commissioner shall have rule-making authority pursuant to s.
227.11 (2), Stats.
Related statutes or rules
None.
Plain language analysis
This proposed rule establishes the fees that participating health care providers must pay to the fund for the fiscal year beginning July 1, 2014. These fees represent a 10% decrease from fees paid for the 2013-2014 fiscal year. The board approved these fees at its meeting on December 18, 2013, based on the recommendation of the board's actuarial and underwriting committee and reports of the fund's actuaries.
The board is also required to promulgate by rule the annual fees for the operation of the injured patients and families compensation medical mediation system, based on the recommendation of the director of state courts. The recommendation of the director of state courts was reviewed by the board's actuarial and underwriting committee. This rule implements the funding level approved by the board on March 19, 2014 by establishing mediation panel fees for the next fiscal year at $7.75 for physicians and $1.50 per occupied bed for hospitals, representing an increase of $7.75 per physician and an increase of $1.50 per occupied bed for hospitals from 2013-14 fiscal year mediation panel fees.
Summary of and comparison with any existing or proposed federal statutes and regulations
To the fund board's and OCI's knowledge there is no existing or proposed federal regulation that is intended to address fund rates, administration or to fund medical mediation panel activities.
Comparison with rules in adjacent states
To the fund board's and OCI's knowledge there are no similar rules in the adjacent states to compare this rule to as none of adjacent states have a fund created by statute where rates are directed to be established yearly by rule as is true in Wisconsin.
A summary of the factual data and analytical methodologies that OCI used in support of the proposed rule:
None. This rule establishes annual fund fees pursuant to the requirements of the above-noted Wisconsin statutes. The recommendation to the board regarding the fund fee and the medical mediation panel assessment is developed and reviewed annually by the fund's actuaries and the board's actuarial and underwriting committee. The actuarial and underwriting committee after review and discussion with the fund's actuaries present the information and the actuaries report to the board for consideration. This proposed rule reflects the rates approved by the board at the December 18, 2013 and March 19, 2014 board meetings.
Analysis and supporting documentation that OCI used in support of OCI's determination of the rule's effect on small business or in preparation of an economic impact analysis
