EmR1410 Revises revising Chapter DHS 115, relating to screening newborns for congenital and metabolic disorders.  

  • Rule-Making Notices
    Notice of Hearings
    Health Services
    Health, Chs. DHS 110—
    NOTICE IS HEREBY GIVEN that pursuant to ss. 227.11 (2) (a) and 253.13 (1) and (4) (b) , Stats., the Department of Health Services will hold a public hearing to consider the emergency rules revising Chapter DHS 115 , relating to screening newborns for congenital and metabolic disorders.
    Hearing Information
    Date:   Friday, August 15, 2014
    Time:   2:30 p.m. to 4:30 p.m.
    Location:
      Department of Health Services
      1 W. Wilson Street
      Room 630
      Madison, WI 53701
    Accessibility
    English
    The Department of Health Services is an equal opportunity employer and service provider. If you need accommodations because of a disability or need an interpreter or translator, or if you need this material in another language or in an alternate format, you may request assistance to participate by contacting Susan Uttech at (608) 267-3561. You must make your request at least 7 days before the activity.
    Spanish
    The Department of Health Services es una agencia que ofrece igualdad en las oportunidades de empleo y servicios. Si necesita algún tipo de acomodaciones debido a incapacidad o si necesita un interprete, traductor o esta información en su propio idioma o en un formato alterno, usted puede pedir asistencia para participar en los programas comunicándose con Susan Uttech al número (608) 267-3561. Debe someter su petición por lo menos 7 días de antes de la actividad.
    Hmong
    The Department of Health Services yog ib tus tswv hauj lwm thiab yog ib qhov chaw pab cuam uas muab vaj huam sib luag rau sawv daws. Yog koj xav tau kev pab vim muaj mob xiam oob qhab los yog xav tau ib tus neeg pab txhais lus los yog txhais ntaub ntawv, los yog koj xav tau cov ntaub ntawv no ua lwm hom lus los yog lwm hom ntawv, koj yuav tau thov kev pab uas yog hu rau Susan Uttech ntawm (608)267-3561. Koj yuav tsum thov qhov kev pab yam tsawg kawg 7 hnub ua ntej qhov hauj lwm ntawd.
    Copies of Rule and Fiscal Estimate — Economic Impact Analysis
    A copy of the rules and fiscal estimate may be obtained from the Department of Health Services at no charge by downloading the documents from www.adminrules.wisconsin.gov or by contacting Susan Uttech, Department of Health Services, 1 W. Wilson Street, Room 218, Madison, WI, (608) 267-3561, susan.uttech@wi.gov .
    Place Where Comments are to be Submitted and Deadline for Submission
    Comments may be submitted to Susan Uttech, Department of Health Services, 1 W. Wilson Street, Room 218, Madison, WI, (608) 267-3561, susan.uttech@wi.gov or to the Wisconsin Administrative Rules Website at http://www.adminrules.wisconsin.gov until August 15, 2014 , 4:30 p.m.
    Analysis Prepared by the Department of Health Services
    Statute interpreted
    Section 253.13 (1) , Stats.
    Statutory authority
    Sections 227.11 (2) (a) and 253.13 (1) and (4) (b) , Stats.
    Explanation of agency authority
    Section 227.11 (2) (a) reads: Rule-making authority is expressly conferred on an agency as follows:
    (a) Each agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation. All of the following apply to the promulgation of a rule interpreting the provisions of a statute enforced or administered by an agency:
    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 ( S creening H earts i n Ne wborns), 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
    ADMINISTRATIVE RULES
    Fiscal Estimate & Economic Impact Analysis
    1. Type of Estimate and Analysis
    X Original   Updated   Corrected
    2. Administrative Rule Chapter, Title and Number
    DHS 115, Screening of Newborns for Congenital and Metabolic Disorders
    3. Subject
    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)
    4. Fund Sources Affected
    5. Chapter 20, Stats. Appropriations Affected
    GPR   FED   PRO   PRS   SEG   SEG-S
    6. Fiscal Effect of Implementing the Rule
    X No Fiscal Effect
    Indeterminate
    Increase Existing Revenues
    Decrease Existing Revenues
    Increase Costs
    Could Absorb Within Agency's Budget
    Decrease Cost
    7. The Rule Will Impact the Following (Check All That Apply)
    State's Economy
    Local Government Units
    Specific Businesses/Sectors
    Public Utility Rate Payers
    Small Businesses (if checked, complete Attachment A)
    8. Would Implementation and Compliance Costs Be Greater Than $20 million?
    Yes   X No
    9. Policy Problem Addressed by the Rule
    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.
    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.
    Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
    11. Identify the local governmental units that participated in the development of this EIA.
    Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
    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)
    Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
    13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
    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.
    14. Long Range Implications of Implementing the Rule
    Indeterminate
    15. Compare With Approaches Being Used by Federal Government
    Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
    16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
    Pursuant to s. 227.137 (5), Stats., the information required under this section does not apply to emergency rules.
    17. Contact Name
    18. Contact Phone Number
    Susan Uttech
    608-267-3561
    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, 2 nd Floor
    Madison WI 53703-3474
    Comments can be emailed to:
    Julie E. Walsh
    Comments submitted through the Wisconsin Administrative Rule Web site at http://adminrules.wisconsin.gov on the proposed rule will be considered.
    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
    Rule No. Agency 145 — Sections Ins 17.01 (3) and Ins 17.28 (6) , Wis. Admin. Code.
    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:
    Sections 655.27 (3) and 655.61 , Wis. Stats.
    Statutory authority
    Sections 601.41 (3) , 655.004 , 655.27 (3) (b) , and 655.61 , Wis. Stats.
    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
    This decrease in fund fees will have a positive effect on small businesses in Wisconsin, particularly those that employ physicians and other health care professionals. The mediation panel fee is assessed only on physicians and hospitals, not on corporations or other health care providers. The mediation panel fees are increasing from the zero level of fiscal year 2013-2014 but are still lower than rates in fiscal year 2011-2012. The fund fee decrease will affect only those small businesses that pay the fund fees and mediation panel fees on behalf of their employed physicians. The fund fee decrease will not have a significant effect nor should it negatively affect the ability of small businesses to compete with other providers.
    Effect on Small Business
    This rule will have little or no effect on small businesses. The decrease contained in the proposed rule will require providers to pay reduced fund fees which will decrease the operational expenses for the providers. The increase in mediation panel fees promulgated by this rule should not result in a significant fiscal effect on the private sector.
    A copy of any Comments and Opinion Prepared by the Board of Veterans Affairs under s. 45.03 (2m) , Stats., for Rules Proposed by the Department of Veterans Affairs.
    None.
    Office of the Commissioner of Insurance Fiscal Estimate for Sections Ins 17.01 and 17.28 (6) , Relating to Injured Patients and Families Compensation Fund Annual Fund Fees and Mediation Panel Fees for the Fiscal Year Beginning July 1, 2014 and Affecting Small Business
    This rule change will have no significant effect on the private sector as this proposed rule reduces fees to participants in the fund and slightly increases mediation panel fees to $7.75 for physicians and $1.50 per occupied bed for hospitals. The fund is a segregated account and does not impact state funds. The rule decreases fees and therefore does not have an effect on county, city, village, town, school district, technical college district and sewerage district fiscal liabilities and revenues.
    Agency Contact Person
    A copy of the full text of the proposed rule changes, analysis and fiscal estimate may be obtained from the Web site at: http://oci.wi.gov/ocirules.htm or by contacting Inger Williams, OCI Services Section, at:
    Phone:   (608) 264-8110
    Address:   125 South Webster St — 2 nd Floor
    Mail:   PO Box 7873, Madison, WI 53707-7873
    STATE OF WISCONSIN
    DEPARTMENT OF ADMINISTRATION
    DOA-2049 (C04/2011)
      Division of Executive Budget and Finance
    101 East Wilson Street, 10th Floor
    P.O. Box 7864
    Madison, WI 53707-7864
    FAX: (608) 267-0372
    ADMINISTRATIVE RULES – FISCAL ESTIMATE
    1.   Fiscal Estimate Version
    X Original Updated Corrected
    2.   Administrative Rule Chapter Title and Number
      INS 1728
    3.   Subject
      Injured Patients and Families Compensation Fund Annual fund and Mediation Panel Fees for the fiscal year beginning July 1, 2014 and affecting small business
    4.   State Fiscal Effect:
    X No Fiscal Effect
    Indeterminate
    Increase Existing Revenues
    Decrease Existing Revenues
    Increase Costs
    Yes No   May be possible to absorb
          within agency's budget.
    X Decrease Costs
    5.   Fund Sources Affected:
    GPR   FED   PRO   PRS   X SEG   SEG-S
    6.   Affected Ch. 20, Stats. Appropriations:
    None
    7.   Local Government Fiscal Effect:
    X No Fiscal Effect
    Indeterminate
    Increase Revenues
    Decrease Revenues
    Increase Costs
    Decrease Costs
    8.   Local Government Units Affected:
    Towns Villages Cities Counties School Districts WTCS Districts Others: None
    9.   Private Sector Fiscal Effect (small businesses only):
    X No Fiscal Effect
    Indeterminate
    Increase Revenues
    Decrease Revenues
    Yes X No   May have significant
        economic impact on a
        substantial number of
        small businesses
    Increase Costs
    Yes No   May have significant
        economic impact on a
        substantial number of
        small businesses
    X Decrease Costs
    10.   Types of Small Businesses Affected:
    Small businesses that employ physicians or other health care professionals participating in the Fund.
    11.   Fiscal Analysis Summary
    No significant impact. For Fund fees a 10% decrease and although the rule proposes an increase from zero for mediation panel fees, the proposed fees are less than the 2011-2012 fees.
    12.   Long-Range Fiscal Implications
    None
    13.   Name — Prepared by
    Julie E. Walsh
    Telephone Number
    (608) 264-8101
    Date
    May 9, 2014
    14.   Name – Analyst Reviewer
    Telephone Number
    Date
    Signature—Secretary or Designee
    Telephone Number
    (608) 267-3782
    Date
    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
    ADMINISTRATIVE RULES
    Fiscal Estimate & Economic Impact Analysis
    1. Type of Estimate and Analysis
    X Original   Updated   Corrected
    2. Administrative Rule Chapter, Title and Number
    Agency 145 Ch Ins 17.01 (3), and 17.28 (6)
    3. Subject
    Injured Patients and Families Compensation Fund Annual Fund fees and Mediation Panel Fees for the fiscal year beginning July 1, 2014.
    4. Fund Sources Affected
    5. Chapter 20, Stats. Appropriations Affected
    GPR   FED   PRO   PRS   X SEG   SEG-S
    None
    6. Fiscal Effect of Implementing the Rule
    X No Fiscal Effect
    Indeterminate
    Increase Existing Revenues
    Decrease Existing Revenues
    Increase Costs
    Could Absorb Within Agency's Budget
    Decrease Cost
    7. The Rule Will Impact the Following (Check All That Apply)
    State's Economy
    Local Government Units
    X Specific Businesses/Sectors
    Public Utility Rate Payers
    X Small Businesses (if checked, complete Attachment A)
    8. Would Implementation and Compliance Costs Be Greater Than $20 million?
    Yes   X No
    9. Policy Problem Addressed by the Rule
    To establish the annual fees that participating health care providers must pay to the Injured Patients and Families Compensation Fund ("Fund") as required by s. 655.27 (3), Wis. Stats., for fiscal year beginning July 1, 2014. The proposed rule will also establish the mediation panel fees for fiscal year 2015 commencing on July 1, 2014. This rule provides the Fund with appropriate and adequate funding and solvency for future years. This is the main vehicle for achieving and maintaining the Fund's solvency.
    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.
    OCI solicited comments generally through publication requesting comments from the public utilizing the OCI website. Additionally OCI solicited comments from businesses, individuals, and local government units related to the implementation and compliance costs. Solicitations were sent to health insurance members of OCI's Health and Life Insurance Advisory Council and interested parties. Members included health insurance companies, health insurance agent representatives, consumer representatives, provider representatives and representatives of small business. Additional solicitations were made to associations representing various affected parties and local government representatives including:
      Wisconsin Association of Health Plans
      Wisconsin Association of Health Underwriters
      Independent Insurance Agents Association of Wisconsin
      National Federation of Independent Business-Wisconsin
      Wisconsin Association of Nurse Anesthetists
      Wisconsin Manufacturers and Commerce
      Wisconsin Dental Association
      Wisconsin Medical Society
      Professional Insurance Agents of Wisconsin
      National Association of Insurance and Financial Advisors-Wisconsin
      Wisconsin Hospital Association
      Wisconsin Association for Justice
      The League of Wisconsin Municipalities
      Wisconsin Counties Association
      Wisconsin Towns Association
      Wisconsin Association of School Boards
      Wisconsin Association of School District Administrators
    11. Identify the local governmental units that participated in the development of this EIA.
    None beyond solicitation for comments.
    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)
    All health care provider participants in the Fund as set forth in s. 655.002 (1), Wis. Stat., will be required to pay a 10% reduced assessment for their medical malpractice coverage under Ch.655, Wis. Stat. The impact is considered to be minimal and in fact positive to the participants. In addition there is a fee this fiscal year for mediation panel fees so while greater than fiscal year 2013-2014 fees of zero, the fees are lower than the fees for fiscal year 2011-2012.
    13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
    The proposed rule will benefit Fund participants by ensuring that fee revenue is adequate to cover anticipated administrative, operating and claims payments costs. The alternatives to this rule would be to establish a Fund fee increase, to maintain current fee amounts or to assess fees lower than the proposed 10% reduction in Fund fees. A greater reduction in fees would leave the Fund with inadequate funding to cover actuarially-based projected costs, while a fee increase or static fee level would present an unnecessary cost to Fund participants. The proposed rule does not significantly impact Wisconsin's economy, productivity, jobs or the overall economic competitiveness of Wisconsin. Wisconsin's health care marketplace is strengthened with an affordable layer of medical malpractice coverage. The Fund has existed in Wisconsin since 1975. Fund participants will benefit from a stable and solvent fund. Additionally, Fund participants should not experience increased compliance costs with the reduction of fund fees even with inclusion this year of mediation panel fees.
    14. Long Range Implications of Implementing the Rule
    The long-range implication of the rule as proposed will be an adequately funded and solvent Fund.
    15. Compare With Approaches Being Used by Federal Government
    Federal government does not address this subject matter.
    16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
    None of the neighboring states have a patient compensation fund or a general program of state-sponsored liability insurance for physicians.
    17. Contact Name
    18. Contact Phone Number
    Louie Cornelius
    608-264-8113
    This document can be made available in alternate formats to individuals with disabilities upon request.
    ATTACHMENT A
    1. Summary of Rule's Economic and Fiscal Impact on Small Businesses (Separately for each Small Business Sector, Include Implementation and Compliance Costs Expected to be Incurred)
    The agency does not anticipate any implementation costs or additional compliance costs for fund participants. All health care provider participants in the Fund as set forth in s. 655.002 (1), Wis. Stat., will be required to pay the reduced assessment for their medical malpractice coverage under Ch. 655, Wis. Stat. In addition there is a fee this fiscal year for mediation panel fees however, while the fees are greater than fiscal year 2013-2014 fees of zero, the fees are lower than the fees for fiscal year 2011-2012.
    2. Summary of the data sources used to measure the Rule's impact on Small Businesses
    The Fund contracts for actuarial services to develop the documentation and analysis necessary for the Actuarial and Underwriting Committee of the Fund. The documentation includes an actuarially indicated rate level for break even financial projections against expected claims reflective of all physician classifications. Since some physicians are small employer practices this information does relay information to the Committee and Board for the impact on small businesses directly impacted by the proposal. The actuarial firm presents its analysis to the Actuarial and Underwriting Committee of the Fund Board of Governors. The Committee reviews all documentation and projections and makes a recommendation to the full Board of Governors for consideration. The Fund Board of Governors reviewed the Committee's recommendation at its December 18, 2013 meeting as well as the underlying analysis by the actuarial firm. Following deliberation, the Board of Governors affirmed the Committee's recommendation of a decrease of 10% for Fund fees and at the March 19, 2014 meeting affirmed the change to the mediation panel fees from last year's fees of zero to $7.75 for physicians and $1.50 per occupied bed for hospitals.
    3. Did the agency consider the following methods to reduce the impact of the Rule on Small Businesses?
    Less Stringent Compliance or Reporting Requirements
    Less Stringent Schedules or Deadlines for Compliance or Reporting
    Consolidation or Simplification of Reporting Requirements
    Establishment of performance standards in lieu of Design or Operational Standards
    Exemption of Small Businesses from some or all requirements
    X Other, describe:
    The Board of Governors discussed maintaining fees at 2014 levels but determined that such action was unnecessary in light of the Fund's present financial condition and the reduced fees would adequately fund the Fund for claims incurred during fiscal year 2015 without shifting the burden of funding to future years and providers.
    4. Describe the methods incorporated into the Rule that will reduce its impact on Small Businesses
    The proposed increase is below breakeven financing for the Fund but sufficient to cover anticipated claims, administrative and operating expenses.
    5. Describe the Rule's Enforcement Provisions
    This rule proposes fees. Failure to pay Fund fees is governed by s. Ins 17.01, Wis. Adm. Code, which requires the Fund to notify the medical examining board of each physician who has not paid the fee and notify the Department of Health Services of each hospital that has not paid the fee as required.
    6. Did the Agency prepare a Cost Benefit Analysis (if Yes, attach to form)
    Yes X No
    Notice of Hearings
    Public Instruction
    NOTICE IS HEREBY GIVEN That pursuant to s. 120.13 (19) , Stats., and interpreting s. 120.13 (19) , Stats., the Department of Public Instruction will hold a public hearing as follows to consider the creation of Chapter PI 80 , relating to community programs and services. This hearing will be regarding both the Chapter PI 80 emergency and permanent rule changes.
    Hearing Information
    Date:   Thursday, September 4, 2014
    Time:   3:00 to 5:00 p.m.*
    Location:
      GEF 3 building
      Room 041
      125 South Webster St.
      Madison, WI
    *For those who cannot attend the public hearing, comments received by the Department will be given the same weight as testimony.
    The hearing site is fully accessible to persons with disabilities. If you require reasonable accommodation to access the meeting, please call Katie Schumacher at (608) 267-9127, or leave a message with the Teletypewriter (TTY) at (608) 267-2427, at least 10 days prior to the hearing date. Reasonable accommodation includes materials prepared in an alternative format, as provided under the Americans with Disabilities Act.
    Place Where Comments Are to be Submitted and Deadline for Submission
    The proposed administrative rule is available to review at http://pb.dpi.wi.gov/pb_rulespg or https://health.wisconsin.gov/admrules/public/Rmo?nRmoId=17063 . Comments can be made by using the contact information below. Written comments on the proposed rules received no later than September 12, 2014 , will be given the same consideration as testimony presented at the hearing.
    Comments should be submitted to Katie Schumacher, Department of Public Instruction, Administrative Rules Coordinator and Small Business Regulatory Coordinator, 125 S. Webster Street, P.O. Box 7841, Madison, WI 53707-7841 or at Katie.Schumacher@dpi.wi.gov .
    Analysis Prepared by the Department of Public Instruction
    Statute interpreted
    Section 120.13 (19) , Stats.
    Statutory authority
    120.13 School board powers. The school board of a common or union high school district may do all things reasonable to promote the cause of education, including establishing, providing and improving school district programs, functions and activities for the benefit of pupils, and including all of the following:
    (19) Community programs and services. E stablish and maintain community education, training, recreational, cultural or athletic programs and services, outside the regular curricular and extracurricular programs for pupils, under such terms and conditions as the school board prescribes. The school board may establish and collect fees to cover all or part of the costs of such programs and services. The school board may not expend moneys on ineligible costs, as defined by the department by rule. Costs associated with such programs and services shall not be included in the school district's shared cost under s. 121.07 (6) .
    Explanation of agency authority
    Under s. 120.13 (19) , Stats., the Department is required to define ineligible costs by rule.
    Related statute or rule
    N/A.
    Plain language analysis
    Ineligible costs means school district costs that are not the actual, additional costs to operate community programs and services. First, costs are ineligible if they are not costs to operate community programs and services. Community programs and services do not include any program that is limited to only school district pupils or any program or service whose schedule presents a significant barrier for age-appropriate school district residents to participate in the program or service. Second, costs must not only be costs to operate community programs and services to be eligible but also must be actual, additional costs. Ineligible costs include costs that would be incurred by the school district if the community programs and services were not provided by the school district.
    Summary of, and comparison with, existing or proposed federal regulations
    N/A.
    Comparison with rules in adjacent states
    No information.
    Summary of factual data and analytical methodologies
    Under current law, a school district may establish community education, training, recreational, cultural, or athletic programs and services. The school board may collect fees to cover all or part of the costs of such community programs and services. Current law excludes such costs from the school district's shared cost. The property taxes levied for community programs and services are outside the district's revenue limit.
    Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report
    It is unknown how many existing school district expenditures on community programs and services will remain eligible costs under this rule. To the extent that school district expenditures change based on the definition of eligible costs defined as a result of this rule, school district revenue limits and local property taxes may change. In 2013-14, school districts levied $79,560,060 for community service fund programs.
    Anticipated Costs Incurred by Private Sector
    There is not expected to be a cost to the private sector.
    Effect on Small Business
    The proposed rules will have no economic impact on small businesses, as defined in s. 227.114 (1) , Stats.
    Agency Contact Person
    Katie Schumacher
    Budget and Policy Analyst
    Wisconsin Department of Public Instruction
    (608) 267-9127
    STATE OF WISCONSIN
    DEPARTMENT OF ADMINISTRATION
    DOA 2049 (R 07/2011)
    ADMINISTRATIVE RULES
    FISCAL ESTIMATE AND
    ECONOMIC IMPACT ANALYSIS
    Type of Estimate and Analysis
    X Original Updated Corrected
    Administrative Rule Chapter, Title and Number
    PI 80, Community Programs and Services
    Subject
    Defining Ineligible Costs
    Fund Sources Affected
    Chapter 20, Stats. Appropriations Affected
    GPR FED PRO PRS SEG SEG-S
    Fiscal Effect of Implementing the Rule
    X No Fiscal Effect
    Indeterminate
    Increase Existing Revenues
    Decrease Existing Revenues
    Increase Costs
    Could Absorb Within Agency's Budget
    Decrease Costs
    The Rule Will Impact the Following (Check All That Apply)
    State's Economy
    X Local Government Units
    Specific Businesses/Sectors
    Public Utility Rate Payers
    Would Implementation and Compliance Costs Be Greater Than $20 million?
    Yes X No
    Policy Problem Addressed by the Rule
    Under 2013 Wisconsin Act 306, the Department must define ineligible costs related to community programs and services. The proposed rule change will create PI 80, which defines the costs that cannot be included by school districts in Fund 80 (the revenue source for community programs and services).
    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)
    Local:
    It is unknown how many existing school district expenditures on community programs and services will remain eligible costs under this rule. To the extent that school district expenditures change based on the definition of eligible costs defined as a result of this rule, school district revenue limits and local property taxes may change. In 2013-14, school districts levied $79,560,060 for community service fund programs.
    State:
    None.
    Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
    The rule change gives the Department legal authority to prevent ineligible costs from being allocated to a school district's community programs and services fund. Without a rule, the Department provided guidance on what constituted ineligible costs but it was only advisory.
    Long Range Implications of Implementing the Rule
    It is unknown how many existing school district expenditures on community programs and services will remain eligible costs under this rule change.
    Compare With Approaches Being Used by Federal Government
    No information.
    Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
    No information.
    Name and Phone Number of Contact Person
    Katie Schumacher, Department of Public Instruction Administrative Rules Coordinator, (608) 267-9127.