Summary of factual data and analytical methodologies
In determining whether to add or delete SCID and related conditions of immunodeficiency to the list of disorders under s.
HFS 115.04, the Department sought advice from the Wisconsin Newborn Screening Umbrella Advisory Group (Advisory Group). The Department and the Advisory Group considered the following criteria under s.
HFS 115.06:
1. Characteristics of the specific disorder, including disease incidence, morbidity, and mortality.
2. The availability of effective therapy and potential for successful treatment.
3. Characteristics of the test, including sensitivity, specificity, feasibility for mass screening and cost.
4. The availability of mechanisms for determining the effectiveness of test procedures.
5. Characteristics of the screening program, including the ability to collect and analyze specimens reliably and promptly, the ability to report test results quickly and accurately and the existence of adequate follow-up and management programs.
6. The expected benefits to children and society in relation to the risks and costs associated with the testing for the specific condition.
In consideration of these criteria, the Advisory Group recommended the Department add the condition known as and related conditions of immunodeficiency to the 13 disorders and types of disorders currently screened for under s.
HFS 115.04.
Initial Regulatory Flexibility Analysis
The rule change will not affect small business as “small business" is defined in s.
227.114 (1) (a), Stats., as small businesses are not involved in the process of screening newborns for congenital and metabolic disorders.
Small business regulatory coordinator
Rosie Greer
608-266-1279
Fiscal Estimate
Summary
Wisconsin Statute 253.13 requires that every infant born be subjected to blood tests for congenital and metabolic disorders; however, parents may refuse to have their infants screened for religious reasons. The Wisconsin Newborn Screening Umbrella Advisory Group recommended to the Department the addition of Severe Combined Immunodeficiency (SCID) and related conditions of immunodeficiency to the screening panel. Infants with SCID are extremely vulnerable to infections, to the degree that the condition is universally fatal if not detected and treated within the first year of life.
The Department of Health and Family Services works closely with the Wisconsin State Laboratory of Hygiene to implement the program.
The rule change would add SCID and related conditions of immunodeficiency to the 13 disorders and disorder types currently screened for under HFS 115.04. All newborn screening tests are currently paid for by user-generated fees. The State Laboratory of Hygiene charges hospitals $69.50 for each newborn screening sample collection card. Hospitals in turn charge parents for newborn screening, which is typically included in the labor and delivery bill and covered by the mother's insurance. A grant from the Jeffrey Modell Foundation, which is matched by the Children's Hospital of Wisconsin/Medical College of Wisconsin, will fund the cost of testing for SCID through 2008. For subsequent years, the Wisconsin State Laboratory of Hygiene and Division of Public Health will actively seek additional grant funding in order to continue screening for SCID and related conditions of immunodeficiency at no cost to the state.
If grant funding is not available, the fee for the newborn screening sample card will need to be increased by January 1, 2009. The annual cost of screening an estimated 71,000 births in Wisconsin for SCID will be approximately $387,000. This increased cost will raise fees by $5.50 per child, for a total screening fee of $75.00 per child screened. In the absence of this screening, babies who are undiagnosed or diagnosed late with SCID typically cost $1-2 million each to treat (this figure is based on audited costs from Children's Hospital of Wisconsin, the facility which treats children with SCID, but without benefit of early diagnosis). Babies diagnosed in the first week of life can be cured by bone marrow transplantation (at least 75% cure rate) at a charge of $170,000/discharge (2005 J Peds, McGhee et.al.). Typically, the cost of this treatment for infants with SCID is paid by the infant's health insurance or Medicaid and is not a cost to the Congenital Disorders Program, which pays only for initial follow-up visits and confirmatory testing. It is expected that the savings to Medicaid may be substantial for each eligible affected child receiving early diagnosis.
Local fiscal effect
None
Private sector fiscal effect
None
Long-range fiscal implications
The surcharge for the newborn screening collection card, currently $69.50, will need to be increased to approximately $75.00 as early as January 1, 2009. This increase will be in user-generated fees. It is possible an increase in the surcharge will not be necessary until 2012, if additional grant funding is obtained.
Notice of Hearing
Insurance
NOTICE IS HEREBY GIVEN that pursuant to the authority granted under s.
601.41 (3), Stats., and the procedures set forth in under s.
227.18, Stats., OCI will hold a public hearing to consider the adoption of a proposed rule affecting sections
Ins 17.01 (3) and
17.28 (6), Wis. Adm. Code, relating to fund fees and mediation panel fees for fiscal year 2009 and affecting small business.
Hearing Information
Date: March 4, 2008
Time: 10:00 a.m., or as soon thereafter as the
matter may be reached
Place: OCI, Room 223
125 South Webster St. - 2nd Floor
Madison, WI
Agency Contact Person and Copy of Rule
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 – 2nd Floor
Madison WI 53703-3474
Mail: PO Box 7873, Madison, WI 53707-7873
Submission of Written Comments
Written comments can be mailed to:
Theresa L. Wedekind
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:
Theresa L. Wedekind
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:
Theresa L. Wedekind
The deadline for submitting comments is 4:00 p.m. on the 14th day after the date for the hearing stated in this Notice of Hearing.
Analysis Prepared by the Office of the Commissioner of Insurance (OCI)
Statutes interpreted
Statutory authority
Explanation of agency authority
The commissioner of insurance, with the approval of the board of governors (board) of the injured patients and families compensation fund (fund), is required to establish by administrative rule the annual fees which participating health care providers must pay to the fund and the annual fee due for the operation of the medical mediation panel.
Related statutes or rule
None
Plain language analysis
This rule establishes the fees which participating health care providers must pay to the fund for the fiscal year beginning July 1, 2008. These fees represent a 0% change with fees paid for the 2007-08 fiscal year. The board approved these fees at its meeting on December 12, 2007, 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 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 by establishing mediation panel fees for the next fiscal year at $18.00 for physicians and $2.50 per occupied bed for hospitals, representing a increase of $1.00 per physician and $1.50 per occupied bed for hospitals from 2007-08 fiscal year mediation panel fees.
Comparison with federal regulations
To the fund board's and OCI's knowledge there is no existing or proposed federal regulation that is intended to address patient compensation fund rates, administration or activities.
Comparison of 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 these states have a patients compensation fund created by statute where rates are directed to be established yearly by rule as is true in Wisconsin.
Summary of factual data and analytical methodologies
None. This rule establishes annual fund fees pursuant to the requirements of the above-noted Wisconsin statutes.
Analysis and supporting documents used to determine effect on small business
This increase in mediation panel fees will have an effect on some small businesses in Wisconsin. The mediation panel fee is assessed only on physicians and hospitals, not on corporations or other health care entities. The increase will affect only those small business that pay the mediation panel fees on behalf of their employed physicians. However, the increase in the mediation panel fee will not have a significant effect nor should it negatively affect the small business's ability to compete with other providers.
Initial Regulatory Flexibility Analysis
This rule will have little or no effect on small businesses. The increase contained in the proposed rule will require providers to pay an increased mediation panel fee which will increase the operational expenses for the providers. However, this increase is very minimal and will have no effect on the provider's competitive abilities.
Fiscal Estimate
Summary
The Injured Patients and Families Compensation Fund (IPFCF or Fund) is a segregated fund. Annual Fund fees are established to become effective each July 1 based on actuarial estimates of the Fund's needs for payment of medical malpractice claims. The proposed fees were approved by the Fund's Board of Governors at its December 12, 2007 meeting.
The Fund is a unique fund; there are no other funds like it in the country. The WI Fund provides unlimited liability coverage and participation is mandatory. These two features make this Fund unique compared to funds in other states. The only persons who will be affected by this rule change are the Fund participants themselves as the IPFCF is fully funded through assessments paid by Fund participants.
There is no effect on GPR.
Private sector fiscal effect
The increase in fees promulgated by this rule does not result in a significant fiscal effect on the private sector. The cost of mediation panel fees is a very small portion of the expenses incurred by health care providers. Although a health care provider may pass this increase on to its patients, there will not be a significant fiscal effect on the private sector as a result of this proposed rule.
