Plain language analysis
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.
Congenital and metabolic disorders screening, also known as newborn screening, are special tests for all newborns. Newborn screening helps parents find out if their baby has certain health problems. A newborn baby can look healthy, but have a serious disorder that cannot be seen. If not treated, these disorders can lead to slow growth, severe illness, brain damage, or possibly death. Early treatment can help prevent these serious problems.
Section
253.13 (2), Stats. (2009-10) authorized the WSLH to impose a fee in an amount sufficient to pay for the cost of the screening provided by the WSLH, and to fund services, including certain follow-up diagnostic services, physician prescribed special dietary treatment and certain follow-up genetic counseling to the patient and the patient's family, as well as periodic evaluation of infant screening programs, the costs of consulting with experts in reviewing and evaluating the program, the costs of administering the newborn hearing screening required under s.
253.115, Stats., and the costs of the department to administer the congenital disorders program.
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 from the WSLH for use when obtaining the newborn's blood sample for testing. When the blood sample is obtained, a purchaser or its agent returns the newborn screening sample collection card to the WSLH to test for the conditions specified by the department under s.
DHS 115.04. The department provides certain follow-up services as prescribed by a physician or as otherwise determined. The WSLH currently imposes, at the time the newborn screening sample collection card is purchased, a fee of $109. This amount includes amounts to fund the testing, services and programs directed under s.
253.13 (2), Stats. (2009-10).
The department under emergency rules and proposed permanent rules creates s. DHS 115. 05 (3) to impose, by rule, a fee of $109 for screening newborns for congenital and metabolic disorders and other services as directed under s.
253.13 (2), Stats., as amended by
2011 Wis. Act 32. The fee amount being imposed is the same fee amount that is currently being imposed by the WSLH by policy to fund the same testing, services and programs that will be funded under the emergency rules and proposed permanent rules. In effect, the emergency and proposed permanent rules conforms Ch.
DHS 115 to statute.
Summary of, and comparison with, existing or proposed federal regulations
There appears to be no existing or proposed federal regulations that address the activities of this rule.
Comparison with rules in adjacent states
Illinois, Iowa, Michigan and Minnesota require newborns to be screened for congenital and other disorders, and the provision of other services and programs. Also similar to Wisconsin, these states impose a fee for the screening and other services. However, it is not possible to accurately and specifically compare Wisconsin's fee of $109 to the fees set by these states because the disorders to be screened may differ, and the additional services and programs funded as permitted by statute and their level of needed funding may differ.
Illinois
Illinois's Department of Public Health assesses institutions or persons submitting a sample for newborn screening a fee of $78, which may be increased if screening for additional disorders. Statements are mailed on a monthly basis to facilities submitting specimens for analysis. Payment is required upon receipt of the statement. 77 Ill. Adm. Code 660.70
Iowa
Iowa's Department of Public Health assesses a fee of $112 for activities associated with the Iowa Newborn Neonatal Metabolic Screening Program. Included in the fee is an amount to fund a program for eligible individuals with certain inherited diseases identified through the program who may be unable to pay the fee. The Department of Public Health is required to review and determine the fee annually. 641 IAC 4.3(9)
Michigan
Michigan's fee for screening newborns and other services is established under Michigan statute, MCLS s.
333.5431 (4) by annual adjustment based on the cumulative annual percentage change in the Detroit Consumer Price Index. The current fee amount is $97.69. Under MCLS s.
333.5430 (3), the newborn screening quality assurance advisory committee must conduct a financial review of any recommended changes to the list of newborn screening tests and make a recommendation to increase or decrease in the amount charged pursuant to section 5431 for newborn screening tests. The recommended change is limited to any net change in the amount of the actual cost of any proposed additional tests and follow-up minus savings from any proposed deleted tests and follow-up.
Minnesota
Minnesota assesses its newborn screening fee in statute. Minn. Stat. s.
144.125 (1) requires its state commissioner of health to charge a fee of $106 per specimen “so that the total of fees collected will approximate the costs of conducting the tests and implementing and maintaining a system to follow-up infants with heritable or congenital disorders, including hearing loss detected through early hearing detection and intervention program". Per an interview of a Minnesota Newborn Screening Program representative, unlike Wisconsin, Minnesota does not pay for special dietary treatment or diagnostic or clinical services. Minnesota pays for intensive review and follow-up for obtaining a blood test and initiating follow-up.
Below is a chart sampling of what the newborn screening fee pays for in Wisconsin, Illinois, Iowa, Michigan, and Minnesota.
|
Wisconsin
|
Illinois
|
Iowa
|
Michigan
|
Minnesota
|
Newborn Screening Fee
|
$109
|
$88
|
$112
|
$97.69
|
$106
|
What you get for the Newborn Screening Fee
|
Lab services (cost - taken from fee)
|
$58.50
|
$44 (approx.)
|
Can not be
separated out
|
$46.79
|
Can not be separated out
|
DHS Surcharge
|
$50.50
|
$44 (approx.)
|
|
$41.42 Admin-$9.48
|
|
|
Formula (A specialized drink that provides protein and essential nutrients in a safe form for people with certain diseases)
|
3
|
3
|
3
|
3
|
|
Special Dietary Treatment
|
Low-Protein Food (A food source with digestible protein for people with certain diseases)
|
3
|
|
3
|
|
|
|
Special Dietary Supplements (Necessary for appropriate growth – similar to vitamins)
|
3
|
|
3
|
3(some)
|
|
Follow-up (case management, non-clinical follow-up, provider education, short-term follow-up)
|
3
|
3
|
3
|
3
|
3
|
Clinical Services (Genetic Counseling, nutritionists, clinical nurses, specialists for follow-up)
|
3
|
3
|
|
3
|
|
Staffing
|
(2 + lab)
|
3( 17 + lab)
|
3 (17 + lab)
|
3(8 + lab)
|
3(16 + lab)
|
Additional Funding Information
|
Does your program have supplemental money to support the Newborn Screening Program?
|
No
|
No
|
Yes
|
Yes
|
Yes
|
Breakdown of additional funding
|
|
|
State Appropriations $160,000
|
Medicaid $170,000
WIC $87,500
Small Federal grants
|
Small Federal grants
|
Summary of factual data and analytical methodologies
In 2010, the department developed the $109 fee amount for the newborn screening sample card which consists of $58.50 to cover the costs of testing provided by the WSLH and $50.50 to cover the services and programs authorized under s.
253.13 (2), Stats. The department analyzed past actual costs and then projected out future costs until SFY 13.
The costs for the Wisconsin Newborn Screening (NBS) program (Program) determine the newborn screening sample card fee. The costs do not solely rely on the number of babies that need to be screened for congenital disorders. The NBS Program costs include the WSLH costs of purchasing, storing, and distributing the cards; laboratory equipment, consumables, and staff salaries to perform the testing for conditions listed under s.
DHS 115.04; short term follow up of all non-normal results reported by the laboratory; and education activities for health care providers regarding newborn screening issues such as specimen collection and reporting of test results. The costs for the NBS Program also include the department costs based on the number of participants in the NBS Program; diagnostic and counseling services (i.e. clinical assessment, nutritional and genetic counseling); special dietary treatment (i.e. coordinating payment of specialty formula and vitamins); consulting with experts (i.e. hosting and coordinating the newborn screening advisory group meetings); administering the congenital disorder program (i.e. program staff and program operations); administering the hearing screening program under s.
253.115, Stats.; periodic evaluation of infant screening programs; and testing due to advancements in science or laboratory procedures. The NBS Program pays in part for the expertise to provide follow-up and individual telephone consultation between the pediatric subspecialist experts and the primary care physicians each time an abnormal result is found on a newborn screening test.
The number of people participating in the NBS Program has increased. Each child with a positive screening result gets a confirmatory test in a specialty center and receives the necessary dietary treatment for life. As children live longer and the cumulative number of patients increases, the overall cost of the program rises. In SFY 2004, the program served 824 patients compared to 954 patients in SFY 2009. In SFY 2008 and SFY 2009 there was a 3.9% and 4.5% increase in patient population respectively. (Citation: Number tabulated from NBS Program Annual Reports and recorded in a DHS Excel file: Newborn Screening Population Increases)
NBS Program costs have been increasing.
•
The costs of the formula and other food products have been rising. Depending on the vendor and product, the annual price increase has been as high as 20% (Example: Applied Nutrition's PhenylAde MTE Amino Acid Blend for PKU prior to September 1, 2008 was $347.67 per case; after September 1, 2008 the cost was increased to $417.15). Expenditures for special dietary treatment were $1,163,155.87 in SFY 2009, $1,385,646.20 in SFY 2010, and $1,450,197.82 in SFY 2011. (Citation: DHS Excel file: SFY Summaries by Condition 09 to 12). Another contributing factor is the rarity of disorders and limited product. There are few vendors providing product so it is not possible to find the same or similar product at a different vendor for a lower cost.
•
The increasing number of adults and growing teens on product is shifting the age (and weight) distribution upward. Adults and growing teens require increased caloric intake compared to that of young children thus increasing the average amount of formula or food product per person.
In order to maintain the NBS Program, revenue should match rising costs; however, revenue has declined because Wisconsin births have declined more than expected. The number of births in Wisconsin has decreased since 2007 which in turn affects the number of blood-testing cards purchased by hospitals. In SFY 2007, 72,453 cards were purchased compared to 66,789 in SFY 2011. (WSLH Surcharge Report (2011))
Statement on the Quality of the Agency Data
To prepare the text and analysis of these rules, the department relied on the following sources or interviews:
1. WSLH Clinical Orders Department NBS Program Customers List (2008)
2. WSLH Surcharge Report (2011)
3. DHS NBS Program Annual Reports
4. DHS Excel file: Newborn Screening Population Increases
5. DHS Excel file: SFY Summaries by Condition 09 to 12
6. Department interview of a Michigan Newborn Screening Program representative (11/30/11)
7. Department interview of a Minnesota Newborn Screening Program representative (11/30/11)
Analysis and supporting documents used to determine effect on small business
The $109 fee imposed under these rules will have no additional economic impact on purchasers of newborn screening sample cards, whether or not the purchasers are small businesses because the rules conform to statute by imposing the fee by rule, instead of by policy. The fee is unchanged from the current amount being imposed by the WSLH.
According to the WSLH Surcharge Report, the number of newborn screening sample cards purchased in SFY 2011 was 66,789. Accordingly, the department estimates that the current economic impact on the private sector, including small businesses in SFY 2011 is approximately $7,280,001 ($109*66,789). This estimate may be higher or lower in future years depending on factors such as the number of births or cards purchased in a given year.
Purchasers of newborn screening sample collection cards may seek reimbursement of the costs of the newborn screening sample cards and any related costs incurred from private insurers, Medicaid, parents of newborns, or the NBS Program for eligible parents.
Effect on Small Business
The $109 fee will have no impact on businesses, including small businesses, because the fee is unchanged since it was initially imposed by the WSLH in 2010. The department expects that purchasers will continue to seek reimbursements of their costs related to the NBS Program.
Small business considerations
The $109 fee in the emergency rules and proposed permanent rules will not have an impact on businesses, including small businesses, because the fee is unchanged since it was initially imposed by the WSLH in 2010. The emergency rules and proposed permanent rules only codify the existing fee amount of $109 in administrative rule. The rule does not include any requirements, including reporting requirements, schedules or deadlines for compliance, or performance standards, from which the department can exempt small businesses. It would be contrary to the objectives of s.
253.13 (2) Stats., to exempt small businesses from the fee required under s.
253.13 (2), Stats. Section
253.13 (2), Stats., requires the department to impose a fee sufficient to pay for testing provided by the WSLH and include as part of the fee amounts to fund the provision of diagnostic and counseling services, special dietary treatment as prescribed by a physician, and periodic evaluation of infant screening programs, the costs of consulting with experts under s.
253.13 (5), Stats., the costs of administering the hearing screening program under s.
253.115, Stats., and the costs of administering the congenital disorder program operated under s.
253.13 (2), Stats. The $109 fee amount is based on the costs to fund the provision of testing and services required under s.
253.13 (2), Stats.
Initial regulatory flexibility analysis
The $109 fee in this proposed order will not have an impact on businesses, including small businesses, because the fee is unchanged since it was initially imposed by the WSLH in 2010. This proposed order only codifies the existing fee amount of $109 in administrative rule. The rule does not include any requirements, including reporting requirements, schedules or deadlines for compliance, or performance standards, from which the department can exempt small businesses. It would be contrary to the objectives of s.
253.13 (2) Stats., to exempt small businesses from the fee required under s.
253.13 (2), Stats. Section
253.13 (2), Stats., requires the department to impose a fee sufficient to pay for testing provided by the WSLH and include as part of the fee amounts to fund the provision of diagnostic and counseling services, special dietary treatment as prescribed by a physician, and periodic evaluation of infant screening programs, the costs of consulting with experts under s.
253.13 (5), Stats., the costs of administering the hearing screening program under s.
253.115, Stats., and the costs of administering the congenital disorder program operated under s.
253.13 (2), Stats. The $109 fee amount is based on the costs to fund the provision of testing and services required under s.
253.13 (2), Stats.
The existing fee applies to hospitals, clinics and laboratories on behalf of hospitals, nurse-midwives, midwives, other birth attendants, other birth facilities, physicians, nurses, parents of newborns, insurers, the WSLH and the Newborn Screening Program.
Small business regulatory coordinator
Rosie Greer
608.266.1279
Fiscal and Economic Impact Analysis
Since 2010, the WSLH has imposed a fee of $109 by policy to pay for the testing and services mandated under s.
253.13 (2), Stats. The fee in the proposed rules is unchanged from the current amount being imposed for testing and other services. As a result, the department does not expect any additional implementation or compliance costs to be incurred by purchasers of newborn sample screening cards. Because there are no new or changed conditions and no estimated increased or decreased costs that would occur if the $109 fee amount is codified in administrative rule, the rule will not have an economic impact on businesses, business sectors, local governmental units, public utility rate payers or the state's economy as a whole.
For increased public participation in the rule, the department established an advisory committee that included representatives from private hospitals, statewide health provider organizations, the State Laboratory of Hygiene, Universities, statewide consumer organizations, local public health departments, and a consumer of the Newborn Screening Program services to help draft the rule and summary (analysis). The majority of the comments (and questions) received from advisory committee members was on the manner and substance of the rule's summary (analysis), including requesting additional information about the newborn screening programs in adjacent states and their program costs. Other comments concerned the reimbursement rate of the fee by the Medicaid program. No member of the advisory committee commented on the fee amount. In response to advisory committee comments, the department made changes to the summary (analysis) by adding additional information on newborn screening programs of neighboring states, accurately describing program costs, and explaining the newborn screening program in greater detail. Also, a second paragraph within the text of the permanent rule was removed after a committee member questioned the purpose and suggested it was not needed. Because the reimbursement rate of the Medicaid program is not germane to the codification of the fee for screening and other services for congenital and metabolic disorders in administrative rules, the department does not address that matter in this analysis.
On January 23, 2012, the department began soliciting information and advice as required under s.
227.137, Stats., and Executive Order #50, to help prepare this economic impact analysis. The comment period ended on February 6, 2012.
Four persons provided comments in response to the department's solicitation. The first comment emphasized the importance of the program and expressed support for sustainable funding of the program. The second comment was a question about whether Amish midwives are charged fees for newborn screening cards. The third comment suggested edits to the explanation of the rule and increased specificity in the language related to counseling services and follow-up. The fourth comment expressed concerns about program sustainability under the current structure, sufficiency of Medicaid fee reimbursement of the fee, opportunity to explore alternative options to the current fee of $109, as well as asked if consideration would be given to decrease the current fee by 10% because the fee was not based on program costs.
There were no comments received from businesses, associations representing businesses, local governmental units, or individuals that suggest that the existing fee being codified in rule would adversely affect, in a material way, such businesses, business sectors, local governmental units, individuals, the economy, productivity, jobs, or the overall competitiveness of the state.
Agency Contact Person
For substantive questions contact:
Katherine Vaughn-Jehring, MPH, MPA
608.267.2173
For rulemaking questions and small business concerns contact:
Rosie Greer
608.266.1279
Place Where Comments are to be Submitted and Deadline for Submission
Notice of Hearing
Natural Resources
Fish, Game, etc., Chs.
NR 1—
(DNR # CF-26-11(E))
NOTICE IS HEREBY GIVEN THAT pursuant to sections 23.09 (26), 23.33 (8) (a), 23.33 (9) (b) 3. to 5., and 227.11, Wis. Stats., interpreting sections 23.33 (8) (a), 23.33 (9) (b) 3. to 5., and 227.11, Wis. Stats., the Department of Natural Resources will hold a public hearing on emergency rule Order CF-26-11(E), relating to Chapter
NR 64, All-Terrain Vehicles, Wis. Adm. Code.
Hearing Information
NOTICE IS HEREBY FURTHER GIVEN THAT the hearing will be held at the following location on:
Date: Monday, June 25, 2012
Time: 6:00 p.m
Location: The Grand Lodge
805 Creske Ave.
Rothschild, WI 54474
Pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of information material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Diane Conklin at (715) 822-8583 with specific information on your request at least 10 days before the date of the scheduled hearing.
Availability of Rules and Submitting Comments
The proposed rule and supporting documents may be reviewed and comments electronically submitted at the following internet site:
http://adminrules.wisconsin.gov. A copy of the proposed rules and supporting documents may also be obtained from Diane Conklin, DNR All–Terrain Vehicle (ATV) Grant Manager, P.O. Box 397, Cumberland, WI 54829 or
Diane.Conklin@wisconsin.gov.
Written comments on the proposed rule may be submitted via U.S. mail or by e-mail to Diane Conklin at the addresses noted above. Written comments, whether submitted electronically or by U.S. mail, will be given the same weight and effect as oral statements presented at the public hearings. Comments may be submitted until 7:30 p.m. on Monday, June 25, 2012.
Analysis Prepared by the Department of Natural Resources
The proposed emergency rule will revise Ch.
NR 64, All-Terrain Vehicles, Wis. Adm. Code, to create a new category of all-terrain trail, commonly referred to as a “troute" or a trail and route combination, that provides a connector between trails and will be eligible for ATV grant funding. An emergency rule is needed since the permanent rule revisions to Ch.
NR 64 in Board Order CF-16-11 that includes these hybrid trails are not expected to be effective until September 2012 at the earliest. These hybrid trails have been in use in WI for several years and account for approximately one-third of all trails in northern Wisconsin. Grant funds help with trail maintenance. This Emergency rule is needed so projects on troutes can be eligible for grant funding during the next round of grant awards in July 2012.
Statutes interpreted
