4. Neisseria meningitidis is a vaccine-preventable disease and a leading cause of bacterial meningitis and sepsis in the United States. The meningococcal vaccine is recommended by the Wisconsin Chapter of the American Academy of Pediatrics and the Wisconsin Academy of Family Physicians to reduce the incidence of bacterial meningitis and sepsis. Since 2005, the CDC Advisory Committee on Immunization Practices has recommended that the vaccine be administered at the 11-12 year old health care visit, along with other routine vaccinations such as Tdap. The department proposes to add the meningococcal vaccine to the list of vaccines required for students entering the 7th grade. This provision will ease the burden on families, providers, and schools by ensuring that both meningococcal and Tdap vaccines are administered at the same visit and the same grade level. The department also proposes a booster dose for students entering 12th grade which is in accordance with ACIP recommendations. This will help to ensure students are fully vaccinated prior to leaving school.
5. Under the current rule, a parent or adult student may report a history of varicella disease as an acceptable exception to varicella vaccination. Recent studies have demonstrated that there is a high incidence of unvaccinated children who report a positive history of varicella that are not immune. The department proposes to allow the exception only when a history of varicella disease has been reported by a health care provider.
6. Chapter DHS 144 currently includes provisions relating to the 2008-2009 phase-in of Tdap and Varicella Vaccine coverage. The department proposes to eliminate these provisions because phase-ins are completed.
7. Curently, schools must only report compliance with program requirements and key indicators of vaccine-preventable disease and outbreaks to local health departments. The department proposes to add the state as a recipient of these reports which would be congruent with the current day care reporting requirements. This will improve the availability of important information and improve the department’s reporting to the legislature, under s. 252.04 (11), Stats.. 8. Chapter DHS 144 has not been substantially revised since 1981. The department proposes to update, correct, or clarify any outdated provisions in order to reflect current definitions, standards, and best practices. There are no reasonable alternative to the proposed rulemaking. The department is required by s. 252.04 (1), Stats., to maintain a statewide immunization program. Summary of, and comparison with, existing or proposed federal regulations
There appear to be no existing or proposed federal regulations that address the activities to be regulated by the proposed rules.
Comparison with rules in adjacent states
Similar to the proposed rule, Illinois, Iowa, Michigan, and Minnesota all require at least one dose of meningococcal conjugate vaccine at either 6th or 7th grade. All states but Michigan require a booster dose either at the appropriate age of 16-18 years or grade 12, as is proposed in the proposed rule.
Similar to the proposed rule, adjacent states all require Tdap vaccine for students entering 7th grade, require a health care provider’s documentation of varicella disease instead of parental reporting, and refer to CSTE case definitions and CDC guidance and recommendations in regards to disease outbreak definitions.
These states all have similar reporting requirements of vaccine preventable diseases.
Illinois:
The Illinois Department of Public Health outlines school and child care immunization requirements in 77 Ill. Admin. Code 665. Beginning with the school year 2015-2016, a student entering the 6th grade is required to have received one dose of meningococcal conjugate vaccine on or after their eleventh birthday. Students who do not meet the age requirement are monitored by the school. A student entering the 12th grade is required to have a second dose after their sixteenth birthday. If the first dose is administered when the student is sixteen years of age or older, only one dose is required.
The Tdap vaccine is required for students entering 7th through 12th grade.
Proof of prior varicella disease must be verified with the date of illness signed by a physician, a health care provider’s interpretation that a parent’s or legal guardian’s description of varicella disease history is indicative of past infection, or laboratory evidence of varicella immunity. A health care provider is defined as a physician, child care or school health professional, or health official.
The Illinois Department of Public Health 77 Ill. Admin. Code 690 outlines mandated reporters, such as health care providers, hospitals, and schools, to report suspected or confirmed cases of vaccine-preventable diseases which include the same diseases as outlined in the proposed rule.
Iowa:
Iowa Code, Chapter 139a.8(6) and Iowa Administrative Code, 641-7.7(139) outline the immunization requirements for student attending school and licensed child care centers. Beginning with the 2017-2018 school year, a student entering the 7th grade is required to have one dose of meningococcal (A, C, W, Y) vaccine. A student entering the 12th grade is required to have two doses, or one dose if the first dose is received at sixteen years of age or older.
The Tdap vaccine is required for students in 7th grade and above.
While not addressed in the codes, per the certificate of immunization document, varicella disease must be certified by a physician, physician assistant, nurse, or certified medical assistant.
Reporting of vaccine preventable diseases is required by Iowa Administrative Code 641-1 and includes the same diseases as outlined in the proposed rule.
Michigan:
School and child care immunization requirements are set forth in MCL 333.9205, 333.9208, 333.9227, and 380.1177. Since the 2014-2015 school year, a student entering the 7th grade has been required to have one dose of meningococcal (A, C, W, Y) vaccine. There is no requirement for a second dose.
The Tdap vaccine is required for students at eleven years of age or older upon entry into the 7th grade or higher.
Michigan requires documentation of either history of varicella disease or current lab immunity.
MCL 333.5111(1)b contains the requirements for reporting communicable diseases and includes the same diseases as the proposed rule.
Minnesota:
Minnesota’s Administrative Rule Chapter 4604 outlines the school and child care immunization requirements. Since the 2014-2015 school year, a student entering the 7th grade has been required to have one dose of meningococcal vaccine (A, C, W, Y). A second dose is required at age sixteen years.
The Tdap vaccine is required for students entering the 7th grade.
Documentation of past varicella disease must include the signature of a provider and the date of the student’s varicella illness, the signature of a provider and a statement that a parent’s or legal guardian’s description of the varicella disease history is indicative of past varicella infection, or the signature of a provider or a representative of a public clinic, and must include laboratory evidence of the child’s varicella immunity. A provider is defined as a licensed physician, registered physician assistant, or advanced practice registered nurse.
Minnesota’s communicable disease rule and requirements are in Chapter 4605 and include the same vaccine preventable diseases as in the proposed rule.
Summary of factual data and analytical methodologies
The department relied on the following sources to draft the proposed rule:
A.
Heymann DL, ed. Control of Communicable Diseases Manual. 20th ed. Washington, DC: American Public Health Association, 2015. B.
Pickering LK, ed. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics, 2015. C.
Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Health Foundation, 2015.The department formed an Advisory Committee consisting of representatives from the Wisconsin Department of Public Instruction, Wisconsin Chapter of the American Academy of Pediatrics, Wisconsin Department of Health Services Medicaid Program, Wisconsin Association of Local Health Departments and Boards, Wisconsin Academy of Family Physicians, Wisconsin Association of School Nurses, Wisconsin Medical Society, and Pharmacy Society of Wisconsin. Proposed rule revision language was drafted based on the recommendations of this committee.
Analysis and supporting documents used to determine effect on small business
An economic impact analysis was completed and no economic impact on small business was found.
Effect on small business
No economic impact on small business was found.
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