No. 27897 (Amendment): R396-100. Immunization Rule for Students

DAR File No.: 27897
Filed: 05/13/2005, 01:03
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule change is necessary to: 1) update Utah's immunization rule specific to the addition of the Hepatitis B, Varicella, and Tetanus/Diphtheria vaccines for 7th grade entry effective July 2006; 2) establish routine vaccination of adolescents not previously vaccinated as an effective strategy to more rapidly lower the incidence of and assist in the elimination of these diseases in the United States. It may also assist in establishing a routine visit to health-care providers for adolescents ages 11-12 years who previously may not visit their provider after childhood; and 3) prevent susceptible older children from entering adulthood without immunity to these diseases.

 

Summary of the rule or change:

This amendment adds the requirement of Hepatitis B, Varicella, and Tetanus/Diphtheria vaccines for 7th grade entry effective July 1, 2005, and to be implemented by July 1, 2006. It updates references of the United States Public Health Service's Advisory Committee on Immunization Practices (ACIP) recommended vaccines and dosing requirements which are incorporated into this rule. It also updates reporting time periods for schools.

 

State statutory or constitutional authorization for this rule:

Sections 53A-11-303 and 53A-11-306

 

This rule or change incorporates by reference the following material:

This amendment incorporates the following: 1) General Recommendations on Immunization: February 8, 2002/Vol 51/No.RR-2; 2) Immunization of Adolescents: November 22, 1996/Vol. 45/No. RR-13; 3) Combination Vaccines for Childhood Immunization; May 14, 1999/Vol. 48/No.RR-5; 4) Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures: August 8, 1991/Vol. 40/No. RR-10; 5) Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Children: March 28, 1997/Vol. 46/No. RR-7; 6) Use of Diphtheria Toxoid-Tetanus Toxoid-Acellular Pertussis Vaccine as a Five-Dose Series: Supplemental Recommendations of the Advisory Committee on Immunization Practices: November 17, 2000/Vol. 49/No. RR-13; 7) Protection Against Viral Hepatitis: February 9, 1990/Vol. 39/No. RR-2; 8) Hepatitis B: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: November 22, 1991/Vol. 40/No. RR-13; 9) Haemophilus b Conjugate Vaccines for Prevention of Haemophilus influenzae Type b Disease Among Infants and Children Two Months of Age and Older: January 11, 1991/Vol. 40/No. RR-1; 10) Recommendations for Use of Haemophilus b Conjugate Vaccines and a Combined Diphtheria, Tetanus, and Pertussis, and Haemophilus b Vaccine: September 17, 1993/Vol. 42/No. RR-13; 11) Measles, Mumps, and Rubella-Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: May 22, 1998/Vol. 47/No. RR-8; 12) Poliomyelitis Prevention in the United States: May 19, 2000/Vol. 49/No. RR-5; 13) Prevention of Varicella: July 12, 1996/Vol. 45/No. RR-11; 14) Prevention of Varicella: Updated Recommendations of the Advisory Committee on Immunization Practices: May 28, 1999/Vol. 48/No. RR-6; and 15) Prevention of Hepatitis A Through Active or Passive Immunization: October 1, 1999/Vol. 48/No. RR-12

 

Anticipated cost or savings to:

the state budget:

It is difficult to estimate the amount of vaccine necessary due to the following situations: 1) Hepatitis B has been required for kindergarten entry since 1999. By the effective date of July 1, 2006, these students will enter the 7th grade, and most students will have already completed the series; 2) Varicella vaccine has been licensed since 1995, before many potential 7th graders were born. Many of these children will have had Varicella disease instead. Only those who have not had Varicella disease will be required to receive the vaccine. It is impossible to estimate how many children have already had Varicella disease and thus do not need the vaccine; and 3) Tetanus/Diphtheria booster is recommended between ages 11-12. Some children will have already received their booster. The following data represents the maximum estimated costs: 1) Hepatitis B - $32,911 from current state vaccine funds. The remainder of the costs for publicly funded vaccine comes from the federal Vaccines for Children (VFC) and federal 317 funds. Since this has been a requirement for kindergarten entry since 1999, this cohort of children should have already received the full series; 2) Varicella - $58,508 from current state vaccine funds. The remainder of the costs for publicly-funded vaccine comes from the federal VFC and federal 317 funds. Varicella vaccine has been licensed since 1995, before many of this cohort were born. Many of these children will have had Varicella disease instead and will not need the vaccine; and 3) Tetanus - $12,189 from current state vaccine funds. The remainder of the costs for publicly-funded vaccine comes from the federal VFC and federal 317 funds. Tetanus/Diphtheria booster is recommended between ages 11-12. Some children will have already received their booster.

 

local governments:

The following data represents the maximum estimated costs. Of the total 38,271 children, 45.5% or 17,413 children are estimated to be covered in the public sector. Publicly-funded vaccines are currently provided to local health departments at no cost to the local health departments through the VFC program to cover children on Medicaid, Children's Health Insurance Program (CHIP), without insurance, who are American Indian/Alaskan Native and those who are underinsured. Local health departments choosing to serve children with private health insurance with vaccines as a covered service would have to purchase vaccine and be reimbursed by contracts with insurance providers. As a public entity they may purchase at a lower Center for Disease Control (CDC) contract price.

 

other persons:

The following data represents the maximum estimated costs: 1) Hepatitis B - of the total 38,271 children, 52% or 19,901 are estimated to receive immunizations through private means. This includes insurance providers, Medicaid managed care providers, and CHIP providers. The costs for this would be $537,327. Hepatitis B has been a standard immunization for many years and is a covered service by the majority of the insurance providers in the state. Most insurance plans will cover all ACIP recommended vaccines; 2) Varicella - of the total 38,271 children, 52% or 19,901 are estimated to receive immunizations through private means. This includes insurance providers, Medicaid managed care providers, and CHIP providers. The costs for this would be $955,248. Varicella has been a standard immunization since 1995 and is a covered service by the majority of insurance providers in the state. Most insurance plans will cover all ACIP recommended vaccines; and 3) Tetanus - of the total 38,271 children, 52% or 19,901 are estimated to receive immunizations through private means. This includes insurance providers, Medicaid managed care providers, and CHIP providers. The costs for this would be $199.010. Tetanus has been a standard immunization for many years and is a covered service by the majority of insurance providers in the state. Most insurance plans will cover all ACIP recommended vaccines.

 

Compliance costs for affected persons:

The costs to an individual not covered by insurance or under a public program would be $27 for a 3 dose Hepatitis B series, $48 for a single dose of Varicella, and $10 for a single dose of Tetanus. Administrative fees to defray part of the labor cost for administering the vaccine may also be charged. $10.50 is the administrative fee paid by Medicaid. Local Health Departments establish their own fee for administration which can range from $0 - 10.50. Most are at $5 or above and they charge the same for public or private vaccine. Private providers may have higher fees than $10.50. Costs for individuals covered by private insurance are dependent upon the co-pay or deductible charged by the insurer.

 

Comments by the department head on the fiscal impact the rule may have on businesses:

I have carefully reviewed the cost estimates detailed in the cost information above and believe they accurately set forth a good faith estimate of the fiscal impact of this proposed amendment. I believe the benefit to public health outweighs any fiscal impact on business. I will carefully review all public comments received, including any new issues on the fiscal impact that they may raise. David N. Sundwall, MD, Executive Director

 

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Community and Family Health Services, Immunization
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY UT 84116-3231

 

Direct questions regarding this rule to:

Caroline Green or Linda Abel at the above address, by phone at 801-538-9219 or 801-538-9450, by FAX at 801-538-9440 or 801-538-9440, or by Internet E-mail at [e-mail] or [e-mail]

 

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

07/01/2005

 

This rule may become effective on:

07/02/2005

 

Authorized by:

David N. Sundwall, Executive Director

 

 

RULE TEXT

R396. Health, Community and Family Health Services, Immunization.

R396-100. Immunization Rule for Students.

R396-100-3. Required Immunizations.

(1) A student born before July 1, [1994]1993 must meet the minimum immunization requirements of the ACIP prior to school entry for the following antigens: Diphtheria, Tetanus, Pertussis, Polio, Measles, Mumps, and Rubella.

(2) A student born after July 1, [1994]1993 must meet the minimum immunization requirements of the ACIP prior to school entry for the following antigens: Diphtheria, Tetanus, Pertussis, Polio, Measles, Mumps, Rubella, and Hepatitis B.

(3) Commencing July 1, 2006, a student born after July 1, 1993, must also meet the minimum immunization requirements of the ACIP prior to entry into the seventh grade for the following antigens: Adult Tetanus/Diphtheria and Varicella.

(4) [Commencing July 1, 2002, a]A student born after July 1, 1996 must meet the minimum immunization requirements of the ACIP prior to school entry for the following antigens: Diphtheria, Tetanus, Pertussis, Polio, Measles, Mumps, Rubella, Hepatitis B, Hepatitis A, and Varicella.

([4]5) To attend a Utah early childhood program, a student must meet the minimum immunization requirements of the ACIP for the following antigens: Diphtheria, Tetanus, Pertussis, Polio, Measles, Mumps, Rubella, and Haemophilus Influenza Type b prior to school entry.

([5]6) The vaccinations must be administered according to the recommendations of the United States Public Health Service's Advisory Committee on Immunization Practices (ACIP) as listed below which are incorporated by reference into this rule:

(a) General Recommendations on Immunization: [January 28, 1994/ Vol. 43/No. RR-1]February 8, 2002/Vol.51/No. RR-2;

(b) Immunization of Adolescents: November 22, 1996/Vol. 45/No. RR-13;

(c) Combination Vaccines for Childhood Immunization: May 14, 1999/Vol. 48/No.RR-5;

(d) Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures: August 8, 1991/Vol. 40/No. RR-10;

([d]e) Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Children: March 28, 1997/Vol. 46/No. RR-7;

([e]f) Use of Diphtheria Toxoid-Tetanus Toxoid-Acellular Pertussis Vaccine as a Five-Dose Series: Supplemental Recommendations of the Advisory Committee on Immunization Practices: November 17, 2000/Vol. 49/No. RR-13;

([f]g) Protection Against Viral Hepatitis: February 9, 1990/Vol. 39/No. RR-2;

([g]h) Hepatitis B: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: November 22, 1991/Vol. 40/No. RR-13;

([h]i) Haemophilus b Conjugate Vaccines for Prevention of Haemophilus influenzae Type b Disease Among Infants and Children Two Months of Age and Older: January 11, 1991/Vol. 40/No. RR-1;

([i]j) Recommendations for Use of Haemophilus b Conjugate Vaccines and a Combined Diphtheria, Tetanus, and Pertussis, and Haemophilus b Vaccine: September 17, 1993/Vol. 42/No. RR-13;

([j]k) Measles, Mumps, and Rubella-Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: May 22, 1998/Vol. 47/No. RR-8;

([k]l) Poliomyelitis Prevention in the United States: May 19, 2000/Vol. 49/No. RR-5;

([l]m) Prevention of Varicella: July 12, 1996/Vol. 45/No. RR-11;

([m]n) Prevention of Varicella: Updated Recommendations of the Advisory Committee on Immunization Practices: May 28, 1999/Vol. 48/No. RR-6; and

([n]o) Prevention of Hepatitis A Through Active or Passive Immunization: October 1, 1999/Vol. 48/No. RR-12.

 

R396-100-6. Reporting Requirements.

(1) Each school and early childhood program shall report the following to the Department in the form or format prescribed by the Department:

(a) by November 30 of each year, a statistical report of the immunization status of students enrolled in a licensed day care center, Head Start program, and kindergartens;

(b) by November 30 of each year, a [written ]statistical report of the two-dose measles

immunization status of all kindergarten through twelfth grade students;[ and]

(c) [by January 31 of each year, a written statistical report of the immunization status of all students kindergarten through twelfth grade new to a school after the school's regular registration period ends.]by November 30 of each year, a statistical report of diphtheria, tetanus, hepatitis B, varicella, and the two-dose measles immunization status of all seventh grade students; and

(d) by June 15 of each year, a statistical follow-up report of those students not appropriately immunized from the November 30 report in all public schools, kindergarten through twelfth grade.

(2) The information that the Department requires in the reports shall be in accordance with the Centers for Disease Control and Prevention guidelines.

 

R396-100-8. Exclusions of Students Who Are Under Exemption and Conditionally Enrolled Status.

(1) A local or state health department representative may exclude a student who has claimed an exemption to all vaccines or to one vaccine or who is conditionally enrolled from school attendance if there is good cause to believe that the student has a vaccine preventable disease and:

(a) has been exposed to a vaccine-preventable disease; or

(b) will be exposed to a vaccine-preventable disease as a result of school attendance.

(2) An excluded student may not attend school until the local health officer is satisfied that a student is no longer at risk of contracting or transmitting a vaccine-preventable disease.

 

KEY: immunization, rules and procedures

[July 19, 2001]2005

Notice of Continuation April 24, 2003

53A-11-303

53A-11-306