DAR File No. 38893

Health, Disease Control and Prevention, Immunization

Rule R396-100

Immunization Rule for Students

Notice of Proposed Rule

(Amendment)

DAR File No.: 38893
Filed: 09/30/2014 11:22:05 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule change is to add a requirement for meningococcal conjugate vaccine to seventh grade school entry requirements. Current national recommendations by the national Advisory Committee on Immunization Practices (ACIP) with the Centers of Disease Control and Prevention (CDC) recommends one dose of meningococcal conjugate vaccine at 11 or 12 years of age aligning with seventh grade school entry. This rule change would meet national recommendations for this vaccine. Section 53A-11-203 requires school entry requirements be based on a national standard which is ACIP. This rule change adds and updates incorporated references.

Summary of the rule or change:

The change requires one dose of meningococcal conjugate vaccine for seventh grade entry.

State statutory or constitutional authorization for this rule:

• Section 53A-11-303
• Section 53A-11-306

This rule or change incorporates by reference the following material:

• Updates Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Routine Poliovirus Vaccination: MMWR, published by Center for Disease Control and Prevention, 08/07/2009
• Updates Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) for the Control and Elimination of Mumps: MMWR, published by Center for Disease Control and Prevention, 06/09/2006
• Updates Prevention of Haemophilus influenza Type b Disease Among Infants and Children Two Months of Age and Older: MMWR Recommendations for Use of Haemophilus b Conjugate Vaccines and a Combined Diphtheria, Tetanus, and Pertussis, and Haemophilus b Vaccine: MMWR, published by Center for Disease Control and Prevention, 09/17/1993
• Updates Prevention of Haemophilus influenza Type b Disease Among Infants and Children Two Months of Age and Older: MMWR, published by Center for Disease Control and Prevention, 01/11/1991
• Adds Prevention and Control of Meningococcal Disease:Recommendations of the Advisory Committee on Immunization Practices (ACIP), published by Center for Disease Control and Prevention, 03/22/2013
• Updates Licensure of a 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Recommendations for Use Among Children�Advisory Committee on Immunization Practices, (ACIP), 2010: MMWR , published by Center for Disease Control and Prevention, 03/12/2010
• Updates Prevention of Hepatitis A Through Active or Passive Immunization: MMWR, published by Center for Disease Control and Prevention, 05/29/2006
• Updates Prevention of Varicella: MMWR, published by Center for Disease Control and Prevention, 06/22/2007

Anticipated cost or savings to:

the state budget:

There is no impact to state budgets as this change will be carried out through existing state budgets. Anticipated vaccine costs would be covered by individual insurance, Medicaid, CHIP, or the Vaccine for Children's Program.

local governments:

Publicly funded vaccines are currently provided to local health departments at no cost to the local health departments through the federal Vaccines For Children program to cover children on Medicaid, 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 purchase vaccine and are reimbursed by contracts with insurance providers. As a public entity, they may purchase at a lower CDC contract price. The meningococcal conjugate vaccine has been available since 2005 and many children have already had this vaccine.

small businesses:

Approximately 70% of children receive immunizations outside of public clinics. Their immunizations are paid for by insurance plans, Medicaid, and CHIP. All children who are not covered by insurance or might be under-insured for these vaccines qualify to receive them at no charge under the federal Vaccines For Children program (VFC). There are 350 private and public clinics enrolled in the VFC program in Utah. Meningococcal conjugate has been a standard immunization for many years and is covered by insurance providers in the state. The Department of Health knows of no insurance plan that does not cover required childhood immunizations, so this change will not be imposing an additional cost to them. It is a recommended vaccine for all LDS missionaries. The meningococcal conjugate vaccine has been available since 2005 and many children have already had this vaccine.

persons other than small businesses, businesses, or local governmental entities:

Approximately 83% of children receive immunizations outside of public clinics. Their immunizations are paid for by insurance plans, Medicaid, and CHIP. All children who are not covered by insurance for these vaccines qualify to receive them at no charge under the federal Vaccines For Children program (VFC). There are 350 private and public clinics enrolled in the VFC program in Utah. Meningococcal conjugate has been a standard immunization for many years and is covered by insurance providers in the state. The Department of Health knows of no insurance plan that does not cover required childhood immunizations, so this change will not be imposing an additional cost to them. It is a recommended vaccine for all LDS missionaries. The meningococcal conjugate vaccine has been available since 2005 and many children have already had this vaccine.

Compliance costs for affected persons:

Compliance costs for affected persons ("person" means any SINGLE individual, partnership, corporation, association, governmental entity, or public or private organization of any character other than an agency): As children's vaccinations are covered by either insurance or are available under the Vaccine For Children program, there is no cost for the vaccine to any individuals. There could be costs for a vaccine administration fee for those with no insurance or who are under-insured. The costs vary by provider and many decrease or defer fees based on ability to pay.

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

This rule will minimally impact insurance plans which already pay for the immunization. Children not covered by insurance, Medicaid and CHIP are eligible at no charge for the federal Vaccines For Children program.

David Patton, PhD, Executive Director

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

Health
Disease Control and Prevention, Immunization
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Linda Abel at the above address, by phone at 801-538-9450, by FAX at 801-538-9440, or by Internet E-mail at label@utah.gov

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:

11/14/2014

This rule may become effective on:

11/21/2014

Authorized by:

David Patton, Executive Director

R396. Health, Disease Control and Prevention, Immunization.

R396-100. Immunization Rule for Students.

R396-100-1. Purpose and Authority.

(1) This rule implements the immunization requirements of Title 53A, Chapter 11, Part 3. It establishes minimum immunization requirements for attendance at a public, private, or parochial kindergarten, elementary, or secondary school through grade 12, nursery school, licensed day care center, child care facility, family home care, or Head Start program in this state. It establishes:

(a) required doses and frequency of vaccine administration;

(b) reporting of statistical data; and

(c) time periods for conditional enrollment.

(2) This rule is required by Section 53A-11-303 and authorized by Section 53A-11-306.

 

R396-100-2. Definitions.

As used in this rule:

"Department" means the Utah Department of Health.

"Early Childhood Program" means a nursery or preschool, licensed day care center, child care facility, family care home, or Head Start program.

"Exemption" means a relief from the statutory immunization requirements by reason of qualifying under Sections 53A-11-302 and 302.5.

"Parent" means a biological or adoptive parent who has legal custody of a child; a legal guardian, or the student, if of legal age.

"School" means a public, private, or parochial kindergarten, elementary, or secondary school through grade 12.

"School entry" means a student, at any grade, entering a Utah school or an early childhood program for the first time.

"Student" means an individual enrolled or attempting to enroll in a school or early childhood program.

 

R396-100-3. Required Immunizations.

(1) A student born before July 1, 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, 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) 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: Tetanus, Diphtheria, Pertussis,[ and] Varicella, and Meningococcal.

(4) 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.

(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, Haemophilus Influenza Type b, Hepatitis A, Hepatitis B, Pneumococcal, and Varicella vaccines prior to school entry.

(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: MMWR, December 1, 2006/Vol. 55/No. RR-15;

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

(c) Combination Vaccines for Childhood Immunization: MMWR, 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;

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

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

[(g)](e) [Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines: March 24, 2006/Vol. 55/No. RR-3;

(h) ]Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on Immunization Practices, 2010: MMWR, January 14, 2011/Vol. 60/No. 1;

(f)  A Comprehensive Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States: MMWR, December 23, 2005/Vol. 54/No. RR-6;

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

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

[(k)](i) [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;

(l) ]Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) for the Control and Elimination of Mumps: MMWR, June 9, 2006/Vol. 55/No. RR-22;

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

(n) ]Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Routine Poliovirus Vaccination: MMWR, August 7, 2009/Vol. 58/No. 30;

(k) Prevention of Varicella: MMWR, June 22, 2007/Vol. 56/No. RR-4;

[(o)](l) Prevention of Hepatitis A Through Active or Passive Immunization: MMWR, May 29, 2006/Vol. 55/No. RR-7;[and]

[(p)](m) [Preventing Pneumococcal Disease Among Infants and Young Children: October 6, 2000/Vol. 49/No. RR-9. ]Licensure of a 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Recommendations for Use Among Children-Advisory Committee on Immunization Practices, (ACIP), 2010: MMWR March 12, 2010/Vol. 59/No. 09; and

(n) Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP): March 22, 2013/62(RR02);1-22.

 

R396-100-4. Official Utah School Immunization Record (USIR).

(1) Schools and early childhood programs shall use the official Utah School Immunization Record (USIR) form as the record of each student's immunizations. The Department shall provide copies of the USIR to schools, early childhood programs, physicians, and local health departments upon each of their requests.

(2) Each school or early childhood program shall accept any immunization record provided by a licensed physician, registered nurse, or public health official as certification of immunization. It shall transfer this information to the USIR with the following information:

(a) name of the student;

(b) student's date of birth;

(c) vaccine administered; and

(d) the month, day, and year each dose of vaccine was administered.

(3) Each school and early childhood program shall maintain a file of the USIR for each student in all grades and an exemption form for each student claiming an exemption.

(a) The school and early childhood programs shall maintain up-to-date records of the immunization status for all students in all grades such that it can quickly exclude all non-immunized students if an outbreak occurs.

(b) If a student withdraws, transfers, is promoted or otherwise leaves school, the school or early childhood program shall either:

(i) return the USIR and any exemption form to the parent of a student; or

(ii) transfer the USIR and any exemption form with the student's official school record to the new school or early childhood program.

(4) A representative of the Department or the local health department may examine, audit, and verify immunization records maintained by any school or early childhood program.

(5) Schools and early childhood programs may meet the record keeping requirements of this section by keeping its official school immunization records in the Utah Statewide Immunization Information System (USIIS).

 

R396-100-5. Exemptions.

A parent claiming an exemption to immunization for medical, religious or personal reasons, as allowed by Section 53A-11-302, shall provide to the student's school or early childhood program the required completed forms. The school or early childhood program shall attach the forms to the student's USIR.

 

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 statistical report of the two-dose measles, mumps, and rubella immunization status of all kindergarten through twelfth grade students;

(c) by November 30 of each year, a statistical report of tetanus, diphtheria, pertussis, hepatitis B, varicella, and the two-dose measles, mumps, and rubella 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.

 

R396-100-7. Conditional Enrollment and Exclusion.

A school or early childhood program may conditionally enroll a student who is not appropriately immunized as required in this rule. To be conditionally enrolled, a student must have received at least one dose of each required vaccine and be on schedule for subsequent immunizations. If subsequent immunizations are one calendar month past due, the school or early childhood program must immediately exclude the student from the school or early childhood program.

(1) A school or early childhood program with conditionally enrolled students shall routinely review every 30 days the immunization status of all conditionally enrolled students until each student has completed the subsequent doses and provided written documentation to the school or early childhood program.

(2) Once the student has met the requirements of this rule, the school or early childhood program shall take the student off conditional status.

 

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.

 

R396-100-9. Penalties.

Enforcement provisions and penalties for the violation or for the enforcement of public health rules, including this Immunization Rule for Students, are prescribed under Section 26-23-6.

 

KEY: immunizations, rules and procedures

Date of Enactment or Last Substantive Amendment: [March 15, 2010]2014

Notice of Continuation: June 28, 2013

Authorizing, and Implemented or Interpreted Law: 53A-11-303; 53A-11-306