Proposed amendments to Section 66-1.1 provide that children entering eighth through twelfth grade in the 2015-2016 school year shall be deemed in compliance with all immunization requirements until graduation, if they had satisfied the immunization requirements in effect in regulation on June 30, 2014.

Proposed amendments to Section 66-1.1 provide that, children entering kindergarten through twelfth grade (excepting those children entering eighth through twelfth grade in the 2015-2016 school year) must have received, in accordance with ACIP minimum intervals and dosage recommendations:

• two doses of measles-containing vaccine, two doses of mumps-containing vaccine, and at least one dose of rubella-containing vaccine.

• five doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP). If, however, the fourth dose of DTaP was given at forty-eight months of age or older, only four doses are required.

• four doses of poliomyelitis vaccine. If, however, the third dose was given at forty-eight months of age or older, only three doses are required.

Proposed amendments to Section 66-1.1 further provide that upon entry to sixth grade or a comparable age level grade equivalent, a child eleven years of age or older must receive a booster immunization containing tetanus and diphtheria toxoids and acellular pertussis vaccine.

The proposed amendments to Section 66-1.1 also update the regulation to incorporate the 2014 ACIP schedule -- the Advisory Committee on Immunization Practices Recommended Immunization Schedules for Persons Aged 0 Through 18 Years.

The amendments to Section 66-1.1 also provide that, students who are “in process” or following the ACIP “catch-up” schedule must follow the minimum intervals prescribed by the ACIP schedule. These proposed amendments do not address additional immunizations that may be required for school admission by the New York City Health Code.

Proposed amendments to Section 66-1.2 update the regulations to conform to changes in the NYSIIS statute (Public Health Law § 2168). The proposed amendments add colleges, professional and technical schools, and children’s overnight and summer day camps as authorized users of NYSIIS and grant access to de-identified registry information for research purposes. Proposed amendments to Section 66-1.2 also permit the exchange of registry information with the Indian Health Service and tribal nations. Proposed amendments to Section 66-1.2 also remove two electronic reporting exemptions and remove the ability to request an extension on the required 14 day reporting period.

Proposed amendments to Section 66-1.6 clarify acceptable certificates of immunization. The proposed amendments provide that a certificate of immunization generally must be signed by a health practitioner licensed in New York State and that a record issued by NYSIIS, the Citywide Immunization Registry (CIR), an official immunization registry from another state, an electronic health record and/or an official record from a foreign nation may be accepted without a health practitioner’s signature.

Statutory Authority:

The authority for school entry immunization requirements stems from Article 21, Title VI, Section 2164 of the Public Health law (PHL): Poliomyelitis and Other Diseases. PHL § 2164 mandates the vaccination of children as a condition of entry/attendance to school. PHL § 2164(10) authorizes the commissioner to promulgate regulations to effectuate the provisions and purposes of PHL § 2164. The authority for the statewide immunization information system stems from Article 21, Title VI, Section 2168 of the Public Health Law (PHL): Poliomyelitis and Other Diseases. PHL § 2168 establishes the New York State Immunization Information System (NYSIIS). PHL § 2168(13) authorizes the commissioner to promulgate regulations to effectuate the provisions of PHL § 2168.

Legislative Objectives:

The legislative objective of PHL § 2164 includes the protection of the health of residents of the state by assuring that children are immunized according to current recommendations before attending day care, pre-k, or school, to prevent the transmission of vaccine preventable disease and accompanying morbidity and mortality. The legislative objective of PHL § 2168 is to establish a comprehensive database of complete, accurate and secure immunization records.

Needs and Benefits:

The purpose of the proposed regulatory changes is to update the existing school immunization requirements to ensure that children receive complete series of measles, mumps and rubella (MMR), diphtheria, tetanus and acellular pertussis (DTaP), and poliomyelitis vaccines by kindergarten or school entry. The school immunization regulations were last updated for the 2014-2015 school year to require that children receive an age-appropriate number of doses of immunizations, as determined by the 2013 Advisory Committee on Immunization Practices (ACIP) Immunization Schedule.

During implementation of the regulatory changes for the 2014-2015 school year, several limitations to the existing regulations were identified, necessitating further amendments to the regulations for the 2015-2016 school year. Chief among these was the timing of the final doses of the MMR, DTaP, and poliomyelitis vaccine series. Prior to the regulatory changes for the 2014-2015 school year, students entering kindergarten through twelfth grade were required to receive two doses of measles-containing vaccine, or other acceptable evidence of immunity, regardless of age. Although ACIP statements on each of these vaccine series recommend completion of these series prior to kindergarten or school entry, the 2013 ACIP Immunization Schedule, which was incorporated by reference into the recently revised regulations, recommended administration of the final doses of each of these series at four to six years of age.^1-4 As a result, students were not required to receive the final dose until the end of the recommended age range – i.e., the child’s seventh birthday. As nearly all students in kindergarten are less than seven years of age, the kindergarten requirement for measles-containing vaccine has effectively been reduced from two doses to one dose. Likewise, students cannot be required under the existing regulation to receive the final doses of DTaP and poliomyelitis vaccines until they reach seven years of age. This was an unanticipated byproduct of the incorporation by reference of the ACIP schedule which was not identified during the regulatory change process.

It is of the utmost public health importance that students entering kindergarten be maximally protected with complete MMR, DTaP and poliomyelitis vaccine series. The United States (U.S.) is currently experiencing a record number of measles cases. Nearly 600 measles cases were reported in the U.S. from January 1 through August 15, 2014 – the highest number of cases reported since measles elimination was documented in the U.S. in 2000.⁵ This number includes a large measles outbreak in New York City (NYC) and additional measles cases in New York State (NYS) outside of NYC in 2014. An ongoing large measles outbreak in the Philippines has contributed to measles cases to the U.S., including four NYS and NYC cases with confirmed or suspected epidemiologic links to the Philippines this year. A recent edition of the Morbidity and Mortality Weekly Report (MMWR) provides details on measles cases and outbreaks in the U.S. in 2014 to date.⁶

Reported cases of pertussis are also increasing nationwide. California has declared a pertussis epidemic, with over 7500 cases, including elementary, middle, and high school outbreaks, reported from January 1, 2014 to August 18, 2014.⁷ NYS experienced a record peak year of pertussis incidence in 2012, with 2,713 cases of pertussis reported outside of NYC, exceeding the last large NYS pertussis outbreak of 1,969 cases in 2004. As pertussis outbreaks occur cyclically and typically peak every three to five years, NYS could experience its next pertussis peak year as soon as 2015.

On May 5, 2014, the director-general of the World Health Organization (WHO) declared the international spread of poliomyelitis to be a public health emergency of international concern under the authority of the International Health Regulations. The WHO has designated four countries (Cameroon, Equatorial Guinea, Pakistan, and Syria) as "exporting wild poliovirus" and an additional six countries (Afghanistan, Ethiopia, Iraq, Israel, Nigeria, and Somalia) are designated as "infected with wild poliovirus.”⁸Although poliomyelitis was declared eliminated from the U.S. in 1979, it remains crucial to maintain high rates of vaccination because poliomyelitis could be brought in to the U.S. from countries where poliovirus is circulating.

In contrast to the MMR, DTaP and poliomyelitis age-based immunization requirements, the regulatory amendments made for the 2014-2015 school year explicitly stated that children entering kindergarten must have received two doses of varicella vaccine or other acceptable evidence of varicella immunity. The proposed regulatory changes mirror the varicella language in the existing regulation to require completion of the poliomyelitis, MMR and DTaP vaccine series, or other acceptable evidence of immunity, for kindergarten and school entry. The move from age-based to kindergarten entry requirements will improve community immunity in schools against these vaccine preventable diseases and enhance the ability of schools to enforce immunization requirements.

In addition, the requirement for vaccine intervals to be consistent with the 2013 ACIP schedule has created significant problems for adolescent students, who received vaccine doses eight or more years ago, under standards of care that may have been appropriate at the time of vaccine administration, but may no longer be consistent with the 2013 ACIP schedule.

To ameliorate this situation, the proposed regulatory change allows those students entering eighth through twelfth grades (or comparable age level grade equivalents) only during the 2015-2016 school year to be in compliance with school immunization requirements until graduation if they had previously satisfied the school immunization requirements in effect in regulation on June 30, 2014. This change would exempt this cohort of students from the revised vaccine interval requirements established by the current ACIP schedule, but still require that such students be age-appropriately vaccinated under the prior school immunization requirements.

To improve the completeness and accuracy of NYSIIS data and to further assist educational institutions with locating up-to-date immunization histories for their students, two exemptions for electronic reporting to NYSIIS have been removed from the regulation. These exemptions were important when NYSIIS was first launched to assist with the initial training of providers. They are no longer needed as NYSIIS has been an active system for over six years. All NYS providers must report complete and timely immunization data to NYSIIS. In addition, to conform to changes in PHL § 2168, the regulations have been updated to add colleges, professional and technical schools, and children’s overnight and summer day camps as authorized users of NYSIIS and to grant access to de-identified registry information for research purposes. The regulations have also been updated to permit the exchange of registry information with the Indian Health Service and tribal nations as also allowed by amendments to PHL § 2168.

Finally, the revised regulations clarify the requirements for acceptable certificates of immunization to allow records issued by NYSIIS, the Citywide Immunization Registry (CIR), or another state immunization registry, an electronic health record, and/or an official record from a foreign nation to be accepted without a health practitioner’s signature. This change reflects the increasing usage of electronic health records and immunization registries.

Costs:

Costs to State Government including the Department of Health:

The proposed regulatory changes are not expected to result in substantial costs to state government, but instead will likely result in cost savings to the state. Routine childhood immunizations have been estimated to result in a cost savings of approximately $13.5 billion in direct costs and $68.8 billion in societal costs. The CDC estimates that every dollar spent on immunization saves at least ten dollars in aggregate societal costs.⁹ Potential savings to Medicaid and other payers are also expected secondary to the prevention of cases of disease.

Costs to Local Governments:

The cost to local governments and school districts is difficult to estimate. School staff already collect immunization records and ensure that students comply with school entry requirements. The move from age-based to kindergarten entry requirements for MMR, DTaP and polio vaccines will only directly impact students four to six years of age as students seven years of age and older are already required to have these doses under existing regulation. While there will be initial work associated with ensuring that students in this age range meet the new kindergarten entry requirements, this change should reduce long-term administrative costs for school districts by markedly reducing the number of “in process” students that the school must monitor. In addition, exempting the cohort of students entering eighth through twelfth grades during the 2015 – 2016 school year from the vaccine interval requirements will significantly reduce immunization assessment work for school districts. The clarification of acceptable certificates of immunization should further reduce administrative costs to school districts associated with verifying that certificates of immunization meet regulatory requirements.

Costs to Private Regulated Parties:

It is difficult to determine what if any additional expenses may be incurred by these measures, however, costs are predicted to be minimal. Given that the revised school entry requirements are consistent with ACIP immunization recommendations, many medical practices already administer these vaccines to their patients prior to kindergarten entry.

Local Government Mandates:

The revised school entry regulations will not impose any additional mandates on local governments or school districts. NYS school districts are already required by PHL § 2164 to verify all students’ immunization histories.

Paperwork:

The revised school entry regulations will not increase the normal amount of the State's paperwork. Because schools are already required to maintain student immunization records, there will be no increase in their paperwork.

Duplication:

No relevant rules or other legal requirements of the state and/or federal government exist that duplicate, overlap or conflict with this rule.

Alternatives:

No alternatives were considered given that other alternatives would only result in inconsistencies with national immunization policy and good medical practice.

Federal Standards:

In the United States, all school entry immunization laws are created by individual states. There is no federal standard with regard to school entry immunization regulations.

Compliance Schedule:

All affected children will be required to adhere to the proposed school entry regulations on and after July 1, 2015.

REFERENCES

1) Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013: Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 2013; 62(RR04); 1-34.

2) Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 1997; 46(RR-7); 1-25.

3) Poliomyelitis Prevention in the United States: Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 2000; 49(RR05); 1-22.

4) Advisory Committee on Immunization Practices Recommended Immunization Schedule for Persons Aged 0 Through 18 Years – United States, 2013. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 2013; 62 (Suppl 1); 2-8.

5) Centers for Disease Control and Prevention. Measles Cases and Outbreaks. Accessed August 22, 2014. http://www.cdc.gov/measles/cases-outbreaks.html.

6) Measles – United States, January 1 – May 23, 2014. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 2014; 63(22); 496-499.

7) California Department of Public Health. Pertussis Summary Reports. Accessed August 22, 2014. http://www.cdph.ca.gov/programs/immunize/Pages/PertussisSummaryReports.aspx.

8) Interim CDC Guidance for Polio Vaccination for Travel to and from Countries Affected by Wild Poliovirus. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, 2014; 63(27); 591-594.

9) Zhou F, Shefer A, Wenger J, Messonnier M, Wang LY, Lopez A, Moore M, Murphy TV, Cortese M, Rodewald L. Economic Evaluation of the Routine Childhood Immunization Program in the United States, 2009. Pediatrics. 2014; 133:1-9.

Effect of Rule:

Any facility defined as a school pursuant to PHL § 2164 will be required to comply. Schools that are affected by this rule will include approximately: 5,498 public, private, or parochial child care centers, 9,338 day care agencies, 642 nursery schools, and 6,387 kindergartens, elementary, intermediate, or secondary class or school buildings.

Compliance Requirements:

All schools must document the immunization status of all students who are entering or attending their facility, including immunizations received, history of disease, serology performed, and/or medical or religious exemptions to said immunization(s).

The approximate number of students are as follows: 128,383 in public, private, or parochial child-caring centers, 187,752 in day care agencies, 39,312 in nursery schools, and 3,081,724 in kindergarten, elementary, intermediate, or secondary class or school buildings. However, because schools were already required to collect immunization information, the burden of compliance with this new rule is substantially minimized.

Professional Services:

Schools are already required to comply with immunization requirements for entering/attending students and therefore immunization record retrieval already occurs with necessary follow-up if applicable. It is not anticipated that schools will need to hire additional staff to meet this requirement.

Compliance Costs:

The cost to schools to meet the requirements of the proposed regulation is estimated to be minimal, because schools are already required to inspect vaccination records of all students and appropriate vaccination of the student body may result in cost savings. Specifically, it is anticipated that any costs incurred to check vaccination records will be offset by savings in direct medical costs by reducing vaccine preventable disease transmission among students, as well as savings in indirect costs associated with student and school staff absenteeism.

Economic and Technological Feasibility:

This proposal is economically and technologically feasible. Many schools currently have read-only access to retrieve immunization information from the New York State Immunization Information System (NYSIIS) for students outside of NYC, and the Citywide Immunization Registry (CIR) for students within NYC. Because schools have direct read-only access to the consolidated immunization record through NYSIIS or the CIR, they are able to efficiently identify children at risk for vaccine preventable diseases secondary to their under-immunization; this is critical during outbreak situations. In addition, access to this information simplifies assessment of immunization coverage as required for school entry/attendance.

No software needs to be purchased and no other fees are required to access the web-based systems. Using electronic tools for student record immunization queries also results in a significant cost savings when compared to the effort required to collect and analyze the volume of paper immunization histories provided by parents to the school.

Minimizing Adverse Impact:

Many, if not all schools already have mechanisms in place to verify immunization requirements.

Small Business and Local Government Participation:

The proposed regulatory changes were drafted in response to feedback from multiple stakeholders, including public and private schools, local health departments, and health care providers. In addition, New York City Department of Health and Mental Hygiene (NYC DOHMH) and New York State Education Department (NYSED) were solicited for comments on the regulations. The NYC DOHMH is a large local government jurisdiction representing nearly half of children in New York State and NYSED oversees prekindergarten through grade 12 programs in New York State. Both NYC DOHMH and NYSED expressed support for the proposed regulatory changes.

Pursuant to section 202-bb of the State Administrative Procedure Act (SAPA), a rural area flexibility analysis is not required. These provisions apply uniformly throughout New York State, including all rural areas.

The proposed rule will not impose an adverse economic impact on rural facilities defined within PHL Articles 28, 36, or 40.

A Job Impact Statement is not included in accordance with Section 201-a(2) of the State Administrative Procedure Act (SAPA), because it will not have a substantial adverse effect on jobs and employment opportunities.