HLT-36-13-00007-P School Immunization Requirements

9/4/13 N.Y. St. Reg. HLT-36-13-00007-P

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 36

September 04, 2013

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-36-13-00007-P

School Immunization Requirements

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Amendment of Subpart 66-1 of Title 10 NYCRR.

Statutory authority:

Public Health Law, sections 2164 and 2168

Subject:

School Immunization Requirements.

Purpose:

To amend and update NYS school entry immunization requirements.

Substance of proposed rule (Full text is posted at the following State website:www.health.ny.gov):

This proposal will amend Subpart 66-1 (School Immunization Requirements) to update regulations so that they comply with current immunization recommendations and medical knowledge. The regulations would be effective July 1, 2014.

Proposed amendments to Section 66-1.1 provide that a child will be considered fully-immunized when (i) the child has received an adequate dosage and number of doses of an immunizing agent commensurate with his or her age or (ii) the child has otherwise demonstrated immunity to measles, mumps, rubella, hepatitis B, poliomyelitis (all three serotypes) and varicella through a positive serologic test or, for varicella only, disease as verified by a physician, nurse practitioner or physician’s assistant. For those immunizations required by Public Health Law (PHL) § 2164 only, the number of doses that a child should have at any given age, and the minimum intervals between these doses, is determined by the Recommended Immunization Schedule for Persons Aged 0 Through 18 Years issued by the Advisory Committee on Immunization Practices (ACIP). If a child is not fully immunized, immunization must take place according to the Catch-Up Schedule of the ACIP.

For all vaccinations except poliomyelitis and varicella, children shall be assessed upon school entry or attendance, and annually thereafter, and be found to be fully immunized commensurate with their age. For poliomyelitis vaccination beginning on or after July 1, 2014, children shall be assessed upon entry or attendance to kindergarten and sixth grade, and/or their equivalent grades, and must be fully immunized commensurate with their age. As the students enrolling in kindergarten and sixth grade move up a grade level each year, the students enrolling in those higher grades, or grade equivalent, must be appropriately immunized against poliomyelitis. For varicella vaccination beginning on and after July 1, 2014, children shall be assessed upon entry or attendance to kindergarten and sixth grade, and/or their equivalent grades, and must have received two adequate doses of vaccine. As the students enrolling in kindergarten and sixth grade move up a grade level each year, the students enrolling in those higher grades, or grade equivalent, must be appropriately immunized against varicella.

The proposed amendments also provide that a child will be considered “in process” of receiving necessary immunizations if he or she has received at least the first dose in each required immunization series and has age appropriate appointments to complete the immunization series or is obtaining serologic tests and has appointments to complete the immunization series within 30 days of notification that serologic tests are negative. Children who are not fully immunized can only continue to attend school if they are in the process of completing the ACIP catch up schedule. If a child does not receive subsequent doses of vaccine in an immunization series according to the age appropriate ACIP catch-up schedule, the child is no longer in process and must be excluded from school, if not otherwise exempt from immunization requirements.

Proposed amendments to Section 66-1.2 update the definitions in the regulation to conform to changes in the New York State Immunization Information System (NYSIIS) statute (PHL § 2168), to account for the implementation of NYSIIS that has occurred since 2008, and to include references to the New York City Immunization Registry (CIR). The proposed amendments also expand upon the definition of authorized users as well as the types of information to be reported to NYSIIS or the CIR to include race, ethnicity, telephone numbers, birth order (if multiple birth), birth state/country, Vaccines for Children Program eligibility and Medicaid number.

Proposed amendments to Section 66-1.3 provide that a school shall not admit a child without receipt of a certificate of immunization from a health care practitioner, or from NYSIIS or the CIR, documenting that the child has been fully immunized, documentation that the child is “in process,” a signed medical exemption, or a completed religious exemption. The proposed changes state that a principal or person in charge of a school shall not refuse to admit a child to school, based on immunization requirements, if that child is in process. The proposed changes also require that a medical exemption must be reissued annually and must contain sufficient information to identify a medical contraindication to a specific immunization and specify the length of time the immunization is medically contraindicated. For both medical and religious exemptions, the principal or person in charge of the school may require additional information supporting the exemption.

Proposed amendments to Section 66-1.4 clarify that the 14 calendar day period for continued school attendance may be extended to not more than 30 calendar days for an individual student who is transferring from out-of-state or from another country and can show a good faith effort to obtain the necessary evidence of immunization.

Proposed amendments to Section 66-1.6 provide that the certificate of immunization shall be prepared by the health practitioner who administers the immunizing agents and shall specify the products administered and the dates of administration. It may also show physician, nurse practitioner, or physician assistant-verified history of varicella disease and/or laboratory evidence of immunity to measles, mumps, rubella, varicella, Hepatitis B and all 3 serotypes of poliomyelitis contained in the polio vaccines.

Proposed amendments to Section 66-1.7 provide that every school shall annually provide the Commissioner of Health, or in the city of New York, the New York City Commissioner of Health, a summary regarding compliance with immunization requirements. For all schools, excluding public schools within New York City, the summary will be provided in the form of the yearly school survey conducted by the Department of Health.

Proposed amendments to Sections 66-1.8 and 66-1.9 clarify the obligation of the school to notify the local health authority, when a child has been excluded because of lack of acceptable evidence of immunization or exemption, and the obligation of the local health authority to arrange for a suitable health practitioner to administer immunizations.

Proposed amendments to Section 66-1.10 provide that, for those diseases listed in PHL § 2164, in the event of an outbreak of disease in a school, the Commissioner, or his or her designee, or in the City of New York, the New York City Commissioner of Health may order the exclusion of children who have been exempted from immunization or are “in process” of receiving required immunizations. Any exclusion shall continue until the Commissioner, or his or her designee, or the New York City Commissioner of Health (as appropriate), determines that the danger of disease transmission has passed. The proposed changes also require schools to maintain a current list of susceptible students who should be excluded from attendance in the event of an outbreak of vaccine-preventable disease.

Text of proposed rule and any required statements and analyses may be obtained from:

Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Summary of Regulatory Impact Statement

Background:

The authority for school entry immunization requirements and the statewide immunization information system stems from Article 21, Title VI, Sections 2164 and 2168 of the Public Health Law (PHL): Poliomyelitis and Other Diseases. 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 disease and accompanying morbidity and mortality. PHL § 2168 establishes the New York State Immunization Information System. Current regulations are out-of-date and need to be amended to comply with currently accepted medical practice and recommendations, to address statutory changes to PHL § 2168 and to account for the implementation of NYSIIS that has occurred since 2008.

The introduction and widespread use of vaccines have profoundly reduced the occurrence of many serious infectious diseases. Prior to vaccines, thousands of children each year, living in the United States (US), could expect to die or be left with life-long disabilities as a result of contracting diseases that are now preventable by vaccination, such as smallpox, poliomyelitis, rubella, measles, diphtheria and pertussis. Similarly, once commonly encountered and often deadly diseases such as diphtheria and rubella are becoming a rarity in the US as a result of the routine use of vaccination against these and other infectious diseases. Many of these now vaccine-preventable diseases, due to their person-to-person mode of transmission, have historically occurred at very high rates in pre-school and school-aged children. Consequently, it is of the utmost importance, that this cohort maintains a high rate of vaccination coverage to prevent disease outbreaks. Historically, both nationwide and in New York State, school vaccination laws/requirements have been instrumental in helping to achieve high rates of immunization among school-aged children and consequently, in helping to prevent many diseases.

The development of school entry laws typically begins with public health recommendations made by the Advisory Committee on Immunization Practices (ACIP). ACIP provides advice and guidance to the Secretary of the U. S. Department of Health and Human Services, the Assistant Secretary for Health, and the CDC on the control of vaccine-preventable diseases. ACIP makes their recommendations based on evidence presented to them by both medical and other health care professional organizations. Their recommendations shape national immunization policy and are usually adopted by such professional organizations such as the American Association of Pediatrics, the American Association of Family Physicians, and the American College of Physicians. ACIP recommendations form the standard of care for immunization practices in the US, and school entry laws need to follow these standards as closely as possible. New York State regulations need to be modified to be current with immunization practices.

Necessity for Regulation Updates:

New York State’s immunization rates for school-aged children have remained high, due in large part to school entry vaccination requirements. New York State has over 650 school districts and over 15,000 schools, including day cares, elementary, secondary, private, and public schools. Overall, immunization rates are consistently over 90 percent throughout the state and also in most individual schools; however, variations do exist. For instance, although the overall rate for religious exemptions in NYS is.53%, the exemption rates by grade group per county vary greatly. For children enrolled in grade 1, religious exemption rates range from 0% to 13.51%. This variation can be explained in part by the inhabitants of a given county. Counties with Amish and Mennonite communities tend to have higher religious exemption rates. The majority of schools in Amish and Mennonite communities do not offer kindergarten or high school grades, only enrolling children in grades 1 through 8. Therefore, the immunization rates for counties with large Amish and Mennonite communities have higher religious exemption rates for grades 1 through 8. There are other schools, where children with religious exemptions tend to cluster.

When a significant proportion of individuals in a community are immunized, those persons serve as a protective barrier against the likelihood of transmission of disease in the community, thus indirectly protecting those who are not fully immunized. This protection is referred to as “community immunity” or “herd immunity.” If a large proportion of a community decides to not be vaccinated, the protection levels that initially existed via herd immunity decline, and disease transmission increases. The importance of high immunization rates in NYS remains paramount, despite the sometimes low rates of disease in the U.S.

The purpose of the proposed regulatory changes is to update regulations so that they comply with current immunization recommendations and knowledge. Over time, through routine vaccine use, it has become obvious that changes in the schedule are necessary to maximize the protection of children and the community. The dangers of under-vaccination have been dramatically demonstrated by the number of outbreaks of diseases that have not been seen in developed countries in large numbers for many years. In addition, a rise in the number of outbreaks related to high rates of exemption to immunization in certain communities around the country, have illustrated the need for stronger school entry requirements.

The changes to these regulations include updating the school entry and attendance immunization requirements to comply with current recommendations of the official schedule as approved by ACIP and other major medical professional societies. These include: increasing the required number of doses of diphtheria, tetanus and acellular pertussis (DTaP) and varicella vaccines, clarifying the age appropriate vaccinations required with polio, hepatitis b, haemophilus influenzae type b, and pneumococcal vaccines, clarifying that appropriate spacing of vaccines is essential for efficacy, and clarifying definitions and key parts of the regulations, such as what constitutes immunity and how to determine the time a student can be in process of receiving their vaccines.

Since 2007, ACIP has recommended two doses of varicella (chicken pox) vaccine, one dose at 12 to 18 months of age and a second dose at 4-6 years of age. This was based on the fact that one dose of varicella vaccine seemed to allow an unacceptable number of breakthrough case of varicella disease. Exact rates of varicella disease are not known for New York State, but national studies have shown a steady decline in the number of cases of the disease as immunization has become more widespread.

All affected children will be required to adhere to the proposed school entry regulations on and after July 1, 2014.

Associated Costs:

The proposed regulatory changes are not expected to result in substantial costs to the state or local 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 $10 billion from direct costs. The CDC estimates that every dollar spent on immunization saves $18.43, producing societal aggregate savings of $42 billion. Potential savings to Medicaid and other payers are also expected secondary to the prevention of cases of disease.

The Vaccines for Children Program (VFC), a federal entitlement program, provides vaccine for eligible children. In addition, the “317” federal grant supports purchase of vaccine for administration at no cost to children at local health departments, and also supports immunization delivery, surveillance, communication and education. Private insurance, the VFC Program and the “317” grant will cover the cost of most of the additional vaccines required for school entry to eligible individuals. The State, however, may be required to use additional funds for the purchase and administration of vaccine to meet the revised school entry requirements for those individuals who are underinsured and/or participate in the State Children’s Health Insurance Program (SCHIP).

The NYSDOH Bureau of Immunization currently operates the New York State Immunization Information System (NYSIIS), which will aid in the recording of immunizations and has the ability to identify and generate notifications to students who are not in compliance with school immunization entry/attendance requirements. Currently 2,425 educational institutions in NYS are actively utilizing NYSIIS. These institutions are currently able to search for a given student’s immunization history, review it and determine compliance with current school entry requirements. These features are already a part of NYSIIS and thus the expansion of immunization requirements will not result in any additional costs for the State.

The NYSDOH will need to provide education on and promote the regulatory changes that will go into effect in the fall of 2014. The NYSDOH has contact information for all schools in NYS and currently communicates with schools across the state on a regular basis. The expansion of school immunization requirements and the need for education of all affected schools will not be a burden to the State as this communication takes place on a frequent basis already. Funds necessary for educational/media campaigns will be made available from the existing Department of Health budget.

The cost to local governments and school districts is difficult to estimate, but should be minimal. School staff already collect immunization records and make sure that students comply with school entry requirements. The great majority of students will already be in compliance with the recommended schedule because this is the standard of care and most physicians and other health care providers comply with the recommendations. Administrative staff at public schools will be responsible for assuring that each student is in compliance with the revised school entry requirements at the time of registration. School staff will be able to utilize NYSIIS to check and record immunization records, a cost saving measure that was not available the last time regulations were changed. Administrative procedures already in place will be utilized to notify students of immunization requirements and to notify deficient students of the need to comply. Given that schools are already checking, recording and notifying deficient students, the costs of implementing these regulations will likely be minimal.

Additional costs for the administration of vaccine by local health departments to meet the revised school entry requirements in the county health department clinics will likely be incurred. A substantial portion of the costs of organizing additional county health departments’ clinic services will be eligible for reimbursement through State public health local assistance or from third party payers.

It is difficult to determine what, if any, additional expenses may be incurred by these measures to private parties, however, costs are predicted to be minimal. Given that the revised school entry requirements incorporate the currently recommended ACIP immunization schedule, many medical practices have already been recommending and administering these vaccines to their patients. It is possible that the new regulations will prompt an initial increase in patient flow to update all children’s vaccine status in accordance with the new school entry requirements. This could require some additional staffing time and/or office hours to accommodate these patients, but any additional visits would be eligible for reimbursement from payers. It is likely, however, that after this initial phase, no further cost will be incurred by private parties.

Regulatory Flexibility Analysis

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-caring centers, 9,338 day care agencies, 642 nursery schools, 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. This information includes immunizations received, and/or history of disease, and/or serology performed, and or medical and/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 kindergartens, 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 mandated 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 mandate.

Compliance Costs:

The cost to facilities to meet this mandate is estimated to be negligible, because facilities 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 technically 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 New York City (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:

The Advisory Committee on Immunization Practices (ACIP) is the body that creates the recommended immunization schedule for children on an annual basis and is the authority in determining the vaccinations types and intervals in which children should be immunized. The proposal to require children to be up to date on their immunizations as specified by the schedule set forth by the ACIP is a generally accepted as the standard of practice. However, the regulations do provide an exception when a medical contraindication or religious exemption exists. It does not include an exception for any other philosophical, social or economic reason because such exceptions substantially undermine the effectiveness of the health initiative. With respect to minimizing the economic impact on the schools, many, if not all schools already have mechanisms in place to verify immunization requirements.

Small Business and Local Government Participation:

Small businesses and local governments would be positively impacted by these regulations in that with improved immunization compliance in school settings, the likelihood of vaccine preventable disease outbreaks, and their resultant negative effects on local communities, would be lessened, if not eliminated.

Rural Area Flexibility Analysis

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. It will require additional documentation, record-keeping and other compliance requirements on public or private entities, but it is not expected to adversely affect rural areas.

Job Impact Statement

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.