PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 31. NUTRITION SERVICES
SUBCHAPTER C. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC)
The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes an amendment to §31.30 and the repeal of §§31.32 - 31.36, concerning the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
BACKGROUND AND PURPOSE
Under federal and state enabling legislation, the WIC Program is funded entirely by a combination of federal grant funds and by rebates from manufacturers of infant formula and infant cereal that can only be expended to defray WIC food costs. The United States Department of Agriculture (USDA) awards federal grant funds to the department to administer the programs, provided the department does so in accordance with federal law and regulations and in accordance with the department's annual submission of a state plan approved by USDA. USDA deems the following types of changes to be substantive amendments to the state plan that require federal approval: rule or policy changes initiated by legislation, USDA, or the state agency; changes affecting client or vendor services and benefits; changes in the monitoring/oversight of vendors and local agencies; any other operational changes aimed at improving or enhancing program delivery or accountability; and changes in related State procedures.
Revisions to these rules are proposed primarily to comply with federal regulations governing the WIC program in 7 Code of Federal Regulations (CFR), Part 246, and to improve administrative efficiency and effectiveness.
SECTION-BY-SECTION SUMMARY
The amendment to §31.30 conforms to federal regulations governing the WIC Program at 7 CFR, §246.7(h)(2) and §246.12(u)(2)(i), concerning mandatory disqualification of WIC clients for fraud or abuse if no administrative hearing is requested. In addition, the department may authorize the Office of Inspector General, Health and Human Services Commission, to perform recovery actions on its behalf.
Repeal of §§31.32 - 31.36 eliminates redundancy and improves administrative efficiency, because it is not legally necessary to adopt provisions in rule that govern WIC vendors and local agencies since the provisions can be included and enforced by reference in the contracts and agreements executed annually between the department and local agencies and vendors.
FISCAL NOTE
Mike Montgomery, Director, Nutrition Services Section, has determined that for each calendar year of the first five years the section or repeals are in effect, there will be no fiscal implications to state or local governments as a result of enforcing or administering the section or repeals as proposed. All activities required by §31.30 will be performed by existing department staff and with existing funding. Concerning the amendment to §31.30, participant disqualification for alleged fraud or abuse of the WIC Program is mandatory without regard to any final action by the state criminal courts, but the participant retains the right to an administrative hearing in which the participant's rights could be upheld. This change to §31.30 represents the reverse of current practice.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Mr. Montgomery has determined that there will be no effect on small businesses or micro-businesses by repeal of §§31.32 - 31.36 because exactly the same provisions now adopted in rule may lawfully be included and enforced by reference in the contracts and agreements executed annually between the department and local agencies and vendors. In addition, small and micro-businesses are not required to provide WIC services. Mr. Montgomery has also determined that the amendment to §31.30, applicable to "Participant Fraud and Abuse" by individual WIC clients, rather than small businesses and micro-businesses, is necessary to comply with federal regulations. There are no anticipated economic costs to persons, including WIC applicants and WIC recipients, who are required to comply with the amendment to §31.30 or repeal of §§31.32 - 31.36 as proposed. There is no anticipated negative impact on local employment.
ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS
Mr. Montgomery has determined that the proposed changes have no adverse economic impact on small businesses. Therefore, an economic impact statement and regulatory flexibility analysis for small businesses are not required.
PUBLIC BENEFIT
Mr. Montgomery has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing or administering the sections will be assurance that federal funds will be utilized more cost-effectively to deliver services to WIC recipients.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendment and repeals do not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, do not constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Valerie Wolfe, Nutrition Services Section, Division of Family and Community Health, MC 1933, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, (512) 458-7444, or by email to Valerie.Wolfe@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' legal authority to adopt.
STATUTORY AUTHORITY
The proposed amendment is authorized under Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
The proposed amendment affects Health and Safety Code, Chapter 1001; and Government Code, Chapter 531.
§31.30.Participant Fraud and Abuse.
(a) (No change.)
(b) If the state agency or the Office of Inspector
General, Health and Human Services Commission, determines that a participant
or parent, guardian, client-designated proxy, state agency-appointed
proxy, or caretaker of a participant has received benefits unlawfully
due to WIC Program abuse, including but not limited to dual participation,
the matter may be referred for criminal prosecution [state
agency may refer the matter for criminal prosecution].
(c) (No change.)
(d) [If prosecution is declined by the appropriate
jurisdiction, the violation does not involve a violation of criminal
law, or final disposition of criminal prosecution has occurred the]
The state agency, or local agency as directed by the state
agency, [shall direct the local agency to] initiate
sanctions which may include disqualification from the Program for
up to one year.
(e) Upon a final determination by the Office of the
Inspector General, Health and Human Services Commission, that a program
violation has occurred [
and that final disposition of any criminal
prosecution has occurred
], the following mandatory disqualifications shall apply.
(1) - (3) (No change.)
(f) If after finding that a program violation
has occurred, the [Upon a final determination by the]
Office of Inspector General, Health and Human Services Commission, further
determines that the [a] program violation
[has occurred that] does not warrant a one year mandatory
disqualification [and no appeals from any criminal prosecution
remain], the following sanctions shall apply.
(1) - (6) (No change.)
(g) Exceptions to disqualification:
(1) The state agency [or the Office of Inspector
General, Health and Human Services Commission,] may decide not
to impose a disqualification if, for violations which resulted in
a claim assessed by the state agency against the participant, parent,
guardian, client designated proxy, state agency-appointed proxy, or
caretaker of a participant, full restitution is made within 30 days
of receipt of a letter demanding repayment or a repayment schedule
is agreed on.
(2) - (3) (No change.)
(h) The state agency [or the Office of the Inspector
General, Health and Human Services Commission, shall] may attempt
to recover, in cash, the value of the benefits received by a participant
or the parent, guardian, client-designated proxy, state agency-appointed
proxy or caretaker of a participant as a result of participant abuse.
The state agency may request and authorize the Office of the Inspector
General, Health and Human Services Commission, to perform this recovery
on its behalf.
(1) The state agency or the Office of the Inspector
General, Health and Human Services Commission, may [shall
] determine the amount of the benefits improperly received by
a participant through an independent review of local agency records
and such other procedures as the state agency considers necessary
under the specific circumstances. The state agency may request
and authorize the Office of the Inspector General, Health and Human
Services Commission, to perform this recovery on its behalf.
(2) In cases involving criminal prosecutions for violations
of law, repayment of cash value of benefits improperly received
,may [shall] become a part of any restitution agreement
with the prosecutor and approved by the court. In such
cases, the participant shall not have the right to a fair hearing
by the department.
(3) (No change.)
(i) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on August 8, 2008.
TRD-200804163
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 21, 2008
For further information, please call: (512) 458-7111 x6972
(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
STATUTORY AUTHORITY
The proposed repeals are authorized under Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
The proposed repeals affect Health and Safety Code, Chapter 1001; and Government Code, Chapter 531.
§31.32.Selection of Vendors for WIC Initial Authorization for Participation.
§31.33.Selection of Vendors for Reauthorization for Participation.
§31.34.Calculation and Use of Vendor Competitive Pricing Data.
§31.35.Vendor Agreement with the State Agency.
§31.36.The Right of a Vendor or Local Agency to Appeal.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on August 8, 2008.
TRD-200804164
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 21, 2008
For further information, please call: (512) 458-7111 x6972
SUBCHAPTER B. IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION
The Executive Commissioner of the Health and Human Services Commission on behalf of the Department of State Health Services (department) proposes amendments to §97.61 and §§97.63 - 97.72, concerning immunization requirements in Texas elementary and secondary schools and institutions of higher education.
BACKGROUND AND PURPOSE
Government Code, §2001.039, requires that each state agency review and consider for readoption every four years each rule adopted by that agency pursuant to the Government Code, Chapter 2001. Sections 97.61 and 97.63 - 97.72 have been reviewed and the department has determined that reasons for proposing amendments to §97.61 and §§97.63 - 97.72 continue to exist because rules on this subject are needed. This rulemaking proposal would make various clarifying amendments designed to improve the efficiency and readability of these rule sections, and would also make certain substantive changes which the department believes are in the best interest of public health.
The substantive amendments to §97.63 are being proposed in order to update the Texas elementary and secondary school immunization requirements so that they adhere more closely to the current version of the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule (see http://www.dshs.state.tx.us/immunize/docs/6-105.pdf). These revisions would amend the frequency of vaccinations and booster shots for diseases already covered in the rule, and would also add vaccinations regarding meningococcal disease (see full discussion in the Section-By-Section Summary). Throughout the rule development process, the following stakeholders were given the opportunity to review the proposed amendments to §97.63 and provide informal feedback: Texas Pediatric Society, Texas Medical Association, various school nurses from the Nurses Alliance, and the San Antonio Metropolitan Health District.
The amendments to §97.64 are being proposed in order to update, simplify and clarify the rule text regarding the vaccines required and the limited exceptions for students enrolled in health-related and veterinary courses. The department intends for the proposed changes to address concerns expressed to the department in the past regarding a perceived lack of clarity in this rule section.
SECTION-BY-SECTION SUMMARY
Section 97.61.
The proposed amendments to §97.61 would revise the section title for clarity, and revise subsection (b) to update to the department's current name. Subsection (c) of the rule is proposed to be updated by deleting the cross-reference to Texas Health and Safety Code, §81.002, because the term "instruction" is not contained in the current version of that statutory provision.
Section 97.63.
The amendments to §97.63 are being proposed primarily in order to update the Texas elementary and secondary school immunization requirements to adhere more closely to the current version of the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule. The department agrees with these recommended changes from a public health perspective. These substantive changes to the rule section have been drafted so that they would become effective for the 2009 - 2010 school year, which should give school districts sufficient time to perform outreach/education regarding the new requirements and also for the required vaccinations to be administered. Changes are also proposed in this section to improve clarity and readability.
The department proposes the following amendments to become effective for the 2009 - 2010 school year:
Section 97.63(2)(B)(ii)(III) concerning Td/Tdap booster requirement:
-The current rule language provides that 1 booster dose of a tetanus/diphtheria containing-vaccine is required within the last 10 years.
-The proposed amendment provides that there be a Tdap requirement for students in 7th grade beginning in the 2009 - 2010 school year.
-The rationale for proposed rule amendment is the following:
(1) ACIP/CDC recommendation for adolescents (11 - 18 years) to receive a single booster dose of Tdap instead of Td (unless medically contraindicated);
(2) Preferred age for Tdap is 11 - 12 year old visit.
Section 97.63(2)(B)(iii) concerning measles, mumps, and rubella:
-The current rule language provides that 2 doses of a measles-containing vaccine are required, 1 dose of mumps and 1 dose of rubella for grades K - 12.
-The proposed rule amendment would require 2 doses of MMR, which is the current combination vaccine that is the recommended method to get the 3 individual vaccines.
-The rationale for the proposed rule amendment is the following:
(1) In order to align the Texas requirements with the most recent ACIP/CDC recommendations.
(2) Recent mumps outbreaks, January 1 through May 2, 2006, resulted in 2,597 cases of mumps in 11 states. The department wants to respond proactively before similar outbreaks occur in Texas.
Section 97.63(2)(B)(iv) concerning Hepatitis B.
The current rule language was written to phase-in a Hepatitis B vaccination requirement, and included a progressive schedule for certain grades by certain years. Now that the phase-in period has passed, the proposed amendment is written to articulate the requirement after the phase-in period and would delete the phase-in language.
Section 97.63(2)(B)(v) concerning varicella:
-The current rule language provides that 1 dose is to be received on/after 1st birthday for grades K - 12, according to the listed schedule.
-The proposed amendment provides that a progressive 2nd dose requirement for varicella at kindergarten entry be added (each subsequent school year, the next grade is added to the schedule).
-The rationale for proposed amendment is the following:
(1) In order to align the Texas requirements with the most recent ACIP/CDC recommendations.
(2) With 1-dose vaccination schedule, vaccine effectiveness of 85% has not been sufficient to prevent varicella outbreaks in highly-vaccinated school populations.
(3) In these school outbreaks, varicella vaccine coverage ranges from 96% to 100%, with vaccine effectiveness ranging from 72% to 85%.
(4) The peak age-specific incidence of varicella has shifted from 3 - 6 year old children in the pre-vaccine era to 9 - 11 year old children in the post-vaccine era, both for immunized and un-immunized children during these outbreaks.
(5) Studies show that the immune response after the 2nd dose of varicella vaccine demonstrate a greater than 10-fold boost.
(6) Approximately >99% of children achieve an antibody response after the 2nd dose of varicella vaccine compared with 76% - 85% of children with a single dose of varicella vaccine.
Section 97.63(2)(B)(vi) concerning Hepatitis A:
-The current rule language provides 2 doses of hepatitis A vaccine for grades K - 3 in 40 counties designated by the department.
-The proposed amendment would require that there be a statewide requirement for hepatitis A for kindergarten enterers in the 2009 - 2010 school year, and in subsequent years, the next grade level will be incorporated. The phrase "The 1st dose shall be administered on or after the 1st birthday" would be added to indicate when the series begins.
-The rationale for the proposed rule amendment is the following:
(1) In order to align the Texas requirements with the most recent ACIP recommendations.
(2) Majority of reported hepatitis A cases come from areas where hepatitis A vaccine is not required for children attending kindergarten through 3rd grade.
(3) A population of young children who may not have received hepatitis A vaccine still exist in counties where hepatitis A vaccine is not required for kindergarten attendance.
Section 97.63(2)(B)(vii) concerning meningococcal:
-Would add a 7th grade requirement for meningococcal vaccine on a schedule similar to Tdap in these proposed rules.
-The rationale for the proposed amendment is the following:
(1) In order to align the Texas requirements with the most recent ACIP/CDC recommendations.
(2) Adolescents and young adults are most likely to get meningococcal disease, especially those living in group settings such as college dorms.
(3) From 2000 - 2006, Texas averaged 106 cases and 4 deaths per year (excluding unknown ages).
(4) 27% of all cases occur in school aged children, 5 - 19 years.
(5) 35% of deaths occur among 10 - 29 year olds.
(6) Among infants aged <1year of age, >50% of cases are caused by serogroup B, for which no vaccine is licensed nor available in the United States (US).
(7) For all reported cases of meningococcal disease among persons aged ≥11 years, 75% are caused by serogroups (C, Y, or W-135), which are included in vaccines licensed and available in the US.
Also, §97.63(1) and (2), is proposed to be amended to improve clarity and readability. Section 97.63(2)(A) is proposed to be amended to improve clarity and readability, to update the agency name and address, and to insert the relevant cross-reference to the department's Immunization Schedule. Section 97.63(2)(B) is proposed to be amended to delete certain references to kindergartens because the rule's age-triggers in those places are sufficient to be protective of the public health. Section 97.63(2)(B)(i), (ii)(I), and (ii)(II), are also proposed to be amended to improve readability. Section 97.63(2)(B)(ii)(IV) is proposed to be amended by adding the phrase "(or prior to)" in order to clarify the schedule for this vaccination.
Section 97.64.
The proposed amendments to §97.64 would reorganize the section to improve clarity and readability, in response to past concerns expressed to the department. Subsection (a) is proposed to be rewritten to provide a clear statement of the section's applicability as to non-veterinary students, with a newly written subsection (d) covering section applicability as to veterinary students. Existing language at subsections (a) and (d) is proposed to be deleted.
The proposed amendments to §97.64 would also update and clarify the rule text regarding the vaccines required for students covered by the section. Existing language at subsection (b) is proposed to be deleted, with new language being proposed which would describe the vaccines that are required. Subsections which currently contain language regarding required vaccines, subsections (d) through (k), are proposed to be deleted, with subsections (d) and (e) replaced with entirely new language.
The following is a summary of the proposed substantive amendments to new §97.64(b) regarding required vaccines:
-Tetanus-diptheria:
One dose of a tetanus-diphtheria toxoid (Td) is required within the last 10 years. The booster dose may be in the form of a tetanus-diphtheria-pertussis containing vaccine (Tdap). The change to allow Tdap in lieu of Td reflects the recommendation by the ACIP for adults at high risk, such as students at post-high school educational institutions covered under this section.
-Measles, mumps, and rubella vaccines:
The proposed amendments to §97.64 would revise the section for measles, mumps, and rubella vaccines for clarity. The proposed reference to MMR reflects that vaccines for the 3 diseases are now commonly given in the 1 combination vaccine.
The proposed amendments to §97.64 also delete existing language in subsection (c) regarding provisional enrollment, and cover that issue through new subsection (c) language, which is stated in terms of "Limited Exceptions." This rewrite is designed to add consistency and clarity to the issue of what exceptions to the general requirements there are and how those exceptions work. The proposed language would allow students to participate in coursework activities described in subsection (a) if: (1) the student receives at least 1 dose of each specified vaccine prior to enrollment and completes the vaccination series according to the stated schedule; or (2) the student provides acceptable proof of serologic confirmation of immunity. The proposed language goes on to state that students claiming to have satisfied 1 of these 2 conditions cannot engage in the activities described in subsection (a) until they have provided acceptable proof.
New proposed language at §97.64(d) would cover applicability of the rule section to students enrolled in schools of veterinary medicine. The existing requirement in subsection (a) for these students to obtain Hepatitis B vaccinations would be moved to subsection (d) as the new (d)(2).
New proposed language at §97.64(e) would provide a cross-reference to §97.68 where requirements regarding "acceptable evidence" are found, since that term is used in this rule section.
Section 97.65.
The proposed amendments to §97.65 would revise the section title for clarity. The proposed amendments to subsection (a) would explicitly state that referenced laboratory report must be a valid one, and would also move the word "either" in the sentence to improve clarity and readability. The proposed amendments to subsection (b) would revise the rule text for clarity and readability, and would specify that statement made by the referenced person should be in writing. Proposed changes to subsection (b) would also state that a legal guardian or managing conservator may also make the referenced statement, if applicable. Proposed changes to this subsection would also provide a reference to a form considered acceptable for a parent, legal guardian, managing conservator, or physician to complete, in lieu of a vaccine record, in order to attest to a child's positive history of varicella disease or varicella immunity.
Section 97.66.
The proposed amendment to §97.66 would revise the section title for clarity, since the provisional enrollment for higher education students is located in §97.64.
Section 97.67.
The proposed amendments to §97.67 would provide that all schools and child-care facilities are required to maintain immunization records sufficient for a valid audit "or other assessment" to be completed by the entities listed. The changes are proposed in order to reflect that not all records checks are full-blown audits, and also to explicitly state the various governmental officials who are authorized under other law to perform records checks, audits, etc.
Section 97.68.
The proposed amendments to §97.68 would revise the section title and subsection (b) for clarity. Proposed amendments at subsection (c) would delete the reference to a "registry" because in Texas today, not all immunization registries are owned by a state or local health department, and further private registries may emerge in the future. Currently, the Texas Health and Safety Code does not acknowledge these private registries in this context, or make them equivalent to those it does reference which are owned by the state or local health departments. Proposed amendments to subsection (d) explicitly state that the referenced record must be an "official" record, and would also revise the rule text for better readability.
Section 97.69.
The proposed amendments to §97.69 would revise the section title for clarity.
Section 97.70.
The proposed amendments to §97.70 would revise the section title for clarity and to improve readability. Additionally, §97.70 is proposed to be amended to reflect the department's ability to view identified immunization records under the Texas Health and Safety Code and other law, and also to better state the purpose of the reviews in question. The proposed changes would also improve readability.
Section 97.71.
The proposed amendments to §97.71 would revise the section title for clarity.
Section 97.72
The proposed amendments to §97.72 are being made in order to clearly and accurately provide a cross-reference to statutory authority under which the department and/or a local health authority may require additional doses of vaccinations, beyond those contained in these rule sections, when circumstances warrant. The Texas Health and Safety Code, Chapter 81, Subchapter E, establishes the statutory scheme where the state and local health authorities can issue control orders to prevent the spread of disease and protect the public health. Under this statutory scheme, the local health authority takes the lead role, but can be preempted by the department. The department can also initiate these actions on its own initiative. The proposed changes are better reflective of current statutory authority than the current rule language.
FISCAL NOTE
Casey S. Blass, Section Director, Disease Prevention and Intervention Section, has determined that for each year of the first five years that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed in §97.61 and §§97.63 - 97.72. The addition of a new vaccine requirement does not pose a fiscal impact. Students between 0 - 18 years of age, who will be required to have new vaccinations in order to comply with these rules, will have access to the required vaccines. Children who are insured will be covered through their healthcare provider's office. Children covered by Medicaid, Children's Health Insurance Program, uninsured, or underinsured are eligible for vaccines at no cost through the Texas Vaccines for Children Program.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Once a provider elects to be within the scope of these proposed rules, by virtue of providing vaccinations to children, then the rules provide for certain things that must be done such that the impacts are definite (e.g., vaccinate children with the newly required vaccines, and with currently required vaccines according to the new schedules). Since these impacts will happen, the department analysis under Economic Impact Statement of this preamble will also serve to satisfy the Small Business Impact Analysis required by Government Code, §2006.002(a).
The Economic Impact Statement of this preamble does not explicitly cover "micro-businesses," but Government Code, §2006.002(a), requires an analysis of the impacts on such businesses. The department believes that many of the health care providers impacted by the proposed rules will be "micro-businesses" as well as "small businesses," and thus the department's analyses regarding the latter will also be applicable to the former. While it is true that a micro-business may be inherently somewhat less able to absorb new regulatory burdens than a small business, the department believes that the new and additional vaccine requirements in the proposed rules would be minimal enough to not place an undue burden on these "micro-business" providers.
There is no anticipated negative impact on local employment.
Government Code, Chapter 2006, was amended by the 80th Legislative Regular Session (House Bill 3430) 2007 to require that, before adopting a rule that may have an adverse economic effect on small businesses, a state agency must first prepare an Economic Impact Statement and a Regulatory Flexibility Analysis.
The definition of a "small business" for purposes of this requirement was codified in Government Code, §2006.001(2). Under this definition, a "small business" is an entity that is: for profit, independently owned and operated; and has fewer than 100 employees or less than $6 million in annual gross receipts. Independently owned and operated businesses are self-controlling entities that are not subsidiaries of other entities or otherwise subject to control by other entities (and are not publicly traded).
Mr. Blass has determined that there may be an adverse economic effect on those small businesses impacted by the proposed rules.
ECONOMIC IMPACT STATEMENT
It is estimated that there may be a possible economic impact to physicians considered small businesses regarding these proposed rules. The approximate number of small businesses (health care providers and provider sites) potentially impacted by the changes to §97.61, and §§97.63 - 97.72 is 9,000 to 14,000 (including pediatricians, general practice physicians, family practice physicians and family medicine physicians). It is important to note that these rules have never required that any particular provider offer childhood vaccinations-rather, these rules specify the vaccines and the number of doses that must be administered in order for a child to be in compliance with the school and child-care facility attendance requirements for immunizations. The discussion below is in the context of providers that will vaccinate children to ensure compliance with school and child-care facility immunization requirements.
Physicians and healthcare providers that vaccinate children will need to purchase additional vaccines, except under the Texas Vaccines For Children program ("TVFC") (discussed below), in order to vaccinate their patients in accordance with these rules. The department, through the TVFC program, provides vaccine to children who are required to have a vaccine for school entry and have no other financial means to obtain the vaccine. In Texas, approximately 70% of children are covered by the program, under which vaccines are provided at no cost to enrolled providers and public clinics statewide to vaccinate eligible children. In addition, providers vaccinating children who receive benefits through Medicaid or the Children's Health Insurance Plan (CHIP) request reimbursement for the administration costs associated with giving a vaccine. The maximum fee that can be reimbursed in Texas for Medicaid clients is $14.85. This amount is set by the federal Centers for Medicaid and Medicare Services (CMS). Uninsured children, underinsured children, American Indian and Alaskan Natives may be charged an out-of-pocket expense for the administrative costs and this fee cannot exceed $14.85. No provider may deny the vaccine due to an inability to pay the administrative fee.
The remaining 30% of children are fully insured and healthcare providers will be reimbursed by the insurance carrier for both the administrative costs of giving a vaccine and the cost of the vaccine itself. There may be an economic impact to some of this subgroup of healthcare providers. Should some providers be reimbursed at a rate that is less than the amount of money the provider has to pay per dose for some vaccines, some providers may pass this unreimbursed cost to patients and some may not. Even though there is a potential for this to occur, key stakeholders, including members of the Texas Medical Association and Texas Pediatric Society, broadly support these proposed rules.
REGULATORY FLEXIBILITY ANALYSIS
Government Code, Chapter 2006, was amended by the 80th Legislative Regular Session (House Bill 3430) 2007 to require, as part of the rulemaking process, state agencies to prepare a Regulatory Flexibility Analysis that considers alternative methods of achieving the purpose of the rule and explains why those methods were not pursued in the rule amendment. There is an exception to this requirement, however. An agency is not required to consider alternatives that, while possibly minimizing adverse impacts on small businesses, would not be protective of the "health, safety and environmental and economic welfare of the state." The department believes that the proposed changes to the vaccination requirements regarding new vaccines and changes to the schedule of currently-required vaccines are in fact necessary to protect the health and safety of the citizens of Texas. The proposed changes are recommended by Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), and the department's medical experts concur with those recommendations as being appropriate to protect against the spread of vaccine-preventable diseases. Current immunization research supports this position. Any weakening of those proposed new requirements would result in a concurrent detriment to public health. That being said, and in the alternative, the department is conducting (below) a Regulatory Flexibility Analysis for these particular proposed rule changes-although the conducting of this analysis should not be read to concede the point that such an analysis is legally required.
Of the potential impact discussed herein, three alternatives would have had less impact on business but were not pursued in the proposed amendments because they would not be adequately protective of public health and safety. These options are: not adding a new meningococcal vaccine requirement; not expanding existing MMR, varicella, and hepatitis A vaccination requirements via the proposed new schedule; and not adding a Tdap vaccine requirement. Specifically, the department rejected these alternatives for the following reasons:
(1) The department could have chosen not to add the new meningococcal vaccine requirement for 7th grade students. The department rejected this choice because that alternative would not be consistent with the official medical recommendations by ACIP. Each year, an estimated 1,400 - 2,800 cases of meningococcal disease occur in the United States. The disease is transmitted through direct contact. Of those diagnosed with meningococcal disease, 10% to 14% die. Eleven to 19% of survivors have life-long disabilities such as neurologic disability, limb loss, or hearing loss. In May 2005, ACIP recommended routine vaccination with 1 dose of MCV4 vaccine for persons aged 11 - 12 years (if not previously vaccinated with MCV4). In June 2007, the ACIP revised its recommendation to include routine vaccination of all persons aged 11 - 18 years with 1 dose of MCV4. The ACIP recommends persons aged 11 - 12 years be routinely vaccinated at the 11th - 12th year health-care visit targeting 11 - 12 year old children. Ideally, the adolescent health-care visit should be done prior to the 7th grade entry for most children. The 7th grade is also targeted because the department selects this middle school grade to measure and monitor middle school compliance for the CDC. The proposed rule amendment is consistent with this most recent recommendation.
(2) For the existing vaccination requirements, the department considered not adding additional doses for varicella, MMR, and hepatitis A vaccines. However, the department rejected this choice in order to be consistent with the ACIP medical recommendations and thus be protective of public health and safety.
(A) In order to align the Texas requirements with current ACIP recommendation, regarding these vaccines, the department proposes to add a progressive 2nd dose for varicella vaccine at kindergarten and 7th grade entry. There have been breakthrough varicella cases in Texas. More than 99% of children achieve an antibody response after the 2nd dose of varicella vaccine, compared with 76% to 85% of children with a single dose of varicella vaccine.
(B) To further align the Texas requirements with the most current ACIP recommendations regarding these MMR vaccines, the department proposes to add additional doses of mumps and rubella vaccine to the existing 2-dose measles requirement. The resulting 2-dose MMR vaccine requirement for kindergarten students will be consistent with the ACIP medical recommendations. Recent mumps outbreaks in 2006 resulted in 2,597 cases of mumps in 11 states--the largest outbreak of mumps in the U.S. in more than 20 years. In response to this nationwide mumps outbreak, ACIP recommendations for prevention and control of mumps were updated. Evidence of immunity through documentation of vaccination is now defined as 2 doses of live mumps vaccine for school-aged children (i.e., grades kindergarten - 12).
(C) Additional alignment of the Texas immunization requirements with the ACIP medical recommendation includes the enhancement of the hepatitis A vaccine requirement for routine vaccination for kindergarten students statewide. Routine vaccination of children is an effective way to reduce hepatitis A incidence in the United States. Since licensure of hepatitis A vaccine during 1995 - 1996, the hepatitis A childhood immunization strategy has been implemented incrementally, starting with the recommendation of the Advisory Committee on Immunization Practices (ACIP) in 1996 to vaccinate children living in communities with the highest disease rates and continuing in 1999 with ACIP's recommendations for vaccination of children living in states, counties, and communities with consistently elevated hepatitis A rates. The most recent updated ACIP recommendations represent the final step in the incremental childhood hepatitis A immunization strategy--routine hepatitis A vaccination of children nationwide. Texas immunization requirements have consistently followed the ACIP recommendations. Currently, Texas immunization requirements for hepatitis A vaccine are for the Texas-Mexico border counties, which were identified as having the highest disease rates, and 40 additional counties, which were identified as having a disease incidence of more than twice the national average for a 10-year period. Incidence rates in the current required 40 counties are now nearly identical to those rates in the non-required counties. The majority of the reported hepatitis A cases come from areas where hepatitis A vaccination is not required for children attending kindergarten, leaving a population of young children who may not have received the complete series of hepatitis A vaccine. Adding a statewide kindergarten requirement for 2 doses of hepatitis A vaccine will address this gap and will align Texas with the most recent ACIP recommendation.
(3) The department could have considered not expanding on the current tetanus-diphtheria (Td) vaccine requirement. However, the department rejected this alternative in order to be consistent with the ACIP medical recommendations. The proposed amendments are necessary to be protective of public health and safety.
Pertussis, an acute, infectious cough illness, remains endemic in the United States despite routine childhood pertussis vaccination for more than half a century and high coverage levels in children for more than a decade. A primary reason for the continued circulation of Bordetella pertussis is that immunity to pertussis wanes approximately 5 - 10 years after completion of childhood pertussis vaccination, leaving adolescents and adults susceptible to pertussis. Tdap is an adolescent and adult vaccine. In 2005, over 2,000 Texas cases of pertussis were reported to CDC, including 9 deaths (8 among infants). Twenty-six infant pertussis deaths have been recorded since 2000 in 21 different Texas counties.
To reduce pertussis morbidity in adolescents and maintain the standard of care for tetanus and diphtheria protection, ACIP now recommends that: 1) adolescents aged 11 - 18 years should receive a single dose of Tdap instead of tetanus and diphtheria toxoids vaccine (Td) for booster immunization against tetanus, diphtheria, and pertussis if they have completed the recommended childhood DTaP vaccination series and have not received Td or Tdap.
Adolescents with pertussis can transmit the disease to infants. Unfortunately, infants are too young to have completed their vaccinations and do not have the same level of maternal antibody protection for pertussis as they do for other diseases (e.g., measles, varicella), leaving them susceptible. Increasingly, physicians and epidemiologists have recognized that adolescents and adults, especially those living with an infant, are the most likely sources of pertussis transmission to infants1.
References:
1. Bisgard, K.M., Pascual, F.B., Ehresmann, K.R., et al. (2004). Infant pertussis: who was the source? Pediatr Infect Dis J, 23, 985--9.
PUBLIC BENEFIT
Mr. Blass has determined that for each year of the first five years that the sections are in effect, the public will benefit from adoption of the sections proposed. The proposed amendments would provide clarity and better readability to the section titles and text. The reorganized sections should be much easier to read and understand than the current language, which will address concerns previously expressed to the department on those issues.
The proposed amendments to §97.63 would benefit the public by aligning the Texas immunization requirements in Texas elementary and secondary schools with the most recent recommendations by the Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices. The department agrees, from a medical perspective, with the rationale behind the federal recommendations and is convinced that the proposed changes would be good for the public health in Texas.
The proposed amendments to §97.64 would benefit the public by updating, reorganizing and clarifying the rule text regarding the vaccines required, and limited exceptions to those requirements, for students enrolled in health-related courses before they may engage in the course activities which will involve direct patient contact with potential exposure to blood or bodily fluids in educational, medical, or dental care facilities. The public would also benefit from the improved readability of this rule section.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed rules do not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, do not constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposed rules may be submitted to Tim Hawkins, Disease Prevention and Intervention Section, Division of Prevention and Preparedness, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, or by email to Tim.Hawkins@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The proposed amendments are authorized by Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004 which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and §161.004 and §161.0041 regarding statewide immunization of children and associated logistics; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.
The proposed amendments affect Health and Safety Code, Chapters 81, 161, and 1001; and Government Code, Chapter 531.
§97.61.Children and Students Included in Vaccine Requirements.
(a) The vaccine requirements apply to all children and students entering, attending, enrolling in, and/or transferring to child-care facilities or public or private primary or secondary schools or institutions of higher education.
(b) The vaccines required in this section are also
required for all children in the State of Texas, including children
admitted, detained, or committed in Texas Department of Criminal Justice,
Department of State Health Services [Texas Mental Health
and Mental Retardation], and Texas Youth Commission facilities.
(c) The vaccine requirements are adopted as a statewide
control measure for communicable disease as defined in Health and
Safety Code, §81.081 and §81.082. [The requirements
are adopted as an "instruction" of the department as that term is
used in the Health and Safety Code, §81.002.]
§97.63.Immunization Requirements in Texas Elementary and Secondary Schools [ and Institutions of Higher Education].
Every child in the state shall be vaccinated [immunized
] against vaccine-preventable [vaccine preventable]
diseases caused by infectious agents, in accordance with
the following immunization schedule.
(1) A vaccine administered up to four days prior to the deadline for that vaccine in the department Immunization Schedule, §97.221 of this title (relating to Department of State Health Services Immunization Schedule), is considered compliant with that deadline.
[(1) In accordance with the Department
of State Health Services Immunization Schedule as informed by the
Advisory Committee on Immunization Practices' (ACIP) recommendations
and adopted by the Executive Commissioner of the Health and Human
Services Commission and published in the Texas Register
annually, for all vaccines herein, vaccine doses administered
less than or equal to four days before the minimum interval or age
shall be counted as valid.]
(2) A child or student shall show acceptable evidence of vaccination prior, for diseases listed below, to entry, attendance, or transfer to a child-care facility or public or private elementary or secondary school, or institution of higher education.
(A) Children enrolled in child-care facilities, pre-kindergarten,
or early childhood programs shall have the following immunizations
(at the ages indicated) against: [
Age-appropriate vaccination against
] diphtheria, pertussis, tetanus, poliomyelitis, Haemophilus influenzae
type b (Hib),
measles, mumps, rubella, hepatitis B, hepatitis A, invasive pneumococcal,
and varicella diseases in accordance with the department [
Department of State Health Services] Immunization Schedule
, §97.221 of this title [
as informed by the Advisory Committee on
Immunization Practices' (ACIP) recommendations and adopted by the
Executive Commissioner of the Health and Human Services Commission
and published in the Texas Register annually.
] A copy of the current schedule is available at www.ImmunizeTexas.com
or by mail to the Department of State Health Services, P.O. Box
149347 [1100 West 49th Street], Austin, Texas
78714-9347 [78756].
(B) Students in kindergarten through twelfth grade shall have the following vaccines.
(i) Poliomyelitis.
(I) Students [Upon entry into kindergarten,
students] are required to have four doses of polio vaccine - one
of which must have been received on or after the fourth birthday.
Or, if the third dose was administered on or after the fourth birthday
, only three doses are required. If any combination of four
doses of OPV and IPV was received before four years of age
, no additional dose is required.
(II) Polio vaccine is not required for persons eighteen years of age or older.
(ii) Diphtheria/Tetanus/Pertussis.
(I) Students [Upon entry into kindergarten,
students] are required to have five doses of a
diphtheria/tetanus/pertussis-containing [
diptheria-tetanus-pertussis containing] vaccine -
one of which must have been received on or after the fourth
birthday. Or, if the fourth dose was administered on or after the
fourth birthday, only four doses are required.
(II) Students seven years of age or older are required
to have at least three doses of a tetanus/diphtheria-containing
vaccine [tetanus-diptheria containing vaccine], provided
at least one dose was administered on or after the fourth birthday.
Any combination of three doses of a tetanus/diphtheria-containing
vaccine [tetanus-diphtheria containing] vaccine will
meet this requirement.
(III) Tdap. Beginning school year (SY) 2009 - 2010, students will be required to have one booster dose of a tetanus/diphtheria/pertussis-containing vaccine for entry into the 7th grade, if at least five years have passed since the last dose of a tetanus-containing vaccine. If five years have not elapsed since the last dose of a tetanus-containing vaccine at entry into the 7th grade, then this dose will become due as soon as the five- year interval has passed. Td vaccine is an acceptable substitute, if Tdap vaccine is medically contraindicated.
[(III) One dose of a tetanus-diptheria
containing vaccine is required within the last ten years.]
(IV) Children who were enrolled in school, grades K
- 12, prior to August 1, 2004, and who received a booster dose of
DTaP or polio vaccine in the calendar month of (or prior to) [
or prior to] their fourth birthday, shall be considered in compliance
with clause (i)(I) (polio) and clause (ii)(I) (DTaP) of this subparagraph.
(iii) MMR. Students are required to have two [Measles. Two
] doses of MMR [measles-containing]
vaccine upon kindergarten entry for the following grades and
school years (The first dose shall be administered on or after the
first birthday): [are required. The first dose shall be
administered on or after the first birthday.]
(I) SY 2009 - 2010: K;
(II) SY 2010 - 2011: K, 1;
(III) SY 2011 - 2012: K, 1, 2;
(IV) SY 2012 - 2013: K, 1, 2, 3;
(V) SY 2013 - 2014: K, 1, 2, 3, 4;
(VI) SY 2014 - 2015: K, 1, 2, 3, 4, 5;
(VII) SY 2015 - 2016: K, 1, 2, 3, 4, 5, 6;
(VIII) SY 2016 - 2017: K, 1, 2, 3, 4, 5, 6, 7;
(IX) SY 2017 - 2018: K, 1, 2, 3, 4, 5, 6, 7, 8;
(X) SY 2018 - 2019: K, 1, 2, 3, 4, 5, 6, 7, 8, 9;
(XI) SY 2019 - 2020: K, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10;
(XII) SY 2020 - 2021: K, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11; and
(XIII) SY 2021 - 2022: K, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.
[(iv) Rubella. One dose of rubella
vaccine received on or after the first birthday is required.]
[(v) Mumps. One dose of mumps vaccine
received on or after the first birthday is required.]
(iv) [(vi)] Hepatitis B.
(I) Students are required to have three [Three
] doses of hepatitis B vaccine upon entry into kindergarten. [
are required for the following grades for the following school years:]
[(-a-) 2004-2005 for kindergarten through
fifth grade and seventh through tenth grade;]
[(-b-) 2005-2006 for kindergarten through eleventh grade; and]
[(-c-) thereafter, beginning in school
year 2006-2007, for all students in grades kindergarten through twelfth
grade.]
(II) In some circumstances, the United States Food
and Drug Administration may officially approve in writing
the use of an alternative dosage schedule for an existing vaccine.
Such an [These] alternative regimen [
regimens] may be used to meet the requirements under this
section [this requirement] only when alternative
regimens are fully documented. Such documentation must include vaccine
manufacturer and dosage received for each dose of that vaccine.
(v) [(vii)] Varicella. Students
are required to have two doses [One dose] of varicella
vaccine received on or after the first birthday [is required]
for the following grades and [for the following]
school years (Two doses are required if the child was thirteen
years old or older at the time the first dose of varicella vaccine
was received):
(I) SY 2009 - 2010: K, 7;
[(I) 2004-2005 for kindergarten through
fourth grade and seventh through tenth grade;]
(II) SY 2010 - 2011: K, 1, 7, 8;
[(II) 2005-2006 for kindergarten through
fifth grade and seventh through eleventh grade; and]
(III) SY 2011- 2012: K, 1, 2, 7, 8, 9;
[(III) thereafter, beginning in school
year 2006-2007, for all students in grades kindergarten through twelfth
grade. Two doses are required if the child was thirteen years old
or older at the time the first dose of varicella vaccine was received.]
(IV) SY 2012 - 2013: K, 1, 2, 3, 7, 8, 9, 10;
(V) SY 2013 - 2014: K, 1, 2, 3, 4, 7, 8, 9, 10, 11;
(VI) SY 2014 - 2015: K, 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12; and
(VII) SY 2015 - 2016: K through 12th grade.
(vi) [(viii)] Hepatitis A. Students
are required to have [Upon entry into kindergarten through
third grade,] two doses of hepatitis A vaccine for the
following grades and school years (The first dose shall be administered
on or after the first birthday): [are required for students
attending a school located in a high incidence geographic area as
designated by the department. The first dose shall be administered
on or after the second birthday. A list of geographic areas for which
hepatitis A is mandated shall be published in the Texas Register
on an annual basis and is
available at www.ImmunizeTexas.com, or by mail request at Department
of State Health Services, 1100 West 49th Street, Austin, Texas 78756.]
(I) SY 2009 - 2010: K;
(II) SY 2010 - 2011: K, 1;
(III) SY 2011 - 2012: K, 1, 2;
(IV) SY 2012 - 2013: K, 1, 2, 3;
(V) SY 2013 - 2014: K, 1, 2, 3, 4;
(VI) SY 2014 - 2015: K, 1, 2, 3, 4, 5;
(VII) SY 2015 - 2016: K, 1, 2, 3, 4, 5, 6;
(VIII) SY 2016 - 2017: K, 1, 2, 3, 4, 5, 6, 7;
(IX) SY 2017 - 2018: K, 1, 2, 3, 4, 5, 6, 7, 8;
(X) SY 2018 - 2019: K, 1, 2, 3, 4, 5, 6, 7, 8, 9;
(XI) SY 2019 - 2020: K, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10;
(XII) SY 2020 - 2021: K, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11; and
(XIII) SY 2021 - 2022: K, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.
(vii) Meningococcal. Students are required to have one dose of meningococcal vaccine for the following grades and school years:
(I) SY 2009 - 2010: 7;
(II) SY 2010 - 2011: 7, 8;
(III) SY 2011 - 2012: 7, 8, 9;
(IV) SY 2012 - 2013: 7, 8, 9, 10;
(V) SY 2013 - 2014: 7, 8, 9, 10, 11; and
(VI) SY 2014 - 2015: 7, 8, 9, 10, 11, 12.
§97.64.Required Vaccinations for Students Enrolled in Health-related and Veterinary Courses in Institutions of Higher Education.
(a) Applicability for non-veterinary students. This section applies to all students enrolled in health-related higher education courses which will involve direct patient contact with potential exposure to blood or bodily fluids in educational, medical, or dental care facilities.
[(a) This section applies to all students
enrolled in health-related courses, which will involve direct patient
contact in medical or dental care facilities. This includes all medical
interns, residents, fellows, nursing students, and others who are
being trained in medical schools, hospitals, and health science centers
listed in the Texas Higher Education Coordinating Board's list of
higher education in Texas; and students attending two-year and four-year
colleges whose course work involves direct patient contact regardless
of the number of courses taken, number of hours taken, and the classification
of the student. Subsection (i) of this section also applies to veterinary
medical students whose course work involves direct contact with animals
or animal remains regardless of number of courses taken, number of
hours taken, and the classification of the student.]
(b) Vaccines Required. Students must have the all the following vaccinations before they may engage in the course activities described in subsection (a) of this section:
(1) Tetanus-diphtheria. One dose of a tetanus-diphtheria toxoid (Td) is required within the last ten years. The booster dose may be in the form of a tetanus-diphtheria-pertussis containing vaccine (Tdap).
(2) Measles, Mumps, and Rubella Vaccines.
(A) Students born on or after January 1, 1957, must show, prior to patient contact, acceptable evidence of vaccination of two doses of a measles-containing vaccine administered since January 1, 1968 (preferably MMR vaccine).
(B) Students born on or after January 1, 1957, must show, prior to patient contact, acceptable evidence of vaccination of one dose of a mumps vaccine.
(C) Students must show, prior to patient contact, acceptable evidence of one dose of rubella vaccine.
(3) Hepatitis B Vaccine. Students are required to receive a complete series of hepatitis B vaccine prior to the start of direct patient care or show serologic confirmation of immunity to hepatitis B virus.
(4) Varicella Vaccine. Students are required to have received one dose of varicella (chickenpox) vaccine on or after the student's first birthday or, if the first dose was administered on or after the student's thirteenth birthday, two doses of varicella (chickenpox) vaccine are required.
[(b) Students may be provisionally
enrolled for up to one semester or one quarter to allow students to
attend classes while obtaining the required vaccines and acceptable
evidence of vaccination.]
(c) Limited Exceptions.
(1) Notwithstanding the other requirements in this section, a student may be provisionally enrolled in these courses if the student has received at least one dose of each specified vaccine prior to enrollment and goes on to complete each vaccination series on schedule in accordance the Centers for Disease Control and Prevention's Recommended Adult Immunization Schedule as approved by the Advisory Committee on Immunization Practices (ACIP), American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians (AAFP), and the American College of Physicians. However, the provisionally enrolled student may not participate in coursework activities involving the contact described in subsection (a) of this section until the full vaccination series has been administered.
(2) Students, who claim to have had the complete series of a required vaccination, but have not properly documented them, cannot participate in coursework activities involving the contact described in subsection (a) of this section until such time as proper documentation has been submitted and accepted.
(3) The immunization requirements in subsections (b) and (d) of this section are not applicable to individuals who can properly demonstrate proof of serological confirmation of immunity. Vaccines for which this may be potentially demonstrated, and acceptable methods for demonstration, are found in rule §97.65 of this title (relating to Exceptions to Immunization Requirements (Verification of Immunity/History of Illness)). Such a student cannot participate in coursework activities involving the contact described in subsection (a) of this section until such time as proper documentation has been submitted and accepted.
[(c) Students cannot be provisionally
enrolled without at least one dose of measles, mumps, and rubella
vaccine if direct patient contact will occur during the provisional
enrollment period.]
(d) Students enrolled in schools of veterinary medicine.
(1) Rabies Vaccine. Students enrolled in schools of veterinary medicine whose coursework involves direct contact with animals or animal remains shall receive a complete primary series of rabies vaccine prior to such contact. Serum antibody levels must be checked every two years, with a booster dose of rabies vaccine administered if the titer is inadequate.
(2) Hepatitis B Vaccine. Students enrolled in schools of veterinary medicine whose coursework involves direct contact with animals or animal remains shall receive a complete series of Hepatitis B vaccine prior to such contact.
[(d) Polio vaccine is not required.
Students enrolled in health-related courses are encouraged to ascertain
that they are immune to poliomyelitis.]
(e) Requirements regarding acceptable evidence of vaccination are found at §97.68 of this title (relating to Acceptable Evidence of Vaccination(s)).
[(e) One dose of tetanus-diphtheria
toxoid (Td) is required within the last ten years.]
[(f) Students who were born on or after
January 1, 1957, must show, prior to patient contact, acceptable evidence
of vaccination of two doses of measles-containing vaccine administered
since January 1, 1968.]
[(g) Students must show, prior to patient
contact, acceptable evidence of vaccination of one dose of rubella
vaccine.]
[(h) Students born on or after January
1, 1957, must show, prior to patient contact, acceptable evidence
of vaccination of one dose of mumps vaccine.]
[(i) Students shall receive a complete
series of hepatitis B vaccine prior to the start of direct patient
care or show serologic confirmation of immunity to hepatitis B virus.]
[(j) Students enrolled in schools of
veterinary medicine shall receive a complete primary series of rabies
vaccine prior to the start of contact with animals or their remains;
and, a booster dose of rabies vaccine every two years unless protective
serum antibody levels are documented.]
[(k) Students shall receive two doses
of varicella vaccine unless the first dose was received prior to thirteen
years of age.]
§97.65.Exceptions to Immunization Requirements [ Requirement ] (Verification of Immunity/History of Illness).
(a) Serologic confirmations of immunity to measles,
rubella, mumps, hepatitis A, hepatitis B, or varicella, are acceptable.
Evidence of measles, rubella, mumps, hepatitis A, or hepatitis B,
or varicella illnesses must consist of a valid laboratory
report that indicates [either] confirmation of
either immunity or infection.
(b) A written statement from a parent (or
legal guardian or managing conservator), school nurse, or physician
attesting to a child's positive [or physician validated]
history of varicella disease (chickenpox), or of varicella
immunity, is acceptable in lieu of a vaccine record
for that disease (see form at http://www.dshs.state.tx.us/immunize/docs/c-9.pdf)
. [A written statement from a physician, or the student's
parent or guardian, or school nurse, must support histories of varicella
disease.]
§97.66.Provisional Enrollment for (Non-Higher Education) Students.
(a) The law requires that students be fully vaccinated against the specified diseases. A student may be enrolled provisionally if the student has an immunization record that indicates the student has received at least one dose of each specified age-appropriate vaccine required by this rule. To remain enrolled, the student must complete the required subsequent doses in each vaccine series on schedule and as rapidly as is medically feasible and provide acceptable evidence of vaccination to the school. A school nurse or school administrator shall review the immunization status of a provisionally enrolled student every 30 days to ensure continued compliance in completing the required doses of vaccination. If, at the end of the 30-day period, a student has not received a subsequent dose of vaccine, the student is not in compliance and the school shall exclude the student from school attendance until the required dose is administered.
(b) A student who is homeless, as defined by §103 of the McKinney Act, 42 USC §11302, shall be admitted temporarily for 30 days if acceptable evidence of vaccination is not available. The school shall promptly refer the student to appropriate public health programs to obtain the required vaccinations.
§97.67.School Records.
All schools and child-care facilities are required to maintain immunization records sufficient for a valid audit or other assessment to be completed by federal, state and/or local public health officials.
§97.68.Acceptable Evidence of Vaccination(s) [Vaccination].
(a) Vaccines administered after September 1, 1991, shall include the month, day, and year each vaccine was administered.
(b) Documentation of vaccines administered that include the signature or stamp of the physician or his/her designee, or public health personnel, is acceptable.
(c) An official immunization record generated from
a state or local health authority [, such as a registry,]
is acceptable.
(d) An official [A] record received
from school officials, including a record from another
state, is acceptable.
§97.69.Transfer of Immunization Records.
(a) A student can be enrolled provisionally for no more than 30 days if he/she transfers from one Texas school to another, and is awaiting the transfer of the immunization record.
(b) A dependent of a person who is on active duty with the armed forces of the United States can be enrolled provisionally for no more than 30 days if he/she transfers from one school to another and is awaiting the transfer of the immunization record.
§97.70.Review of Records and Providing Assistance.
Representatives of the department and local health authorities
may advise and assist schools in meeting these requirements. The department
shall conduct periodic review of [de-identified] school
immunization records in order to determine compliance with this
subchapter [allow public health officials to obtain information
required for public health purposes].
§97.71.Annual Report of Immunization Status of Students.
Schools shall submit annual reports of the immunization status of students, in a format prescribed by the department, to monitor compliance with these requirements.
§97.72.Additional Vaccination Requirements [Vaccine-Preventable Disease Outbreaks].
Under Texas Health and Safety Code, Chapter 81, Subchapter
E, additional vaccinations may be required by the department and/or
the local health authority in specific situations under the mechanism
of a control order containing control measures. [In the
event of an outbreak of vaccine-preventable disease, the local health
authority may require or recommend additional doses or boosters to
provide further protection.]
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on August 8, 2008.
TRD-200804158
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 21, 2008
For further information, please call: (512) 458-7111 x6972