TITLE 64 INTERPRETIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES BUREAU FOR PUBLIC HEALTH

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1 64CSR95 TITLE 64 INTERPRETIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES BUREAU FOR PUBLIC HEALTH SERIES 95 IMMUNIZATION REQUIRMENTS AND RECOMMENDATIONS FOR NEW SCHOOL ENTERERS General Scope. -- This rule establishes immunization requirements for enrollment as a new school enterer in a West Virginia School. Additionally, the rule includes recommendations for immunizations to promote public health Authority. -- W. Va. Code , , , and Filing Date. -- January 28, Effective Date. -- February 28, Applicability - This rule applies to all new school enterers and to students transferring into a West Virginia school from out of state. This rule supersedes the legislative rule, Immunization Criteria for Transfer Students, 64CSR Purpose - The purpose of this rule is to clearly define the requirements and recommendations for immunizations for new school enterers Standards - The standards of medical practice used in this rule incorporate the most current recommendations issued by the U.S. Department of Health and Human Services, Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) Definitions Bureau - means the Bureau for Public Health in the Department of Health and Human Resources Child - means any person between the ages of birth and eighteen years or up to twentyone years of age when that child is attending school Commissioner - means the Commissioner of the Bureau for Public Health as that term is defined in W. Va. Code , or his or her designee Contraindication - means a medical condition which renders an immunization improper for a particular individual. Contraindications for each vaccine are found in statements written and published by the Advisory Committee on Immunization Practices (ACIP) as Recommendations of the Immunization Practices Advisory Committee and in Vaccine Information Statements (VIS) from the Centers for Disease Control and Prevention (CDC). The recommendations of the ACIP and VIS regarding contraindications can be found at Delinquent - means lacking age appropriate immunization(s) which are required to have been completed prior to school entry Local Health Officer - means the individual physician, with a current West Virginia license to practice medicine, who supervises and directs the medical activities of a local health department and is appointed by the local board of health with approval from the Commissioner Medical exemption - means an exemption from any of the requirements for compulsory immunization due to a contraindication or precaution to any or all of the vaccines required by law and this rule. 1

2 64CSR New School Enterer means any child entering a school building housing kindergarten through twelfth grade students to attend classes or programs or to participate in extracurricular activities taking place in the school building and includes children entering for pre-school programs as well as all students in grades kindergarten through twelfth grade and students who transfer into a West Virginia school from another state Precaution means a condition defined under the current standards of immunization practice that might increase the chance or severity of an adverse vaccine reaction or compromise the ability of the vaccine to produce immunity State Health Officer - means the person appointed to serve as State Health Officer who is a licensed physician authorized to practice medicine in accordance with West Virginia Code Recommended Immunization Schedules. The recommended immunization schedule for childhood immunization is the schedule jointly approved by the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians. This schedule is issued annually and can be found at by searching under Immunization Schedules. Recommended schedules for children birth to age 6 as well as for children age 7 through 18 may be found at this website Immunizations Required for School Entry and Specifics of Each Immunization Requirement All new school enterers attending a West Virginia school for the first time shall show proof of immunization against the following diseases: 4.1.a. DIPHTHERIA; 4.1.b. HEPATITIS B; 4.1.c. MUMPS; 4.1.d. PERTUSSIS (whooping cough); 4.1.e. POLIOMYELTIS; 4.1.f. RUBELLA; 4.1.g. RUBEOLA (measles); 4.1.h. TETANUS; and 4.1.i. VARICELLA (chickenpox) Dosage and interval schedule for diphtheria, pertussis and tetanus vaccines are as follows: 4.2.a. Before being admitted to school, each child shall show proof that he or she has received a minimum of four doses of DIPHTHERIA, TETANUS, acellular PERTUSSIS (DTaP) vaccine, with the last dose having been received on or after the child s fourth birthday and prior to school entry; and 4.2.b. The interval between the third and fourth or final dose shall be at least six months; and 4.2.c. Children seven years of age and older may receive tetanus, diphtheria (Td) vaccine in lieu of DTaP vaccine. A single dose of Tdap vaccine should be considered in the series if age appropriate. 4.2.d. Occurrence of prior disease may be used as evidence of immunity for pertussis in accordance with subsection 6.4 of this rule Children entering school shall show proof that they have received at least three doses of HEPATITIS B vaccine with at least one dose having been given on or after six months of age. The second and third doses should be separated by at least two months. Occurrence of prior disease may be used as evidence of immunity in accordance with subsection 6.4. of this rule Children entering school shall show proof that they have received two doses of RUBEOLA (MEASLES) vaccine, the first dose 2

3 64CSR95 on or after the first birthday and the second dose no less than one month after the first dose. Alternatively, immunity may be proven through laboratory testing. Occurrence of prior disease may be used as evidence of immunity in accordance with subsection 6.4. of this rule Children entering school shall show proof that they have received at least two doses of MUMPS vaccine, the first dose on or after the first birthday and the second dose no less than one month after the first dose. Alternately, immunity may be shown through laboratory testing. Occurrence of prior disease may be used as evidence of immunity in accordance with subsection 6.4. of this rule Dosage and interval schedule for the POLIO vaccine is as follows: 4.6.a. Before being admitted to school each child shall show proof that he or she has received a minimum of three doses of trivalent polio vaccine (PV) with the last dose having been received on or after the child s fourth birthday and prior to school entry. Although less desirable, immunity may be shown through laboratory testing showing immunity to all 3 poliovirus strains included in the vaccine. The impact on duration of immunity given an incomplete series but positive titers is not known Children entering school shall show proof that they have received at least two doses of RUBELLA vaccine, the first dose on or after the first birthday and the second dose no less than one month after the first dose. Alternately, immunity may be proven through laboratory testing. Occurrence of prior disease may be used as evidence of immunity in accordance with subsection 6.4. of this rule Children entering school shall show proof that they have received two doses of VARICELLA (CHICKENPOX) vaccine, the first dose on or after the first birthday and the second dose no less than three month after the first. Alternately, immunity may be shown through the written or verbal statement of a parent or legal guardian attesting to the fact of their child s history of chickenpox. A third alternative is to show immunity through laboratory testing For preschool children entering a school housing other children in grades kindergarten through twelfth, the above immunization requirements hold to the extent that they are age appropriate in accordance with the immunization schedules referenced in section 3 of this rule Compliance with the Law A child shall be considered to be in compliance with the law requiring compulsory immunizations of school children prior to school entry when that child has a complete certificate of immunization, or similar medical record of immunizations If a child has been determined to be medically exempt from receiving one or more vaccinations, in accordance with the provisions of section nine of this rule, the certificate of immunization shall note specifically which vaccine the child is exempt from, the reason for the exemption, and whether or not the reason for the exemption is permanent or temporary. If the exemption is temporary, a notation shall be made as to the future date at which the exemption should be reevaluated A student who does not have a completed certificate of immunization or other similar medical record of immunizations shall show proof that he or she has received at least one dose of each of the required vaccines in order to be provisionally enrolled in school Provisional enrollment may continue for up to seven months from school entry. After attending school for a maximum of seven months, all provisionally enrolled students shall show proof to the school that they have completed all of the required immunizations Children who are delinquent for any required vaccinations, or who have exceeded the seven month provisional enrollment period, will be considered to be out of compliance with the law and may be required to stop attending school until the appropriate vaccine(s) are received and the records are amended. 3

4 64CSR Proof of Immunity Proof that a child has received the immunizations required by law and this rule, in the correct number and spacing of doses, shall be recorded on a completed document, such as a certificate of immunization, for all new school enterers A Certificate of Immunization form has been developed by the West Virginia Department of Health and Human Resources, Bureau for Public Health, Immunization Program. This form is available to appropriate health care providers electronically through participation in the West Virginia Statewide Immunization Information System (WVSIIS) asp. The form is also available from: ATTN: WVSIIS Bureau for Public Health Immunization Program 350 Capitol Street, Room 125 Charleston, WV The documentary evidence of immunizations shall contain the day, month and year of each vaccine received by the child or sufficient information of the time interval between doses to enable verification that the minimum intervals required or suggested by this rule have been observed Proof of prior measles, mumps, rubella, pertussis or hepatitis B disease being used in lieu of vaccination requires a document signed by a physician indicating, at a minimum, the name of the patient, the date of the illness and any obtained laboratory evidence of the diagnosis. If the historical disease diagnosis is in question, current laboratory evidence of immunity may be required The verbal or written statement of the parent or legal guardian of a child shall suffice to prove that a child has had chickenpox and is considered to be proof of immunity Commissioner s Authority to Change Immunization Requirements for New School Enterers. The Commissioner may, by Order filed with the Secretary of State, modify, add or delete vaccines to be required for new school enterers. The Commissioner s Orders shall be made after consultation with the State Health Officer and shall be consistent with the immunization schedules referenced in section 3 of this rule. The Commissioner s Orders shall not exceed those recommendations Recommended Vaccines. The following vaccines are recommended for children attending West Virginia schools: 8.1. INFLUENZA VACCINE. 8.1.a. Any child aged six months or older may be vaccinated against influenza. Children from six to twenty-three months are at substantially increased risk for influenza-related hospitalizations and children ages twenty-four to fifty-nine months are at increased risk for influenza-related clinic and emergency room visits. Children and school personnel with certain medical conditions and school personnel who are older are at increased risks of influenza complications and death. 8.1.b. An annual flu vaccine is recommended in accordance with annually released ACIP recommendations MENINGOCOCCAL VACCINE 8.2.a. Meningitis caused by Neisseria meningitides, termed meningococcal meningitis, is one of the leading causes of bacterial meningitis in the U.S. While children less than 1 year of age are at highest risk of the disease, children ages are at increased risk compared to the general population. College freshmen housed in dormitories or other settings where adolescents and young adults are housed in close quarters also are at higher risk. Ten to fourteen percent of those contracting meningococcal meningitis die. Meningococcal disease can also result in significant disability. While the vast majority of cases are sporadic, localized outbreaks of this disease do occur. Given disease severity and the challenges of managing this disease in the institutional or 4

5 64CSR95 school setting, vaccination of all children is now recommended. 8.2.b. Meningococcal Vaccination is recommended at age It is also recommended for previously unvaccinated children at high school entry Tdap VACCINE 8.3.a. Diphtheria and tetanus boosters are typically recommended throughout one s lifetime. Pertussis is a disease that has been increasing in West Virginia and the United States. Protection from the pertussis component of the primary DTaP series wanes over time. While pertussis disease is less severe in older children and young adults, they can readily pass the disease to younger children at high risk of severe disease or death from pertussis. The Tdap vaccine offers an opportunity to boost immunity to not only diphtheria and tetanus, but also to pertussis. 8.3.b. Tdap vaccine is recommended for children age years who have completed the recommended childhood DTP/DTaP vaccine series and have not already received a tetanus and diphtheria (Td) booster dose. Adolescents age who missed the year old Tdap/Td dose and who have completed the primary DTP/DTaP series should also be given a dose of Tdap vaccine HUMAN PAPILLOMAVIRUS VACCINE - HPV Vaccine. 8.4.a. Approximately twenty million people in the United States are infected by genital human papillomavirus (HPV) and about six million more become infected each year. HPV can cause cervical cancer in women. Every year in the United States about ten thousand women get cervical cancer and three thousand seven hundred die from it. It is the second leading cause of cancer deaths among women worldwide. HPV is also associated with several less common types of cancer in both men and women and causes genital warts and warts in the upper respiratory tract. More than fifty percent of sexually active men and women are infected with HPV at some time in their lives. The HPV vaccine works against the four types of the virus which are responsible for seventy percent of cervical cancer cases and ninety percent of genital warts cases. 8.4.b. The best way to ensure disease prevention is to give the HPV vaccine prior to the individual becoming sexually active. 8.4.c. The HPV vaccine is currently licensed for use in females ages nine to twentysix. It consists of a three dose series. The first dose is recommended for girls at age eleven to twelve. It is also recommended for girls ages who have not previously been vaccinated Other vaccines recommended for various high risk populations in the school setting may be found on the immunization schedules jointly approved by the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians at by searching under Immunization Schedules Medical Exemptions The provisions of this rule may not apply if a child has a valid medical contraindication or precaution to a particular vaccine. To obtain a medical exemption the child s parent or guardian shall present a written request for an exemption from a physician who has treated or examined the child to the local health officer in the county where the child attends school The physician s request for exemption from immunization shall state specifically which vaccine or vaccines the child should be exempt from receiving, an explanation of the medical contraindication or precaution relied upon to make the request, and whether the reason for the exemption is permanent or temporary. If the medical exemption is temporary, the request shall also provide the future date or time when the exemption should be reevaluated Requests for medical exemption from vaccine requirements shall be reviewed and approved or denied initially by the local health 5

6 64CSR95 officer in the county where the requestor attends school. Approval or denial of a request shall be in writing and a copy of the response shall be sent to the State Health Officer Local health officials shall verify that immunization exemptions are entered into the West Virginia Statewide Immunization Information System -- WVSIIS-- to enable support of individuals at increased risk of disease in an outbreak and to aid in disease control and surveillance The local health officer s decision on a request for a medical exemption from immunization may be reviewed by the State Health Officer. The request for state level review and the State Health Officer s decision on such requests shall be in writing Appeal from the ruling of the State Health Officer may be made through the administrative review procedure described in section ten of this rule All requests for medical exemption from immunization shall be reviewed, and determinations made, based on current medical science and recommendations from the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) Administrative Due Process. Any person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in the manner prescribed in the Bureau s procedural rule, Rules for Contested Case Hearings and Declaratory Rulings, 64CSR1. 6

7 BUREAU FOR PUBLIC HEALTH Commissioner s Office 350 Capitol Street, Room 702 Charleston, West Virginia Telephone: (304) Fax: (304) MEMORANDUM TO: Rocco Fucillo, Deputy Secretary and General Counsel Department of Health and Human Resources Chris Curtis, Acting Commissioner Bureau for Public Health John Law, Assistant Secretary Department of Health and Human Resources FROM: RE: Ann A. Spaner, Director Public Heath Regulations Commissioner s legal authority to add immunization requirements by interpretive rule DATE: November 20, 2007 There is statutory support for the Bureau to promulgate a rule to govern the number of diseases and the doses and sequence requirements for administering immunizations to school children in accordance with all of the relevant WV Code sections addressing immunizations for children. Read together, in pari materia, the clear objective of state law is to protect the health of children through age-appropriate immunizations against vaccine preventable illnesses in accordance with recommendations from nationally recognized medical experts. The Secretary of the Department of Health and Human Resources and the Commissioner of the Bureau for Public Health have both general and specific statutory authority to promulgate rules to protect public health. Included in their broad duty to protect public health is the specific charge to prevent illness and promote good health for children. More specifically, state law requires compulsory vaccinations for children prior to school entry. This is the long-standing law to accomplish the public health objective of disease prevention in children. Relevant WV Code sections supporting immunization rulemaking authority include: 1

8 Proposal of rules by the secretary. The secretary may propose rules,, that are necessary and proper to effectuate the purposes of this chapter. The rules may include, but are not limited to, the regulation of: (j) Other health-related matters which the department is authorized to supervise and for which the rule-making authority has not been otherwise assigned. and, Powers and duties of the commissioner. The commissioner is the chief executive, administrative and fiscal officer of the bureau for public health and has the following powers and duties:.. (t) To exercise all other powers delegated to the commissioner by the secretary or by this chapter or otherwise in this code, to enforce all health laws, and to pursue all other activities necessary and incident to the authority and area of concern entrusted to the bureau or the commissioner. WV Code governs compulsory immunization of school children. This law was last amended in Some version of this law has been on the books in West Virginia since The current law contains a list of six diseases requiring compulsory immunization prior to school entry. Importantly, the very next section of the article on PREVENTION AND CONTROL OF COMMUNICABLE DISEASES lists nine specific diseases for which the state director of health (now Commissioner) must obtain vaccine and deliver it to local health departments and providers. Logic and common sense demand that the acquisition and distribution of vaccines for children, along with the requirement that these vaccines be provided free of charge, will culminate in the delivery of the medicine to the intended recipients, children. The language of , amended in 1994, contemplates the expansion of vaccines in response to public health necessity and more current national recommendations Distribution of free vaccine preventatives of disease. (a) Declaration of legislative findings and purpose. The Legislature finds and declares that early immunization for preventable diseases represents one of the most cost-effective means of disease prevention.... Immunization of children at an early age serves as a preventative measure both in time and money and is essential to maintain our children s health and wellbeing. (excerpts of subsection and emphasis mine) (b) The state director of health shall acquire vaccine for the prevention of polio, measles, mumps, rubella, diphtheria, pertussis, tetanus, hepatitis-b, haemophilus influenzae-b and other vaccine preventatives of disease as may be deemed necessary or required by law, and shall distribute the same, free of charge,. without expense to the citizens. to check contagions and control epidemics. (excerpts and emphasis mine) This section also establishes the Childhood Immunization Advisory Committee (CIAC) which 2

9 has studied the issue of additional immunizations and has made recommendations to the Commissioner about additional diseases for which vaccines are available and necessary to protect the heath of children, specifically, Mumps, Hepatitis B, Chickenpox, new adolescent and annual flu vaccines. The types and number of diseases for which children and the public can be protected by immunizations has been growing over the years as new vaccines are developed, tested and approved for use. Receiving an effective vaccine is much safer and less costly than acquiring the disease mandated benefits; from WVPEIA Public Employees Insurance Act. There is additional statutory authority for the Bureau to add immunizations in an existing section of law in Chapter 5, article 16, section 9. This section was a part of HB 4379, passed in the 2006 session. Chapter 5, Article 16 is the West Virginia Public Employees Insurance Act. The relevant subsection reads as follows: (i) The director shall provide by contract or contracts entered into under the provisions of this article the costs for coverage of children s immunizations services from birth through age sixteen years to provide immunizations against the following illnesses: Diphtheria, polio, mumps, measles, rubella, tetanus, hepatitis-b, haemophilus influenzae-b and whooping cough. Additional immunizations may be required by the commissioner of the bureau of public health for public health purposes. (the section goes on about the specifics of coverage, emphasis mine) Here state law clearly and unequivocally grants authority to the commissioner of the bureau for public health to add more immunizations for insurance coverage for state employees who are covered by PEIA insurance. Surely legislators do not intend for a public health official to discriminate in requiring less health protection by vaccination for children who are not covered by the state PEIA insurance. In any case, the Bureau for Public Health, with the help of local health departments, does provide equal access to vaccines for all residents by offering immunizations free of charge as noted in WV Code (b), above. It is the Commissioner s duty to maintain, and periodically update, immunization requirements to protect West Virginian children from disease. It is significant that the section authorizes consideration of immunization service for children from birth through age sixteen. This is the most recent state law to address childhood immunizations and it includes adolescents. The HPV vaccine is now available to help prevent cervical cancer. It is recommended that this vaccine be given to girls entering middle school. Conclusions When these code sections are read together and an analysis of the dates of enactment is made, it is evident that the Bureau has authority to propose a rule setting forth a comprehensive list of the diseases for which children must be vaccinated and the recommended doses and spacing for vaccine administration in accordance with best practices and recent national 3

10 medical recommendations. We have strong laws in West Virginia to protect the health of school children through this time-tested, reasonable and effective method of compulsory immunizations. This legal analysis applies to the promulgation of an interpretive rule. The Bureau rule interprets the authority vested in public health by all of the relevant statutes governing immunization of school children. The progression over the years has been to add new vaccines and to acknowledge the expertise of the Commissioner (and State Health Officer) of the Bureau for Public Health to determine which immunization children shall receive and when. By promulgating this interpretive rule the Commissioner assumes that responsibility clearly and decisively. An Interpretive rule is filed for public comment for 30 days, after which time it becomes a rule upon final filing by the agency, with any corrections or changes made in response to the comments received. This is purely a medical issue. It is not about religious exemptions from immunization requirements. Our law does not mention religious exemptions and neither does the interpretive rule. 4

11 WEST VIRGINIA CODE Compulsory immunization of school children; information disseminated; offenses; penalties. Whenever a resident birth occurs, the state director of health shall promptly provide parents of the newborn child with information on immunizations mandated by this state or required for admission to a public school in this state. All children entering school for the first time in this state shall have been immunized against diphtheria, polio, rubeola, rubella, tetanus and whooping cough. Any person who cannot give satisfactory proof of having been immunized previously or a certificate from a reputable physician showing that an immunization for any or all diphtheria, polio, rubeola, rubella, tetanus and whooping cough is impossible or improper or sufficient reason why any or all immunizations should not be done, shall be immunized for diphtheria, polio, rubeola, rubella, tetanus and whooping cough prior to being admitted in any of the schools in the state. No child or person shall be admitted or received in any of the schools of the state until he or she has been immunized as hereinafter provided or produces a certificate from a reputable physician showing that an immunization for diphtheria, polio, rubeola, rubella, tetanus and whooping cough has been done or is impossible or improper or other sufficient reason why such immunizations have not been done. Any teacher having information concerning any person who attempts to enter school for the first time without having been immunized against diphtheria, polio, rubeola, rubella, tetanus and whooping cough shall report the names of all such persons to the county health officer. It shall be the duty of the health officer in counties having a full-time health officer to see that such persons are immunized before entering school: Provided, That persons enrolling from schools outside of the state may be provisionally enrolled under minimum criteria established by the director of the department of health so that the person's immunization may be completed while missing a minimum amount of school: Provided, however, That no person shall be allowed to enter school without at least one dose of each required vaccine. In counties where there is no full-time health officer or district health officer, the county commission or municipal council shall appoint competent physicians to do the immunizations and fix their compensation. County health departments shall furnish the biologicals for this immunization free of charge. Health officers and physicians who shall do this immunization work shall give to all persons and children a certificate free of charge showing that they have been immunized against diphtheria, polio, rubeola, rubella, tetanus and whooping cough, or he or she may give the certificate to any person or child whom he or she knows to have been immunized against diphtheria, polio, rubeola, rubella, tetanus and whooping cough. If any physician shall give any person a false certificate of immunization against diphtheria, polio, rubeola, rubella, tetanus and whooping cough, he or she shall be guilty of a misdemeanor, and, upon conviction, shall be fined not less than twenty-five nor more than one hundred dollars. Any parent or guardian who refuses to permit his or her child to be immunized against diphtheria, polio, rubeola, rubella, tetanus and whooping cough, who cannot give satisfactory proof that the child or person has been immunized against diphtheria, polio, rubeola, rubella, tetanus and whooping cough previously, or a certificate from a reputable physician showing that immunization for any or all is impossible or improper, or sufficient reason why any or all immunizations should not be done, shall be guilty of a misdemeanor, and except as herein otherwise provided, shall, upon conviction, be punished by a fine of not less than ten nor more than fifty dollars for each offense Distribution of free vaccine preventives of disease. (a) Declaration of legislative findings and purpose. -- The Legislature finds and declares that early immunization for preventable diseases represents one of the most cost-effective means of disease prevention. The savings which can be realized from immunization, compared to the cost of health care necessary to treat the illness and lost productivity, are substantial. Immunization of children at an early age serves as a preventative measure both in time and money and is essential to maintain our children's health and well-being. The costs of childhood immunizations should not be allowed to preclude the benefits available from a comprehensive, medically supervised child immunization service. Furthermore, the federal government has established goals that require ninety percent of all children to be immunized by age two and provided funding to allow uninsured children to meet this goal. (b) The state director of health shall acquire vaccine for the prevention of polio, measles, mumps, rubella, diphtheria, pertussis, tetanus, hepatitis-b, haemophilus influenzae-b and other vaccine preventives of disease as may be deemed necessary or required by law, and shall distribute the same, free of charge, in such quantities as he or she may deem necessary, to county and municipal health officers, to be used by them for the benefit of, and without expense to the citizens within their respective jurisdictions, to check contagions and control epidemics.

12 (c) The county and municipal health officers shall have the responsibility to properly store and distribute, free of charge, vaccines to private medical or osteopathic physicians within their jurisdictions to be utilized to check contagions and control epidemics: Provided, That the private medical or osteopathic physicians shall not make a charge for the vaccine itself when administering it to a patient. The county and municipal health officers shall provide a receipt to the state director of health for any vaccine delivered as herein provided. (d) The director of the division of health is charged with establishing a childhood immunization advisory committee to plan for universal access, make recommendations on the distribution of vaccines acquired pursuant to this section and tracking of immunization compliance in accordance with federal and state laws. The childhood immunization advisory committee shall be appointed by the secretary of the department of health and human resources no later than the first day of July, one thousand nine hundred ninety-four, and shall be comprised of representatives from the following groups: Public health nursing, public health officers, primary health care providers, pediatricians, family practice physicians, health care administrators, state medicaid program, the health insurance industry, the public employees insurance agency, the self-insured industry and consumers. The state epidemiologist shall serve as an advisor to the committee. Members of the advisory committee shall serve two-year terms. (e) All health insurance policies and prepaid care policies issued in this state which provide coverage for the children of the insured shall provide coverage for child immunization services to include the cost of the vaccine, if incurred by the health care provider, and all costs of administration from birth through age sixteen years. These services shall be exempt from any deductible, per-visit charge and/or copayment provisions which may be in force in these policies or contracts. This section does not exempt other health care services provided at the time of immunization from any deductible and/or copayment provisions. (f) Attending physicians, midwives, nurse practitioners, hospitals, birthing centers, clinics and other appropriate health care providers shall provide parents of newborns and preschool age children with information on the following immunizations: Diphtheria, polio, mumps, measles, rubella, tetanus, hepatitis-b, haemophilus influenzae-b and whooping cough. This information should include the availability of free immunization services for children.

13 M E M O R A N D U M TO: Local Health Departments Local Health Officers Department of Education County School Superintendents Vaccines for Children (VFC) Providers FROM: Catherine C. Slemp, M.D., M.P.H., Acting State Health Officer Loretta E. Haddy, Ph.D., Director Division of Surveillance and Disease Control State Epidemiologist DATE: February 5, 2008 RE: Interpretive Rule, 64CSR95, Immunization Requirements and Recommendations for New School Enterers The attached interpretive rule will become effective February 28 th, This rule adopts the most current recommendations from the Centers for Disease Control and Prevention s (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) to clearly define immunization requirements and recommendations for new school enterers in West Virginia. The most significant changes in the rule are: Varicella (chickenpox), hepatitis B, and mumps vaccines are now required for all children prior to entry into grades K-12. Pre-kindergarten children enrolled in programs in a school building with K-12 students must be age-appropriately immunized. The minimum number of doses of DTaP required of children < 7 years of age is now four instead of three. Section 9 of the rule sets forth the procedures by which parents may obtain a valid medical exemption. It will be of utmost importance for the local health officer to establish an official repository within his/her health department to collect and maintain a file of children in its county with medical exemptions for use during outbreaks or public health emergencies. LHDs should share the file, at a minimum, on an annual basis with their local board of education (school nurses) and the Bureau for Public Health (Immunization Program).

14 As per section 9.3, requests for medical exemptions and the corresponding responses should be sent to the state health officer by mail or fax to: State Health Officer 505 Capitol Street Charleston, WV Or by fax to The Immunization Program may receive information on children with medical exemptions by mail to: WV Immunization Program 350 Capitol Street, Room 125 Charleston, WV Or by fax at Please contact Jeff Neccuzi of the Immunization Program with any comments or questions by telephone at

15 Types of Rules There are three types of normal rules -- Legislative, Procedural and Interpretive. The term "administrative rules" refers generally to rules promulgated by an administrative agency. Emergency rules are legislative rules which are promulgated in an emergency. Legislative Legislative rules are proposed by an agency subject to the Administrative Procedures Act (APA), but must be approved by the Legislature before they go into effect, unless they are filed as Emergency rules. A legislative rule is the only form of rule under the APA which: carries the force of law, or supplies a basis of civil or criminal liability, or grants or denies a specific benefit. A legislative rule may be used to determine any issue affecting public rights, privileges or interests. Except when specifically provided in the W. Va. Code, legislative rules do not include: findings or determinations of fact made or reported by an agency, including any such findings and determinations as required to be made by any agency as a condition precedent to proposal of a rule to the legislature; declaratory rulings issued by an agency; orders; or executive orders or proclamations by the governor issued solely in the exercise of executive power. Procedural Interpretive Procedural rules are those which set rules of procedure, practice or evidence for dealings with or proceedings before an agency, and may include forms used by the agency. Procedural rules are not reviewed or approved by the Legislature. Interpretive rules are rules which provide information or guidance regarding the agency's interpretations, policy or opinions upon the law enforced or administered by it. They are not to be used to determine any issue affecting private rights, privileges or interests. Interpretive rules are not reviewed or approved by the Legislature.

16 Using Law, Policy, and Research to Improve the Public s Health: A National Conference Session Notes: Regulatory Approaches to Policy Making and Legislative Advocacy September 14, 2010, 8:15 9:30 a.m. Massachusetts Public Health Council Statutory authority: Massachusetts public health regulations passed to support H1N1 vaccination efforts: Vaccination for hospital (105 CMR ), clinic (105 CMR ), and long term care facility personnel (105 CMR (D)(8)): Expanded vaccination authority for designated health professionals, 105 CMR (A): Examples of regulations passed to implement Massachusetts health care reform: Health Care Associated Infection, 105 CMR Prescription Monitoring Program, 105 CMR 700, etc.; FAQ at Serious Reportable Events,105 CMR : Expansion of Determination of Need, 105 CMR Contact Information: Geoff Wilkinson, Senior Policy Advisor Office of the Commissioner Massachusetts Department of Public Health 250 Washington Street, Boston, MA (617) geoff.wilkinson@state.ma.us

TITLE 64 INTERPRETIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES BUREAU FOR PUBLIC HEALTH

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