Frequently Asked Questions for House Bill

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1 Frequently Asked Questins fr Huse Bill Belw are Frequently Asked Questins (FAQ) the Clrad Department f Public Health and Envirnment (CDPHE) has received regarding varius cmpnents f Huse Bill (HB-1288). These FAQs will be updated peridically. If yu have HB-1288 questins, please cdphe.dcdimmunizatin@state.c.us. Basics What is HB-1288 and what des it say? In May 2014, the Clrad General Assembly passed HB-1288, which tk effect n July 1, This legislatin cntains several key cmpnents: Schls/childcares are required t make the immunizatin and exemptin rates f their enrlled students publicly available, upn request. Furthermre, the law directs CDPHE t prvide assistance t schls/childcares with the analysis and interpretatin f the immunizatin data. Clrad Bard f Health (BOH) is directed t make rules regarding an nline educatin mdule including the benefits and risks f immunizatin, evidence-based research, resurces and infrmatin frm credible scientific and public health rganizatins, and peer-reviewed studies. CDPHE anticipates this mdule may be used by parents, prviders r ther interested parties. Clrad BOH is directed t make rules regarding the frequency f submitting immunizatin exemptin frms. CDPHE is directed t wrk with ther state departments t develp jint immunizatin data cllectin and sharing plicies. What HB-1288 des NOT say? This law des nt direct CDPHE t cllect, publish, r reprt immunizatin and exemptin rates frm schls/childcares. It des nt direct schls/childcares t reprt their immunizatin and exemptin data t neither CDPHE, the Clrad Department f Educatin (CDE), nr the Clrad Department f Human Services (CDHS). It des nt give deadlines fr the creatin f the educatinal mdule, nr des it tell the BOH by when it must make rules regarding the frequency f immunizatin exemptin frms. Finally, the law des nt define a timeline, frmat, r mechanism by which schls/childcares have t make immunizatin r exemptin rates available. Wh des HB-1288 apply t? CDPHE and the BOH fr the creatin and cntent f the nline educatin mdule and the frequency f submitting immunizatin exemptin frms. CDPHE fr the prvisin f technical assistance t schls/childcares regarding hw t analyze and interpret immunizatin data, and the directin t wrk with ther state departments t develp jint immunizatin data sharing plicies. Schls/childcares fr the requirement t make the immunizatin and exemptin rates f their enrlled students publicly available, upn request. Schls/childcares are defined as a public, private, r parchial nursery schl, day care center, child care facility, schl-age child care center, day camps, resident camps, day treatment centers, family child care hme, fster care hme, Head Start prgram, kindergarten, r elementary r secndary schl thrugh grade twelve, r a cllege r university. Schls/childcares d nt include a public services shrt-term Last Updated: Octber 2014 Page 1

2 child care facility as defined in sectin (6.7), C.R.S., a guest child care facility as defined in sectin (5), C.R.S., a ski schl as defined in sectin (6), C.R.S., r cllege r university curses which are ffered ff-campus; r are ffered t nntraditinal adult students, as defined by the gverning bard f the institutin; r are ffered at clleges r universities which d nt have residence hall facilities. Will CDPHE, CDE r CDHS ask r require schls/childcares t reprt their rates t the state? At this time, CDPHE, CDE nr CDHS is asking nr requiring schls/childcares t reprt their immunizatin and exemptin rates t the state. Will CDPHE, CDE r CDHS have rates fr schls/childcares n their website? At this time, CDPHE, CDE nr CDHS will have schl/childcare-level data psted n ur websites. Individual schls/childcares will need t have their immunizatin and exemptin rates readily available t anyne wh requests the infrmatin. What is the timing fr implementatin f the requirements f HB-1288? The requirements f this law tk effect July 1, Schls/childcares shuld expect requests fr immunizatin and exemptin rates at any time. The BOH is scheduled t address the frequency f submitting exemptins frms and cntent f the educatinal mdule n the fllwing dates in The request fr rulemaking will ccur in February 2015 and rulemaking will ccur in April CDPHE expects t have the educatinal mdule develped and made available in spring Are schls required t use a certain methdlgy t calculate immunizatin r exemptin rates? N, schls/childcares may use any methd t calculate their immunizatin r exemptin rates. CDPHE has develped materials t assist with this prcess and cntinues t prvide technical assistance t schls/childcares that request it. The Child Care and Schl Immunizatin Rates Guide prvides guidance n hw t manually generate immunizatin and exemptin rates. It directs facilities t cmpare each student's current immunizatin recrd with the number and type f vaccines they shuld have fr their current age and prvides a wrksheet with guidance n hw t determine the aggregate immunizatin and exemptin rate fr the entire schl r childcare center. Please nte that this methd is nt cnsistent with all f the requirements f the Advisry Cmmittee n Immunizatin Practices (ACIP)- recmmended schedule f immunizatins and nly takes int accunt the number f dses a student has received; nt whether the dses were given at the crrect age r meets minimum interval requirements. Fr questins r suggestins n hw t imprve this guidance, please us at: cdphe.dcdimmunizatin@state.c.us. The CIIS Immunizatin Rates Reprt fr Child Care and Schl prvides guidance n hw t use the Clrad Immunizatin Infrmatin System (CIIS) t generate immunizatin rates fr the entire schl r childcare center. Please nte that CIIS fllws the current ACIP-recmmended immunizatin schedule, including minimum intervals between dses and age requirements. CIIS des nt take int accunt the ACIP catch-up schedules fr 0-18 year lds. Currently, there is n way fr schls r child cares t calculate exemptin rates in CIIS. Hwever, a simple frmula t calculate exemptin rates is included at the bttm f the tutrial. Fr questins r suggestins n hw t imprve this guidance, please cntact Lrin Sctt-Okerblm, CIIS Schl Crdinatr, at r lrin.sctt-kerblm@state.c.us. Has the BOH determined the frequency with which exemptin frms will be submitted? The BOH has nt yet determined the frequency with which exemptin frms will be required t be submitted. The current requirement is that an exemptin frm needs t be signed nce by the parent/emancipated student, and kept n file by the schl. The future frequency f Last Updated: Octber 2014 Page 2

3 submitting exemptin frms will be determined in The request fr rulemaking is scheduled in February 2015 and rulemaking is scheduled fr April What will the educatin mdule include? The mdule will cver vaccine preventable diseases, including the risk f the disease and the impact n the cmmunity when parents chse nt t vaccinate their children. The mdule will explain the immunizatins recmmended fr children and adlescents including the ACIP-recmmended schedule fr each vaccine and infrmatin abut the safety, side effects and ptential risks f each vaccine. The mdule will cntain safety infrmatin available n the Centers fr Disease Cntrl and Preventin (CDC) website, and infrmatin frm credible, peer-reviewed, published research studies. Where studies acknwledge research gaps, thse gaps will be nted in the mdule. The mdule will cver vaccine efficacy and dcument vaccine effectiveness fr each vaccine. Student Privacy: What is the Family Educatinal Rights and Privacy Act (FERPA)? FERPA is a Federal Law that prtects the privacy f students educatin recrds. The law applies t all educatinal agencies including schls that receive funds under an applicable prgram f the U.S. Department f Educatin/ A student s health recrds, including immunizatin recrds, that are maintained by the schl are cnsidered t be educatin recrds and are subject t FERPA. The Health Insurance Prtability and Accuntability Act (HIPAA) Privacy Rule specifically excludes frm its cverage any recrds that are prtected by FERPA. Des FERPA impact the ability f a schl t prvide immunizatin and exemptin rates? Aggregating student-level data int a schl level reprt is permissible under FERPA since risk f disclsure is minimized if there wuld be n direct identifiers in the schl aggregate reprt. Sme risk f disclsure may ccur if there are situatins where a small number f students may have a unique identifier (e.g. medical exemptin), which wuld cause them t be identified when reprting exemptin rates. Schls will be respnsible fr prtecting persnally identifiable infrmatin (PII) when aggregating immunizatin and exemptin rates t minimize the risk f revealing infrmatin abut an individual student. In rder t prtect student privacy, is there a minimum number f students a schl r childcare center must have befre releasing immunizatin and exemptin rates? FERPA nr HIPAA identifies a minimum number f students required in regards t aggregate reprting. Hwever, bth indicate that the selected number shuld serve t preserve the privacy f student-level data. In ther wrds, the reprting size shuld nt be s small that a persn in the cmmunity culd reasnably determine the identity f the students. Given this standard, the apprpriate minimum number f students will need t be determined n a schl by schl basis. Schls: If yu believe yur schl has t few students such that their privacy wuld be cmprmised, please cntact Kathy Patrick, Assistant Directr f Health and Wellness, Clrad Department f Educatin (patrick_k@cde.state.c.us). Childcares: Please refer t the Child Care Regulatins General Rules fr Child Care Facilities fr guidance n hw t maintain privacy when sharing immunizatin infrmatin. Bard f Health Rule-making Prcess What is the prcess the BOH fllws fr rule-making? Rules are like a mini-statute that the state legislature asks an agency r bard t create. Rules are enfrceable law, and ften prvide details r requirements nt specified in statute. Rulemaking is a prcess fr develping and issuing rules. The rulemaking prcess can lead t the issuance f a new rule, an amendment t an existing rule, r the repeal f an existing rule. CDPHE generally fllws a specified prcess (See Appendix A) when develping rules. The majr steps f this prcess include: Rule Develpment Last Updated: Octber 2014 Page 3

4 Request fr a Rulemaking hearing Prvide Ntice f rulemaking hearing Hld rulemaking hearing After deliberatin, rule adpted Rulemaking hearings prvide an pprtunity fr interested individuals and advcates t give a firsthand accunt f the ptential impact f prpsed rules. Stakehlders may becme aware f rulemaking hearing thrugh direct cmmunicatin frm CDPHE, CDPHE s website r thrugh the Secretary f State s website. Public cmments will be accepted during the fficial rule-making prcess. The BOH will cnduct the public rule-making hearing and encurages frmal participatin during this prcess by accepting ral cmments during the public rule-making hearing, r written cmments. Written cmments may be submitted t the Clrad Bard f Heath, ATTN: Jamie Thrntn: Mail: Clrad Department f Public Health and Envirnment, 4300 Cherry Creek Drive Suth (EDO-A5), Denver, CO Fax: jamie.thrntn@state.c.us Infrmal questins r cmments may be addressed t the Clrad Immunizatin Branch at: cdphe.dcdimmunizatin@state.c.us. Specific questins already received abut the educatinal mdule: Hw des the CDC cllect infrmatin abut vaccine safety? CDC is cmmitted t ensuring that vaccines prvided t the public are safe and effective. Once vaccines are licensed in the United States, CDC actively mnitrs the safety f these vaccines thrugh several systems: Vaccine Adverse Event Reprting System (VAERS) an early warning public health system where peple can reprt vaccine cncerns, that helps CDC and FDA detect pssible side effects r adverse events fllwing vaccinatin. Vaccine Safety Datalink (VSD) a cllabratin between CDC and several healthcare rganizatins which uses de-identified health recrds t mnitr and evaluate adverse events fllwing vaccinatin. Clinical Immunizatin Safety Assessment (CISA) a cllabratin between CDC and several medical research centers in the United States t cnduct research int hw adverse events might be caused by vaccines. Vaccine safety mnitring cntinues t becme mre imprtant with the develpment and use f new vaccines, expanded vaccine recmmendatins, and new glbal immunizatin initiatives. Reprting systems and vaccine safety activities, such as VAERS, VSD, and CISA, will cntinue t be used t mnitr and study adverse events, s vaccines can cntinue t be held t very high standards f safety. Hw will the differences between recmmended and required vaccines be handled? The educatin mdule will prvide infrmatin fr all vaccines recmmended fr children and adlescents per the ACIP as well as which vaccines are required fr schl per the BOH. Wh will prvide input t guide the develpment f the educatin mdule? The educatin mdule will be develped by CDPHE staff with input frm the current schl immunizatin taskfrce, which includes pediatric, and family practice prviders, lcal public health staff, schl health staff, and parents. The mdule will als be reviewed by the Vaccine Advisry Cmmittee f Clrad (VACC) and a member f the current BOH. As the BOH is required t make rules regarding the cntent f the educatin mdule, any individual may cntribute t rule develpment by prviding written r ral cmments during the rulemaking perid, as described abve. Appendix A Clrad Administrative Prcedure Act Last Updated: Octber 2014 Page 4

5 The Clrad Administrative Prcedure Act (APA) gverns the legal and prcedural requirements that the state must fllw when prmulgating rules and regulatins. The APA applies t all state departments, agencies, and bards required r permitted by law t make rules, including CDPHE and the Bard f Health. Rulemaking prcedures prvide the public with an pprtunity t prvide input prir t the requirement taking effect. CDPHE generally fllws a specified prcess when develping rules. The majr steps f this prcess include: Rule Develpment (ften with stakehlder engagement). CDPHE staff will develp a prpsed rule t take befre the State Bard f Health. Request a Rulemaking hearing at least 2 mnths prir t rulemaking hearing. A Request fr Rulemaking Hearing is a brief discussin f the prpsed rule and an fficial request frm staff t the Bard f Health t set a date fr the rulemaking hearing. At this time, the Bard f Health will be given a draft f the prpsed rule and ther required dcuments (cver mem, statement f basis and purpse and specific statutry authrity, regulatry analysis, stakehlder cmment). Prvide Ntice f rulemaking hearing. Prir t ur planned rulemaking, CDPHE will submit a ntice f rulemaking t the ffice f the Clrad Secretary f State fr publicatin in the Clrad Register. The Ntice will include: the time, place and nature f the public rulemaking hearing, the authrity under which the rule is prpsed, and the text f the prpsed rule r a descriptin f the subjects and issues invlved in the rule. The Clrad Register is published n the 10th and 25th f each mnth. In additin t publicatin in the Clrad Register, CDPHE will infrm all stakehlders f the upcming rulemaking hearing. Hld rulemaking hearing. The rulemaking hearing is when the public and interested stakehlders have the pprtunity t testify in supprt f r ppsitin t the department prpsal. The hearing chair will pen the rulemaking hearing and ask fr the staff presentatin. Staff will describe the prpsed rule, any changes that have ccurred between the request fr rulemaking and the rulemaking hearing, and any utstanding issues. Next, public cmment n the prpsal is taken frm persns that have signed up t testify. Depending n the number f peple wanting t testify, the Bard may limit each persn t three minutes. In sme instances the Bard may receive written cmments rather than permitting testimny. After all testimny and bard questins are respnded t, the Bard will mve int deliberatins. During deliberatins, the Bard will discuss the issues and prpsed rule. After the deliberatins are cmpleted, the hearing chair will ask fr a mtin and a secnd regarding the prpsal, and a vte is taken regarding adptin f the rule. Rule passed, and becmes effective n a specific date. Last Updated: Octber 2014 Page 5