What does GINA Mean? A Guide to the Genetic Information

Nondiscrimination Act

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TableofContents

GINA:AnOverview ............................................................................................ 3TheHistoryofGINA ........................................................................................... 4WhyGINA? .............................................................................................................................4TheLongRoadtoPassage .......................................................................................................5GINAVictoryCelebration ........................................................................................................5

HowdoesGINAimpactME?............................................................................... 7TitleI:GeneticNondiscriminationinHealthInsurance ............................................................7Whataboutsubmittingclaimstomyhealthinsurancecompany?............................................ 7WhatdoesGINAnotdo? ........................................................................................................... 8

TitleII:ProhibitingEmploymentDiscriminationontheBasisofGeneticInformation ..............9Underwhatcircumstancescananemployer,employmentagency,laborunion,ortrainingprogramhaveaccesstomygeneticinformation?..................................................................... 9Ifanemployer,employmentagency,labororganization,orjointlabor‐managementcommitteedoespossessmygeneticinformation,whateffortsmustbemadetoensuremyinformationiskeptconfidential? ............................................................................................. 10WhatdoesGINAnotdo? ......................................................................................................... 10

HypotheticalExamplesofGeneticDiscrimination .................................................................12InHealthInsurance .................................................................................................................. 12InEmployment ......................................................................................................................... 12

ForHealthInsurers .......................................................................................... 14Whatinformationcaninsurersrequestinmakingcoveragedeterminationsforspecificclaims? ..................................................................................................................................... 14

ForEmployers .................................................................................................. 15Whenmayanemployerrequestoruseanemployee’sgeneticinformation?......................... 15Whateffortsmustemployersmaketoensurethegeneticinformationofemployeesiskeptconfidential? ............................................................................................................................ 16

ForCliniciansandHealthcareProviders............................................................ 17ForResearchers ............................................................................................... 17ForStates......................................................................................................... 17ImportantGINADefinitionsandExamples ....................................................... 18AdditionalResources ....................................................................................... 19

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GINA:AnOverviewPresidentBushsignedtheGeneticInformationNondiscriminationAct(GINA)intolawonMay21,2008.Wecontinuetocelebratethismonumentaleventastheculminationofthirteenyearsofdedicationandperseverancefromtheentiregeneticscommunity,ledbytheCoalitionforGeneticFairness,andmorethan500CongressionalofficesonCapitolHill.BeforeGINA,manyindividualsforwentgenetictestingservices,importanttoolsformanaginghealth,duetofearsofmisuseoftheinformationwereittobeobtainedbyemployersorhealthinsurers;researchandindustrysufferedfromdecreasedenrollmentinclinicaltrials,dueinparttothesefears;andclinicianshadtoinformpatientsaboutthepotentialfordiscrimination.Asthefirstmajorcivilrightsbillofthenewcentury,GINAprovidesindividualswithfederalprotectionsagainstgeneticdiscriminationinhealthinsuranceandemployment.Thehealthinsuranceprovisionsofthebill,TitleI,willtakeeffect12monthsafterthedateofsigning,onMay21,2009.Theprotectionsinemployment,TitleII,willtakeeffect18monthsafterthedateofsigning,onNovember21,2009.Allindividualsresidingwithinthe50StatesandUSterritoriesbenefitfromtheseprotections.NoweveryAmericancanfeelsafefromgeneticdiscriminationinhealthinsuranceandemployment.

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TheHistoryofGINA

WhyGINA?Geneticscontinuestotransformhowwelookathumanhealth.Familyhealthhistoryhelpsustounderstandthehereditarybasisofdisease.Furthermore,geneticsresearchhascontributedtoourknowledgeoftheoccurrenceandprogressionofdiseaseandtheeffectivenessofmedicationsandtherapies—theresultinggenetictechnologiesandservicesarenowutilizedinpersonalhealthmanagement.Theadvancesingenetictestingaloneprovideamodelforthisgrowth:since1995,thenumberofgenetictestsavailablehasincreasedfive‐fold.Whileinthepast,genetictestswereusuallylimitedtorarediseases,newtestsarenowbeingdevelopedthatwillallowfortheidentificationofgeneticpredispositionstomanycommonhealthconditions.Thebenefitsofintegratinggeneticinformationintohealthmanagementaretremendous,andincludeenablinganindividualtomakeproactiveandinformeddecisions.Knowledgeaboutone’sgenescanbeinvaluabletohealthcaredelivery.However,thatknowledgeisalsosusceptibletomisuse.Becausenooneisexemptfromthisharm—eachofuscarriesanumberofmutatedgenes—geneticdiscriminationanditsrelatedprivacyconcernsshouldbeprofoundlyimportanttoeachofus.Concernsofgeneticdiscrimination,moststronglyidentifiedinhealthinsuranceandemployment,promptedtheneedforfederalantidiscriminationlegislation.Onthestatelevel,legislaturesbegantorespondtoconcernsbyprovidingvariouslevelsofprotection,howeverthispatchworkofstatelawsleftmanyindividualsvulnerable.CasesofgeneticdiscriminationinemploymentbegantoemergeintheUS.Inhealthinsurance,individualsrealizedtheprivacyprotectionsaffordedbyHIPAAdidnotprohibitinsurersfromrequiringgenetictestingorfromdenyingcoveragebasedongeneticinformation.Wewerealllosingundertheoldguidelines:individualswouldoftenforegogenetictestingservices,thushinderingtheirownaccesstothehighestqualityhealthcareavailable.Thisalsoimpactedhealthcareproviders,researchers,andindustry.Largenumbersofindividualsoptedoutofclinicaltrials,andinturnslowedthetranslationofresearchintotreatmentsanddiagnostics.TheGeneticInformationNondiscriminationAct(GINA)answersconcernsofgeneticdiscriminationinhealthinsuranceandemploymentbyprovidingafederalbaselineforprotections.Thelegislationcomesatatimewhenhealthcarecostsremainanationaldilemma,andindividualscontinuetoexpressworriesthathealthinsurersandemployers,lookingforwaystosavemoney,willusegeneticinformationasatooltocutcosts.WhenGINAbecomesfullyactiveinNovember2009,allAmericanswillbefreetoputtheirhealthconcernsfirst.

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TheLongRoadtoPassageLegislationregardinggeneticnondiscriminationwasfirstintroducedintheHouseofRepresentativesin1995byRepresentativeLouiseSlaughter(D‐NY).In1996,Sen.OlympiaSnowe(R‐ME)introducedsimilarlegislationintheSenate.Bothbillsspecificallyaddresseddiscriminationinhealthinsurance.Neitherbillpassedinthat104thCongress.SimilarlegislationwasintroducedinbothchambersofCongressinthe105thand106thCongresses,howevernotoneofthesebillsmadeittothePresident’sdesk.

In1997,theCoalitionforGeneticFairnesswasfoundedwiththeobjectivetourgeCongresstopasscomprehensivefederallegislationoutlawinggeneticdiscriminationandtoeducatethepublicabouttheseprotections.Initially,theCoalitionconsistedofcivilrights,disease‐specific,andhealthcareorganizations.In2005,itwasexpandedtoincludeindustrygroupsandemployers.FromitsfoundingthroughthedayGINApassed,theCoalitionunitedasonevoicethehundredsoforganizationsandthousandsofindividualswhostoodinsupportofgeneticantidiscriminationlegislation.

Sen.OlympiaSnowe(R‐ME)firstintroducedtheGeneticInformationNondiscriminationAct(GINA)in2002duringthe107thCongress.Thebilladdresseddiscriminationinbothhealthinsuranceandemploymentdecisions.Thebilldidnotpass.

Similarlegislationwasintroducedonceagaininthe108thCongress.IntheHouseofRepresentatives,thebill(H.R.1910)wasintroducedbyRep.LouiseSlaughter(D‐NY)andgained242cosponsors.IntheSenate,thebill(S.1053)wasintroducedbySen.OlympiaSnowe(R‐ME)andgained23cosponsors.TheSenatebillpassed95‐0,howevertheHousebilldidnotpass.

Inthe109thCongress,Rep.JudyBiggert(R‐IL)introducedthebill(H.R.1227)intheHouseofRepresentatives.Itgained244cosponsors,butagaindidnotpass.IntheSenate,Sen.OlympiaSnowe(R‐ME)introducedthebill(S.306)anditpassed98‐0.

GINAVictoryCelebrationOnMay21,2008,afterpassingintheUSHouseofRepresentatives414‐1andtheUSSenate95‐0inthe110thCongress,PresidentGeorgeW.BushsignedGINAintolaw.Incelebrationofthisvictoryforeveryindividualinthenation,thegeneticscommunitycametogetherattheGeneticAllianceAnnualConferenceonFriday,July11,2008,toreflectuponthelongjourney,recognizeourGINAchampions,andshareintheexcitementforthefutureofgeneticsandhealth.Guestsrepresentingacross‐sectionofthegeneticsandhealthcommunitieswereencouragedtodressinfestiveattire,whichbroughtanairoflightnessandfuntotheevent.Theevening

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beganwiththeGINAHistoryVideo—acelebrationofthehistoricalmoments,movingstories,andunwaveringvoicescontributingtothepassageofthelegislation.Attheconclusionofthevideo,SharonTerry,PresidentandCEOofGeneticAlliance,presentedatoastinhonoroftheMembersoftheHouseandSenatewhocarvedthepathforGINA.Shethenpresentedasecondtoasttousall—wehaveallbeentouchedbythissignificantpieceoflegislation.

DiversemembersofthegeneticsandhealthcommunitywerethenaskedtosayafewwordsabouteachofourCongressionalheroesandtheirkeystaffmembers,whowerepresentedwithawardsfortheirtirelesssupportofGINAthroughoutitslongjourneytopassage.Dr.FrancisCollins,whohadrecentlyresignedfromhispostasDirectoroftheNationalHumanGenomeResearchInstitute(NHGRI),NIH,recognizedSharonTerryforhervisionaryleadershipandpassionthenledtheguestsinacelebratorysong,“G‐I‐N‐A”,whichhewrotefortheoccasion.Afterabriefdemonstrationofthedancestepscorrespondingtothe“G‐I‐N‐A”song—anadaptationofYMCA—themusicalnumberkickedoffmanyhoursofentertainmentanddelight,asthecrowddancedthenightawayincelebrationofthisincrediblevictoryforeveryindividualinthenation.Congratulationstousall.

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HowdoesGINAimpactME?

TitleI:GeneticNondiscriminationinHealthInsuranceTheGeneticInformationNondiscriminationAct(GINA)outlinesunlawfulpracticesforhealthinsurersintheuseofgeneticinformation.Morespecifically,GINAstrictlyprohibitsthefollowing:

• Healthinsurersmaynotrequireindividualstoprovidetheirgeneticinformationorthegeneticinformationofafamilymembertotheinsurerforeligibility,coverage,underwriting,orpremium‐settingdecisions;

• Healthinsurersmaynotusegeneticinformationeithercollectedwithintent,orincidentally,tomakeenrollmentorcoveragedecisions;

• Healthinsurersmaynotrequestorrequirethatanindividualoranindividual’sfamily

memberundergoagenetictest;and

• IntheMedicaresupplementalpolicyandindividualhealthinsurancemarkets,geneticinformationcannotbeusedasapreexistingcondition.

Researchexception:Forjointresearchactivitiesconductedbyhealthinsurersincollaborationwithexternalresearchentities,ahealthinsurerineitherthegrouporindividualmarketmayrequest,butnotrequire,inwritingthatanindividualundergoagenetictest.Theindividualmayvoluntarilychoosetoundergosuchgenetictesting,butnon‐compliancewillnothaveanegativeeffectonthepremiumorenrollmentstatusoftheindividual.Geneticinformationmayonlybeusedforresearchandnotforunderwritingpurposes.

Whataboutsubmittingclaimstomyhealthinsurancecompany? Withregardtomakingcoveragedeterminationsforaspecificclaim,theinsurercouldrequiregeneticinformation.Forexample,theinsurermayrequestinformationaboutanindividual’sBRCAstatustodeterminecoverageforprophylacticmastectomy.Theinsurermayrequestonlytheminimumamountofinformationnecessaryfordecision‐making.Ifanindividualwouldnotliketoprovidegeneticinformationtotheirhealthinsureraboutsuchaclaim,theindividualcanelecttopayforthetestortreatmentout‐of‐pocket.

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WhatdoesGINAnotdo?ThehealthinsuranceprovisionsofGINAdonotapplytomembersoftheUSmilitary,toveteransobtaininghealthcarethroughtheVeteran’sAdministration,ortotheIndianHealthService.Furthermore,theprotectionsofGINAdonotincludeprotectionsfromgeneticdiscriminationinlife,disability,orlong‐term‐careinsurance.GINAdoesnotrestrictgeneticservices,thepracticeofmedicine,ortheauthorityofhealthcareprofessionals,whetherornottheyareaffiliatedwithahealthplanorissueroranemployer.Cliniciansandhealthcareproviderscanrequestthatanindividualoranindividual’sfamilymemberundergoagenetictestforthepurposesofthatindividual’smedicalbenefit.ThehealthinsuranceprovisionsofGINAdonotcoveranindividual’smanifesteddiseaseorcondition—onethathasalreadyappeared.GINAprotectsanindividual’spredictivegeneticinformation.However,GINAdoesprotectinformationaboutmanifesteddiseaseinanindividual’sfamilymembers(forexample,theirfamilyhistoryofdisease).GINAprovidesabaselineforprotectionagainstgeneticdiscriminationforallAmericans.GINAdoesnotpreemptstatelaw;thereforeifastate’sgeneticdiscriminationlawprovidesmoreextensiveprotectionsthanGINA,GINAdoesnotchangeit.

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TitleII:GeneticNondiscriminationinEmploymentTitleIIoftheGeneticInformationNondiscriminationAct(GINA)outlinesunlawfulactivitiesforanemployer,employmentagency,labororganization,ortrainingprogramintheuseofgeneticinformation.Morespecifically,GINAstrictlyprohibitsthefollowing:

Anemployermaynotusegeneticinformationinmakingdecisionsregardinghiring,promotion,termsorconditions,privilegesofemployment,compensation,ortermination.

Anemployer,employmentagency,labororganization,ortrainingprogrammaynotlimit,segregate,orclassifyanemployeeormember,ordeprivethatemployeeormemberofemploymentopportunities,onthebasisofgeneticinformation.

Anemployer,employmentagency,labororganization,ortrainingprogrammaynotrequest,require,orpurchasegeneticinformationoftheindividualorafamilymemberoftheindividualexceptinrarecases.Pleaserefertothenextsection.

Anemploymentagency,labororganization,ortrainingprogrammaynotfailorrefuseto

referanindividualforemploymentonthebasisofgeneticinformation,normaytheagency,labororganization,ortrainingprogramattempttocauseanemployertodiscriminateagainstanindividualonthebasisofgeneticinformation.

• Anemployer,labororganization,orjointlabor‐managementcommitteemaynotuse

geneticinformationinmakingdecisionsregardingadmissiontooremploymentinanyprogramforapprenticeshiportrainingandretraining,includingon‐the‐jobtraining.

• Alabororganizationmaynotexcludeorexpelfrommembership,orotherwise

discriminateagainst,anindividualbecauseofgeneticinformation.

Underwhatcircumstancescananemployer,employmentagency,laborunion,ortrainingprogramhaveaccesstomygeneticinformation?

Whentheinformationisinadvertentlyprovidedaspartoftheindividual’smedicalhistoryorthemedicalhistoryofafamilymember;

Whentheinformationispubliclyavailable(althoughnotwhentheinformationiscontainedinmedicaldatabasesorcourtrecords);

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Whentheemployerhasobtainedtheindividual’swrittenauthorizationaspartofanemployer‐sponsoredgeneticmonitoringprogramofthebiologicaleffectsoftoxicsubstancesintheworkplace,orifstateorfederallawrequiresthegeneticmonitoringprogram.Ineithercase,onlythehealthcareprofessionalandtheemployeecanknowoftheindividualandidentifiablegeneticinformation,andtheemployeemustbeinformedofindividualmonitoringresults.Theemployercanonlyhaveaccesstothecollectivegeneticinformationoftheentiregroupofemployees,withoutidentifyinginformation.

Whentheemployeroffershealthorgeneticservices,includingservicesofferedaspart

ofawellnessprogram,andwiththeindividual’swrittenauthorization.Insuchcases,onlythehealthcareprofessionalorboardcertifiedgeneticcounselorinvolvedinprovidingtheservicesmayknowofindividuallyidentifiablegeneticinformation.Again,theemployermayknowonlyofthecollectivegeneticinformationoftheentiregroupofemployees,withoutidentifyinginformation;and

Wheretheemployeroperatesasalawenforcemententityandrequirestheindividual’s

DNAforqualitycontrolpurposesintheforensiclaborhumanremainsidentificationsettings.Theinformationmaynotbeusedforanydeterminationsofthetermsofemployment.

Ifanemployer,employmentagency,labororganization,orjointlabor‐managementcommitteedoespossessmygeneticinformation,whateffortsmustbemadetoensuremyinformationiskeptconfidential?Anygeneticinformationthattheypossessaboutanindividualmustbetreatedastheconfidentialmedicalrecordoftheindividualandmustbemaintainedinseparateformsandinseparatefiles.Anindividual’sgeneticinformationmaynotbedisclosedexceptattheindividual’swrittenrequestorinresponsetoacourtorder.Furthermore,inordertomaintaincompliancewithexistinglaws,theaforementionedorganizationsorgroupsmayalsoprovidetheindividual’sgeneticinformationtotheFederal,State,orlocalauthorities.

WhatdoesGINAnotdo?TheemploymentprovisionsofGINAapplytothoseemployerscoveredundertheAmericanswithDisabilitiesAct(ADA)andTitleVIIoftheCivilRightsActof1964;thereforeitdoesnotcoveremployerswithfewerthan15employees.Furthermore,GINAdoesnotapplytomembersoftheUSmilitary.TheemploymentprovisionsofGINAdonotinterferewithanemployee’sabilitytoqualifyforfamilyormedicalleaveunderstateorfederalFamilyandMedicalLeavelaws,nortoparticipate

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inanemployer‐sponsoredwellnessprogramorothergeneticservicesofferedbyanemployer.Furthermore,GINAdoesnotinterferewithanemployer’sabilitytoofferasafeandhealthyworkenvironmentthroughfederalorstaterequiredgeneticmonitoringofthebiologicaleffectsonemployeesoftoxicsubstancesintheworkplace.GINAprovidesabaselineforprotectionagainstgeneticdiscriminationforallAmericans.GINAdoesnotpreemptstatelaw;thereforeifastate’sgeneticdiscriminationlawprovidesmoreextensiveprotectionsthanGINA,GINAdoesnotchangeit.

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HypotheticalExamplesofGeneticDiscriminationThefollowingexampleshavebeenadaptedfrom“GeneticDiscrimination.”CouncilforResponsibleGenetics.2001.http://www.gene‐watch.org/programs/privacy/genetic‐disc‐position.html.

InHealthInsurance• Lisa’syoungsonhasbeenhavingdifficultyinschool.Suspectingalearningdisability,she

consultsherdoctor.Herdoctorperformsafewgenetictests,anduponreceiptoftheresults,informsLisathathersonhasfragileXsyndrome,aninheritedformofintellectualimpairment.Nottoolongaftervisitingthedoctor,herhealthinsurancecompanyeliminatesherson’shealthcoverage,claimingthathisdisabilityrepresentsapreexistingcondition.Lisasearchesunsuccessfullyforanothercompanythatiswillingtoinsureherson.SheultimatelyquitsherjobinordertoqualifyforMedicaid.

• Lastyear,Jonathon’smotherAprilwasdiagnosedwithcoloncancer.BecauseApril’saunt

diedofcoloncancer,andhersisterwasundergoingchemotherapyforthecancer,Aprildecidedtoundergogenetictestingtodetermineifthecancercouldbehereditary.ShetestedpositiveforamutationinoneoffourgenesregulatingthereplicationofDNAinhercells,alsoknownasLynchsyndrome.Lastmonth,Jonathon’shealthinsurancecostsincreaseddramaticallyinresponsetothegenetictestresultsofhismother.

InEmployment• Marissahasworkedinalawfirmforfiveyearsandhasbecomeveryclosewithher

colleagues.Overlunchoneafternoon,shementionedtoapartnerinherfirmthatherfatherdiedofHuntington’sdisease.Marissaherselfhasa50%chanceofdevelopingthisgeneticcondition.Overthefollowingmonth,Marissabegantonoticehercaseloadwaning,andmanyofhercolleagueswhohadbeenwiththelawfirmforlesstimethanshewerereceivinghigherprofilecases.Shehasreceivednothingbutoutstandingperformancereviewsthroughouthertimeatthelawfirm,andcanfindnootherreasonasidefromthelunchconversationwithhercolleaguesthatcouldberesponsibleforthissuddenchange.

• Paullearnsthroughacompanymemothatamemberofthelargecardboardfactoryhe

worksforwasrecentlyfiredduetodrugabuseonthejob.Thecompanyhasdecidedtoinstitutemandatorydrugscreeningofallemployees.Paulwillinglyparticipatedintherandomdrug‐testingprogram,havingnoconcernsaboutpassing.Healwaystakeshisjobveryseriously,unlikesomeofhiscoworkers.Twomonthslater,Pauloverheardhissupervisorsdiscussingtheimpacttheeconomywashavingonthecompany.Thefollowing

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month,Paulwascalledintohissupervisor’soffice,wherehewasinformedthatthecompanyhadfallenonsomehardtimesandwouldneedtolethimgo.Confusedastowhyhewouldbeselectedamongtheindividualstobedischarged,overthenextfewweekshemetwithfriendsstillworkingatthecardboardfactoryandlearnedofsimilarlyconfusingcasesofhigh‐performing,dedicatedindividualswhowereletgowithlittlereason.Paulhasageneticpredispositiontoaheartconditionandhighcholesterol,whichcouldmeanhigherhealthcarecoststothecompany,buthedidn’tthinkhisemployerwouldknowthat.

Theaboveexamplesdonotconclusivelyidentifygeneticdiscriminationinhealthinsuranceandemployment;theyrepresentsituationsinwhichgeneticdiscriminationcouldbetakingplace.Individualsshouldconsultlawexpertisetodetermineiftheyhaveacaseforgeneticdiscrimination.

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ForHealthInsurersGINAoutlinesthefollowingactivitiesasunlawfulinsurancepracticesanddiscriminatoryonthebasisofgeneticinformation:

• Therequirementthatindividualsprovidegeneticinformationorthegeneticinformationofafamilymemberindeterminingeligibility,coverage,underwriting,orpremium‐settingdecisions,inthegroup,Medicaresupplementalpolicy,orindividualhealthinsurancemarkets;

• Theusegeneticinformationeithercollectedwithintent,orincidentally,tomakeenrollmentorcoveragedecisions;

• Therequestorrequirementthatanindividualoranindividual’sfamilymemberundergo

agenetictest;and;

• TheuseofgeneticinformationasapreexistingconditionintheMedicaresupplementalpolicyandindividualhealthinsurancemarkets.

Researchexception:Forjointresearchactivitiesconductedincollaborationwithexternalresearchentities,ahealthinsurerineitherthegrouporindividualmarketmayrequest,butnotrequire,inwritingthatanindividualundergoagenetictest.Thecompliancebytheindividualwithsucharequestisvoluntary,andnoncomplianceshallnothaveanegativeeffectonthepremiumorenrollmentstatusoftheindividual.Geneticinformationmayonlybeusedforresearchandnotforunderwritingpurposes.

Whatinformationcaninsurersrequestinmakingcoveragedeterminationsforspecificclaims?Aninsurercanrequiregeneticinformationtomakecoveragedeterminationsforaspecificclaim.Forexample,theinsurermayrequestinformationaboutanindividual’sBRCAstatustodeterminecoverageforprophylacticmastectomy.Theinsurermayrequestonlytheminimumamountofinformationnecessaryfordecision‐making.Anindividualcanelectnottosubmitgeneticinformationtotheinsureraboutsuchaclaim,andpayforthetreatment,test,orserviceout‐of‐pocket.

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ForEmployersGINAoutlinesthefollowingactivitiesasunlawfulemploymentpracticesanddiscriminatoryonthebasisofgeneticinformation:

Theuseofgeneticinformationinmakingdecisionsregardinghiring,promotion,termsorconditions,privilegesofemployment,compensation,ortermination.

Limiting,segregating,orclassifyinganemployee,ordeprivingthatemployeeofemploymentopportunities,onthebasisofgeneticinformation.

Therequest,requirement,orpurchaseofgeneticinformationoftheindividualorafamilymemberoftheindividualexceptinrarecases,

• Theuseofgeneticinformationinmakingdecisionsregardingadmissiontoor

employmentinanyprogramforapprenticeshiportrainingandretraining,includingon‐the‐jobtraining.

Furthermore,employersshouldbeawarethatitisunlawfulforanemploymentagency,labororganization,ortrainingprogramtofailorrefusetoreferanindividualforemploymentonthebasisofgeneticinformation,normaytheagencyorlabororganizationattempttocauseanemployertodiscriminateagainstanindividualonthebasisofgeneticinformation.

Whenmayanemployerrequestoruseanemployee’sgeneticinformation?

Whentheinformationisinadvertentlyprovidedaspartoftheindividual’smedicalhistoryorthemedicalhistoryofafamilymember;

Whentheinformationispubliclyavailable(althoughnotwhentheinformationiscontainedinmedicaldatabasesorcourtrecords);

Whentheemployerhasobtainedtheindividual’swrittenauthorizationaspartofan

employer‐sponsoredgeneticmonitoringprogramofthebiologicaleffectsoftoxicsubstancesintheworkplace,orifstateorfederallawrequiresthegeneticmonitoringprogram.Ineithercase,onlythehealthcareprofessionalandtheemployeecanknowoftheindividualandidentifiablegeneticinformation,andtheemployeemustbeinformedofindividualmonitoringresults.Theemployercanonlyhaveaccesstothecollectivegeneticinformationoftheentiregroupofemployees,withoutidentifyinginformation.

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Whentheemployeroffershealthorgeneticservices,includingservicesofferedaspartofawellnessprogram,andwiththeindividual’swrittenauthorization.Insuchcases,onlythehealthcareprofessionalorboardcertifiedgeneticcounselorinvolvedinprovidingtheservicesmayknowofindividuallyidentifiablegeneticinformation.Again,theemployermayknowonlyofthecollectivegeneticinformationoftheentiregroupofemployees,withoutidentifyinginformation;and

Wheretheemployeroperatesasalawenforcemententityandrequirestheindividual’s

DNAforqualitycontrolpurposesintheforensiclaborhumanremainsidentificationsettings.Theinformationmaynotbeusedforanydeterminationsofthetermsofemployment.

Whateffortsmustemployersmaketoensurethegeneticinformationofemployeesiskeptconfidential?Anygeneticinformationanemployerpossessesaboutanindividualmustbetreatedastheconfidentialmedicalrecordoftheindividualandmustbemaintainedinseparateformsandinseparatefiles.Anindividual’sgeneticinformationmaynotbedisclosedexceptattheindividual’swrittenrequestorinresponsetoacourtorder.Furthermore,inordertomaintaincompliancewithexistinglaws,anemployermayalsoprovidetheindividual’sgeneticinformationtotheFederal,State,orlocalauthorities.TheprovisionsofGINAhaveimpactsatvariouslevelsoftheemploymentsector,especiallyinthehumanresourcesdivision.BusinessesandorganizationsneedtopreparefortheimpactofGINAontheirhumanresourcepractices.

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ForCliniciansandHealthcareProvidersGINAdoesnotrestrictgeneticservices,thepracticeofmedicine,ortheauthorityofhealthcareprofessionals,whetherornottheymaybeaffiliatedwithahealthplanissueroranemployer.Cliniciansandhealthcareproviderscanrequestthatanindividualoranindividual’sfamilymemberundergoesagenetictestforthepurposesofthatindividual’smedicalbenefit.

ForResearchersTheresearchcommunitywillbenefitfromincreasedenrollmentinclinicaltrialsandresearchactivitiesduetotheprotectionsagainstgeneticdiscriminationasaffordedbyGINA.Intheinformedconsentprocess,whendiscussingthepotentialrisksassociatedwithaparticularresearchactivityorstudy,researchersshouldpreparetoincludeinformationaboutGINAorresourcesforparticipantstoaccesstoobtainadditionalinformationaboutGINAonceGINAbecomesfullyactive.Thehealthinsuranceprovisionsofthebillwilltakeeffect12monthsafterthedateofsigning,onMay21,2009.Theprotectionsinemploymentwilltakeeffect18monthsafterthedateofsigning,onNovember21,2009.AtthispointGINAwillbeconsideredfullyactive.

ForStatesTheGeneticInformationNondiscriminationAct(GINA)providesabaselineforprotectionagainstgeneticdiscriminationforallAmericans.However,GINAdoesnotpreemptastateanti‐discriminationlawthatprovidesmoreextensiveprotectionsthanGINA,eitherinhealthinsuranceoremployment.Todeterminecompliancewithbothstateandfederallaw,stateswillneedtocompareGINAtothecurrentstatelawsinplaceandbesuretocomplywiththehighestlevelofprotectionprovidedbythelegislation.

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ImportantGINADefinitionsandExamplesGeneticinformation: informationaboutanindividual’sgenetictestsorthegenetictestsoftheindividual’sfamilymembers,andthemanifestationofadiseaseordisorderintheindividual’sfamilymembers.Furthermore,geneticinformationalsoincludestherequestorreceiptofgeneticservicesorparticipationinclinicalresearchthatincludesgeneticservices,forboththeindividualandtheindividual’sfamilymembers.Informationregardinganindividual’ssexorageisNOTprotectedgeneticinformationunderGINA.Genetictest:theanalysisofhumanDNA,RNA,chromosomes,proteins,ormetabolitesthatdetectsgenotypes,mutations,orchromosomalchanges.UnderGINA,agenetictestdoesnotincludetheanalysisofproteinsormetabolitesdirectlyrelatedtothemanifestationofadiseasethatcouldreasonablybedetectedbyahealthcareprofessionalwithappropriatetrainingandexpertiseinthefieldofmedicineinvolved.ExamplesoftestscoveredbyGINA:testsforBRCA1/BRCA2(breastcancer)orHNPCC(coloncancer)mutations;testsforHuntington’sdiseasemutations,carrierscreeningfordisorderssuchascysticfibrosisandfragileXsyndrome,andclassificationsofgeneticpropertiesofanexistingtumortohelpdeterminetherapy.ExamplesoftestsNOTcoveredbyGINA:routinetestssuchasroutinebloodcounts,cholesteroltests,andliver‐functiontests.1Geneticservices:agenetictest,geneticcounseling,geneticeducation,orparticipationinaresearchstudy.Familymember:adependentoranyotherindividualwhoisafirst,second,third,orfourthdegreerelative.Geneticmonitoring: theperiodicexaminationofemployeestoevaluateacquiredmodificationstotheirgeneticmaterials,suchaschromosomaldamageorevidenceofincreasedoccurrenceofmutations,thatmayhavedevelopedinthecourseofemploymentduetoexposuretotoxicsubstancesintheworkplace,inordertoidentify,evaluate,andrespondtoptheeffectsorcontroladverseenvironmentalexposuresintheworkplace.

1 Hudson,KathyL.,Ph.D.,M.K.Holohan,J.D.,andFrancisS.Collins,M.D.,Ph.D.“KeepingPacewiththeTimes—TheGeneticInformationNondiscriminationActof2008.”NewEnglandJournalofMedicine.358.25(2008):2661‐2663.

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AdditionalResourcesCoalitionforGeneticFairnesswww.geneticfairness.orgTheCoalitionforGeneticFairness(CGF)wasfoundedin1997toaddressthegrowingconcernsurroundingthemisuseofgeneticinformationininsuranceandemploymentdecisions.TheCoalition’sobjectivewastourgeCongresstopasscomprehensivefederallegislationoutlawinggeneticdiscriminationandtoeducatethepublicabouttheseprotections.Initially,theCoalitionconsistedofcivilrights,patientandhealthcareorganizations,butwasexpandedin2005toincludeindustrygroupsandemployers.WithGINA’spassage,theCoalitionforGeneticFairnesswilleducatethepublicandraiseawarenessofthelegislation,whatitmeans,andhowitwillimpactnotonlyhealthinsuranceandemployment,buthealthcaredelivery,research,andemergingtechnologies.TheCoalitionwillencouragedialogueandcreatethespacetoshareintheexcitementforthefuture,voiceconcerns,andseeksolutionstothoseconcerns.GeneticsandPublicPolicyCenterwww.dnapolicy.orgThetremendoussuccessoftheHumanGenomeProjecthaslaidthefoundationforatruerevolutioninpublichealth,promisingimproveddiagnosis,moreeffectivemedicines,andindividuallytailoredhealthcare.TheGeneticsandPublicPolicyCenterwascreatedin2002atJohnsHopkinsUniversitybyPewCharitableTruststohelppolicymakers,thepress,andthepublicunderstandandrespondtothechallengesandopportunitiesofgeneticmedicineanditspotentialtotransformglobalpublichealth.NationalHumanGenomeResearchInstitute(NHGRI),NationalInstitutesofHealthwww.genome.govTheNationalHumanGenomeResearchInstitute(NHGRI)ledtheNationalInstitutesofHealth's(NIH)contributiontotheInternationalHumanGenomeProject,whichhadasitsprimarygoalthesequencingofthehumangenome.ThisprojectwassuccessfullycompletedinApril2003.Now,theNHGRI'smissionhasexpandedtoencompassabroadrangeofstudiesaimedatunderstandingthestructureandfunctionofthehumangenomeanditsroleinhealthanddisease.TothatendNHGRIsupportsthedevelopmentofresourcesandtechnologythatwillaccelerategenomeresearchanditsapplicationtohumanhealth.AcriticalpartoftheNHGRImissioncontinuestobethestudyoftheethical,legalandsocialimplications(ELSI)ofgenomeresearch.NHGRIalsosupportsthetrainingofinvestigatorsandthedisseminationofgenomeinformationtothepublicandtohealthprofessionals.

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U.S.EqualEmploymentOpportunityCommissionwww.eeoc.govThefive‐memberCommissionmakesequalemploymentopportunitypolicyandapprovesmostlitigation.TheGeneralCounselisresponsibleforconductingEEOCenforcementlitigationunderTitleVIIoftheCivilRightsActof1964(TitleVII),theEqualPayAct(EPA),theAgeDiscriminationinEmploymentAct(ADEA),andtheAmericanswithDisabilitiesAct(ADA).U.S.DepartmentofHealthandHumanServices(HHS),OfficeforCivilRights(OCR)www.hhs.gov/ocrTheDepartmentofHealthandHumanServices(HHS),throughtheOfficeforCivilRights(OCR),promotesandensuresthatpeoplehaveequalaccesstoandopportunitytoparticipateinandreceiveservicesfromallHHSprogramswithoutfacingunlawfuldiscrimination,andthattheprivacyoftheirhealthinformationisprotectedwhileensuringaccesstocare.Throughpreventionandeliminationofunlawfuldiscriminationandbyprotectingtheprivacyofindividuallyidentifiablehealthinformation,OCRhelpsHHScarryoutitsoverallmissionofimprovingthehealthandwellbeingofallpeopleaffectedbyitsmanyprograms.

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WewouldliketoacknowledgethemembersoftheCoalitionforGeneticFairnessfortheircontributionstothisresource,aswellastheentiregeneticscommunity—healthcareprofessionals,disease‐specificorganizations,researchers,industrypartners,andindividuals,families,andcommunitiesaffectedbygeneticconditions.WeworkedasoneforGINA’spassage,andnoweveryindividualinthenationwillbenefitfromitsprotections.Thenextstep:InordertorealizeGINA’spotential,wemustnotstopatthelegislation’spassage.WemusteducateeachotherandraiseawarenessofGINA,whatitmeans,andhowitwillimpactnotonlyhealthinsuranceandemployment,buthealthcaredelivery,research,andemergingtechnologies.Wemustencouragedialogue,shareintheexcitementforthefuture,voiceconcerns,andseeksolutionstothoseconcerns.TheCoalitionforGeneticFairnesswillconvenethespaceforthisdialogue—spacethatisopenandwhereallperspectivesarerepresented.Throughthis,wewillinformtheregulatoryprocess,addresstheneedsofthecommunity,andcreateanddisseminateavarietyofeducationalmaterialsandresources.WouldyouoryourorganizationliketobecomeinvolvedintheCoalition’sinitiatives,butarenotyetamember?Visithttp://www.geneticfairness.orgorcontactAndriaCornellatacornell@geneticalliance.orgformoreinformationandtolearnhowyoucanensurethevalueofGINAisrealized!