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formularies usually only have two copays: one for generic drugs and one for brand drugs. Tiered
formularieshavemorethantwocopays,andeachtierisassociatedwithadifferentcopayamount.
Mostcopaysaresettocoveruptoa1-monthsupplyofmedication(28–31daysoftherapy,depending
on the health plan). Thus, a patient who received a prescription for a 7-day course of therapy of
prednisoneforanacuteallergicreactionwouldlikelyhavethesamecopaymentasapatientwhoreceived
aprescriptionfora30-daycourseoftherapyofprednisoneforchronicuse.
Some plans may allow patients who are receiving a stable dose of a maintenance medication
(medicationsusedforchronicconditions)toreceivemorethan1monthofmedicationatatime.Forthese
maintenance medications, manyhealth plans allow patients to receive a 90-day supply of medication.
Healthplansusuallychargepatientsthreecopaysfora90-daysupply(three1-monthsupplycopays).For
example,ifa patient paid a $10 copayfor a1-monthsupply,thenthe 90-daysupplywould cost $30.
Health plans can offer reduced copayments as an enticement for patients to order their maintenance
medications from a mail-order pharmacy service; a 90-day supply of medication might only cost the
patienttheequivalentoftwocopaymentsinsteadofthree.
Intherigidformularysystemsutilizedinthe1990s,atwo-tieredprescriptioncopaymentsystemwas
usedbymosthealthplansandpharmacybenefitsmanagers(PBM);thelowercopaymenttierwasusedfor
genericmedications,whereasthehighercopaymenttierwasusedforformularybrand-namemedications.
Nonformulary medications were rarely covered by health plans or PBMs without prior approval; if
granted,theprescriptionwouldfall intothehighercopaymenttier.Nonformularymedicationsthatwere
not approved by the health plan were not covered; either patients paid the full retail price for the
prescription out of their own pocket or the prescription was switched to a formulary agent by the
prescriber.
Fueledbyunsustainableprescriptioncostincreases,MCOsabandonedthetwo-tieredformularysystem
infavor of higher-tiered formularydesigns, rangingfrom three-tiered systems upto themore recently
adoptedfour-orhigher-tieredsystems.Withinthree-tieredformularysystems,thefirsttwotiersaresetup
thesameas theprevioustwo-tieredsystem,withthefirst(lowest)tiercopaymentreservedforgeneric
productsandthesecond-tiercopaymentreservedforpreferredbrand-nameproducts.Agentsinthethird
tierarethenonpreferredbrand-nameproducts;thecopaymentissubstantiallyhigherthanthesecond-tier
copayment.Plansareincreasinglyaddingfourthorfifthtierstotheirformulary,whichincludehigh-cost
specialty medications (with the highest prescription copayments). Among employer-sponsored
prescriptiondrugbenefitplans,39%operateformularieswiththreecopaymenttiersand45%havefour
or more copayment tiers (Kaiser Family Foundation, 2019). Three- and four-tiered formularies have
introduced value considerations to patients: Do they value a specific third-tier or fourth-tier product
enoughtopaythehighercopaymentorwillafirst-tierorsecond-tierproduct(withalowercopayment)
besuitablefortheirneeds?Themultiple-tieredcopaymenthasbeenproventosuccessfullymovepatients
to products in the first and second tiers of the formulary without restricting access to prescription
products(Edlin,2015).
FunctionsofFormularies
Formularies have been used to promote the prescribing of safe, efficacious, and cost-effective
medications.Formularies’mainfunctionsare to promotetheuse ofless costlyandequallyefficacious
medications (which are most often generic medications). For brand-name medications, formularies
financiallyincentivizetheuseofpreferredbranddrugsovernonpreferredbranddrugsorplacebarriers
thatpreventnonpreferredbrandedmedicationsfrombeingcoveredbytheMCO.MCOsalsoimplement
policiesorprogramswiththeirformulariestopromoteappropriatedrugutilizationandtheuseofgeneric
drugsandpreferred branddrugspriortotheuse ofnonpreferred andnonformularydrugs.Examplesof
suchpoliciesorprogramsincludegenericsubstitution,therapeuticinterchange,priorauthorization,step
therapy, medical necessity, and dispensing limitations around quantity, duration of therapy, age and
gender.
GenericSubstitution
Ahighlyeffective methodofreducingthecostof thepharmacybenefitisgeneric substitution.Generic
substitutionistheprocessofdispensinganappropriategeneric equivalentofa prescribed brand-name
drug.Prescribinggenericproductscanreducethecostofprovidingprescriptionmedicationsforpatients;
generic-medicationuseresultedin10-yearsavingsofnearly$2trillionfrom2009to2018(Association
forAccessibleMedicines,2019).Genericsubstitutionhasbeensupportedbycostminimizationanalyses;
as thebrandandgeneric agentsare considered identicalincompositionandactivity, cost becomesthe
contributingfactorforanagent’sselection.
Agenericmedicationisconsideredequal,orbioequivalent,toitsparentbrand-namemedication,must
undergostringentsafetyandequivalencytesting,andcomplywithspecificcriteriaestablishedbytheU.S.
FoodandDrugAdministration(FDA).TheFDAhassetcertaintherapeuticequivalenceevaluationcodes
toshowtherelativebioequivalenceofgenericagentstotheircorrespondingbrand-namedrugs(Foodand
DrugAdministration,2018).Therearetwobasicratingcodes:AandB.The“A”ratingindicatesthatthe
drug is considered therapeutically equivalent to other pharmaceutically equivalent products. The “B”
ratingindicatesthattheagentisnottherapeuticallyequivalenttootherpharmaceuticallyequivalentagents.
BothA-andB-rateddrugsarefurtherdifferentiatedbasedondosageform.An“AB”ratingstatesthatthe
product’s bioequivalence problems have been resolved, and evidence exists supporting the
bioequivalencetopharmaceuticallyequivalentagents.
Anexampleofgenericsubstitutionisdispensingpregabalinwhentheprescriberwritestheprescription
forLyricaandtheprescriberhasnotindicatedthatthebrand-nameproductismedicallynecessary.Insuch
asituation,thepharmacistisfillingtheprescriptionwith anFDA-approved, bioequivalentformofthe
brand-namedrug.Someinsuranceplansmayallowthepatientorprescriber torequestthebrand-name
agent,butthisoftenresultsinahighercopaymentforthepatient(Navarroetal.,2009).Theincreasein
copaymentmaybeaslargeasthedifferenceincosttothehealthplanbetweenthebrandandthegeneric
agents.
To maximize generic substitution, plans may use restrictive strategies such as dispense as written
(DAW) blocks. A DAW code describes the rationale for the drug’s selection and is entered into the
prescriptionclaimbythepharmacistbeforeitistransmittedtothehealthplanforadjudication.Thereare
DAW codes for substitution permissible (DAW 0), dispense as written (DAW 1), patient requests
brand(DAW2),andotherchoicestoprovidearationaleforthechosenagent.Ahealthplancanrequire
that the patient receive an acceptable generic substitutionfor a brand-name productunless a suitable
DAWcodehasbeenentered.ADAWcodeof7isusedforproductswithanarrowtherapeuticindex.Due
totheriskofdisruptingthelevelofdruginthepatient’sblood,drugswithanarrowtherapeuticindexmay
nothavetobeautomaticallysubstitutedforanequivalentgeneric agent.ADAWcode of7informsthe
health plan that the physician, pharmacist, or patient has elected to continue use of the brand-name
product.Drugsinthiscategoryincludewarfarin(Coumadin)andlevothyroxine(Synthroid).
TherapeuticInterchange
Therapeutic interchange is defined as the procedure of dispensing prescribed medications that are
chemically different but deemed therapeutically similar to the medication prescribed (Holmes et al.,
2011). Ingeneral, therapeutic interchange involves thesubstitutionofdrugsthatare different chemical
compounds but are considered to exert the same therapeutic effect andhave similar toxicity and side
effect profiles (e.g., HMG-CoA reductase inhibitors: substitution of generic atorvastatin [Lipitor] for
Crestor).Theuseoftherapeuticinterchangehasincreasedsignificantlybecauseofalargeinfluxofnew
medications that do not offer any therapeutic advantages over existing therapies but are priced much
higher than theestablishedproducts. Thesemedicationsarecommonlyknownas me too drugs. Some
popular examples of therapeutic categories that contain me too drugs include proton pump inhibitors
(PPIs),HMG-CoAreductaseinhibitors(statins),angiotensinreceptorblockers,andbisphosphonates.
Pharmaceutical manufacturers offer rebates to health plans to compete for preferred status on
formularies, whichlowerstheprescriptionbenefitcost.Controversiestendtoarise whendiscountsare
used to exchange one drug over another when the drugs are in different classes. If a therapeutic
interchange involves two drugs of the same therapeutic class, it can be considered an example of
therapeuticminimizationbecausetheonlydifference betweenthetwoagentsiscost(assumingthatthe
relativesafety/efficacydataforthetwoagentsaresimilar).
Therapeuticinterchangeisusedforreasonsotherthancontrollingcosts,includingpromotingtheuseof
agentsassociatedwithfewerdrug–druginteractions(e.g.,substitutionoffluconazoleforketoconazole)or
ofagentswitha more convenient dosingschedule (e.g.,once-dailyenalaprilinsteadoftwo-to threetimesdailycaptopril). These interventionsmaypreventunnecessarydrug–druginteractions or enhance
medicationcompliance,whichcould,inturn,improvecareanddecreaseoverallhealthcarecosts.
In the outpatient pharmacy setting, therapeutic interchange must be verified and accepted by the
prescribingpractitioner.Intheinstitutionalsetting,therapeuticinterchangedoesnotnecessarilyrequirea
prescriber’s approval if the institution’s pharmacy and therapeutics (P&T) committee approves the
specific interchange protocol. The American Medical Association (AMA) endorses the practice of
therapeuticinterchangeinsettingsthathaveanorganizedmedicalstaffandafunctioningP&Tcommittee
(AmericanMedicalAssociation[AMA],1994).
Drug-DispensingLimitations
Limitations regarding dispensing drugs are developed and implemented to promote appropriate
prescribingofmedicationsandareoftenstructuredaroundFDA-approved labelingandevidence-based
medical data. Examples ofdruglimitationsincludedrugquantitylimits,durationoftherapylimits,age
limits, and gender limits. Drug quantity limitations are used to promote the appropriate quantity of
medicationthat should be prescribed. There are two main types of quantitylimits: quantityper filled
prescriptionandquantityperdays.Limitsonquantityperfilledprescriptionareimplementedfordrugs
thatareprescribedforshort-termuse,suchasanalgesicsandantibiotics.Anexampleofsuchaquantity
limitwouldbelimitingtheprescribingofaddictive,high-potencynarcoticanalgesicsindicatedforacute
pain to 10 tablets per prescription. Limits on quantity per days are utilized for chronically used
(maintenance)medications.Anexampleofthistypeofquantitylimitwouldbelimitingtheprescribingof
simvastatinto1tabletperday.Limitsondurationoftherapyareimplementedtomanagehowlongadrug
shouldbeused,especiallyformedicationsthatarenotconsideredmaintenancemedications.Anexample
ofasuchalimitwouldbea3-weekduration-of-therapylimitfortheprescribingofmusclerelaxants(e.g.,
cyclobenzaprine). Age limitations prevent the use of medications either above or below what is
recommendedbytheFDA.Anexampleofanagelimitwould be to preventthe useofbarbiturates in
membersgreaterthan65yearsofage.Genderlimitspreventtheuseofmedicationsfora genderwhen
prescribingwouldnotbesafeand/orappropriate;anexampleofthistypeoflimitswouldbeprevention
ofprescriptionsoforalcontraceptivesformales.
PriorAuthorizationandStepTherapyPrograms
Priorauthorizationreferstotheapprovalprocessthathealthplansmayrequireforcertainmedications
beforetheywillbecovered.Theprimarypurposeofapriorauthorizationprocessistocontroltheuseof
andpreventtheoveruse of nonformulary, hazardous, or inappropriately prescribed medications. More
recently,healthplanshavebeguntomovetowardincreasinglyopenformularieswiththreeandfourtiers
of copayments. Further, health plans are requiring prior authorizations for most nonformulary drugs,
expensive drugs, newly approved drugs, and drugs with less expensive alternatives (Navarro et al.,
2009).Ninety-fourpercentofemployers offeringhealthinsuranceusedpriorauthorizationprogramsin
2018 (TakedaPharmaceuticals,2018),and priorauthorizationsare used bya majorityofthestates in
theirMedicaidprograms(NationalConferenceofStateLegislatures,2018).
Thecriteriaforapprovalofeachdrugundergoingthepriorapprovalprocesswilldependonthedrug,
thepatient,the disease stateinvolved, andtheprescribingpractitioner. Someprior authorizationsmay
requirea diagnosis alongwithpertinentlaboratoryvalues,whereasothersmayrequire apatienttofail
therapywithcertaindrugsthatareindicatedtotreatthesamediseaseastherestrictedagent.Othercriteria
mayincludepatientdemographics,suchasageorgenderlimits,orprescriberlimits,whereonlyspecific
specialtytypes are allowedto prescribe for certainmedications (e.g.,only allowingdermatologiststo
prescribeisotretinoin).
Theusualchain ofeventsinvolvingprior authorization startswith a patientpresentinga pharmacist
with a prescription for a newly prescribed medication. The pharmacist, after submitting a claim and
havingitrejected,learnsthatthemedicationrequirespriorauthorization(oftenfromamessagesentwith
therejectedclaim). Thepharmacistor patientthencontacts theprescriber,tells theprescriberthatthe
medicationrequirespriorauthorization,andrequeststhattheprescribercontacttheMCOtoexplainwhy
thepatientrequiresthatmedication.EitherprescriberscandecidetocontacttheMCOandpursueprior
authorizationortheymaychoosenottopursuepriorauthorizationandselectanalternativeagent.MCOs
often accept prior authorization requests from practitioners by mail, fax, telephone, or Internet.
Completingthepriorauthorizationprocessmayresultinthedrug’sapprovalforuseinthatpatient,orthe
MCOmayagainrejecttheclaimandofferalistofalternativemedicationsthatarecoveredbytheplan.
If the prescriber knows that the drug requires prior authorization, the necessary paperwork can be
completed tohave thedrugapproved for the patient before the patiententers the pharmacy. Problems
arisewhenthepatientandprescriberareunawareofwhichagentsontheMCO’sformularyrequireprior
authorization.Thisconfusesmanypatients,possiblyleadingthemtothinkthattheprescriberorderedthe
wrongmedicationorthepharmacistmadeanerrorinfillingtheprescription(Bendix,2013).
Steptherapyprogramsareutilizationmanagementprogramsthatareaversionofpriorauthorization,in
whichtheypromotetheuseofonedrugbeforeanother(Navarroetal.,2009).Therearetwomaintypes
of step therapy programs: those driven by cost-effectiveness and those that promote more clinically
effective medications before less effective medications. The cost-effectiveness step therapy programs
promotetheuseofcost-effectivegenericmedicationbeforetheuseofanexpensivebrandedmedication.
They can be implemented using drugs within the same therapeutic class or different categories. An
exampleofa steptherapywithina therapeuticclass would be torequire the useofa genericatypical
antipsychotic,suchasaripiprazolefortheadjunctivetreatmentofmajordepressivedisorder,beforethe
approvalofabrandedatypicalantipsychoticlikeRexulti.Anexampleofasteptherapyusingdifferent
categories would be to require the use of metformin before the approval of dipeptidyl peptidase-4
(DPP4)inhibitorslikesitagliptinandsaxagliptin.Steptherapyprogramsimplementedforthepurposeof
promotingclinicaleffectivenessareusuallybasedonpracticeguidelinesorevidence-basedmedicaldata.
Anexampleofthistypeofprogramwouldbetorequiretheuseofnasalcorticosteroidsornon-sedating
antihistaminesbeforetheapprovalofleukotrieneinhibitorsforthetreatmentofallergicrhinitis.
MCOshaveincreasedtheireffortstoprospectivelyreviewprescriptionsrequiringpriorauthorization
duringtheclaimadjudicationprocess.Whenapharmacysendsaclaimforapriorauthorizationdrugto
thePBMforadjudication,thePBMcanreviewthepatient’sprescriptionclaimhistoryandtheclaimitself
to determine if the prior authorization criteria have been met. This step can decrease the number of
rejectedprescriptionclaimsandminimizethetimeandeffortsofprescribers,pharmacists,andpatientsin
obtainingpriorauthorizations.Wheninitiatedeffectivelybyinformingpractitionersofthedrug’sstatus
andthepreapprovalprocess, priorauthorizationcanbecomeaveryefficientmechanismforcontrolling
costsanddruguse.
MedicalNecessity
SomeMCOsusethetermmedicalnecessityinterchangeablywithpriorauthorization.Inmostsettings,a
medicationlistedasa medicalnecessityisa nonformularydrugthatisoftenextremelyexpensive and
usually has less expensive generic alternatives and/or less expensive brand name alternatives, or is
considered a relatively unsafe medication compared to available alternatives (Navarro et al., 2009).
Some MCOs make medical necessity drugs available only after failure of drug therapy with a drug
requiringpriorauthorization.MCOscarefullyevaluatedrugsbeforeclassifyingthemasmedicalnecessity
drugs, knowingthat the drugs will be restricted if theyare covered. Likethe criteria for medications
requiringpriorauthorization,thecriteriaforcoveragevaryfromdrugtodrug.
PHARMACYANDTHERAPEUTICSCOMMITTEE
StructureandFunction
AP&Tcommitteeisagroupthatmeetsperiodicallytoreviewandrevisetheorganization’sformulary.
Thecommitteeiscomposedprimarilyofphysiciansandpharmacistsandmayalsoincludenurses,nurse
practitioners, physicians’ assistants, patient care advocates, and members of the organization’s
administration.Thephysiciansonthecommitteeoftencompriseadiversegroupfromvariousfieldsof
practice,withgeneralpractitionersandmultiplespecialistsrepresented.Thecommitteeshouldbeawellbalancedmixofpractitionerswhocanviewhealthcarepoliciesfromdifferentperspectivesandprovide
soundrecommendations.
FormularyManagement
The main responsibilities of a P&T committee are to develop and revise the formulary, create and
implementmedicationusepolicies,andprovideeducationforpractitioners.Formularyreviewsinclude
evaluating new medications for formulary consideration, periodic drug class reviews, and utilization
analyses.AmajorgoaloftheP&Tcommitteeistoprovidecost-effective,clinicallysafe,andeffective
therapy. Frequentformularyrevisionsareneededforseveral reasons:theintroductionofnew products
intothemarketplace,modificationstoaproduct’slabelingtoincludenewtreatmentindications,emerging
research indicating a previously unknown benefit or risk of therapy, changes in consensus disease
treatmentguidelines,andchangesinthebrand/genericstatusofaproductorotherpricingconcerns.
Theinclusionandexclusionofagentsareatime-intensiveprocessforP&Tcommittees.Assuch,many
P&Tcommittees elect to delay their consideration of a new product until it has a sufficient bodyof
evidencetoperformareviewand/orithasbeenonthemarketforasufficientlengthoftime(e.g.,1year),
which provides an opportunity for any adverse events undetected in clinical trials to be noted. P&T
committeesmayconsiderawidevarietyofinformationwhenevaluatinganewproduct,includingpeerreviewedclinicaltrials,adverseevent/safetydata,patient-orientedhealthoutcomes(e.g.,theabilityofan
antihypertensive to reducetheriskofmyocardialinfarctions,notmerelyto lower blood pressure),the
FDA-approvedproductlabelingforthenewagent,quality-of-liferesearch,andpharmacoeconomicdata
(Box8.1). Thecommitteemustconsider theissueof biaswhenevaluatingresultsofclinical or health
outcomes research, data analyses, or pharmacoeconomic modeling sponsored by the pharmaceutical
manufacturer.Publicationsthatincludedatacomparingthenewagentwithanagentcurrentlyusedtotreat
thesamedisorderareprizedbyP&Tcommitteesfortheirutilityincomparingonedrugwithanother.If
thenewagentoffers a clinical, safety,or economicadvantageover existingformularyagents,theP&T
committeemayplacetheagentontheformularyandcandoso byaddingthenewproduct;thismaybe
accompaniedbyremovingor notremovinganexistingproductorproductsfromtheformulary. Further,
committees can add the drug to the formulary unconditionally or may recommend implementation of
certainrestrictions onthecoverage(priorauthorization,quantity limitations,step therapy)of thenew
agenttoallowitsinclusionintheformulary.
Box8.1 InformationConsideredbyaPharmacyandTherapeuticsCommitteeWhen
ReviewingaProductfortheFormulary
1.FDA-approvedindications
2.Pharmacology/mechanismofaction
3.Pharmacokinetic/pharmacodynamicdata
4.Dosingandadministration,includingspecialmonitoringordrugadministrationrequirements
5.Adverseeffectprofile,warnings,precautions,contraindications,andblackboxwarnings
6.Druginteractions(withotherdrugs,foods,ormedicalconditions)
7. Clinical evidence: clinical trials, health outcomes research, retrospective database analyses,
quality-of-liferesearch
8.Risksversusbenefitsregardingclinicalefficacyandsafetyofaparticulardrugrelativetoother
drugswiththesameindication
9.Pharmacoeconomicdataandmodeling
10.Off-labelusesandutilizationratesforoff-labeluses
11.Costcomparisonsagainstotherdrugsavailabletotreatthesamemedicalcondition(s)
12.Sourceofsupplyandreliabilityofmanufactureranddistributor
Because of the increase in prescription drug spending by health plans, cost now plays a more
significantrole in theformulary decision-makingprocess andformularytier placement, althoughmany
organizations claim that cost is considered only after safety and efficacy data have been evaluated.
Pharmacoeconomicmodelingallowsanorganizationtoestimatetheimpactofaformularychangeonboth
the health outcomes experienced by their members and the total prescription drug and health care
spending.Toimprovethelikelihoodofa drug’sadditiontoa formulary,pharmaceutical manufacturers
mayofferprescriptionvolume-dependentrebatestoMCOsasincentives.
DevelopmentofDiseaseManagementProgramsandTreatmentProtocols
Another responsibilityofa P&Tcommitteeistodeveloporapprove diseasemanagementprogramsor
treatmentprotocolsfortheorganization.Theseprogramsandprotocolsprovideusefulrecommendations
forpractitionerstreatingvariousdiseases.Theymaybebasedoncurrentconsensuspracticeguidelines,
ortheymaybedevelopedbytheP&Tcommitteeusingcurrentclinicaldata.Amainpurposeofguidelines
oralgorithms istominimizetreatmentvariationsandimprovepatientoutcomeswhile minimizingcosts
(Navarroetal.,2009).
ENSURINGFORMULARYANDPRACTICEGUIDELINECOMPLIANCE
Oneoftheprimaryreasons thatMCOsdevelopformularies andpracticeguidelines is to minimize the
cost of the prescription drug benefit. Unfortunately, merely printing and distributing formularies and
algorithmsoftenarenotenoughtoalterprescribingpractices.Patientsandpharmacistsmayalsobewary
oftheformularysystem,failingtounderstandbothitsnecessityanditsutility.Whileeducationalprograms
(includingseminars, newsletters, provider peer-to-peercommunications, andone-on-onemeetings)are
useful,thesetoolsalonedonotensureimprovedformularycompliance.MCOshavedevelopedavariety
of payment and reimbursement strategies to improve formulary compliance. The following sections
describethewaysthatMCOsevaluateformularyandtreatmentguidelinecomplianceandhowtheyuse
differentlevelsofpaymentstoimprovecompliance.
PrescriberIncentivesforCompliance
MCOscanmonitorcompliancetotheformularyandtreatment protocols witha varietyof tools. Many
MCOsusethelevelofpeercompliancetodeterminetheamountofaprescriber’sorpractice’syear-end
incentives. Prescriberscanbe eligible forfinancial incentives if their compliance to the formularyor
treatmentprotocolsmeetsthethresholdestablishedbytheMCO(Navarroetal.,2009).
Some MCOs may tie a portion of a provider’s compensation to their level of compliance. If a
practitionerfailstofollowtreatmentprotocolscloselyandinexplicablyhighprescriptioncostsresult,an
MCOmaywithholdaportionoftheprovider’scompensation.Inacapitatedplan,theproviderreceivesa
fixed,predetermined,per-memberpaymentbytheMCOtoprovideservicesformembers,regardlessof
howmuchorhowfrequentlyamemberusestheservice.Providerscanreapfinancialrewardiftheycan
provideservicesatacostlowerthantheirlevelofpaymentbutareresponsibleforallcostsifexpenses
shouldriseabovetheirlevelofpayment.WhilecapitationremainsafrequentlyutilizedtoolbyMCOsto
managemedicalcostsandencouragesproviderstofocusonefficiencyandcostcontrol(Hodgin,2018),
few(ifany)healthplansutilizeacapitatedpharmacybenefit.
EvaluatingCompliance:PercentageFormularyCompliance
The simplest way for an MCO to evaluate formulary compliance is to determine the prescriber’s
percentageofprescriptionsforgenericandpreferredbrandedformularyproducts.Althoughthismethod
isusefulfordeterminingformularycompliance(e.g.,theuseofgenericandbrandedformularyangiotensin
receptorblockers[ARBs]comparedwithnonformulary-brandedARBs),itdoesnotevaluatethequality
ofprescribing;justbecauseaformularyagentisprescribeddoesnotmaketheprescriptionappropriate.It
maybemoreusefultodetermineiftheprescriberisfollowingconsensusdiseasetreatmentguidelines.A
prescriberwhoprescribesaformularyagentbutisnotfollowingtreatmentguidelinesmayhavethesame
percentageformularycomplianceasaprescriberwhousesadifferentandpotentiallylessexpensiveor
more appropriate formulary medication by following treatment guidelines. Also, prescribers who use
medicallynecessaryorappropriatenonformularydrugsarepenalizedinthissystem.ManyMCOshave
initiated programs to evaluate the quality of the prescriber by implementing practitioner profiling
programs,whereMCOcliniciansevaluatequestionableprescribingwiththeprovider.
Because of these limitations withpercentageformularycompliance,MCOsalso use another tool to
evaluatecompliance:per-member–per-month(PMPM)reports.
HealthCareTrendReporting
When analyzing health care trends for an MCO, many variables are reviewed and factored in to
evaluateandjustifythetrendsduringanyparticularyear.PMPMreportsareaunitofmeasurerelatedto
eachenrolleeforeachmonth.Whenusedtoevaluateprescribingpractices,averagePMPMprescription
costsaredeterminedforeachprovider.Theoretically,prescriberswhoadheretoformularyandpractice
guidelines will achieve lower PMPM prescription costs than their peers who do not. This is not a
foolproofmethodtoevaluatecompliancebecauseasmallnumberofpatientsrequiringexpensivetherapy
(e.g., chemotherapy, antipsychotics) can substantially increase a prescriber’s PMPM amount. More
frequently,MCOsusePMPMreportstoevaluateprescriptioncostsforaspecificdisease.Anexampleof
a disease-specific PMPM report appears in Table 8.2. Although prescriber A is responsible for the
highestdollarexpenditureonantihyperlipidemics,theirPMPMprescriptioncostisclosetotheaverage
oftheprescriber’s peers.Ontheotherhand,despiteprescriberC’slow overall dollarexpenditureon
lipidagents,theirPMPMprescriptioncostisthehighest.
TABLE8.2
Per-Member–Per-MonthPrescriptionCostsforPatientsReceivingAntihyperlipidemicTherapy
Prescriber NumberofMemberMonths LipidPrescriptionCosts($) PMPMPrescriptionCosts($)
A 561 67,622 120.54
B 240 26,462 110.26
C 285 36,759 128.98
D 496 53,464 107.79
E 357 43,568 122.04
F 489 56,978 116.52
Allprescribers 2,428 284,853 117.32
PMPM,per-member–per-month.
Anotherfactorthatis consideredinevaluatinghealthcaretrendsis drugcost.Monitoringtherateof
increase indrugcosthas become a significantfactorinoverall healthcarespending.Astheprices of
prescriptionmedicationsincrease,MCOsareadjustingtheiroverallplandesignstocompensateforthat
increase.Theseadjustmentsmayincludechangesinproductstatusondrugformularies,implementationof
priorauthorizationandsteptherapyprogramsforexpensiveproducts,increasesinmembercopayments,
orincreasesinmemberpremiums.
ImprovingFormularyCompliance
In addition to prescribers, MCOs have an opportunity to improve formulary and practice guideline
compliancebyprovidingfinancialincentivesordisincentivestotheprescriptiondispenser(pharmacist)
and the prescription recipient (patient). These financial incentives include bonuses, differential
reimbursementrates,anddifferentlevelsofprescriptioncopayment.
PharmacistReimbursement
AnMCOcaninfluencepharmacistsasasecondarystepinlimitingtheuseofnonformularymedications.
Asapartofthecontractingprocess,MCOsimposerequirementsonpharmaciesifthepharmacywishesto
servemembersoftheplan.MCOscanrequirethatpharmaciesdispensegenericproductswhenavailable,
unlesstheprescriberrequires theprescriptionto be DAWorthemedicationhas a narrowtherapeutic
index(e.g., phenytoin[Dilantin], warfarin). Many statesalready require automatic generic substitution
whenapplicable.Toreducewastedorunusedmedication,MCOsoftenimposealimitontheamountof
medicationthata communitypharmacistcandispense—usuallynomorethan30days’worthata time.
Onceapatientisstabilizedonamaintenancedoseformedicationsusedtotreatchronicillnesses(e.g.,
hypertension,diabetes),MCOsmayrequirethatpatientsreceivea3-monthsupplyofmedicationfroma
mail-orderpharmacy;thiscanbedoneatalowerexpensetotheMCO.
Pharmaciesthataresuccessfulinincreasingformularycomplianceorreducingmemberpharmacycosts
maybeeligibleforbonusesortheymayreceiveahigherreimbursementrate.Alternatively,pharmacies
thatfail tomeettherequirementsofthecontractmayreceivealower reimbursementrateorhavetheir
contract terminated altogether. MCOs frequently audit the claims of pharmacies with a higher-thanaveragenumberofDAWorderstoensurethattheprescriberdoesinfactrequirethatthebrand-namedrug
bedispensedtothepatient.
PatientPrescriptionCopayment
Theimpactofprescriptioncopaymentonpatientswasreviewedearlier inthis chapter.Insummary,as
formularies have progressivelybecome more open, health plans have responded by using differential
copayments with significant price differentials between tiers in an effort to encourage patients to use
lower-costgenericorpreferredbrandmedications.Patientswhoarehesitanttopayahighprescription
copayment whenlower-priced alternatives are availablefrequentlyasktheir provider toprescribethe
product with the lower copayment; the provider will often comply with the patient’s request if they
believethechangecanbemadewithoutadverselyaffectingtheexpectedoutcomesofcare.
ELECTRONICPRESCRIBINGANDELECTRONICHEALTHRECORDS
Beforetheintroductionofelectronicprescribing,practitionerswere facedwithavarietyofoptionsby
whichtheycouldprescribemedications:writtenordersonprescriptionpads,typedorderssentviafax,or
verbalorderscommunicatedthroughtelephonecalls.Theseprescribingoptionsleaveroomforerror,as
there is the potential for illegible handwriting, poorly scanned images, and inaudible messages.
Furthermore,theseoptionsarenotexemptfromtamperingorfraud,asindividualscanalterhandwritten
prescriptions,sendfalsifiedprescriptionsviafax,orcallinfakeprescriptionsoverthephone.Withthe
advent of electronic prescribing, practitioners were presented with an additional option that has the
potential to save time and money, as well as reduce medication errors and fraud. The SUPPORT for
Patients and Communities Act requires the use of electronic prescribing for all controlled substances
covered under Medicare Part D beginning January 1, 2021 (Uhrig, 2019). Due to the COVID-19
pandemic,acompliancedateofJanuary1,2022wassettoallowhealthcareprovidersadditionaltimeto
implementelectronicprescribingwithoutpenalty(CMA,2020).
Electronic prescribing, or e-prescribing, is the process wherebya prescriber orders and submitsa
prescription throughan application thatelectronically transmitstheprescription toa pharmacy inreal
time(CMS,2014).Avarietyofe-prescribingsoftwareprogramsexist,andthus,theremaybedifferences
infunctionalityamongthee-prescribingsoftwareprogramsavailabletoclinicians.Ideally,thesoftware
programsshould allow theprescribers to view a patient’scurrent medicationlist, medication history,
available pharmacy, and prescription insurance plan (Health Resources and Services Administration
[HRSA],2015).
E-prescribingsoftwarerequires auser (theprescriberoranauthorizedrepresentative)tologintoa
secure system and verify his or her identity using a username and password combination. After
authentication,theprescribercansearchforandselectapatientrecordwithinthee-prescribingsystem
usingpatient-specificinformation(i.e.,firstname,lastname,dateofbirth,etc.).Theprescribercanthen
choosetoreviewthepatient’srecordsandbegintoenterandeditaprescription
(HRSA,2015).
Afterenteringtheintendedprescriptioninformation,theprescribercansendtheordertothetransaction
hub,whichlinkstheprescriber toboththepharmacyandthePBM.Thisinteroperabilityallowsforthe
verificationofpatienteligibilityforprescriptioncoveragebysubmittingtheprescriptioninformationto
thePBMbeforethee-prescriptionarrivesatthepharmacy.Oncetheinformationhasbeensubmitted,the
PBMdeterminesifthedrugisacoveredbenefitforthemember.Theprescriberthenreceivesamessage
regarding the drug’s coverage status. If the drug is covered, the prescriber may choose to send the
prescriptiontothepharmacyforittobefilled.Ontheotherhand,ifthedrugisnotcovered,theprescriber
hastheoptionoforderingadifferentmedicationorcontactingthePBMforpriorauthorizationofthedrug
(HRSA,2015).
Theabilityofprescriberstodirectlytransmitprescriptionsfromtheofficetothepharmacyeliminates
theneed for the patient totakeit tothepharmacyto be filled. Since patients arenotrequired to take
electronicallytransmittedprescriptionstothepharmacy,thereareincreasedchancesthattheprescriptions
actuallyarriveatthepharmacy.
E-prescribinghasalsobeenshowntoreduceprescribingerrors.ResearchersatWeillCornellMedical
College found 37 errors for every 100 prescriptions writtenby handbutonly7 errors for every100
prescriptionsordered via e-prescribingsoftware (Kaushal etal.,2010). These benefits,alongwiththe
potentialfortimeandcostsavings,explaintherationale behindthemeaningfuluseincentivepayments
programofferedby theCenters forMedicare & MedicaidServices (CMS),whichbeganin2009 and
endedin2013(CMS,2019c).
E-prescribingrepresentsonlyonepartofagreaterchangetothehealthcaresystem:electronichealth
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