FinalRule:RequirementsforParticipation
MegaRule
OnOctober4,2016CMSreleasedthefinalrevisedrequirementsforparticipation,aka,
theMegaRule.ThisisasummaryofrelevantpointsfromASCP’scommentsin
comparisontotheFinalRule.Implementationphases:
• Phase1:November28,2016
• Phase2:November28,2017
• Phase3:November28,2019
§483.5Definitions:CMShasaddedsome
definitionsinthefinalrule.Implementation
phase1.
ASCPrecommendedthatPharmacistsbe
addedtothedefinitionofLicensedHealth
Professional(§483.5).Additionally,ASCP
recommendsaphasedinimplementationof
theprovisionsinthisproposedruleto
improveelectronicsystemsconsistentwith
theOfficeoftheNationalCoordinatorfor
HealthInformationTechnology(ONC)
interoperabilityroadmap.
FinalRule:Alicensedhealthprofessionalisaphysician;physicianassistant;nurse
practitioner;physical,speech,oroccupationaltherapist;physicaloroccupationaltherapy
assistant;registeredprofessionalnurse;licensedpracticalnurse;orlicensedorcertifiedsocial
worker;orregisteredrespiratorytherapistorcertifiedrespiratorytherapytechnician.
Note:Thedefinitiondoesnotincludepharmacists.CMSexplainsthatthetermisdefinedin
statuteatsection1819(b)(5)(G)oftheSocialSecurityActandtheagencydoesn’thave
authoritytore-definetheterm.
§483.21ComprehensivePerson-Centered
CarePlanning-NewSection
ASCPrecommended72hoursforcareplan.
Includeconsultantanddispensing
pharmacist.Andpharmacistnotificationupon
admission.
ASCPrecommendedtheconsultant
pharmacistisincludedincareplan
development.ACPcompletesaCMRduring
keytransitionsofcare.
FinalRule:
• Facilities must develop and implement a baseline care plan for each resident, within 48
hoursoftheiradmission,whichincludestheinstructionsneededtoprovideeffectiveand
person-centeredcarethatmeetsprofessionalstandardsofqualitycare.
§483.21(c)(2)(iii),(iv)Medication
ASCPrecommendedinteroperabtily,
Reconciliationupondischarge:
includinginter-professionalcollaboration,
ImplementationPhase1withthefollowing
pharmacistsbeingabletoorderandinclude
exceptions:
pharmacistsrecommendationsaspartofthe
medicalrecord
• Baselinecareplan—Implementedin
Phase2.
FinalRule:Physicianshavetoreportonpharmacistrecommendations,includingrationalefor
their decision to either follow, or reject the pharmacist recommendations. Medication
reconciliationisrequiredtobeapartofthedischargesummary.
§483.45.PharmacyServices:DRR.
ImplementationPhase1
ASCPsupportedCMS’proposedprovisions
forpharmacyservices.Whiletheexpectation
isthatconsultantpharmacists’monthly
reviewincludesareviewofthemedical
record,ASCPbelievesitisappropriatethatin
additiontocurrentmonthlyMRRs,CMS
requireadditionalreviewsofthemedical
recordwhenspecificcircumstancesdictate.
ASCPalsobelievesthattheconsultant
pharmacistmusthavefullaccesstothe
completemedicalrecordinordertoproperly
completethesereviews.
FinalRule:requiresapharmacisttoperformadrugregimenreview(DRR)foreachresidentat
leastonceamonth.Inadditiontotheattendingphysiciananddirectorofnursing,who
alreadyreceivetheDRR,CMSisrequiringthefacility’smedicaldirectortogetacopyofthe
DRR.Finally,facilitiesarerequiredtodeveloppoliciesandproceduresconcerningtheDRR
includingtimeframes,pharmacistprocedures,andnotificationprocedures.
§483.45(d)UnnecessaryDrugs:
ASCPsupportedF329thatdefined
ImplementationPhase1
unnecessarymediationas“inexcessivedose
(includingduplicativetherapy);or,for
excessiveduration,withoutadequate
monitoring;or,withoutadequateindications
foruse;or,inthepresenceofadverse
consequenceswhichindicatethedoseshould
bereducedordiscontinued.”Wesupported
expandingthistoincludemedicationsgiven
withoutmedicalnecessity.
FinalRule:UnnecessaryDrugs-Aresident’sdrugregimenmustbefreeofunnecessarydrugs.
Anunnecessarydrugisanydrugwhenusedin:
• Excessivedose(includingaduplicatedrug)
• Excessiveduration
• Withoutadequatemonitoring
• Withoutadequateindicationforitsuse
• Inthepresenceofadverseconsequenceswhichindicatethedoseshouldbereducedor
discontinued,or
• Anycombinationoftheabove.
483.45(e)PsychotropicDrugs:
ASCPExpressedconcernthatthedefinition
ImplementationPhase2(date)
wastoobroadandcouldimpede
administrationofopioidanagesic
medicationsandanymedicaitonthatcould
causedizziness,sleepiness,orchangesin
behavior.Further,wehighlightedclinical
issueswithbroadGRDrequirements.GDR
shouldapplyonlywhenitisinthebest
interestofthepatient.ASCPsuggestedCMS
consideralongerperiodoftimeforPRN,
suchas7days,sothatmedicationsarenot
stoppedtoosoon.
FinalRule:Psychotropicdrugs-
• Wearerevisingexistingrequirementsregarding“antipsychotic”drugstoreferto
“psychotropic”drugsanddefine“psychotropicdrug”asanydrugthataffectsbrain
activitiesassociatedwithmentalprocessesandbehavior.Wearerequiringseveral
provisionsintendedtoreduceoreliminatetheneedforpsychotropicdrugs,ifnot
clinicallycontraindicated,tosafeguardtheresident’shealth.Opioidanalgesicare
excludedfromthedefinition.Basedonacomprehensiveassessmentofaresident,the
facilitymustensurethat
• Residentswhohavenotusedpsychotropicdrugsarenotgiventhesedrugsunlessthe
medicationisnecessarytotreataspecificconditionasdiagnosedanddocumentedinthe
clinicalrecord;
• Residentswhoreceivethesedrugsmustreceivegradualdosereductionsandbehavioral
interventions,unlessotherwisecontraindicated,inanefforttodiscontinuethesedrugs
• ResidentsarenottoreceivePRNordersforpsychotropicdrugsunlessthedrugisintended
totreataconditionthatisdocumentedintheclinicalrecord.
• PRNordersarelimitedto14days,unlesstheprescriberbelievesitisappropriateto
extendtheorderbeyond14daysanddocumentsthisintheclinicalrecord.
• PRNorderscannotberenewedbeyond14daysunlesstheprescriberhasevaluatedthe
residentfortheappropriatenessofthemedication.
• IftheprescriberbelievestheresidentrequiresanantipsychoticdrugonaPRNbasisfor
longerthan14days,he/shewillberequiredtowriteanewPRNscriptevery14daysafter
theresidenthasbeenevaluated.(detailsinsubregulatoryguidance)
483.80:InfectionControl:Implementation
ASCPRecommendedthatCMSmustgive
Phase1withthefollowingexceptions:
clearerguidanceontheexpected
qualificationsoftheIPCOinordertomake
• AslinkedtoFacilityAssessmentat
thispositionabeneficialadditiontothe
§483.70(e)—ImplementedinPhase2.
clinicalstaffataskillednursingfacility.
• (a)(3)Antibioticstewardship—
Additionally,ASCPrecommendsthatCMS
ImplementedinPhase2.
recognizetheconsultantpharmacistasan
• (b)Infectionpreventions(IP)—
idealcandidateforthisposition.
ImplementedinPhase3.
• (c)IPparticipationonQAAcommittee—
ImplementedinPhase3.
CMSisrequiringfacilitiestodevelopanInfectionPreventionandControlProgram(IPCP)that
includesanAntibioticStewardshipProgramanddesignateatleastoneInfectionPreventionist
(IP).
AdditionalHighlights:
• ExpandedrequiredelementsoffacilityInfectionPrevention&ControlProgram(IPCP).
• AnnualreviewoffacilityIPCPandupdateprogramasnecessary.
• SpecificqualificationrequirementsforInfectionPreventionist.
• InfectionPreventionistmustbememberofQAAcommitteeandreportonIPCPona
regularbasis.
• Incorporateslanguagechangefromresident’slegalrepresentativetoresident’s
representative.