2016 Billing and Coding Guide for PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
TableofContents
1.  Introduc4on
2.  CodingQuickReferenceGuide
3.  CodingforProbuphine®(buprenorphine)injec4on
•  Na1onalDrugCodes(NDC)1
•  HealthcareCommonProcedureCodingSystem
(HCPCS)2
•  Interna1onalClassifica1onofDiseases,Clinical
Modifica1oncodes(ICD-10CM)3
•  CurrentProceduralTerminology(CPT®)code4
4.  SitesofService
•  Provideroffice,communitybasedprovider:CMS-1500
claimform5
•  Hospitaloutpa1entclinic:UB-04/CMS14506claim
form
5.BraeburnAccessProgram
•  Pa1entEnrollmentOrderForm
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Introduc4on
Thisguidecontainsgeneralcodingandbillinginforma4ontoconsider
relatedtoProbuphine(buprenorphine)implant.Thisguideisprovidedas
generalinforma4ononlyandisnotintendedascoverageorcoding
advice.Braeburncannotprovidespecificreimbursementrates,anddoes
notguaranteereimbursement.Youshouldalwaysverifytheappropriate
reimbursementinforma4onforservicesoritemsyouprovide.
Probuphine(buprenorphine)implantforsubdermaladministra4onCIII
INDICATIONSANDUSAGE
PROBUPHINEcontainsbuprenorphine,apar1alopioidagonist.Probuphineis
indicatedforthemaintenancetreatmentofopioiddependenceinpa1entswho
haveachievedandsustainedprolongedclinicalstabilityonlow-to-moderatedoses
ofatransmucosalbuprenorphine-containingproduct(i.e.,dosesofnomorethan8
mgperdayofSubutexorSuboxonesublingualtabletorgenericequivalent).
PROBUPHINEshouldbeusedaspartofacompletetreatmentprogramtoinclude
counselingandpsychosocialsupport.
PROBUPHINEisnotappropriatefornewentrantstotreatmentandpa1entswho
havenotachievedandsustainedprolongedclinicalstability,whilebeingmaintained
onbuprenorphine8mgperdayorlessofaSubutexorSuboxonesublingualtablet
orgenericequivalent.
PleaseseeImportantSafetyInforma4onincludingBOXED
WARNINGonpage15&16
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
CodingQuickGuide
Item
Code
HCPCS1Code
J3490
Unclassified Drugs
Hospital
Outpatient
HCPCS1 Code
C9399
Unclassified Drugs or Biologicals
CPT®2 Code
17999
Unlisted procedure, skin, mucous membrane and subcutaneous
F11.10
Opioid Abuse Uncomplicated
Potential
ICD-10-CM3
Codes
F11.20
Opioid Dependence Uncomplicated
F11.21
Opioid Dependence in Remission
11 Digit NDC4
58284-0100-14
Description
Each Probuphine System Kit contains: 4 Probuphine nonbiodegradable implantable rods (a subdermal implant containing
74.2 mg of buprenorphine which is the equivalent of 80 mg of
buprenorphine hydrochloride); and one Probuphine Applicator
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Na4onalDrugCodes:NDC
TheDrugLis1ngActof1972requiresregistereddrugestablishmentsto
providetheFoodandDrugAdministra1on(FDA)withacurrentlistofall
drugsmanufactured,prepared,propagated,compounded,orprocessedby
itforcommercialdistribu1on.(SeeSec1on510oftheFederalFood,Drug,
andCosme1cAct(Act)(21U.S.C.§360)).Drugproductsareiden1fiedand
reportedusingaunique,three-segmentnumber,calledtheNa1onalDrug
Code(NDC),whichservesasauniversalproductiden1fierfordrugs.FDA
publishesthelistedNDCnumbersandtheinforma1onsubmidedaspartof
thelis1nginforma1onintheNDCDirectorywhichisupdateddaily.
TheNDCforProbuphine®(buprenorphine)implantare:
NDCNumber
Number
11DigitNDC
58284-0100-14
Number
Descrip4on
EachProbuphineSystemKitcontains:4
Probuphinenon-biodegradableimplantable
rods(asubdermalimplantcontaining74.2mgof
buprenorphinewhichistheequivalentof80mg
ofbuprenorphinehydrochloride);andone
ProbuphineApplicator
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
HealthcareCommonProcedureCodingSystem(HCPCS)1Codes
TheHCPCSLevelIICodeSetisoneofthestandardcodesetsusedformedicalclaimsprocessingofoffice
administereddrugs.TheHCPCSisdividedintotwoprincipalsubsystems,referredtoaslevelIandlevelIIofthe
HCPCS.LevelIoftheHCPCSiscomprisedofCPT®(CurrentProceduralTerminology),anumericcodingsystem
maintainedbytheAmericanMedicalAssocia1on(AMA).TheCPT®isauniformcodingsystemconsis1ngof
descrip1vetermsandiden1fyingcodesthatareusedprimarilytoiden1fymedicalservicesandprocedures
furnishedbyphysiciansandotherhealthcareprofessionals.ThesehealthcareprofessionalsusetheCPT®to
iden1fyservicesandproceduresforwhichtheybillpublicorprivatehealthinsuranceprograms.Decisions
regardingtheaddi1on,dele1on,orrevisionofCPT®codesaremadebytheAMA.TheCPT®codesare
republishedandupdatedannuallybytheAMA.LevelIoftheHCPCS,theCPT®codes,doesnotincludecodes
neededtoseparatelyreportmedicalitemsorservicesthatareregularlybilledbysuppliersotherthanphysicians.
LevelIIoftheHCPCSisastandardizedcodingsystemthatisusedprimarilytoiden1fyproducts,supplies,and
servicesnotincludedintheCPT®codes,suchasambulanceservicesanddurablemedicalequipment,
prosthe1cs,ortho1cs,andsupplies(DMEPOS)whenusedoutsideaphysician'soffice.BecauseMedicareand
otherinsurerscoveravarietyofservices,supplies,andequipmentthatarenotiden1fiedbyCPT®codes,the
levelIIHCPCScodeswereestablishedforsubmiingclaimsfortheseitems.ThedevelopmentanduseoflevelII
oftheHCPCSbeganinthe1980's.LevelIIcodesarealsoreferredtoasalpha-numericcodesbecausetheyconsist
ofasinglealphabe1callederfollowedby4numericdigits,whileCPT®codesareiden1fiedusing5numeric
digits.
Poten4alLevelIIHCPCSCodesforbillingProbuphine®
HCPCSCode
J3490
C9399
Descrip4on
Use
UnclassifiedDrug
Mostpayersandsitesofservice
UnclassifiedDrugsor
Biologicals
Outpa1entClaimsbilledunder
MedicareusingtheHospital
Outpa1entProspec1veClaims
System
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Poten4alLevelICurrentProceduralTerminology(CPT®)Administra4on
CodesforbillingProbuphine®
Therearenocurrentadministra1oncodesthatdescribetheimplanta1on
orremovalofProbuphine®.Providersshouldconsultwiththeirlocal
carrierstoiden1fythemostappropriateadministra1oncodingprocedures
andrequireddocumenta1on.
CPT®Code
17999
unlistedprocedure,skin,mucousmembrane
andsubcutaneous
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Poten4alInterna4onalClassifica4onofDiseases,10thRevision,Clinical
Modifica4on(ICD-10-CM)6CodesforusewhenbillingaProbuphine®
claim.
TheInterna1onalClassifica1onofDiseases,TenthRevision,Clinical
Modifica1on(ICD-10-CM)isasystemusedbyphysiciansandother
healthcareproviderstoclassifyandcodealldiagnoses,symptoms
andproceduresrecordedinconjunc1onwithhospitalcareinthe
UnitedStates.
ICD-10-CMiscomposedofcodeswith3,4,5,6or7characters.
CodeswiththreecharactersareincludedinICD-10-CMasthe
headingofacategoryofcodesthatmaybefurthersubdividedby
theuseoffourth,fikh,sixthorseventhcharacterstoprovide
greaterspecificity.Athree-charactercodeistobeusedonlyifitis
notfurthersubdivided.Whilediagnosiscodingtothecorrectlevel
ofspecificityisthegoalforallclaims,for12monthsakerICD-10
implementa1on,ifavalidICD-10codefromtherightfamily(see
ques1on5)issubmided,Medicarefee-for-servicewillprocessand
notauditvalidICD-10codesunlesssuchcodesfallin.
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Poten4alICD-10-CMCodesforusewhenbillingaProbuphine®Claim
usemostspecificsub-codingpossible
Codedescrip4on
ICD-10-CMCode
F11
Opioidrelateddisorders
F11.1
Opioidabuse
F11.10
Opioidabuseuncomplicated
F11.2
Opioiddependence
F11.20
Opioiddependenceuncomplicated
F11.21
Opioiddependenceinremission
F11.24
Opioiddependencewithopioid-inducedmooddisorder
F11.25
Opioiddependencewithopioid-inducedpsycho1cdisorder
F11.29
Opioiddependencewithotheropioid-induceddisorderwithunspecifiedopioid-induceddisorder
F11.9
Opioiduse,unspecified
F11.90
Opioiduse,unspecifieduncomplicated
F11.99
Opioiduse,unspecifiedwithunspecifiedopioid-induceddisorder
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
2016 Physician Office Sample Claim Form: CMS-15005,6
Item 19 - When billing a not-otherwise-classified HCPCS code like
J3490, some payers may ask providers to specify Probuphine®
(subdermal buprenorphine implant) with dosage administered and
NDC 58284-0100-14, Kit
NOTE: Some payers require alternate product codes (i.e., Medicaid
claims). Please consult with your local payers or contact The
Braeburn Access Program at 1-844-859-6341 to confirm payer
specific coding requirements.
Item 21 - Indicate diagnosis/diagnoses using appropriate ICD-10CM codes, such as F11.10 (Opioid Abuse Uncomplicated), F11.20
(Opioid dependence, uncomplicated) or F11.21 (Opioid
Dependence in Remission).
Item 24D - lndicate appropriate CPT and HCPCS codes and
modifiers if required. Be sure to enter the unlisted CPT code 17999
(unlisted procedure, skin, mucous membrane and subcutaneous).
NOTE: Individual payers will require documentation to adjudicate
any claim billed with an unlisted CPT code. Please consult with
your local payer or Braeburn Access Program at 1-844-859-6341 to
confirm payer requirements. Additional information on the
procedure may be placed in Item 19.
Item 24E - Refer to the diagnosis for this service (see box 21).
Enter only one diagnosis pointer per line.
Item 24C- Enter 1 unit for the kit of 4 Probuphine subdermal
implants (296.8 mg of Buprenorphine or 320 mg Buprenorphine
HCL).
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Sample CMS-1500 claim form (physician office billing)
SAMPLE CMS-1500 CLAIM FORM
(PHYSICIAN OFFICE BILLING)
XXX-12345
x
Smith, Joe B
xx
123 State St
xx
Smith, Joe B
x
xx
Same
x
Hometown
XX
12345-6789
XXX
XXX-XXXX
123456
xx
x
xx
x
xx
x
x
x
ADDITIONAL
CLAIM
INFORMATION
(FIELD 19)
DIAGNOSIS
CODE
(FIELD 21)
ICD
INDICTOR
(FIELD 21)
PA
NUBER
(FIELD 23)
19
Probuphine ( buprenorphine) implant for subdermal administration, 58284-0100-14, 1 Kit
2
21
2
F11.10
1
2
24A
xx
xx
xx
xx
xx
xx
xx
xx
PRODUCT
CODE
ODUCT
INFORMATIO(FIELD 4A) (FIELD 24D)
24E
2
J3490
17999
xxx xx
1
4
SERVICE
UNITS
(FIELD 24G)
24
PROCEDURE
DIAGNOSIS
CODE
(FIELD 24D)
CODE (FIELD 24E)
PLEASE PRINT OR TYPE
APPROVED OMB-0938-1197 FORM 1500 (02-12)
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
48
2016 HOPD Sample Claim Form: UB-04/CMS 14507,6
Locator Box 42 - List revenue codes in ascending order.
•  For Medicare, revenue code 0636 (drugs that require detailed coding)
•  For non-Medicare payers, revenue code 0250 (general pharmacy)
•  Injection services may be reported with revenue code 0510 (clinic, general service)
Locator Box 43 - Describe the implant procedure
Locator Box 44 - lndicate appropriate CPT and HCPCS codes and
modifiers if required. Be sure to enter the unlisted CPT code 17999
(unlisted procedure, skin, mucous membrane and subcutaneous). Additional
information on the procedure may be placed in Locator Box 80. Medicare
claims require HCPCS C9399, Private payers may require C9399 or J3490.
NOTE: Individual payers will require documentation to adjudicate any
claim billed with an unlisted CPT code. Please consult with your local payer
or The Braeburn Access Program at 1-844-859-6341 to confirm payer
requirements.
Locator Box 46 - Enter 1 unit for the kit of 4 Probuphine subdermal
implants (296.8 mg of Buprenorphine or 320 mg Buprenorphine HCL).
Locator Box 47 - lndicate total charges.
Locator Box 67 - Indicate diagnosis/diagnoses using appropriate ICD-10CM codes, either F11.10 (Opioid Abuse Uncomplicated), F11.20 (Opioid
dependence, uncomplicated) or F11.21 (Opioid Dependence in Remission).
Locator Box 80 - When billing a not-otherwise-classified HCPCS code like
J3490, some payers may ask providers to specify Probuphine® (subdermal
buprenorphine implant) with dosage administered and NDC
58284-0100-14.
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Sample UB-04 (CMS-1450) claim form (institutional billing)
3a PAT.
CNTL #
b. MED.
REC. #
2
1
4 TYPE
OF BILL
6
5 FED. TAX NO.
8 PATIENT NAME
9 PATIENT ADDRESS
a
STATEMENT COVERS PERIOD
a
c
b
b
10 BIRTHDATE
11 SEX 12
OCCURRENCE
31
CODE
DATE
DATE
ADMISSION
13 HR 14 TYPE 15 SRC 16 DHR
OCCURRENCE
32
CODE
DATE
17 S TAT
18
OCCURRENCE
OCCURRENCE
33
DATE
CODE
34
CODE
7
THR OUGH
FROM
19
20
35
CODE
DATE
CONDITION CODES
24
22
23
21
25
26
27
e
29 ACDT 30
S TAT E
OCCURRENCE
36
CODE
OCCURRENCE SPAN
THROUGH
FROM
d
28
FROM
37
SPAN
THROUGH
a
a
b
b
REVENUE
CODE
38
(FIELD 42)
HCPCS CODE
(FIELD 44)
VALUE CODES
39
CODE
40
CODE
AMOUNT
VALUE CODES
VALUE CODES
41
CODE
AMOUNT
AMOUNT
a
b
c
d
2
42 REV. CD.
1
0636
2
0250
3
0510
43 DESCRIPTION
43
44
44 HCPCS / RATE / HIPPS CODE
46 SERV. UNITS
45 SERV. DATE
C9399
N458284-0100-14
N458284-0100-14
N458284-0100-14
47 TO TAL CHARGES
48 NON-COVERED CHARGES
49
1
J3490
1
1
17999
1
3
2
4
4
5
5
6
6
7
SERVICE UNITS
(FIELD 46)
DESCRIPTION
(FIELD 43)
8
9
7
8
9
10
10
11
11
12
12
13
13
14
14
15
15
16
16
17
17
18
18
19
19
20
20
21
21
22
22
PAGE
23
OF
TO TALS
CREATION DATE
50 PAYER NAME
52 REL.
INFO
51 HEALTH PLAN ID
53 ASG.
BEN.
23
55 EST. AMOUNT DUE
54 PRIOR PAYMENTS
56 NPI
A
57
A
B
OTHER
B
PRV ID
C
DIAGNOSIS AND PROCEDURECODE
58 INSURED’S NAME
QUALIFIER(FIELD
66)
C
59 P. REL 60 INSURED’S UNIQUE ID
62 INSURANCEGROUP NO.
61 GROUP NAME
A
A
B
B
C
C
64 DOCUMENT CONTROL NUMBER
63 TREATMENT AUTHORIZATION CODES
65 EMPLOYER NAME
A
A
B
B
C
F11.10
67
6
66
DX
6
69 ADMIT
I
9
0
DX
74
c.
6
67
A
J
70 PATIENT
REASON DX
PRINCIPAL PROCEDURE
a.
CODE
DATE
OTHER PROCEDURE
CODE
DATE
d.
DIAGNOSIS
B
K
C
C CODE D
a
b
OTHER PROCEDURE
CODE
DATE
L (FIELD 67)
M
c
b.
71 PPS
E
N
CODE
OTHER PROCEDURE
CODE
DATE
REMARKS
e.
OTHER PROCEDURE
(FIELD
80)
CODE
DATE
OTHER PROCEDURE
DATE
CODE
75
F
72
ECI
G
P
O
a
76 ATTENDING
b
NPI
LAST
77 OPERATING
H
Q
c
68
73
QUAL
FIRST
NPI
LAST
QUAL
FIRST
81CC
80
80 REMARKS
Probuphine(buprenorphine)implantforsubdermal
administra4on,58284-0100-14,1Kit
UB-04 CMS-1450
.
APPROVED OMB NO. 0938-0997
a
78 OTHER
b
LAST
c
79 OTHER
d
LAST
NUBC
™
National Uniform
Billing Committee
NPI
QUAL
FIRST
NPI
QUAL
FIRST
THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Footnotes
1.
NDCNa4onalDrugCode:TheDrugLis1ngActof1972requiresregistereddrugestablishmentstoprovidetheFoodandDrugAdministra1on
(FDA)withacurrentlistofalldrugsmanufactured,prepared,propagated,compounded,orprocessedbyitforcommercialdistribu1on.(See
Sec1on510oftheFederalFood,Drug,andCosme1cAct(Act)(21U.S.C.§360)).Drugproductsareiden1fiedandreportedusingaunique,threesegmentnumber,calledtheNa1onalDrugCode(NDC),whichservesasauniversalproductiden1fierfordrugs.FDApublishesthelistedNDC
numbersandtheinforma1onsubmidedaspartofthelis1nginforma1onintheNDCDirectorywhichisupdateddaily.Theinforma1onsubmided
aspartofthelis1ngprocess,theNDCnumber,andtheNDCDirectoryareusedintheimplementa1onandenforcementoftheAct.
2.
HCPCSLevelIICodingProcess&Criteria:TheCentersforMedicareandMedicaid(CMS)publishedonAugust17,2000(45CFR162.10002)to
implementtheHIPAArequirementforstandardizedcodingsystemsestablishedtheHCPCSlevelIIcodesasthestandardizedcodingsystemfor
describingandiden1fyinghealthcareequipmentandsuppliesinhealthcaretransac1onsthatarenotiden1fiedbytheHCPCSlevelI,CPTcodes.
TheHCPCSlevelIIcodingsystemwasselectedasthestandardizedcodingsystembecauseofitswideacceptanceamongbothpublicandprivate
insurers.PublicandprivateinsurerswererequiredtobeincompliancewiththeAugust2000regula1onbyOctober1,2002.TheHCPCSLevelII
CodingProcess/CriteriadocumentdescribesHCPCSlevelIIcodingproceduresandcodingcriteria.
3.
ICD-10-CM:TheInterna1onalClassifica1onofDiseases,TenthRevision,ClinicalModifica1on(ICD-10-CM)isasystemusedbyphysiciansand
otherhealthcareproviderstoclassifyandcodealldiagnoses,symptomsandproceduresrecordedinconjunc1onwithhospitalcareintheUnited
States.TheCentersforDiseaseControldevelopedandmaintainstheICD-10-CMcodeset.
hdps://www.cms.gov/Outreach-and-Educa1on/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCSCode-Sets-Educa1onal-Tool-ICN900943.pdf
4.
CPT®,CurrentProceduralTerminology:TheAmericanMedicalAssocia1ondevelopedandmaintainstheofficialCurrentProceduralTerminology
(CPT®)codeset.AccordingtotheAMAwebsite(
hdp://www.ama-assn.org/ama/pub/physician-resources/solu1ons-managing-your-prac1ce/coding-billing-insurance/cpt/about-cpt)TheCPT
mostwidelyacceptedmedicalnomenclatureusedtoreportmedicalproceduresandservicesunderpublicandprivatehealthinsurance
programs.CPTismaintainedbytheCPTEditorialPanel,whichmeetsthree1mesayeartodiscussissuesassociatedwithnewandemerging
technologiesaswellasdifficul1esencounteredwithproceduresandservicesandtheirrela1ontoCPTcodes.
5.
CMS1500Form:TheFormCMS-1500isthestandardpaperclaimformtobillMedicareFee-For-Service(FFS)Contractorswhenapaperclaimis
allowed.Inaddi1ontobillingMedicare.FormCMS-1500maybesuitableforbillingvariousgovernmentandsomeprivateinsurers.
hdps://www.cms.gov/Outreach-and-Educa1on/Medicare-Learning-Network-MLN/MLNProducts/downloads/form_cms-1500_fact_sheet.pdf
6.
DevelopedbyAlchemyHealthcareSolu4onsLLC,5/2016
7.
UB-04(CMS-1450)Form:TheFormCMS-1450,alsoknownastheUB-04,isthestandardclaimformtobillMedicareAdministra1veContractors
(MACs)whenapaperclaimisallowed.Inaddi1ontobillingMedicare,the837IandFormCMS-1450maybesuitableforbillingvarious
governmentandsomeprivateinsurers.
hdps://www.cms.gov/Outreach-and-Educa1on/Medicare-Learning-Network-MLN/MLNProducts/Downloads/837I-FormCMS-1450ICN006926.pdf
PleaseseeImportantSafetyInforma1onincludingBOXEDWARNINGonpage15&16
Important Safety Information (ISI)
INDICATIONS AND USAGE
PROBUPHINE contains buprenorphine, a partial opioid agonist. PROBUPHINE is indicated for the maintenance
treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-tomoderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of
Subutex or Suboxone sublingual tablet or generic equivalent).
PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained
prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone
sublingual tablet or generic equivalent.
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE
DAMAGE ASSOCIATED WITH INSERTION and REMOVAL
Risk Associated with Insertion and Removal
Insertion and removal of PROBUPHINE are associated with the risk of implant
migration, protrusion, expulsion resulting from the procedure. Rare but serious
complications including nerve damage and migration resulting in embolism and death
may result from improper insertion of drug implants inserted in the upper arm.
Additional complications may include local migration, protrusion and expulsion.
Incomplete insertions or infections may lead to protrusion or expulsion.
Because of the risks associated with insertion and removal, PROBUPHINE is available
only through a restricted program called the PROBUPHINE REMS Program. All
Healthcare Providers must successfully complete a live training program on the insertion
and removal procedures and become certified, prior to performing insertions or
prescribing PROBUPHINE implants. Patients must be monitored to ensure that
PROBUPHINE is removed by a healthcare provider certified to perform insertions.
CONTRAINDICATIONS
•  Hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).
WARNINGS AND PRECAUTIONS
•  Serious Complications from Insertion and Removal: Rare but serious complications including nerve damage and
migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper
arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or
infections may lead to protrusion or expulsion. All Healthcare Providers must successfully complete a live training
program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior
to performing insertions or prescribing PROBUPHINE implants.
•  Addiction, Abuse and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients
for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
•  Respiratory and CNS Depression: Significant respiratory depression and death have occurred in association with
buprenorphine particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other
CNS depressants (including alcohol). Consider dose reduction of CNS depressants when used concomitantly.
•  Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(NOWS) is an expected and treatable
outcome of prolonged use of opioids during pregnancy.
•  Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the
opioid.
•  Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from
children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
•  Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued,
monitor patients for withdrawal and treat appropriately.
•  Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment.
•  Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on
transmucosal buprenorphine and not dependent on full agonists before inserting PROBUPHINE.
•  Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is
required, monitor patients closely because higher doses may be required for analgesic effect.
•  Impairment of Ability to Drive and Operate Machinery: PROBUPHINE may impair the mental or physical abilities
required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
•  Other systemic effects: Probuphine may cause orthostatic hypotension in ambulatory patients. Buprenorphine, may
elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions,
and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and
changes in the level of consciousness that may interfere with patient evaluation. Buprenorphine has been shown to
increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with
dysfunction of the biliary tract.
•  Infection at Implant Site: Infection may occur at the site of the insertion or removal. Excessive palpation may
increase an opportunity for infection. Improper removal carries risk of implant-site infection.
•  General Precautions: PROBUPHINE should be administered with caution in debilitated patients and those with
myxedema or hypothyroidism; adrenal cortical insufficiency (e.g., Addison’s disease); CNS depression or coma;
toxic psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; or kyphoscoliosis.
PROBUPHINE should also be administered with caution in patients with a history of keloid formation, connective
tissue disease, e.g., scleroderma or history of recurrent MRSA infections.
•  Most common side effects of PROBUPHINE include: headache, insomnia, rhinorrhea, upper respiratory tract
infection, nausea, anxiety, back pain, depression, constipation, and vomiting.
PLEASE READ THE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND
MEDICATION GUIDE, which you can access at www.PROBUPHINE.com
To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
PR0035-001