DALVANCE (DALBAVANCIN) FOR INJECTION CODING & BILLING REFERENCE GUIDE
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1 DLVNE (DLVNIN) FOR INJETION ODING & ILLING REFERENE GUIDE For more information: all the DLVNE ONNETS SM program toll-free Program oordinators are available 9:00 am to 6:00 pm Eastern time, Monday through Friday. What is the relevant billing and claims information for DLVNE in my setting of care? Please see Indication and Important Safety Information on page 8.
2 ode Set Setting of are ode and Description Location on laim Form HPS DLVNE Physician office Free-standing infusion center DLVNE will be reported with a non-specific unclassified HPS code. Effective January 1, 2016, DLVNE will have a unique product-specific HPS code that will need to be reported. J3490 Unclassified drugs In addition, enter drug-identifying information as required by payor; generally, drug name (brand and generic), ND, dose, method of administration. Example: DLVNE (dalbavancin), ND , 500 mg via IV infusion MS-1500 Paper: ox 24D to enter unclassified HPS code; ox 19 to enter drug-identifying information as shown in the example on the left Electronic: Loop ID 2400, Segment SV101 (2-6) to enter unclassified HPS code; Loop ID 2300, Segment NTE-PWK to enter drug-identifying information as shown in the example on the left s of January 1, 2015, Medicare and other payors require DLVNE to be reported with a unique product-specific -ode (HPS ode) for hospital services. The -ode will not be required once DLVNE has a unique J-ode effective January 1, Other payors may or may not adopt this code. 9443, injection, dalbavancin, 10 mg* (required by Medicare in the hospital setting; other payors may use it) In addition, enter the number of units administered; 1 unit equals 10 mg Example: 1000 mg IV infusion would be coded as 100 units (1000 mg/10 mg = 100 units) Paper: Field 44 to enter drug specific -ode; Field 46 enter the appropriate number of units administered. See example on the left Electronic: Loop 2400, Segment SV202-2 (SV202-1=H/HP) to enter drug specific -ode; Loop 2400, segment SV205 to enter the appropriate number of units administered. See example on the left *DLVNE is reimbursed by 10 mg units as defined by the 2015 HPS reimbursement code. 2
3 ode Set Setting of are ode and Description Location on laim Form NDs used to report DLVNE Physician office Free-standing infusion center Most payors will require the 11-digit ND to identify the drug administered as DLVNE, especially while it is billed with an unclassified code. ND: mg dalbavancin, single-use vial MS-1500 Paper: ox 19 Electronic: Loop ID 2300, Segment NTE-PWK laim form requirements for NDs vary by payor; some payors require the ND be reported in the MS-1500 ox 19 field, while other payors require it listed as a line item in MS-1500 ox 24 or MS-1450 Field 80 s of January 1, 2015, Medicare and other payors require DLVNE to be reported with a unique product-specific -ode (HPS ode) for hospital services. The -ode will not be required once DLVNE has a unique J-ode effective January 1, Other payors may or may not adopt this code. 9443, injection, dalbavancin, 10 mg* (required by Medicare in the hospital setting; other payors may use it) Paper: Field 44 Electronic: Loop 2400 In addition, enter the number of units administered; 1 unit equals 10 mg. Example: 1000 mg IV infusion would be coded as 100 units (1000 mg/10 mg = 100 units) PT IV infusion Physician office Free-standing infusion center DLVNE is administered via IV infusion over 30 minutes Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour NOTE: The medical record documented start and stop time of IV infusion must be >15 minutes. MS-1500 Paper: ox 24D Electronic: Loop ID 2400, Segment SV101 (2-6) Paper: Field 44 Electronic: Loop 2400, Segment SV202-2 (SV202-1=H/HP) Revenue odes Revenue codes capture hospital facility cost data by, which the facility uses for cost reporting purposes Drugs requiring detailed coding (required by Medicare to obtain pass-through payment for drugs in HOPD) 0250 Pharmacy 0510 linic Some revenue codes are required to obtain appropriate reimbursement for a specific service performed in a specific setting of care; for other services, revenue codes may vary Paper: Field 42 Electronic: Loop 2400, Segment SV201 *DLVNE is reimbursed by 10 mg units as defined by the 2015 HPS reimbursement code. Please see Indication and Important Safety Information on page 8. 3
4 ode Set Setting of are ode and Description Location on laim Form ID-9-M diagnoses ID-10-M is expected to replace ID-9-M effective October 1, 2015 all DLVNE ONNETS SM toll-free at for more information on ID-10-M, International lassification of Diseases, 10th Revision, linical Modification codes THIS IS NOT N LL-INLUSIVE LIST; ONSULT WITH PYOR TO OTIN SPEIFI OVERGE POLIIES ND REQUIREMENTS FOR OVERED INDITIONS Physician office Free-standing infusion center DLVNE is indicated for SSSI caused by designated susceptible strains of Gram-positive microorganisms. 681.XX: ellulitis and abscess of finger and toe 682.XX: Other ellulitis and abscess 686.XX: Other local infections of skin and subcutaneous tissue 958.3: Posttraumatic wound infection, not elsewhere classified 998.5X: Postoperative wound infection 035: Erysipelas MS-1500 Paper: ox 21 Electronic: Loop ID 2300, Segment HI01-2, HI02-2, HI03-2, HI04-2, HI05-2, HI06-2, HI07-2, HI08-2, HI09-2, HI10-2, HI11-2, HI12-2 Paper: Field 67 a-q Electronic: Loop 2300, Segment HI01-2 (HI01-1=K) ID-9-M Procedure procedures ID-10-PS is expected to replace ID-9-M effective October 1, 2015 all DLVNE ONNETS SM toll-free at for more information on ID-10-M, International lassification of Diseases, 10th Revision, Procedure oding System codes DLVNE is administered via IV infusion over 30 minutes Injection or infusion of other therapeutic or prophylactic substance Paper: Field 74 Electronic: Loop 2300, HI01-2 (HI01-1= R) Loop 2300, HI01-4 (HI01-1=R) MS-DRG stay THIS IS NOT N LL-INLUSIVE LIST The primary MS-DRG will vary by primary diagnosis and procedure codes present at hospital discharge. 602 ellulitis with M 603 ellulitis without M Paper: Field 71 Electronic: Loop 2300, Segment HI01-2 (HI01-1=DR) 4
5 GLOSSRY SSSI=acute bacterial skin and skin structure infections; SP=average sales price; WP=average wholesale price; =comorbid condition; PT=urrent Procedural Terminology; ED=emergency ; FSI=free-standing infusion center; HPS=Healthcare ommon Procedure oding System; HH=home health; HH=home health agency; HOP=hospital-owned provider-based ; HOPD=hospital ; ID-9-M=International lassification of Diseases, 9th Revision, linical Modification PPS=Prospective Payment System; M=major comorbid condition; MPFS=Medicare Physician Fee Schedule; MS-DRG=Medicare Severity Diagnosis-Related Group; ND=National Drug ode; OPPS=Outpatient Prospective Payment System; SNF=skilled nursing facility; W=wholesale acquisition cost PT opyright 2012 merican Medical ssociation (M). ll rights reserved. PT is a registered trademark of the M. pplicable Federal cquisition Regulations System/Defense Federal cquisition Regulation Supplement restrictions apply to government use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the M, are not part of PT, and the M is not recommending their use. The M does not directly or indirectly practice medicine or dispense medical services. The M assumes no liability for data contained or not contained herein. DISLIMER This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice, nor does it promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all PT and HPS codes are supplied for informational purposes only and represent no statement, promise, or guarantee by ctavis, Inc., that these codes will be appropriate or that reimbursement will be made. It is the responsibility of the health care provider to determine the appropriate code(s) for services provided to his or her patient. The fact that a drug, device, procedure, or service is assigned an HPS code and a payment rate does not imply coverage by the Medicare and/or Medicaid program, but indicates only how the product, procedure, or service may be paid if covered by the program. Medicare dministrative ontractors (Ms) and/or State Medicaid program administration determine whether a drug, device, procedure, or other service meets all program requirements for coverage. The information provided in this document is not intended to increase or maximize reimbursement by any payor. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend you consult the payor organization for its reimbursement policies. Please see Indication and Important Safety Information on page 8. 5
6 MS-1450 FOR SERVIES PERFORMED IN THE HOSPITL Sample ID-9-M DLVNE (dalbavancin) IV Injection 1 2 3a PT. NTL # 4 TYPE OF ILL b. MED. RE. # 5 FED. TX NO. 6 STTEMENT OVERS PERIOD 7 FROM THROUGH 8 PTIENT NME a 9 PTIENT DDRESS a b b c d 10 IRTHDTE 11 SEX DMISSION ONDITION ODES 12 DTE 13 HR 14 TYPE 15 SR 16 DHR 29 DT STT STTE e 31 OURRENE 32 OURRENE 33 OURRENE 34 OURRENE 35 OURRENE SPN 36 OURRENE SPN 37 ODE DTE ODE DTE ODE DTE ODE DTE ODE FROM THROUGH ODE FROM THROUGH This document is provided for your guidance only. Please call DLVNE ONNETS SM at to verify coding and claim information for specific payors VLUE ODES 40 VLUE ODES 41 VLUE ODES ODE MOUNT ODE MOUNT ODE MOUNT a b c d REV. D. 43 DESRIPTION 44 HPS / RTE / HIPPS ODE 45 SERV. DTE 46 SERV. UNITS 47 TOTL HRGES 48 NON-OVERED HRGES Drugs requiring detailed information 9399 MM DD YY 1 xxx.xx (DLVNE) 0510 linic visit MM DD YY 1 xxx.xx (IV infusion in ) Fields 42-43: Enter the 8 appropriate revenue 9 code and description 10 corresponding to the HPS 11 code in Field 12 44; eg, for 13 DLVNE for 14 IV infusion 15 administered in the 16 Note: Other revenue codes 17 may apply PYER NME PGE Fields 44: Enter appropriate PT/HPS codes and modifiers; eg, - Drug: 9443 for DLVNE (for Medicare) - dministration: for drug administration Note: Other HPS codes may apply for non-medicare payors; eg, OFSMPLE - J3490 Unclassified drugs RETION DTE TOTLS TLS SMPLE56 SMPLENPI 52 REL. 53 SG. 51 HELTH PLN ID 54 PRIOR PYMENTS 55 EST. MOUNT DUE INFO EN. SMPLE57 OTHER Fields 46: Enter appropriate number of units of service; eg, unit equals 10 mg. Therefore a 1000 mg injection would be 100 units (1000 mg/10 mg = 100 units) Note: Some payors may provide alternate guidance PRV ID INSURED S NME 59 P.REL 60 INSURED S UNIQUE ID 61 GROUP NME 62 INSURNE GROUP NO. Fields 66: Identify the type of ID diagnosis code used; eg, enter a 9 for ID-9-M or a 0 for ID-10-M 63 TRETMENT UTHORIZTION ODES Fields 67 and 67-67Q: Enter the appropriate diagnosis code Final code may depend on medical record documentation Note: Other diagnosis codes may apply 64 DOUMENT ONTROL NUMER 65 EMPLOYER NME 66 DX 67 9 D E F G H I J K L M N O P Q a b c 69 DMIT 70 PTIENT 71 PPS DX RESON DX Fields 74: Enter principal ID-9-M ODE procedure EI code; 74 PRINIPL PROEDURE a. OTHER PROEDURE b. OTHER PROEDURE ODE DTE ODE DTE 75 eg, for IV infusion ODE DTE 76 TTENDING NPI QUL MMDDYY LST FIRST c. OTHER PROEDURE d. OTHER PROEDURE e. OTHER PROEDURE ODE DTE ODE DTE ODE DTE 77 OPERTING NPI QUL LST FIRST 80 REMRKS 81 a 78 OTHER NPI QUL DLVNE (dalbavancin), 1000 mg, ND b LST FIRST , IV Infusion c 79 OTHER NPI QUL d LST FIRST U-04 MS-1450 PPROVED OM NO. THE ERTIFITIONS ON THE REVERSE PPLY TO THIS ILL ND RE MDE PRT HEREOF. National Uniform format as allowed by payor NU illing ommittee LI Fields 80: Enter the appropriate drug identifying information as required by payor; eg, brand and generic drug name, National Drug ode (ND) 11-digit format, dosage, method of administration, etc; when using 9443, Medicare will no longer require this information. Note: dditional information may also be sent via attachment electronically or other 68 6
7 MS-1500 FOR SERVIES PERFORMED IN THE PHYSIIN OFFIE Sample MS /12 (ID-9-M) DLVNE (dalbavancin) IV Injection This document is provided for your guidance only. Please call DLVNE ONNETS SM at to verify coding and claim information for specific payors ox 19 dditional Information: Enter the appropriate drug identifying information as required by payor; eg, brand and generic drug name, National Drug ode (ND) 11-digit format, dosage, method of administration, etc Note: dditional information may also be sent via attachment electronically or other format as allowed by payor ox 21 Diagnosis: Enter the appropriate diagnosis code; eg, ID-9-M: for MRS Final code depends on medical record documentation Note: Other diagnosis codes may apply ox 21 ID Indicator: Identify the type of ID diagnosis code used; eg, enter a 9 for ID-9-M or a 0 for ID-10-M DLVNE (dalbavancin), Dose 500 mg, ND , IV Infusion over 30 minutes XXXXXX ox 23 Prior uthorization: Enter the payor authorization number as obtained prior to services rendered MM DD YY MM DD YY 11 J3490 XXX.XX 1 MM DD YY MM DD YY XXX.XX 1 ox 24D Procedures/Services/Supplies: Enter the appropriate PT/HPS codes and modifiers; eg, - Drug: J3490 for DLVNE - dministration: for IV infusion ox 24E Diagnosis Pointer: Enter the letter (-J) that corresponds to the diagnosis in ox 21 ox 24G Units: Enter the appropriate number of units of service; eg, J3490 has no specific unit value, therefore a 1 is typically entered in this field Note: Some payors may provide alternate guidance PLESE PRINT OR TYPE PPROVED OM FORM 1500 (02-12) Please see Indication and Important Safety Information on page 8. 7
8 INDITION DLVNE (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (SSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus). IMPORTNT SFETY INFORMTION ontraindications DLVNE is contraindicated in patients with known hypersensitivity to dalbavancin. Warnings and Precautions HYPERSENSITIVITY RETIONS Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DLVNE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DLVNE should be discontinued. INFUSION-RELTED RETIONS Rapid intravenous infusion of DLVNE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash. HEPTI EFFETS LT elevations with DLVNE treatment were reported in al trials. LOSTRIDIUM DIFFIILE-SSOITED DIRRHE lostridium difficile-associated diarrhea (DD) has been reported with nearly all systemic antibacterial agents, including DLVNE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. DEVELOPMENT OF DRUG-RESISTNT TERI Prescribing DLVNE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. dverse Reactions The most common adverse reactions in patients treated with DLVNE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%). Use in Specific Populations There have been no adequate and well-controlled studies with DLVNE in pregnant or nursing women. DLVNE should only be used if the potential benefit justifies the potential risk in these populations. In patients with renal impairment whose known creatinine clearance is less than 30 ml/min and who are not receiving regularly scheduled hemodialysis, the recommended two-dose regimen for DLVNE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DLVNE can be administered without regard to the timing of hemodialysis. aution should be exercised when prescribing DLVNE to patients with moderate or severe hepatic impairment (hild-pugh lass or ) as no data are available to determine the appropriate dosing in these patients. ctavis and its design are trademarks of ctavis, Inc. or its affiliates. Dalvance and its design are trademarks of Durata Therapeutics Holding.V., an ctavis affiliate. DLVNE ONNETS is a service mark of ctavis, Inc. or its affiliates. ctavis ll rights reserved. DV /15 8
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