Billing and Coding Guide

Billing and Coding Guide

INDICATION MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. IMPORTANT SAFETY INFORMATION

WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY ? L eft Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF).

Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function. ? E mbryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

HER2=human epidermal growth factor receptor 2.

Please see Important Safety Information on pages 6-7, and full Prescribing Information, including Boxed Warning.

Introduction

MacroGenics has created this guide to assist healthcare professionals (HCPs) in obtaining insurance reimbursement for MARGENZA? (margetuximab-cmkb).

MacroGenics has identified the potential billing codes listed on the next page to assist HCPs with obtaining insurance reimbursement for MARGENZA and its administration. Please note that coverage, coding, and payment may vary significantly by patient, payer, plan, treatment setting, and site of care. MacroGenics makes no representation, warranty, or guarantee that the information provided herein is up to date and/or accurate, will satisfy the requirements of the patient's insurer or payer, or result in payment. All codes included in this guide are for informational purposes only and do not guarantee payment of any claim. It is the sole responsibility of HCPs to select the appropriate codes and ensure the accuracy of all claims submitted for reimbursement.

MARGENZA Patient Support is here to help Healthcare providers and prescribers can call 1-844-MED-MGNX to speak with a Case Manager who can assist with:

? Ordering information ? Billing and coding assistance ? Reimbursement support ? Patient Assistance Program and Copay Assistance Program details

Case Managers are available Monday-Friday, 9 AM to 7 PM ET.

Please see Important Safety Information on pages 6-7, and full Prescribing Information,

including Boxed Warning.

2

Potential Billing Codes for MARGENZA? (margetuximab-cmkb)

Code Type

Codes

Category of Treatment or Description

ICD-10-CM Diagnosis Codes1 Permanent HCPCS J-code2,a National Drug Codes CPT? Procedure Codes5

AHA Revenue Codes6

C50.011-C50.019, C50.111-C50.119, C50.211-C50.219, C50.311-C50.319, C50.411-C50.419, C50.511-C50.519, C50.611-C50.619, C50.811-C50.819, C50.911-C50.919

Malignant neoplasm of female breast

C50.021-C50.029, C50.121-C50.129, C50.221-C50.229, C50.321-C50.329, C50.421-C50.429, C50.521-C50.529, C50.621-C50.629, C50.821-C50.829, C50.921-C50.929

Malignant neoplasm of male breast

J9353

Injection, margetuximab-cmkb, 5 mg

10-digit NDC3

11-digit NDC3,4

74527-022-02

74527-0022-02 One (250 mg/10 mL) single-dose vial

74527-022-03 96413 96415 96417

74527-0022-03

Four (250 mg/10 mL) single-dose vials

Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug

Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for primary procedure)

Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour (list separately in addition to code for primary procedure)

0335

Chemotherapy administration, intravenous

0636

Drugs requiring detailed coding

0250 0260

Pharmacy, general Intravenous therapy, general

aEffective for dates of service on or after July 1, 2021. CPT? is a registered trademark of the American Medical Association. AHA=American Hospital Association; CPT?=Current Procedural Terminology?; HCPCS=Healthcare Common Procedural Coding System; ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification; NDC=National Drug Code.

Please see Important Safety Information on pages 6-7, and full Prescribing Information,

including Boxed Warning.

3

Sample CMS-1500 Claim Form ? Physician's Office Setting7

The CMS-1500 Claim Form is used to bill for products and services administered in a physician's office.8 Below is a sample CMS-1500 Claim Form as a reference on how a form may be completed for MARGENZA? (margetuximab-cmkb).

A B

D

E

F

C

PLEASE PRINT OR TYPE

APPROVED OMB-0938-1197 FORM 1500 (02-12)

For illustrative purposes only. All coding and documentation requirements should be confirmed with each health plan.

PLEASE PRINT OR TYPE

APPROVED OMB-0938-1197 FORM 1500 (02-12)

A Item 19

Health plans may require inclusion of MARGENZA, route of administration (infusion), NDC, and total dosage. Check with the health plan to verify requirements.

E Item 24E

Insert the ICD-10-CM diagnosis code reference letter, as shown in Item 21, to relate MARGENZA and infusion administration listed in Box 24D.

B Item 21 Insert the appropriate ICD-10-CM diagnosis code.

C Item 24A-B Insert the date of infusion administration and the applicable place of service code.

F Item 24G Insert the number of billing units for each line item. For example, 1 billing unit = 5 mg of MARGENZA. Actual units reported will be determined by the dosage amount required for each individual patient. Use the JW modifier to report discarded units as required by Medicare or other health plans.

D Item 24D

Insert the permanent HCPCS J-code for MARGENZA (J9353)2 and CPT? code(s) for infusion administration.

Please see Important Safety Information on pages 6-7, and full Prescribing Information,

including Boxed Warning.

4

__

__

8 PATIENT NAME

a

b

9 PATIENT ADDRESS

a

b

b. MED. REC. #

5 FED. TAX NO.

6 STATEMENT COVERS PERIOD

7

FROM

THR OUGH

c

d

e

10 BIRTHDATE 8 PATIENT NAME

11 SEX a

12

DATE

ADMISSION 13 HR 14 TYPE

15 SRC

16 DHR

17 STAT 9 PATIENT

1A8DDRES1S9

20a

CONDITION CODES

21

22

23

24

25

26

27

29 ACDT 30

28

STATE

b

b

c

d

31 OCCURRENCE

32 OCCURRENCE

33 OCCURRENCE

34 OCCURRENCE

35

OCCURRENCE SPAN

36

OCCURRENCE SPAN

37

Sample CMS-1450 (UB-04) Claim Form ? Institutional or Hospital Setting C1O0DBEIRTHDATE DATE a

11 CSOEDXE 12

DATE DATE

ADMISSCIOONDE 13 HR 14 TYPE

15

DATE SRC

16

DHR

C17ODSTEAT

DATE

18

19

2C0ODE 21

FCRO2O2NMDITION23CODETSH2R4OUGH25

CODE 26

FROM

27

28

29 ACDTTH3R0OUGH

STATE

9

e a

b 31 OCCURRENCE

32 OCCURRENCE

33 OCCURRENCE

34 OCCURRENCE

35

OCCURRENCE SPAN

36

OCCURRENCE SPAN

37

b

38CODE

DATE

CODE

DATE

CODE

DATE

CODE

DATE

CODE 39

FROVMALUE CODES THROUGH 40 CODE VALUE COFRDOEMS

4T1HROUGH VALUE CODES

The CMa S-1450 (UB-04) Claim Form is used for submitting institauCtOioDEnal cAlMaOUimNT s for inCpODaE tienAtMOaUNnTd

CODE

AMOUNT

a

outpatieb 3n8 t services.10 Below is a sample CMS-1450 (UB-04) Claibm39FormVAaLUsE COaDErSeferen4c0 e on how VALUE CODES

41

VALUE CODES

b

a form may be completed for MARGENZA? (margetuximab-cmkbca).CODE AMOUNT

CODE

AMOUNT

CODE

AMOUNT

d b

42 REV. CD. 43 DESCRIPTION

44 HCPCS / RATE / HIPPS CODE

c

45 SERV. DATE

46 SERV. UNITS

47 TOTAL CHARGES

48 NON-COVERED CHARGES 49

A 1

2

42 REV. CD.

B

43 DESCRIPTION

C

44 HCPCS / RATE / HIPPS CODE

d D

45 SERV. DATE

E

46 SERV. UNITS

47 TOTAL CHARGES

1

2

48 NON-COVERED CHARGES 49

3

3

1

1

4

4

2

2

5

5

3

3

6

6

4

4

7

7

__

5

__

__

5

1

8 PATIENT NAME b 10 BIRTHDATE

8

2

6

3a PAT. CNTL #

b. MED. REC. #

9

7

5 FED. TAX NO.

a

9 PATIENT ADDRESS

a

10

8

11 SEX 12 DATE

b

ADMISSION 13 HR 14 TYPE

15 SRC

16 DHR

17 STAT

18

19

20

CONDITION CODES

21

22

23

24

25

6 STATEMENT COVERS PERIOD

7

FROM

THR OUGH

c

d

26

27

29 ACDT 30

28

STATE

4 TYPE OF BILL

e

8

6

9

7

10

8

31 OCCURRENCE

CODE

DATE

a

b 38

11

9

32 OCCURRENCE

CODE

DATE

12

10

13

11

42 REV. CD.

14

12

43 DESCRIPTION

33 OCCURRENCE

CODE

DATE

34 OCCURRENCE

CODE

DATE

35 CODE

OCCURRENCE SPAN

FROM

THROUGH

36 CODE

OCCURRENCE SPAN

37

FROM

THROUGH

a

39 CODE a

b

c

VALUE CODES AMOUNT

40 CODE

VALUE CODES AMOUNT

b

41 CODE

VALUE CODES AMOUNT

44 HCPCS / RATE / HIPPS CODE

d 45 SERV. DATE

46 SERV. UNITS

47 TOTAL CHARGES

48 NON-COVERED CHARGES 49

A Form Locator (FL) 42

D FL 45

11

9

12

10

13

11

14

12

1

15

2

13

3

16

4

14

5

6

17

7

15

1

2

Insert applicable AHA

3

4

5

revenue codes.

6

7

Insert the date of infusion

15

13

16

administration.

14

17

15

8

18

9

16

10

11

19

17

12

8

9

10

11

12

B FL 43

18

16

E FL 46

19

17

13

20

13

14

18

14

15

15

16

21

16

19

17

17

18

22

18

19

20

19

20

21

22

23

PAGE

50 PAYER NAME

A

B

C

58 INSURED'S NAME A

23

21

PAGE

OF

O5F0 PAYER NAME

22

51 HEALTH PLAN ID

CREATION DATE

52 REL. 53 ASG. 54 PRIOR PAYMENTS

INFO

BEN.

TOTALS

55 EST. AMOUNT DUE

A 23

PAGE

OF

B

59 P. REL 60 INSURED'S UNIQUE ID

50 PAYER NAME

61 GROUP NAME

20

21

22

51 HEALTH PLAN23

ID

56 NPI

57

A

OTHER

B

PRV ID

C

62 INSURANCE GROUP NO.

51 HEALTH PLAAN ID

B

C

B

C

A

C

63 TREATMENT AUTHORIZATION CODES

64 DOCUMENT CONTROL NUMBER

65 EMPLOYER NAME

Insert a description for the

Insert the number of billing

20

18

AHA revenue code listed

units for each line item. For

21

19

22

CiRnEFALTIO4N2.DATE

TOTALS

example,

1

billing

unit

=

5

mg 20

23

21

52 REL. 53 ASG. 54 PRIOR PAYMENTS

of 55 EST. AMOUNT DUE MA56RNPGI ENZA. Actual units

INFO

BEN.

22

C CFRLE4AT4ION DATE

TOTALS

report57ed

will

be

determined

byA 23

Insert the permanent HCPCS the dosage amount required 52REL. INFO

53 ASG. 54 PRIOR PAYMENTS

BEN.

55 EST. AMOUNT DUE

OTHER 56 NPI

B

J-code for MARGENZA

for

each PRV ID 57

individual

patient.

C A

A

58 INSURED'S NAME

B

B

C

A

66 DX

67

A C

B

C

I J K L 69 ADMIT a b DX

B70 PATIENT

REASON DX

58 INSURED'S NAME 74

PRINCIPAL PROCEDURE

a.

OTHER PROCEDURE

b.

CODE

DATE

CODE

DATE

C

c.

A OTHER PROCEDURE

d.

OTHER PROCEDURE

e.

CODE

DATE

CODE

DATE

D

M

c

71 PPS CODE

OTHER PROCEDURE

CODE

DATE

E N

72 ECI

75

OTHER PROCEDURE

CODE

DATE

F O a

76 ATTENDING

LAST

77 OPERATING

G P b

NPI

NPI

59 P. RELA 60 INSURED'S UNIQUE ID

61 GROUP NAME

B C

(J9353)2 and CPT? code(s)

for infusion administration. H

68

Q

c

73

59 P. REL 60 INSURED'S UNIQUE ID

61 GROUP NAME

QUAL

FIRST

QUAL

Use

the JW modifier 62 INSURANCE GROUP NO. OTHER

to

report

B

A

discarPdRVeIDd units as required byBC

62 INSURANCE GROUP NO.

Medicare or other health plansC.

A

80 REMARKS

63 TREATMEN8T1CC AUTHORIZATION CODES

B

a

LAST

78 OTHER

NPI

FIRST QUAL

64 DOCUMENT CONTROL NUMBER

65 EMPLOYER NAME

B

b

LAST

FIRST

A

c

C

d

79 OTHER

NPI

LAST

QUAL FIRST

A C

UB-04 CMS-1450

APPROVED OMB NO. 0938-0997

B

NUBCTM National Uniform Billing Committee LIC9213257

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.

B

63 TREATMENT AUTHORIZATION CODES

64 DOCUMENT CONTROL NUMBER

65 EMPLOYER NAME

C

C

F 67 A

66 BDX

A

B

C

D

E

F

G

H

68

A B

C

I

J

K

L

M

N

O

P

Q

C

69 ADMIT

70 PATIENT

66 DX 7D4 X

REASON DX

67 A PRINCIPAL PROCEDURE

a.

I J CODE

DATE

a B b C OTHER PROCEDURE

b.

K L CODE

DATE

71 PPS

c CODE

D OTHER PROCEDURE

M CODE

DATE

72

E ECI N75

a F O 76 ATTENDING

b G P NPI

c H QQUAL

73 68

69 ADMIT

70 PATIENT

c. DX

OTHER PROCEDURE REASON DdX.

74 CODPERINCIPAL PROCEDUATREE

a.

CODE

DATE

a b OTHER PROCEDURE

CODEOTHER PROCEDUDRAETE

CODE

DATE

e.

c 71 PPS OTHER PROCCEODDUERE

b. CODEOTHER PROCEDUDRAETE

CODE

DATE

72 ECI

75

a LAST

77 OPERATING 76 ATTENDING

b

NPI NPI

cFIRST

73

QUAL

QUAL

G 80c.REMARKS OTHER PROCEDURE

CODE

DATE

81CC

d.

OTHER PROCEDaURE

CODE

DATE

e.

OTHER PROCEDURE

CODE

DATE

LAST LAST

78 OTHER 77 OPERATING

NPI NPI

FIRST FIRST QUAL QUAL

b

LAST

FIRST

LAST

FIRST

80 REMARKS UB-04 CMS-1450

81Cc C a

d b

APPROVED OMB NO. 0938-0997

c

NUBCTM National Uniform Billing Committee LIC9213257

79 OTHER 78 OTHER

NPI NPI

QUAL QUAL

LAST

FIRST

LAST

FIRST

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.

79 OTHER

NPI

QUAL

d

LAST

FIRST

ForUBi-l0l4uCsMtSr-1a45t0ive

purposes

oAnPPlRyO.VAEDlOl McBoNdO.i0n93g8-0a99n7

d

documentation

requirements should

NUBCTM National Uniform Billing Committee LIC9213257

be

cToHnE fCiErRmTIFeICdATIOwNSitOhN TeHEaRcEhVEhRSeEaAlPtPhLY

TpOlTaHnIS.BILL

AND

ARE

MADE

A

PART

HEREOF.

F FL 67

Insert the appropriate ICD-10-CM diagnosis code.

G FL 80

Health plans may require inclusion of MARGENZA, route of administration (infusion), NDC, and total dosage. Check with the health plan to verify requirements.

Please see Important Safety Information on pages 6-7, and full Prescribing Information,

including Boxed Warning.

5

 ................
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