YOUR GUIDE TO EVENITY BILLING AND CODING INFORMATION - Amgen Assist ...

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YOUR GUIDE TO EVENITY™
                               BILLING AND CODING
                               INFORMATION

                                                FOR PHYSICIAN OFFICES USING THE CMS 1500

                                                FOR HOSPITALS/INSTITUTIONS USING THE CMS 1450

The information provided in this guide is of a general nature and for informational purposes only. Coding and coverage policies change
periodically and often without warning. The responsibility to determine coverage and reimbursement parameters, and appropriate
coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. The information provided in
this guide should in no way be considered a guarantee of coverage or reimbursement for any product or service.

                                               Call Amgen Assist® for assistance with specific payer requirements:
                                               1-866-AMG-ASST (1-866-264-2778) Monday through Friday, 9:00 am to 8:00 pm ET.

INDICATION
EVENITY™ is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of
osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
The anabolic effect of EVENITY™ wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY™ use should be limited to
12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered.
IMPORTANT SAFETY INFORMATION
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY™ may increase the risk of myocardial infarction, stroke and cardiovascular death.
EVENITY™ should not be initiated in patients who have had a myocardial infarction or
stroke within the preceding year. Consider whether the benefits outweigh the risks in
patients with other cardiovascular risk factors. Monitor for signs and symptoms of
myocardial infarction and stroke and instruct patients to seek prompt medical attention
if symptoms occur. If a patient experiences a myocardial infarction or stroke during
therapy, EVENITY™ should be discontinued.

Please see additional Important Safety Information on the back cover.
Physician Office Billing Information                                                                                                               Completing the CMS 1500 for Physician Offices

                                                                                                                                                                                                                                                                                                           PHYSICIAN OFFICES (CMS 1500)
EVENITY™ (romosozumab-aqqg) Coding Information
 Additional Claim Information
 in Box 19:                                         EVENITY™ (romosozumab-aqqg), 210 mg, subcutaneous injection, NDC 55513088002
 (Electronic Form: Loop 2300,
 or 2400, NTE, 02)1
                                                    As with most newly FDA-approved products, a temporary J-Code is required until a
                                                    permanent code for EVENITY™ is established.
                                                    J3590 (Unclassified biologics) or J3490 (Unclassified drugs).2,3                                                                                                        X                                  XXX-XX-XXXX
 Coding Information in Box 24D:                     Billing requirements for unclassified or miscellaneous codes may vary by payer;
                                                                                                                                                                         Doe, Jane J                                        06 01 1930                   X      Doe, Jane J
 (Electronic Form: Loop 2400, SV1, 01-2)1           however, payers typically require providers to list product name, route of administration,
                                                    total dosage, and NDC number(s) for units used during the billing period in Box 19 (or                               1123 Main Street
                                                    corresponding field for electronic claims).*
                                                    NDC number 55513-0880-02 can be used for billing purposes.4                                                          Hometown                                    MA
 Number of Units in Box 24G:                        Indicate 1 unit for one kit. Each EVENITY™ kit contains one dose, which is 2 injections for a                        01234                  XXX XXX-XXXX
 (Electronic Form: Loop 2400, SV1,                  total dose of 210 mg.4
 04 [03=UN])1                                       The NDC number covers both injections.                                                                                                                                                                       11111
                                                                                                                                                                                                                                              X                  06 01 1930                            X
Administration and Professional Service Coding Information*                                                                                                                                                                                   X                  ABC Employer
                                                    The following code may be available to report administration of EVENITY™. Other codes may
                                                    be appropriate on a payer-specific basis. It is the provider’s responsibility to ensure that                                                                                              X
                                                    codes used are consistent with payer policy and reflect service performed under such codes:
                                                    • 96372 (therapeutic, prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous             (BOX 19) ADDITIONAL                                                                            X
 Coding Information in Box 24D:                                                                                                                                       CLAIM INFORMATION:
                                                      or intramuscular)5
 (Electronic Form: Loop 2400, SV1, 01-2)1                                                                                                                         Indicate EVENITY™
                                                    • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in
                                                      addition to other professional services, the following modifier may be required to distinguish it as        (romosozumab-aqqg), 210 mg,
                                                                                                                                                                  subcutaneous injection, NDC
                                                      a separate service: -.25 (significant, separately identifiable evaluation and management service by
                                                                                                                                                                  55513088002
                                                      the same physician on the same day of the procedure or other service)
                                                                                                                                                                                                                                                                          (BOX 24G) DAYS
                                                    Each EVENITY™ kit contains one dose, which is 2 injections for a total dose of 210 mg.4                                                                                                                               OR UNITS:
 Considerations:                                    Applicable codes cover both injections.
                                                                                                                                                                            EVENITY™ (romosozumab-aqqg), 210 mg, subcutaneous injection, NDC 55513088002            Indicate 1 unit for one kit.
                                                                                                                                                                                                                                                                    Each EVENITY™ kit contains
Diagnosis Code Information*                                                                                                                                                M80.0
                                                                                                                                                                                                                                                                    one dose, which is 2 injections.

                                                    The following primary ICD-10-CM diagnosis code may be appropriate to describe patients
                                                    with current osteoporotic fracture treated with EVENITY™:
                                                    • M80.0 (Age-related osteoporosis with current pathological fracture)6
 ICD-10-CM Code in Box 21:                                                                                                                                            (BOX 21) DIAGNOSIS
                                                    Please see page 6 for additional examples for patients with current osteoporotic fracture.                        OR01
                                                                                                                                                                         NATURE
 (Electronic Form: Loop 2300, HI, 01-2)     1                                                                                                                              23 14OF01 23 14              11          J3590                                        XXX XX    1
                                                    The following primary diagnosis code may be appropriate to describe patients                                      ILLNESS OR INJURY:
                                                    without current osteoporotic fracture treated with EVENITY™:                                                  Indicate01  23 14 ICD01
                                                                                                                                                                           appropriate         23 14
                                                                                                                                                                                            diagnosis   11          96372                                        XXX XX    1
                                                    • M81.0 (Age-related osteoporosis without current pathological fracture)6,†                                   code as reflected in the patient’s
                                                                                                                                                                  medical record. ICD-10 code                    (BOX 24D) PROCEDURES,
*The sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include               example: M80.0 (Age-related                    SERVICES, OR SUPPLIES:
 FDA-approved indications for EVENITY™. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns,              osteoporosis with current                  Indicate appropriate HCPCS and CPT codes.
 and the services rendered.                                                                                                                                       pathological fracture).                    Example: J3590 (Unclassified biologics) or
†According to the ICD-10-CM Official Guidelines for Coding and Reporting, M81 code is for use with patients with osteoporosis who do not currently have                                                      J3490 (Unclassified drugs). 96372 (Therapeutic,
 a pathologic fracture due to the osteoporosis, even if they have had a fracture in the past. For patients with a history of osteoporosis fractures, status                                                  prophylactic, or diagnostic injection [specify
 code Z87.310 (personal history of [healed] osteoporosis fracture) should follow the code from the M81 category.7                                                                                            substance or drug]; subcutaneous or
                                                                                                                                                                          11-1111111                    X    intramuscular).                X                      XXX XX
                                                                                                                                                                                                             Please note: Each EVENITY™ kit contains one
                                                                                                                                                                                                             dose, which is 2 injections. Applicable codes     John Smith MD
     Call Amgen Assist® for support with billing and coding questions: 1-866-AMG-ASST (1-866-264-2778)                                                                                                       cover both injections.                            2 Doctors Blvd
     Monday through Friday, 9:00 am to 8:00 pm ET.                                                                                                                                                                                                             Hometown, MA 01234
                                                                                                                                                                                             08-22-17           XXXXXXXXX                                       XXXXXXXXX

                                                                                                                                                          2   3
Hospital/Institutional Billing Information                                                                                                       Completing the CMS 1450 Form for Hospitals

EVENITY™ (romosozumab-aqqg) Coding Information                                                                                                                                  __                                                                                                   __                                                                                                                                        __

  Revenue Code in Box 42:                     Medicare: 0636, drugs requiring detailed coding.9
                                                                                                                                                                         Anytown Hospital
                                                                                                                                                                       1                                                                     2                                                                                          3a PAT.                                                                                 4    TYPE
                                                                                                                                                                                                                                                                                                                                        CNTL #                                                                                      OF BILL

  (Electronic Form: Loop 2400, SV201)8        Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer.9,10                                           100 Main Street
                                                                                                                                                                                                                                                                                                                                        b. MED.
                                                                                                                                                                                                                                                                                                                                        REC. #

                                                                                                                                                                         Anytown, Anystate 01010
                                                                                                                                                                                                                                                                                                                                                                          6        STATEMENT COVERS PERIOD                7
                                                                                                                                                                                                                                                                                                                                         5 FED. TAX NO.
                                              As with most newly FDA-approved products, temporary J-Codes and C-Codes are required                                                                                                                                                                                                                                                  FROM         THROUGH

                                              until a permanent code for EVENITY™ is established.                                                                      8 (BOX               Smith,
                                                                                                                                                                                   42) REVENUE CODES:James
                                                                                                                                                                         PATIENT NAME     a                                                                  9 PATIENT ADDRESS                  a
                                                                                                                                                                                                                                                                                                    123 Main Street, Anytown, Anystate 12345
                                              HCPCS Code (J-Code): J3590 (Unclassified biologics) or J3490 (Unclassified drugs)2,3                              Product
                                                                                                                                                                   b                                                                    b                                                                                                                                            c            d                                 e
                                                                                                                                                                                                         ADMISSION                                                                                                      CONDITION CODES                                                       29 ACDT 30
                                              Billing requirements for unclassified or miscellaneous codes may vary by payer; however, payers typically         Medicare:   Use revenue
                                                                                                                                                                   10 BIRTHDATE      11 SEX
                                                                                                                                                                                           code
                                                                                                                                                                                             12  0636, drugs
                                                                                                                                                                                                 DATE      13 HR 14requiring
                                                                                                                                                                                                                    TYPE 15 SRC 16 DHR 17 STAT   18    19                                      20                 21     22      23     24            25            26        27         28    STATE
  Coding Information in Box 44:               require providers to list product name, route of administration, total dosage, and NDC number(s)                  detailed coding.                                                                                                                              (BOX 46)
  (Electronic Form: Loop 2400,                for units used during the billing period in Box 80 (or corresponding field for electronic claims).*
                                                                                                                                                                   31
                                                                                                                                                                Other
                                                                                                                                                                         OCCURRENCE
                                                                                                                                                                       payers:DATE
                                                                                                                                                                    CODE
                                                                                                                                                                                        32
                                                                                                                                                                                Use revenue
                                                                                                                                                                                         CODE
                                                                                                                                                                                              OCCURRENCE
                                                                                                                                                                                                codeDATE
                                                                                                                                                                                                                33
                                                                                                                                                                                                      0250, general
                                                                                                                                                                                                                 CODE
                                                                                                                                                                                                                      OCCURRENCE
                                                                                                                                                                                                                             DATE
                                                                                                                                                                                                                                       34
                                                                                                                                                                                                                                        CODE
                                                                                                                                                                                                                                              OCCURRENCE
                                                                                                                                                                                                                                                    DATE
                                                                                                                                                                                                                                                                                                 35
                                                                                                                                                                                                                                                                                                 CODE         SERVICE
                                                                                                                                                                                                                                                                                                                  FROM  UNITS:
                                                                                                                                                                                                                                                                                                                 OCCURRENCE SPAN
                                                                                                                                                                                                                                                                                                                                THROUGH
                                                                                                                                                                                                                                                                                                                                                              36
                                                                                                                                                                                                                                                                                                                                                              CODE
                                                                                                                                                                                                                                                                                                                                                                              (BOX
                                                                                                                                                                                                                                                                                                                                                                               FROM
                                                                                                                                                                                                                                                                                                                                                                                   OCCURRENCE SPAN
                                                                                                                                                                                                                                                                                                                                                                                    47) THROUGH
                                                                                                                                                                                                                                                                                                                                                                                                                          37

  SV202-2 [SV202-1=HC/HP])8                                                                                                                                       a
                                                                                                                                                                pharmacy (or 0636, if required by a given payer).                                                                            Indicate 1 unit for one kit.                                                     TOTAL CHARGES:
                                                                                                                                                                                                                                                                                                                                                                                                                                              a

                                              C-Code: C9399 (Unclassified drugs or biologicals)11.
                                                                                                                                                                                                                                                                                             Each EVENITY™       kit
                                                                                                                                                                  b                                                                                                                                                                                                                                                                           b

                                                                                                                                                                Related
                                                                                                                                                                   38      Administration Procedure                                                                                                   39     VALUE CODES                                   40        Report   appropriate41charges
                                                                                                                                                                                                                                                                                                                                                                       VALUE CODES              VALUE CODES
                                              C-Codes are unique temporary pricing codes for hospital outpatient department services                                                                                                                                                         contains    one dose,
                                                                                                                                                                                                                                                                                                      CODE           which
                                                                                                                                                                                                                                                                                                                AMOUNT                                     CODE           AMOUNT          CODE     AMOUNT
                                                                                                                                                                Use most appropriate revenue code or cost center                                                                                   a                                                                 for product used and related
                                              and procedures.                                                                                                                                                                                                                                is 2 injections.                                                        procedures.
                                                                                                                                                                where services were performed (eg, 0510, clinic).                                                                                             b
                                              NDC number 55513-0880-02 can be used for billing purposes.4                                                                                                                                                                                                     c

  Service Units in Box 46:                    Indicate 1 unit for one kit. Each EVENITY™ kit contains one dose, which is 2 injections for a total                                                                                                                                                             d

                                              dose of 210 mg.4 The NDC number covers both injections.
                                                                                                                                                                       42 REV. CD.       43 DESCRIPTION                                                     44 HCPCS / RATE / HIPPS CODE                               45 SERV. DATE         46 SERV. UNITS              47 TOTAL CHARGES                 48 NON-COVERED CHARGES        49
  (Electronic Form: Loop 2400, SV205)8                                                                                                                            1
                                                                                                                                                                        0636               EVENITY 210 mg                                                    C9399                                                     MMDDYY                     1                                      XXXXX                                                1

                                                                                                                                                                        0510               Clinic                                                            96372                                                     MMDDYY                     1                                      XXXXX
Administration Coding Information*
                                                                                                                                                                  2                                                                                                                                                                                                                                                                           2

                                                                                                                                                                  3                                                                                                                                                                                                                                                                           3

                                                                                                                                                                                                                                                                                                                                                                                                                                                   HOSPITALS/INSTITUTIONS (CMS 1450)
                                                                                                                                                                  4                                                                                                                                                                                                                                                                           4

  Revenue Code in Box 42:                     Appropriate revenue code for the cost center in which the service is performed.
                                                                                                                                                                  5             (BOX 43) DESCRIPTION:                                                        (BOX 44) PRODUCT AND                                                                                                                                                             5

  (Electronic Form: Loop 2400, SV201)   8                                                                                                                         6
                                                                                                                                                                           Indicate the drug name and unit of                                                PROCEDURE CODES:                                                                                                                                                                 6

                                                                                                                                                                  7
                                                                                                                                                                           measure: EVENITY™ 210 mg.                                                 Product                                                                                                                                                                                  7

  Description in Box 43:                      Indicate drug name and unit of measure, for example EVENITY™ 210 mg.                                                8                                                                                                                                                                                                                                                                           8
                                                                                                                                                                                                                                                     Use C9399 (Unclassified drugs or biologics)
  (Not required by Medicare)8                                                                                                                                     9                                                                                                                                                                                                                                                                           9

                                                                                                                                                                                                                                                     Related Administration Procedure
                                              • 96372, therapeutic, prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous
                                                                                                                                                                  10                                                                                                                                                                                                                                                                          10

                                                                                                                                                                  11                                                                                 Use CPT code representing procedure performed,                                                                                                                                           11
                                                or intramuscular5                                                                                                                                                                                    such as 96372, therapeutic, prophylactic, or
  Coding Information in Box 44:                                                                                                                                   12                                                                                                                                                                                                                                                                          12

                                              • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in addition                     13                                                                                 diagnostic injection [specify substance or drug];                                                                                                                                        13
  (Electronic Form: Loop 2400,
                                                to other professional services, the following modifier may be required to distinguish it as a separate            14                                                                                 subcutaneous or intramuscular. Please note,                                                                                                                                              14

  SV202-2 [SV202-1=HC/HP])8                                                                                                                                                                                                                          each EVENITY™ kit contains one dose, which is 2
                                                service: -.25 (significant, separately identifiable evaluation and management service by the same                 15                                                                                                                                                                                                                                                                          15

                                                physician on the same day of the procedure or other service)                                                      16
                                                                                                                                                                                                                                                     injections. Applicable codes cover both injections.                                                                                                                                      16

                                              Each EVENITY™ kit contains one dose, which is 2 injections for a total dose of 210 mg. Applicable
                                                                                                                                           4
                                                                                                                                                                  17
                                                                                                                                                                                                                                                     Healthcare providers should consult the payer or                                                                                                                                         17

  Considerations:                             codes cover both injections.
                                                                                                                                                                  18

                                                                                                                                                                  19
                                                                                                                                                                                                                                                     Medicare contractor to determine which code is
                                                                                                                                                                                                                                                                                                                                                                                                                                              18

                                                                                                                                                                                                                                                                                                                                                                                                                                              19
                                                                                                                                                                                                                                                     most appropriate for administration of EVENITY™.
                                                                                                                                                                  20                                                                                                                                                                                                                                                                          20

Diagnosis/Condition Code Information*                                                                                                                             21

                                                                                                                                                                  22
                                                                                                                                                                                                                                                                                                                                                                                                                                              21

                                                                                                                                                                                                                                                                                                                                                                                                                                              22

 Revenue Code:                                N/A                                                                                                                 23
                                                                                                                                                                                         PAGE             OF                                                           CREATION DATE
                                                                                                                                                                                                                                                                                     52 REL.         53 ASG.
                                                                                                                                                                                                                                                                                                                                             TOTALS                                                                                           23

                                                                                                                                                                       50 PAYER NAME                                                 51 HEALTH PLAN ID                                                            54 PRIOR PAYMENTS               55 EST. AMOUNT DUE                     56 NPI
                                              Appropriate ICD-10-CM code(s) for patient condition.
                                                                                                                                                                                                                                                                                      INFO            BEN.

                                                                                                                                                                  A                                                                                                                                                                                                                      57                                                   A

                                              Sequencing of codes may vary based on patient’s condition and payer’s policy.                                       B                                                                                                                                                                                                                      OTHER                                                B

                                                                                                                                                                  C                                                                                                                                                                                                                      PRV ID                                               C
                                              The following primary ICD-10-CM diagnosis code may be appropriate to describe patients
                                                                                                                                                                       58 INSURED’S NAME                                                          59 P. REL 60 INSURED’S UNIQUE ID                                                     61 GROUP NAME                                     62 INSURANCE GROUP NO.

 ICD-10-CM Code in Box 66:                    with current osteoporotic fracture treated with EVENITY™:                                                           A
                                                                                                                                                                           (BOX 66) DIAGNOSIS CODES:                                                                                                                                                                                                                                          A

 (Electronic Form: Loop 2300,                 • M80.0 (Age-related osteoporosis with current pathological fracture)6                                            Indicate appropriate ICD diagnosis code as
                                                                                                                                                                  B                                                                                                                                                                                                                                                                           B

                                                                                                                                                                reflected in the patient’s medical record.
 HI01-2 [HI01-1=BK])8                         Please see page 6 for additional examples for patients with current osteoporotic fracture.                          C                                                                                                                                                                                                                                                                           C

                                                                                                                                                                ICD-10   code example:
                                                                                                                                                                    63 TREATMENT AUTHORIZATIONM80.0
                                                                                                                                                                                               CODES (Age-related                                                 64 DOCUMENT CONTROL NUMBER                                                                  65 EMPLOYER NAME
                                              The following primary ICD-10-CM diagnosis code may be appropriate to describe patients                            osteoporosis with current pathological fracture).
                                                                                                                                                                  A                                                                                                                                                                                                                                                                           A

                                              without current osteoporotic fracture treated with EVENITY™:                                                        B                                                                                                                                                                                                                                                                           B

                                              • M81.0 (Age-related osteoporosis without current pathological fracture)6,†                                         C                                                                                                                                                                                                                                                                           C

                                                                                                                                                                       66
                                                                                                                                                                       DX      67
                                                                                                                                                                             M80.0                        A    B                                      C                     D                                      E                        F                            G                        H                  68

*The sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would                                          I                    J    K                                      L                     M                                      N                        O                             P                       Q
 include FDA-approved indications for EVENITY™. Other codes may be more appropriate given internal system guidelines, payer requirements,                              69 ADMIT
                                                                                                                                                                          DX
                                                                                                                                                                                                  70 PATIENT
                                                                                                                                                                                                  REASON DX   a
                                                                                                                                                                                                 (BOX 80) REMARKS:
                                                                                                                                                                                                                                                 b                   c         71 PPS
                                                                                                                                                                                                                                                                                  CODE
                                                                                                                                                                                                                                                                                                                            72
                                                                                                                                                                                                                                                                                                                            ECI            a                             b                        c             73

 practice patterns, and the services rendered.                                                                                                                         74       PRINCIPAL PROCEDURE
                                                                                                                                                                              CODE              DATE
                                                                                                                                                                                                             a.            OTHER PROCEDURE
                                                                                                                                                                                                                        CODE            DATE
                                                                                                                                                                                                                                                             b.         OTHER PROCEDURE
                                                                                                                                                                                                                                                                     CODE              DATE
                                                                                                                                                                                                                                                                                                                       75
                                                                                                                                                                                                                                                                                                                                         76 ATTENDING         NPI                                       QUAL

†According to the ICD-10-CM Official Guidelines for Coding and Reporting, M81 code is for use with patients with osteoporosis who do not currently                                        Payers typically require providers to list product name, route of administration,                                                              LAST                                                         FIRST

 have a pathologic fracture due to the osteoporosis, even if they have had a fracture in the past. For patients with a history of osteoporosis fractures,              c.
                                                                                                                                                                                          total dosage, andd.NDCCODE
                                                                                                                                                                                  OTHER PROCEDURE
                                                                                                                                                                               CODE            DATE               number(s)    forDATE
                                                                                                                                                                                                                    OTHER PROCEDURE
                                                                                                                                                                                                                                    the units
                                                                                                                                                                                                                                           e.
                                                                                                                                                                                                                                              used
                                                                                                                                                                                                                                                CODEduring theDATE
                                                                                                                                                                                                                                                                 billing period.
                                                                                                                                                                                                                                                   OTHER PROCEDURE
                                                                                                                                                                                                                                                                                                                                         77 OPERATING         NPI                                       QUAL

 status code Z87.310 (personal history of [healed] osteoporosis fracture) should follow the code from the M81 category.7                                                                                                                                                                                                                 LAST                                                         FIRST
                                                                                                                                                                                                                                           81CC
                                                                                                                                                                       80 REMARKS                                                                                                                                                        78 OTHER             NPI                                       QUAL
                                                                                                                                                                                                                                              a

                                                                                                                                                                            EVENITY (romosozumab-aqqg),                                      b                                                                                           LAST                                                         FIRST

                                                                                                                                                                            subcutaneous, 210 mg
     Call Amgen Assist® for support with billing and coding questions: 1-866-AMG-ASST (1-866-264-2778)                                                                      NDC: 55513088002
                                                                                                                                                                                                                                             c

                                                                                                                                                                                                                                             d
                                                                                                                                                                                                                                                                                                                                         79 OTHER

                                                                                                                                                                                                                                                                                                                                         LAST
                                                                                                                                                                                                                                                                                                                                                              NPI                                       QUAL

                                                                                                                                                                                                                                                                                                                                                                                                      FIRST

     Monday through Friday, 9:00 am to 8:00 pm ET.                                                                                                                     UB-04 CMS-1450                         APPROVED OMB NO. 0938-0997
                                                                                                                                                                                                                                                                           NUBC
                                                                                                                                                                                                                                                                                      ™    National Uniform
                                                                                                                                                                                                                                                                                          Billing Committee
                                                                                                                                                                                                                                                                                                                                        THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.

                                                                                                                                                       4    5
PhysicianExamples of ICD-10-CM
                       Office Billing       Codes Relevant for Patients With Current
                                      Information
                                  Osteoporotic Fracture Treated With EVENITY™
                                                                 6
                                                                                                                                                                                    Hypothetical Scenarios Illustrating Specificity of M80.0_ _ _ ICD-10-CM Codes

EVENITY™ (romosozumab-aqqg)          Coding
            Age-related osteoporosis with      Information
                                          current pathological fracture                                                                                                             CLINICAL DIAGNOSIS DETAILS                                   POTENTIAL ICD-10-CM CODE6
         M80.0___
 Additional               (laterality) (anatomic site) (encounter type)*
               Claim Information
 in Box 19:                                EVENITY™ (romosozumab-aqqg), 210 mg, subcutaneous injection, NDC 55513088002
 (Electronic Form: Loop 2300,                                  Encounter    Type  †
                                                                                                                                                                                                                                                                  Age-related
 or 2400, NTE, 02)1                                                                                                                                                                                                                                               osteoporosis
                                                        Subsequent        Subsequent          Subsequent        Subsequent
                                                     As  with mostfor
                                                       encounter   newly FDA-approved
                                                                         encounter for products,   a temporary
                                                                                             encounter for     J-Code is required
                                                                                                               encounter  for     until a                                                                                                                         with current
       Anatomic Site                                                                                                                                                                                                                                              pathological
                                   Initial encounter permanent
                                                       fracture with      fracture with
                                                                 code for EVENITY™           fracture with
                                                                                     is established.           fracture with
       and Laterality                 for fracture    routine healing eddelayed  healing        nonunion ed drugs).
                                                                                                                 malunion          Sequela                                                                                                                          fracture
                                                     J3590  (Unclassifi   biologics) or J3490 (Unclassifi          2,3
                                                                                                                                                                                        • Postmenopausal osteoporosis
 Coding     Information
      UNSPECIFIED   SITE in Box   24D:
                               M80.00XA                         M80.00XD
                                                           Billing                M80.00XG
                                                                   requirements for                  M80.00XK
                                                                                    unclassified or miscellaneous codesM80.00XP         M80.00XS
                                                                                                                        may vary by payer;                                              • Vertebral fractures
      SHOULDER
 (Electronic  Form: Loop 2400, SV1, 01-2)1                 however, payers typically require providers to list product name, route of administration,                                   • Encounter for evaluating and continuing
       Right
       Left
                                M80.011A
                               M80.012A
                                                           totalM80.011D
                                                                 dosage, and NDC number(s)
                                                           corresponding
                                                                                 M80.011G for unitsM80.011K
                                                               M80.012D field forM80.012G
                                                                                                       used during the billing
                                                                                  electronic claims).*M80.012K
                                                                                                                               period in Box M80.011S
                                                                                                                         M80.011P
                                                                                                                         M80.012P
                                                                                                                                             19 (or
                                                                                                                                            M80.012S
                                                                                                                                                                                          treatment for the fractures                                             M80.08XA                                       Initial encounter
                                                                                                                                                                                                                                                                                                                    for fracture
       Unspecified             M80.019A                    NDCM80.019D           M80.019Gcan be used
                                                                 number 55513-0880-02                M80.019K            M80.019P
                                                                                                       for billing purposes. 4              M80.019S
      HUMERUS
 Number                                                                                                                                                                                                                                                                                Fracture of
       Right of Units in Box 24G:
                               M80.021A
                                                           Indicate 1 unit for one M80.021G
                                                               M80.021D
                                                                                   kit. Each EVENITY™M80.021K
                                                                                                      kit contains one dose, which is 2 injections
                                                                                                                        M80.021P
                                                                                                                                                   for a
                                                                                                                                            M80.021S
 (Electronic                                               total dose of 210 mg.4                                                                                                                                                                                                       vertebrae
       Left Form:   Loop 2400, SV1,
                               M80.022A                        M80.022D           M80.022G           M80.022K           M80.022P            M80.022S
 04 [03=UN])   1                                           The NDC number covers both injections.
       Unspecified             M80.029A                        M80.029D                M80.029G                M80.029K                M80.029P                M80.029S
      FOREARM
Administration and Professional
       Right              M80.031D Service
                                M80.031A     Coding Information*
                                        M80.031G    M80.031K  M80.031P                                                                   M80.031S
                                                                                                                                                                                    CLINICAL DIAGNOSIS DETAILS                                   POTENTIAL ICD-10-CM CODE
       Left                    M80.032A                       M80.032D          M80.032G            M80.032K             M80.032P        M80.032S
                                                          The following code may be available to report administration of EVENITY™. Other codes may
       Unspecified             M80.039A                       M80.039D on a payer-specifi
                                                          be appropriate        M80.039G c basis. ItM80.039K             M80.039P to ensure
                                                                                                     is the provider’s responsibility    M80.039S
                                                                                                                                            that
      HAND                                                codes used are consistent with payer policy and reflect service performed under such codes:
       Right                   M80.041A                        M80.041D              M80.041G              M80.041K               M80.041P         M80.041S                                                                                                       Age-related
                                                          • 96372 (therapeutic, prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous
 CodingLeftInformation in Box     24D:
                               M80.042A                        M80.042D              M80.042G              M80.042K               M80.042P         M80.042S                                                                                                       osteoporosis
                                                            or intramuscular) 5
                                                                                                                                                                                                                                                                  with current
 (Electronic  Form:
       Unspecified  Loop 2400, SV1, 01-2)1
                               M80.049A                       M80.049D               M80.049G              M80.049K              M80.049P          M80.049S
                                                          • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in                                                                                                                  pathological
      FEMUR                                                 addition to other professional services, the following modifier may be required to distinguish it as
       Right                    M80.051A                       M80.051D
                                                                                                                                                                                        • Postmenopausal osteoporosis                                               fracture                  Left
                                                            a separate  service: -.25M80.051G              M80.051K
                                                                                      (significant, separately                    M80.051P
                                                                                                               identifiable evaluation              M80.051S
                                                                                                                                       and management service by
                                                                                                                                                                                        • Fracture of left wrist
       Left                    M80.052A                     theM80.052D              M80.052G
                                                                 same physician on the                     M80.052Kor other service)
                                                                                         same day of the procedure                M80.052P         M80.052S
                                                                                                                                                                                        • Follow-up encounter for routine fracture                                                                                 Subsequent
       Unspecified             M80.059A                       M80.059D               M80.059G              M80.059K              M80.059P          M80.059S
 Considerations:
      LOWER LEG
       Right                   M80.061A
                                                          Each EVENITY™ kit contains one dose, which is 2 injections for a total dose of 210 mg.
                                                          Applicable codes cover both injections.
                                                               M80.061D                M80.061G                M80.061K                M80.061P
                                                                                                                                                          4

                                                                                                                                                               M80.061S
                                                                                                                                                                                          management (after active treatment
                                                                                                                                                                                          has been completed)                                                     M80.032D                                        encounter for
                                                                                                                                                                                                                                                                                                                  fracture with
                                                                                                                                                                                                                                                                                                                 routine healing
       Left                    M80.062A                        M80.062D                M80.062G                M80.062K                M80.062P                M80.062S
Diagnosis Code Information*
       Unspecified             M80.069A                        M80.069D                M80.069G                M80.069K                M80.069P                M80.069S
                                                                                                                                                                                                                                                                                    Fracture of
      ANKLE AND FOOT
                                                          The following primary ICD-10-CM diagnosis code may be appropriate to describe patients                                                                                                                                     forearm
       Right                    M80.071A
                                                          withM80.071D           M80.071G
                                                               current osteoporotic fracture treatedM80.071K
                                                                                                    with EVENITY™: M80.071P          M80.071S
       Left                    M80.072A                       M80.072D           M80.072G            M80.072K              M80.072P        M80.072S
                                                          • M80.0 (Age-related osteoporosis with current pathological fracture)6
       Unspecified
 ICD-10-CM                     M80.079A
                 Code in Box 21:                              M80.079D           M80.079G            M80.079K              M80.079P        M80.079S
      VERTEBRA(E)              M80.08XA                   Please see page 6 for additional
                                                              M80.08XD           M80.08XG examples     for patients with current
                                                                                                     M80.08XK                     osteoporotic
                                                                                                                           M80.08XP            fracture.
                                                                                                                                           M80.08XS
 (Electronic Form: Loop 2300, HI, 01-2)1
                                                  The following primary diagnosis code may be appropriate to describe patients
     See the next page for hypothetical scenarios      illustrating
                                                  without    currentspecifi  city of these
                                                                       osteoporotic         M80.0_
                                                                                       fracture     _ _ ICD-10-CM
                                                                                                treated              codes. The diagnosis code
                                                                                                         with EVENITY™:                                                             References: 1. Palmetto GBA. ASC 837 v5010 to CMS-1500 Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/CMS1500_837v5010_
     examples above and the hypothetical scenarios on back of the insert are informational and should not be a substitute                 for an
                                                  • M81.0 (Age-related osteoporosis without current pathological fracture)6,†                                                       Crosswalk.pdf/$File/CMS1500_837v5010_Crosswalk.pdf. Accessed February 14, 2019. 2. HCPCS.codes. HCPCS J-Codes. http://hcpcs.codes/j-codes/J3590/.
     independent clinical decision. They are not intended to be directive or a guarantee of reimbursement. The responsibility to determine                                          Accessed February 14, 2019. 3. HCPCS.codes. HCPCS J-Codes. http://hcpcs.codes/j-codes/J3490/. Accessed February 14, 2019. 4. EVENITY™ (romosozumab-aqqg)

                                                                                                                                                                                                                                                                                                                                                                                          ICD-10-CM CODE EX AMPLES
     coverage
*The sample    andare
            codes   reimbursement     parameters,
                       informational and            and
                                         not intended     appropriate
                                                       to be directive orcoding  for a of
                                                                          a guarantee  particular patient,and
                                                                                          reimbursement    is always  the responsibility
                                                                                                              include potential codes thatof the include
                                                                                                                                          would  provider                           prescribing information, Amgen. 5. American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) copyright 2016 American
     or physician.
 FDA-approved      Please contact
               indications          your payer
                            for EVENITY™.        with any
                                          Other codes  mayquestions.
                                                            be more appropriate given internal system guidelines, payer requirements, practice patterns,                            Medical Association. All rights reserved. 6. Centers for Disease Control and Prevention. 2019 ICD-10-CM tabular list of diseases and injuries. In: International
 and the services rendered.                                                                                                                                                         Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM). FY 2019. Full PDF. ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/
                                                                                                                                                                                    ICD10CM/2019/. Accessed February 14, 2019. 7. CMS. ICD-10-CM official guidelines for coding and reporting, FY 2019. https://www.cdc.gov/nchs/icd/
     *According
†According  to thetoICD-10-CM
                      the ICD-10-CM    OffiGuidelines
                                 Official   cial Guidelines for Coding
                                                      for Coding         and Reporting,
                                                                   and Reporting,           M80.0
                                                                                     M81 code        codes
                                                                                                  is for useare  forpatients
                                                                                                              with   patientswith
                                                                                                                               whoosteoporosis
                                                                                                                                      have a current
                                                                                                                                                   whopathologic   fracturehave
                                                                                                                                                          do not currently  at      data/10cmguidelines-FY2019-final.pdf. Accessed February 14, 2019. 8. Palmetto GBA. ASC 837I version 5010A2 Institutional Health Care Claim to the CMS-
      the timefracture
 a pathologic   of an encounter.
                         due to theTh e codes under
                                    osteoporosis,       M80if identify
                                                     even     they havethehad
                                                                           sitea of the fracture.
                                                                                 fracture           A code
                                                                                           in the past.   Forfrom  category
                                                                                                               patients  with M80,   not of
                                                                                                                              a history  a traumatic   fracture
                                                                                                                                            osteoporosis         code, should
                                                                                                                                                             fractures, status be   1450 Claim Form Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_
 codeused   for (personal
      Z87.310   any patienthistory
                             with known     osteoporosis
                                    of [healed]            who suff
                                                  osteoporosis       ers a fracture,
                                                                 fracture)            even the
                                                                            should follow    if the  patient
                                                                                                   code  fromhadtheaM81
                                                                                                                     minor  fall or trauma,
                                                                                                                         category.   7
                                                                                                                                             if that fall or trauma would not       v5010A2_crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. Accessed February 14, 2019. 9. Value
      usually break a normal, healthy bone.7                                                                                                                                        Healthcare Services. Understanding hospital revenue codes. http://valuehealthcareservices.com/education/
      †According to the ICD-10-CM Official Guidelines for Coding and Reporting, seventh character A is for use as long as the patient is receiving                                  understanding-hospital-revenue-codes/. Accessed February 14, 2019. 10. Centers for Medicare & Medicaid
       active
      Call    treatment
            Amgen        for the ®fracture.
                      Assist                Assignment
                                    for support        of the
                                                    with      seventh
                                                           billing  andcharacter
                                                                          coding is based on whether
                                                                                     questions:       the patient is undergoing(1-866-264-2778)
                                                                                                    1-866-AMG-ASST              active treatment and not                            Services. Publication 100-04: Medicare Claims Processing Manual. Chapter 17: drugs and biologicals. Section
       whether the provider is seeing the patient for the first time. Seventh character D is to be used for encounters after the patient has completed                              80.9: required modifiers for ESAs administered to non-ESRD patients. http://www.cms.gov/Regulations-
      Monday      through
       active treatment.       Friday,
                          The other       9:00
                                      seventh     am to listed
                                              characters, 8:00under
                                                                  pm each
                                                                       ET. subcategory in the Tabular List, are to be used for subsequent encounters for                            and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Accessed February 14, 2019. 11. HCPCS.codes.
       treatment of problems associated with healing, such as malunions, nonunions, and sequelae.7                                                                                  HCPCS C-Codes. http://hcpcs.codes/j-codes/C9399/. Accessed February 14, 2019.

                                                                                                                                                                               6
                                                                                                                                                                               2    7

                                                                                                                                                                                                                                                                                                                         USA-785-80323 04-19   All rights reserved.   © 2019 Amgen Inc.
                                                                 Please see additional Important Safety Information on the back cover.                                                                                                                                                                                                                       www.amgen.com                                           after rendering service
Considerations
                                                                          Important Safety Information
for Complete                                                              POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
                                                                          EVENITY™ may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY™ should not be initiated in patients who
Claim Submission                                                          have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other
                                                                          cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical
                                                                          attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY™ should be discontinued.
                                                                          In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite
                                                                          endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY™ compared to those
CORRECT AND COMPLETE PATIENT                                              treated with alendronate.
INFORMATION:
                                                                          Contraindications: EVENITY™ is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating
  Patient name                                                            therapy with EVENITY™. EVENITY™ is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any
  – ID number                                                             component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.
  – Health insurer name and/or                                            Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in
    group number                                                          EVENITY™-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and
                                                                          discontinue further use of EVENITY™.
  Provider name
                                                                          Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY™. Correct hypocalcemia prior to initiating EVENITY™. Monitor patients
  – National provider ID number
                                                                          for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement
  – Contact information                                                   patients with calcium and vitamin D while on EVENITY™.
                                                                          Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with
COLLECT EVENITY™ INFORMATION:                                             delayed healing, and has been reported in patients receiving EVENITY™. A routine oral exam should be performed by the prescriber prior to
  Correct HCPCS code and units                                            initiation of EVENITY™. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis
                                                                          inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral
  Diagnosis code to the highest level                                     hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.
  of specificity
                                                                          For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are
  – Primary diagnosis code
                                                                          suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may
  PA if available                                                         exacerbate the condition. Discontinuation of EVENITY™ should be considered based on benefit-risk assessment.
                                                                          Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving
INCLUDE REQUIRED SUPPLEMENTAL                                             EVENITY™. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.
DOCUMENTATION :                                                                                                                                                                                                                Th
                                                                          During EVENITY™ treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh        pe
  Original diagnostic T-score                                             or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY™ therapy should be considered based on           co
  Previous therapies                                                      benefit-risk assessment.                                                                                                                             thi
  – Reason for discontinuations                                           Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY™ were arthralgia and headache.

  Calcium levels                                                          EVENITY™ is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

  Prior fracture history                                                  Please see accompanying EVENITY™ full Prescribing Information, including Medication Guide.
  – Location of fracture
    (please provide ICD-10 number[s])
                                                                                                                                                                                                                               IND
  Cardiovascular risk assessment                                                                                                                                                                                               EV
  – List any documented myocardial                                                                                                                                                                                             os
                                                                                                                                                                                                                               Th
                                               ICD-10-CM CODE EX AMPLES

    infarction or stroke events within
    the last 12 months
                                                                                                                       BUSINESS CARD                                       BUSINESS CARD                                       12
                                                                                                                        CLEAR SLEEVE                                        CLEAR SLEEVE
  Copy of wholesaler invoice                                                                                                                                                                                                   IM
                                                                                                                                                                                                                               PO
CONFIRM BILLING AND PAYER                                                                                                                                                                                                      EV
REQUIREMENTS:                                                                                                                                                                                                                  EV
  Consult with software vendors and claims                                                                                                                                                                                     str
  clearinghouse on billing requirements                                                                                                                                                                                        pa
                                                                                                                                                                                                                               my
  Omit or include punctuation as required in                                                                                                                                                                                   if s
  submitted claims                                                                                                                                                                                                             the
  Follow required timeframe for submission                                One Amgen Center Drive
                                                                          Thousand Oaks, CA 91320-1799
  after rendering service                                                 www.amgen.com                                                                                                                                        Pl
                                                                          © 2019 Amgen Inc. All rights reserved. USA-785-80323 04-19

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