Your Guide to Evenity® Billing and Coding Information

Hypothetical Scenarios Illustrating Speciﬁcity of M80.0_ _ _ ICD-10-CM Codes

CLINICAL DIAGNOSIS DETAILS POTENTIAL ICD 10 CM CODE5

Age-related osteoporosis with current pathological • Postmenopausal osteoporosis fracture • Vertebral fractures • Encounter for evaluating and continuing Initial encounter treatment for the fractures M80.08XA for fracture

Fracture of vertebrae

CLINICAL DIAGNOSIS DETAILS POTENTIAL ICD 10 CM CODE

Age-related osteoporosis with current pathological • Postmenopausal osteoporosis fracture Left • Fracture of left wrist • Follow-up encounter for routine fracture Subsequent management (after active treatment encounter for has been completed) M80.032D fracture with routine healing

Fracture of forearm

References: 1. Palmetto GBA. ASC 837 v5010 to CMS-1500 Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/CMS1500_837v5010_ ICD10CM CODE EXAMPLES Crosswalk.pdf/$File/CMS1500_837v5010_Crosswalk.pdf. Accessed August 21, 2019. 2. Centers for Medicare and Medicaid Services. HCPCS Release Code Sets. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/Other-Codes-2019-July-Revised.zip. Accessed August 21, 2019. 3. EVENITY® (romosozumab-aqqg) prescribing information, Amgen. 4. American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) copyright 2016 American Medical Association. All rights reserved. 5. Centers for Disease Control and Prevention. 2019 ICD-10-CM tabular list of diseases and injuries. In: International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM). FY 2019. Full PDF. ftp://ftp.cdc.gov/pub/Health_Statistics/ NCHS/Publications/ICD10CM/2019/. Accessed August 21, 2019. 6. CMS. ICD-10-CM official guidelines for coding and reporting, FY 2019. https://www.cdc.gov/ nchs/icd/data/10cmguidelines-FY2019-final.pdf. Accessed August 21, 2019. 7. Palmetto GBA. ASC 837I version 5010A2 Institutional Health Care Claim to the CMS-1450 Claim Form Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_v5010A2_ crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. Accessed August 21, 2019. 8. Value Healthcare Services. Understanding hospital revenue codes. http://valuehealthcareservices.com/education/ understanding-hospital-revenue-codes/. Accessed August 21, 2019. 9. Centers for Medicare & Medicaid Services. Publication 100-04: Medicare Claims Processing Manual. Chapter 17: drugs and biologicals. Section 80.9: required modifiers for ESAs administered to non-ESRD patients. http://www.cms.gov/ Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Accessed August 21, 2019.

Please see additional Important Safety Information on the back cover. back the on Information Safety Important additional see Please

www.amgen.com

ousand Oaks, CA 91320-1799 CA Oaks, ousand

One Amgen Center Drive Center Amgen One

therapy, EVENITY therapy, should be discontinued. be should

if symptoms occur. If a patient experiences a myocardial infarction or stroke during stroke or infarction myocardial a experiences patient a If occur. symptoms if

myocardial infarction and stroke and instruct patients to seek prompt medical attention medical prompt seek to patients instruct and stroke and infarction myocardial

patients with other cardiovascular risk factors. Monitor for signs and symptoms of symptoms and signs for Monitor factors. risk cardiovascular other with patients

rendering service rendering

stroke within the preceding year. Consider whether the beneﬁ ts outweigh the risks in risks the outweigh ts beneﬁ the whether Consider year. preceding the within stroke

Follow required time frame for submission after after submission for frame time required Follow

should not be initiated in patients who have had a myocardial infarction or infarction myocardial a had have who patients in initiated be not should EVENITY

submitted claims submitted

EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. cardiovascular and stroke infarction, myocardial of risk the increase may

® ®

Omit or include punctuation as required in in required as punctuation include or Omit

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH CARDIOVASCULAR AND STROKE, INFARCTION, MYOCARDIAL OF RISK POTENTIAL

CONFIRM BILLING AND PAYER REQUIREMENTS: PAYER AND BILLING CONFIRM

IMPORTANT SAFETY INFORMATION SAFETY IMPORTANT

CLEAR SLEEVE CLEAR SLEEVE CLEAR

12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. considered. be should agent antiresorptive an with therapy continued warranted, remains therapy osteoporosis If doses. monthly 12 or stroke events within the last 12 months months 12 last the within events stroke or BUSINESS CARD CARD BUSINESS CARD BUSINESS

Confirm patients had no myocardial infarction infarction myocardial no had patients Confirm – e anabolic eff ect of EVENITY of ect eff anabolic e use should be limited to limited be should use EVENITY of duration the erefore, therapy. of doses monthly 12 after wanes

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ICD10CM CODE EXAMPLES CODE ICD10CM assessment risk Cardiovascular osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. osteoporosis available other to intolerant are or failed have who patients or fracture; for factors risk multiple or fracture, osteoporotic

Risk factors for fracture for factors Risk EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, deﬁ ned as a history of of history a as ned deﬁ fracture, for risk high at women postmenopausal in osteoporosis of treatment the for indicated is

INDICATION Referring physician orders physician Referring

(please provide ICD-10 number[s]) ICD-10 provide (please

Location of fracture fracture of Location –

full Prescribing Information, including Medication Guide. Medication including Information, Prescribing full EVENITY accompanying see Please

1-866-AMG-ASST (1-866-264-2778) Monday through Friday, 9:00 am to 8:00 pm ET. pm 8:00 to am 9:00 Friday, through Monday (1-866-264-2778) ®

Prior osteoporosis-related fracture history fracture osteoporosis-related Prior

Amgen Assist Amgen Call Call for assistance with speciﬁ c payer requirements: requirements: payer c speciﬁ with assistance for

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

® ® Calcium levels Calcium

Adverse Reactions: Adverse e most common adverse reactions (≥ 5%) reported with EVENITY with reported 5%) (≥ reactions adverse common most e were arthralgia and headache. and arthralgia were

Reason for discontinuations for Reason ® –

Previous therapies Previous beneﬁt-risk assessment. beneﬁt-risk this guide should in no way be considered a guarantee of coverage or reimbursement for any product or service. or product any for reimbursement or coverage of guarantee a considered be way no in should guide this

or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY of Interruption fracture. femur incomplete an out rule to evaluated be should pain groin or therapy should be considered based on on based considered be should therapy

coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. e information provided in in provided information e physician. or provider the of responsibility the always is procedure, and/or patient particular a for coding predicted fracture risk fracture predicted ®

Original diagnostic T-score and/or FRAX FRAX and/or T-score diagnostic Original treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh thigh with presents who patient Any pain. groin or hip, thigh, unusual or new report to advised be should patients treatment, EVENITY During

periodically and often without warning. e responsibility to determine coverage and reimbursement parameters, and appropriate appropriate and parameters, reimbursement and coverage determine to responsibility e warning. without often and periodically ®

EUT N AEA PRPIT: APPROPRIATE AS DATE AND RESULTS

e information provided in this guide is of a general nature and for informational purposes only. Coding and coverage policies change change policies coverage and Coding only. purposes informational for and nature general a of is guide this in provided information e EVENITY . Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated. treated. been not have who patients osteoporotic in occur also fractures these as established been not has Causality .

CONSIDERATIONS INCLUDING TEST INCLUDING CONSIDERATIONS

Atypical Femoral Fractures: Femoral Atypical Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving receiving patients in reported been have shaft femoral the of fractures trauma low or low-energy Atypical

SUPPLEMENTAL DOCUMENTATION SUPPLEMENTAL

exacerbate the condition. Discontinuation of EVENITY of Discontinuation condition. the exacerbate should be considered based on beneﬁt-risk assessment. beneﬁt-risk on based considered be should

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 may ONJ treat to surgery dental patients, these In surgeon. oral an or dentist a by care receive should ONJ develop who or having of suspected

NDC reporting reporting NDC

Medicaid and commercial payers may require require may payers commercial and Medicaid For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are are who Patients patient. each of plan management the guide should judgment clinical procedures, dental invasive requiring patients For

(if required) (if

hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. coagulopathy. and anemia, infection, or disease dental pre-existing hygiene,

Determine prior authorization criteria authorization prior Determine

inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral oral poor radiotherapy, cancer, include ONJ for factors risk Other ONJ. developing of risk the increase may corticosteroids) and inhibitors,

FOR HOSPITALS/INSTITUTIONS HOSPITALS/INSTITUTIONS FOR USING THE CMS 1450 CMS THE USING Identify appropriate administration code administration appropriate Identify

initiation of EVENITY of initiation . Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis angiogenesis denosumab, bisphosphonates, (chemotherapy, ONJ with associated drugs of administration Concomitant .

delayed healing, and has been reported in patients receiving EVENITY receiving patients in reported been has and healing, delayed . A routine oral exam should be performed by the prescriber prior to to prior prescriber the by performed be should exam oral routine A .

® Primary diagnosis code diagnosis Primary –

Osteonecrosis of the Jaw (ONJ): (ONJ): Jaw the of Osteonecrosis ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with with infection local and/or extraction tooth with associated generally is spontaneously, occur can which ONJ,

Diagnosis code to the highest level of speciﬁcity of level highest the to code Diagnosis

patients with calcium and vitamin D while on EVENITY on while D vitamin and calcium with patients . .

Correct HCPCS code and units and code HCPCS Correct ®

for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement supplement Adequately dialysis. receiving or impairment renal severe with patients in particularly hypocalcemia, of symptoms and signs for

FOR PHYSICIAN OFFICES OFFICES PHYSICIAN FOR USING THE CMS 1500 CMS THE USING

COLLECT PRODUCT AND BILLING INFORMATION: BILLING AND PRODUCT COLLECT

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY receiving patients in occurred has Hypocalcemia . Monitor patients patients Monitor . EVENITY initiating to prior hypocalcemia Correct .

® ®

. EVENITY of use further Contact information Contact

– ®

-treated patients. If an anaphylactic or other clinically signiﬁcant allergic reaction occurs, initiate appropriate therapy and discontinue discontinue and therapy appropriate initiate occurs, reaction allergic signiﬁcant clinically other or anaphylactic an If patients. -treated EVENITY

National provider ID number ID provider National –

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in in occurred have urticaria and rash, dermatitis, multiforme, erythema angioedema, including reactions, Hypersensitivity Provider name Provider

INFORMATION – Health insurer name and/or group number group and/or name insurer Health – component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria. and multiforme, erythema angioedema, included have Reactions formulation. product the of component

is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any any to or romosozumab to hypersensitivity systemic of history a with patients in contraindicated is EVENITY . EVENITY with therapy

– ID number ID –

® ®

Contraindications: Contraindications: is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating initiating to prior corrected be must hypocalcemia Pre-existing hypocalcemia. with patients in contraindicated is EVENITY Patient name Patient ®

BILLING AND CODING AND BILLING

INFORMATION: treated with alendronate. with treated

CORRECT AND COMPLETE PATIENT COMPLETE AND CORRECT

endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY with treated patients in stroke, nonfatal and infarction myocardial nonfatal death, cardiovascular of endpoint compared to those those to compared

® In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite composite a (MACE), events cardiac adverse major of rate higher a was there women, postmenopausal in trial controlled randomized a In

YOUR GUIDE TO EVENITY TO GUIDE YOUR

attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY therapy, during stroke or infarction myocardial a experiences patient a If occur. symptoms if attention should be discontinued. be should

cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical prompt seek to patients instruct and stroke and infarction myocardial of symptoms and signs for Monitor factors. risk cardiovascular

have had a myocardial infarction or stroke within the preceding year. Consider whether the beneﬁts outweigh the risks in patients with other with patients in risks the outweigh beneﬁts the whether Consider year. preceding the within stroke or infarction myocardial a had have Claim Submission Claim

EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY death. cardiovascular and stroke infarction, myocardial of risk the increase may should not be initiated in patients who patients in initiated be not should

® ®

for Complete for POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH CARDIOVASCULAR AND STROKE, INFARCTION, MYOCARDIAL OF RISK POTENTIAL

Considerations Important Safety Information Safety Important Physician Oﬃ ce Billing Information Completing the CMS 1500 for Physician Oﬃ ces PHYSICIAN OFFICES CMS OFFICES 1500PHYSICIAN

EVENITY® (romosozumab-aqqg) Coding Information Additional Claim Information in Box 19: EVENITY® (romosozumab-aqqg), 210 mg (Electronic Form: Loop 2300, or 2400, NTE, 02)1

Coding Information in Box 24D: HCPCS code (J-code): J3111 (injection, romosozumab-aqqg, 1 mg)2 (Electronic Form: Loop 2400, SV1, 01-2)1

® X XXX-XX-XXXX Number of Units in Box 24G: Indicate 210 units for one kit. Each EVENITY kit contains one dose, which is 2 injections for a total dose of 210 mg.3 (Electronic Form: Loop 2400, SV1, Doe, Jane J 06 01 1930 X Doe, Jane J 04 [03=UN])1 e NDC number covers both injections. 1123 Main Street Administration and Professional Service Coding Information* Hometown MA ® e following code may be available to report administration of EVENITY . Other codes may 01234 XXX XXX-XXXX be appropriate on a payer-specifi c basis. It is the provider’s responsibility to ensure that codes used are consistent with payer policy and refl ect service performed under such codes: 11111 Coding Information in Box 24D: • 96372 (therapeutic, prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous or intramuscular)4 X 06 01 1930 X (Electronic Form: Loop 2400, SV1, 01-2)1 • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in X addition to other professional services, the following modifi er may be required to distinguish it as ABC Employer a separate service: -.25 (signifi cant, separately identifi able evaluation and management service by X the same physician on the same day of the procedure or other service) X Each EVENITY® kit contains one dose, which is 2 injections for a total dose of 210 mg.3 BOX 21 DIAGNOSIS BOX 19 ADDITIONAL OR NATURE OF Considerations: Applicable codes cover both injections. CLAIM INFORMATION: ILLNESS OR INJURY: Indicate EVENITY® Indicate appropriate ICD diagnosis Diagnosis Code Information* (romosozumab-aqqg), 210 mg3 code as refl ected in the patient’s medical record. ICD-10 code e following primary ICD-10-CM diagnosis code may be appropriate to describe patients example: M80.0 (Age-related BOX 24G DAYS with current osteoporotic fracture treated with EVENITY®: osteoporosis with current OR UNITS: • M80.0 (Age-related osteoporosis with current pathological fracture)5 pathological fracture). Indicate 210 units for one kit.3 EVENITY® (romosozumab-aqqg), 210 mg ICD-10-CM Code in Box 21: Please see page 6 for additional examples for patients with current osteoporotic fracture. ® 1 Each EVENITY kit contains (Electronic Form: Loop 2300, HI, 01-2) one dose, which is 2 injections. e following primary diagnosis code may be appropriate to describe patients M80.0 without current osteoporotic fracture treated with EVENITY®: • M81.0 (Age-related osteoporosis without current pathological fracture) 5,†

N4 55513088002 ML2.34 01 23 14 01 23 14 11 J3111 XXX XX 210 * e sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include FDA-approved indications for EVENITY®. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, BOX01 24A23 14 01 23 14 11 96372 XXX XX 1 and the services rendered. SHADED BOX: † According to the ICD-10-CM Oﬃ cial Guidelines for Coding and Reporting, M81 code is for use with patients with osteoporosis who do not currently have a Medicaid and commercial BOX 24D PROCEDURES, SERVICES, OR SUPPLIES: 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 code payers may require NDC 6 Indicate appropriate HCPCS and CPT codes. Example: J3111 (injection, Z87.310 (personal history of [healed] osteoporosis fracture) should follow the code from the M81 category. ® reporting for EVENITY romosozumab-aqqg, 1 mg). 96372 ( erapeutic, prophylactic, or diagnostic submissions. injection [specify substance or drug]; subcutaneous or intramuscular).2 Please note: Each EVENITY® kit contains one dose, which is 2 injections. Call Amgen Assist® for support with billing and coding questions: 1-866-AMG-ASST (1-866-264-2778) Applicable codes cover both injections. Monday through Friday, 9:00 am to 8:00 pm ET. 11-1111111 X X XXX XX John Smith MD 2 Doctors Blvd 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 ______8 Medicare: 0636, drugs requiring detailed coding. 1 2 3a PAT. 4 TYPE Revenue Code in Box 42: CNTL # OF BILL 7 8,9 Anytown Hospital b. MED. (Electronic Form: Loop 2400, SV201) Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer. REC. # 100 Main Street 6 STATEMENT COVERS PERIOD 7 5 FED. TAX NO. Coding Information in Box 44: Anytown, Anystate 01010 FROM THROUGH (Electronic Form: Loop 2400, HCPCS Code (J-Code): J3111 (injection, romosozumab-aqqg, 1 mg)2 8 BOX PATIENT NAME 42 REVENUEa Smith, CODES: James 9 PATIENT ADDRESS a 7 123 Main Street, Anytown, Anystate 12345 SV202-2 [SV202-1=HC/HP]) Productb b c d e ADMISSION CONDITION CODES 30 10 BIRTHDATE 11 SEX 16 DHR 17 STAT 29 ACDT Indicate 210 units for one kit. Each EVENITY® kit contains one dose, which is 2 injections for a Medicare: Use revenue code12 DATE0636, drugs13 HR 14 requiring TYPE 15 SRC 18 19 20 21 22 23 24 25 26 27 28 STATE 3 detailed coding. BOX 46 Service Units in Box 46: total dose of 210 mg. 31 OCCURRENCE 32 OCCURRENCE 33 OCCURRENCE 34 OCCURRENCE 35 OCCURRENCE SPAN 36 OCCURRENCE SPAN 37 7 OtherCODE payers: DATEUse revenueCODE codeDATE 0250, generalCODE DATE CODE DATE CODESERVICEFROM UNITS:THROUGH CODE BOX FROM 47 THROUGH (Electronic Form: Loop 2400, SV205) a a e NDC number covers both injections.3 pharmacy (or 0636, if required by a given payer). Indicate 210 units for one TOTAL CHARGES: b kit.3 Each EVENITY® kit b Related38 Administration Procedure 39 VALUE CODES 40 ReportVALUE CODESappropriate41 chargesVALUE CODES containsCODE one dose, AMOUNT which CODE AMOUNT CODE AMOUNT Use most appropriate revenue code or cost center a for product used and related Administration Coding Information* is 2 injections. where services were performed (eg, 0510, clinic). b procedures. c Revenue Code in Box 42: Appropriate revenue code for the cost center in which the service is performed. (Electronic Form: Loop 2400, SV201)7 d 42 REV.REV. CD.CD. 43 DESCRIPTION 44 HCPCS / RATERATE / HIPPS CODE 45 SE SERV.RV. D DATEATE 46 SE SERV.RV. UNITS 47 TOTTALAL CHARGES 48 NON-COVERED CHARGES 49 Description in Box 43: 1 ® 1 Indicate drug name and unit of measure, for example, EVENITY® 210 mg. 0636 EVENITY 210 mg J3111 MMDDYY 210 XXXXX (Not required by Medicare)7 2 0510 Clinic 96372 MMDDYY 1 XXXXX 2 3 3

• 96372 (therapeutic, prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous HOSPITALS/INSTITUTIONSCMS 1450 4 4 or intramuscular)4 Coding Information in Box 44: 5 BOX 43 DESCRIPTION: BOX 44 PRODUCT AND 5 • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in addition 6 6 (Electronic Form: Loop 2400, Indicate the drug name and unit of PROCEDURE CODES: 7 ® 7 7 to other professional services, the following modifi er may be required to distinguish it as a separate measure: EVENITY 210 mg. Product SV202-2 [SV202-1=HC/HP]) 8 8 service: -.25 (signifi cant, separately identifi able evaluation and management service by the same Use J3111 (injection, romosozumab-aqqg, physician on the same day of the procedure or other service) 9 9 10 1 mg) 10 ® 3 Each EVENITY kit contains one dose, which is 2 injections for a total dose of 210 mg. Applicable 11 Related Administration Procedure 11 Considerations: codes cover both injections. 12 Use CPT code representing procedure performed, 12 13 such as 96372 (therapeutic, prophylactic, or 13 14 diagnostic injection [specify substance or drug]; 14 Diagnosis/Condition Code Information* 15 subcutaneous or intramuscular). 15 Revenue Code: N/A 16 Please note: Each EVENITY® kit contains one dose, 16 17 which is 2 injections. Applicable codes cover both 17 Appropriate ICD-10-CM code(s) for patient condition. 18 18 injections. Healthcare providers should consult the Sequencing of codes may vary based on patient’s condition and payer’s policy. 19 payer or Medicare contractor to determine which code 19 20 20 is most appropriate for administration of EVENITY®.3 e following primary ICD-10-CM diagnosis code may be appropriate to describe patients 21 21 ® ICD-10-CM Code in Box 66: with current osteoporotic fracture treated with EVENITY : 22 22 (Electronic Form: Loop 2300, • M80.0 (Age-related osteoporosis with current pathological fracture)5 23 PAGE OF CREATION DATE TOTALS 23 52 REL. 53 ASG. 50 PAYER NAME 51 HEALTH PLAN ID 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI HI01-2 [HI01-1=BK])7 Please see page 6 for additional examples for patients with current osteoporotic fracture. INFO BEN. A 57 A

e following primary ICD-10-CM diagnosis code may be appropriate to describe patients B OTHER B without current osteoporotic fracture treated with EVENITY®: C PRV ID C • M81.0 (Age-related osteoporosis without current pathological fracture)5,† 58 BOX INSURED’S 66 NAME DIAGNOSIS CODES: 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO. A A

IndicateB appropriate ICD diagnosis code as B

reﬂC ected in the patient’s medical record. C

ICD-1063 TREATMENT code example: AUTHORIZATION M80.0 CODES (Age-related 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME

* e sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would osteoporosisA with current pathological fracture). A ® include FDA-approved indications for EVENITY . Other codes may be more appropriate given internal system guidelines, payer requirements, B B practice patterns, and the services rendered. C C † 66 68 According to the ICD-10-CM Offi cial Guidelines for Coding and Reporting, M81 code is for use with patients with osteoporosis who do not currently DX M80.067 ABCDEFGA B C D E F G H 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, IIJKLJ K L M NNOPQO P Q 6 69 ADMIT 70 PATIENT 71 PPS 72 73 status code Z87.310 (personal history of [healed] osteoporosis fracture) should follow the code from the M81 category. DX REASON DX a b c CODE ECI a b c 74 PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE 75 QUAL CODE BOXDATE 80 REMARKS:CODE DATE CODE DATE 76 ATTENDING NPI Payers typically require providers to list product name, route of administration, LAST FIRST c. OTHER PROCEDURE d. OTHER PROCEDURE e. OTHER PROCEDURE QUAL CODE total dosage,DATE and NDCCODE number(s) forDATE the units usedCODE during theDATE billing period. 77 OPERATING NPI ® LAST FIRST 81CC Call Amgen Assist for support with billing and coding questions: 1-866-AMG-ASST (1-866-264-2778) QUAL 80 REMARKS a 78 OTHER NPI Monday through Friday, 9:00 am to 8:00 pm ET. EVENITY® (romosozumab-aqqg), b LAST FIRST subcutaneous, 210 mg c 79 OTHER NPI QUAL N4 55513088002 ML2.34 d LAST FIRST UB-04 CMS-1450 APPROVED OMB NO. 0938-0997 THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. ™ National Uniform NUBC Billing Committee 4 5 PhysicianExamples Office Billing of ICD-10-CM Information Codes Relevant for Patients With Current Osteoporotic Fracture Treated With EVENITY® 5 Hypothetical Scenarios Illustrating Specifi city of M80.0_ _ _ ICD-10-CM Codes

® EVENITY (romosozumab-aqqg)Age-related osteoporosis Coding with current Information pathological fracture CLINICAL DIAGNOSIS DETAILS POTENTIAL ICD 10 CM CODE5 AdditionalM80.0___ Claim Information(laterality) (anatomic site) (encounter type)* in Box 19: EVENITY® (romosozumab-aqqg), 210 mg † (Electronic Form: Loop 2300, Encounter Type Age-related or 2400, NTE, 02)1 Subsequent Subsequent Subsequent Subsequent osteoporosis CodingAnatomic Information Site in Box 24D: HCPCSencounter code for(J-code): encounter J3111 (injection, for romosozumab-aqqg,encounter for encounter 1 mg) effective for October 1st, 2019.2 with current 1 3 pathological (Electronicand Laterality Form: Loop 2400,Initial SV1, encounter 01-2) NDCfracture number: with 55513-0880-02 fracture with fracture with fracture with for fracture routine healing delayed healing nonunion malunion Sequela • Postmenopausal osteoporosis fracture Number of Units in Box 24G: Indicate 210 units for one kit. Each EVENITY® kit contains one dose, which is 2 injections for UNSPECIFIED SITE M80.00XA M80.00XD M80.00XG3 M80.00XK M80.00XP M80.00XS • Vertebral fractures (Electronic Form: Loop 2400, SV1, a total dose of 210 mg. SHOULDER • Encounter for evaluating and continuing 04 [03=UN])1 e NDC number covers both injections. Initial encounter Right M80.011A M80.011D M80.011G M80.011K M80.011P M80.011S treatment for the fractures M80.08XA for fracture Left M80.012A M80.012D M80.012G M80.012K M80.012P M80.012S AdministrationUnspecifi ed andM80.019A Professional M80.019D Service M80.019G Coding M80.019KInformation* M80.019P M80.019S HUMERUS e following code may be available to report administration of EVENITY®. Other codes may Fracture of Right M80.021Abe appropriate M80.021D on a payer-specific M80.021G basis. It M80.021Kis the provider’s responsibility M80.021P to ensure M80.021S that vertebrae Left M80.022Acodes M80.022D used are consistent M80.022G with payer policy M80.022K and reflect service M80.022P performed under M80.022Ssuch codes: Unspecifi ed M80.029A M80.029D M80.029G M80.029K M80.029P M80.029S Coding Information in Box 24D: • 96372 (therapeutic, prophylactic, or diagnostic injection [specify substance or drug]; subcutaneous FOREARM or intramuscular)4 (Electronic Form: Loop 2400, SV1, 01-2)1 Right M80.031A• Relevant M80.031D evaluation and M80.031G management (E&M) M80.031K code. Note when an M80.031P E&M service is billed M80.031S in CLINICAL DIAGNOSIS DETAILS POTENTIAL ICD 10 CM CODE Left M80.032Aaddition M80.032D to other professional M80.032G services, the following M80.032K modifier may M80.032P be required to distinguish M80.032S it as Unspecifi ed M80.039Aa separate M80.039D service: -.25 M80.039G (significant, separately M80.039K identifiable evaluation M80.039P and management M80.039S service by HAND the same physician on the same day of the procedure or other service) Right M80.041A M80.041D M80.041G M80.041K M80.041P M80.041S Age-related Each EVENITY® kit contains one dose, which is 2 injections for a total dose of 210 mg.3 Left M80.042A M80.042D M80.042G M80.042K M80.042P M80.042S osteoporosis Considerations: Applicable codes cover both injections. Unspecifi ed M80.049A M80.049D M80.049G M80.049K M80.049P M80.049S with current FEMUR pathological • Postmenopausal osteoporosis fracture DiagnosisRight Code Information*M80.051A M80.051D M80.051G M80.051K M80.051P M80.051S Left • Fracture of left wrist Left M80.052A M80.052D M80.052G M80.052K M80.052P M80.052S e following primary ICD-10-CM diagnosis code may be appropriate to describe patients • Follow-up encounter for routine fracture Subsequent Unspecifi ed M80.059A M80.059D M80.059G M80.059K® M80.059P M80.059S with current osteoporotic fracture treated with EVENITY : management (after active treatment encounter for LOWER LEG • M80.0 (Age-related osteoporosis with current pathological fracture)5 has been completed) M80.032D fracture with Right M80.061A M80.061D M80.061G M80.061K M80.061P M80.061S ICD-10-CM Code in Box 21: Please see page 6 for additional examples for patients with current osteoporotic fracture. routine healing (ElectronicLeft Form: Loop 2300, HI,M80.062A 01-2)1 M80.062D M80.062G M80.062K M80.062P M80.062S Unspecifi ed M80.069Ae M80.069Dfollowing primary diagnosis M80.069G code may M80.069K be appropriate to M80.069Pdescribe patients M80.069S ® Fracture of ANKLE AND FOOT without current osteoporotic fracture treated with EVENITY : forearm Right M80.071A• M81.0 M80.071D (Age-related osteoporosis M80.071G without current M80.071K pathological fracture) M80.071P 5,† M80.071S Left M80.072A M80.072D M80.072G M80.072K M80.072P M80.072S Unspecifi ed M80.079A M80.079D M80.079G M80.079K M80.079P M80.079S VERTEBRA(E) M80.08XA M80.08XD M80.08XG M80.08XK M80.08XP M80.08XS *e sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include FDA-approvedSee the next indications page for for hypothetical EVENITY®. Other scenarios codes may illustrating be more specifi appropriate city of given these internal M80.0_ system _ _ ICD-10-CM guidelines, payer codes. requirements, e diagnosis practice code patterns, and examplesthe services above rendered. and the hypothetical scenarios on back of the insert are informational and should not be a substitute for an

References: 1. Palmetto GBA. ASC 837 v5010 to CMS-1500 Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/fi les/CMS1500_837v5010_ ICD10CM CODE EXAMPLES †According independent to the ICD-10-CM clinical decision. Official Guidelines ey are fornot Coding intended and toReporting, be directive M81 code or a isguarantee for use with of patients reimbursement. with osteoporosis e responsibility who do not currentlyto determine have a Crosswalk.pdf/$File/CMS1500_837v5010_Crosswalk.pdf. Accessed August 21, 2019. 2. Centers for Medicare and Medicaid Services. HCPCS Release Code Sets. pathologiccoverage fracture and duereimbursement to the osteoporosis, parameters, even if they and haveappropriate had a fracture coding in thefor past.a particular For patients patient, with isa historyalways of the osteoporosis responsibility fractures, of the status provider code https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/Other-Codes-2019-July-Revised.zip. Accessed August 21, 2019. 3. EVENITY® 6 Z87.310or physician. (personal historyPlease of contact [healed] your osteoporosis payer with fracture) any questions. should follow the code from the M81 category. (romosozumab-aqqg) prescribing information, Amgen. 4. American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) copyright 2016 American Medical Association. All rights reserved. 5. Centers for Disease Control and Prevention. 2019 ICD-10-CM tabular list of diseases and injuries. In: International Classifi cation of Diseases, 10th Revision, Clinical Modifi cation (ICD-10-CM). FY 2019. Full PDF. ftp://ftp.cdc.gov/pub/Health_Statistics/ * According to the ICD-10-CM Offi cial Guidelines for Coding and Reporting, M80.0 codes are for patients who have a current pathologic fracture at NCHS/Publications/ICD10CM/2019/. Accessed August 21, 2019. 6. CMS. ICD-10-CM offi cial guidelines for coding and reporting, FY 2019. https://www.cdc.gov/ the time of an encounter.® e codes under M80 identify the site of the fracture. A code from category M80, not a traumatic fracture code, should be nchs/icd/data/10cmguidelines-FY2019-fi nal.pdf. Accessed August 21, 2019. 7. Palmetto GBA. ASC 837I version 5010A2 Institutional Health Care Claim to the Callused Amgen for any patient Assist with known for support osteoporosis with who billing suff ers anda fracture, coding even questions:if the patient had 1-866-AMG-ASST a minor fall or trauma, if (1-866-264-2778) that fall or trauma would not CMS-1450 Claim Form Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/fi les/EDI_837I_v5010A2_ 6 Mondayusually break through a normal, Friday, healthy bone. 9:00 am to 8:00 pm ET. crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. Accessed August 21, 2019. 8. Value Healthcare † According to the ICD-10-CM Offi cial Guidelines for Coding and Reporting, seventh character A is for use as long as the patient is receiving active Services. Understanding hospital revenue codes. http://valuehealthcareservices.com/education/ treatment for the fracture. Assignment of the seventh character is based on whether the patient is undergoing active treatment and not whether understanding-hospital-revenue-codes/. Accessed August 21, 2019. 9. Centers for Medicare & Medicaid the provider is seeing the patient for the fi rst time. Seventh character D is to be used for encounters after the patient has completed active Services. Publication 100-04: Medicare Claims Processing Manual. Chapter 17: drugs and biologicals. treatment. e other seventh characters, listed under each subcategory in the Tabular List, are to be used for subsequent encounters for treatment Section 80.9: required modifi ers for ESAs administered to non-ESRD patients. http://www.cms.gov/ of problems associated with healing, such as malunions, nonunions, and sequelae.6 Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Accessed August 21, 2019.

62 7

Please see additional Important Safety Information on the back cover. back the on Information Safety Important additional see Please

www.amgen.com

ousand Oaks, CA 91320-1799 CA Oaks, ousand

One Amgen Center Drive Center Amgen One

therapy, EVENITY therapy, should be discontinued. be should

if symptoms occur. If a patient experiences a myocardial infarction or stroke during stroke or infarction myocardial a experiences patient a If occur. symptoms if

myocardial infarction and stroke and instruct patients to seek prompt medical attention medical prompt seek to patients instruct and stroke and infarction myocardial

patients with other cardiovascular risk factors. Monitor for signs and symptoms of symptoms and signs for Monitor factors. risk cardiovascular other with patients

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stroke within the preceding year. Consider whether the beneﬁts outweigh the risks in risks the outweigh beneﬁts the whether Consider year. preceding the within stroke

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should not be initiated in patients who have had a myocardial infarction or infarction myocardial a had have who patients in initiated be not should EVENITY

submitted claims submitted

EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. cardiovascular and stroke infarction, myocardial of risk the increase may

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POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH CARDIOVASCULAR AND STROKE, INFARCTION, MYOCARDIAL OF RISK POTENTIAL

CONFIRM BILLING AND PAYER REQUIREMENTS: PAYER AND BILLING CONFIRM

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CLEAR SLEEVE CLEAR SLEEVE CLEAR

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INDICATION Referring physician orders physician Referring

(please provide ICD-10 number[s]) ICD-10 provide (please

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full Prescribing Information, including Medication Guide. Medication including Information, Prescribing full EVENITY accompanying see Please

1-866-AMG-ASST (1-866-264-2778) Monday through Friday, 9:00 am to 8:00 pm ET. pm 8:00 to am 9:00 Friday, through Monday (1-866-264-2778) ®

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Amgen Assist Amgen for assistance with speciﬁc payer requirements: requirements: payer speciﬁc with assistance for Call

® ® Calcium levels Calcium

Adverse Reactions: Adverse e most common adverse reactions (≥ 5%) reported with EVENITY with reported 5%) (≥ reactions adverse common most e were arthralgia and headache. and arthralgia were

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therapy should be considered based on on based considered be should therapy EVENITY of Interruption fracture. femur incomplete an out rule to evaluated be should pain groin or

coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. e information provided in provided information e physician. or provider the of responsibility the always is procedure, and/or patient particular a for coding predicted fracture risk fracture predicted ®

periodically and often without warning. e responsibility to determine coverage and reimbursement parameters, and appropriate and parameters, reimbursement and coverage determine to responsibility e warning. without often and periodically ®

EUT N AEA PRPIT: APPROPRIATE AS DATE AND RESULTS

e information provided in this guide is of a general nature and for informational purposes only. Coding and coverage policies change policies coverage and Coding only. purposes informational for and nature general a of is guide this in provided information e EVENITY . Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated. treated. been not have who patients osteoporotic in occur also fractures these as established been not has Causality .

CONSIDERATIONS INCLUDING TEST INCLUDING CONSIDERATIONS

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(if required) (if

hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. coagulopathy. and anemia, infection, or disease dental pre-existing hygiene,

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Considerations Important Safety Information Safety Important Hypothetical Scenarios Illustrating Speciﬁcity of M80.0_ _ _ ICD-10-CM Codes

CLINICAL DIAGNOSIS DETAILS POTENTIAL ICD 10 CM CODE5

Fracture of vertebrae

CLINICAL DIAGNOSIS DETAILS POTENTIAL ICD 10 CM CODE

Fracture of forearm

Please see additional Important Safety Information on the back cover. back the on Information Safety Important additional see Please

www.amgen.com

ousand Oaks, CA 91320-1799 CA Oaks, ousand

One Amgen Center Drive Center Amgen One

therapy, EVENITY therapy, should be discontinued. be should

if symptoms occur. If a patient experiences a myocardial infarction or stroke during stroke or infarction myocardial a experiences patient a If occur. symptoms if

myocardial infarction and stroke and instruct patients to seek prompt medical attention medical prompt seek to patients instruct and stroke and infarction myocardial

patients with other cardiovascular risk factors. Monitor for signs and symptoms of symptoms and signs for Monitor factors. risk cardiovascular other with patients

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stroke within the preceding year. Consider whether the beneﬁts outweigh the risks in risks the outweigh beneﬁts the whether Consider year. preceding the within stroke

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should not be initiated in patients who have had a myocardial infarction or infarction myocardial a had have who patients in initiated be not should EVENITY

submitted claims submitted

EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. cardiovascular and stroke infarction, myocardial of risk the increase may

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POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH CARDIOVASCULAR AND STROKE, INFARCTION, MYOCARDIAL OF RISK POTENTIAL

CONFIRM BILLING AND PAYER REQUIREMENTS: PAYER AND BILLING CONFIRM

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Confi rm patients had no myocardial infarction infarction myocardial no had patients rm Confi – e anabolic effect of EVENITY of effect anabolic e wanes after 12 monthly doses of therapy. erefore, the duration of EVENITY of duration the erefore, therapy. of doses monthly 12 after wanes use should be limited to limited be should use

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(please provide ICD-10 number[s]) ICD-10 provide (please

Location of fracture fracture of Location –

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Prior osteoporosis-related fracture history fracture osteoporosis-related Prior

Amgen Assist Amgen for assistance with speciﬁc payer requirements: requirements: payer speciﬁc with assistance for Call

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therapy should be considered based on on based considered be should therapy EVENITY of Interruption fracture. femur incomplete an out rule to evaluated be should pain groin or coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. e information provided in provided information e physician. or provider the of responsibility the always is procedure, and/or patient particular a for coding edicted fracture risk fracture edicted pr ®

RESULTS AND DATE AS APPROPRIATE : APPROPRIATE AS DATE AND RESULTS

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hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. coagulopathy. and anemia, infection, or disease dental pre-existing hygiene,

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® Primar y diagnosis code diagnosis y –

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patients with calcium and vitamin D while on EVENITY on while D vitamin and calcium with patients

. .

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FOR PHYSICIAN OFFICES PHYSICIAN FOR SN H M 1500 CMS THE USING

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cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical medical prompt seek to patients instruct and stroke and infarction myocardial of symptoms and signs for Monitor factors. risk cardiovascular

have had a myocardial infarction or stroke within the preceding year. Consider whether the beneﬁ ts outweigh the risks in patients with other other with patients in risks the outweigh ts beneﬁ the whether Consider year. preceding the within stroke or infarction myocardial a had have Claim Submission Claim

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Considerations Considerations Important Safety Information Safety Important