® . Prolia ® reduces the incidence of vertebral, nonvertebral, and hip fractures. nonvertebral, of vertebral, the incidence reduces ® is contraindicated in patients with a history of systemic hypersensitivity to hypersensitivity of systemic with a history in patients is contraindicated also reduced the incidence of vertebral fractures. of vertebral the incidence also reduced ® ®

. Prolia ® ® 1500 using the CMS offices physician For 1450 using the CMS hospitals/institutions For for assistance with specific payer with specific payer assistance for ® 1-866-AMG-ASST (1-866-264-2778) 1-866-AMG-ASST CODING AND BILLING BILLING AND CODING GUIDE INFORMATION PROLIA is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy therapy deprivation androgen receiving fracture in men at high risk for bone mass increase to as a treatment is indicated inhibitor aromatase adjuvant receiving fracture at high risk for in women bone mass increase to as a treatment is indicated is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history defined as a history fracture, at high risk for in men with osteoporosis bone mass increase to treatment for is indicated who at high risk of fracture in men and women osteoporosis of glucocorticoid-induced the treatment for is indicated is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of defined as a history fracture, at high risk for with osteoporosis women of postmenopausal the treatment for is indicated is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia initiating prior to be corrected must hypocalcemia Pre-existing with hypocalcemia. in patients is contraindicated ® ® ® ® ® ® Contact Amgen Assist Contact requirements: requirements: Prolia The information provided in this guide is of a general nature and for informational purposes Codingonly. and coverage policies change periodically and often without warning. The parameters, appropriate and reimbursement coverage and responsibility determine to 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 coverage of or reimbursement for any product or service. Contraindications Prolia Indications Prolia is contraindicated in women who are pregnant and may cause fetal harm. In women of reproductive potential, pregnancy testing should testing pregnancy potential, of reproductive harm. In women fetal cause and may pregnant who are in women is contraindicated with Prolia initiating treatment prior to be performed osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis osteoporosis other available to intolerant or are failed who have or patients fracture; for risk factors or multiple fracture, osteoporotic Prolia with osteoporosis, women In postmenopausal therapy. for nonmetastatic prostate cancer. In these patients Prolia In these patients cancer. prostate nonmetastatic for cancer. breast for therapy of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available other available to intolerant or are failed who have or patients fracture; for risk factors or multiple fracture, of osteoporotic therapy. osteoporosis Prolia and of prednisone 7.5 mg or greater to dosage equivalent in a daily glucocorticoids systemic either initiating or continuing are fracture, of osteoporotic is defined as a history fracture 6 months. High risk of at least for on glucocorticoids remain to expected therapy. osteoporosis other available to intolerant or are failed have who or patients fracture, for risk factors multiple Prolia any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria. swelling facial included anaphylaxis, have Reactions of the product. any component Prolia Please see Important Safety Information on the back. Information Safety see Important Please Hypothetical Scenarios Illustrating SpecificityofM80.0__ICD-10-CMCodes Clinical Diagnosis Details Diagnosis Clinical Clinical Diagnosis Details Diagnosis Clinical Accessed October 30, 2019. 3. 30, October Accessed pdf/$File/CMS1500_837v5010_Crosswalk.pdf. Accessed October 30, 2019. 2. 30, October Accessed pdf/$File/CMS1500_837v5010_Crosswalk.pdf. 1. References: October 30, 2019. 30, October for modifiers required 80.9: Section Accessed http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. patients. to administered biologicals. non-ESRD and 17:ESAs drugs Chapter Manual. Processing Claims Medicare 100-04: Publication Services. & Medicaid 2019. 30, October Accessed 9. http://valuehealthcareservices.com/education/understanding-hospital-revenue-codes/. codes. October Accessed 30, 2019. 8. crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_v5010A2_ crosswalk. Form Claim CMS-1450 the to 2019. Claim 7. 30, Care Health October Accessed cdc.gov/nchs/data/icd/10cmguidelines_2017_final.pdf. http://www. 6. reserved. rights All 2019.PDF. Full FY (ICD-10-CM). Modification Clinical 5. Revision, 10th Disease, of Classification International In: injuries. and diseases of list tabular Postmenopausal osteoporosis Vertebral fractures treatment for thefractures Encounter for evaluating andcontinuing Postmenopausal osteoporosis Fracture ofleft wrist been completed) management (after active treatment has Follow-up encounter for routine fracture Palmetto v5010 837 ASC GBA. to CMS-1500 http://www.palmettogba.com/Palmetto/Providers.Nsf/files/CMS1500_ Crosswalk. 837v5010_Crosswalk. American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) copyright 2016 American Medical Association. Association. Medical American 2016 copyright (CPT) Terminology Procedural Current Edition, Professional 2017 Association. Medical American . ® group than group ® -treated -treated ® , prescribers , prescribers ® -treated men with -treated ® Centers for Medicare and Medicaid Services. ICD-10-CM official guidelines for coding and reporting, FY 2017. FY reporting, and coding for guidelines official ICD-10-CM Services. Medicaid and Medicare for Centers therapy. ® Prolia . ® full Prescribing full ® resulted in significant resulted compared to placebo. Most Most placebo. to compared ® ® ® (denosumab) information, prescribing 4. Amgen. if severe symptoms develop. symptoms if severe in patients with bone loss receiving ADT for for ADT receiving with bone loss in patients The most common adverse reactions (>5% reactions adverse common The most ® ® Potential ICD-10-CMPotential Code Potential ICD-10-CMPotential Code . ® osteoporosis osteoporosis group. A causal relationship to drug exposure has not exposure drug to relationship A causal group. pathological pathological with current with current Age-related Age-related ® fracture fracture group. In men with osteoporosis, new malignancies were malignancies were new with osteoporosis, In men group. ® Adverse Adverse Reactions: with postmenopausal in women than placebo) common and more musculoskeletal back pain, pain in extremity, are osteoporosis common The most and cystitis. pain, hypercholesterolemia, in men than placebo) common and more (> 5% reactions adverse and nasopharyngitis. back pain, arthralgia, are with osteoporosis with Prolia has been reported Pancreatitis In a clinical trial (N= 7808) in women with women 7808) in trial (N= In a clinical Infections: Serious to leading infections serious osteoporosis, postmenopausal Prolia in the frequently more reported were hospitalization trial in In the same clinical Reactions: Adverse Dermatologic and dermal epidermal osteoporosis, with postmenopausal women at occurred and rashes dermatitis, eczema such as events adverse with Prolia rate higher a significantly bone, incapacitating and occasionally Severe Pain: Musculoskeletal Prolia taking in patients pain has been reported joint, and/or muscle with trials in women In clinical of Bone Turnover: Suppression Prolia osteoporosis, postmenopausal of these events were not specific to the injection site. Consider the injection site. not specific to were of these events Prolia discontinuing suppression of bone remodeling as evidenced by markers of bone markers by as evidenced of bone remodeling suppression of these The significance and bone histomorphometry. turnover Monitor unknown. are treatment of long-term findings and the effect and fractures, including ONJ, atypical these consequences, for patients healing. fracture delayed of new malignancies was 4.3% in the placebo group and 4.8% in the group 4.3% in the placebo malignancies was of new Prolia nonmetastatic prostate cancer receiving ADT, a greater incidence of incidence a greater ADT, receiving cancer prostate nonmetastatic observed. was cataracts immunogenicity. for is potential there proteins, patients. The incidence of opportunistic infections and the overall and the overall infections of opportunistic The incidence patients. groups. the treatment between similar were of infections incidence signs develop if they attention medical seek prompt to Advise patients cellulitis. including infection, of severe or symptoms In serious infections. risk for be at increased may immune systems on Prolia while serious infections who develop patients in the placebo group. Serious skin infections, as well as infections of as infections as well infections, Serious skin group. in the placebo patients in frequent more were and ear urinarythe abdomen, tract with Prolia treated should assess the need for continued Prolia continued the need for assess should Consider discontinuing use if severe symptoms develop. symptoms use if severe discontinuing Consider reported in no patients in the placebo group and 4 (3.3%) patients in and 4 (3.3%) patients group in the placebo in no patients reported the Prolia been established. with glucocorticoid-induced in patients group) than active-control and headache. bronchitis, back pain, hypertension, are osteoporosis with Prolia reported prostate cancer or adjuvant AI therapy for breast cancer are arthralgia arthralgia are cancer breast for AI therapy or adjuvant cancer prostate also pain have and musculoskeletal in extremity and back pain. Pain in Prolia trials. Additionally, in clinical been reported

HCPCS.codes. HCPCS J-codes. http://hcpcs.codes/j-codes/J0897/. http://hcpcs.codes/j-codes/J0897/. J-codes. HCPCS HCPCS.codes. incidence the overall osteoporosis, with postmenopausal In women As with all therapeutic antibody. Denosumab is a human monoclonal or with impaired agents immunosuppressant on concomitant Patients Please see Prolia accompanying Information, including Medication Guide. common (> 3% and more reactions adverse common The most reactions ≥ 10%) adverse incidence (per patient common The most in Prolia frequently more also reported was Endocarditis

Value Healthcare Services. Understanding hospital revenue revenue hospital Understanding Value Services. Healthcare . Centers for Disease Control and Prevention. 2019 ICD-10-CM ICD-10-CM 2019 Prevention. and Control Disease for Centers ® , ® . M80.0 3 M80.0 ® ® . The risk ® should not should Palmetto GBA. ASC 837I version 5010A2 Institutional Institutional 5010A2 version 837I ASC GBA. Palmetto should be should treatment, treatment, . ® ® ® ® . Prior vertebral . Prior vertebral ® Fracture of Fracture of vertebrae 4 4 forearm

8X . Symptoms have included have . Symptoms ® Left 2 D A contains the same active ingredient ingredient the same active contains treatment is discontinued, patients is discontinued, treatment ® ® therapy should be considered, pending be considered, should therapy is contraindicated in patients with a in patients is contraindicated Atypical low-energy, or low trauma or low low-energy, Atypical ® Centers for Medicare Medicare for Centers . Patients receiving Prolia receiving . Patients ®

® is contraindicated in women who are who are in women is contraindicated is contraindicated in patients with in patients is contraindicated Initial encounter routine healing ® ® encounter for fracture with Subsequent injection. Concomitant use of calcimimetic use of calcimimetic injection. Concomitant for fracture ® . Prolia . If Prolia ® . ® ® . Prolia ® . treatment, patients should be advised to report new or new report be advised to should patients treatment, ® Amgen Drive One Amgen Center 91320-1799 CA Thousand Oaks, www.amgen.com © 2020 Amgen Inc. reserved. All rights USA-162-82262 05/20 ® . A dental examination with appropriate preventive dentistry is dentistry preventive with appropriate examination . A dental ® Following discontinuation of Prolia discontinuation Following Treatment: ® 11

pregnant and may cause fetal harm. In women of reproductive of reproductive harm. In women fetal cause and may pregnant initiating prior to be performed should testing pregnancy potential, with Prolia treatment history of systemic hypersensitivity to any component of the product. of the product. component any to hypersensitivity of systemic history urticaria. and swelling facial included anaphylaxis, have Reactions Prolia Contraindications: hypocalcemia. Pre-existing hypocalcemia must be corrected prior be corrected must hypocalcemia Pre-existing hypocalcemia. initiating Prolia to Multiple Vertebral Fractures (MVF) Following Discontinuation of Discontinuation (MVF) Following Fractures Vertebral Multiple Prolia fracture was a predictor of multiple vertebral fractures after Prolia after fractures vertebral of multiple a predictor was fracture should be transitioned to an alternative antiresorptive therapy. antiresorptive an alternative to be transitioned should discontinuation. Evaluate an individual’s benefit/risk before initiating benefit/risk before an individual’s Evaluate discontinuation. with Prolia treatment fracture risk increases, including the risk of multiple vertebral vertebral including the risk of multiple risk increases, fracture as 7 months as early occurred fractures vertebral New fractures. dose of Prolia the last 19 months) after (on average Atypical Femoral Fractures: Femoral Atypical Same Active Ingredient: Prolia Ingredient: Same Active including hypersensitivity significant Clinically Hypersensitivity: with Prolia has been reported anaphylaxis with infection and/or local extraction tooth with associated is generally Prolia receiving in patients reported healing, and has been delayed drugs may worsen hypocalcemia risk and serum calcium should be should risk and serum calcium hypocalcemia worsen drugs may with calcium all patients supplement Adequately monitored. closely D. and vitamin (denosumab) found in XGEVA (denosumab) found a risk/benefit assessment, on an individual basis. a risk/benefit assessment, hypotension, dyspnea, throat tightness, facial and upper airway edema, and upper airway facial tightness, throat dyspnea, hypotension, significant or other clinically If an anaphylactic pruritus, and urticaria. and discontinue therapy appropriate initiate occurs, reaction allergic further use of Prolia of ONJ may increase with duration of exposure to Prolia to of exposure with duration increase of ONJ may Prolia receiving in patients been reported of the shaft have fractures should guide the management plan of each patient. Patients who guide the management plan of each patient. Patients should by care receive ONJ should of having or who develop suspected are ONJ treat to surgery dental Extensive surgeon. or an oral a dentist of Prolia Discontinuation the condition. exacerbate may considered based on individual benefit-risk assessment. considered especially in patients with severe renal impairment. In patients impairment. In renal with severe in patients especially metabolism, of mineral and disturbances hypocalcemia to predisposed drugs, clinical with other calcium-lowering including treatment recommended is highly levels and mineral of calcium monitoring of Prolia within 14 days An oral exam should be performed by the prescriber prior to initiation prior to the prescriber by be performed should exam An oral of Prolia Causality has not been established as these fractures also occur in also occur as these fractures Causality has not been established agents. with antiresorptive not been treated who have patients osteoporotic receive XGEVA receive recommended prior to treatment in patients with risk factors for ONJ for with risk factors in patients treatment prior to recommended concomitant diagnosis of cancer, procedures, dental such as invasive angiogenesis inhibitors), corticosteroids, (e.g., chemotherapy, therapies hygiene Good oral disorders. and co-morbid hygiene, poor oral with Prolia during treatment be maintained should practices unusual thigh, hip, or groin pain. Any patient who presents with thigh pain. Any patient who presents unusual thigh, hip, or groin femur out an incomplete rule to be evaluated pain should or groin of Prolia Interruption fracture. with the use of Prolia worsen may Hypocalcemia Hypocalcemia: spontaneously, occur ONJ, which can of the Jaw (ONJ): Osteonecrosis

judgment clinical procedures, dental invasive requiring patients For OSTEOPOROSIS  EXAMPLES During Prolia Important Safety Information Safety Important ICD 10 CM CODE CODE ICD 10 CM

ICD 10 CM CODE EXAMPLES National provider ID number National provider information Contact Primary diagnosis code discontinuations for Reason Location of fracture of fracture Location (please provide ICD-10 number[s]) provide (please mit or include punctuation as required in mit or include punctuation as required

Patient name Patient and units HCPCS code Correct specificity – (if required) NDC reporting require and/or FRAX T-score Original diagnostic O claims submitted service rendering after name Provider therapies Previous of level the highest to Diagnosis code code administration Identify appropriate criteria prior authorization Determine may payers and commercial Medicaid levels Calcium history fracture Prior osteoporosis-related orders physician Referring fracture for Risk factors submission for time frame required Follow CORRECT AND COMPLETE PATIENT PATIENT COMPLETE AND CORRECT INFORMATION: BILLING AND PRODUCT COLLECT INFORMATION: DOCUMENTATION SUPPLEMENTAL TEST (INCLUDING CONSIDERATIONS APPROPRIATE): AS DATE AND RESULTS CONFIRM BILLING AND PAYER PAYER AND BILLING CONFIRM REQUIREMENTS: – ID number number and/or group name insurer Health – – – risk fracture predicted – – Considerations Considerations Complete for Submission Claim Physician Office Billing Information – Osteoporosis Completing the CMS 1500 for Physician Offices – Osteoporosis (CMS 1500)(CMS OSTEOPOROSIS

® Prolia (denosumab) Coding Information OFFICE PHYSICIAN

Additional Claim Information in Box 19: • Prolia® (denosumab) 60 mg (Electronic Form: Loop 2300, or 2400, NTE, 02)1

Coding Information in Box 24D: • HCPCS code (J-code): J0897 (injection, denosumab 1 mg)2 (Electronic Form: Loop 2400, SV1, • NDC number: 55513-0710-013 01-2)1 X XXX-XX-XXXX

® Number of Units in Box 24G: Use of a 60 mg prefilled syringe of Prolia is reported as: Doe, Jane J xx xx xx X Doe, Jane J (Electronic Form: Loop 2400, SV1, • 60 units 1 1123 Main Street 04 [03 = UN]) The NDC number covers both injections3 Hometown MA Diagnosis Coding Information* 01234 XXX XXX-XXXX The following primary diagnosis codes may be appropriate to describe patients with current osteoporotic fracture treated with Prolia®: 11111 • M80.0 (Age-related osteoporosis with current pathological fracture)4 X 06 01 1930 X Please see page 10 for additional examples of patients with current osteoporotic fracture. X ABC Employer ICD-10-CM Code in Box 21: The following primary diagnosis codes may be appropriate for patients without current ® (Electronic Form: Loop 2300, osteoporotic fracture treated with Prolia : X 1 HI, 01-2) • M81.0 (Age-related osteoporosis without current pathological fracture)4,† Box 21. Diagnosis or • M81.8 (Other osteoporosis without current pathological fracture) 4,† Nature of Illness X The following secondary diagnosis codes may be appropriate to describe patients for or Injury: Indicate appropriate glucocorticoid-induced osteoporosis: Box 19. Additional ICD diagnosis code as Claim Information: • T38.0X5 Adverse effect of glucocorticoids and synthetic analogues, sequela ® reflected in the patient’s Indicate Prolia medical record. ICD-10 (denosumab) 60 mg Administration and Professional Service Coding Information* code example: M81.0 Box 24G. Days or Units: (Age-related osteoporosis Indicate 60 units for use of ® Coding Information in Box 24D: The following code may be available to report administration of Prolia . Other codes may be appropriate without current a 60 mg prefilled syringe of (Electronic Form: Loop 2400, on a payer-specific basis. It is the provider’s responsibility to ensure that codes used are consistent with pathological fracture) Prolia® Prolia® (denosumab) 60 mg SV1, 01-2)1 payer policy and reflect service performed under such codes: Indicate 1 for the CPT code • 96372 (therapeutic, prophylactic or diagnostic injection [specify substance or drug]; subcutaneous M81.0 or intramuscular)5 • 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 a separate service: -.25 (significant, separately identifiable evaluation and management service by the same physician on the same day of the procedure or other service) 01 23 14 01 23 14 11 J0897 XXX XX 60 01 23 14 01 23 14 11 96372 XXX XX 1 * The 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 Prolia®. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, and the services rendered. † 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 Box 24A. Dates Box 24D. Procedures, a pathologic fracture due to the osteoporosis, even if they have had a fracture in the past. For patients with a history of osteoporotic fractures, status of Service: Services, or Supplies: code Z87.310 (personal history of [healed] osteoporosis fracture) should follow the code from the M81 category.6 Indicate appropriate HCPCS and CPT Medicaid and codes. Example: J0897 (Injection, commercial payers denosumab, 1 mg). 96372 (Therapeutic, may require NDC prophylactic, or diagnostic injection reporting for Prolia® [specify substance or drug]; subcutaneous submissions. or intramuscular) 11-1111111 X X XXX XX John Smith MD 2 Doctors Blvd Hometown, MA 01234 08-22-17 XXXXXXXXX XXXXXXXXX

2 Please see Important Safety Information on the back. 3 Physician Office Billing Information – Completing the CMS 1500 for Physician Offices – CTIBL Cancer Treatment-Induced Bone Loss (CTIBL)

Prolia® (denosumab) Coding Information Additional Claim Information in Box 19: • Prolia® (denosumab) 60 mg (Electronic Form: Loop 2300, or 2400, NTE, 02)1

Coding Information in Box 24D: • HCPCS code (J-code): J0897 (injection, denosumab 1 mg)2 (Electronic Form: Loop 2400, SV1, NDC number: 55513-0710-013 01-2)1 •

Number of Units in Box 24G: Use of a 60 mg prefilled syringe of Prolia® is reported as: (Electronic Form: Loop 2400, SV1, Doe, John D xx xx xx Doe, John D 1 • 60 units

04[03 = UN]) CTIBL  1500) (CMS 5555 Any Street OFFICE PHYSICIAN Diagnosis/Condition Coding Information* Anytown AS Coding requirements for men receiving androgen deprivation therapy for nonmetastatic prostate cancer 01010 XXX XXX-XXXX or women receiving adjuvant aromatase inhibitor therapy for breast cancer will vary from payer to payer. Sample factors appear below: ICD-10-CM Code Cancer Diagnosis: in Box 21: • C61 (malignant neoplasm of prostate)4 (Electronic Form: Loop 2300, Use of Androgen Deprivation or Aromatase Inhibitor Therapy: 1 HI, 01-2) • Z79.818 (long-term [current] use of other agents affecting estrogen receptors and estrogen levels)4,† OR • Z79.899 (other long-term [current] drug therapy)4 Box 21. Diagnosis or Other Risk Factors for Fracture: Nature of Illness • M85.9 (disorder of bone density and structure, unspecified)4,‡ or Injury: Box 19. Additional Indicate appropriate Administration and Professional Service Coding Information* ICD diagnosis code as Claim Information: reflected in the patient’s ® ® Coding Information The following code may be available to report administration of Prolia . Other codes may be appropriate Indicate Prolia medical record. ICD-10 in Box 24D: on a payer-specific basis. It is the provider’s responsibility to ensure that codes used are consistent with (denosumab) 60 mg code example: M81.0 (Electronic Form: Loop 2400, payer policy and reflect service performed under such codes: (Age-related osteoporosis SV1, 01-2)1 without current • 96372 (therapeutic, prophylactic or diagnostic injection [specify substance or drug]; subcutaneous Box 24E. Diagnosis Code: 5 pathological fracture) or intramuscular) Prolia® (denosumab) 60 mg Specify diagnosis from Box 21 • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in addition relating to each HCPCS or CPT to other professional services, the following modifier may be required to distinguish it as a separate M85.9 C61 Z79.818 code in Box 24D service: -.25 (significant, separately identifiable evaluation and management service by the same Box 24G. Days or Units: physician on the same day of the procedure or other service). Some payers, including Medicare, will Indicate 60 units for use of not allow a Level 1 office visit to be billed with an injection/infusion code for the same date of service, a 60 mg prefilled syringe of ® and only allow for other levels when Modifier 25 is billed. Prolia N4 55513071001 ML1 Considerations: The Medicare Claims Processing Manual (CPM) and the American Medical Association (AMA) Indicate 1 for the CPT code 01 23 14 01 23 14 11 J0897 A,B,C XXX XX 60 indicate that chemotherapy codes may be appropriate in the treatment of noncancer diagnosis or to substances, such as certain monoclonal antibody agents, and other biologic response modifiers. 01 23 14 01 23 14 11 96372 A,B,C XXX XX 1 However, third-party payers (or local carriers in the case of Medicare) make the determination for which specific codes are appropriate for billing. Healthcare providers should consult the payer or Medicare contractor to determine which code is most Box 24A. Dates Box 24D. Procedures, appropriate for administration of Prolia®. of Service: Services, or Supplies: Medicaid and Indicate appropriate HCPCS and CPT commercial payers codes. Example: J0897 (Injection, * The sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include may require NDC ® denosumab, 1 mg). 96372 (Therapeutic, FDA-approved indications for Prolia . Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, reporting for Prolia® and the services rendered. prophylactic, or diagnostic injection submissions. [specify substance or drug]; subcutaneous † Diagnosis code Z79.818 may be used for males receiving androgen deprivation therapy (eg, leuprolide acetate or goserelin acetate) for prostate cancer. or intramuscular) ‡ Code M85.9 may apply for osteopenia.

4 Please see Important Safety Information on the back. 5 Hospital/Institution Billing Information – Osteoporosis Completing the CMS 1450 for Hospital/Institutions – Osteoporosis

® Prolia (denosumab) Coding Information ______

Revenue Code in Box 42: 8,9 • Medicare: 0636 (drugs requiring detailed coding) 1 2 3a PAT. 4 TYPE Anytown Hospital CNTL # OF BILL (Electronic Form: Loop 2400, 8 b. MED. 7 • Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer REC. # SV201) 100 Main Street 6 STATEMENT COVERS PERIOD 7 5 FED. TAX NO. Anytown, Anystate 01010 FROM THROUGH

Coding Information in Box 44: 2 • HCPCS code (J-code): J0897 (subcutaneous injection, denosumab, 1 mg) Box8 42.PATIENT Revenue NAME Codes:a Smith, James 9 PATIENT ADDRESS a (Electronic Form: Loop 2400, 123 Main Street, Anytown, Anystate 12345 NDC number: 55513-0710-013 Productb b c d e 7 • ADMISSION CONDITION CODES 30 SV202-2 [SV202-1 = HC/HP]) 10 BIRTHDATE 11 SEX 16 DHR 17 STAT 29 ACDT Medicare: Use revenue 12codeDATE 063613 (drugsHR 14 TYPE requiring15 SRC detailed18 coding)19 20 21 22 Box23 46.24 Service25 26 27 28 STATE

Other31 payers:OCCURRENCE Use revenue32 OCCURRENCE code 0250,33 generalOCCURRENCE pharmacy34 OCCURRENCE (or 0636, if35 OCCURRENCEUnits: SPAN 36 OCCURRENCE SPAN 37 Service Units in Box 46: requiredCODE by aD AgivenTE payer)CODE DATE CODE DATE CODE DATE CODE FROM IndicateTHR 60OUGH unitsCOD forE FROM THROUGH a Box 47. Total a (Electronic Form: Loop 2400, • 60 units (Prolia dose is 60 mg, per label) use of a 60 mg prefilled b Charges: b 7 syringe of Prolia® SV205) Related38 Administration Procedure 39 VALUE CODES 40 VALUE CODES Report41 appropriateVALUE CODES Use most appropriate revenue code or cost center where services CODE AMOUNT CODE AMOUNT chargesCODE for AMOUNTproduct were performed (eg, 0510, clinic) a Indicate 1 for the CPT b used and related code procedures Diagnosis/Condition Coding Information* c Revenue Code: N/A d 42 REV. CD. 43 DESCRIPTION 44 HCPCS / R ATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TO TAL CHARGES 48 NON-COVERED CHARGES 49 Document the appropriate ICD-10-CM code(s) for the patient’s condition. 1 0636 PROLIA 60 mg J0897 MMDDYY 60 XXXXX 1 Sequencing of codes may vary based on patient’s condition and payer’s policy. 2 0510 Clinic 96372 MMDDYY 1 XXXXX 2 3 3

The following ICD-10-CM diagnosis code may be appropriate to describe patients with current 4 4 ® osteoporotic fracture treated with Prolia : 5 5 Box 43. Description: Box 44. Product and Product Procedure Codes: 4 6 6 • M80.0 (Age-related osteoporosis with current pathological fracture) Indicate the drug name and unit of Product

7 7 (CMS 1450)OSTEOPOROSIS  ICD-10-CM Code in Box 67: measure: Prolia® 60 mg Use J0897 (subcutaneous injection, denosumab, 1 mg) 8 8 Please see page 10 for additional examples of patients with current osteoporotic fracture. HOSPITAL/INSTITUTION (Electronic Form: Loop 2300, HI01-2 [HI01-1 = BK])7 The following primary diagnosis codes may be appropriate for patients without current osteoporotic 9 9 10 Related Administration Procedure 10 fracture treated with Prolia®: Use CPT code representing procedure performed, 11 11 4,† such as 96372, therapeutic, prophylactic, or diagnostic • M81.0 (Age-related osteoporosis without current pathological fracture) 12 12 injection [specify substance or drug]; subcutaneous or • M81.8 (Other osteoporosis without current pathological fracture)4,† 13 intramuscular 13 14 14 The following secondary diagnosis codes may be appropriate to describe patients for 15 Healthcare providers should consult the payer or 15 glucocorticoid-induced osteoporosis: 16 Medicare contractor to determine which code is most 16 • T38.0X5 Adverse effect of glucocorticoids and synthetic analogues, sequela 17 appropriate for administration of Prolia® 17 18 18 Administration Coding Information* 19 19 20 20 Revenue Code in Box 42: 21 21 (Electronic Form: Loop 2400, Appropriate revenue code for the cost center in which the service is performed. 22 22 SV201)7 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 INFO BEN. • 96372 (therapeutic, prophylactic or diagnostic injection [specify substance or drug]; subcutaneous A 57 A 5 or intramuscular) B OTHER B Coding Information in Box 43: Relevant evaluation and management (E&M) code. Note when an E&M service is billed in addition C PRV ID C (Electronic Form: Not required by • to other professional services, the following modifier may be required to distinguish it as a 58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO. Medicare)7 separate service: -.25 (significant, separately identifiable evaluation and management service by A Box 67. Diagnosis Codes: A the same physician on the same day of the procedure or other service) B Indicate appropriate ICD-10-CM diagnosis B C code as reflected in patient’s medical record. C 63 TREATMENT AUTHORIZATION CODES 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME * 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 osteoporosis FDA-approved indications for Prolia®. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, A with current pathological fracture) A and the services rendered. B B † 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 C C 66 68 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 DX 67 A B C D E F G H code Z87.310 (personal history of [healed] osteoporosis fracture) should follow the code from the M81 category.6 M80.0I J K L M N O P Q 69 ADMIT 70 PATIENT 71 PPS 72 73 DX BoxREASON 80. DX Remarks:a b c CODE ECI a b c 74 PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE 75 QUAL CODE PayersDATE typicallyCODE require providersDATE toCODE list productD Aname,TE route of 76 ATTENDING NPI administration, total dosage, and NCD number(s) for the units usedLAST FIRST c. OTHER PROCEDURE d. OTHER PROCEDURE e. OTHER PROCEDURE QUAL CODE duringDATE the billingCODE period DATE CODE DATE 77 OPERATING NPI LAST FIRST 81CC QUAL 80 REMARKS a 78 OTHER NPI PROLIA (denosumab) b LAST FIRST Subcutaneous, 60 mg c 79 OTHER NPI QUAL NDC: 55513-0710-01 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 6 Please see Important Safety Information on the back. NUBC Billing Committee 7 Hospital/Institution Billing Information – Completing the CMS 1450 for Hospitals/Institutions – CTIBL Cancer Treatment-induced Bone Loss (CTIBL)

® Prolia (denosumab) Coding Information ______

8,9 • Medicare: 0636 (drugs requiring detailed coding) 1 2 3a PAT. 4 TYPE Revenue Code in Box 42: CNTL # OF BILL 8 Anytown Hospital 7 • Other Payers: 0250, general pharmacy; OR 0636, if required by a given payer b. MED. (Electronic Form: Loop 2400, SV201) REC. # 100 Main Street 6 STATEMENT COVERS PERIOD 7 5 FED. TAX NO. Anytown, Anystate 01010 FROM THROUGH Coding Information in Box 44: • HCPCS code (J-code): J0897 (subcutaneous injection, denosumab, 1 mg)2 (Electronic Form: Loop 2400, NDC number: 55513-0710-013 8 PATIENT NAME a Smith, James 9 PATIENT ADDRESS a 7 • 123 Main Street, Anytown, Anystate 12345 SV202-2 [SV202-1 = HC/HP]) Boxb 42. Revenue Codes: b c d e ADMISSION CONDITION CODES 30 10 BIRTHDATE 11 SEX 16 DHR 17 STAT 29 ACDT Service Units in Box 46: • 60 units (Prolia dose is 60 mg, per label) Product 12 DATE 13 HR 14 TYPE 15 SRC 18 19 20 21 22 Box23 46.24 Service25 26 27 28 STATE 7 3 Medicare: Use revenue code 0636 (drugs requiring detailed coding) (Electronic Form: Loop 2400, SV205) The NDC number covers both injections 31 OCCURRENCE 32 OCCURRENCE 33 OCCURRENCE 34 OCCURRENCE 35 OCCURRENCEUnits: SPAN 36 OCCURRENCE SPAN 37 CODE DATE CODE DATE CODE DATE CODE DATE CODE FROM IndicateTHR 60OUGH unitsCOD forE FROM THROUGH Othera payers: Use revenue code 0250, general pharmacy (or 0636, if Box 47. Total a use of a 60 mg prefilled requiredb by a given payer) Charges: b syringe of Prolia® Diagnosis/Condition Coding Information* 38 39 VALUE CODES 40 VALUE CODES Report41 appropriateVALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT Related Administration Procedure a charges for product Revenue Code: N/A Indicate 1 for the CPT Use most appropriate revenue code or cost center where services b used and related Coding requirements for men receiving androgen deprivation therapy for nonmetastatic prostate code were performed (eg, 0510, clinic) c procedures cancer or women receiving adjuvant aromatase inhibitor therapy for breast cancer will vary from d payer to payer. Sample factors appear below: 42 REV. CD. 43 DESCRIPTION 44 HCPCS / R ATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TO TAL CHARGES 48 NON-COVERED CHARGES 49 Cancer Diagnosis: 1 0636 PROLIA 60 mg J0897 MMDDYY 60 XXXXX 1 ICD-10-CM Code in Box 67: • C61 (malignant neoplasm of prostate)4 2 0510 Clinic 96372 MMDDYY 1 XXXXX 2 (Electronic Form: Loop 2300, Use of Androgen Deprivation or Aromatase Inhibitor Therapy: 3 3 HI01-2 [HI01-1 = BK])7 • Z79.818 (long-term [current] use of other agents affecting estrogen receptors and estrogen levels)4,† 4 4 5 5 OR Box 43. Description: Box 44. Product and Product Procedure Codes: • Z79.899 (other long-term [current] drug therapy)4 Indicate6 the drug name and unit 6 7 Product 7 Other Risk Factors for Fracture: of measure: Prolia® 60 mg 8 Use J0897 (subcutaneous injection, denosumab, 1 mg) 8 • M85.9 (disorder of bone density and structure, unspecified)4,‡ 9 9

10 Related Administration Procedure 10 Document product administration with appropriate CPT code Administration Coding Information* 11 11

12 Example: 96372 (therapeutic, prophylactic, or diagnostic injection 12 Revenue Code in Box 42: [specify substance or drug]; subcutaneous or intramuscular) Appropriate revenue code for the cost center in which the service is performed. 13 13 (Electronic Form: Loop 2400, SV201)7 14 14 ® The following codes may be available to report administration of Prolia . Other codes may be 15 15

appropriate on a payer-specific basis. It is the provider’s responsibility to ensure that codes used are 16 16

consistent with payer policy and reflect service performed under such codes: 17 17 • 96372 (therapeutic, prophylactic or diagnostic injection [specify substance or drug]; subcutaneous 18 18 Coding Information in Box 44: or intramuscular)5 19 19 20 20 (Electronic Form: Loop 2400, • Relevant evaluation and management (E&M) code. Note when an E&M service is billed in addition 7 21 21 SV202-2 (SV202-1=HC/HP) to other professional services, the following modifier may be required to distinguish it as a 22 22 HOSPITAL/INSTITUTION

separate service: -.25 (significant, separately identifiable evaluation and management service by CTIBL  1450) (CMS 23 PAGE OF CREATION DATE TOTALS 23 the same physician on the same day of the procedure or other service). Some payers, including 52 REL . 53 ASG. 50 PAYER NAME 51 HEALTH PLAN ID 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI Medicare, will not allow a Level 1 office visit to be billed with an injection/infusion code for the INFO BEN. A Box 67. Diagnosis Codes: 57 A same date of service, and only allow for other levels when Modifier 25 is billed. B Indicate appropriate ICD-10-CM diagnosis code as reflected in patient’s OTHER B

The Medicare Claims Processing Manual (CPM) and the American Medical Association (AMA) indicate C medical record PRV ID C

that chemotherapy codes may be appropriate in the treatment of noncancer diagnosis or to substances, 58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO. Example: M85.9 (disorder of bone density and structure, unspecified) such as certain monoclonal antibody agents, and other biologic response modifiers. However, third- A A

party payers (or local carriers in the case of Medicare) make the determination for which specific codes B B Considerations: Example secondary diagnosis: C61 (malignant neoplasm of prostate) are appropriate for billing. C C Healthcare providers should consult the payer or Medicare contractor to determine which code is most 63 TREATMENTExample AUTHORIZATION additional CODES diagnosis code: Z79.818 (long-term64 DOCUMENT CONTROL [current] NUMBER use of 65 EMPLOYER NAME appropriate for administration of Prolia®. A other agents affecting estrogen receptors and estrogen levels) A B B

C C

* The sample codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include 66 68 FDA-approved indications for Prolia®. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, DX 67 A B C D E F G H and the services rendered. M85.9I J K L M N O P Q 69 ADMIT 70 PATIENT 71 PPS 72 73 † Diagnosis code Z79.818 may be used for males receiving androgen deprivation therapy (eg, leuprolide acetate or goserelin acetate) for prostate cancer. DX BoxREASON 80. DX Remarks:a b c CODE ECI a b c 74 PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE 75 76 ATTENDING NPI QUAL ‡ Code M85.9 may apply for osteopenia. CODE PayersDATE typicallyCODE require providersDATE toCODE list productD Aname,TE route of administration, total dosage, and NCD number(s) for the units usedLAST FIRST c. OTHER PROCEDURE d. OTHER PROCEDURE e. OTHER PROCEDURE QUAL CODE duringDATE the billingCODE period DATE CODE DATE 77 OPERATING NPI LAST FIRST 81CC QUAL 80 REMARKS a 78 OTHER NPI PROLIA (denosumab) b LAST FIRST Subcutaneous, 60 mg c 79 OTHER NPI QUAL NDC: 55513-0710-01 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 8 Please see Important Safety Information on the back. NUBC Billing Committee 9 Examples of ICD-10-CM Codes Relevant for Patients With Current Osteoporotic Fracture Treated With Prolia®4 Hypothetical Scenarios Illustrating Specificity of M80.0_ _ _ ICD-10-CM Codes

Age-related osteoporosis with current pathological fracture Clinical Diagnosis Details Potential ICD-10-CM Code4 M80.0_ _ _ [laterality] [anatomic site] [encounter type]* † Encounter Type Postmenopausal osteoporosis Anatomic Site Subsequent Subsequent Subsequent Subsequent Age-related Initial encounter encounter for encounter for encounter for encounter for and Laterality Sequela osteoporosis for fracture fracture with fracture with fracture with fracture with with current Initial encounter routine healing delayed healing nonunion malunion pathological M80.08XA for fracture UNSPECIFIED SITE M80.00XA M80.00XD M80.00XG M80.00XK M80.00XP M80.00XS Vertebral fractures fracture SHOULDER R ght M80.011A M80.011D M80.011G M80.011K M80.011P M80.011S Fracture of vertebrae Left M80.012A M80.012D M80.012G M80.012K M80.012P M80.012S Encounter for evaluating and continuing Unspecified M80.019A M80.019D M80.019G M80.019K M80.019P M80.019S treatment for the fractures HUMERUS Right M80.021A M80.021D M80.021G M80.021K M80.021P M80.021S Left M80.022A M80.022D M80.022G M80.022K M80.022P M80.022S Clinical Diagnosis Details Potential ICD-10-CM Code4 Unspecified M80.029A M80.029D M80.029G M80.029K M80.029P M80.029S FOREARM Right M80.031A M80.031D M80.031G M80.031K M80.031P M80.031S Postmenopausal osteoporosis Left Left M80.032A M80.032D M80.032G M80.032K M80.032P M80.032S Age-related Subsequent osteoporosis Unspecified M80.039A M80.039D M80.039G M80.039K M80.039P M80.039S encounter for with current HAND fracture with pathological M80.032D Right M80.041A M80.041D M80.041G M80.041K M80.041P M80.041S Fracture of left wrist routine healing fracture Left M80.042A M80.042D M80.042G M80.042K M80.042P M80.042S Unspecified M80.049A M80.049D M80.049G M80.049K M80.049P M80.049S Fracture of FEMUR Follow-up encounter for routine fracture forearm Right M80.051A M80.051D M80.051G M80.051K M80.051P M80.051S management (after active treatment has been completed) Left M80.052A M80.052D M80.052G M80.052K M80.052P M80.052S Unspecified M80.059A M80.059D M80.059G M80.059K M80.059P M80.059S LOWER LEG Right M80.061A M80.061D M80.061G M80.061K M80.061P M80.061S References: Left M80.062A M80.062D M80.062G M80.062K M80.062P M80.062S 1. Palmetto GBA. ASC 837 v5010 to CMS-1500 Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/CMS1500_ 837v5010_Crosswalk. Unspecified M80.069A M80.069D M80.069G M80.069K M80.069P M80.069S pdf/$File/CMS1500_837v5010_Crosswalk.pdf. Accessed October 30, 2019. 2. HCPCS.codes. HCPCS J-codes. http://hcpcs.codes/j-codes/J0897/. Accessed October 30, 2019. 3. Prolia® (denosumab) prescribing information, Amgen. 4. Centers for Disease Control and Prevention. 2019 ICD-10-CM ANKLE AND FOOT tabular list of diseases and injuries. In: International Classification of Disease, 10th Revision, Clinical Modification (ICD-10-CM). FY 2019. Full PDF. Right M80.071A M80.071D M80.071G M80.071K M80.071P M80.071S 5. American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) copyright 2016 American Medical Association. Left M80.072A M80.072D M80.072G M80.072K M80.072P M80.072S All rights reserved. 6. Centers for Medicare and Medicaid Services. ICD-10-CM official guidelines for coding and reporting, FY 2017. http://www. cdc.gov/nchs/data/icd/10cmguidelines_2017_final.pdf. Accessed October 30, 2019. 7. Palmetto GBA. ASC 837I version 5010A2 Institutional Unspecified M80.079A M80.079D M80.079G M80.079K M80.079P M80.079S Health Care Claim to the CMS-1450 Claim Form crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_v5010A2_ VERTEBRA(E) M80.08XA M80.08XD M80.08XG M80.08XK M80.08XP M80.08XS crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. Accessed October 30, 2019. 8. Value Healthcare Services. Understanding hospital revenue codes. http://valuehealthcareservices.com/education/understanding-hospital-revenue-codes/. Accessed October 30, 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 See the next page for hypothetical scenarios illustrating specificity of these M80.0_ _ _ ICD-10-CM codes. The diagnosis code ESAs administered to non-ESRD patients. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Accessed examples above and the hypothetical scenarios on back of the insert are informational and should not be a substitute for an October 30, 2019. independent clinical decision. They are not intended to be directive or a guarantee of reimbursement. The responsibility to determine coverage and reimbursement parameters, and appropriate coding for a particular patient, is always the responsibility of the provider

or physician. Please contact your payer with any questions. OSTEOPOROSIS  EXAMPLES * According to the ICD-10-CM Official Guidelines for Coding and Reporting, M80.0 codes are for patients who have a current pathologic fracture at the time

of an encounter. The codes under M80 identify the site of the fracture. A code from category M80, not a traumatic fracture code, should be used for any ICD 10 CM CODE patient with known osteoporosis who suffers a fracture, even if the patient had a minor fall or trauma, if that fall or trauma would not usually break a normal, healthy bone.6 † 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 active treatment for the fracture. Assignment of the seventh character is based on whether the patient is undergoing active treatment and not 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 active treatment. The other seventh characters, listed under each subcategory in the Tabular List, are to be used for subsequent encounters for treatment of problems associated with healing, such as malunions, nonunions, and sequelae.6

10 Please see Important Safety Information on the back. 11

00AgnIc Alrgt eevd UA12822 05/20 USA-162-82262 reserved. rights All Inc. Amgen 2020 ©

Please see Important Safety Information on the back. back. the on Information Safety Important see Please www.amgen.com www.amgen.com

Thousand Oaks, CA 91320-1799 CA Oaks, Thousand

One Amgen Center Drive Center Amgen One

Amgen

guarantee of coverage or reimbursement for any product or service. or product any for reimbursement or coverage of guarantee

or physician. The information provided in this guide should in no way be considered a a considered be way no in should guide this in provided information The physician. or

coding for a particular patient and/or procedure, is always the responsibility of the provider provider the of responsibility the always is procedure, and/or patient particular a for coding

responsibility to determine coverage and reimbursement parameters, and appropriate appropriate and parameters, reimbursement and coverage determine to responsibility should be transitioned to an alternative antiresorptive therapy. antiresorptive alternative an to transitioned be should

treatment is discontinued, patients patients discontinued, is treatment Prolia If . treatment with Prolia with treatment only. Coding and coverage policies change periodically and often without warning. The The warning. without often and periodically change policies coverage and Coding only.

® ®

Information, including Medication Guide. Guide. Medication including Information,

discontinuation. Evaluate an individual’s benefit/risk before initiating initiating before benefit/risk individual’s an Evaluate discontinuation.

The information provided in this guide is of a general nature and for informational purposes purposes informational for and nature general a of is guide this in provided information The

rendering service rendering after

full Prescribing Prescribing full Prolia accompanying see Please

fracture was a predictor of multiple vertebral fractures after Prolia after fractures vertebral multiple of predictor a was fracture

®

®

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

. Prior vertebral vertebral Prior . (on average 19 months) after the last dose of Prolia of dose last the after months) 19 average (on

®

1-866-AMG-ASST (1-866-264-2778) 1-866-AMG-ASST requirements: requirements:

proteins, there is potential for immunogenicity. for potential is there proteins,

fractures. New vertebral fractures occurred as early as 7 months months 7 as early as occurred fractures vertebral New fractures.

submitted claims submitted

Denosumab is a human monoclonal antibody. As with all therapeutic therapeutic all with As antibody. monoclonal human a is Denosumab

fracture risk increases, including the risk of multiple vertebral vertebral multiple of risk the including increases, risk fracture

Contact Amgen Assist Amgen Contact

for assistance with specific payer payer specific with assistance for mit or include punctuation as required in in required as punctuation include or mit O

®

treatment, treatment, Prolia of discontinuation Following Treatment: Treatment: Prolia

cataracts was observed. was cataracts

® ®

REQUIREMENTS:

Multiple Vertebral Fractures (MVF) Following Discontinuation of of Discontinuation Following (MVF) Fractures Vertebral Multiple nonmetastatic prostate cancer receiving ADT, a greater incidence of of incidence greater a ADT, receiving cancer prostate nonmetastatic

CONFIRM BILLING AND PAYER PAYER AND BILLING CONFIRM

-treated men with with men -treated

been reported in clinical trials. Additionally, in Prolia in Additionally, trials. clinical in reported been ICD 10 CM CODE EXAMPLES a risk/benefit assessment, on an individual basis. individual an on assessment, risk/benefit a

®

and back pain. Pain in extremity and musculoskeletal pain have also also have pain musculoskeletal and extremity in Pain pain. back and

therapy should be considered, pending pending considered, be should therapy fracture. Interruption of Prolia of Interruption fracture.

®

Risk factors for fracture fracture for factors Risk prostate cancer or adjuvant AI therapy for breast cancer are arthralgia arthralgia are cancer breast for therapy AI adjuvant or cancer prostate

or groin pain should be evaluated to rule out an incomplete femur femur incomplete an out rule to evaluated be should pain groin or

any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria. and swelling facial anaphylaxis, included have Reactions product. the of component any

in patients with bone loss receiving ADT for for ADT receiving loss bone with patients in reported with Prolia with reported

unusual thigh, hip, or groin pain. Any patient who presents with thigh thigh with presents who patient Any pain. groin or hip, thigh, unusual ®

Referring physician orders physician Referring

is contraindicated in patients with a history of systemic hypersensitivity to to hypersensitivity systemic of history a with patients in contraindicated is Prolia . Prolia with treatment initiating to prior performed be

The most common (per patient incidence ≥ 10%) adverse reactions reactions adverse 10%) ≥ incidence patient (per common most The

® ® treatment, patients should be advised to report new or or new report to advised be should patients treatment, Prolia During

®

is contraindicated in women who are pregnant and may cause fetal harm. In women of reproductive potential, pregnancy testing should should testing pregnancy potential, reproductive of women In harm. fetal cause may and pregnant are who women in contraindicated is

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

osteoporosis are back pain, hypertension, bronchitis, and headache. and bronchitis, hypertension, pain, back are osteoporosis

osteoporotic patients who have not been treated with antiresorptive agents. antiresorptive with treated been not have who patients osteoporotic

Location of fracture fracture of Location

Prolia . Prolia initiating to prior corrected be must hypocalcemia Pre-existing hypocalcemia. with patients in contraindicated is Prolia

–

than active-control group) in patients with glucocorticoid-induced glucocorticoid-induced with patients in group) active-control than

® ® ®

Causality has not been established as these fractures also occur in in occur also fractures these as established been not has Causality

The most common adverse reactions (> 3% and more common common more and 3% (> reactions adverse common most The Prior osteoporosis-related fracture history fracture osteoporosis-related Prior

Contraindications

. . fractures of the shaft have been reported in patients receiving Prolia receiving patients in reported been have shaft the of fractures

®

been established. been

Atypical low-energy, or low trauma trauma low or low-energy, Atypical Atypical Femoral Fractures: Femoral Atypical Calcium levels Calcium

therapy for breast cancer. breast for therapy

group. A causal relationship to drug exposure has not not has exposure drug to relationship causal A group. the Prolia the

®

considered based on individual benefit-risk assessment. benefit-risk individual on based considered

Reason for discontinuations for Reason

is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor inhibitor aromatase adjuvant receiving fracture for risk high at women in mass bone increase to treatment a as indicated is Prolia –

reported in no patients in the placebo group and 4 (3.3%) patients in in patients (3.3%) 4 and group placebo the in patients no in reported

®

should be be should may exacerbate the condition. Discontinuation of Prolia of Discontinuation condition. the exacerbate may

®

group. In men with osteoporosis, new malignancies were were malignancies new osteoporosis, with men In group. Prolia Previous therapies Previous

®

a dentist or an oral surgeon. Extensive dental surgery to treat ONJ ONJ treat to surgery dental Extensive surgeon. oral an or dentist a

also reduced the incidence of vertebral fractures. vertebral of incidence the reduced also Prolia patients these In cancer. prostate nonmetastatic for

of new malignancies was 4.3% in the placebo group and 4.8% in the the in 4.8% and group placebo the in 4.3% was malignancies new of ®

are suspected of having or who develop ONJ should receive care by by care receive should ONJ develop who or having of suspected are

predicted fracture risk fracture predicted

is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy therapy deprivation androgen receiving fracture for risk high at men in mass bone increase to treatment a as indicated is Prolia

In women with postmenopausal osteoporosis, the overall incidence incidence overall the osteoporosis, postmenopausal with women In ®

rgnldansi -cr n/rFA FRAX and/or T-score diagnostic Original should guide the management plan of each patient. Patients who who Patients patient. each of plan management the guide should

. Pancreatitis has been reported with Prolia with reported been has Pancreatitis

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 For patients requiring invasive dental procedures, clinical judgment judgment clinical procedures, dental invasive requiring patients For

®

RESULTS AND DATE AS APPROPRIATE): AS DATE AND RESULTS

with osteoporosis are back pain, arthralgia, and nasopharyngitis. nasopharyngitis. and arthralgia, pain, back are osteoporosis with

expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, fracture, osteoporotic of history a as defined is fracture of risk High months. 6 least at for glucocorticoids on remain to expected

. of ONJ may increase with duration of exposure to Prolia to exposure of duration with increase may ONJ of CONSIDERATIONS (INCLUDING TEST (INCLUDING CONSIDERATIONS

adverse reactions (> 5% and more common than placebo) in men men in placebo) than common more and 5% (> reactions adverse

®

are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and and prednisone of greater or mg 7.5 to equivalent dosage daily a in glucocorticoids systemic continuing or initiating either are SUPPLEMENTAL DOCUMENTATION DOCUMENTATION SUPPLEMENTAL . The risk risk The . practices should be maintained during treatment with Prolia with treatment during maintained be should practices

pain, hypercholesterolemia, and cystitis. The most common common most The cystitis. and hypercholesterolemia, pain,

®

poor oral hygiene, and co-morbid disorders. Good oral hygiene hygiene oral Good disorders. co-morbid and hygiene, oral poor

is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who who fracture of risk high at women and men in osteoporosis glucocorticoid-induced of treatment the for indicated is Prolia osteoporosis are back pain, pain in extremity, musculoskeletal musculoskeletal extremity, in pain pain, back are osteoporosis

®

therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), inhibitors), angiogenesis corticosteroids, chemotherapy, (e.g., therapies and more common than placebo) in women with postmenopausal postmenopausal with women in placebo) than common more and

require NDC reporting reporting NDC require

osteoporosis therapy. osteoporosis

such as invasive dental procedures, diagnosis of cancer, concomitant concomitant cancer, of diagnosis procedures, dental invasive as such The most common adverse reactions (>5% (>5% reactions adverse common most The Adverse Reactions: Reactions: Adverse Medicaid and commercial payers may may payers commercial and Medicaid

recommended prior to treatment in patients with risk factors for ONJ ONJ for factors risk with patients in treatment to prior recommended of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available available other to intolerant are or failed have who patients or fracture; for factors risk multiple or fracture, osteoporotic of

delayed fracture healing. fracture delayed

(if required) (if . A dental examination with appropriate preventive dentistry is is dentistry preventive appropriate with examination dental A . of Prolia of

is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history history a as defined fracture, for risk high at osteoporosis with men in mass bone increase to treatment for indicated is Prolia

®

patients for these consequences, including ONJ, atypical fractures, and and fractures, atypical ONJ, including consequences, these for patients ® Determine prior authorization criteria authorization prior Determine An oral exam should be performed by the prescriber prior to initiation initiation to prior prescriber the by performed be should exam oral An

findings and the effect of long-term treatment are unknown. Monitor Monitor unknown. are treatment long-term of effect the and findings

. . delayed healing, and has been reported in patients receiving Prolia receiving patients in reported been has and healing, delayed

reduces the incidence of vertebral, nonvertebral, and hip fractures. hip and nonvertebral, vertebral, of incidence the reduces Prolia osteoporosis, with women postmenopausal In therapy.

® Identify appropriate administration code administration appropriate Identify

®

turnover and bone histomorphometry. The significance of these these of significance The histomorphometry. bone and turnover is generally associated with tooth extraction and/or local infection with with infection local and/or extraction tooth with associated generally is

osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis osteoporosis available other to intolerant are or failed have who patients or fracture; for factors risk multiple or fracture, osteoporotic

suppression of bone remodeling as evidenced by markers of bone bone of markers by evidenced as remodeling bone of suppression

Primary diagnosis code diagnosis Primary ONJ, which can occur spontaneously, spontaneously, occur can which ONJ, Osteonecrosis of the Jaw (ONJ): Jaw the of Osteonecrosis –

is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of of history a as defined fracture, for risk high at osteoporosis with women postmenopausal of treatment the for indicated is Prolia

resulted in significant significant in resulted postmenopausal osteoporosis, Prolia osteoporosis, postmenopausal

®

®

specificity

and vitamin D. vitamin and

In clinical trials in women with with women in trials clinical In Suppression of Bone Turnover: Bone of Suppression

Indications

Diagnosis code to the highest level of of level highest the to code Diagnosis closely monitored. Adequately supplement all patients with calcium calcium with patients all supplement Adequately monitored. closely

Consider discontinuing use if severe symptoms develop. symptoms severe if use discontinuing Consider

drugs may worsen hypocalcemia risk and serum calcium should be be should calcium serum and risk hypocalcemia worsen may drugs

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incidence of infections were similar between the treatment groups. groups. treatment the between similar were infections of incidence INFORMATION GUIDE INFORMATION ®

patients. The incidence of opportunistic infections and the overall overall the and infections opportunistic of incidence The patients.

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Claim Submission Claim

the abdomen, urinary tract and ear were more frequent in patients patients in frequent more were ear and tract urinary abdomen, the initiating to prior performed be should testing pregnancy potential,

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® ® Important Safety Information Safety Important

® . Prolia ® reduces the incidence of vertebral, nonvertebral, and hip fractures. nonvertebral, of vertebral, the incidence reduces ® is contraindicated in patients with a history of systemic hypersensitivity to hypersensitivity of systemic with a history in patients is contraindicated also reduced the incidence of vertebral fractures. of vertebral the incidence also reduced ® ®

. Prolia ® ® 1500 using the CMS offices physician For 1450 using the CMS hospitals/institutions For for assistance with specific payer with specific payer assistance for ® 1-866-AMG-ASST (1-866-264-2778) 1-866-AMG-ASST CODING AND BILLING BILLING AND CODING GUIDE INFORMATION PROLIA is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history defined as a history fracture, at high risk for in men with osteoporosis bone mass increase to treatment for is indicated who at high risk of fracture in men and women osteoporosis of glucocorticoid-induced the treatment for is indicated therapy deprivation androgen receiving fracture in men at high risk for bone mass increase to as a treatment is indicated inhibitor aromatase adjuvant receiving fracture at high risk for in women bone mass increase to as a treatment is indicated is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of defined as a history fracture, at high risk for with osteoporosis women of postmenopausal the treatment for is indicated is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia prior to be corrected must hypocalcemia Pre-existing with hypocalcemia. in patients is contraindicated ® ® ® ® ® ® Contact Amgen Assist Contact requirements: requirements: Prolia Indications Prolia Contraindications Prolia The information provided in this guide is a general of nature and for informational purposes Codingonly. and coverage policies change periodically and often without warning. The parameters, appropriate and reimbursement coverage and responsibility determine to 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. is contraindicated in women who are pregnant and may cause fetal harm. In women of reproductive potential, pregnancy testing should testing pregnancy potential, of reproductive harm. In women fetal cause and may pregnant who are in women is contraindicated with Prolia initiating treatment prior to be performed osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis osteoporosis other available to intolerant or are failed who have or patients fracture; for risk factors or multiple fracture, osteoporotic Prolia with osteoporosis, women In postmenopausal therapy. of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available other available to intolerant or are failed who have or patients fracture; for risk factors or multiple fracture, of osteoporotic therapy. osteoporosis Prolia and of prednisone 7.5 mg or greater to dosage equivalent in a daily glucocorticoids systemic either initiating or continuing are fracture, of osteoporotic is defined as a history fracture 6 months. High risk of at least for on glucocorticoids remain to expected therapy. osteoporosis other available to intolerant or are failed have who or patients fracture, for risk factors multiple Prolia Prolia In these patients cancer. prostate nonmetastatic for cancer. breast for therapy any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria. swelling facial included anaphylaxis, have Reactions of the product. any component Prolia Please see Important Safety Information on the back. Information Safety see Important Please Clinical Diagnosis Details Diagnosis Clinical Hypothetical Scenarios Illustrating SpecificityofM80.0__ICD-10-CMCodes Accessed October 30, 2019. 3. 30, October Accessed 2019. 2. 30, October Accessed pdf/$File/CMS1500_837v5010_Crosswalk.pdf. 1. References: Details Diagnosis Clinical October 30, 2019. 30, October for modifiers required 80.9: Section Accessed http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. patients. to administered biologicals. non-ESRD and 17:ESAs drugs Chapter Manual. Processing Claims Medicare 100-04: Publication Services. & Medicaid 2019. 30, October Accessed 9. http://valuehealthcareservices.com/education/understanding-hospital-revenue-codes/. codes. October Accessed 30, 2019. 8. crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_v5010A2_ crosswalk. Form Claim CMS-1450 the to 2019. Claim 7. 30, Care Health October Accessed cdc.gov/nchs/data/icd/10cmguidelines_2017_final.pdf. http://www. 6. reserved. rights All 2019.PDF. Full FY (ICD-10-CM). Modification Clinical 5. Revision, 10th Disease, of Classification International In: injuries. and diseases of list tabular treatment for thefractures Encounter for evaluating andcontinuing Vertebral fractures Postmenopausal osteoporosis been completed) management (after active treatment has Follow-up encounter for routine fracture Fracture ofleft wrist Postmenopausal osteoporosis Palmetto v5010 837 ASC GBA. to CMS-1500 http://www.palmettogba.com/Palmetto/Providers.Nsf/files/CMS1500_ Crosswalk. 837v5010_Crosswalk. American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) copyright 2016 American Medical Association. Association. Medical American 2016 copyright (CPT) Terminology Procedural Current Edition, Professional 2017 Association. Medical American . ® group than group ® -treated -treated ® , prescribers , prescribers ® -treated men with -treated ® Centers for Medicare and Medicaid Services. ICD-10-CM official guidelines for coding and reporting, FY 2017. FY reporting, and coding for guidelines official ICD-10-CM Services. Medicaid and Medicare for Centers therapy. ® Prolia . ® full Prescribing full ® resulted in significant resulted compared to placebo. Most Most placebo. to compared ® ® ® (denosumab) information, prescribing 4. Amgen. if severe symptoms develop. symptoms if severe in patients with bone loss receiving ADT for for ADT receiving with bone loss in patients The most common adverse reactions (>5% reactions adverse common The most ® ® Potential ICD-10-CMPotential Code Potential ICD-10-CMPotential Code . ® osteoporosis osteoporosis group. A causal relationship to drug exposure has not exposure drug to relationship A causal group. pathological pathological with current with current Age-related Age-related ® fracture fracture group. In men with osteoporosis, new malignancies were malignancies were new with osteoporosis, In men group. ® In the same clinical trial in In the same clinical Reactions: Adverse Dermatologic and dermal epidermal osteoporosis, with postmenopausal women at occurred and rashes dermatitis, eczema such as events adverse with Prolia rate higher a significantly In a clinical trial (N= 7808) in women with women 7808) in trial (N= In a clinical Infections: Serious to leading infections serious osteoporosis, postmenopausal Prolia in the frequently more reported were hospitalization bone, incapacitating and occasionally Severe Pain: Musculoskeletal Prolia taking in patients pain has been reported joint, and/or muscle with trials in women In clinical of Bone Turnover: Suppression Prolia osteoporosis, postmenopausal Adverse Reactions: with postmenopausal in women than placebo) common and more musculoskeletal back pain, pain in extremity, are osteoporosis common The most and cystitis. pain, hypercholesterolemia, in men than placebo) common and more (> 5% reactions adverse and nasopharyngitis. back pain, arthralgia, are with osteoporosis with Prolia has been reported Pancreatitis of these events were not specific to the injection site. Consider the injection site. not specific to were of these events Prolia discontinuing suppression of bone remodeling as evidenced by markers of bone markers by as evidenced of bone remodeling suppression of these The significance and bone histomorphometry. turnover Monitor unknown. are treatment of long-term findings and the effect and fractures, including ONJ, atypical these consequences, for patients healing. fracture delayed of new malignancies was 4.3% in the placebo group and 4.8% in the group 4.3% in the placebo malignancies was of new Prolia nonmetastatic prostate cancer receiving ADT, a greater incidence of incidence a greater ADT, receiving cancer prostate nonmetastatic observed. was cataracts immunogenicity. for is potential there proteins, patients. The incidence of opportunistic infections and the overall and the overall infections of opportunistic The incidence patients. groups. the treatment between similar were of infections incidence signs develop if they attention medical seek prompt to Advise patients cellulitis. including infection, of severe or symptoms In serious infections. risk for be at increased may immune systems on Prolia while serious infections who develop patients should assess the need for continued Prolia continued the need for assess should in the placebo group. Serious skin infections, as well as infections of as infections as well infections, Serious skin group. in the placebo in patients frequent more were and ear urinarythe abdomen, tract with Prolia treated Consider discontinuing use if severe symptoms develop. symptoms use if severe discontinuing Consider reported in no patients in the placebo group and 4 (3.3%) patients in and 4 (3.3%) patients group in the placebo in no patients reported the Prolia been established. with glucocorticoid-induced in patients group) than active-control and headache. bronchitis, back pain, hypertension, are osteoporosis with Prolia reported prostate cancer or adjuvant AI therapy for breast cancer are arthralgia arthralgia are cancer breast for AI therapy or adjuvant cancer prostate also pain have and musculoskeletal in extremity and back pain. Pain in Prolia trials. Additionally, in clinical been reported

HCPCS.codes. HCPCS J-codes. http://hcpcs.codes/j-codes/J0897/. http://hcpcs.codes/j-codes/J0897/. J-codes. HCPCS HCPCS.codes. incidence the overall osteoporosis, with postmenopausal In women As with all therapeutic antibody. Denosumab is a human monoclonal or with impaired agents immunosuppressant on concomitant Patients Please see Prolia accompanying Information, including Medication Guide. common (> 3% and more reactions adverse common The most reactions ≥ 10%) adverse incidence (per patient common The most in Prolia frequently more also reported was Endocarditis

Value Healthcare Services. Understanding hospital revenue revenue hospital Understanding Value Services. Healthcare . Centers for Disease Control and Prevention. 2019 ICD-10-CM ICD-10-CM 2019 Prevention. and Control Disease for Centers ® , ® . M80.0 3 M80.0 ® ® . The risk ® should not should Palmetto GBA. ASC 837I version 5010A2 Institutional Institutional 5010A2 version 837I ASC GBA. Palmetto should be should treatment, treatment, . ® ® ® ® . Prior vertebral . Prior vertebral ® Fracture of Fracture of vertebrae 4 4 forearm

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® is contraindicated in women who are who are in women is contraindicated is contraindicated in patients with in patients is contraindicated Initial encounter routine healing ® ® encounter for fracture with Subsequent injection. Concomitant use of calcimimetic use of calcimimetic injection. Concomitant for fracture ® . Prolia . If Prolia ® . ® ® . Prolia ® . treatment, patients should be advised to report new or new report be advised to should patients treatment, ® Amgen Drive One Amgen Center 91320-1799 CA Thousand Oaks, www.amgen.com © 2020 Amgen Inc. reserved. All rights USA-162-82262 05/20 ® . A dental examination with appropriate preventive dentistry is dentistry preventive with appropriate examination . A dental ® Following discontinuation of Prolia discontinuation Following Treatment: ® 11

pregnant and may cause fetal harm. In women of reproductive of reproductive harm. In women fetal cause and may pregnant initiating prior to be performed should testing pregnancy potential, with Prolia treatment history of systemic hypersensitivity to any component of the product. of the product. component any to hypersensitivity of systemic history urticaria. and swelling facial included anaphylaxis, have Reactions Prolia Contraindications: hypocalcemia. Pre-existing hypocalcemia must be corrected prior be corrected must hypocalcemia Pre-existing hypocalcemia. initiating Prolia to Multiple Vertebral Fractures (MVF) Following Discontinuation of Discontinuation (MVF) Following Fractures Vertebral Multiple Prolia fracture was a predictor of multiple vertebral fractures after Prolia after fractures vertebral of multiple a predictor was fracture should be transitioned to an alternative antiresorptive therapy. antiresorptive an alternative to be transitioned should discontinuation. Evaluate an individual’s benefit/risk before initiating benefit/risk before an individual’s Evaluate discontinuation. with Prolia treatment fracture risk increases, including the risk of multiple vertebral vertebral including the risk of multiple risk increases, fracture as 7 months as early occurred fractures vertebral New fractures. dose of Prolia the last 19 months) after (on average drugs may worsen hypocalcemia risk and serum calcium should be should risk and serum calcium hypocalcemia worsen drugs may with calcium all patients supplement Adequately monitored. closely D. and vitamin Atypical Femoral Fractures: Femoral Atypical Same Active Ingredient: Prolia Ingredient: Same Active in XGEVA (denosumab) found including hypersensitivity significant Clinically Hypersensitivity: with Prolia has been reported anaphylaxis with infection and/or local extraction tooth with associated is generally Prolia receiving in patients reported healing, and has been delayed a risk/benefit assessment, on an individual basis. a risk/benefit assessment, hypotension, dyspnea, throat tightness, facial and upper airway edema, and upper airway facial tightness, throat dyspnea, hypotension, significant or other clinically If an anaphylactic pruritus, and urticaria. and discontinue therapy appropriate initiate occurs, reaction allergic further use of Prolia fractures of the shaft have been reported in patients receiving Prolia receiving in patients been reported of the shaft have fractures of ONJ may increase with duration of exposure to Prolia to of exposure with duration increase of ONJ may should guide the management plan of each patient. Patients who guide the management plan of each patient. Patients should by care receive ONJ should of having or who develop suspected are ONJ treat to surgery dental Extensive surgeon. or an oral a dentist of Prolia Discontinuation the condition. exacerbate may considered based on individual benefit-risk assessment. considered especially in patients with severe renal impairment. In patients renal with severe in patients especially metabolism, of mineral and disturbances hypocalcemia to predisposed drugs, clinical with other calcium-lowering including treatment recommended is highly levels and mineral of calcium monitoring of Prolia within 14 days An oral exam should be performed by the prescriber prior to initiation prior to the prescriber by be performed should exam An oral of Prolia Causality has not been established as these fractures also occur in also occur as these fractures Causality has not been established agents. with antiresorptive not been treated who have patients osteoporotic receive XGEVA receive recommended prior to treatment in patients with risk factors for ONJ for with risk factors in patients treatment prior to recommended concomitant diagnosis of cancer, procedures, dental such as invasive angiogenesis inhibitors), corticosteroids, (e.g., chemotherapy, therapies hygiene Good oral disorders. and co-morbid hygiene, poor oral with Prolia during treatment be maintained should practices unusual thigh, hip, or groin pain. Any patient who presents with thigh pain. Any patient who presents unusual thigh, hip, or groin femur out an incomplete rule to be evaluated pain should or groin of Prolia Interruption fracture. with the use of Prolia worsen may Hypocalcemia Hypocalcemia: spontaneously, occur ONJ, which can of the Jaw (ONJ): Osteonecrosis

judgment clinical procedures, dental invasive requiring patients For OSTEOPOROSIS  EXAMPLES During Prolia Important Safety Information Safety Important ICD 10 CM CODE CODE ICD 10 CM

ICD 10 CM CODE EXAMPLES Reason for discontinuations for Reason of fracture Location National provider ID number National provider Primary diagnosis code Contact information Contact (please provide ICD-10 number[s]) provide (please mit or include punctuation as required in mit or include punctuation as required

rendering service rendering after (if required) NDC reporting require and/or FRAX T-score Original diagnostic O claims submitted Patient name Patient and units HCPCS code Correct specificity – Follow required time frame for submission submission for time frame required Follow code administration Identify appropriate criteria prior authorization Determine may payers and commercial Medicaid therapies Previous levels Calcium history fracture Prior osteoporosis-related orders physician Referring fracture for Risk factors name Provider of level the highest to Diagnosis code CONFIRM BILLING AND PAYER PAYER AND BILLING CONFIRM REQUIREMENTS: SUPPLEMENTAL DOCUMENTATION DOCUMENTATION SUPPLEMENTAL TEST (INCLUDING CONSIDERATIONS APPROPRIATE): AS DATE AND RESULTS COLLECT PRODUCT AND BILLING BILLING AND PRODUCT COLLECT INFORMATION: CORRECT AND COMPLETE PATIENT PATIENT COMPLETE AND CORRECT INFORMATION: risk fracture predicted – – – ID number number and/or group name insurer Health – – – Considerations Considerations Complete for Submission Claim