Important Safety Information Considerations for Complete POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who Claim Submission have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical ® attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued. YOUR GUIDE TO EVENITY In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite ® CORRECT AND COMPLETE PATIENT endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY compared to those INFORMATION: treated with alendronate. BILLING AND CODING Patient name Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating – ID number therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any – Health insurer name and/or group number component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria. INFORMATION Provider name Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in – National provider ID number EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue – Contact information further use of EVENITY®. Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients COLLECT PRODUCT AND BILLING INFORMATION: for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement FOR PHYSICIAN OFFICES USING THE CMS 1500 Correct HCPCS code and units patients with calcium and vitamin D while on EVENITY®. Diagnosis code to the highest level of specificity Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with – Primary diagnosis code delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to Identify appropriate administration code initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis FOR HOSPITALS/INSTITUTIONS USING THE CMS 1450 inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral Determine prior authorization criteria (if required) hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. Medicaid and commercial payers may require For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are NDC reporting 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 exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment. SUPPLEMENTAL DOCUMENTATION Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving CONSIDERATIONS INCLUDING TEST ® RESULTS AND DATE AS APPROPRIATE : EVENITY . Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated. e information provided in this guide is of a general nature and for informational purposes only. Coding and coverage policies change Original diagnostic T-score and/or FRAX During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh periodically and often without warning. e responsibility to determine coverage and reimbursement parameters, and appropriate predicted fracture risk or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on coding for a particular patient and/or procedure, is always the responsibility of the provider or physician. e information provided in Previous therapies benefit-risk assessment. this guide should in no way be considered a guarantee of coverage or reimbursement for any product or service. – Reason for discontinuations Adverse Reactions: e most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache. Calcium levels EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity. Call Amgen Assist® for assistance with specifi c payer requirements: Prior osteoporosis-related fracture history ® 1-866-AMG-ASST (1-866-264-2778) Monday through Friday, 9:00 am to 8:00 pm ET. – Location of fracture Please see accompanying EVENITY full Prescribing Information, including Medication Guide. (please provide ICD-10 number[s]) Referring physician orders INDICATION Risk factors for fracture EVENITY® is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defi ned as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Cardiovascular risk assessment EXAMPLES CODE ICD10CM – Confirm patients had no myocardial infarction e anabolic eff ect of EVENITY® wanes after 12 monthly doses of therapy. erefore, the duration of EVENITY® use should be limited to or stroke events within the last 12 months BUSINESS CARD BUSINESS CARD 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. CLEAR SLEEVE CLEAR SLEEVE CONFIRM BILLING AND PAYER REQUIREMENTS: IMPORTANT SAFETY INFORMATION POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH Omit or include punctuation as required in ® submitted claims EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or Follow required time frame for submission after rendering service stroke within the preceding year. Consider whether the benefi ts outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued. One Amgen Center Drive ousand Oaks, CA 91320-1799 www.amgen.com Please see additional Important Safety Information on the back cover. © 2019 Amgen Inc. All rights reserved. USA-785-80916 11/19 7 Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Accessed August 21, 2019. 21, August Accessed Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Section 80.9: required modifiers for ESAs administered to non-ESRD patients. http://www.cms.gov/ patients. non-ESRD to administered ESAs for modifiers required 80.9: Section Services. Publication 100-04: Medicare Claims Processing Manual. Chapter 17: drugs and biologicals. and drugs 17: Chapter Manual. Processing Claims Medicare 100-04: Publication Services. 9. 9. Centers for Medicare & Medicaid & Medicare for Centers 2019. 21, August Accessed understanding-hospital-revenue-codes/. Services. Understanding hospital revenue codes. http://valuehealthcareservices.com/education/ codes. revenue hospital Understanding Services. 8. Value Healthcare Value 2019. 21, August Accessed crosswalk.pdf/$File/EDI_837I_v5010A2_crosswalk.pdf. CMS-1450 Claim Form Crosswalk. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/EDI_837I_v5010A2_ Crosswalk. Form Claim CMS-1450 7. 7. Palmetto GBA. ASC 837I version 5010A2 Institutional Health Care Claim to the to Claim Care Health Institutional 5010A2 version 837I ASC GBA. Palmetto 2019. 21, August Accessed nchs/icd/data/10cmguidelines-FY2019-final.pdf. 6. CMS. ICD-10-CM official guidelines for coding and reporting, FY 2019. https://www.cdc.gov/ 2019. FY reporting, and coding for guidelines official ICD-10-CM CMS. 2019. 21, August Accessed NCHS/Publications/ICD10CM/2019/. injuries. In: International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM). FY 2019. Full PDF. ftp://ftp.cdc.gov/pub/Health_Statistics/ PDF. Full 2019. FY (ICD-10-CM). Modification Clinical Revision, 10th Diseases, of Classification International In: injuries. 5. Centers for Disease Control and Prevention. 2019 ICD-10-CM tabular list of diseases and diseases of list tabular ICD-10-CM 2019 Prevention. and Control Disease for Centers reserved. rights All Association. Medical American 2016 copyright 4. (r American Medical Association. 2017 Professional Edition, Current Procedural Terminology (CPT) Terminology Procedural Current Edition, Professional 2017 Association. Medical American Amgen. information, prescribing omosozumab-aqqg)