PROLIA CODING AND BILLING INFORMATIONAL …

1 PROLIA . CODING AND BILLING . INFORMATIONAL RESOURCES. USING THE CMS 1500 FORM. With ICD-10-CM Codes Contact Amgen Assist for assistance with specific payer requirements: 1-866-AMG-ASST (1-866-264-2778). The information provided in this guide is of a general nature and for INFORMATIONAL purposes only . CODING and coverage policies change periodically and often without warning. The responsibility to determine coverage and reimbursement parameters, and appropriate CODING for a particular patient and/or procedure is always the responsibility of the provider or physician. The information provided in this guide should in no way be considered a guarantee of coverage or reimbursement for any product or service. Please see Indications and Important Safety Information on the back and the accompanying PROLIA full Prescribing Information, including Medication Guide.

2 PHYSICIAN OFFICE BILLING INFORMATION COMPLETING THE CMS 1500 FOR PHYSICIAN OFFICES *. PROLIA (denosumab) CODING Information1. HCPCS Code (J-Code) in Box 24D J0897 (Injection, denosumab, 1 mg). Use of a 60 mg prefilled syringe of PROLIA is reported as: Number of Units in Box 24G. 60 units X XXX-XX-XXXX. Doe, Jane J 06 01 1930 X Doe, Jane J. Administration and Professional Service CODING Information2,* 1123 Main Street Hometown MA. The following code may be available to report administration of PROLIA . Other codes may be appropriate on a payer-specific basis. It is the provider's 01234 XXX XXX-XXXX. responsibility to ensure that codes used are consistent with payer policy and reflect service performed under such codes: 11111. CPT Code in Box 24D 96372 (therapeutic, prophylactic or diagnostic injection [specify substance or drug]; X 06 01 1930 X.)

3 Subcutaneous or intramuscular). X ABC Employer 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 X. it as a separate service: (significant, separately identifiable evaluation and management service by the same physician on the same day of the procedure or other service) X. Box 21. Diagnosis or Nature of Illness or Injury: Indicate appropriate ICD diagnosis code Diagnosis Code Information * as reflected in the patient's medical record. ICD-10 code example: (Age-related osteoporosis without current pathological The following primary diagnosis codes may be appropriate to describe fracture). patients without current osteoporotic fracture treated with PROLIA : ICD-10-CM Codes 3, . ICD Code in Box 21. (Age-related osteoporosis without current pathological fracture) 01 23 14 01 23 14 11 J0897 XXX XX 60 Box 24G.

4 Days or Units: (Other osteoporosis without current pathological fracture) Indicate 60 units 01 23 14 01 23 14 11 96372 XXX XX 1. Box 24D. Procedures, Services, or Supplies: * The sample codes are INFORMATIONAL and not intended to be directive or a guarantee of reimbursement and include potential codes that would include Indicate appropriate HCPCS and CPT codes. FDA-approved indications for PROLIA . Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, Example: J0897 (Injection, denosumab, and the services rendered. 1 mg). 96372 (Therapeutic, prophylactic, or . See insert on the back for examples of ICD-10 codes for patients with current osteoporotic fracture. diagnostic injection [specify substance or drug];. According to the ICD-10-CM Official Guidelines for CODING and Reporting, M81 code is for use for patients with osteoporosis who do not currently have a subcutaneous or intramuscular).

5 Pathologic fracture due to the osteoporosis, even if they have had a fracture in the past. For patients with a history of osteoporosis fractures, status code (personal history of [healed] osteoporosis fracture) should follow the code from the M81 11-1111111 X X XXX XX. John Smith MD. 2 Doctors Blvd Hometown, MA 01234. 11-22-16. XXXXXXXXX XXXXXXXXX. Please see Indications and Important Safety Information on the back and the accompanying PROLIA full Prescribing Information, including Medication Guide. PROLIA FDA-Approved Indications Multiple Vertebral Fractures (MVF) Following Discontinuation of PROLIA . PROLIA is indicated for the treatment of postmenopausal women with osteoporosis Treatment: Following discontinuation of PROLIA treatment, fracture risk at high risk for fracture, defined as a history of osteoporotic fracture, or multiple increases, including the risk of multiple vertebral fractures.

6 New vertebral risk factors for fracture; or patients who have failed or are intolerant to other fractures occurred as early as 7 months (on average 19 months) after the last available osteoporosis therapy. In postmenopausal women with osteoporosis, dose of PROLIA . Prior vertebral fracture was a predictor of multiple vertebral PROLIA reduces the incidence of vertebral, nonvertebral and hip fractures. fractures after PROLIA discontinuation. Evaluate an individual's benefit/risk before initiating treatment with PROLIA . If PROLIA treatment is discontinued, PROLIA is indicated for treatment to increase bone mass in men with osteoporosis consider transitioning to an alternative antiresorptive therapy. at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other Serious Infections: In a clinical trial (N = 7808) in women with available osteoporosis therapy.

7 Postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the PROLIA group than in the placebo group. Important Safety Information Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with PROLIA . Contraindications: PROLIA is contraindicated in patients with hypocalcemia. Endocarditis was also reported more frequently in PROLIA -treated patients. Pre-existing hypocalcemia must be corrected prior to initiating PROLIA . The incidence of opportunistic infections and the overall incidence of PROLIA is contraindicated in women who are pregnant and may cause infections were similar between the treatment groups. Advise patients to fetal harm. PROLIA is contraindicated in patients with a history of systemic seek prompt medical attention if they develop signs or symptoms of severe hypersensitivity to any component of the product.

8 Reactions have included infection, including cellulitis. anaphylaxis, facial swelling and urticaria. Patients on concomitant immunosuppressant agents or with impaired Same Active Ingredient: PROLIA contains the same active ingredient immune systems may be at increased risk for serious infections. In patients (denosumab) found in XGEVA . Patients receiving PROLIA should not who develop serious infections while on PROLIA , prescribers should assess receive XGEVA . the need for continued PROLIA therapy. Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis Dermatologic Adverse Reactions: In the same clinical trial in women with has been reported with PROLIA . Symptoms have included hypotension, postmenopausal osteoporosis, epidermal and dermal adverse events such dyspnea, throat tightness, facial and upper airway edema, pruritus and as dermatitis, eczema and rashes occurred at a significantly higher rate with urticaria.

9 If an anaphylactic or other clinically significant allergic reaction PROLIA compared to placebo. Most of these events were not specific to the occurs, initiate appropriate therapy and discontinue further use of PROLIA . injection site. Consider discontinuing PROLIA if severe symptoms develop. Hypocalcemia: Hypocalcemia may worsen with the use of PROLIA , especially Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, in patients with severe renal impairment. In patients predisposed to and/or muscle pain has been reported in patients taking PROLIA . Consider hypocalcemia and disturbances of mineral metabolism, clinical monitoring of discontinuing use if severe symptoms develop. calcium and mineral levels is highly recommended within 14 days of PROLIA . injection. Adequately supplement all patients with calcium and vitamin D.

10 Suppression of Bone Turnover: In clinical trials in women with postmenopausal osteoporosis, PROLIA resulted in significant suppression Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is of bone remodeling as evidenced by markers of bone turnover and bone generally associated with tooth extraction and/or local infection with delayed histomorphometry. The significance of these findings and the effect of healing, and has been reported in patients receiving PROLIA . An oral exam long term treatment are unknown. Monitor patients for consequences, should be performed by the prescriber prior to initiation of PROLIA . A dental including ONJ, atypical fractures, and delayed fracture healing. examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental Adverse Reactions: The most common adverse reactions (>5% and more procedures, diagnosis of cancer, concomitant therapies ( chemotherapy, common than placebo) in women with postmenopausal osteoporosis are corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, disorders.