AVEED Billing and Coding Guide

Transcription

1 AVEED Billing and Coding Guide myAVEED ( ) INDICATIONS AND USAGE AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptochordism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis. Limitations of use: Safety and efficacy of AVEED in males less than 18 years old have not been established. IMPORTANT SAFETY INFORMATION WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including lifethreatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Following each injection of AVEED, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis. Because of the risks of serious POME reactions and anaphylaxis, AVEED is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program.

2 Table of Contents Ordering AVEED... 3 The AVEED Provider Enrollment Program... 3 Choose Buy-and-Bill or Specialty Pharmacy... 3 The Buy-and-Bill Method... 3 The Specialty Pharmacy Method... 6 myaveed - Reimbursement Hotline... 8 Get Started With myaveed... 9 Determining Coverage for AVEED Benefits Investigation Prior Authorization Assistance myaveed Reimbursement Services AVEED Patient Savings Program AVEED Coding Information CMS-1500 Claim Example for Medical Practices Using the Buy-and-Bill Method Process for Ordering AVEED and Submitting Claims Forms and Resources Frequently Asked Questions Glossary Indication and Important Safety Information

3 Ordering AVEED The AVEED Provider Enrollment Program The AVEED Provider Enrollment Program is required by the FDA as part of the AVEED REMS. The program is designed to train all healthcare professionals who prescribe and/or administer AVEED about the risk of immediate post-injection reactions, specifically pulmonary oil microembolism (POME) and anaphylaxis. Program Requirements Healthcare settings must be certified in the AVEED REMS* Program to be able to order AVEED. One representative needs to enroll per healthcare setting (the Authorized Representative ). Prescribing Healthcare Providers must be certified in the AVEED REMS Program to be able to prescribe AVEED. Non-prescribing Healthcare Providers who will administer AVEED to patients must be trained on the AVEED REMS Education Program for Healthcare Providers. *Risk Evaluation and Mitigation Strategy For further information and to enroll in the AVEED Provider Enrollment Program, please visit the AVEED Provider Enrollment Program website at AveedREMS.com or call to request materials. Choose Buy-and-Bill or Specialty Pharmacy Based on the dispensing preference selected on the Benefits Investigation and Enrollment Form, and the requirements of your patient s health plan, AVEED may be obtained via a specialty distributor (Buy-and-Bill) or a Specialty Pharmacy. The Buy-and-Bill Method Buy AVEED exclusively through one of the wholesale pharmacies or distributors listed below and bill it to the patient or patient s health plan. Collect copay/coinsurance from the patient. AVEED is available from the distributors listed in the chart below. Buy-and-Bill Distributors Besse Medical Cardinal Specialty McKesson Specialty Smith Medical Partners Acute Care: Urology: specialtyonline.cardinalhealth.com IMPORTANT SAFETY INFORMATION AVEED Risk Evaluation and Mitigation Strategy (REMS) Program AVEED is available only through a restricted program called the AVEED REMS Program because of the risk of serious POME and anaphylaxis. 3

4 The Buy-and-Bill Method After coverage has been determined, and AVEED is administered to a patient, the practice prepares a claim to bill the patient s health plan for the documented use of the drug. Based on the information that the practice supplies on the claim, the health plan will process the claim and provide reimbursement to the provider according to a provider fee schedule or a provider contract. After a health plan processes a covered claim, the patient may have a financial obligation to the practice in the form of a deductible and/or copay. The amount that the practice must collect from each patient (or the patient s secondary insurer, if any) varies according to the terms of the patient s insurance benefits and the status of his deductible. The health plan will provide an Explanation of Benefits (EOB) to the provider and the patient, detailing the claim that was submitted, the amount that has been paid by the plan, and what is owed by the patient. During the benefits investigation, myaveed can help a practice obtain a preliminary determination regarding whether a patient s insurance covers AVEED, any payer requirements for coverage and the patient s estimated financial responsibility. If you use the Buy-and-Bill method, the patient may also be eligible for savings. See page 12 for more information about the AVEED Patient Savings Program. Key Points for the Buy-and-Bill Method Product is stocked in the office and readily available to treat the patient Provider is financially responsible for the drug until payment is received from the patient s insurance plan Patient pays the provider for any copay or coinsurance associated with the drug and the drug administration Medicare only allows Buy-and-Bill (no Specialty Pharmacy option); the provider is reimbursed according to a published fee schedule For commercial patients, the provider is reimbursed according to their contract with the payer Use J Code 3145 (Injection, Testosterone Undecanoate, 1 mg) and be sure to bill for 750 units per injection. Healthcare providers are encouraged to enroll patients in myaveed as early in the treatment plan as possible to help ensure appropriate access to AVEED. IMPORTANT SAFETY INFORMATION (CONT) CONTRAINDICATIONS Men with carcinoma of the breast or known or suspected carcinoma of the prostate. Women who are or may become pregnant, or who are breastfeeding. Testosterone can cause fetal harm when administered to a pregnant woman. AVEED may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. Men with known hypersensitivity to AVEED or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate). 4

5 Buy-and-Bill Checklist Submit a Benefits Investigation and Enrollment Form to myaveed to request a benefits investigation on behalf of your patient. myaveed will provide you with a benefit summary that outlines: Patient eligibility for health plan benefits Prior authorization requirements, if any Patient s financial obligation Contact a specialty distributor to purchase AVEED myaveed can provide you with a list of specialty distributors/wholesalers Inquire about payment terms (the amount of time you have before you pay the distributor) with the distributor Administer injection Collect appropriate copay from the patient (eg, for AVEED, administration of injection and ancillary services) Submit a timely and accurate claim to the patient s health plan myaveed can provide information to help you prepare clean claims and compile any necessary relevant supporting documentation. Use J Code 3145 (Injection, Testosterone Undecanoate, 1 mg) and be sure to bill for 750 units per injection. Your patient can complete and fax or send the Rebate Form, along with the EOB and the bill indicating the amount the patient paid for AVEED. The rebate will be mailed directly to the patient. Rebate forms are available from your Sales Representative and AveedUSA.com. Eligible patients paying cash can also receive a rebate of up to $165 IMPORTANT SAFETY INFORMATION (CONT) WARNINGS AND PRECAUTIONS Serious Pulmonary Oil Microembolism (POME) Reactions and Anaphylaxis Serious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate 1000 mg (4 ml). The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization. To minimize the risk of intravascular injection of AVEED, care should be taken to inject the preparation deeply into the gluteal muscle, being sure to follow the recommended procedure for intramuscular administration. In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular testosterone undecanoate. Both serious POME reactions and anaphylaxis can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Patients with suspected hypersensitivity reactions to AVEED should not be re-treated with AVEED. Following each injection of AVEED, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions and anaphylaxis. 5

6 The Specialty Pharmacy Method Getting started via Specialty Pharmacy is as easy as completing and faxing a Benefits Investigation and Enrollment Form to myaveed at With the help of myaveed, you can acquire AVEED exclusively through a Specialty Pharmacy Provider, which bills the patient or patient s health plan directly, then delivers the medication after payment is received. In this scenario, you only bill for your professional services. The prescription will be sent to a certified healthcare setting, such as your office or hospital. To order via Specialty Pharmacy, fax a Benefits Investigation and Enrollment Form to , or call myAVEED ( ) If you use the Specialty Pharmacy method, your patients may also be eligible for savings. With a signed Patient Authorization Form on file, myaveed will determine eligibility for the AVEED Patient Savings Program. See page 12 for more information about the AVEED Patient Savings Program. Although the physician does not include AVEED on a claim to the patient s health plan, the physician may be able to bill for the administration of AVEED and other professional services provided during the patient encounter. You will need to collect from the patient any copay that is applicable. Key Points for the Specialty Pharmacy Method Provider obtains the drug via Specialty Pharmacy Specialty Pharmacy is financially responsible for the drug (the assignment of benefit) Patient-specific drug is shipped to the provider or facility to be administered to the patient Specialty Pharmacy bills the payer for the drug and collects drug copay/coinsurance from the patient Provider bills the payer for drug administration services only and collects administration copay/coinsurance from the patient If a Prior Authorization is required the SP will contact you directly for any necessary information or action required on your behalf Patient must pay copay and consent to each shipment. It is important that the patient respond to any calls from their SP. Non-response will result in a delay of shipment and therapy Healthcare providers are encouraged to enroll patients in myaveed as early in the treatment plan as possible to help ensure appropriate access to AVEED. IMPORTANT SAFETY INFORMATION (CONT) Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer - Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at an increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens. Polycythemia - Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of testosterone. Check hematocrit prior to initiating testosterone treatment. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events. 6

7 Specialty Pharmacy Checklist Submit a Benefits Investigation and Enrollment Form (which includes prescription) to myaveed to request a benefits investigation on behalf of the patient. Check the Specialty Pharmacy box under Dispensing Preference. Any clinical information submitted with the BIEF will be forwarded to the Specialty Pharmacy and may save time if a prior authorization is required. myaveed will provide you with a benefit summary that outlines: Patient eligibility for health plan or prescription drug benefits Prior authorization requirements, if any Patient s financial obligation Network Specialty Pharmacy requirements, if any Fax a Patient Authorization Form, signed by the patient, to myaveed to enroll the patient in the Patient Savings Program. Please let your patient know that the Specialty Pharmacy will be contacting them prior to each shipment. The patient must pay copay (if any) and authorize shipment before the Specialty Pharmacy will ship the medication myaveed will triage the prescription to the appropriate Specialty Pharmacy Provider. Specialty Pharmacy Provider collects the copay for AVEED directly from the patient or via the Patient Savings Program, if the patient is eligible. (The medical practice will not be billed for AVEED ) If a Prior Authorization is required the SP will contact you directly for any necessary information or action required on your behalf Specialty Pharmacy Provider submits a claim for AVEED to the patient s health plan or prescription drug plan Medical practice collects appropriate copay or coinsurance for the items and services provided by the healthcare provider (eg, administration of the injection, ancillary services) Medical practice submits a claim to the patient s health plan for the items and services provided by the healthcare provider. The practice does not submit a claim for AVEED Subsequent doses of AVEED are automatically initiated by the Specialty Pharmacy Provider Refills must be indicated and must be within the valid 6 month time frame of the CIII medication Patient must pay copay and consent to each shipment. It is important that the patient respond to any calls from their SP. Non-response will result in a delay of shipment and therapy The prescription will be only be sent to a certified healthcare setting, such as your office or hospital. The SP will contact your office to coordinate the AVEED delivery. IMPORTANT SAFETY INFORMATION (CONT) Venous thromboembolism (VTE) - There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as AVEED. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with AVEED and initiate appropriate workup and management. 7

8 Reimbursement Hotline myaveed Is Your One-Stop Source For Product Support To get started, complete a Benefits Investigation and Enrollment Form and a Patient Authorization Form and fax them to Dedicated resources at myaveed include: Reimbursement Case Advocates(RCA): are the primary interface between the Support Center, patients and health care professionals with respect to reimbursement services. The Reimbursement Case Advocates will assist in managing reimbursement services to include benefits verification, Prior Authorization, Appeals and the Patient Savings Program. Regional Reimbursement Access Specialists(RRAS): Are a part of the Endo Field reimbursement team. Regionally based, serving as an extension of our Support Center services, to assist with patient specific case management, along with reimbursement billing and coding support. With myaveed, healthcare professionals call just one phone number for assistance with: Contacting patient health plan to verify benefit coverage and eligibility Ordering AVEED for your patients Reimbursement support Questions about coding AVEED on health plan claims Ordering and processing Specialty Pharmacy prescriptions Managing prior authorizations Determining eligibility and enrollment in AVEED Patient Savings Program myaveed is a confidential HIPAA-compliant service. There is no cost associated with the use of this program. IMPORTANT SAFETY INFORMATION (CONT) Use in Women - Due to lack of controlled evaluations in women and potential virilizing effects, AVEED is not indicated for use in women. Potential for Adverse Effects on Spermatogenesis - With large doses of exogenous androgens, including AVEED, spermatogenesis may be suppressed through feedback inhibition of pituitary folliclestimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count. Hepatic Adverse Effects - Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. AVEED is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue AVEED while the cause is evaluated. 8

9 Get Started With In order to access the support provided by myaveed, please contact a hotline representative at myAVEED ( ). To initiate a benefits investigation or a prescription via Specialty Pharmacy, complete and fax a Benefits Investigation and Enrollment Form to along with any relevant clinical information To determine patient eligibility for the AVEED Patient Savings Program, have the patient sign the Patient Savings portion of the Patient Authorization Form and fax with the Benefits Investigation and Enrollment Form Forms are available through your sales representative or by visiting AveedUSA.com/PrescriberResources myaveed will also provide you with information about the designated specialty distributors and/or specialty pharmacies from which AVEED is available. IMPORTANT SAFETY INFORMATION (CONT) Edema - Androgens, including AVEED, may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Gynecomastia - Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism. Sleep Apnea - The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Lipids - Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. 9

10 Determining Coverage for AVEED Benefits Investigation A healthcare provider may obtain AVEED either from a specialty distributor or wholesaler (the Buy-and-Bill method) or from a Specialty Pharmacy (the Specialty Pharmacy method). After you send a Benefits Investigation and Enrollment Form to myaveed, a myaveed representative will contact the health plan on your patient s behalf to determine which acquisition method(s) are acceptable to the plan. A physician or medical practice may also contact the patient s health plan directly for this information. This information is obtained from the health plan as part of a benefits investigation, which is best conducted prior to treatment and is specific to the patient who is being treated. A benefits investigation can also determine whether the payer has prior authorization, Specialty Pharmacy network or other requirements, as well as the amount of the patient s expected copay. When myaveed completes the benefits investigation, a myaveed representative will provide a benefit summary outlining this important information. Prior Authorization Assistance myaveed can assist with information about the prior authorization process and, if necessary, any appeals. IMPORTANT SAFETY INFORMATION (CONT) Hypercalcemia - Androgens, including AVEED, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients. Decreased Thyroxine-binding Globulin - Androgens, including AVEED, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Laboratory Monitoring - Monitor prostatic specific antigen (PSA), hemoglobin, hematocrit, and lipid concentrations at the start of treatment and periodically thereafter. ADVERSE REACTIONS AVEED was evaluated in an 84-week clinical study using a dose regimen of 750 mg (3 ml) at initiation, at 4 weeks, and every 10 weeks thereafter in 153 hypogonadal men. The most commonly reported adverse reactions ( 2%) were: acne, injection site pain, prostate specific antigen increased, hypogonadism, estradiol increased, fatigue, irritability, hemoglobin increased, insomnia, and mood swings. In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Adverse reactions leading to discontinuation included: hematocrit increased, estradiol increased, prostatic specific antigen increased, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis. Postmarketing Experience Pulmonary Oil Microembolism (POME) and Anaphylaxis Serious pulmonary oil microembolism (POME) reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate 1000 mg (4 ml) in post-approval use outside the United States. 10

11 myaveed Reimbursement Services To access any of the services below, fax a completed Benefits Investigation and Enrollment Form to myaveed Benefits Investigation myaveed verifies that patient is eligible for benefits and identifies specific coverage for AVEED Product Ordering Information myaveed can help practices identify product ordering options, including Specialty Pharmacy and Buy-and-Bill Prior Authorization Information myaveed provides information needed for medical practice to request prior authorization when prior authorization is necessary Prior Authorization Tracking/Appeal myaveed follows up on prior authorization until resolution Billing and Coding Support myaveed provides medical practice with information regarding HCPCS, CPT, and ICD-9-CM or ICD-10-CM diagnosis coding, and any other information required to submit clean and accurate claims Patient Savings Program Eligibility Determination With a signed Patient Authorization Form, myaveed enrolls patients into the AVEED Patient Savings Program and applies savings, if eligible FAX A BENEFITS INVESTIGATION AND ENROLLMENT FORM TO OR CALL FOR ASSISTANCE myAVEED ( ) 8 am to 8 pm EST Claims Investigations and Denials myaveed investigates issues with denied or underpaid claims and determines next steps (eg, appeal) Claims Denial myaveed determines the denial reason and provides information to the medical practice for their submission of appeal Communicates appeal outcome and next steps Claims Adjustment myaveed determines the reason for underpayment myaveed communicates to and educates the health plan about AVEED 11

12 AVEED Patient Savings Program $0 Copay on Your Patient s First 2 Injections and No More Than $30 Copay for Each Additional Injection* Eligible patients pay $0 copay on their first 2 injections with the AVEED Patient Savings Program.* The program will pay up to a maximum reimbursement of $165 for each of their first 2 AVEED injections PLUS, up to a maximum reimbursement of $135 for each injection thereafter. If their total out of pocket expense exceeds these amounts, they are responsible for the additional amounts. Some restrictions apply. Offer not valid for prescriptions that may be reimbursed under a federal or state healthcare program, including Medicare, Medicaid, or any other federal or state healthcare programs. Here s How Patients Receive the Rebate If you choose the Buy-and-Bill method: If your patient is insured, copay will need to be collected by your practice. Your patient can then submit a rebate form, along with their EOB and the bill indicating the amount the patient paid for AVEED, to have the rebate mailed to them. Rebate forms are available from your sales representative or through AveedUSA.com/PatientSavings. Eligible patients paying cash can also receive a rebate of up to $165. If you choose to order via Specialty Pharmacy with processing by myaveed: Patients will automatically be evaluated for copay savings eligibility, and the savings will be applied through the order, reducing the cost, once the signed Patient Authorization Form has been submitted. To get started, please contact a hotline representative at myAVEED ( ), or complete and fax a Benefits Investigation and Enrollment Form to Download forms at AveedUSA.com/PhysicianResources or contact your AVEED sales representative. * On the first 2 AVEED injections, maximum savings is $165 per use. On subsequent injections, patient pays the first $30 of copay. Program pays up to a maximum of $135 per use. Patient is responsible for any balance remaining, and for reporting receipt of this coupon benefit to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the coupon, as may be required. Patient and prescriber agree not to seek reimbursement for all or any part of the benefit received by the patient through this offer. Terms and Conditions: Offer good only in the USA and void where prohibited or otherwise restricted by law. Offer is valid for patients with private insurance or paying cash. Offer not valid for prescriptions that may be reimbursed under a federal or state healthcare program, including Medicare, Medicaid, or any other federal or state healthcare programs, including any state medical pharmaceutical assistance programs. If there are any questions, please call Limitations apply, Endo Pharmaceuticals Inc. reserves the right to rescind, revoke, or amend this program without notice. Patient is responsible for reporting receipt of program rewards to any private insurer that pays for or reimburses any part of the prescriptions filled with this program. Offer expires on 3/1/

13 AVEED Patient Savings Program Process Specialty Pharmacy Buy-and-Bill Physician faxes a Benefits Investigation and Enrollment Form and a Patient Authorization Form to myaveed to enroll patient and acquire AVEED via Specialty Pharmacy Patient receives Rebate Program Brochure and Form from physician or downloads rebate form and completes online registration at AveedUSA.com myaveed representative determines eligibility for Patient Savings Program Patient completes form and faxes, mails, or s completed form and EOB as instructed on form If patient is eligible, myaveed representative notifies Specialty Pharmacy to process claim using Patient Savings Program When all required information is provided, eligible patients receives rebate letter and rebate check Specialty Pharmacy processes claim using Patient Savings Program IMPORTANT SAFETY INFORMATION (CONT) DRUG INTERACTIONS Insulin - Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication. Oral Anticoagulants - Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy. Corticosteroids - The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease. 13

14 AVEED Coding Information Commonly Used Codes for AVEED J Code J3145 AVEED Injection, testosterone undecanoate, 1 mg BE SURE TO CODE FOR 750 BILLING UNITS PER INJECTION HCPCS Code (for hospital use) C9023 National Drug Code (NDC) AVEED Injection, testosterone undecanoate, 1 mg (10-digit) (11-digit) AVEED 750 mg/3 ml (250 mg/ml) The 11-digit billing format is an electronic transaction standard required by many health plans that require NDC codes for billing. Check with the health plan for the requirements specific to your patient. Diagnosis Code (ICD-9-CM) Testicular dysfunction (other testicular hypofunction) includes testicular hypogonadism CPT Code (Intramuscular Injection of AVEED ) Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular IMPORTANT SAFETY INFORMATION (CONT) USE IN SPECIFIC POPULATIONS Geriatric Use - There have not been sufficient numbers of geriatric patients in controlled clinical studies with AVEED to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There are insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer. DRUG ABUSE AVEED contains testosterone undecanoate, a Schedule III controlled substance in the Controlled Substances Act. Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects. 14

15 CMS-1500 Claim Example for Practices Using the Buy-and-Bill Method This example is intended to illustrate the types of information generally required by health plans and is for reference only. Practices filing claims electronically must cross-walk the paper CMS-1500 to a format compatible with their individual billing software packages in compliance with health plan electronic transaction requirements. Field 21 (Diagnosis or Nature of Illness or Injury): Enter the ICD-9-CM diagnosis code(s) that best describe the reason(s) the patient is receiving care SAMPLE UN J Field 24D: Enter NDC code in shaded area above HCPCS (Example shows coding for Medicare) Commercial(10-digit) N (10digit) UN1 Medicare(11 digit) N (11digit) UN1 Field 19: Enter drug NCD and description; (Example shows coding for Medicare) Field 24E (Diagnosis Pointer): Enter the line letter(s) from Field 21 that best describe(s) the medical necessity for the service Field 24G (Days or Units): Requirements for Field 24G vary by health plan. For example, some payers rely on the information in Field 19 for this data and request a placeholder of 1 in Field 24G. Other payers may require 1 unit per milligram of drug used in the care of the patient (in this example, that would be 750) PLEASE PRINT OR TYPE APPROVED OMB FORM 1500 (02-12) 15

16 Process for Ordering AVEED and Submitting Claims STEP 1 AVEED Provider Enrollment Provider, administrator, and facility enroll at AveedREMS.com STEP 2 Verify Patient Benefits Medical practice faxes a Benefits Investigation and Enrollment Form to myaveed to initiate benefits investigation myaveed representative sends benefit summary to prescriber myaveed confirms that prescriber, administrator, and facility are enrolled in the AVEED Provider Enrollment Program Specialty Pharmacy Method Buy-and-Bill Method Submit Patient Authorization Form to myaveed myaveed will: Triage the prescription to the appropriate Specialty Pharmacy Provider Enroll the patient into the Patient Savings Program and apply savings, if eligible Specialty Pharmacy Files Drug Claim and Collects Patient Copay Specialty Pharmacy: Submits Prior authorization if required. SP may contact HCP for any clinical documentation needed or action required on behalf of HCP Bills health plan for AVEED Collects drug copay or coinsurance (as appropriate) and consent directly from patient prior to each shipment. Applies Patient Savings Program for eligible patients Specialty Pharmacy Contacts HCP to arrange shipment of AVEED to REMS enrolled Site of Care Injection Administration HCP administers AVEED to patient Injection Administration HCP administers AVEED to patient Collect Patient Copay Medical practice collects copay or coinsurance for AVEED and for professional services, as appropriate Patient may register and download the rebate form at AveedUSA.com File Claim for AVEED and Professional Services to Health Plan Medical practice submits claim to health plan for AVEED and related professional services Medical practice contacts myaveed for assistance with claim follow-up or appeal, if needed Patient completes Rebate Form, and faxes or mails along with the EOB and the bill indicating the amount the patient paid for AVEED. The rebate will be mailed directly to the patient. Rebate forms are available from your Sales Representative. Eligible patients paying cash can also receive a rebate of up to $165 File Claim for Professional Services Medical practice bills health plan for professional services (practice does not bill for AVEED ) Medical practice collects professional services copay (if any) directly from patient 16

17 Forms and Resources AVEED (testosterone undecanoate) Benefits Investigation & Enrollment Form Please see accompanying full Prescribing Information, including Boxed Warning. AVEED (testosterone undecanoate) Phone MYAVEED ( ) Fax Male Female Instructions for Completing the AVEED (testosterone undecanoate) Benefits Investigation & Enrollment Form Phone: MYAVEED ( ) Fax: J-code: J3145 Injection, testosterone undecanoate, 1 mg 1. Confirm Healthcare Provider and Setting are Enrolled in AVEED Provider Enrollment Program Note: CIII prescriptions are valid by Federal law for a maximum of 6 months from the written date. Please select one prescription option below. To Enroll: Visit the AVEED REMS website (AveedREMS.com) Ensure Healthcare Provider is enrolled in AVEED REMS Program Ensure Healthcare Setting is enrolled in AVEED REMS Program 2. Complete Benefits Investigation & Enrollment Form Please complete each section : Patient Patient Healthcare Setting Site of Administration Information section Only complete alternate site of Administration section if applicable Administration: Dispensing preference can have both Specialty Pharmacy as well as Buy and Bill checked Administration: Prescription Information section CIII prescriptions are valid by Federal law for a maximum of 6 months from written date. Please select one prescription option. Initial prescription Sign Prescription Authorization/Certification of Medical Necessity/Authorization to Release Patient Information Authorization allows Endo Reimbursement Service Hotline to conduct an investigation of the. patient s insurance coverage. Please see accompanying full Prescribing Information, including Boxed Warning. 3. Fax Completed Form to Please include the following documents: Insurance card(s); front and back Chart notes Applicable laboratory results (i.e. Testosterone Test) Completed and signed Patient Authorization form Patient Savings: By completing this Benefits Investigation & Enrollment Form and Patient Authorization your patient will automatically be evaluated for copay savings eligibility. Rx Only AVEED is a U.S. registered trademark of Endo Pharmaceuticals Inc Endo Pharmaceuticals Inc. All Rights Reserved. Malvern, PA AV-03016(1)/December ENDO (3636) Download additional forms at AveedUSA.com/PhysicianResources or contact your AVEED sales representative. 17

18 Forms and Resources AVEED (testosterone undecanoate) injection Patient Authorization Form Patient Authorization to Use/Disclose Health Information: myaveed By signing this Authorization, I authorize my physician, health plans and pharmacy providers to disclose my personal health information, including, but not limited to, information relating to medical condition, treatment, care management, and health insurance, as well as all information provided on this form and any prescription ( Personal Health Information ), to the myaveed Support Center and its representatives, agents, and contractors for the following purposes: 1) establish my benefit eligibility and potential out-of-pocket costs for AVEED ; 2) communicate with my healthcare providers and health plans about my treatment plan; 3) provide support services, including patient education and financial assistance for AVEED ; 4) coordinate shipment of AVEED ; 5) evaluate the effectiveness of patient support programs and conduct market analysis, including aggregating my health information with other data for such analysis; and administer the Risk Evaluation and Mitigation Strategy surveys for AVEED. I understand that my pharmacy providers may receive remuneration for disclosing my Protected Health Information pursuant to this Authorization. I understand that Personal Health Information disclosed under the Authorization may no longer be protected by federal privacy law and may be re-disclosed by myaveed. I understand that Endo Pharmaceuticals Inc., may contact me to participate in surveys about Endo products and services, however, Endo agrees to protect my information by using it only for the purposes described above or as required by law. I further understand that I may refuse to sign this authorization and if I do not sign it, my eligibility for health plan benefits and treatment will not change, but I will not have access to myaveed support services described above. I may cancel this Authorization at any time by mailing a letter requesting such revocation to: myaveed, PO box 2910, Phoenix, AZ 85062, but that this cancellation will not apply to any information already used or disclosed through this Authorization. This Authorization expires five (5) years from the date signed below. Signature of Patient or Legal Representative Date Print Name of Patient or Legal Representative Legal Representative s Relationship to Patient (if applicable) AVEED Patient Savings Program Participation I authorize myaveed to enroll me in the AVEED Patient Savings Program ( Program ) and to use my personally identifiable information related to AVEED therapy for Program administration. By signing below, I acknowledge and attest to the following: (1) the Program assists with outof-pocket costs related to the cost of AVEED (drug only). No other expenses are covered by this program; (2) I would otherwise by responsible for making the full co-pay or co-insurance amount due to my physician or pharmacy; (3) I understand that a failure, by me or my physician, to follow the program rules may void my participation in the Program (4) I will disclose my participation in the Program if required by my insurance company; (5) I am not covered by a federal- or state-funded program. This Authorization expires five (5) years from the date signed below. Signature of Patient or Legal Representative Date Print Name of Patient or Legal Representative Legal Representative s Relationship to Patient (if applicable) Additional Support and Patient Program Participation I would like to receive information in the future about AVEED and related product information. Signature of Patient or Legal Representative Date Print Name of Patient or Legal Representative Legal Representative s Relationship to Patient (if applicable) Fax completed form to For questions, please call myaveed toll-free at myAVEED ( ) Rx Only AVEED is a U.S. registered trademark of Endo Pharmaceuticals Inc Endo Pharmaceuticals Inc. All Rights Reserved. Malvern, PA AV-03135(2)/December ENDO (3636) Download additional forms at AveedUSA.com/PhysicianResources or contact your AVEED sales representative. 18

19 Frequently Asked Questions Q: How does a medical practice know whether a patient s health plan will cover AVEED? A: The best way to find out is to contact the health plan on behalf of the patient and inquire. myaveed is available to assist with this type of benefits investigation when a medical practice enrolls a patient for this service. A myaveed representative will contact the patient s health plan and relay the response back to the medical practice. A fax summarizing the patient s coverage will also be provided. Q: During the benefits investigation, it was determined that the patient s health plan requires a prior authorization for AVEED. Can myaveed help with this process? A: During the benefits investigation, the myaveed representative will inquire about the health plan s prior authorization process, obtain any payer-required forms, and provide this information to the medical office. Your myaveed representative will follow up with the health plan until a decision has been reached, which can take 7 to 14 days on average. If the prior authorization request is denied, your representative can also assist you in preparing an appeal. If you are utilizing a Specialty Pharmacy (SP), the SP will submit the prior authorization. The SP will contact you for any needed clinical documentarian or action required on your behalf. Q: Our medical practice reported HCPCS code J3145 for AVEED, but the health plan has not paid the claim. Is there another HCPCS code we should use? A: HCPCS code J3145 is the appropriate code unless the health plan has given specific instructions to use another code. Review your claim to be certain that in addition to HCPCS code J3145, you have provided the health plan with the name of the drug, the NDC code, the route of administration, and the amount of drug used to care for the patient. This is often provided as free text somewhere on the paper or electronic claim. If this information was not provided on the original claim, it will be necessary to file a corrected claim. myaveed can assist you in contacting the health plan to verify the free-text requirements. IMPORTANT SAFETY INFORMATION (CONT) ADVERSE REACTIONS AVEED was evaluated in an 84-week clinical study using a dose regimen of 750 mg (3 ml) at initiation, at 4 weeks, and every 10 weeks thereafter in 153 hypogonadal men. The most commonly reported adverse reactions ( 2%) were: acne, injection site pain, prostate specific antigen increased, hypogonadism, estradiol increased, fatigue, irritability, hemoglobin increased, insomnia, and mood swings. In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Adverse reactions leading to discontinuation included: hematocrit increased, estradiol increased, prostatic specific antigen increased, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis. 19

20 Q: Our medical practice reported HCPCS code J3145 for AVEED, but it seems that the health plan has underpaid the claim. Why did this happen and how can we prevent it? A: To obtain accurate reimbursement for AVEED, a medical practice must be certain that the amount of drug used to care for the patient is accurately conveyed to the health plan on the claim in the format that the health plan is prepared to accept. Since the J Code for Aveed is in 1 mg units it is critical to bill for 750 billing units per injection. Health plans have different requirements about where medical practices should place this information on paper or electronic claim forms. myaveed can assist you in contacting the health plan to verify how the plan wishes this information to be reported and where it should be placed on the paper or electronic claim. It may be necessary for the medical practice to file a corrected claim to obtain appropriate reimbursement. If the apparent underpayment is deemed to be an error on the part of the health plan, myaveed can assist by contacting the payer to inquire about the problem and can also assist you in preparing an appeal if needed. Q: Does AVEED have an HCPCS code for hospital use? A: Yes, C9023 AVEED Injection, testosterone undecanoate, 1 mg should be used in hospital settings. INDICATIONS AND USAGE AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptochordism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis. Limitations of use: Safety and efficacy of AVEED in males less than 18 years old have not been established. IMPORTANT SAFETY INFORMATION WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Following each injection of AVEED, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis. Because of the risks of serious POME reactions and anaphylaxis, AVEED is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program. 20

21 Glossary Buy-and-Bill: The traditional method of acquiring drugs administered in a medical practice. The medical practice incurs the financial risk associated with purchasing the drugs and submits claims to health plans after the purchased drugs have been used in the care of a patient. Centers for Medicare and Medicaid Services (CMS): The federal agency that administers the Medicare and Medicaid programs. Coinsurance: A percentage of the allowable that is designated by a patient s health plan that the patient must pay to the provider for covered medical services. Copay/Copayment: A flat dollar amount designated by a patient s health plan that the patient must pay to the provider for covered medical services. CPT Code: CPT (Current Procedural Terminology) is a listing of descriptive terms and identifying codes developed and maintained by the American Medical Association for reporting medical services and procedures performed by physicians and other eligible healthcare professionals. HCPCS Code: HCPCS (Healthcare Common Procedure Coding System) are alpha-numeric codes developed and maintained by CMS that describe items and services that are not included in the CPT coding system. Many health plans require medical practices to use HCPCS codes to report injected or infused drugs purchased by medical practices and used in the care of their patients. ICD-9-CM Diagnosis Code: A system of numeric codes that identify diseases and medical conditions. ICD-9-CM diagnosis codes are reported on claims to convey the medical necessity for the items and services provided in the care of a patient. J-Code: The term J-code (or other alpha-numeric term such as C-code or Q-code ) is commonly used to refer to HCPCS codes for injected or infused drugs. See HCPCS Code, above. Medical Benefit: The portion of a health plan s benefit that includes coverage and payment of major medical services. Drugs purchased by a medical practice and used in the care of the practice s patients (eg, drugs within the Buy-and-Bill method) are commonly covered by a patient s medical benefit. National Drug Code (NDC): An NDC is a 10-digit code maintained by the Food and Drug Administration that uniquely identifies a drug by package, formulation, and manufacturer. For purposes of electronic claims filing, many health plans that request NDC codes (in lieu of or in addition to HCPCS codes) required that the 10-digit NDC codes be converted to a standard 11-digit format. See Page 14 of this guide for the NDC code for AVEED and its 11-digit format conversion. Pharmacy Benefit (Prescription Drug Benefit): The portion of a health plan s benefit that manages coverage and reimbursement for prescription drugs. Management may be done by the health plan itself or by a contracted Pharmacy Benefit Manager. Specialty Pharmacy Provider: A pharmacy that manages drugs that are typically: 1) injected or infused; 2) have premium pricing; 3) require special handling for shipping or storage; or 4) are used to treat a chronic condition. Specialty Distributors: Specialty Distributors focus on the supply and distribution of specialty drugs and have immediate inventory of these drugs and the supplies needed for proper drug administration. Specialty pharmacies work with manufacturers and wholesale distribution channels to ensure continuous supplies and to manage drug costs. Wholesaler: Wholesalers acquire drugs in large quantities directly from the drug manufacturers and resell them to retail outlets rather than directly to consumers or patients. 21