Reimbursement Information: Amgen Assist™
Providing Access to Reimbursement Services, Patient Co-pay Support, and Uninsured Patient Support
Amgen’s medicines make a difference in the lives of patients who have serious illnesses, and we believe patients should have access to our medicines regardless of their ability to pay.
Amgen Assist™ gives patients and healthcare providers a single destination for access to e-Service and online forms, and makes it easier to find a program that would best meet each patient's unique needs, including:
- Coverage and reimbursement services that help guide healthcare providers through insurance verifications, prior authorizations, and claim inquiries.
- Co-pay support information about ways to help pay co-pays either through Amgen-supported programs or independent, nonprofit co-pay foundations.
- Assistance for uninsured patients who may be eligible for products at no cost through The Safety Net Foundation.
Our goal is to make Nplate® affordable for adult patients with chronic ITP.
- We ensure robust reimbursement and access programs for patients and providers.
- We offer generous patient assistance programs for eligible patients who might have difficulty affording Nplate®.
- We make every effort to identify the avenues for patients to access our medicines regardless of their financial or health insurance status.
| Amgen Program | Insured | Uninsured |
| The Nplate FIRST STEP™ Program Co-Pay coupon program for eligible patients |
√ Commercially insured |
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| The Safety Net Foundation Free goods and donations of Amgen products |
√ | |
| Independent 3rd-Party Co-pay Assistance Cash donations by Amgen to help patients with co-pay burden |
√ Medicare and/or commercially insured |
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Coverage and reimbursement services for healthcare providers
Amgen Assist™ gives patients and healthcare providers a single destination for access to e-Service and online forms, and makes it easier to find a program that would best meet each patient's unique needs.
- Insurance verification
- Prior authorization
- Billing and claims support
- Policy and program updates
About insurance verification assistance
- Offers help in verifying patients' benefits and determining specific insurers' coverage guidelines
- Assists in identifying and complying with prior authorization guidelines
- Helps providers, administrators, and patients with verification
Have questions about Nplate® reimbursement? Talk with a live representative
FAQs
Medicare
1. How will Medicare cover and reimburse for Nplate® (romiplostim) in the physician's office setting?
MEDICARE TYPICALLY COVERS NPLATE® WHEN IT IS GIVEN IN THE PHYSICIAN'S OFFICE FOR ITS FDA-APPROVED INDICATION. AS OF JANUARY 1, 2010, THE UNIQUE HCPCS CODE FOR NPLATE® IS J2796. REIMBURSEMENT FOR NPLATE® IS BASED ON THE AVERAGE SALES PRICE (ASP) PLUS 6%.
2. How should I bill my Medicare carrier for Nplate® (romiplostim) when it is administered in the physician's office?
You should bill for Nplate® using the CMS-1500 form (or electronic equivalent) to bill for services rendered in your physician's office. Nplate® has a unique HCPCS code, J2796. The claim should include the appropriate ICD-9 diagnosis code(s) and the Current Procedural Terminology (CPT) code for Nplate® administration, such as 96372 (subcutaneous or intramuscular injection).
3. How does Medicare cover and reimburse for Nplate® (romiplostim) under the ambulatory payment classification (APC) system in the Hospital Outpatient Department setting (HOPD)?
MEDICARE SHOULD COVER NPLATE® WHEN IT IS GIVEN IN THE HOSPITAL OUTPATIENT DEPARTMENT FOR ITS FDA-APPROVED INDICATION. AS OF JANUARY 1, 2010, THE UNIQUE HCPCS CODE FOR NPLATE® IS J2796.
Current reimbursement rates in the HOPD are available in the CMS Hospital Outpatient Prospective Payment System (OPPS) Addendum B file, available at http://www.cms.hhs.gov/HospitalOutpatientPPS/AU/list.asp#TopOfPage.
4. How should the hospital bill Medicare for Nplate® (romiplostim) administered in the Hospital Outpatient Department (HOPD) setting?
Effective for dates of service on or after January 1, 2010, providers can document Nplate® usage on a UB-04 claim form by using revenue code 0636 (drugs requiring detailed coding) and HCPCS code J2796.
Providers should bill for the administration of Nplate® using the appropriate Current Procedural Terminology (CPT) code, such as 96372 (subcutaneous or intramuscular injection) as well as for any other appropriate services provided.
Centers for Medicare and Medicaid Services (CMS) 2010 Alpha-Numeric HCPCS File. Available at: http://www.cms.hhs.gov/HCPCSReleaseCodeSets/ANHCPCS/list.asp#TopOfPage.
5. Will Medicare cover and reimburse for Nplate® (romiplostim) in the pharmacy setting?
Medicare Part D plans may provide coverage for Nplate®. However, it is important to know that Nplate® should be covered under the patient's Part B benefit, and it generally is not permissible for patients to “brown bag” product. In other words, patients may not acquire product from the pharmacy and bring it to the physician’s office for administration.
6. How does Medicare pay for Nplate® (romiplostim) use during an inpatient hospital stay?
Under the Medicare Severity-Diagnosis Related Group (MS-DRG) payment system, hospitals receive a fixed payment for each patient discharged. Payment for Nplate® will be included in the DRG payment. Actual DRG assignment is based on a combination of factors including the patient's age, diagnoses, complications/comorbidities, and procedures performed.
7. My patient has a Medicare managed care policy. Is Nplate® (romiplostim) covered?
Medicare managed care plans, or Medicare Advantage plans, are required to provide their Medicare enrollees services that are covered under Medicare and available to other fee-for-service Medicare beneficiaries residing in the geographic area covered by the plan. Managed care plans may require prior authorization or may restrict coverage to a particular setting.
Medicaid
1. How will Medicaid cover and reimburse for Nplate® (romiplostim) in the physician's office setting?
Most state Medicaid programs cover and reimburse for administration of injectable drugs in the physician's office. Medicaid should cover Nplate® for the FDA-approved indication; however, reimbursement rates will vary depending on the state Medicaid agency and upon the setting of care.
2. How do I bill Medicaid for Nplate® (romiplostim)?
In the physician's office setting, many states will require providers to bill using an HCPCS code to represent Nplate®. For dates of service on or after January 1, 2010, providers should report Nplate® with J2796, romiplostim, 10 mcg.
In addition to the HCPCS code, many states also will require providers to bill the 11-digit National Drug Code (NDC) number preceded by the N4 identifier. It also is necessary to report the quantity and unit of measure.
3. How will Medicaid cover and reimburse for Nplate® (romiplostim) in the retail pharmacy?
Medicaid may cover Nplate® for the FDA-approved indication in the retail pharmacy. Reimbursement rates will vary from state to state; however, most states base payment on the average wholesale price (AWP) minus a certain percentage or average sales price (ASP) plus a certain percentage.
4. How do I bill Medicaid for Nplate® (romiplostim) dispensed from the pharmacy?
Most states require pharmacies to use the appropriate NDC for Nplate®. In addition, some states may require prior authorization.
5. How will Medicaid cover and reimburse for Nplate® (romiplostim) in the hospital inpatient setting?
Medicaid should cover Nplate® administered to a patient in the hospital. Reimbursement mechanisms for inpatient stays vary by state, with payments usually made on a per diem basis, using a Diagnosis-Related Group (DRG) model similar to Medicare's system, or based on allowable cost.
Private Payer Coverage, Coding, and Reimbursement
1. How will commercial insurers cover and reimburse for Nplate® (romiplostim)?
Most private insurance plans should cover Nplate® when it is used for the FDA-approved indication. However, the specifics of coverage may vary by plan. Coverage may vary by the type of setting in which the treatment is provided (for example, hospital outpatient and inpatient settings, the physician's office, through a home care agency, or pharmacy).
Have additional questions about Nplate® reimbursement?
INDICATION
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
Important Safety Information
Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
- In Nplate® clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed.
- Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.
Thrombotic/Thromboembolic Complications
- Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate® use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate®. Nplate® should be used with caution in patients with ITP and chronic liver disease.
- To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L.
Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
- Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®.
- In a clinical study, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy. Clinical studies are in progress to assess the risk of bone marrow fibrosis and clinical consequences with cytopenias.
- If new or worsening morphological abnormalities or cytopenia(s) occur, consider a bone marrow biopsy to include staining for fibrosis.
Worsened Thrombocytopenia after Cessation of Nplate®
- In clinical studies of patients with chronic ITP who had Nplate® discontinued, four of 57 patients developed thrombocytopenia of greater severity than was present prior to Nplate® therapy. This worsened thrombocytopenia resolved within 14 days.
- Following discontinuation of Nplate®, obtain weekly CBCs, including platelet counts, for at least 2 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines.
Lack or Loss of Response to Nplate®
- Hyporesponsiveness or failure to maintain a platelet response with Nplate® should prompt a search for causative factors, including neutralizing antibodies to Nplate®.
- To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). Amgen will assay these samples for antibodies to Nplate® and thrombopoietin (TPO).
- Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.
Laboratory Monitoring
- Obtain CBCs, including platelet counts, weekly during the dose adjustment phase of Nplate® therapy and then monthly following establishment of a stable Nplate® dose.
- Obtain CBCs, including platelet counts, weekly for at least two weeks following discontinuation of Nplate®.
Adverse Reactions
- In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity.
- Most common adverse reactions (≥ 5% higher patient incidence in Nplate® versus placebo) were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%) , Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
Please see Prescribing Information and Medication Guide
Have questions about the Indication, Important Safety Information, Prescribing Information or Medication Guide?
THE NPLATE® FIRST STEP™ PROGRAM
Helps your eligible commercially insured patients who are appropriate for Nplate® treatment meet their out-of-pocket costs.
Learn How To Enroll Your PracticeACCESS THE NPLATE® CLINICAL DATA YOU NEED
Clinical studies have evaluated the safety and efficacy of Nplate® treatment in adult patients with chronic ITP. Nplate® clinical trials have been conducted in both splenectomized and non-splenectomized patients, with some patients receiving Nplate® treatment for > 5 years.
Review Nplate® Clinical Data
