Billing for drug administration

Depending on the method of administration of Venofer® (iron sucrose injection, USP), report the most appropriate Current Procedural Terminology (CPT) code1:

  96374   Therapeutic, prophylactic or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug
       
  96365   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
       
       
  1 CPT ©2010 American Medical Association. All rights reserved.




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Outpatient Departments

Reimbursement
Under the Outpatient Prospective Payment System (OPPS) drugs and biologicals, which include Venofer® (iron sucrose injection, USP), receive either packaged payment or separate payment. Payment for drugs and biologicals with estimated per day costs equal to or below the applicable drug packaging threshold is packaged into the payment for the associated procedure, commonly a drug administration procedure. Drugs and biologicals with per day costs above the applicable drug packaging threshold are paid separately through their own Ambulatory Payment Classification (APC). The APC number for Venofer® is 9046; the reimbursement from Medicare for this APC includes the cost of Venofer®.

ICD-9-CM Coding for Venofer®
International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnosis codes identify the patient's diagnosis and tell the claims examiner why a service was provided. Medicare claims for drugs, including Venofer®, must include an appropriate diagnosis to explain the need for the drugs billed. Thus, accurate coding is critical to obtaining appropriate reimbursement for Venofer®.

Examples of diagnosis codes, regardless of the setting, that may support the use of Venofer® include the following:

  280.0   Iron deficiency anemia secondary to blood loss (chronic)*
  280.1   Iron deficiency anemia secondary to inadequate dietary iron intake*
  280.8   Other specified iron deficiency anemias*
  280.9   Unspecified iron deficiency anemia*
  285.21   Anemia in chronic kidney disease
  585.1   Chronic kidney disease, Stage I
  585.2   Chronic kidney disease, State II (mild)
  585.3   Chronic kidney disease, Stage III (moderate)
  585.4   Chronic kidney disease, Stage IV (severe)
  585.5   Chronic kidney disease, Stage V
  585.6   End stage renal disease (ESRD)
  585.9   Chronic kidney disease, unspecified






* Some Medicare contractors require use of both a 280 code and a 585 code to obtain reimbursement for Venofer®.  Note Venofer® is only approved for treatment of adult CKD patients with iron deficiency anemia.  No representation is made by American Regent that Venofer® is safe and effective for non-CKD iron deficiency anemia or that reimbursement for non-CKD anemia is permissible or legal.  Please check you local coverage decision for specifc ICD-9-CM codes to be used.

Please note that only a physician is qualified to make a diagnosis, and the diagnosis must be documented in the patient's medical record.

American Regent, Inc. does not recommend the use of any particular diagnosis code in any particular situation. The above is for reference only; coding as submitted is the sole responsibility of the prescribing physician.


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Physician's Offices

Coverage and coding in physicians' offices is the same as in the outpatient department section above. Please note that in the physicians' offices Venofer® is only covered when administered incident to a provider's service (under his or her direct supervision).

Medicare: As of January 1, 2011, payment for Part B drugs administered in the physicians' offices remains at Average Sales Price (ASP) plus 6 percent.

Other payers: Reimbursement for Venofer® varies by payer. For private payers, reimbursement typically may be based on ASP or subject to negotiated rates. Medicaid reimbursement varies by state and typically is based on cost.


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Dialysis Centers

The reimbursement for dialysis centers has changed effective January 1, 2011.  Both freestanding and hospital based dialysis facilities are now being paid either under a fully bundled payment system (ESRD Prospective Payment System), or on a combination of the bundled payment system (25%) and the former composite rate system (75%).  Those centers that are not entirely in the bundled payment system will slowly move into the system by an additional 25% per year until they become fully bundled in January 2014.  In the bundled payment system, there is a base payment rate that is adjusted based on the wage index, facility volume, and patient acute and chronic illness adjusters.  For more information on the system, please see www.cms.gov.

In the dialysis facility, the reimbursement for Venofer®, like all anti-anemia agents, will be based on the payment methodology that is in effect for the facility from Medicare on the date of service.


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National Drug Code (NDC)

Some insurers and third party payers may require providers to bill using the National Drug Code (NDC) for Venofer®, while others establish state-specific local codes.

Venofer® (iron sucrose injection, USP) is preservative-free and is available as 50 mg/2.5 mL single use vials, 100 mg/5 mL single use vials, and 200 mg/10 mL single use vials.  The NDC numbers are:

 
NDC# 0517-2325-10........................................2.5 mL Single Use Vial (50 mg) (10 pack)
NDC# 0517-2340-10...........................................5 mL Single Use Vial (100 mg) (10 pack)
NDC# 0517-2340-25...........................................5 mL Single Use Vial (100 mg) (25 pack)
NDC# 0517-2310-05.........................................10 mL Single Use Vial (200 mg) (5 pack)



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IMPORTANT SAFETY INFORMATION

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP).  Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse.  If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately.  Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion.  Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance (7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), pain in extremity (5.6%) and diarrhea (5.2%). In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer® administration, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).

In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer® treated patients (27/47) receiving 0.5 mg/kg Venofer® experienced a treatment-emergent adverse reaction, 11% of which were serious. The most common treatment-emergent adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).



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