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
       
  96366   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour, up to 8 hours (List separately in addition to code for primary procedure.)
       
  96367   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion, up to 1 hour (List separately in addition to code for primary procedure.)
       
  96368   Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion (List separately in addition to code for primary procedure.)
       
  1 CPT ©2008 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 maysupport the use of Venoferinclude 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*
  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 (and in HD and PD patients only if on an ESA).  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 your local coverage decision for specific 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).

Reimbursement
Medicare: As of January 1, 2010, 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

Dialysis Centers are paid based on a composite rate from Medicare; most other payers follow the Medicare payment guidelines. Venofer® is separately billable in addition to the composite rate and can be billed using its J code, J1756. The coding is identical to that of hospital outpatient departments and physician offices.


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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® is available as 100 mg/5 mL single dose, preservative-free vials and 200 mg/10 mL single dose, preservative-free vials. The NDC numbers are:

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




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American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ 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%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


Please see Full Prescribing Information.