ntroduction
Understanding today's complex world of reimbursement takes a good sense of direction. Daily changes in payment policy, the expanding role of government, and multiple treatment options make it difficult for providers to stay informed.
Caring for CKD patients requires that healthcare professionals work closely with third-party payers to ensure that appropriate reimbursement is provided for medically necessary healthcare services. American Regent, Inc. is committed to helping providers better understand reimbursement issues and has prepared these answers to common billing questions about Venofer® (iron sucrose injection, USP).
This section provides general coverage, coding, and reimbursement information that will help you understand the policies of the Medicare program and other payers of Venofer®. In addition, American Regent's Venofer® Reimbursement Hotline is available to provide expert assistance with all types of insurance claims, including Medicare.
This service can be reached at 800-282-7712, Monday through Friday, between 9:00 AM and 5:00 PM, Eastern time.
Understanding today's complex world of reimbursement takes a good sense of direction. Daily changes in payment policy, the expanding role of government, and multiple treatment options make it difficult for providers to stay informed.
Caring for CKD patients requires that healthcare professionals work closely with third-party payers to ensure that appropriate reimbursement is provided for medically necessary healthcare services. American Regent, Inc. is committed to helping providers better understand reimbursement issues and has prepared these answers to common billing questions about Venofer® (iron sucrose injection, USP).
This section provides general coverage, coding, and reimbursement information that will help you understand the policies of the Medicare program and other payers of Venofer®. In addition, American Regent's Venofer® Reimbursement Hotline is available to provide expert assistance with all types of insurance claims, including Medicare.
This service can be reached at 800-282-7712, Monday through Friday, between 9:00 AM and 5:00 PM, Eastern time.
Click here to visit Patient Site.
Venofer iron sucrose injection, USP. Reinvigorating anemia management
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 Venofer® 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 Venofer®. 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 Venofer® administration.
Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® 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 Venofer® 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 Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® 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 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%), 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 Venofer® 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 Venofer®, 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%).
Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® 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 Venofer® 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 Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® 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 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%), 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 Venofer® 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 Venofer®, 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%).
No comments:
Post a Comment