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Sample Letter of Appeal for RISPERDAL® CONSTA® (risperidone)
Long-acting therapy by injection
In some cases, a claim denial may be overturned after a phone call to payer. However, payers will often require a formal letter of appeal. The following is a sample appeal letter for RISPERDAL® CONSTA® (risperidone).
[Date][Contact][Title][Name of Health Insurance Company][Address][City, State, Zip Code]Insured: [Patient name]Policy Number: [Policy number]Group Number: [Group number]Diagnosis: [Diagnosis and ICD-9-CM code]
This letter serves as a request for reconsideration of a claim representing charges for RISPERDAL® CONSTA® (risperidone) administered to [patient name] on [date of service]. [Patient name] has been under my treatment for [his/her] diagnosis of [diagnosis]. You have indicated that RISPERDAL® CONSTA® (risperidone) is not covered by [insurance name] because [reason for denial].
RISPERDAL® CONSTA® (risperidone) is indicated for treatment of schizophrenia and monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. Because of (insert relevant patient information — history, diagnosis, etc.), I have administered RISPERDAL® CONSTA® (risperidone) as a medically necessary part of this patient’s treatment and we would appreciate your reconsideration of the [date of service] claim for [patient name]. Please contact me at [physician telephone number, including area code] if you require additional information.
Thank you in advance for your immediate attention to this request.
Attachments [original claim form, denial/EOB, additional supporting documents]
Reimbursement and Billing Guide
The information contained in this guide is provided to assist you in understanding the reimbursement process. It is intended to help providers in accurately obtaining reimbursement for healthcare services. It is not intended to increase or maximize reimbursement by any payer. We strongly suggest that you consult your payer organization with regard to local reimbursement policies. This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While Janssen®, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it.
Please consult with your counsel or reimbursement specialist for any reimbursement or billing questions. Similarly, all Current Procedural Terminology (CPT®)* & Healthcare Common Procedural Coding System (HCPCS) billing codes are supplied for information purposes only and represent no statement, promise or guarantee by Janssen® that these codes will be appropriate or that reimbursement will be made.
Current Procedural Terminology (CPT) is copyright 2008 American Medical Association (AMA). All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.
*CPT® is a registered trademark of the American Medical Association.
For more information on RISPERDAL® CONSTA®, please see the accompanying full Prescribing Information
including Boxed Warning.
RISPERDAL® CONSTA® (risperidone) long-acting injection is indicated for the treatment of schizophrenia and the maintenance treatment of Bipolar I Disorder, either as monotherapy or as adjunctive therapy to lithium or valproate
IMPORTANT SAFETY INFORMATION FOR RISPERDAL® CONSTA®
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL® CONSTA® is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL® CONSTA®. Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.
Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL® CONSTA®. Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Hyperprolactinemia: As with other drugs that antagonize dopamine D receptors, RISPERDAL® CONSTA® elevates
prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Orthostatic Hypotension: RISPERDAL® CONSTA® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL® CONSTA® should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.
Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a decline in WBC and in the absence of other causative factors, discontinuation of RISPERDAL® CONSTA® (risperidone) should be considered.
Potential for Cognitive and Motor Impairment: RISPERDAL® CONSTA® has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL® CONSTA® does not affect them adversely.
Seizures: RISPERDAL® CONSTA® should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.
Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.
Priapism has been reported. Severe priapism may require surgical intervention.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported.
Administration: RISPERDAL® CONSTA® should be injected into the deltoid or gluteal muscle, and care must be taken to avoid inadvertent injection into a blood vessel.
Suicide: The possibility of suicide attempt is inherent in schizophrenia or bipolar disorder. Close supervision of high-risk patients should accompany drug therapy.
Increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.
Use RISPERDAL® CONSTA® with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses (e.g. recent myocardial infarction or unstable cardiac disease).
Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.
Commonly Observed Adverse Reactions for RISPERDAL® CONSTA®: The most common adverse reactions in clinical trials in patients with schizophrenia (≥5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.
The most common adverse reactions in clinical trials in patients with bipolar disorder were weight increased (5% in monotherapy trial) and tremor and Parkinsonism (≥10% in adjunctive therapy trial).
International Accounting Standard 8 Accounting Policies, Changes in Accounting Estimates and Errors This version includes amendments resulting from IFRSs issued up to 31 December 2008. IAS 8 Net Profit or Loss for the Period, Fundamental Errors and Changes in Accounting Policies wasissued by the International Accounting Standards Committee in December 1993. It replacedIAS 8 Unusual and Pri
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