Coverage Policy
The information displayed below pertains specifically to the Physician Office setting of care. For information tailored to the Hospital Outpatient setting or Pharmacy setting, please select the appropriate tab to the right. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. See below
Medicare
In general, Medicare considers subcutaneous injectable medications to be self-administered and, therefore, covered under Part D. However, Medicare covers FRAGMIN® (dalteparin sodium injection) under Part B when administered under a physician’s supervision and under Part D when dispensed for self-administration by a patient or caregiver. When provided as a Part B benefit, claims for FRAGMIN® are billed to contractors such as Fiscal Intermediaries (hospital outpatient setting), carriers (physician office setting) or the new Part A/B Medicare Administrative Contractors (MACs). Part D benefit claims for FRAGMIN® are billed to Part D plan sponsors. Providers should ensure that they are adhering to appropriate local contractor or Part D plan sponsor claim filing requirements when submitting claims for FRAGMIN®.
More information about Medicare Part B
Payor Reimbursement1
Medicare Part B reimbursement for FRAGMIN® in the physician office setting is based on Average Sales Price (ASP). Medicare sets an allowable payment amount, updated quarterly, at ASP plus 6%. Medicare reimbursement is based on the lesser of this allowable amount or actual charges, as follows: physician offices are reimbursed for 80% of the allowable amount and the patient or patient’s secondary insurer is responsible for the remaining 20% coinsurance.
Administration Services
Medicare reimbursement for FRAGMIN® drug administration services provided in the physician office setting is based on the national fee schedule that is adjusted for geographic variations and updated annually. Medicare reimbursement is based on the lesser of the adjusted fee schedule amount or actual charges, as follows: physicians are reimbursed for 80% of the allowable amount and the patient or patient’s secondary insurer is responsible for the remaining 20% coinsurance.
1. Medicare Claims Processing Manual Chapter 17 Drugs and Biologicals, Section 20.1.2 Average Sales Price (ASP Payment Methodology). Information available on http://www.cms.gov/manuals/downloads/clm104c17.pdf. Accessed February 16, 2011.
Indications
FRAGMIN® is a low molecular weight heparin (LMWH) indicated for:
- Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
- Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
- Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. In these patients, the FRAGMIN® therapy begins with the initial VTE treatment and continues for six months.
Limitations of Use
- FRAGMIN® is not indicated for the acute treatment of VTE.
Important Safety Information
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
- A history of traumatic or repeated epidural or spinal punctures
- A history of spinal deformity or spinal surgery
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions and Drug Interactions].
- FRAGMIN® is contraindicated in patients with active major bleeding, history of heparin induced thrombocytopenia, hypersensitivity to dalteparin sodium, heparin, or pork products.
- FRAGMIN® is contraindicated in patients undergoing epidural/neuraxial anesthesia as a treatment for unstable angina and non-Q-wave MI and for prolonged VTE prophylaxis due to an increased risk of bleeding associated with the dosage of FRAGMIN® recommended for these indications.
- FRAGMIN®, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage; bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site.
- FRAGMIN® should be used with caution in patients with bleeding diathesis, thrombocytopenia or platelet defects, severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding.
- FRAGMIN® should be used with extreme caution in patients
with history of heparin-induced thrombocytopenia.
- In FRAGMIN® clinical trials supporting non-cancer indications, platelet count of <50,000/mm3 occurred in <1% of patients.
- In FRAGMIN® clinical trials supporting the extended treatment of symptomatic VTE in patients with cancer, platelet counts of <100,000/mm3 occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/mm3. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the FRAGMIN® arm and 8.1% of patients in the oral anticoagulant arm. FRAGMIN® dose was decreased or interrupted in patients whose platelet counts fell below 100,000/mm3.
- Thrombocytopenia of any degree should be monitored closely. Heparin-induced thrombocytopenia can occur with administration of FRAGMIN®. The incidence of this complication is unknown at present. In clinical practice, rare cases of thrombocytopenia with thrombosis have also been observed.
- Each multiple-dose vial of FRAGMIN® contains benzyl alcohol as a preservative. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Because benzyl alcohol may cross the placenta, use caution when administering FRAGMIN® preserved with benzyl alcohol to pregnant women. If anticoagulation with FRAGMIN® is needed during pregnancy, use preservative-free formulations, where possible.
- Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with FRAGMIN®.
- The most commonly reported side effect is hematoma at the injection site.
- Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred. A few cases of anaphylactoid reactions have been reported.
- Use FRAGMIN® with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding.
- FRAGMIN® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low molecular weight heparins.
- FRAGMIN® Injection is not intended for intramuscular administration.
For more information about FRAGMIN, please see Full Product Information.
