Billing FAQ
Indication
Cathflo Activase (Alteplase) is indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood.
Safety Information
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation.
In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.
Please click here for full prescribing information.
Cathflo Frequently Asked Questions on Medicare Billing
The following information is provided for general education purposes only; payment cannot be guaranteed. Genentech cannot guarantee the exact amount of money, if any, that a physician or facility will receive. If you need further assistance regarding Medicare or Medicaid reimbursement policies or procedures, please contact your local carrier directly.
General Information
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What is Cathflo? |
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Cathflo is a thrombolytic agent that gives you a viable treatment option for central venous access device (CVAD) occlusions. A human tissue plasminogen activator (t-PA) produced by recombinant DNA technology, Cathflo allows you to restore catheter function with efficacy, safety, and ease. |
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What is Cathflo indicated for? |
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Cathflo is indicated for the restoration of function to CVADs, as assessed by the ability to withdraw blood. |
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What other thrombolytics are FDA-approved for the restoration of function to central venous access devices? |
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Cathflo is the only thrombolytic that is both FDA-approved and marketed for the treatment of occluded catheters.1 |
Coverage
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Does Medicare cover Cathflo for the treatment of CVAD occlusions? |
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Medicare does not have a specific national coverage policy on Cathflo for the treatment of occluded CVADs, but LCDs for some Medicare Administrative Contractors (MACs) support use of Cathflo2, 3 . Additionally, the absence of a coverage policy does not mean non-coverage. In general, Medicare covers a drug used in the outpatient setting if it is not usually self-administered and its use is reasonable and necessary for treatment of the patient's condition.4 |
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Do private payers cover Cathflo? |
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Most private payers do not have coverage policies related to the use of Cathflo for the treatment of occluded CVADs, but the absence of a coverage policy does not mean non-coverage. Please contact individual payers as necessary to determine their specific coverage guidelines. |
Coding
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What is the billing code for Cathflo? |
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Providers may bill for Cathflo using the Healthcare Common Procedural Coding System (HCPCS) code J2997, Injection, alteplase recombinant, 1 mg. HCPCS codes are only separately payable by Medicare in the outpatient hospital, physician office, and free-standing clinic (i.e., a clinic that is not operated as part of a hospital) settings. Providers should be sure to bill the appropriate number of units that corresponds to the total amount of Cathflo administered (e.g., bill two units of J2997 to report administration of a 2mg dose). |
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What is the National Drug Code (NDC) for Cathflo? |
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The NDC for Cathflo is 50242-041-64, Cathflo powder for injection (2 mg vial). |
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What is the billing code for the administration of Cathflo? |
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Providers may bill for the administration of Cathflo with Current Procedure Terminology (CPT®5) code 36593, Declotting by thrombolytic agent of implanted vascular access device or catheter. A physician must be directly supervising the procedure in order for this code to be billed.6 This code may be billed by physicians in any setting of care, but may only be reported by a facility if Cathflo is administered in an outpatient hospital or ambulatory surgical center. |
Reimbursement
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How is Cathflo reimbursed by Medicare when administered in the inpatient setting? |
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Reimbursement for all services, supplies, and drugs furnished to a Medicare beneficiary during an inpatient hospitalization is bundled into a single prospective payment under the Medicare Severity Diagnosis-Related Group (MS-DRG) system. Cathflo is not separately reimbursed. |
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How is Cathflo reimbursed by Medicare when used in the outpatient hospital setting? |
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Effective January 1, 2011, Cathflo is reimbursed at Average Sales Price (ASP) plus 5% when administered to Medicare beneficiaries in the outpatient hospital setting (ASP is published quarterly by the Centers of Medicare and Medicaid Services). |
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How is Cathflo reimbursed by Medicare when used in a physician office/free-standing clinic? |
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Effective January 1, 2011, Cathflo is reimbursed at Average Sales Price (ASP) plus 6% when administered to Medicare beneficiaries in a physician office or free-standing clinic (ASP is published quarterly by the Centers of Medicare and Medicaid Services). |
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How is a physician reimbursed by Medicare for the administration of Cathflo? |
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In all settings of care, physicians can bill for the administration of Cathflo using CPT code 36593. They are then paid according to the Medicare Physician Fee Schedule, which assigns a payment rate to each CPT code. |
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Can an outpatient hospital or a physician office/free-standing clinic be reimbursed by Medicare for the administration of Cathflo? |
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The outpatient hospital can bill Medicare using CPT code 36593 and will be paid according to Ambulatory Payment Classifications (APCs), which assign payments by groups of services that are clinically similar and require comparable resource use. Each APC is associated with a single payment rate, but a hospital may receive more than one APC payment for a single patient encounter, depending on the services provided during that visit. Reimbursement for the physician office/free-standing clinic is included in the physician payment provided under the Medicare Physician Fee Schedule, which assigns a payment rate for each CPT code. |
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What about payment for uninsured patients? |
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Genentech has established the Access to Care Foundation for each of its marketed products. The program is designed to provide products to patients who are uninsured or rendered uninsured due to payer denial and who meet the program's medical and financial criteria. For information on Genentech's Access to Care Foundation, please visit LyticExperience.com. |
US Food and Drug Administration. Vaccines, Blood & Biologics: http://www.fda.gov/BiologicsBloodVaccines/default.htm
Trailblazers Health Enterprises, LLC. LCD L26772, Thrombolytic Agents - 4I-91AB-R4. Updated Sept. 9, 2010.
National Government Services, Inc. Article A46754, Alteplase Recombinant (e.g., Cathflo® Activase®) – Related to LCD L25820. Updated Aug. 1, 2010.
Centers for Medicare and Medicaid Services. Pub.100-02 – Medicare Benefit Policy Manual. Chapter 15 – Covered Medical and Other Health Services. Rev. May 21, 2010.
CPT is a registered trademark of the American Medical Association. Copyright 2011 American Medical Association. All rights reserved.
Centers for Medicare and Medicaid Services. Pub. 100-02 – Medicare Benefit Policy Manual. Chapter 15 – Covered Medical and Other Health Services. Rev. May 21, 2010.
