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Hospital outpatient settings of care: coverage and reimbursement

This guide includes general descriptions of coding, billing, coverage, and reimbursement matters related to the use of Activase (Alteplase) and is provided for informational purposes only. Please consult Centers for Medicare & Medicaid Services or other payers to verify appropriate codes and learn about payer coverage policies, reimbursement rates, or billing requirements. The submission and completion of reimbursement- or coverage-related documentation are the responsibility of the patient and healthcare provider. Genentech, Inc. and its subsidiaries make no representation or guarantees concerning reimbursement or coverage for any service or item.

The hospital outpatient setting is a setting of care in which medical services are provided by a hospital or other qualified facility to a patient within a 24-hour period (ie, the patient is never admitted) and includes items and services provided by the hospital in the emergency room.

The following provides more detailed information on coverage and reimbursement as it relates to the outpatient setting.

Medicare hospital outpatient payment overview

Medicare pays for items and services provided by the hospital outpatient department through the Hospital Outpatient Prospective Payment System (HOPPS). Under HOPPS, Current Procedural Terminology (CPT®*) and Healthcare Common Procedural Coding System (HCPCS) codes billed by hospitals are assigned to Ambulatory Payment Classifications (APCs).

APCs are not billing codes but rather HOPPS payment groupings categorized by type of item and service provided. The items and services are grouped based on clinical similarity and hospital resource utilization. Each CPT® or HCPCS billing code "maps" to an APC and each APC has its own payment rate. The payment for one Medicare outpatient hospital visit will be the sum of APCs that are associated with the patient's treatment.

APC drug payment rates are set by CMS at average acquisition cost and may vary annually. For 2010, APC payments for drugs used in the Medicare hospital outpatient setting are set at average sales price (ASP) + 4%.

Private payers and state Medicaid agencies have different policies regarding coverage and reimbursement for items and services provided to patients in the hospital outpatient setting. Please consult individual payers for more information.

  • *
  • CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is copyright 2010 American Medical Association. 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 therein. Applicable FARS/DFARS restrictions apply to government use.

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Acute ischemic stroke
Indication

Activase (Alteplase) is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS).

Important Safety Information
Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation, recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000) (see CONTRAINDICATIONS for full list).

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

The risks of Activase therapy may be increased and should be weighed against the anticipated benefits in certain conditions. [See WARNINGS in full prescribing information].

  • Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
  • Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).

Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended.

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

Pulmonary embolism
Indication

Activase (Alteplase) is indicated in the management of acute massive pulmonary embolism (PE) in adults: (1) for the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs; (2) for the lysis of pulmonary emboli accompanied by unstable hemodynamics, eg, failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.

Safety Information
Activase therapy in patients with pulmonary embolism (PE) is contraindicated in certain situations because of an increased risk of bleeding (eg, active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See CONTRAINDICATIONS in the full prescribing information].

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately, along with any concomitant therapy with heparin.

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in full prescribing information].

Treatment of PE with Activase has not been shown to constitute adequate clinical treatment of underlying deep vein thrombosis. The possible risk of reembolization due to the lysis of underlying deep venous thrombi should be considered.

Please click here for full prescribing information.