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Stroke telemedicine: 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.

Telemedicine services, also known as telehealth, are generally described as the use of telecommunication equipment to link healthcare practitioners and patients in different locations. The originating site (site where the beneficiary is located) generally must be in either a rural health professional shortage area or a county that is not included in a Metropolitan Statistical Area (MSA). In addition, to be covered by Medicare, the services generally must be provided via an interactive telecommunication system, to include, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner (ie, telephones do not qualify).

Medicare reimbursements for telemedicine services provided by the physician or other practitioner at the remote site (not the location of the beneficiary) are the same as if the service was provided without the use of telecommunications equipment. In addition, Medicare pays a flat facility fee to the originating site. Reimbursement for telemedicine is separate from the MS-DRG payment.

Please visit the CMS Web site for a list of covered telemedicine services at: http://www.cms.hhs.gov/manuals/downloads/clm104c12.pdf

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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.