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Reimbursement Coding

This section provides general coding information related to the use of Activase and it is intended for informational purposes only. Please consult the Centers for Medicare & Medicaid Services (CMS) for specific information and requirements.

The submission and completion of reimbursement- or coverage-related documentation are the responsibility of the patient and healthcare provider. Genentech, Inc. and its affiliates make no representation or guarantees concerning reimbursement for any service or item.

In addition to information provided on this page, there are helpful links and resources relevant to coding:

Genentech is neither affiliated with nor endorses any of the above organizations.

Hospital Inpatient

Hospitals use International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to identify the diagnoses and procedures associated with inpatient stays.

ICD-9-CM diagnosis codes are used to identify diseases and conditions, and provide documentation for any procedures performed on a patient. All appropriate ICD-9-CM diagnosis codes should be reported on the claim form. ICD-9-CM procedure codes are used to identify services or treatment provided to patients in the hospital inpatient setting. ICD-9-CM diagnosis and procedure codes should be reported to the highest level of specificity. Some payers may require additional coding and patient-specific clinical information to determine coverage and payment for the inpatient stay.

Hospitals should code all diagnoses and procedures appropriately. Please consult payers to verify appropriate codes and learn about payer coverage policies, reimbursement rates, or billing requirements.

ICD-9-CM diagnosis code

Hospital Outpatient

On claim forms, hospitals use International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to report patient diagnoses and Healthcare Common Procedural Coding System (HCPCS) Level II codes and American Medical Association (AMA) Current Procedural Terminology (CPT®*) to report items and procedures provided during outpatient encounters. ICD-9-CM diagnosis codes are used to identify diseases and conditions, and provide justification for any procedures performed on the patient. All appropriate ICD-9-CM diagnosis codes should be reported on the claim form. ICD-9-CM diagnosis codes should be reported to the highest level of specificity.

Medicare may require additional coding and patient-specific clinical information to determine coverage and payment for the outpatient visit. CPT codes are 5-digit number codes created by the AMA to designate specific procedures performed.

HCPCS Level II codes are used to identify items like drugs and supplies, as well as services not described by CPT codes. The HCPCS codes used to identify drugs are often referred to as J codes.

  • *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 herein. Applicable FARS/DFARS restrictions apply to government use.

Physician Services

A CMS-1500 claim form that reflects the administration of Activase when used in acute ischemic stroke by a physician may include the following codes. Please note that because the hospital provides Activase, the hospital would bill the payer for Activase. The physician would only bill for services provided, such as the administration of Activase.

The coding reference provided below outlines the basic codes that may be applicable to physician billing for treatment of an acute ischemic stroke case involving Activase. The following codes are not inclusive of all applicable codes that may be included on the claim for an individual patient. Physicians should document and bill all appropriate ICD-9-CM diagnosis and procedure codes:

ICD-9-CM diagnosis codes CPT* codes
Stroke
433.x1 Occlusion and stenosis of precerebral arteries
434.x1 Occlusion of cerebral arteries
Pulmonary embolism
415.11 Iatrogenic pulmonary embolism and infarction
415.19 Pulmonary embolism and infarction, other
Stroke
CPT 37195 Thrombolysis, cerebral, by
intravenous infusion
Pulmonary embolism
CPT 37201 Transcatheter therapy, infusion for thrombolysis other than coronary
  • *All Current Procedural Terminology (CPT) five-digit numeric codes, descriptions, numeric modifiers, instructions, guidelines, and other material are Copyright 2010 American Medical Association. All rights reserved.

Stroke Conditions and Critical Care Services

Patient diagnoses and services furnished by the attending physician(s) must be documented appropriately at all times. It is the responsibility of the neurologist to report the ICD-9-CM diagnosis codes and CPT®* codes that most accurately identify the patient's stroke condition and all services provided to them, respectively.

To assist neurologists in coding appropriately, the American Academy of Neurology has provided the following resources as guides to understanding coding for cerebrovascular diseases and critical care services provided to stroke patients.

Genentech is neither affiliated with nor endorses any of the above organizations.

Please note that in this case, critical care services refer specifically to the evaluation and management of a critically ill patient. The neurologist may also bill for the administration of Activase if used in stroke treatment. The appropriate billing code may vary based on indication. Neurologists should thus confirm the appropriate codes with each payer (eg, Medicare or private/commercial payer).

Telestroke

The National Center for Health Statistics (NCHS) has issued an ICD-9-CM diagnosis V-code, effective October 1, 2008, to identify acute ischemic stroke patients who had been treated with t-PA at a different facility within 24 hours of admission to the current facility. Generally, ICD-9-CM "V-codes" identify factors, other than a disease or injury, which may be relevant to the patient's treatment. This new code may be relevant to healthcare providers using Activase for stroke treatment due to the growing occurrence of "drip and ship" scenarios in stroke management. The full descriptor for the code is provided below:

ICD-9-CM diagnosis codes CPT* codes
V45.88 Status post administration of t-PA (rt-PA) in a different facility within the last 24 hours prior to admission to current facility
0188T Remote, real-time interactive videoconferenced critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes
0189T Each additional 30 minutes (list separately in addition to code for primary service)

For more information on the V-code, visit the American Academy of Neurology website.

  • *All Current Procedural Terminology (CPT) five-digit numeric codes, descriptions, numeric modifiers, instructions, guidelines, and other material are Copyright 2010 American Medical Association. All rights reserved.

Indications

Activase (alteplase) is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset.

Activase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure.

Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

Activase is indicated for the lysis of acute massive pulmonary embolism (PE), defined as:

  • Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments.
  • Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures.

Important Safety Information

Contraindications

Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage (ICH); subarachnoid hemorrhage; active internal bleeding; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Do not administer Activase to treat acute myocardial infarction or pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Warnings and Precautions

Bleeding

Activase can cause internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. The concomitant administration of heparin and aspirin with and following infusions of Activase during the first 24 hours after symptom onset has not been investigated. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. If serious bleeding occurs, terminate the Activase infusion.

In the following conditions, the risks of bleeding with Activase are increased and should be weighed against the anticipated benefits: recent major surgery or procedure; cerebrovascular disease; recent intracranial hemorrhage; recent gastrointestinal or genitourinary bleeding; recent trauma; hypertension; high likelihood of left heart thrombus; acute pericarditis; subacute bacterial endocarditis; hemostatic defects including those secondary to severe hepatic or renal disease; significant hepatic dysfunction; pregnancy; diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions; septic thrombophlebitis or occluded AV cannula at seriously infected site; advanced age; and patients currently receiving oral anticoagulants, or any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because its location.

Orolingual Angioedema

Orolingual angioedema has been observed during and up to 2 hours after infusion. In many cases, patients received concomitant angiotensin-converting enzyme inhibitors. Monitor patients treated with Activase during and for several hours after Activase infusion for orolingual angioedema. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy.

Cholesterol Embolization

Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. It is associated with invasive vascular procedures and/or anticoagulant therapy.

Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism

Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Consider the possible risk of reembolization due to the lysis of underlying deep venous thrombi in this setting.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy unless specific precautions are taken to prevent in vitro artifacts.

Adverse Reactions

The most frequent adverse reaction associated with Activase therapy is bleeding.

Although exploratory analyses of the AIS clinical studies suggest that severe neurological deficit (National Institutes of Health Stroke Scale [NIHSS > 22]) at presentation was associated with an increased risk of intracranial hemorrhage, efficacy results suggest a reduced but still favorable clinical outcome for these patients.

Allergic type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported.

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