Reimbursement FAQs

Activase (t-PA) is a thrombolytic agent approved for treating acute myocardial infarction (AMI), acute ischemic stroke, and acute massive pulmonary embolism (PE). Activase (t-PA) is a human tissue plasminogen activator produced by recombinant DNA technology.

• Activase (t-PA) is indicated for use in the management of AMI in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure, and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms.
• Activase (t-PA) is indicated in the management of acute massive PE in adults:
  • – For the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs
  • – For the lysis of pulmonary emboli accompanied by unstable hemodynamics, eg, failure to maintain blood pressure without supportive measures
• 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 in the full prescribing information).

Safety Information
All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. Not all patients with acute ischemic stroke will be eligible for Activase therapy, including patients with evidence of recent or active bleeding; recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke; uncontrolled high blood pressure; or impaired blood clotting.

Please see the full prescribing information for safety information regarding Activase (t-PA) for treatment of patients with AMI, PE, and AIS.

Hospital outpatient departments (including emergency departments) will bill for Activase (t-PA) using HCPCS codes. The billing code, or HCPCS "J code," for Activase (t-PA) is J2997 (injection, Alteplase recombinant, 1 mg). Providers should bill multiple units of the J code to reflect the number of milligrams of drug used for each patient.

Genentech Access Solutions. This program is designed to provide patients and healthcare providers with coverage and reimbursement support, patient assistance, and information resources related to Genentech's products. For information, please visit GenentechAccessSolutions.com.

When a payer denies a claim, generally a letter or note is sent to the healthcare provider that lists the reason(s) for the denial. Inaccurate coding, misspellings, and missing information may be possible reasons for claim rejections. In such cases, claims may be corrected and resubmitted.

Payers may also request clarification about the medical necessity of the procedure. In this case, you may need to submit one or more of the following items to the insurer:

• Letter of medical necessity: The payer may request a letter verifying medical necessity in order to consider payment on a case-by-case basis.
• Clinical information on Activase (t-PA): The payer may need information explaining the use of the drug for patients with ischemic stroke, AMI, or PE.

Please contact the payer for more specific information on billing and claims submission for Activase (t-PA).

Medicare reimburses hospital inpatient stays under the Medicare Severity Diagnosis-Related Group (MS-DRG) system. The MS-DRG system assigns individual cases to an MS-DRG according to the patient's diagnoses (identified by ICD-9-CM diagnosis codes), the procedures performed (identified by ICD-9-CM procedure codes), and severity of patient's condition as identified by the presence or absence of complications and comorbidities (CCs) or major CCs (MCCs).

MS-DRGs provide a single bundled payment which serves as reimbursement for all items and services provided to the Medicare beneficiary during a single hospitalization. Exceptionally high-cost cases may qualify for outlier payments.

Hospitals that administer Activase (t-PA) during an inpatient stay should include the appropriate ICD-9-CM procedure code (99.10, injection or infusion of thrombolytic agent) and any relevant ICD-9-CM diagnosis codes, including applicable MCCs or CCs (as secondary ICD-9-CM diagnosis codes) on the UB-04 claim form.

Activase (t-PA) and its administration are not reimbursed separately from the MS-DRG payment but are bundled with other services provided during the patient's stay.

Ambulatory Payment Classifications (APCs) are Medicare payment groupings for hospital outpatient items and services, categorized by type of item and service provided. The items and services (designated by CPT^®* and HCPCS codes) are grouped based on clinical similarity and the amount of resources a hospital uses to provide them. Each CPT or HCPCS 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 associated with the patient's treatment.

Note: APC codes are not billing codes. (Please see below for information on billing).

A hospital is required to use HCPCS J codes on the claim form when billing drugs used in the hospital outpatient setting. Each J code has a defined number of units associated with it. The J code for Activase (t-PA) is J2997 (injection, Alteplase recombinant, 1 mg). Hospitals should bill for multiple units of the product as the number of milligrams of Activase (t-PA) provided to the patient.

The hospital may also bill Medicare for the administration of Activase (t-PA). The appropriate billing code may vary based on indication. Hospitals should confirm the appropriate codes with each payer (eg, Medicare or private/commercial payer).

Medicare payment for physician services is based on the Medicare Physician Fee Schedule (PFS). In general, Medicare pays 80% of the fee schedule amount or the physician's actual charge, whichever is less. In either case, patients are responsible for the remaining 20%.

The physician may also bill Medicare for the administration of Activase (t-PA). The appropriate billing code may vary based on indication. Physicians should confirm the appropriate codes with each payer (eg, Medicare or private/commercial payer).

Because the hospital supplies Activase (t-PA) and therefore bills payers for the drug, the physician would not bill for Activase (t-PA) in the hospital setting. The physician would only bill for services provided, such as the administration of Activase (t-PA).

CMS's contractors and other payers have customer service lines that are set up to answer calls on a variety of topics. Additionally, you may consult your Medicare contractor or other payer's Web site for specific information on how to bill for Activase (t-PA).

"Drip and ship" cases are cases where patients have received t-PA at one hospital and are subsequently transferred for advanced care at a different facility.

The National Center for Health Statistics (NCHS) has issued a new 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 (Alteplase) 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:

For more information on the new V-code, visit the American Academy of Neurology Web site at:
http://www.aan.com/news/?event=read&article_id=5264&page=125.54.33

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 (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.

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 (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 services were 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 Ambulatory Payment Classification payments.

Medicare reimbursement for telemedicine provided by the physician or other practitioner at the remote site (not the location of the beneficiary) is the same as if the service was provided without the use of telecommunications equipment. A consulting physician providing telemedicine consultations would bill the appropriate CPT^®* code for the consultation service provided.

Effective as of July 1, 2008, the American Medical Association (AMA) has approved two new Category III CPT codes to report the critical care services provided by physicians via telemedicine.

While the new codes may be applicable to telemedicine stroke services, the codes are not limited to stroke services and may cover all critical care conditions. Please see the American Academy of Neurology Web site for more information on how administration of t-PA may qualify for critical care coding: http//www.aan.com.

National coverage and payment policies for Category III CPT codes do not exist. Coverage and payment for CPT 0188T and 0189T may vary by public and commercial payers. Some payers may not recognize the new Category III CPT codes.

For more information on Category III codes 0188T and 0189T, visit the American Medical Association Web site at http://www.ama-assn.org/ama1/pub/upload/mm/362/categoryiiicodes.pdf