General Reimbursement Information

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Reimbursement for Cathfo Activase® information varies based on healthcare settings

Review general reimbursement information specific to Medicare onlya

This section provides general coding information related to the use of Cathflo and 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 representations or guarantees concerning reimbursement for any service or item.

Hospitals use the International Classification of Diseases (ICD) code sets to report medical diagnoses and procedures associated with inpatient stays. As of October 1, 2015, the tenth revision of these codes (ICD-10) replaced the previous ninth revision (ICD-9) codes.

Reimbursement for all services, drugs, and supplies administered to Medicare beneficiaries during a single inpatient hospitalization is bundled into a single prospective payment amount. This payment amount is determined by the Medicare Severity Diagnosis Related Group (MS-DRG) system, which classifies patients into clinically cohesive groups that have similar hospital resource use and length of stay. The MS-DRG assignment for each case is based on the combination of ICD-10-CM diagnosis and procedure codes reported on the hospital claim form, the Unified Bill 2004 (UB-04) (see description of coding systems below).

Under the MS-DRG system, Cathflo is not separately reimbursable when administered to Medicare beneficiaries in the inpatient setting. Instead, its cost is intended to be covered by the single MS-DRG payment. To ensure appropriate reimbursement, be sure to accurately code for all patient diagnoses and procedures performed.

Private payers may employ different reimbursement methodologies that may or may not allow for the separate reimbursement of Cathflo when administered in the inpatient setting. Some payers may require additional coding and patient-specific clinical information to determine coverage and payment for the inpatient stay. Please contact individual private payers as needed to clarify their specific reimbursement policies for Cathflo.

View an illustrative chart to guide you through the billing process applicable for inpatient hospitals.

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On claim forms, hospitals use the International Classification of Diseases (ICD) code sets to report medical diagnoses and Healthcare Common Procedural Coding System (HCPCS) Level II codes and American Medical Association (AMA) Current Procedural Terminology (CPT®b) to report items and procedures provided during outpatient encounters.

As of October 1, 2015, all claims need to use the tenth revision of the ICD diagnosis codes to report medical diagnoses (ICD-10-CM) in order to receive reimbursement. All codes should be reported on the claim form 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.

Certain supplies, services, procedures, and drugs administered to Medicare beneficiaries in the outpatient setting may be reimbursed separately. Reimbursement for Cathflo administered in the outpatient setting is set at Average Sales Price (ASP) plus 6% (except 340B hospitals; ASP published quarterly by the Centers for Medicare and Medicaid Services).

To bill Medicare for the services provided and supplies furnished to patients, outpatient hospitals use the UB-04 claim form. The form must be completed with revenue codes, Healthcare Common Procedure Coding System (HCPCS) codes, and ICD-10-CM diagnosis codes (see description of coding systems below). Hospitals should be as thorough as possible in coding to ensure appropriate reimbursement.

View an illustrative chart to guide you through the billing process applicable for outpatients.

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Reimbursement for Cathflo administered in a physician's office or freestanding clinic (ie, a clinic that is not operated as part of a hospital) is set at Average Sales Price (ASP) plus 6% (ASP published quarterly by the Centers for Medicare and Medicaid Services).

Both physicians’ offices and freestanding clinics bill Medicare using the CMS-1500 claim form.

The form must be completed with Healthcare Common Procedure Coding System (HCPCS) codes and ICD-10-CM diagnosis codes (see description of coding systems below). Physician providers must also list a doctor's order and medical justification (diagnosis) in the patient's chart for the services provided.

An illustrative chart to guide you through the billing process applicable to a physician's office or a freestanding clinic.

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Depending on the setting of care, certain code systems are used on the patient's claim form to describe the services provided during the healthcare visit.

Revenue codes

Three-digit codes that providers (physicians, freestanding clinics, hospitals) use to categorize provided services. When completing the UB-04, providers must describe the services related to the revenue code used.

Healthcare Common Procedure Coding System (HCPCS) codes

Five-digit alphanumeric codes that describe provided services. These codes are divided into three levels.

  • Level I: Common Procedural Terminology (CPT®b) codes for physician services
  • Level II: Non-physician services and supplies (including injectable drugs) that are not described by CPT codes
  • Level III: Local codes assigned by local carriers and fiscal intermediaries when no national codes have been assigned for allowed services
International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10-CM)

There are two types of ICD-10-CM codes:

  • Diagnosis codes: Numeric codes that describe the patient's medical condition during their hospitalization. The patient's primary and secondary diagnoses must be present on the UB-04 and CMS-1500 forms. Every service provided to the patient should be supported by at least one ICD-10-CM diagnosis code on the submitted bill
  • Procedure codes: Numeric codes that describe procedures performed during a patient's medical visit. Any procedure code listed on a patient's claim form should be supported by a diagnosis code

Please select the appropriate billing code when filing all claims. Billing codes should be based on diagnosis and the services provided. The codes most commonly associated with the billing and reimbursement of Cathflo are given below. We cannot guarantee that use of the following billing codes will result in reimbursement.c

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For further information regarding drug pricing, please refer to the Medicare website.

Correctly coded claim forms facilitate the claims process and decrease the likelihood of having claims denied.

Visit our Resource Center for a list of downloadable forms, interactive files, and other documents designed to facilitate successful claim submissions. Examples of claim forms that you may use when billing for Cathflo are included.

aPlease contact other payers as needed to clarify their reimbursement guidelines for Cathflo.
bCurrent Procedural Terminology (CPT) is a registered trademark of the American Medical Association. 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.
cAll CPT 5-digit numeric codes, descriptions, numeric modifiers, instructions, guidelines, and other materials included in this webpage are copyright 2010 American Medical Association. All rights reserved.

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Genentech cannot guarantee the exact amount of money, if any, your facility will receive. If you need further assistance regarding Medicare or Medicaid reimbursement policies or procedures, please contact your local carrier directly.

Indication

Cathflo® Activase® (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

Contraindications

Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation.

Precautions
General

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. catheter malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen). These types of conditions should be considered before treatment with Cathflo Activase.

Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation.

Bleeding

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard.

Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter.

Infections

Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation. As with all catheterization procedures, care should be used to maintain aseptic technique.

Hypersensitivity

Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary.

Drug Interactions and Drug/Laboratory Test Interactions

The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.

Potential interactions between Cathflo Activase and laboratory tests have not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adverse Reactions

In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information for additional Important Safety Information.

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