Article for Alteplase Recombinant (e.g., Cathflo® Activase ®) – Related to LCD L25820 (A46754)


Contractor Information

 
Contractor Name 
National Government Services, Inc.
Contractor Number 
NumberTypeState(s)
00130 FI IN
00131 FI IL
00160 FI KY
00332 FI OH
00450 FI WI
00452 FI MI
00453 FI VA, WV
00630 Carrier IN
00660 Carrier KY
13101 MAC CT – Part A
13102 MAC CT – Part B
13201 MAC NY – Part A
13202 MAC NY – Part B
13282 MAC NY – Part B
13292 MAC NY – Part B
Contractor Type 
Carrier
Fiscal Intermediary
MAC – Part A
MAC- Part B


Article Information

 
Article ID Number 
A46754 
Article Type 
Article
Key Article 
Yes
Article Title 
Alteplase Recombinant (e.g., Cathflo® Activase ®) – Related to LCD L25820 
AMA CPT / ADA CDT Copyright Statement 
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.
 
Primary Geographic Jurisdiction 
NumberTypeState(s)
00130 FI IN
00131 FI IL
00160 FI KY
00332 FI OH
00450 FI WI
00452 FI MI
00453 FI VA, WV
00630 Carrier IN
00660 Carrier KY
13101 MAC CT – Part A
13102 MAC CT – Part B
13201 MAC NY – Part A
13202 MAC NY – Part B
13282 MAC NY – Part B
13292 MAC NY – Part B
 
Original Article Effective Date 
03/01/2008
Article Revision Effective Date 
07/01/2010
Article Text 
This article defines coding and coverage for alteplase recombinant including off-label indications. National Government Services Local Coverage Determination (LCD) "Coverage of Drugs and Biologicals for Label and Off-Label Uses" allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI), the American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such indications or if National Government Services has published an article or LCD expanding such coverage. Effective for dates of service on or after 11/25/2008, American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson Micromedex DrugDex® compendium has replaced the USP-DI and Thomson Healthcare DrugsPoints®. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services LCD, which describes the requirements for such a request, can be accessed through our contractor Web site at www.NGSMedicare.com or on the Medicare Coverage Database at www.cms.gov/mcd.

Abstract:

Alteplase is a tissue plasminogen activator produced by recombinant DNA technology. Upon introduction into the systemic circulation, it causes lysis of thrombi by binding to fibrin in a thrombus and converting plasminogen to plasmin.

Indications:

Alteplase is most commonly used in the hospital setting for the management of acute myocardial infarction, acute ischemic strokes and massive pulmonary embolism.

Venous catheter occlusion, central

Arteriovenous fistula thrombosis

Arterial thrombosis

Vascular graft occlusion

Venous thromboembolism

May be effective and safe in the prevention of vasospasm and delayed ischemia secondary to subarachnoid hemorrhage due to aneurysmal rupture and is effective when given as a single bolus intraoperatively into the cisternal spaces or when administered as multiple postoperative intrathecal doses.

Alteplase administered directly into the ventricular chamber may reduce mortality in patients after an intraventricular hemorrhage episode.

Alteplase has been used intraocularly for fibrinolysis of fibrin formation following cataract surgery and vitrectomy. (CPT codes 66830 – 66940, 66982 – 66984, 67005 and 67010)

Indications expanded by this Article:

National Government Services is also extending coverage for alteplase, when used for declotting dialysis/chemotherapy catheters and dialysis shunts/grafts.

Cathflo®Activase® is indicated to restore patency in a hemodialysis central venous access device (CVAD) when there is:
  • Clinically significant decrease in blood flow, defined as a flow deficit of 60 to 80 per cent or less of prescribed blood flow; or
  • partial occlusion of the CVAD defined as blood flow of less than 200 mL/min with a venous pressure of less than 300 mm/Hg (a positive pressure) and an arterial pressure of less than -250 to -300 mm/Hg (a negative pressure) without reversing blood lines; or
  • complete occlusion of the CVAD defined as the inability of the clinician to aspirate greater than 3 mL of blood from the catheter.
    If one of the above criteria is met, then the drug may be instilled once and, if not effective, may be used once more. (See Cathflo®Activase® package insert for administration instructions.)

Limitations:

If catheter function is not restored at 120 minutes after 1 dose, a second dose may be instilled. There is, however, no efficacy or safety information on dosing in excess of 2 mg per dose for this indication and such administrations will be considered not reasonable or necessary and will not be covered.

Coding Guidelines:

General Guidelines for claims submitted to Carriers or Intermediaries or Part A or Part B MAC:



Alteplase recombinant should be reported with HCPCS code J2997 per 1 mg.

The number of services provided should be entered in item 24G of the CMS 1500 claim form or the electronic equivalent and in the CMS-1450 or its electronic equivalent for Medicare Part A. The number of services reported should reflect the multiples of 1 mg provided.

For claims submitted to the carrier or Part B MAC:

Alteplase recombinant should be billed using therapeutic/diagnostic administration codes and is payable in the following places of service: office (11), home (12), assisted living facility (13), group home (14), temporary lodging (16), urgent care facility (20), custodial care facility (33), independent clinic (49) and state or local public health clinic (71), only when supplied as an "incident to" service by the physician.


Coding Information

 
Bill Type Codes: 

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

13x Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
72x Clinic-hospital based or independent renal dialysis facility
85x Special facility or ASC surgery-rural primary care hospital (eff 10/94)
 
CPT/HCPCS Codes 

J2997 INJECTION, ALTEPLASE RECOMBINANT, 1 MG
 
ICD-9 Codes that are Covered 

410.00 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL EPISODE OF CARE UNSPECIFIED
410.01 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL INITIAL EPISODE OF CARE
410.02 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL SUBSEQUENT EPISODE OF CARE
410.10 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL EPISODE OF CARE UNSPECIFIED
410.11 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL INITIAL EPISODE OF CARE
410.12 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL SUBSEQUENT EPISODE OF CARE
410.20 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL EPISODE OF CARE UNSPECIFIED
410.21 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL INITIAL EPISODE OF CARE
410.22 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL SUBSEQUENT EPISODE OF CARE
410.30 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL EPISODE OF CARE UNSPECIFIED
410.31 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL INITIAL EPISODE OF CARE
410.32 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL SUBSEQUENT EPISODE OF CARE
410.40 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL EPISODE OF CARE UNSPECIFIED
410.41 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL INITIAL EPISODE OF CARE
410.42 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL SUBSEQUENT EPISODE OF CARE
410.50 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL EPISODE OF CARE UNSPECIFIED
410.51 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL INITIAL EPISODE OF CARE
410.52 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL SUBSEQUENT EPISODE OF CARE
410.60 TRUE POSTERIOR WALL INFARCTION EPISODE OF CARE UNSPECIFIED
410.61 TRUE POSTERIOR WALL INFARCTION INITIAL EPISODE OF CARE
410.62 TRUE POSTERIOR WALL INFARCTION SUBSEQUENT EPISODE OF CARE
410.70 SUBENDOCARDIAL INFARCTION EPISODE OF CARE UNSPECIFIED
410.71 SUBENDOCARDIAL INFARCTION INITIAL EPISODE OF CARE
410.72 SUBENDOCARDIAL INFARCTION SUBSEQUENT EPISODE OF CARE
410.80 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES EPISODE OF CARE UNSPECIFIED
410.81 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES INITIAL EPISODE OF CARE
410.82 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES SUBSEQUENT EPISODE OF CARE
410.90 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE EPISODE OF CARE UNSPECIFIED
410.91 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE INITIAL EPISODE OF CARE
410.92 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE
415.11 IATROGENIC PULMONARY EMBOLISM AND INFARCTION
415.12 SEPTIC PULMONARY EMBOLISM
415.19 OTHER PULMONARY EMBOLISM AND INFARCTION
430 SUBARACHNOID HEMORRHAGE
431 INTRACEREBRAL HEMORRHAGE
434.90 CEREBRAL ARTERY OCCLUSION UNSPECIFIED WITHOUT CEREBRAL INFARCTION
434.91 CEREBRAL ARTERY OCCLUSION UNSPECIFIED WITH CEREBRAL INFARCTION
444.0 EMBOLISM AND THROMBOSIS OF ABDOMINAL AORTA
444.1 EMBOLISM AND THROMBOSIS OF THORACIC AORTA
444.21 ARTERIAL EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY
444.22 ARTERIAL EMBOLISM AND THROMBOSIS OF LOWER EXTREMITY
444.81 EMBOLISM AND THROMBOSIS OF ILIAC ARTERY
444.89 EMBOLISM AND THROMBOSIS OF OTHER ARTERY
444.9 EMBOLISM AND THROMBOSIS OF UNSPECIFIED ARTERY
453.0 BUDD-CHIARI SYNDROME
453.1 THROMBOPHLEBITIS MIGRANS
453.2 OTHER VENOUS EMBOLISM AND THROMBOSIS OF INFERIOR VENA CAVA
453.3 EMBOLISM AND THROMBOSIS OF RENAL VEIN
453.40 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF UNSPECIFIED DEEP VESSELS OF LOWER EXTREMITY
453.41 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF DEEP VESSELS OF PROXIMAL LOWER EXTREMITY
453.42 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF DEEP VESSELS OF DISTAL LOWER EXTREMITY
453.51 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF DEEP VESSELS OF PROXIMAL LOWER EXTREMITY
453.52 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF DEEP VESSELS OF DISTAL LOWER EXTREMITY
453.6 VENOUS EMBOLISM AND THROMBOSIS OF SUPERFICIAL VESSELS OF LOWER EXTREMITY
453.71 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF SUPERFICIAL VEINS OF UPPER EXTREMITY
453.72 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF DEEP VEINS OF UPPER EXTREMITY
453.73 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY, UNSPECIFIED
453.74 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF AXILLARY VEINS
453.75 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF SUBCLAVIAN VEINS
453.76 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF INTERNAL JUGULAR VEINS
453.77 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF OTHER THORACIC VEINS
453.79 CHRONIC VENOUS EMBOLISM AND THROMBOSIS OF OTHER SPECIFIED VEINS
453.81 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF SUPERFICIAL VEINS OF UPPER EXTREMITY
453.82 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF DEEP VEINS OF UPPER EXTREMITY
453.83 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY, UNSPECIFIED
453.84 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF AXILLARY VEINS
453.85 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF SUBCLAVIAN VEINS
453.86 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF INTERNAL JUGULAR VEINS
453.87 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF OTHER THORACIC VEINS
453.89 ACUTE VENOUS EMBOLISM AND THROMBOSIS OF OTHER SPECIFIED VEINS
453.9 EMBOLISM AND THROMBOSIS OF UNSPECIFIED SITE
996.1 MECHANICAL COMPLICATION OF OTHER VASCULAR DEVICE IMPLANT AND GRAFT
996.56 MECHANICAL COMPLICATION DUE TO PERITONEAL DIALYSIS CATHETER
996.73 OTHER COMPLICATIONS DUE TO RENAL DIALYSIS DEVICE IMPLANT AND GRAFT
996.74 OTHER COMPLICATIONS DUE TO OTHER VASCULAR DEVICE IMPLANT AND GRAFT
V45.61 CATARACT EXTRACTION STATUS
V45.69 OTHER STATES FOLLOWING SURGERY OF EYE AND ADNEXA
V56.1 FITTING AND ADJUSTMENT OF EXTRACORPOREAL DIALYSIS CATHETER
V58.81 FITTING AND ADJUSTMENT OF VASCULAR CATHETER
 
ICD-9 Codes that are Not Covered 
Not applicable
 


Other Information

 
Other Comments 
CPT code 36593 - Declotting by thrombolytic agent of implanted vascular access device or catheter, will be denied when billed by an ESRD facility. Staff time used to administer separately billable drugs is covered under the composite rate and may not be billed separately (CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8, Section 60.2.1.1. See also CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 11, Section 30.4.2).

Thrombolytics used to declot central venous catheters are separately billable by renal dialysis facilities when used to treat the patient’s renal condition. These separately billable drugs may only be billed by an ESRD facility if they are actually administered in the facility by the facility staff…[T]he supplies used to administer these drugs may be billed in addition to the composite rate (CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8, Section 60.2.1.1. See also CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 11, Section 30.4.2).

Sources of Information:

AdmisaStar Federal fiscal intermediary LCD Illinois [L23644], Indiana [L23640], Kentucky [L23638], Ohio [L23642].

American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.

Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 04/30/2009.

National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 04/30/2009.

Thomson Micromedix DrugDex®. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 04/30/2009.

US Food and Drug Administration. Product Approval Information. 1996.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed 12/04/2007.

United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional. 2007.
Revision History Explanation 
Article published July 2010: ICD-9-CM code 996.56 has been added to the “ICD-9 Codes that are Covered” section of the article effective for dates of service on or after 03/01/2008 for HCPCS code J2997.

Article published December 2009: ICD-9-CM codes V45.61 and V45.69 have been added to the “ICD-9 Codes that are Covered” section of the article as payable diagnoses for intraocular injections for fibrinolysis of fibrin formation following cataract surgery and vitrectomy effective 11/25/2008. Places of service temporary lodging (16) and urgent care facility (20) have been added to the coding guidelines for claims submitted to the carrier or Part B MAC.

Article published October 2009: Article published October 2009: Based on the annual ICD-9-CM updates for 2010, the "ICD-9 Codes that are Covered" section of the article has been modified as follows: the terminology for ICD-9-CM codes, 453.2, 453.40, 453.41, and 453.42 has been revised. ICD-9-CM codes 453.51, 453.52, 453.6, 453.71, 453.72, 453.73, 453.74, 453.75, 453.76, 453.77 and 453.79 have been added. ICD-9-CM code 453.8 has been deleted and replaced with ICD-9-CM codes 453.81, 453.82, 453.83, 453.84, 453.85, 453.86, 453.87, and 453.89. In the "Coding Guidelines" section for claims submitted to the carrier or the Part B MAC, reference to the administration codes has been revised from "Alteplase recombinant should not be billed using chemotherapy administration codes" to "Alteplase recombinant should be billed using therapeutic/diagnostic administration codes." In the "Sources of Information" section, the formatting of the Web sites for Clinical Pharmacology, National Comprehensive Cancer Network and Micromedix DrugDex® has been revised.

08/08/2009 - This article was updated by the ICD-9 2009-2010 Annual Update.

06/05/2009 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00270 was removed from this article as the claims processing for New Hampshire and Vermont was transitioned to NHIC, the Part A/Part B MAC contractor in these states.

05/15/2009 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary numbers 00180 and 00181 were removed from this Article as the claims processing for Maine and Massachusetts was transitioned to NHIC, the Part A/Part B MAC contractor in these states.

Correction (published 01/29/2009): the description for ICD-9-CM code 410.72 has been corrected on the Web site version to match what is listed in the CMS Medicare Coverage Database.

Article published January 2009: Source of revision – Internal/External: Based on an external comment the following ICD-9-CM codes, 410.00-410.02, 410.10-410.12, 410.20-410.22, 410.30-410.32, 410.40-410.42, 410.50-410.52, 410.60-410.62, 410.70-410.72, 410.80-410.82, 410.90-410.92, 415.11, 415.12, 415.19, 434.90 and 434.91 have been added to the "ICD-9-CM Codes That Support Medical Necessity" section of the article effective for dates of service on or after 03/01/2008. The "Article Text" and "Sources of Information" have been revised to include compendia recognized by CMS based on Change Request 6191 (Compendia as Authoritative Sources for Use in the Determination of a Medically Accepted Indication of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen, effective 11/25/2008). This article has been reviewed using all listed compendia and the following indications have been added: "May be effective and safe in the prevention of vasospasm and delayed ischemia secondary to subarachnoid hemorrhage due to aneurysmal rupture and is effective when given as a single bolus intraoperatively into the cisternal spaces or when administered as multiple postoperative intrathecal doses," when administered directly into the ventricular chamber may reduce mortality in patients after an intraventricular hemorrhage episode and when used intraocularly for fibrinolysis of fibrin formation following cataract surgery and vitrectomy, (CPT codes 66830 – 66940, 66982 – 66984, 67005 and 67010). ICD-9-CM codes 430 and 431 have been added effective for dates of service on or after 11/25/2008. Minor changes were made to reflect current template language.

11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

This revised article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the article is effective on August 1, 2008; for Upstate New York – Part B, the article is effective on September 1, 2008; and for New York and Connecticut – Part A, the article is effective on November 14, 2008. For New York – Part A (contract 00308), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

This article was revised to add the Jurisdiction 13 (J-13) MAC contractor numbers and to retain the most clinically appropriate medical policy information within the jurisdiction, including off-label indications and approved indications from DrugPoints®.

The following indications have been added: venous catheter occlusion, central, arteriovenous fistula thrombosis, arterial thrombosis, vascular graft occlusion and venous thromboembolism. The following ICD-9-CM codes have been added: 444.0, 444.1, 444.21, 444.22, 444.81, 444.89, 444.9, 453.0, 453.1, 453.2, 453.3, 453.40, 453.41, 453.42, 453.8 and 453.9. The places of service for claims submitted to the carrier have been revised. Thomson Healthcare DrugPoints® has been added to the "Article Text" paragraph and "Sources of Information".

Article published March 2008: Original version of article.

The original version of the corresponding LCD became effective on 12/01/2007.
 
Related Documents 
Article(s)
A44930 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses - Supplemental Instructions Article
LCD(s)
L25820 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses