|Article for Alteplase Recombinant (e.g., Cathflo® Activase ®) – Related to LCD L25820 (A46754)|
|Contractor Type |
|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.
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.
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
Vascular graft occlusion
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:
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.
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.