Draft LCD for Percutaneous VENTRICULAR ASSIST Device (pvad) (DL31518)

Transcription

1 Image description. Draft Stamp End of image description. Draft LCD for Percutaneous VENTRICULAR ASSIST Device (pvad) (DL31518) Please note: This is a Draft policy. Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor. Contractor Information Contractor Name NHIC, Corp. Contractor Number Contractor Type MAC - Part B LCD Information LCD ID Number DL31518 LCD Title Percutaneous VENTRICULAR ASSIST Device (pvad) Contractor's Determination Number AMA CPT / ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2010 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. CMS National Coverage Policy 1. Title XVIII of the Social Security Act, Section 1862

2 (a)(7). This section excludes routine physical examinations. 2. Title XVIII of the Social Security Act, Section 1862(a) (1)(A). This section allows coverage and payment for only those services considered medically reasonable and necessary. 3. Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim. 4. Title XVIII of the Social Security Act, Section 1862 (a)(1)(d) (Investigational or Experimental) 5. CMS Publication 100-3, Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Section Artificial Hearts And Related Devices Primary Geographic Jurisdiction New Hampshire Oversight Region Region I Projected Determination Effective Date Original Determination Ending Date Revision Effective Date Revision Ending Date Indications and Limitations of Coverage and/or Medical Necessity Abstract Current American College of Cardiology and American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) guidelines support the use of intra-aortic balloon pump (IABP) counterpulsation as method of first choice for mechanical assistance in cardiogenic shock (1,2). ACC/AHA ST-Segment Elevation Myocardial Infarction (STEMI) guidelines list IABP therapy in cardiogenic shock as a class IB recommendation (3). Yet, the evidence for the efficacy of IABP counterpulsation in STEMI has been questioned (4) and in-hospital mortality from cardiogenic shock remains about 50% (5).

3 The recent introduction of percutaneous VENTRICULAR ASSIST devices (pvads) potentially offer the opportunity to lower the mortality rate further in that they provide active circulatory support requiring less residual left ventricular function. Currently, two pvads are available for clinical use: the TandemHeart and the Impella Recover LP system. The Impella LVAD is a catheter-based, impeller-driven, axial flow pump which pumps blood directly from the left ventricle into the ascending aorta. The TandemHeart is a percutaneous left atrial-to-femoral arterial LVAD, driven by a low-speed centrifugal continuous flow pump. Whereas the IABP augments cardiac output by only L/min, the Impella and TandemHeart devices augment cardiac output by approximately 2.5 L/min and 4 L/min, respectively. In addition, pvads do not require a stable rhythm in order to time augmentation. However, while studies comparing pvads to IABP uniformly demonstrate superior hemodynamic support, there was no difference in 30-day survival and complications such as severe groin bleeding and acute limb ischemia were more common (6-8). The absence of a survival advantage may be more a function of the highrisk patient population for which these devices are used than the mechanical efficiency of the pump (9). The increased complication rate is probably related to catheter size; an IABP is introduced via an 8 French sheath, versus 13 and 17 French sheaths for the Impella and TandemHeart, respectively. A recent metaanalysis concluded that results do not yet support percutaneous LVAD as first-choice approach in the mechanical management of cardiogenic shock (5). A Phase III randomized trial (PROTECT) is currently underway comparing Impella versus IABP in high risk PCI patients. Note: The NCD on artificial hearts and related devices (20.9) does not speak to short-term pvads included in this LCD. Indications of Coverage Pending further evidence, coverage of pvads is limited to cardiogenic shock: Refractory to IABP, or When IABP may be contraindicated (no stable rhythm, interferes with other interventions while inflated). 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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 011x Hospital Inpatient (Including Medicare Part A) 012x Hospital Inpatient (Medicare Part B only)

4 Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes CPT/HCPCS Codes Tandem Heart: use 0048T and 0050T Impella: use UNLISTED PROCEDURE, CARDIAC SURGERY 0048T 0050T IMPLANTATION OF A VENTRICULAR ASSIST DEVICE, EXTRACORPOREAL, PERCUTANEOUS TRANSSEPTAL ACCESS, SINGLE OR DUAL CANNULATION REMOVAL OF A VENTRICULAR ASSIST DEVICE, EXTRACORPOREAL, PERCUTANEOUS TRANSSEPTAL ACCESS, SINGLE OR DUAL CANNULATION ICD-9 Codes that Support Medical Necessity CARDIOGENIC SHOCK Diagnoses that Support Medical Necessity ICD-9 Codes that DO NOT Support Medical Necessity ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity

5 General Information Documentation Requirements Appendices Utilization Guidelines Sources of Information and Basis for Decision 1. Smith SC, et. al. ACC/AHA Guidelines for Percutaneous Cardiac Intervention (Revision of the 1993 Guidelines) Executive Summary. Circulation 2001;103: Dickstein, K., et. al. Guidelines for the diagnosis treatment of acute, chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008;29: Antman EM, et. al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction).Circulation 2004;110:e82 e Sjauw KD, et. al.. A systematic review and meta-analysis of intra aortic balloon pump therapy in STelevation myocardial infarction: should we change the guidelines? Eur Heart J (2009) 30(4): Cheng JM. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a meta-analysis of controlled trials. Eur Heart J 2009:30: Burkhoff D, Cohen H, Brunckhorst C, O Neill WW. A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock. Am Heart J 2006;152: Sjauw KD, et.al. Left Ventricular Unloading in Acute STEMI Patients is Safe and Feasible and provides Acute and Sustained Left Ventricular Recovery. The AMCMACH 2 study. J Am Coll Cardiol 2008;51: Thiele H, Smalling RW, Schuler GC. Percutaneous left ventricular assist devices in acute myocardial infarction complicated by cardiogenic shock. Eur Heart J 2007;28: Aroesty JM, et. al. Circulatory assist devices: Cardiopulmonary assist device and short-term left ventricular assist devices. UpToDate Online: _result#h6 accessed 10/21/ J14 Carrier Advisory Committee (CAC) Advisory Committee Meeting Notes 02/07/2011 Start Date of Comment Period

6 02/07/2011 End Date of Comment Period 03/23/2011 Start Date of Notice Period Revision History Number Revision History Explanation Reason for Change Last Reviewed On Date 10/28/2010 Related Documents This LCD has no Related Documents. LCD Attachments There are no attachments for this LCD. Draft Contact Craig Haug M.D. - craig.haug@hp.com NHIC, Corp. 75 Sargeant William Terry Drive Hingham, MA All Versions Updated on 11/23/2010 with effective dates N/A - N/A