If you have any questions, please contact your carrier or A/B MAC at their toll-free number, which maybe found at http://www.cms.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMSweb site.DisclaimerThis article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links tostatutes, regulations, or other policy materials. <strong>The</strong> information provided is only intended to be a general summary. It is not intended to take the place of eitherthe written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statementof their contents. CPT only copyright 2009 American Medical Association.Ventricular Assist Devices as Destination <strong>The</strong>rapyMLN Matters® Number: MM7220 RevisedRelated Change Request (CR) #: 7220Related CR Release Date: December 8, 2<strong>01</strong>0Effective Date: November 9, 2<strong>01</strong>0Related CR Transmittal #: R129NCDImplementation Date: <strong>January</strong> 6, <strong>2<strong>01</strong>1</strong>Note: This article was revised on December 9, 2<strong>01</strong>0 to reflect the revised CR 7220 released on December 8,2<strong>01</strong>0. <strong>The</strong> CR release date, transmittal number, and the Web address for accessing CR were revised. Allother information is the same.Provider Types AffectedThis article is for physicians, providers, and suppliers submitting claims to <strong>Medicare</strong> contractors (carriers,fiscal intermediaries [FIs], and/or A/B <strong>Medicare</strong> administrative contractors [A/B MACs]) for ventricularassist device (VAD) implantation services provided to <strong>Medicare</strong> beneficiaries.What You Need to KnowEffective for claims with dates of service on or after November 19, 2<strong>01</strong>0, the Centers for <strong>Medicare</strong> &Medicaid Services (CMS) has expanded coverage for VAD implantation as destination therapy asreasonable and necessary when the device has received Food and Drug Administration (FDA) approvalfor a destination therapy indication and only for patients with New York Heart Association (NYHA)Class IV end-stage ventricular heart failure who are not candidates for a heart transplant and who meetall specific conditions as outlined in the revised CMS Internet-Only (IOM) Publication 100-03, <strong>Medicare</strong>National Coverage Determinations (NCD) Manual, Chapter 1, Section 20.9.BackgroundA VAD or left ventricular assist device (LVAD) is surgically attached to one or both intact ventricles andis used to assist a damaged or weakened native heart in pumping blood. <strong>Medicare</strong> currently covers thesedevices for three general indications:1. Postcardiotomy,2. Bridge to transplantation, and3. Destination therapy.Destination therapy is for patients who are not candidates for heart transplantation and requirepermanent mechanical cardiac support. Coverage for destination therapy is currently restricted based onpatient selection criteria including:• New York Heart Association (NYHA) class,• Time on optimal medical management,• Left ventricular ejection fraction, andCPT codes and descriptors are only copyright 2<strong>01</strong>0 American Medical Association (or such other date publication of CPT)<strong>The</strong> <strong>Medicare</strong> <strong>Monthly</strong> <strong>Review</strong> 54 <strong>MMR</strong> <strong>2<strong>01</strong>1</strong>-<strong>01</strong>, <strong>January</strong> <strong>2<strong>01</strong>1</strong>
• Peak oxygen consumption.Note: VADs implanted for destination therapy are only covered when performed in a hospital that is<strong>Medicare</strong>-approved to provide this procedure.CR 7220 instructs that, effective for claims with dates of service on and after November 9, 2<strong>01</strong>0, CMS hasdetermined that the evidence is adequate to conclude that VAD implantation as destination therapyimproves health outcomes and is reasonable and necessary when:• <strong>The</strong> device has received FDA approval for a destination therapy indication, and only for patientswith New York Heart Association (NYHA) Class IV end-stage ventricular heart failure who are notcandidates for heart transplant, and• Who meet all of the following conditions:o Have failed to respond to optimal medical management (including beta-blockers, andAntiotensin-Converting Enzyme (ACE) inhibitors if tolerated) for at least 45 of the last 60 days, orhave been balloon pump-dependent for 7 days, or IV inotrope-dependent for 14 days;o Have a left ventricular ejection fraction (LVEF) < 25%; and,o Have demonstrated functional limitation with a peak oxygen consumption of ≤14 ml/kg/minunless balloon pump ot inotrope dependent or physicially unable to perform the test.Note: <strong>The</strong>re are no changes to existing claims processing requirements/editing for VADs as destinationtherapy.Additional Information<strong>The</strong> official instruction, CR 7220, issued to your carriers, FIs, and A/B MACs regarding this change maybe viewed at http://www.cms.gov/Transmittals/downloads/R129NCD.pdf on the CMS Web site.If you have any questions, please contact your carriers, FIs, or A/B MACs at their toll-free number, whichmay be found at http://www.cms.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on theCMS Web site.News Flash - Each Office Visit is an Opportunity. <strong>Medicare</strong> patients give many reasons for not gettingtheir annual flu vaccination, but the fact is that there are 36,000 flu-related deaths in the United Stateseach year, on average. More than 90 percent of these deaths occur in people 65 years of age and older.Please talk with your <strong>Medicare</strong> patients about the importance of getting their annual flu vaccination. This<strong>Medicare</strong>-covered preventive service will protect them for the entire flu season. And remember,vaccination is important for health care workers too, who may spread the flu to high risk patients. Don’tforget to immunize yourself and your staff. Protect your patients. Protect your family. Protect yourself.Get Your Flu Vaccine - Not the Flu.Remember – Influenza vaccine plus its administration are covered Part B benefits. Note that influenzavaccine is not a Part D covered drug. For information about <strong>Medicare</strong>’s coverage of the influenza vaccineand its administration, as well as related educational resources for health care professionals and theirstaff, please visit http://www.cms.gov/MLNProducts/Downloads/Flu_Products.pdf andhttp://www.cms.gov/AdultImmunizations on the CMS Web site.DisclaimerThis article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links tostatutes, regulations, or other policy materials. <strong>The</strong> information provided is only intended to be a general summary. It is not intended to take the place of eitherthe written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statementof their contents.CPT codes and descriptors are only copyright 2<strong>01</strong>0 American Medical Association (or such other date publication of CPT)<strong>The</strong> <strong>Medicare</strong> <strong>Monthly</strong> <strong>Review</strong> 55 <strong>MMR</strong> <strong>2<strong>01</strong>1</strong>-<strong>01</strong>, <strong>January</strong> <strong>2<strong>01</strong>1</strong>
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