(Medicare National Coverage Determinations Manual)

Destination therapy (DT) is for patients that require mechanical cardiac support.  The VADs used for DT are covered only if they have received approval from the FDA for that purpose.   Patient Selection (effective November 9, 2010):   The VA Ds are covered for patients who have chronic end- stage heart failure (New York Heart Association Class IV end -stage left ventricular failure) who are not candidates for heart transplantation at the time of VAD implant, and meet the following conditions:    Have failed to respond to optimal medical management (including beta -blockers and ACE inhibitors if tolerated) for 45 of the last 60 days, or have been balloon pump-dependent for 7 days, or IV inotrope -dependent for 14 days; and,    Have a left ventricular ejection fraction (LVEF) <25%; and,    Have demonstrated functional limitation with a peak oxygen consumption of 14 ml/kg/min unless balloon pump-  or inotrope -dependent or physically unable to perform the test.   Facility Criteria (effective October 30, 2013) :  Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare- approved facilities until October 30, 2014.  At the conclusion of this transition period, these facilities must be in compliance with the foll owing criteria as determined by a credentialing organization.  As of the effective date, new facilities must meet the following criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A) of the Social Security Act (the Act):   Beneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training, and experience.  The team embodies collaboration and dedication across m edical specialties to offer optimal patient- centered care.  Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent.  The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.   The team must include, at a minimum:    At least one physician with cardiothoracic surgery privileges and indi vidual experience implanting at least 10 durable, intracorporeal, left VADs as BTT or DT over the course of the previous 36 months with activity in the last year.    At least one cardiologist trained in advanced heart failure with clinical competence in medi cal and device- based management including VADs, and clinical competence in the management of patients before and after heart transplant.   A VAD program coordinator.   A social worker.    A palliative care specialist.   Facilities must be credentialed by an organization approved by the Centers for Medicare & Medicaid Services.   C. Nationally Non -Covered Indications   All other indications for the use of VADs not otherwise listed remain non- covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the National Coverage Determinations (NCD) Manual.   D. Other   This policy does not address coverage of VADs fo r right ventricular support, biventricular support, use in beneficiaries under the age of 18, use in beneficiaries with complex congenital heart disease, or use in beneficiaries with acute heart failure without a history of chronic heart failure.  Coverage  under section 1862(a)(1)(A) of the Act for VADs in these situations will be made by local A/B MACs within their respective jurisdictions.   20.10 - Cardiac Rehabilitation Programs (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04 -10-23)    This section of the NCD Manual was repealed February 22, 2010, as a result of section 144 of the Medicare Improvements  for Patients  and Providers  Act. Instead, refer to Pub. 100- 04, chapter 32, section 140.   20.10.1  Cardiac Rehabilitation Programs for Chronic Heart Failure  (Rev. 171, Issued: 07- 18-14, Effective: 02 -18-14, Implementation: 08- 18-14)  A. General   As per sections 1861(s)(2)(CC) and 1861(eee)(1) of the Social Security Act, items and services furnished under a Cardiac Rehabilitation (CR) program may be covered under Medicare Part B.  Among other things, Medicare regulations at 42CFR410.49 define key terms, address the components of a CR program, establish the standards for physician supervision, and limit the maximum number of program sessions that may be furnished.  The regulations also describe the cardiac conditions that would enable a beneficiary to obtain CR services.   Effective for dates of service on and after January 1, 2010, coverage is  permitted for beneficiaries who have experienced one or more of the following:    Acute myocardial infarction within the preceding 12 months   Coronary artery bypasses surgery   Current stable angina pectoris   Heart valve repair or replacement   Percutaneous trans luminal coronary angioplasty (PTCA) or coronary stenting  A heart or heart -lung transplant   The Centers for Medicare & Medicaid Services (CMS) may add other cardiac conditions as specified through a national coverage determination (See 42 CFR 410.49(b)(1)(vii).   B. Nationally Covered Indications   Effective for dates of service on and after  February 18, 2014, CMS has determined that the evidence is sufficient to expand coverage for cardiac rehabilitation services under 42 CFR  410.49(b)(1)(vii) to beneficiaries with stable, chronic heart failure, defined as patients with left ventricular ejection fraction of 3 5% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least six weeks.  Stable patients are defined as patients who have not had recent (6 weeks) or planned (6 months) major cardiovascular hospitalizations or procedures.  (See section A above for other indications covered under 42 CFR 410.49(b)(1)(vii).   C. Nationally Non -Covered Indications   Any cardiac indication not specifically identified in 42 CFR  410.49(b)(1)(vii) or identi fied as covered in this NCD or any other NCD in relation to cardiac rehabilitation services is considered non- covered.   D. Other  NA  (This NCD last reviewed February 2014.)   20.11 - Intraoperative Ventricular Mapping  (Rev. 1, 10- 03-03) CIM 35 -75  Intraope rative ventricular mapping is the technique of recording cardiac electrical activity directly from the heart.  The recording sites are usually identified from an anatomical grid and may consist of epicardial, intramural, and endocardial sites.  A probe wit h electrodes is used to explore these surfaces and generate a map that displays the sequence of electrical activation.  This information is used by the surgeon to locate precisely the site of an operative intervention.  The intraoperative ventricular mappi ng procedure is covered under Medicare only for the uses and medical conditions described below:    Localize accessory pathways associated with the Wolff -Parkinson- White (WPW) and other preexcitation syndromes;    Map the sequence of atrial and ventricular act ivation for drug- resistant supraventricular tachycardias;    Delineate the anatomical course of His bundle and/or bundle branches during corrective cardiac surgery for congenital heart diseases; and    Direct the surgical treatment of patients with refractory ventricular tachyarrhythmias.  20.12 - Diagnostic Endocardial Electrical Stimulation (Pacing)  (Rev. 1, 10- 03-03) CIM 35 -78  Diagnostic endocardial electrical stimulation (EES), also called programmed electrical stimulation of the heart, is cover ed under Medicare when used for patients with severe cardiac arrhythmias.   Diagnostic endocardial electrical stimulation involves the detection and stimulation of cardiac electrical activity for the purpose of studying arrhythmias and abnormalities of the hearts conduction system.  Intracardiac electrode catheters, intracardiac and extracardiac recordings and a stimulator device are required.  From two to six multi -polar electrode catheters are inserted percutaneously, usually through the femoral veins, and advanced to the heart under fluoroscopic control.  Other venous or arterial routes may be employed as well.  An intracardiac His bundle cardiogram is usually obtained during EES as are conventional electrocardiograms.  No separate charge will be recognized for the His Bundle cardiogram.  (See 20.16.)   The EES is used to investigate the mechanisms, site of origin and pathways of cardiac arrhythmias as well as to select therapeutic approaches for their resolution.  EES is also employed to identify patients  at risk of sudden arrhythmic death.  The principal use for EES is in the diagnosis and treatment of sustained ventricular tachycardia.  However, it has also proven to be of value in the diagnosis and management of other complex arrhythmias, conduction def ects, and after cardiac arrest.   20.13 - HIS Bundle Study  (Rev. 1, 10- 03-03) CIM 50 -3  The HIS Bundle Study is a specialized type of electrocardiography requiring catheterization of the right side of the heart and is a recognized diagnostic procedure. Medi care coverage of the procedure would be limited to selected patients: those with complex ongoing acute arrhythmias, those with intermittent or permanent heart block in whom pacemaker implantation is being considered, and those patients who have recently developed heart block secondary to a myocardial infarction.  When heart catheterization and the His Bundle Study are performed at the same time, the program will cover only one catheterization and a small additional charge for the study.  When a His bundle c ardiogram is obtained as part of a diagnostic endocardial electrical stimulation, no separate charge will be recognized for the His bundle study.  (See 20.12, Diagnostic Endocardial Electrical Stimulation.)   20.14 - Plethysmography  (Rev. 1, 10- 03-03) CIM 50 -6  Plethysmography involves the measurement and recording (by one of several methods) of changes in the size of a body part as modified by the circulation of blood in that part.  Plethysmography is of value as a noninvasive technique for diagnostic, preoperative and postoperative evaluation of peripheral artery disease in the internal medicine or vascular surgery practice.  It is also a useful tool for the preoperative podiatric evaluation of the diabetic patient or one who has intermittent claudication or other signs or symptoms indicative of peripheral vascular disease which have a bearing on the patients candidacy for foot surgery.   The oldest form of plethy smography is the venous occlusive pneumoplethysmography.  This method is cumbersome, time consuming, and requires considerable training to give useful, reproducible results.  Nonetheless, in the setting of the hospital vascular laboratory, this technique i s considered a reasonable and necessary procedure for the diagnostic evaluation of suspected peripheral arterial disease.  It is unsuitable for routine use in the physicians office.   Recently, however, a number of other plethysmographic methods have been developed which make use of phenomena such as changes in electric impedance or changes in segmental blood pressure at constant volume to assess regional perfusion.  Several of these methods have reached a level of development which makes them clinically valuable.   Medicare coverage is extended to those procedures listed in Category I below when used for the accepted medical indications mentioned above.  The procedures in Category II are still considered experimental and are not covered at this time.  Denial  of claims because a noncovered procedure was used or because there was no medical indication for plethysmographic evaluation of any type should be based on 1862(a)(1)  of the Act.   Category I - Covered   Segmental Plethysmography -  Included under this procedure are services performed with a regional plethysmograph, differential plethysmograph, recording oscillometer, and a pulse volume recorder.   Electrical Impedance Plethy smography  Ultrasonic Measurement of Blood Flow (Doppler) -  While not strictly a plethysmographic method, this is also a useful tool in the evaluation of suspected peripheral vascular disease or preoperative screening of podiatric patients with suspected peripheral vascular compromise.  (See 220.5 for the applicable coverage policy on this procedure.)   Oculoplethysmography -  See 20.17, Noninvasive Tests of Carotid Function.