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Regence Medicare Advantage Policy Manual TOPIC: Ventricular Assist Devices and Total Artificial Hearts Section: Medicare Manual – Surgery Approval Date: December 2016 Policy No: M-SUR52 Published Date: 01/01/2017 IMPORTANT REMINDER: The health plan’s Medicare Advantage Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with the member Evidence of Coverage (EOC) booklet. Benefit determinations are based in all cases on any applicable EOC language and any applicable CMS policy. To the extent there may be any conflict, applicable EOC language or applicable CMS policy take precedence over the health plan’s Medicare Advantage Medical Policy. Associated Clinical Documentation: It is critical that the list of information below is submitted for review to determine if the policy criteria are met. If any of these items are not submitted, it could impact our review and decision outcome: • • • • History and Physical documenting indications for procedure and device; Type of therapy (bridge-to-transplant [BTT], destination therapy [DT], or postcardiotomy for VADs); For artificial hearts: The names of the device and Coverage with Evidence Development (CED) study; For VADs: Name of device to be used, date of open heart surgery (if applicable), facility where the procedure will be performed, documentation of stage of chronic heart failure, failed optimal medical management, left ventricular ejection fraction (LVEF), and documentation of demonstrated functional limitation with a peak oxygen consumption of ≤ 14 ml/kg/min (see NCD for exceptions to this requirement). MEDICARE MEDICAL POLICY CRITERIA 1 - M-SUR52 MEDICARE MEDICAL POLICY CRITERIA CMS Coverage Manuals None National Coverage Determinations (NCD) For artificial hearts: Artificial Hearts and Related Devices (20.9) For Medicare-approved artificial heart bridge-to-transplant (BTT) and destination therapy (DT) CED studies, see CMS Website. Note: If the procedure is rendered as part of a Category A IDE study, the device itself is non-covered.(2) For ventricular assist devices (VADs) (for implantable aortic counterpulsation ventricular assist systems, see the LCD row below): Ventricular Assist Devices (20.9.1) For Medicare-approved VAD destination therapy facilities, see CMS Website. Noridian Healthcare Solutions (Noridian) Local Coverage Determinations (LCD) and Articles (LCA) For insertion of percutaneous ventricular assist devices (CPT codes 33990 and 33991): Percutaneous Endovascular Cardiac Assist Procedures and Devices (A52967) For implantable aortic counterpulsation ventricular assist systems (Category III CPT codes 0451T-0463T): Non-Covered Services (L35008) **Scroll to the “Public Version(s)” section at the bottom of the LCD for links to prior versions if necessary. REFERENCES 1. Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, §320 - Artificial Hearts and Related Devices 2. Medicare Managed Care Manual, Chapter 4 – Benefits and Beneficiary Protections, §10.7.2 – Payment for Investigational Device Exemption (IDE) Studies 3. Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, §320.3 – Ventricular Assist Devices (VADs) 2 - M-SUR52 CROSS REFERENCES Surgical Ventricular Restoration, Surgery, Policy No. M-149 Heart Transplants, Transplant, Policy No. M-02 Heart/Lung Transplants, Transplant, Policy No. M-03 CODES NUMBER DESCRIPTION Note: There is no specific code for reporting prolonged extracorporeal percutaneous transseptal ventricular assist device; the appropriate code for reporting this procedure is 33999. CPT 33975 Insertion of ventricular assist device; extracorporeal, single ventricle 33976 33977 Insertion of ventricular assist device; extracorporeal, biventricular Removal of ventricular assist device; extracorporeal, single ventricle 33978 Removal of ventricular assist device; extracorporeal, biventricular 33979 Insertion of ventricular assist device, implantable intracorporeal, single ventricle Removal of ventricular assist device, implantable intracorporeal, single ventricular 33980 33981 33982 Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass 33983 Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass 33990 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only 33991 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; both arterial and venous access, with transseptal puncture 33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion Repositioning of percutaneous ventricular assist device with imaging guidance at separate and distinct session from insertion 33993 0051T Implantation of a total replacement heart system (artificial heart) with 3 - M-SUR52 CODES NUMBER DESCRIPTION recipient cardiectomy 0052T 0053T Replacement or repair of thoracic unit of a total replacement heart system (artificial heart) Replacement or repair of implantable component or components of total replacement heart system (artificial heart) excluding thoracic unit 0451T Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters; complete system (counterpulsation device, vascular graft, implantable vascular hemostatic seal, mechano-electrical skin interface and subcutaneous electrodes) 0452T 0453T ; aortic counterpulsation device and vascular hemostatic seal ; mechano-electrical skin interface 0454T 0455T ; subcutaneous electrode Removal of permanently implantable aortic counterpulsation ventricular assist system; complete system (aortic counterpulsation device, vascular hemostatic seal, mechano-electrical skin interface and electrodes) 0456T 0457T ; aortic counterpulsation device and vascular hemostatic seal ; mechano-electrical skin interface 0458T ; subcutaneous electrode 0459T Relocation of skin pocket with replacement of implanted aortic counterpulsation ventricular assist device, mechano- electrical skin interface and electrodes 0460T Repositioning of previously implanted aortic counterpulsation ventricular assist device; subcutaneous electrode ; aortic counterpulsation device 0461T 0462T Programming device evaluation (in person) with iterative adjustment of the implantable mechano-electrical skin interface and/or external driver to test the function of the device and select optimal permanent programmed values with analysis, including review and report, implantable aortic counterpulsation ventricular assist system, per day 0463T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient 4 - M-SUR52 CODES NUMBER DESCRIPTION encounter, implantable aortic counterpulsation ventricular assist system, per day HCPCS Q0478Q0509 Ventricular assist device accessories, code range 5 - M-SUR52