AUGUST 2017 COVERAGE, CODING & PAYMENT BULLETIN - …

1 AUGUST 2017 . coverage , CODING &. PAYMENT BULLETIN Micra . Transcatheter Pacing system CMS Approval of the Medtronic Micra Transcatheter Pacing system Post-Approval Study (PAS) & Prospective Longitudinal Study, the Micra CED. Brief Background Micra Transcatheter Pacing system is the world's smallest pacemaker, delivered percutaneously via a minimally invasive approach, directly into the right ventricle without the use of leads. Leadless pacemakers, also known as intracardiac or transcatheter pacemakers, are the first and only pacemakers in which the components are combined into a single device implanted directly within the heart, without any subcutaneous pocket or tunneling. This is in contrast to traditional transvenous pacemakers that require a subcutaneous generator plus transvenous/epicardial lead(s).

2 On July 28, 2017 , the Centers for Medicare & Medicaid Services (CMS) released the National coverage Determination for the Leadless Effective Jan. 18, 2017 , the CMS will cover leadless pacemakers that are used according to the FDA-labeled indications for the device through coverage with Evidence Development (CED) as outlined below. Nationally Covered Indications CMS will provide coverage for leadless pacemakers when procedures are performed: In an FDA-approved post approval study (PAS) such as the Micra Transcatheter Pacing system Post-Approval Study (PAS);. or In a prospective longitudinal study for leadless pacemakers that have either: An associated ongoing FDA-approved PAS; or Completed an FDA PAS. Each study must be approved by CMS and listed on the CMS website before coverage is effective and PAYMENT can be made.

3 CMS has reviewed and approved the Micra PAS (effective Feb. 9, 2017 ) and the Longitudinal coverage with Evidence Development Study on Micra Leadless Pacemakers, hereafter referred to as the Micra CED prospective longitudinal study, known as the Micra CED (effective March 9, 2017 ). Additional details on each study are below. FDA Post-Approval Study: The Medtronic Micra PAS was approved by the FDA in April 2016. The National Clinical Trial (NCT) number assigned to this study is NCT02536118. Effective Feb. 9, 2017 and as posted on CMS' CED website at: coverage -with-Evidence- , the Micra PAS has been approved by CMS as meeting the CED. requirement for leadless pacemaker coverage . This means Medicare patients enrolled and implanted at a trained and contracted Micra PAS site are eligible for coverage and PAYMENT .

4 Prospective Longitudinal Study: The Micra CED study allows broad patient access for leadless pacemaker implants meeting FDA indications. The NCT. number assigned to this study is NCT03039712. CMS approved this study on March 9, 2017 and their posting on the CMS CED website is at: Micra procedures performed according to FDA indications are eligible for Medicare coverage and reimbursement. Page 1 of 6 | AUGUST 2017 . FDA Approved Indications Leadless pacemakers are non-covered when furnished outside of a CMS approved study. As a reminder, the Micra leadless pacemaker device is FDA approved for patients who have experienced one or more of the following conditions: Symptomatic paroxysmal or permanent high-grade AV block in the presence of AF. Symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy Symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy CODING for Leadless Pacemaker Therapy These CODING suggestions do not replace seeking CODING advice from the payer and/or your own CODING staff.

5 The ultimate responsibility for correct CODING lies with the provider of services. The medical record must include documentation to support the medical necessity of the procedure and the diagnosis and procedure codes selected to report the service. Physician and Hospital Outpatient Procedure Codes The following Category III CPT 2 codes describe procedures associated with leadless (transcatheter) pacemaker therapy implants. Category III CPT codes reflect emerging technologies. Category III CPT Code Category III CPT Code Description 0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular 0388T Transcatheter removal of permanent leadless pacemaker, ventricular 0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system 0390T Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure or test with analysis, review and report, leadless pacemaker system 0391T Interrogation device evaluation (in-person)

6 With analysis review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system Micra is a single chamber pacemaker, as such, we believe it falls under the CMS National coverage Determination (NCD). Cardiac Pacemaker Evaluation Services guidelines. You should check with your Medicare Administrative Contractor (MAC). for further guidance. Remote Monitoring There are not specific Category III codes for remote monitoring, as such, there are two possible options as shown in the table below. The ultimate responsibility for correct CODING lies with the provider of services. CPT Description Option 1. 93294 Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim analysis, review(s) and report(s) by a physician or other qualified health care professional 93296 Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system or implantable cardioverter-defibrillator system , remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results Option 2.

7 93799 Unlisted cardiovascular service or procedure Reference: The CMS NCD titled Cardiac Pacemaker Evaluation Services is available at: Page 2 of 6 | AUGUST 2017 . Hospital Inpatient Procedure Codes ICD-10 Procedure CODING system (PCS) ICD-10 PCS Code Description 02HK3NZ 3 Insertion of intracardiac pacemaker into right ventricle, percutaneous approach 02PA3NZ3,4 Removal of intracardiac pacemaker from heart, percutaneous approach, for the removal of the leadless pacemaker 02WA3NZ3,4 Revision of intracardiac pacemaker in heart, percutaneous approach, for the repositioning of the leadless pacemaker 02PA3NZ3,4 Removal of intracardiac pacemaker from heart, percutaneous approach, for the removal of the and leadless pacemaker; and 02HK3NZ3 Insertion of intracardiac pacemaker into right ventricle, percutaneous approach Supply HCPCS (Healthcare Common Procedure CODING system ) code Hospitals should report the following codes for the Micra device: C1786 Pacemaker, Single Chamber, Rate-Responsive (Implantable).

8 Product number MC1VR01 which includes the device and delivery catheter C1894 Introducer/sheath, other than guiding, other than intracardiac electrophysiological, non-laser. Product number M12355A; Micra introducer sheath. 2017 Medicare payments for Leadless Pacemaker Services Inpatient Medicare-Severity Diagnosis Related Groups (MS-DRGs). If medical necessity criteria are met to support an inpatient admission for the leadless pacemaker procedure the MS-DRG. (Medicare Severity Diagnosis Related Group) assignment may be: FY 2017 MS-DRG Medicare National Payment5. ICD-10 Procedure CODING without any hospital specific adjustments;. system (PCS) MS-DRG and Descriptions the 2% sequestration adjustment is included. 02HK3NZ* 228: Other cardiothoracic procedures $41,414. Or w/MCC. 02PA3NZ* Or Or 229: Other cardiothoracic procedures $27,733.

9 02WA3NZ*. w/o MCC. * IPPS FY 2017 Final Rule Appendix D MS-DRG Surgical Hierarchy by MDC and MS-DRG and a calculated National Medicare PAYMENT (Medicare National payments for Labor, Non-Labor and Capital multiplied by the MS-DRG weight and then reduced by 2%). MCC: Major Complication or Comorbidity. Procedure CODING descriptions can be found above. Physician The Category III CPT codes reflect emerging technologies, and there are no assigned Relative Value Units (RVUs) for the calculation of physician PAYMENT . Medicare assigned XXX (the global concept does not apply) to all five codes; PAYMENT is at the discretion of the applicable Medicare Administrative Contractor (MAC). Because there is no assigned Medicare PAYMENT for Category III codes, physicians submitting a claim for the Micra implant are advised to reference an existing service or procedure that is comparable to the Micra procedure in costs and resources.

10 Page 3 of 6 | AUGUST 2017 . Potential reference procedures* may include: CPT Description 33207 Insertion of new or replacement of permanent pacemaker with transvenous electrode(s), ventricular 33216 Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator 93580 Percutaneous transcatheter closure of congenital interatrial communication ( , Fontan fenestration, atrial septal defect) with implant 93581 Percutaneous transcatheter closure of a congenital ventricular septal defect with implant * One or more of these comparisons might be provided in claims submission to help determine appropriate reimbursement for this implant procedure. Each provider must determine the most appropriate reference code. These are examples only, not an exhaustive or definitive list.