Humana Percutaneous Coronary Intervention - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories NCD Percutaneous Transluminal Angioplasty (PTA) LCD LCA Percutaneous Coronary Interventions Percutaneous Coronary Intervention Cardiac Catheterization and Coronary Angiography Percutaneous Coronary Interventions Cardiac Catheterization and Coronary Angiography Percutaneous Coronary Intervention LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA 20.7 L34761 A57479 L33623 A56823 L33557 A52850 L34761 A57479 L33959 A56500 L33623 A56823 Percutaneous Coronary Intervention Page: 2 of 12 J5 - Wisconsin Physicians Service Insurance Corporation J6 - National Government Services, Inc. (Part A/B MAC) J6 - National Government Services, Inc. (Part A/B MAC) J8 - Wisconsin Physicians Service Insurance Corporation J15 - CGS Administrators, LLC (Part A/B MAC) JK - National Government Services, Inc. (Part A/B MAC IA, KS, MO, NE IL, MN, WI IL, MN, WI IN, MI KY, OH CT, NY, ME, MA, NH, RI, VT Description A percutaneous coronary intervention (PCI) is used to dilate (widen) narrowed arteries in the heart to relieve chest pain, treat myocardial infarction (heart attack) and potentially enhance activity level. During a PCI, a catheter is advanced to the origin of a coronary artery. A wire with a deflated balloon is then passed beyond the obstruction and advanced into the narrowed part of the coronary artery. Coronary artery angioplasty (also known as percutaneous transluminal coronary angioplasty [PTCA]) is performed when the balloon is inflated to enlarge the channel for blood flow. In most PCIs, a coronary (cardiac) stent (expandable metal mesh tube) crimped on a balloon is then delivered in a similar fashion, and the balloon is inflated to expand the stent, effectively scaffolding the arterial wall to improve blood flow to the heart muscle. As an alternative to angioplasty, atherectomy removes plaque using a rotating shaver or laser at the catheter tip to open narrow or blocked arteries. To reduce the risk of target vessel restenosis, drug-eluting stents (DES) may be used during PCI. DES vary according to the stent platform, polymer used and antirestenotic drug type (eg, everolimus, ridaforolimus, zotarolimus). Drug-eluting stents are coated with antirestenotic medication that is slowly released after implantation to help prevent build-up of new plaque in the stented artery and prevent restenosis. Information regarding specific US Food & Drug Administration (FDA)-approved coronary stents may be found on the FDA website. Percutaneous Coronary Intervention Page: 3 of 12 Intravascular (endoluminal) imaging techniques are used to enhance visualization of coronary vessel or graft lesions during a diagnostic or therapeutic cardiac catheterization procedure in order to guide treatment decisions. Intravascular ultrasound (IVUS) allows visualization of the coronary artery wall by utilizing ultrasound to delineate plaque morphology and distribution and to provide guidance for transcatheter coronary intervention. Optical coherence tomography (OCT) relies on the reflection of light to obtain cross-sectional detailed images of the coronary artery to characterize the structure and extent of atherosclerosis and assess acute stent placement. Coverage Determination Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Percutaneous Coronary Intervention Percutaneous coronary intervention will be considered medically reasonable and necessary when the following requirements are met: • Coronary artery diameter stenosis greater than 70% (other than left main artery) with one or more of the following: o Fractional flow reserve (FFR) less than or equal to 0.80; OR o Instantaneous wave free ratio (iFR) less than or equal to 0.89; OR o Lifestyle-limiting chest pain* despite guideline directed medical therapy (GDMT)**; OR • Coronary artery disease (CAD) treatment in conjunction with planned percutaneous valve procedure (eg, transcatheter aortic valve replacement; OR • Individual with acute coronary syndrome (eg, acute myocardial infarction, unstable angina)15; OR • Individual with silent ischemia15; OR • In-stent restenosis as evidenced by the following: o Chest pain* or myocardial ischemia; AND o Individual expected to tolerate postprocedural dual antiplatelet therapy (eg, clopidogrel or ticagrelor and aspirin); Percutaneous Coronary Intervention Page: 4 of 12 AND either of the following:  Greater than or equal to 70% restenosis of a non-left main coronary vessel; OR  Greater than or equal to 50% restenosis of the left main artery; OR • Left main coronary artery stenosis appropriate for percutaneous coronary intervention (PCI) as indicated by: o Anatomic conditions associated with low to intermediate risk of PCI procedural complications and intermediate to high likelihood of good long-term outcome (eg, SYNTAX score less than 33); AND o Significant stenosis as indicated by one or more of the following:  50% or greater luminal diameter stenosis5; OR  FFR5 less than or equal to 0.80; OR  iFR5 less than or equal to 0.89; OR  Lumen area less than 6 square millimeters5; OR  Lumen diameter less than 2.8 millimeters5; AND either of the following: o High surgical revascularization risk as determined by a heart team (including a cardiac surgeon and an interventional cardiologist) that is associated with clinical characteristics such as moderate to severe chronic obstructive pulmonary disease (COPD), disability from prior stroke, prior cardiac surgery, and/or Society of Thoracic Surgery [STS] Predictive Risk of Mortality greater than 2% (not an all-inclusive list); OR o Individual chooses not to undergo surgical revascularization as documented in the clinical record *Chest pain includes pain, pressure, tightness or discomfort in the chest, shoulders, arms, neck, back, upper abdomen or jaw, as well as shortness of breath and fatigue and should all be considered anginal equivalents.6 **GDMT represents individualized optimal medical therapy and lifestyle modifications for CAD and may include antianginal, antihypertensive, antiplatelet and statin or other lipid-lowering therapies along with diet modification, physical activity and smoking cessation. Percutaneous Transluminal Angioplasty Please refer to the above Medicare guidance for percutaneous transluminal angioplasty. Doppler Functional Flow Reserve Studies Doppler functional flow reserve studies to assess the degree of stenosis within a vessel will be considered medically reasonable and necessary. Percutaneous Coronary Intervention Page: 5 of 12 Intracoronary Ultrasound Intracoronary ultrasound will be considered medically reasonable and necessary when one or more of the following requirements are met: • Assessment of the extent of coronary stenosis if equivocal on angiography; OR • Assessment of the patency and integrity of a coronary artery post-intervention The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider MCG Guidelines. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage The following percutaneous coronary intervention (PCI) indications will not be considered medically reasonable and necessary: • An individual that can be managed medically13; OR • An individual with stable CAD13