3.0 POLICY
3.1 Medically
necessary services and supplies required in the diagnosis and treatment
of illness or injury involving the cardiovascular system are covered.
3.2 Ventricular Assist Devices
(VADs).
3.2.1 VADs (external and implantable)
are covered if the device is United States (US) Food and Drug Administration
(FDA) approved and used in accordance with FDA approved indications.
3.2.2 VADs as destination therapy
(Current Procedural Terminology (CPT) codes 33979, 0451T-0463T)
are covered if they have received approval from the FDA for that
purpose and are used according to the FDA approved labeling instructions.
Benefits are authorized when the procedure is performed at a TRICARE-certified
heart transplantation center, a TRICARE-certified pediatric consortium
heart transplantation center, or a Medicare facility which is approved
for VAD implantation as destination therapy, for patients who meet
all of the following conditions:
3.2.2.1 The patient has chronic end-stage
heart failure (New York Heart Association Class IV end-stage left ventricular
failure for at least 90 calendar days with a life expectancy of
less than two years).
3.2.2.2 The patient is not a candidate
for heart transplantation.
3.2.2.3 The patient’s Class IV heart
failure symptoms have failed to respond to optimal medical management, including
a dietary salt restriction, diuretics, digitalis, beta-blockers,
and ACE inhibitors (if tolerated) for at least 60 of the last 90
calendar days.
3.2.2.4 The patient has Left Ventricular
Ejection Fraction (LVEF) less than 25%.
3.2.2.5 The patient has demonstrated
functional limitation with a peak oxygen consumption of less than
12 ml/kg/min; or the patient has a continued need for intravenous
inotropic therapy owing to symptomatic hypotension, decreasing renal
function, or worsening pulmonary congestion.
3.2.2.6 The patient has the appropriate
body size (by device per FDA labeling) to support the VAD implantation.
3.3 Gamma and beta intracoronary
radiotherapy (brachytherapy) is covered for the treatment of in-stent restenosis
in native coronary arteries.
3.4 Transmyocardial
Revascularization (TMR) (CPT codes 33140 and 33141).
3.4.1 Coverage
is available for patients with stable class III or IV angina which
has been found refractory to standard medical therapy, including
drug therapy at the maximum tolerated or maximum safe dosages. In addition,
the angina symptoms must be caused by areas of the heart not amenable
to surgical therapies such as percutaneous transluminal coronary
angioplasty, stenting, coronary atherectomy or coronary bypass.
3.4.2 Coverage is limited to those
uses of the laser used in performing the procedure which have been approved
by the FDA for the purpose for which they are being used.
3.5 TMR as an adjunct to Coronary
Artery Bypass Graft (CABG) is covered for patients with documented
areas of the myocardium that are not amenable to surgical revascularization
due to unsuitable anatomy.
3.7 Endovenous Radiofrequency Ablation
(RFA)/obliteration (CPT codes 36475 and 36476) and endovenous laser
ablation/therapy (CPT codes 36478 and 36479) for the treatment of
saphenous venous reflux of named saphenous veins (which include
greater, small, anterior accessory and posterior accessory) with
symptomatic varicose veins and/or incompetent perforator veins is
covered when:
3.7.1 One of the following indications
is present:
3.7.1.1 Persistent
symptoms interfering with activities of daily living in spite of
conservative/non-surgical management. Symptoms include aching, cramping,
burning, itching and/or swelling during activity or after prolonged
standing.
3.7.1.2 Significant recurrent attacks
of superficial phlebitis.
3.7.1.3 Hemorrhage from a ruptured
varix.
3.7.1.4 Ulceration from venous stasis
where incompetent varices are a contributing factor.
3.7.2 A trial of conservative, non-operative
treatment has failed. This would include mild exercise, avoidance of
prolonged immobility, periodic elevation of legs, and compressive
stockings.
3.7.3 The patient’s anatomy is amenable
to endovenous ablation.
3.8 Ambulatory
Blood Pressure Monitoring (ABPM) is only covered for beneficiaries
with suspected white coat hypertension and is NOT covered for any
other uses. The information obtained by ABPM is necessary in order to
determine the appropriate medical management of the beneficiary.
Suspected white coat hypertension is considered to exist when the
following is documented:
3.8.1 There
is no evidence of end-organ damage;
3.8.2 Office
blood pressure greater than 140/90 mm Hg on at least three separate
clinic/office visits with two separate measurements made at each
visit; and
3.8.3 At least two blood pressure
measurements taken outside the office which are less than 140/90
mm Hg.
3.9 Pulmonary
vein isolation/ablation (CPT code 93651) is covered for beneficiaries
who meet the guidelines published in the Heart Rhythm Society (HRS)/European
Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society
(ECAS) 2007 Consensus Statement as follows:
3.9.1 Symptomatic
Atrial Fibrillation (AF) refractory or intolerant to at least one
Class 1 or 3 antiarrhythmic medication.
3.9.2 In rare
clinical situations, as first line therapy.
3.9.3 Selected symptomatic patients
with heart failure and/or reduced ejection fraction.
3.9.4 The presence of a Left Atrial
(LA) thrombus is a contraindication.
3.10 Primary percutaneous transluminal
mechanical thrombectomy (CPT codes 37184 and 37185) and secondary
percutaneous transluminal mechanical thrombectomy (CPT code 37186)
are proven and are covered for the treatment of acute limb ischemia
due to peripheral arterial occlusion.
3.11 Percutaneous
Transluminal Angioplasty (PTA) of the carotid artery with stenting
(CPT codes 37215, 0075T, and 0076T) in beneficiaries at high risk
for Carotid Endarterectomy (CEA) is proven and covered when all
of the following criteria are met:
3.11.1 Beneficiaries who have symptomatic
Carotid Artery Stenosis (CAS) greater than 70%.
3.11.2 Beneficiaries are at high risk
for CEA due to one or more of the following significant comorbidities
and/or anatomic risk factors:
• Congestive heart failure (New
York Heart Association Class I, II/IV).
• Left ventricular ejection fraction
of less than 30%.
• Myocardial Infarction (MI)
within past 30 calendar days.
• Unstable Angina.
• Known severe Coronary Artery
Disease (CAD).
• Severe Chronic Obstructive
Pulmonary Disease (COPD).
• Contralateral carotid artery
occlusion.
• Contralateral laryngeal nerve
palsy.
• Previous radiation therapy
to the neck.
• Previous radical neck dissection.
• Previous ipsilateral endarterectomy
with restenosis.
• Surgically inaccessible lesion.
• Inability to move the neck
to a suitable position for surgery.
• Tracheostomy.
• Coagulopathy or other coagulation
issues leading to contraindication for endarterectomy.
3.11.3 Beneficiaries who have had
a disabling stroke are excluded from coverage.
3.11.4 Coverage is limited to procedures
performed using FDA approved carotid artery stents and embolic protection
devices.
3.11.5 The use of a distal embolic
protection device is required. If deployment of the distal embolic
protection device is not technically possible, then the procedure
should be aborted due to the risks of CAS without distal embolic
protection.
3.11.6 The degree of CAS shall be
measured by duplex Doppler ultrasound or carotid artery angiography
and recorded in the beneficiary’s medical records. If the stenosis
is measured by ultrasound prior to the procedure, then the degree
of stenosis must be confirmed by angiography at the start of the
procedure. If the stenosis is determined to be less than 70% by
angiography, then CAS should not proceed.
3.11.7 All procedures are performed
in a Centers for Medicare and Medicaid Services (CMS) approved facility that
has been determined to be competent in performing the evaluation,
procedure, and follow-up necessary to ensure optimal patient outcomes.
3.12 Transcatheter Aortic Valve
Replacement (TAVR) for the treatment of severe symptomatic aortic
stenosis is proven safe and effective for patients who are not candidates
for Surgical Aortic Valve Replacement (SAVR).
3.13 Percutaneous transluminal mechanical
thrombectomy (CPT codes 37184, 37185, 37186) with stent retrievers
for the treatment of adults with acute ischemic stroke is proven
safe and effective.
3.14 TAVR for the treatment of severe
symptomatic aortic stenosis in high-risk operative patients is considered proven
safe and effective.
3.15 Intracranial angioplasty with
stenting (CPT code 61635) of the venous sinuses may be considered
for cost-sharing for the treatment of pseudotumor cerebri (also
known as idiopathic intracranial hypertension and benign intracranial
hypertension).
3.16 Cardiography:
electrocardiograms, rhythm strips, stress testing; Cardiovascular
Monitoring: continuous ambulatory monitors (e.g., Holter monitor,
Zio Patch), mobile cardiac telemetry, and event monitors; Implantable and
Wearable Cardiac Devices: pacemakers, defibrillators, and loop recorders
are covered when approved by the FDA and in accordance with
Chapter 8, Section 5.1.
3.17 Left Atrial Appendage (LAA)
closure for the prevention of embolism in patients with non-valvular
atrial fibrillation is covered when performed with an FDA approved
device used according to labeled specifications (e.g., WATCHMAN™
device).
3.18 Minimally
Invasive Direct Coronary Artery Bypass (MIDCAB) is covered when
medically necessary and appropriate.
3.19 Insertion, evaluation, replacement,
and removal of wireless cardiac stimulator for pacing of the lower
left chamber of the heart (CPT codes 0515T-0522T) is covered for
use with WiSE-CRT system (in accordance with the FDA-approved investigational
device exemption policy,
Chapter 8, Section 5.1).
3.20 Noninvasive fractional flow
reserve from coronary computed tomography angiography (FFRCT) (CPT codes
0501T-0504T) is covered for the assessment of coronary artery disease
in clinically stable patients who do not appear to need urgent revascularization
when using FDA approved software (e.g., HeartFlow FFRCT).
4.0 EXCLUSIONS
4.1 Thermogram;
cephalic (CPT code 93760); peripheral (CPT code 93762) are unproven.
4.2 Percutaneous Myocardial Laser
Revascularization (PMR) is unproven.
4.3 Cardiomyoplasty
(Cardiac Wrap) for treatment of heart failure is unproven.
4.4 Port Access Coronary Artery
Bypass (PACAB) is unproven.
4.5 Percutaneous
Transluminal Angioplasty (PTA) in the treatment of obstructive lesions
of the vertebral and cerebral arteries is unproven. PTA of the carotid
artery without stenting is unproven. PTA of the carotid artery with stenting
but without embolic protection (CPT code 37216) is unproven.
4.6 Signal-Average Electrocardiography
(CPT code 93278) is unproven.
4.7 Percutaneous
transluminal mechanical thrombectomy vein(s) including intraprocedural
pharmacological thrombolytic injections and fluroscopic guidance
(CPT code 37187) is unproven.
4.8 Percutaneous
transluminal mechanical thrombectomy, vein(s) including intraprocedural pharmacological
thrombolytic injections and fluroscopic guidance, repeat treatment
on subsequent day during course of thrombolytic therapy (CPT code
37188) is unproven.
4.9 LAA closure
using the LARIAT® Suture Delivery Device is excluded as the LARIAT®
device fails to meet the off-label device requirements in
Chapter 8, Section 5.1.
5.0 EFFECTIVE DATES
5.1 March
1, 2001, for gamma and beta intracoronary radiotherapy (brachytherapy).
5.2 January 1, 2002, for TMR.
5.3 October 1, 2003, for VADs as
destination therapy.
5.4 December
1, 2003, for endovenous RFA/obliteration.
5.5 January
1, 2005, for ABPM.
5.6 March
17, 2005, for PTA of the carotid artery with stenting in beneficiaries
at high risk for CEA.
5.7 March
21, 2006, for percutaneous transluminal mechanical thrombectomy
for acute limb ischemia.
5.8 January
1, 2007, for pulmonary vein isolation/ablation.
5.9 January 1, 2009, for endovenous
laser ablation/therapy.
5.10 May 1,
2011, for endovenous RFA/obliteration for the treatment of incompetent
perforator veins.
5.11 July 27,
2012, for endovenous laser ablation/therapy for the treatment of
incompetent perforator veins.
5.12 February
8, 2012, for TAVR for the treatment of severe symptomatic aortic
stenosis in patients who are not candidates for SAVR.
5.13 July 27, 2012, for TAVR, for
treatment of severe symptomatic aortic stenosis in high-risk operative patients.
5.14 June 25, 2014, for intracranial
angioplasty with stenting of the venous sinuses for the treatment
of pseudotumor cerebri.
5.15 November
30, 2014, for continuous ambulatory Electrocardiogram (ECG) recording
greater than 48 hours.
5.16 January
7, 2015, for percutaneous transluminal mechanical thrombectomy with
stent retrievers.
5.17 July 2,
2015, for LAA closure for the prevention of embolism in patients
with non-valvular atrial fibrillation.
5.18 January 1, 2017, for VADs (CPT
codes 0451T-0463T).
5.19 December
29, 2011, for MIDCAB.
5.20 January
22, 2019, for FFRCT.