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 U.S. 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) procedure 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 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 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 procedures 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 procedure codes 36475 and 36476) and endovenous laser ablation/therapy
(CPT procedure 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 procedure 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 procedure codes 37184 and 37185) and secondary
percutaneous transluminal mechanical thrombectomy (CPT procedure
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 procedure 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 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 procedure 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 procedure 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 procedure code 93760); peripheral (CPT procedure 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 procedure code 37216)
is unproven.
4.6 Signal-Average
Electrocardiography (CPT procedure code 93278) is unproven.
4.7 Percutaneous
transluminal mechanical thrombectomy vein(s) including intraprocedural pharmacological
thrombolytic injections and fluroscopic guidance (CPT procedure
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 procedure 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 procedure codes 0451T-0463T).
5.19 December
29, 2011, for MIDCAB.
5.20 January
22, 2019, for FFRCT.