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.