Billing chart: Blues highlight medical, benefit policy changes

Q4147, Q4149, Q4161, Q4164, Q4165

Basic benefit and medical policy

Skin and tissue substitutes

The safety and effectiveness of skin and tissue substitutes approved by the U.S. Food and Drug Administration have been established for patients meeting specified selection criteria. They may be useful therapeutic options when indicated.

Human tissue products are subject to the rules and regulations of banked human tissue by the American Association of Tissue Banks.

Alloderm^® is a human tissue product that is established for use in breast reconstruction and treatment of severe burns.

Theraskin^® is a human tissue product that is established for use in standard therapeutic compression for venous stasis ulcers and standard diabetic foot ulcer care for neuropathic diabetic foot ulcers.

GraftJacket^® Regenerative Tissue Matrix-Ulcer Repair is a human tissue product that is established for the treatment of neuropathic diabetic foot ulcers.

EpiFix^® is an amniotic membrane allograft that is established for the treatment of neuropathic diabetic foot ulcers and venous stasis ulcers that have failed to respond to conservative measures.

Human tissue products other than Alloderm, Theraskin, GraftJacket and EpiFix are considered experimental.

Inclusions:

The following skin and tissue substitutes are considered established because they have been approved by the FDA. This list may not be all-inclusive:

• Apligraft^®
• Biobrane^®
• Dermagraft^®
• Endoform Dermal Template™
• Epicel^® has FDA Humanitarian Device Approval
• E-Z Derm™
• Hyalomatrix^®
• Integra^® Bilayer Matrix
• Integra^® Dermal Regeneration Template
• Integra^® Flowable Wound Matrix
• MatriStem^® Burn Matrix
• MatriStem^® MicroMatrix™
• MatriStem^® Wound Sheet
• MediSkin^®
• Oasis^® Burn Matrix
• Oasis^® Ultra Tri-Layer Wound Matrix
• Oasis^® Wound Matrix
• OrCel^®
• Permacol™
• PriMatrix™
• Strattice™
• SurgiMend^®
• Talymed™
• TenoGlide™
• Unite^® Biomatrix

Application of bioengineered skin substitutes will be covered when the following conditions are met and documented as appropriate for the individual patient:

• Presence of neuropathic diabetic foot ulcers for greater than four weeks’ duration.
• Presence of venous stasis ulcers of greater than three months’ duration that have failed to respond to documented conservative measures for greater than two months’ duration.
• Presence of neuropathic diabetic foot ulcers that have failed to respond to documented conservative measures for greater than one month’s duration. These measures must include appropriate steps to off-load pressure during treatment.
• Presence of partial or full-thickness ulcers.
• Measurements of the initial ulcer size, the size following cessation of any conservative management and the size at the beginning of skin substitute treatment. In all cases, the ulcer must be free of infection and underlying osteomyelitis. Documentation must be provided that these conditions have been successfully treated and resolved before instituting skin substitute treatment.

Exclusions:

• Any product not approved by the FDA as a skin or tissue substitute.
• Any indication other than that approved by the FDA.
• Human-derived skin and tissue products other than Alloderm, Theraskin, GraftJacket and EpiFix for the approved indications.

78459, 78491, 78492

Basic benefit and medical policy

Cardiac PET scanning

The safety and effectiveness of cardiac PET scanning have been established. It may be considered a useful diagnostic option for patients meeting specified selection criteria.

An exclusion has been added, effective Sept. 1, 2016.

Payment policy
This service is subject to the radiology management program, when applicable.

Inclusions:

Cardiac PET scanning is established for the following indications:

• Assessing myocardial perfusion for diagnosing coronary artery disease in patients with indeterminate SPECT scan
• For patients for whom SPECT could be reasonably expected to be suboptimal in quality on the basis of body habitus (e.g., BMI > 40, large breasts, breast implants, mastectomy, chest wall deformity, pleural or pericardial effusion)
• For assessing the myocardial viability in patients with severe left ventricular dysfunction as a technique to determine candidacy for a revascularization procedure
• For diagnosing cardiac sarcoidosis in patients who are unable to undergo MRI scanning. Examples of patients who are unable to undergo MRI include patients with pacemakers, automatic implanted cardioverter-defibrillators or other metal implants.

Exclusions:

• Quantification of myocardial blood flow in patients diagnosed with CAD.

33215-33218, 33220, 33223, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262-
33264, 33270-33273, 93260, 93261, 93282-93284, 93287, 93289, 93295, 93296

Basic benefit and medical policy

Automatic implantable cardioverter defibrillator and electronic surveillance of the automatic implantable cardioverter defibrillator

The safety and effectiveness of an automatic implantable cardioverter defibrillator, or ICD, and electronic surveillance of the automatic implantable cardioverter defibrillator, or AICD, have been established. It may be considered a useful therapeutic option for patients who meet selection criteria.

The safety and effectiveness of a subcutaneous automatic implantable cardioverter defibrillator and electronic surveillance of the AICD have been established. It may be considered a useful therapeutic option for patients who meet selection criteria.

Inclusionary criteria have been updated, effective Sept. 1, 2016.

Inclusions:

Standard automatic implantable cardioverter defibrillators

I. Adults

The use of the automatic implantable cardioverter defibrillator, or ICD, may be considered established in adults who meet the following criteria:

Primary prevention

Inclusions:

• Ischemic cardiomyopathy with New York Heart Association functional Class II or Class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35 percent or less
• Ischemic cardiomyopathy with NYHA functional Class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment and left ventricular ejection fraction of 30 percent or less.
• Nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35 percent or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined.
• Hypertrophic cardiomyopathy, or HCM, with one or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; one or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.
• Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
• Congenital long QT syndrome
• Brugada syndrome
• Short QT syndrome
• Catecholaminerigic polymorphic ventricular tachycardia

Exclusions:

The use of the ICD is considered experimental in primary prevention patients who:

• Have had an acute myocardial infarction (i.e., less than 40 days before ICD treatment)
• Have New York Heart Association class IV congestive heart failure (unless patient is eligible to receive a combination cardiac resynchronization therapy ICD device)
• Have had a cardiac revascularization procedure in past three months (coronary artery bypass graft or percutaneous transluminal coronary angioplasty) or are candidates for a cardiac revascularization procedure
• Have noncardiac disease that would be associated with life expectancy less than one year

Secondary prevention

Inclusions:

• Patients with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia after reversible causes (e.g., acute ischemia) have been excluded before qualifying for the service.

Exclusions:

The use of the ICD is considered experimental for all other indications.

II. Pediatrics

Inclusions:

The use of the ICD may be considered established in children who meet any of the following criteria:

• Survivors of cardiac arrest, after reversible causes have been excluded.
• Symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation.
• Congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias.
• Hypertrophic cardiomyopathy, or HCM, with one or more major risk factors for sudden cardiac death (history or premature HCM-related sudden death in one or more first-degree relatives younger than 50 years old; massive left ventricular hypertrophy based on age-specific norms; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.
• Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
• Congenital long QT syndrome
• Brugada syndrome
• Short QT syndrome
• Catecholaminergic polymorphic ventricular tachycardia

Exclusions:

The use of the ICD is considered experimental for all other indications in pediatric patients.

Subcutaneous automatic implantable cardioverter defibrillators

FDA-approved subcutaneous cardioverter-defibrillators are established for adult or pediatric people who meet patient selection criteria for an implanted cardioverter-defibrillator and do not need pacing and the placement of a conventional AICD is precluded due to any of the following conditions:

• Poor vascular access secondary to dialysis or other vascular conditions
• A high risk for infection, e.g., immune-compromised patients or those with a history of a previous transvenous infection
• History of congenital heart disease with anatomic limitations for transvenous placement of the AICD

Basic benefit and medical policy

Transcatheter aortic valve implantation for aortic stenosis

The transcatheter aortic valve implantation for aortic stenosis policy has been updated. This policy is effective Sept. 1, 2016.

Transcatheter aortic valve replacement performed with an FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling, may be indicated for patients with aortic stenosis.

Inclusions:

Transcatheter aortic valve replacement with a device approved by the FDA performed via an approach consistent with the device’s FDA-approved labeling is established for patients with aortic stenosis when all of the following conditions are present:

• Severe aortic stenosis with a calcified aortic annulus
• New York Heart Association heart failure class II, III or IV symptoms.
• Left ventricular ejection fraction greater than 20 percent
• Patient isn’t an operable candidate for open surgery, as judged by at least two cardiovascular specialists including a cardiac surgeon.
• Patient is an operable candidate but is at high risk for open surgery (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15 percent risk of mortality at 30 days).

Edwards SAPIEN XT transcatheter heart valve:

1. Severe aortic stenosis with a calcified aortic annulus and one or more of the following:
• An aortic valve area of ≤ 1.0 cm² or aortic valve area index ≤ 0.6 cm2/m2
• A mean aortic valve gradient ≥ 40 mmHg
• A peak aortic-jet velocity ≥ 4.0 m/sec
• Native anatomy appropriate for the 23, 26, or 29 mm valve system (between 18 and 28 mm)

2. New York Heart Association heart failure Class II, III or IV symptoms
3. Patient is not a candidate for open surgery, as judged by a heart team, including a cardiac surgeon, or to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).

Medtronic CoreValve™ (Evolut) system:

1. Severe aortic stenosis with a calcified aortic annulus and one or more of the following:
• An aortic valve area of ≤ 1.0 cm² OR aortic valve area index ≤ 0.6 cm2/m2
• A mean aortic valve gradient ≥ 40 mmHg
• A peak aortic-jet velocity ≥ 4.0 m/sec
• Native aortic annulus diameters between 23 and 31 mm

2. New York Heart Association heart failure Class II, III or IV symptoms
3. Patient is judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ≥ 15% at 30 days).

Exclusions:

Transcatheter aortic valve replacement is considered experimental for all other indications, including but not limited to:

• Patients with a degenerated bio-prosthetic valve (“valve-in-valve” implantation)
• The individual is an appropriate candidate for the standard, open surgical approach but has refused.
• Hypersensitivity or contraindication to an anticoagulation/antiplatelet regimen
• Presence of active bacterial endocarditis or other active infections
• Non-FDA-approved systems

Relative contraindications:

In some cases, the benefits of transcatheter aortic valve implantation may exceed potential risks. In such instances, the cardiologist should provide an attestation indicating that a relative contraindication exists and that the patient fully understands all risks. While the items below are not absolute exclusions, the safety and effectiveness of transcatheter aortic valve implantation have not been evaluated in patients with the following characteristics or co-morbidities:

• Patients without aortic stenosis
• Untreated, clinically significant coronary artery disease requiring revascularization
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Transarterial access not able to accommodate an 18-Fr sheath
• Sinus of valsalva anatomy that would prevent adequate coronary perfusion
• End-stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min
• Symptomatic carotid or vertebral artery disease
• Safety, effectiveness and durability have not been established for valve-in-valve procedure
• Non-calcified aortic annulus
• Severe ventricular dysfunction with ejection fraction < 20 percent
• Congenital unicuspid or congenital bicuspid aortic valve
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
• Pre-existing prosthetic heart valve or prosthetic ring in any position
• Severe mitral annular calcification, severe mitral insufficiency, moderate to severe mitral or tricuspid regurgitation, or Gorlin syndrome
• Moderate to severe mitral stenosis
• Blood dyscrasias defined as: leukopenia, acute anemia (Hb < 9 g/dL), thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• Hypertrophic cardiomyopathy with or without obstruction
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Excessive calcification of vessel at access site
• Bulky calcified aortic valve leaflets in close proximity to coronary ostia
• The safety and effectiveness of the Medtronic CoreValve™ system have not been evaluated in the pediatric population.

86780, 87389, 87502, 87806, 87810, 87850

Basic benefit and medical policy

Additions to Physician Office Lab List

Procedure codes 86780, 87389, 87502, 87806, 87810 and 87850 have been added to the Physician Office Lab List and are now available in the office setting.

J9228

Basic benefit and medical policy

Payable diagnosis codes

Effective Nov. 1, 2015, J9228 had additional payable diagnosis codes of:

• C43.0 Malignant melanoma of lip
• C43.10 Malignant melanoma of unspecified eyelid, including canthus  
• C43.11 Malignant melanoma of right eyelid, including canthus
• C43.12 Malignant melanoma of left eyelid, including canthus
• C43.20 Malignant melanoma of unspecified ear and external auricular canal
• C43.21 Malignant melanoma of right ear and external auricular canal
• C43.22 Malignant melanoma of left ear and external auricular canal

81401, 81404, 81405, 81406, 81407, 81408, 81479

Basic benefit and medical policy

Genetic testing for retinal dystrophies

The peer reviewed medical literature has not demonstrated the clinical utility of genetic testing for retinal dystrophies. Therefore, this service is experimental, effective Sept. 1, 2016.

0421T

Basic benefit and medical policy

Aquablation of the prostate
Aquablation of the prostate is experimental. It has not been scientifically demonstrated to be as safe and effective as conventional treatment. This policy is effective Sept. 1, 2016.