Billing chart: Blues highlight medical, benefit policy changes

33418, 33419, 0345T

Basic benefit and medical policy

Transcatheter mitral valve repair performed with an FDA-approved transcatheter valve system, performed via an approach consistent with the device’s FDA-approved labeling, has been shown to be safe and effective. It is established for patients with severe mitral regurgitation who are considered high-risk for traditional open-heart mitral valve surgery and who meet the clinical criteria outlined in this policy. The approach used must be determined by the attending physician based on individual clinical, anatomic and prognostic factors.

The safety and efficacy of transcatheter implantable mitral valve annulus reshaping devices for the treatment of mitral valve regurgitation are under clinical trial evaluation. Therefore, this service is experimental.

This policy change is effective July 1, 2015.

Group variations
Not a covered benefit for all Fiat Chrysler Automobiles and URMBT

Inclusionary guidelines
Transcatheter mitral valve repair with an FDA-approved mitral valve repair system (i.e. Mitraclip^®) is indicated when all of the following criteria are met:

• Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR)
• Patients who have been determined to be at prohibitive risk for open mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease
• Existing comorbidities wouldn’t preclude the expected benefit from reduction of the mitral regurgitation.

Exclusionary guidelines

• Patients who can’t tolerate procedural anticoagulation or post procedural antiplatelet regimen
• Active endocarditis of the mitral valve
• Rheumatic mitral valve disease
• Evidence of intracardiac, inferior vena cava or femoral venous thrombus
• The individual is an appropriate candidate for the standard, open surgical approach but has refused
• Transcatheter mitral valve annulus reshaping devices are under clinical trials

Note: The inclusionary and exclusionary criteria are derived from FDA labeling information for the MitraClip Clip Delivery System.

81256

Basic benefit and medical policy

The safety and effectiveness of genetic testing for hereditary hemochromatosis have been established. It may be considered a useful diagnostic tool when indicated. Genetic testing should be performed in conjunction with appropriate pre- and post-test genetic counseling. The criteria have been updated, effective Jan. 1, 2016.

Group variations
Diagnostic restrictions don’t apply to FEP.
Individual consideration still applies for MPSERS and SOM.

Inclusionary guidelines
Testing for HFE mutations may be performed in the following situations:

• Patients with transferrin saturation ≥45% or ferritin above the upper limit of normal
• Screening of first degree relatives of individuals with HFE-related hereditary hemochromatosis to detect early disease and prevent complications

Exclusionary guidelines

• Screening for non-HFE related hereditary hemochromatosis
• Screening for HFE mutations in the general population

33930, 33933, 33935

Basic benefit and medical policy

Heart/lung transplant

The safety and effectiveness of heart/lung transplantation have been established. It may be considered a useful therapeutic option for carefully selected patients with end-stage cardiac and pulmonary disease. Heart/lung retransplantation after a failed primary heart/lung transplant may be considered established in patients who meet criteria for heart/lung transplantation. The criteria have been updated. This policy is effective May 1, 2016.

Inclusionary guidelines
Heart/lung transplantation may be considered appropriate for the following diagnoses:

• Irreversible primary pulmonary hypertension with heart failure
• Nonspecific severe pulmonary fibrosis, with severe heart failure
• Eisenmenger complex with irreversible pulmonary hypertension and heart failure
• Cystic fibrosis with severe heart failure
• Chronic obstructive pulmonary disease with heart failure
• Emphysema with severe heart failure
• Pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure

Heart/lung retransplantation after a failed primary heart/lung transplant may be considered established in patients who meet criteria for heart/lung transplantation.

Cardiac specific
Specific criteria for prioritizing donor thoracic organs for transplant are provided by the Organ Procurement and Transplantation Network and implemented through a contract with the United Network for Organ Sharing. Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital and pediatric status. Patients who are most severely ill (Status 1A) are given highest priority. Criteria from OPTN for listing status are as follows:

Status 1A
A patient is admitted to the listing transplant center hospital and has at least one of the following devices or therapies in place:

• Mechanical circulatory support that includes at least one of the following:
• Total artificial heart
• Intra-aortic balloon pump
• Extracorporeal membrane oxygenator
• Continuous mechanical ventilation
• Requires continuous infusion of a single high-dose intravenous inotrope or multiple intravenous inotropes, and requires continuous hemodynamic monitoring of left ventricular filling pressures.

or

A patient has one of the following two devices or therapies in place (with or without being admitted to the listing transplant center hospital):

• Mechanical circulatory support that includes at least one of the following:
• Left ventricular assist device
• Right ventricular assist device
• Left and right ventricular assist devices
• Mechanical circulatory support and there is medical evidence of significant device-related complications including thromboembolism, device infection, mechanical failure or life-threatening ventricular arrhythmias.

Status 1B
A patient has at least one of the following devices or therapies in place:

• Left ventricular assist device 
• Right ventricular assist device
• Left and right ventricular assist devices
• Continuous infusion of intravenous inotropes

Status 2
A patient that doesn’t meet Status 1A or 1B is listed as Status 2.

Pediatric patients
A candidate listed as Status 1A must meet at least one of the following criteria:

• Requires assistance with a mechanical ventilator
• Requires assistance with a mechanical assist device (e.g., ECMO)
• Requires assistance with a balloon pump
• Is younger than 6 months old with congenital or acquired heart disease exhibiting reactive pulmonary hypertension at greater than 50 percent of systemic level. Such a candidate may be treated with prostaglandin E (PGE) to maintain patency of the ductus arteriosus
• Requires infusion of a single high dose of an intravenous inotrope or multiple intravenous inotropes or multiple inotropes (e.g., addition of dopamine at ≥5.0 μg/kg/min)
• Has a life expectancy without a heart transplant of less than 14 days.

A candidate listed as Status 1B must meet at least one of the following criteria:

• Requires infusion of low-dose single inotropes
• Is younger than 6 months and doesn’t meet the criteria for Status 1A
• Is in the less than 5th percentile for the candidate’s expected height or weight according to most recent Centers for Disease Control and Prevention’s National Center for Health Statistics pediatric clinical growth chart
• Is 1.5 or more standard deviations below the candidate’s expected height growth or weight growth according to the most recent CDC National Center for Health Statistics pediatric clinical growth chart

General exclusions (contraindications):
Potential contraindications are subject to the judgment of the transplant center and include the following:

• Known current malignancy, including metastatic cancer
• Recent malignancy with high risk of recurrence
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to heart or lung disease
• History of cancer with a moderate risk of recurrence
• Stable systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

When the candidate is eligible to receive a heart in accordance with United Network for Organ Sharing guidelines for cardiac transplantation, the lung(s) shall be allocated to the heart-lung candidate from the same donor. When the candidate is eligible to receive a lung in accordance with the UNOS Lung Allocation System, the heart shall be allocated to the heart-lung candidate from the same donor if no suitable Status 1A isolated heart candidates are eligible to receive the heart. Status 1A is described earlier.

Status 7 patients are temporarily inactive on the transplant list and are considered temporarily unsuitable to receive a thoracic organ transplant.

The status is determined by the information provided by the transplant facility.

20605, 20606, 20610, 20611, J7321, J7323, J7324, J7325, J7326, J7327, J7328, Q9980

Basic benefit and medical policy
Hyaluronan intra-articular injections to the knee joint and the temporomandibular joint are considered safe and effective as a treatment for pain from osteoarthritis. They are useful therapeutic options when indicated. This policy has been updated, effective May 1, 2016.

Inclusionary guidelines
Candidates for a single course of three to five weekly injections (depending on the brand used) of intra-articular hyaluronan injections are patients with painful osteoarthritis of the knee or TMJ who have:

• Insufficient pain relief from conservative nonpharmacologic therapy (such as physical therapy) and simple analgesics, and
• Failed conservative therapy with non-steroidal anti-inflammatory drugs or who have contraindications to NSAID therapy.

Candidates for repeat treatment cycles include patients:

• For whom the initial or previous treatment cycle resulted in clinically significant improvements in functional capabilities or symptoms (e.g., pain), when compared to baseline treatment with conservative measures (e.g., rest, anti-inflammatory medications, physical therapy).
• Who had no significant complications (e.g., infection, allergic reaction) occurred during the previous treatment cycle.

Exclusionary guidelines:
Inappropriate uses of hyaluronan include:

• Injection of the substance into joints other than the knee or the temporomandibular joint
• Diagnoses other than osteoarthritis of the knee joint or TMJ, including chondromalacia

Payable:
S0157 

Not covered (considered experimental):

Basic benefit and medical policy

The safety and effectiveness of recombinant platelet-derived growth factor have been established as useful therapeutic options when indicated.

The use of autologous platelet derived growth factors or autologous platelet gel hasn’t been established. There’s insufficient evidence to draw definitive conclusions regarding the clinical efficacy of autologous platelet concentrate or gel; therefore, it’s considered experimental.

The exclusionary guidelines have been updated, effective May 1, 2016.

Inclusionary guidelines
Recombinant preparations when used as an adjunct to standard wound management for the following indications:

• When used according to the U.S. Food and Drug Administration-labeled indication, (e.g., neuropathic diabetic ulcers extending into the subcutaneous tissue)
• As a treatment of pressure ulcers extending into the subcutaneous tissue

Exclusionary guidelines
Recombinant preparations used for:

• Ischemic ulcers
• Ulcers related to venous stasis
• Ulcers not extending through the dermis into the subcutaneous tissue

Autologous blood-derived preparations (e.g., Aurix™ [previously Autologel™] and SafeBlood^®) used for:

• Acute or chronic non-healing wounds, including surgical wounds and nonhealing ulcers

Established:
J0470, J0600, J0895 and
J3520

Billed with:
96364, 96366, 96374 and
S9355

Experimental:
M0300

Basic benefit and medical policy

Chelation therapy, including off-label uses

The safety and effectiveness of chelation therapy for specified conditions have been established. It is a useful therapeutic option for patients meeting patient selection guidelines. The criteria have been updated. This policy is effective May 1, 2016.

Inclusionary guidelines (must have one of the following diagnoses):

• Aluminum overload in people with end-stage renal failure
• Biliary cirrhosis
• Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) and due to non-transfusion-dependent thalassemia
• Control of ventricular arrhythmias or heart block associated with digitalis toxicity***
• Cooley’s anemia (thalassemia major)
• Cystinuria
• Emergency treatment of hypercalcemia***
• Extreme conditions of metal toxicity (heavy metal poisoning). Note: heavy metals include antimony, arsenic, bismuth, cadmium, cerium, chromium, cobalt, copper, gallium, gold, iron, lead, manganese, mercury, nickel, platinum, silver, tellurium, thallium, tin, uranium, vanadium and zinc. Toxic levels should be confirmed with blood levels where appropriate.
• Hemochromatosis: Clinical symptoms of chronic iron toxicity should correlate with an elevated serum ferritin. Parenteral chelation therapy isn’t medically necessary in genetic or hereditary hemochromatosis. Subcutaneous infusion of deferoxamine via a portable pump may be considered medically necessary for acquired hemochromatosis complicating a chronic hemolytic anemia such as thalassemia or sideroblastic anemia or when hypoproteinemia precludes phlebotomy as treatment.
• Hemochromatosis
• Lead poisoning
• Sickle cell anemia
• Wilson disease (hepatolenticular degeneration)

***Most patients with this diagnosi should be treated with other modalities. Digitalis toxicity is currently treated in most patients with Fab monoclonal antibodies. The FDA removed the approval for NaEDTA as chelation therapy, due to safety concerns, and recommended that other chelators be used. This was the most common chelation agent used to treat digitalis toxicity and hypercalcemia.

Exclusionary guidelines
Off-label applications of chelation therapy are considered experimental, including:

• Alzheimer disease
• Arthritis (includes rheumatoid arthritis)
• Atherosclerosis (e.g., coronary artery disease, secondary prevention in patients with myocardial infarction or peripheral vascular disease)
• Autism
• Cadmium exposure
• Chronic fatigue syndrome secondary to dental amalgam therapy
• Diabetes
• Multiple sclerosis
• Parkinson’s disease
• Rheumatoid arthritis
• All other conditions not mentioned in inclusionary guidelines

37215, 37216, 37217, 37218

Basic benefit and medical policy

Extracranial carotid angioplasty/stenting

The criteria are updated for extracranial carotid angioplasty/stenting policy. Carotid angioplasty with stenting and embolic protection has been established. It may be considered a safe and effective treatment in specified situations.

This policy is effective May 1, 2016.

Inclusionary guidelines
Carotid angioplasty with associated stenting and embolic protection in patients with:

• Fifty to 99 percent stenosis (North American Symptomatic Carotid Endarterectomy Trial measurement)
• Symptoms of focal cerebral ischemia (transient ischemic attack or monocular blindness) in previous 120 days, symptom duration less than 24 hours or nondisabling stroke
• Anatomic contraindication for carotid endarterectomy, such as prior radiation treatment or neck surgery, lesions surgically inaccessible, spinal immobility or tracheostomy

Exclusionary guidelines
Carotid angioplasty with or without associated stenting and embolic protection for all other indications, including, patients with carotid stenosis who are suitable candidates for CEA and patients with carotid artery dissection.

Revenue code 0657

Evaluation and management codes:

Payment policy

Additional evaluation and management codes are now payable when reported with revenue code 0657 for hospice physician services, effective Jan. 1, 2015.

81403

Basic benefit and medical policy

Fetal RHD genotyping using maternal plasma is experimental. It hasn’t been scientifically demonstrated to improve patient clinical outcomes. This policy is effective May 1, 2016.

81225, 81226, 81227
81291, 81401

Basic benefit and medical policy

Genetic testing for pharmacogenetic testing for pain management

Genetic testing for pain management is considered experimental for all indications. It hasn’t been scientifically demonstrated to improve patient clinical outcomes

This policy is effective May 1, 2016.