Blues highlight medical, benefit policy changes

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Medical Policy

Extracorporeal Membrane Oxygenation
The safety and effectiveness of extracorporeal membrane oxygenation have been established for the management of adults with acute respiratory, cardiac or combined cardiorespiratory failure refractory to optimal conventional therapy, or as a bridge to heart, lung, or combined heart-lung transplantation. It may be considered a useful therapeutic option when indicated.

The safety and effectiveness of extracorporeal membrane oxygenation in neonatal and pediatric patients have been established when conventional therapies have failed to support the function of the heart and lungs adequately and when risk of mortality is high and imminent. It may be considered a useful therapeutic option when indicated.  This policy is effective May 1, 2015.

Inclusions:
The use of extracorporeal membrane oxygenation  is established for the management of adults with acute respiratory failure when all of the following criteria are met:

• Respiratory failure is due to a potentially reversible etiology
• Respiratory failure is considered severe as determined by one of the following:
• A standardized severity instrument such as the Murray score (see Respiratory Failure Severity section)
• One of the criteria for respiratory failure severity outlined in the policy.

The use of extracorporeal membrane oxygenation in adults is established as a bridge to heart, lung, or combined heart-lung transplantation for the management of adults with respiratory, cardiac, or combined cardiorespiratory failure refractory to optimal conventional therapy.

The use of extracorporeal membrane oxygenation in the neonatal and pediatric populations is established when conventional therapies have failed to support the function of the heart and lungs adequately and when risk of mortality is high and imminent.

Exclusions:

• The presence of an irreversible cause of a critical illness
• Increased risk of bleeding; (neonatologist may determine medical necessity in pediatric cases)
• High ventilator pressure (peak inspiratory pressure >30 cm H2O) or high FIO2 (>80%) ventilation for more than 7-10 days; (neonatologist may determine medical necessity in pediatric cases)
• Signs of intracranial bleeding; (neonatologist may determine medical necessity in pediatric cases)
• Multisystem organ failure
• Prior (i.e., before onset of need for extracorporeal membrane oxygenation) diagnosis of a terminal condition with expected survival < 6 months;
• A do-not-resuscitate directive
• Cardiac decompensation in a patient already declined for ventricular assist device  or transplant
• Known neurologic devastation without potential to recover meaningful function
• Determination of care futility (see “Assessment of ECMO Futility” section).

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Medical Policy

The quadrivalent Fluzone^® Influenza Virus Vaccine is established for use in individuals 6 months of age and older.

This policy is effective 9/20/13.

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Medical Policy

Transcatheter Aortic Valve Implantation for Aortic Stenosis

Transcatheter aortic valve replacement performed withan FDA-approved transcatheter heart 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 aortic stenosis 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.  This policy is effective May 1, 2015.

Inclusions:
Transcatheter aortic valve replacement with a device approved by the U.S. Food and Drug Administration  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:

Edwards SAPIEN XT Transcatheter Heart Valve:

• 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 27 mm)
• New York Heart Association heart failure Class II, III or IV symptoms
• 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™ system:

• Severe aortic stenosis with a calcified aortic annulus and one or more of the following:
• An aortic valve area of ≤ 0.8 cm²
• A mean aortic valve gradient > 40 mmHg
• A peak aortic-jet velocity > 4.0 m/sec
• Native aortic annulus diameters between 18 and 29 mm
• New York Heart Association heart failure Class II, III or IV symptoms
• 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 ≥ 50% at 30 days).

Exclusions:

• 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

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(s) 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 comorbidities:

• 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 procedures.
• Non-calcified aortic annulus
• Severe ventricular dysfunction with ejection fraction < 20%
• 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 (MAC), 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.

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Medical Policy

Genetic Testing for Hereditary Hearing Loss  

The safety and effectiveness of genetic testing for hereditary hearing loss mutations (GJB2, GJB6 and other hereditary hearing loss-related mutations) have been established. It may be considered a useful diagnostic option in specified situations. This policy is effective May 1, 2015.

Inclusions

• Genetic testing for hereditary hearing loss mutations (GJB2, GJB6 and other hereditary hearing loss-related mutations) in individuals with hearing loss to confirm the diagnosis of hereditary hearing loss.
• Preconception genetic testing (carrier testing) for hereditary hearing loss mutations (GJB2, GJB6 and other hereditary hearing loss-related mutations) in parents when at least one of the following conditions has been met:
• Offspring with hereditary hearing loss
• One or both parents with suspected hereditary hearing loss
• First- or second-degree relative affected with hereditary hearing loss
• First-degree relative with offspring who is affected with hereditary hearing loss.

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Medical Policy

Heart/Lung Transplant

Medical Policy reviewed the Heart/Lung Transplant policy and updated the Inclusionary/Exclusionary guidelines. This policy is effective May 1, 2015.

Inclusions:

1. I.  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
2. Cardiac specific:
The United Network for Organ Sharing  prioritizes donor thoracic organs according to the severity of illness as follows:

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

1. Mechanical circulatory support for acute hemodynamic decompensation that includes at least 1 of the following:
1. Left and/or right ventricular assist device implanted
2. Total artificial heart
3. Intra-aortic balloon pump, or
4. Extracorporeal membrane oxygenator
2. Mechanical circulatory support
3. Mechanical ventilation
4. Continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures
5. If criteria A, B, C and D are not met, such status can be obtained by application to the applicable Regional Review Board

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

1. left and/or right ventricular device implanted, or
2. continuous infusion of intravenous inotropes

A patient that does not meet Status 1A or 1B is listed as Status 2.

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.

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

1. Known current malignancy, including metastatic cancer
2. Recent malignancy with high risk of recurrence
3. Untreated systemic infection making immunosuppression unsafe, including chronic infection
4. Other irreversible end-stage disease not attributed to heart or lung disease
5. History of cancer with a moderate risk of recurrence
6. Stable systemic disease that could be exacerbated by immunosuppression
7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
8. 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 (LAS), 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.

Medical Policy

Procalcitonin Testing

The safety and effectiveness of procalcitonin testing for detection and monitoring of bacterial infections and sepsis in specified patient populations have been established.  Procalcitonin testing is a useful diagnostic option for patients meeting selection criteria in the inpatient and/or outpatient setting when used as part of the physician’s total treatment armamentarium. This policy was effective July 1, 2014.

Inclusions:
For use in the inpatient and/or outpatient (emergency department, observation care, etc.) setting for the following conditions:

• Initiating and/or discontinuing antibiotic therapy or 
• Routine use in hospitalized patients with known respiratory tract infections in order to reduce antibiotic prescription rates and duration of use. 

Exclusions:
The use of procalcitonin testing is experimental for the following indications because of insufficient evidence of its effectiveness. (Note: This is not an all-inclusive list.)  These indications include the diagnoses of:

• Surgical infections (including monitoring of the infection
• Appendicitis
• Chronic renal insufficiency
• Infective endocarditis
• Non-alcoholic fatty liver disease
• Parapneumonic pleural effusions
• Spontaneous bacterial peritonitis

It is also considered experimental for:

• Measuring the differentiation of infection from other inflammatory complications following stem cell transplantation
• The evaluation of fever of uncertain source in infants
• Predicting outcomes in persons with acute coronary syndrome.
• Prediction of neurological deficits following carotid endarterectomy

Group Variations:
This policy excludes GM, Delphi and URMBT.

Medical Policy

Locum Tenens  
The Blue Cross Blue Shield of Michigan Locum Tenens policy has been reviewed and the Medical Policy Statement has been updated. This policy is effective Jan. 1, 2015.

Medical Policy Statement:

• Blue Cross will allow services provided by locum tenens physicians to be billed under the PIN of the regular physician for up to 60 continuous days.
• If a locum tenens physician is treating Blue Cross PPO members for longer than 60 continuous days he or she must register with BCBSM and bill under his or her own PIN. If the locum tenens physician is treating PPO patients for longer than 60 continuous days, he or she must be credentialed in the TRUST network or out of network sanctions will be applied to claims.  Physicians who anticipate providing locum tenens services on a regular basis involving multiple practices (>2) within a 12-month period should be credentialed in the TRUST network.
• Each covered clinical service (procedure code) delivered by the locum tenens physician under the regular physician’s PIN must be appended with modifier Q6 (Service furnished by a locum tenens physician).
• Locum tenens physicians must be licensed in the state in which the service are delivered and must only provide services within their scope of practice.
• The regular physician will pay the locum tenens physician a per diem or agreed amount and the locum tenens physician will not bill BCBSM for the services independently.
• When a physician leaves a group, the locum tenens physician’s services may be billed using either the replaced physician’s PIN or the Group PIN for up to 60 days.
• This policy applies to the following provider classes only:  M.D., D.O. and D.P.M.

Additional comments:

• This policy applies when the regular physician is not available.  The locum tenens physician is not a physician extender and therefore should see patients in place of, not along with, the regular physician.

• Documentation addressing contractual arrangements, licensure and malpractice insurance should be maintained and available if requested.
• A record of all clinical services provided by the locum tenens physician must be maintained and available if requested.

Cone Drive Operations

Effective May 1, 2015, Medicare-eligible retirees of the Cone Drive Operations will have Blue Cross Blue Shield of Michigan’s Medicare Advantage PPO plan, Medicare Plus Blue^SM Group PPO for their medical, surgical and prescription drug benefits. The group number is 60840 with suffixes 600 and 601. Suffix 602 will terminate as of May 1, 2015.  You can identify members by the XYL prefix on their ID cards, like those of other Medicare Plus Blue Group PPO plans.

For information about our Medicare Advantage PPO plan, go to bcbsm.com/provider/ma.

Visteon , group number 73200

Effective June 1, 2015, Visteon is starting a Diabetes Management Program.
The program lowers out-of-pocket expenses for active salaried members with  certain diabetic conditions (only active salaried members in group number 73200):

• After the deductible is met, the Blue Cross system will automatically waive coinsurance for services, supplies, and equipment when billed with a general diabetes diagnosis code.  Coinsurance will be waived when   rendered both in-network or out-of-network by participating providers after the deductible is met.
• Specific diabetic drugs are covered 100 percent of the allowed amount, with no deductible and no coinsurance.

Members do not enroll in the program or comply with any guidelines. They automatically receive the benefit for certain services, supplies and equipment when a member’s primary diagnosis is diabetes.