Blues highlight medical, benefit policy changes

96900, 96910, 96912, 96913, 96999

Basic Benefit and Medical Policy
The Light Therapy for Vitiligo Policy is established. This policy is effective Nov. 1, 2014.

Medical Policy Statement
Psoralen plus ultraviolet A, narrowband ultraviolet B  and targeted phototherapy with excimer laser, with or without the use of oral or topical medications for the treatment of vitiligo, are considered established treatments. They may be useful therapeutic options when indicated.

Inclusionary Guidelines

• Vitiligo that is not responsive to other forms of conservative therapy (e.g., topical corticosteroids and coal or tar preparations).
• NB-UVB and excimer laser phototherapy in individuals ≥ 3 years of age.
• Topical PUVA can be performed in children ≥ 2 years of age when up to 20 percent of their body surface area.
• Systemic PUVA or oral PUVA is restricted to children > 12 years who have widespread vitiligo ( ≥ 20 percent body surface area).
• Treatment of vitiligo is restricted to the face, neck, trunk and extremities.

Exclusionary Guidelines

• Systemic PUVA or oral PUVA is contraindicated in children < 12 years of age.
• Treatment of vitiligo of the acral areas (fingers, palms, soles of feet)

0051T-0053T, 33975-33983, 33990-33993

Basic Benefit and Medical Policy
Total artificial hearts and implantable ventricular assist devices.

The safety and effectiveness of implantable ventricular assist devices and total artificial hearts have been established. They are useful therapeutic options for patients meeting specified selection criteria.

The safety and effectiveness of the use of a percutaneous ventricular assist device have been established for a subset of patients. They are useful therapeutic options for patients meeting specified selection criteria.

All other uses for pVADs are considered experimental. The evidence on the use of pVADs does not support the conclusion that these devices improve health outcomes for any other situations.

Criteria has been updated, effective Nov. 1, 2014.

Implantable ventricular assist devices must have FDA approval or clearance

Inclusionary Guidelines
For post-cardiotomy setting and bridge to recovery

• For patients in the post-cardiotomy setting who are unable to be weaned off cardiopulmonary bypass.

For use as a bridge to transplantation

• Implantable ventricular assist devices with FDA approval or clearance when used as a bridge to heart transplantation patients who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation
• Implantable ventricular assist devices with FDA approval or clearance, including HDEs, in children 16 years of age or younger who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation.

For use of implantable ventricular assist devices with FDA approval or clearance as destination therapy

• For patients with end-stage heart failure who are ineligible for human heart transplant and who meet the following “REMATCH Study” criteria:
• New York Heart Association (NYHA) Class IV heart failure for >60 days, or
• NYHA Class III/IV heart failure for 28 days, received with over 14 days’ support with intra-aortic balloon pump or dependent on IV inotropic agents, with two failed weaning attempts

In addition, patients must not be candidates for human heart transplant for one or more of the following reasons:

• Age over 65 years
• Insulin-dependent diabetes mellitus with end-organ damage
• Chronic renal failure (serum creatinine >2.5 mg/dL for >90 days)
• Presence of other clinically significant condition

Exclusionary Guidelines

• Patients not meeting the above patient selection guidelines.
• The use of non-FDA approved or cleared ventricular assist devices. For patients under age 16, HDE approval is acceptable
• Percutaneous ventricular assist device must be FDA-approved

Inclusionary Guidelines

• For providing short term circulatory support for patients with severe cardiogenic shock who are unstable to the point where IABP support would not be tolerated or effective.
• As an adjunct to percutaneous coronary intervention in the following high-risk patients:
• Patients with a cardiac ejection fraction of less than 35 percent who are undergoing unprotected left main or last-remaining-conduit PCI.
• Patients with three-vessel disease and ejection fraction less than 30 percent.

The Impella^® 2.5 Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass.

Exclusionary Guidelines

• The use of a pVAD for any other indication not listed above.
• Total artificial hearts (must have FDA approval or clearance)
• Bridge to transplantation only

Inclusionary Guidelines
When used as a bridge to heart transplantation for patients with biventricular failure who have no other reasonable medical or surgical treatment options and

• Who are ineligible for other univentricular or biventricular support devices and
• Who are currently listed as heart transplantation candidates or undergoing evaluation to determine candidacy for heart transplantation and not expected to survive until a donor heart can be obtained

Exclusionary Guidelines

• Patients not meeting the above patient selection guidelines
• The use of non-FDA approved or cleared implantable ventricular assist devices or total artificial hearts
• The use of total artificial hearts as destination therapy

A9520

Basic Benefit and Medical Policy
Effective June 13, 2014, the FDA-approved LYMPHOSEEK™ (Technetium tc-99m, tilmanocept) will be recognized under NDC 52579-1695-01 when billed with procedure code A9520 along with 78195 as indicated for:

• Lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.
• Guiding sentinel lymph node biopsy, using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.

38242

Basic Benefit and Medical Policy
The inclusionary and exclusionary guidelines for the Donor Lymphocyte Infusion for Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant Policy were updated. This policy is effective Nov. 1, 2014.

Inclusionary Guidelines
Donor lymphocyte infusion may be considered established following allogeneic-hematopoietic stem cell transplantation that was originally considered medically necessary for the following indications:

• Treatment of a hematologic malignancy that has relapsed or is refractory to treatment
• Prevention of relapse in the setting of a high risk of relapse**
• To convert a patient from mixed to full donor chimerism.

**Settings considered high risk for relapse include T cell depleted grafts or nonmyeloablative (reduced-intensity conditioning) allogeneic HSCT.

Exclusionary Guidelines

• Donor lymphocyte infusion following allogeneic hematopoietic stem-cell transplantation that was originally considered experimental for the treatment of a hematologic malignancy.
• Donor lymphocyte infusion as a treatment of nonhematologic malignancies following a prior allogeneic HSCT.
• Genetic modification of donor lymphocytes.

61885, 61886, 64553, 64568-64570, 95970, 95974, 95975

Basic Benefit and Medical Policy
The safety and effectiveness of vagus nerve stimulation has been established. It may be considered a useful therapeutic or diagnostic option when indicated.

Non implanted and transcutaneous vagal nerve stimulators are considered experimental. Their positive impact on clinical outcomes has not been definitively demonstrated.

Exclusionary criteria have been updated, effective Nov. 1, 2014.

Inclusionary Guidelines

• Partial-onset seizures that are refractory to conventional and newer anticonvulsant drugs
• A history of at least four to six identifiable partial onset seizures each month
• A diagnosis of intractable epilepsy for at least two years
• Patients with epilepsy who experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs
• Patients with partial-onset seizures who are ineligible for epilepsy surgery or who have a history of previous epilepsy surgery that was unsuccessful in controlling the seizures
• Patients with mental retardation or psychosis may be candidates for VNS if it is possible to measure the benefit to the recipient in spite of their comorbid condition

Exclusionary Guidelines

• Other types of epilepsy in patients with seizures other than partial-onset seizures
• Patients with partial-onset seizures who are candidates for epilepsy surgery
• A progressive seizure disorder
• Non implantable and transcutaneous vagus nerve stimulation devices
• Other disorders not listed in the inclusions, including, but not limited to:
• Heart failure
• Fibromyalgia
• Depression
• Essential tremor
• Obesity
• Headaches
• Tinnitus
• Traumatic brain injury

92065, 99199**

Basic Benefit and Medical Policy
The safety and effectiveness of orthoptic training and vision therapy for specific medical conditions have been established. It may be considered a useful therapeutic option for the treatment of any of the following:

• Amblyopia for which occlusion therapy is administered
• Acquired esotropia that involves the use of prism adaptation prior to corrective surgery
• Strabismus, intermittent exotropia, convergence insufficiency and accommodative deficiencies (such as accommodative insufficiency and infacility), which also involves the use of orthoptics or prisms

Orthoptic training (including “optometric vision therapy”) for the treatment of learning disabilities, dyslexia, mild traumatic brain injury and other conditions not listed above is considered experimental. It has not been scientifically demonstrated to improve patient clinical outcomes.

The policy has been updated, effective Nov. 1, 2014.

Payment Policy
**Use procedure code *99199 to report “vision therapy” (i.e., behavioral optometry or optometric vision therapy)

Inclusionary Guidelines
Office-based vergence or accommodative therapy may is considered established for patients whose symptoms of convergence insufficiency have failed to improved following a minimum of 12 weeks of home-based therapy, including, but not limited to:

• Push-up exercises (pencil push-ups) using an accommodative target
• Push-up exercises (pencil push-ups) with additional base-out prisms
• Jump to near convergence exercises; stereogram convergence exercises;
• Recession from a target, and
• Maintaining convergence for 30-40 seconds

Conditions treated by pleoptic therapy include:

• Accommodative dysfunction disorders (focusing problems)
• Acquired esotropia (the turning inward of the eye) that involves the use of prism lenses prior to corrective surgery
• Amblyopia (lazy eye) for which eye-patching therapy is being used
• Amblyopia (poorly developed vision in one or both eyes)
• Convergence insufficiency
• Intermittent exotropia
• Non-strabismus binocular dysfunction disorders (inefficient eye teaming)
• Nystagmus (rapid, involuntary eye movement)
• Strabismus (misalignment of the eyes)

Documentation should include the following:

• The initial evaluation must include measurable data supporting the diagnosis in order to establish a baseline against which follow-up evaluations can be measured.
• There should be a written treatment plan that includes the projected period of treatment.
• There should be reasonable expectation that vision therapy will produce improvement that can be measured in a reasonable period of time. If there is no improvement after the first two months of therapy, the need for further therapy should be questioned.
• There should be monthly re-evaluations with documentation of percentage of improvement from the start of therapy.
• There should be written documentation of any changes in the patient’s treatment plan. All progress should be documented.
• Vision therapy includes both office visits and a home treatment program. There should be documentation of the patient’s compliance or noncompliance.
• Because all patients are different, each vision therapy program may differ in the number of visits per week and the total number of visits. Vision therapy programs may require from 24 to 32 visits over the course of a few months, with follow up instructions for continuing the program in the home. Vision therapy is performed in an optometrist or ophthalmologist’s office once or twice a week for a number of months with instructions for a follow-up program to continue at home.

Exclusionary Guidelines

• Any other conditions not listed under the inclusions listed above, including but not limited to learning disabilities, dyslexia and mild traumatic head injury.
• Orthoptic training (including “optometric vision therapy”) for the treatment of learning disabilities, dyslexia, mild traumatic brain injury and other conditions not listed above

Established procedures
A4222, A4230, A4231, A4232, A9274, E0784, J1817, K0552, K0601-K0605

Experimental procedures
99091, E1399, S9145

Basic Benefit and Medical Policy
The safety and effectiveness of external insulin pumps have been established for patients meeting specific patient selection criteria. They are useful therapeutic options when indicated.

Procedure codes 99091, E1399 and S9145 are considered experimental for the Continuous Subcutaneous Insulin Infusion and Transdormal Insulin Delivery Systems Policy.

Transdermal insulin delivery systems (e.g., V-Go Transdermal Basal-Bolus Insulin Delivery Device) are considered experimental. There is insufficient evidence in medical literature to determine if the use of these devices result in improved patient clinical outcomes. This policy is effective Nov. 1, 2014.

Inclusionary Guidelines
External infusion pumps and related drugs and supplies are established in the home setting for the treatment of diabetes in the following situations, if determined to be medically necessary and prescribed by an allopathic or osteopathic physician.

Patients must meet all the following criteria:

• The patient must complete a comprehensive diabetes education program.
• The patient has been on a regime of at least three injections daily with frequent self-adjustments for at least six months prior to the initiation of the pump.
• The patient has documented the frequency of glucose self-testing on average at least four times per day during the two months prior to initiation of the insulin pump.
• The patient also meets one of the following criteria on a multiple daily injection regimen:
• Glycosylated hemoglobin level (HbA1c) > 7.0 percent
• History of recurring hypoglycemia
• Wide fluctuations in blood glucose before mealtime
• “Dawn” phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
• History of severe glycemic excursions

For gestational diabetics, only the following criteria must be met to qualify for insulin pump therapy:

• Insulin injections are required greater than or equal to three times per day and
• The patient cannot be controlled by the use of intermittent dosing.

Exclusionary Guidelines

• Patients with major psychiatric disorders such as psychosis and severe depression
• Patients with eating disorders
• Young children who cannot tolerate the cannula or refrain from changing pump settings
• Patients who fail to comply with treatment regimen
• Patients who, in the judgment of the diabetic specialist, are non-responsive to a trial of insulin pump therapy
• Transdermal insulin delivery devices (e.g., V-Go)

Basic Benefit and Medical Policy
Negative oral pressure therapy for the treatment of obstructive sleep apnea is considered experimental, effective Nov. 1, 2014. There is insufficient scientific evidence in the current medical literature to support its efficacy and use in clinical practice.

**Procedure codes A7002 and E0600 may be payable when used to report another service.