Billing chart: Blues highlight medical, benefit policy changes

J3490, J3590

Basic benefit and medical policy

Luxturna will require prior authorization.

Luxturna™ (voretigene neparvovec-rzyl) is approved and will require prior authorization.

Luxturna (voretigene neparvovec-rzyl) is considered established when criteria are met, effective Feb. 1, 2018.

1. Coverage of the requested drug is provided when all the below criteria are met:
1. Prescribed for an FDA-approved indication
2. Prescribed and administered by an ophthalmologist
3. Documentation of biallelic RPE65 gene mutation
4. Visual acuity of 20/60 or worse in both eyes or a binocular visual field less than 20 degrees in any meridian
5. Retinal thickness of >100 microns within the posterior pole
   
   
2. Quantity limitations, authorization period and renewal criteria
1. Quantity limit: Maximum one injection per eye, lifetime
2. Initial authorization period: One month
3. Renewal criteria: None. One lifetime injection per eye
   
   
3. Voretigene neparvovec-rzyl is considered investigational when used for all other conditions including, but not limited to:
1. Other types of Leber congenital amaurosis (e.g., Type 3, Type 15)
2. Other inherited retinal disorders
   
   
4. FDA-approved indication and diagnosis for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. 

Patient must have viable retinal cells as determined by the treating physician.

Note: Requests must be supported by submission of chart notes and patient specific documentation.

Verify group coverage for Luxturna.

81401, 81405, 81408, 81410, 81411, 81479**

**Unlisted procedure used for individual mutation testing of genes not coded by CPT*

Basic benefit and medical policy

Genetic testing for Marfan and other syndromes associated with thoracic aortic aneurysms

The safety and effectiveness of genetic testing for Marfan syndrome and other syndromes associated with thoracic aortic aneurysms and dissections, and related disorders have been established. It may be considered a useful diagnostic option when indicated. Inclusionary and exclusionary criteria have been updated, effective May 1, 2018.

Inclusions:

Individual genetic testing for the diagnosis of Marfan syndrome and other syndromes associated with thoracic aortic aneurysms and dissections, and related disorders when one of the following occurs:

• Focused genetic testing of the following genes: FBN1, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, MYLK, TGFBR1 and TGFBR2
• A panel of at least nine genes that must include FBN1, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, MYLK, TGFBR1 and TGFBR2 when one of the following occurs:
• Signs and symptoms of a connective tissue disorder are present, but a definitive diagnosis can’t be made using established clinical diagnostic criteria (e.g., Ghent criteria).
• Assessing future risk of disease in an asymptomatic individual when there is a known pathogenic variant in the family.

Exclusions:

• Genetic testing panels for Marfan syndrome and other syndromes associated with thoracic aortic aneurysms and dissections, and related disorders that don’t include genes listed under inclusions
• For the prenatal or pre-implantation genetic diagnosis of Marfan syndrome in the offspring of patients with known disease-causing variants

19303, 19304, 19318, 19350, 54520, 55970, 55980, 56805, 57291, 57292, 57335, 58150, 58152, 58180, 58260, 58262, 58275, 58291, 58541, 58542, 58543, 58544, 58550, 58552, 58553, 58554

Not covered:

Basic benefit and medical policy

Transgender services

The safety and effectiveness of select medical and surgical treatments of gender dysphoria have been established. The established treatments of gender dysphoria include:

• Puberty suppression in adolescents
• Cross-sexual hormone therapy (for masculinization or feminization)
• Medically necessary gender reassignment surgery:**
• Genitalia reconstruction
• Mastectomy in female-to-male transitions

**Gender reassignment surgery may require prior authorization.

Gender-specific services may be medically necessary for transgender people appropriate to their anatomy. Examples include:

• Breast cancer screening may be medically necessary for female-to-male transitioned people who haven’t undergone a mastectomy.
• Prostate cancer screening may be medically necessary for male-to-female transitioned people who have retained their prostate.
• Cervical screening may be medically necessary for female-to-male transitioned people, as needed.

The policy has been reviewed and updated, effective May 1, 2018.

Group variations:

Verify member benefits to determine eligibility.

Inclusions:

Assessment, diagnosis and treatment should be provided through a multidisciplinary gender services clinic or program affiliated with a major medical center. If this level of service is unavailable, there should be documentation that reflects a coordinated approach to care by specialists involved (mental health specialists, physicians, surgeons, etc.).

Puberty suppression**

Puberty suppression hormones for adolescents may be indicated for members who meet all the following inclusionary criteria:

• Onset of puberty to at least Tanner stage 2.
• The adolescent has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed).
• Gender dysphoria emerged or worsened with the onset of puberty.
• Any coexisting psychological, medical or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment.
• The adolescent has given informed consent and, particularly when the adolescent hasn’t reached the age of medical consent, the parents or other caretakers or guardians (must have legal authority to consent on behalf of a non-emancipated minor) have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.
• The absence of contraindications to therapy in the judgment of the managing physician.

**Medications for puberty suppression may be managed under the member’s pharmacy benefit.

Hormone therapy**

Hormone therapy may be indicated for members who meet all the following inclusionary criteria:

• Persistent, well-documented gender dysphoria.
• Capacity to make a fully informed decision and to consent for treatments.
• Eighteen years of age or older (age of majority).
• If significant medical or mental health concerns are present, they must be reasonably well-controlled.
• The absence of contraindications to therapy in the judgment of the managing physician.

**Medications for hormone therapy may be managed under the member’s pharmacy benefit.

Gender reassignment surgery

Gender reassignment surgery may be indicated for members who meet all the following inclusionary criteria:

• Persistent, well-documented gender dysphoria.
• The provider must supply documentation that supports the member meets criteria for gender reassignment surgery.
• This includes detailed psychological assessments by two mental health providers: either psychiatrist, PhD prepared clinical psychologist or master’s prepared clinicians who are licensed to practice independently in their state.
• Eighteen years of age or older.
• Capacity to make a fully informed decision and to consent for treatment.
• If significant medical or mental health concerns are present, they must be controlled.
• Twelve continuous months of hormone therapy** as appropriate to the patient’s gender role (unless there is a contraindication to hormonal therapy).
• **Hormonal therapy is not required prior to mastectomy in biological female-to-male patients.
• The aim of hormone therapy prior to gonadectomy is primarily to introduce a period of reversible estrogen or testosterone suppression, before the patient undergoes irreversible surgical intervention.
• Twelve continuous months of living in a gender role that is congruent with their gender identity.
• **Living in a gender role congruent with gender identity for 12 continuous months is not required prior to mastectomy in biological female-to-male patients.
• If gender reassignment surgery is approved for a biological male transitioning to female, permanent hair removal (by electrolysis) may be considered established following medical review. Permanent hair removal is considered established only when the scrotal and surrounding tissues are used in the surgical construction of the vagina.

Some patients receiving transgender services may require and benefit from ongoing behavioral health services, including psychotherapy.

Exclusions:

• Transgender services aren’t covered if contract or certificate language contains specific exclusion of these services.
• Reversal of transgender surgical procedures.
• All surgical procedures that are primarily cosmetic and not medically necessary including, but not limited to:
• Abdominoplasty
• Blepharoplasty
• Breast enhancements
• Brow lift
• Calf implants
• Cheek/malar implants
• Chin/nose implants
• Chondrolaryngoplasty (Adam’s apple reduction)
• Collagen injections
• Construction of a clitoral hood
• Drugs for hair loss or growth
• Forehead lift
• Hair removal
• Hair transplantation
• Lip reduction
• Liposuction
• Mastopexy
• Neck tightening
• Pectoral implants
• Removal of redundant skin
• Rhinoplasty
• Speech-language therapy
• Non-covered services

81210, 81275, 81276, 81311, 81403, 81404, 88363

Basic benefit and medical policy

Genetic testing for KRAS, NRAS and BRAF mutation analysis in metastatic colorectal cancer

The safety and effectiveness of KRAS, NRAS and BRAF mutation analyses have been established and may be considered a useful diagnostic option to predict nonresponse to anti-EGFR monoclonal antibodies cetuximab and panitumumab in the treatment of all patients with metastatic colorectal cancer. It’s a useful therapeutic option when indicated.

Inclusions:

KRAS, NRAS and BRAF mutation analysis in patients with metastatic colorectal cancer in order to determine their nonresponse to EGFR inhibitor drugs such as Vectibix^® (panitumumab) and Erbitux^® (cetuximab).

The effective date is May 21, 2018.

84999**

**Not otherwise classified procedure

Basic benefit and medical policy

Measurement of antibodies to infliximab, adalimumab or vedolizumab

Measurement of antibodies to infliximab, adalimumab, or vedolizumab in a patients receiving treatment with infliximab, adalimumab or vedolizumab, whether alone or as a combination test that includes the measurement of serum infliximab, adalimumab or vedolizumab levels, is considered experimental. The use of these tests hasn’t been clinically proven to improve patient clinical outcomes or alter patient management. The updated policy is effective May 1, 2018.

J7178

Basic benefit and medical policy

Congenital fibrinogen deficiency

Payable for FDA-approved indication of congenital fibrinogen deficiency, effective June 7, 2017.

0485T, 0486T

Basic benefit and medical policy

Optical coherence tomography of the middle ear (e.g., Photonicare Clearview^® System)

Optical Coherence Tomography, or OCT, of the middle ear isn’t an established procedure. While this service may be safe, its effectiveness in this clinical indication hasn’t been scientifically determined. Therefore, this service is experimental. This policy is effective May 1, 2018.

81328

Basic benefit and medical policy

Genetic testing for statin-induced myopathy

The peer-reviewed medical literature hasn’t demonstrated the clinical utility of genetic testing for the presence of variants in the SLCO1B1 gene to identify patients at risk of statin-induced myopathy. Therefore, this service is considered experimental. This policy is effective May 1, 2018