Billing chart: Blues highlight medical, benefit policy changes

J3590

Basic benefit and medical policy

Kanjinti (trastuzumab-anns)

Effective June 13, 2019, Kanjinti (trastuzumab-anns) is payable for its U.S. Food and Drug Administration-approved indications. Kanjinti (trastuzumab-anns) should be reported with Not Otherwise Classified Code J3590 and National Drug Code 55513-0141-01 or 55513-0132-01 until a permanent code is established.
 
Kanjinti (trastuzumab-anns) is a biosimilar to Herceptin (trastuzumab) and a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer, HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

URMBT groups are excluded from coverage of this drug. 

Medical drug management doesn’t require prior authorization for this drug.

19303, 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:

11950, 11951, 11952, 11954, 15820, 15821, 15822, 15823, 15824, 15825, 15826, 15828, 15830, 15832, 15833, 15834, 15835, 15836, 15837, 15838, 15839, 15876, 15877, 15878, 15879, 17380,*** 21120, 21121, 21122, 21123, 21125, 21127, 30400, 30410, 30420, 30430, 30435, 30450

**Gender reassignment surgery may require prior authorization.

Basic benefit and medical policy

Transgender services

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

• Puberty suppression in adolescents
• Hormone therapy (for masculinization/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 for female-to-male transitioned people who haven’t undergone a mastectomy
• Prostate cancer screening for male-to-female transitioned people who have retained their prostate
• Cervical screening for female-to-male transitioned people, as needed
• Obstetric services in female-to-male transitioned people

Criteria have been updated, effective May 1, 2020. 

Inclusions:
For University of Michigan Gender-Affirming Services (facial feminization, hair removal or chondrolaryngoplasty), reference the Medical Policy Partner document.

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 that meet all the following inclusionary criteria:

Inclusions:

• 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, guardians or other legally authorized caretakers 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 that meet all the following inclusionary criteria:

Inclusions:

• Persistent, well-documented gender dysphoria
• Capacity to make a fully informed decision and to consent for treatments
• 18 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 that meet all the following inclusionary criteria:

Inclusions:

• Persistent, well-documented gender dysphoria
• The provider must supply documentation that supports the member meets criteria for gender reassignment surgery:
  • For mastectomy in biological female-to-male patients, or for gender reassignment surgery, both of the following:
    • A (one) detailed psychological assessment by a mental health provider: either a psychiatrist, Ph.D.-prepared clinical psychologist or master’s prepared clinician who is licensed to practice independently in their state and has experience with gender dysphoria.
    • The psychological evaluation must be performed within a year of the surgery.

• 18 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.

Electrolysis

• 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.
• If gender reassignment surgery is approved for a biological female transitioning to male, permanent hair removal (by electrolysis) may be considered established following medical review. Permanent hair removal is considered established only when free flap or other donor tissues are used for phalloplasty performed in conjunction with vaginectomy and full-length urethroplasty.

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 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
  • Drugs for hair loss or growth
  • Forehead lift
  • Hair removal (for exception: see electrolysis under inclusions)
  • Hair transplantation
  • Lip reduction
  • Liposuction
  • Mastopexy
  • Neck tightening
  • Pectoral implants
  • Removal of redundant skin
  • Rhinoplasty
  • Speech-language therapy
  • Non-covered services

**For University of Michigan Gender-Affirming Services (facial feminization, hair removal or chondrolaryngoplasty), reference the Medical Policy Partner document.

Established
20979, E0760

Basic benefit and medical policy

Bone Growth Stimulation: Ultrasound Accelerated Fracture Healing Device policy

The safety and effectiveness of low-intensity ultrasound treatment for the treatment of specified fractures have been established. It’s a useful therapeutic option for patients at high risk for delayed fracture healing or nonunion.

Inclusions:

• Low-intensity ultrasound treatment may be considered established when used as an adjunct to conventional management (e.g., closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals. A fracture is most commonly defined as “fresh” for seven days after the fracture occurs. Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These risk factors may include either locations of fractures or patient comorbidities and include the following:
  • Patient comorbidities:
    • Diabetes
    • Steroid therapy
    • Osteoporosis
    • History of alcoholism
    • History of smoking
  • Fracture locations:
    • Jones fracture (fracture in the meta-diaphyseal junction of the fifth metatarsal of the foot)
    • Fracture of navicular bone in the wrist (also called the scaphoid)
    • Closed fractures of the distal radius (Colles fracture)
    • Closed or grade I open, tibial diaphyseal fractures
    • Fracture of metatarsal
    • Fractures associated with extensive soft tissue or vascular damage

• Low-intensity ultrasound treatment may be considered established when used as a treatment of delayed union of bones, excluding the skull and vertebra. Delayed union is defined as a decelerating healing process as determined by serial X-rays, together with a lack of clinical and radiologic evidence of union, bony continuity or bone reaction at the fracture site for no less than three months from the index injury or the most recent intervention.
• Low-intensity ultrasound treatment may be considered established for non-unions of the appendicular skeleton (non-skull or vertebrae) if there has been no X-ray evidence of progression of healing for three or more months despite appropriate fracture care, and all the following criteria are met:
  • Bone is noninfected
  • Bone is stable on both ends by means of cast or fixation
  • The two portions of the involved bone are separated by less than 1cm
  • Nonunion isn’t related/secondary to malignancy

Exclusions:
Other applications of low-intensity ultrasound treatment are experimental, including, but not limited to, treatment of:

• Congenital pseudarthroses
• Open fractures
• Fresh surgically treated closed fractures in patients who aren’t at high risk for delayed fracture healing or nonunion stress fractures
• Stress fractures
• Arthrodesis
• Failed arthrodesis

This policy is effective May 1, 2020.

Established
64566, 97014, 97032, 0587T, 0588T, 0589T, 0590T

Experimental, not medically necessary
64999

Basic benefit and medical policy

Measurement Percutaneous Tibial Nerve Stimulation policy

The safety and effectiveness of posterior tibial nerve stimulation for non-neurogenic urinary dysfunction have been established. It may be considered a useful therapeutic option when indicated.

Inclusions:

Posterior tibial nerve stimulation, known as PTNS, is established in patients with non-neurogenic urinary dysfunction who meet all the following criteria:

• There is a diagnosis of urinary frequency, nocturia or urinary urgency.
• Active urinary tract infections and anatomical abnormalities of the lower urinary tract have been excluded as a cause of urinary dysfunction.
• The patient has tried and failed conservative behavioral therapies (e.g., biofeedback, fluid management, pelvic floor exercises) for at least a sufficient duration to fully assess its efficacy.
• There is documented failure or intolerance of pharmacologic treatment (anti-cholinergic drugs or a combination of an anti-cholinergic and a tricyclic anti-depressant).
• PTNS treatment consists of 30-minute weekly sessions for 12 treatments.
• After weekly 12 sessions, treatments may continue at a frequency of one per month, up to a total of two years. The two-year time period begins with the initiation of PTNS treatment.

Note: For continuation of treatment, patients should report an improvement in symptoms of urinary frequency, nocturia or urinary urgency within the initial six weeks (six sessions) of PTNS treatment. PTNS should be discontinued if symptoms don’t improve within the initial six treatment sessions.

Exclusions:

• PTNS isn’t established for all other indications, including stress and neurogenic incontinence.
• PTNS hasn’t been established for fecal incontinence.
• PTNS treatment beyond two years hasn’t been extensively studied and is therefore not established for long-term use.

This policy is effective May 1, 2020.

Basic benefit and medical policy

Genetic Testing for Huntington’s Disease  policy

The safety and effectiveness of genetic testing for Huntington’s disease have been established. It may be considered a useful diagnostic option when indicated.

Inclusions:

• Genetic testing for Huntington’s disease to confirm the diagnosis of Huntington’s disease when clinical signs, symptoms and imaging results are consistent with Huntington’s disease

Table 1. Symptoms of Huntington’s disease

Source: Suchowersky, O. Huntington disease: clinical features and diagnosis. UpToDate. November 2019.

• Testing in asymptomatic first- or second-degree relatives of a person with a genetically confirmed diagnosis of Huntington’s disease.
• Prenatal testing in fetuses from families in which there is a history of Huntington’s disease

Neuroimaging: Axial MRI images through the lateral ventricles demonstrate caudate atrophy, defined by the loss of the normal protrusion of the caudate head into the lateral ventricle in late-stage Huntington’s disease. Caudate atrophy, quantified by simple analysis of linear caudate measurements, correlates with change in cognitive function. Functional imaging using positron-emission tomography, or PET, and MRI also show abnormal metabolic changes in the caudate. 

Exclusions:

• Genetic testing for HD for routine screening

This policy is effective May 1, 2020.

J3490
J3590

Basic benefit and medical policy

Ervebo (Ebola Zaire vaccine, live)

Beginning Dec. 19, 2019, Ervebo (Ebola Zaire vaccine, live) is considered established when used for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.

Limitations of use

• The duration of protection conferred by Ervebo is unknown.
• Ervebo doesn’t protect against other species of Ebolavirus or Marburgvirus.
• Effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin, or blood or plasma transfusions is unknown.

Basic benefit and medical policy

Keytruda (pembrolizumab)

Effective June 10, 2019, Keytruda (pembrolizumab) is covered for the following new FDA indication: endometrial carcinoma. Effective Sept. 17, 2019, Keytruda (pembrolizumab) is payable for the updated indications for head and neck squamous cell cancer.

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody.

Endometrial carcinoma

• In combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and aren’t candidates for curative surgery or radiation

Head and neck squamous cell cancer

• In combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC
• As a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test 
• As a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy

Dosage information:

• Endometrial carcinoma: 200 mg every three weeks with lenvatinib 20 mg orally once daily for tumors that aren’t MSI-H or dMMR
• HNSCC: 200 mg every three weeks 

Pharmacy doesn’t require prior authorization of this drug.

Established
S0157

Experimental, not medically necessary
0232T, G0460, P9020, S9055

Basic benefit and medical policy

Recombinant and autologous platelet-derived growth factors

The criteria have been updated for the Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non-Orthopedic Conditions policy.

This policy is effective May 1, 2020.

Inclusions:

Recombinant platelet-derived growth factor (Regranex^®) 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, (i.e., neuropathic diabetic ulcers extending into the subcutaneous tissue)
• As a treatment of pressure ulcers extending into the subcutaneous tissue

Exclusions:

Recombinant platelet-derived growth factor (Regranex®) for:

• Ischemic ulcers
• Venous stasis ulcers
• Ulcers not extending through the dermis into the subcutaneous tissue

The use of platelet-rich plasma (i.e., autologous blood-derived growth factors or autologous platelet gel [e.g., Aurix^™/Autologel^™ and SafeBlood^®]) for the treatment of acute or chronic wounds, including surgical wounds and nonhealing ulcers, is considered experimental.

Basic benefit and medical policy

Zirabev-(bevacizumab-bvzr)

Zirabev-(bevacizumab-bvzr) is considered established effective June 27, 2019.

Zirabev is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment
• Metastatic colorectal cancer, in combination with fluoropyrimidineirinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen

Limitations of use: Zirabev isn’t indicated for adjuvant treatment of colon cancer. 

• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment
• Recurrent glioblastoma in adults
• Metastatic renal cell carcinoma in combination with interferon alfa
• Persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan

Dosing information:

Don’t administer Zirabev for 28 days following major surgery and until surgical wound is fully healed.

Metastatic colorectal cancer:

• 5 mg/kg every two weeks with bolus-IFL
• 10 mg/kg every two weeks with FOLFOX4
• 5 mg/ kg every two weeks or 7.5 mg/kg every three weeks with fluoropyrimidine-irinoteca or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line bevacizumab product-containing regimen

First-line non-squamous non-small cell lung cancer:

• 15 mg/kg every three weeks with carboplatin and paclitaxel

Recurrent glioblastoma:

• 10 mg/kg every two weeks

Metastatic renal cell carcinoma:

• 10 mg/kg every two weeks with interferon alfa

Persistent, recurrent, or metastatic cervical cancer:

• 15 mg/kg every three weeks with paclitaxel and cisplatin or paclitaxel and topotecan
• Administer as an intravenous infusion

Pharmacy doesn’t require prior authorization of this drug.

This drug isn’t a benefit for URMBT. 

Basic benefit and medical policy

Mvasi (bevacizumab-awwb)

Effective June 24, 2019, Mvasi (bevacizumab-awwb) is covered for the following new U.S. Food and Drug Administration indication: recurrent glioblastoma in adults.

Mvasi is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

Limitations of use:

Mvasi isn’t indicated for adjuvant treatment of colon cancer.

• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment
• Recurrent glioblastoma in adults
• Metastatic renal cell carcinoma in combination with interferon-alfa
• Persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan

Dosing information:

Don’t administer Mvasi for 28 days following major surgery and until surgical wound is fully healed. 

Metastatic colorectal cancer:

• 5 mg/kg every two weeks with bolus-IFL
• 10 mg/kg every two weeks with FOLFOX4
• 5 mg/kg every two weeks or 7.5 mg/kg every three weeks with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line bevacizumab product-containing regimen

First-line non-squamous non-small cell lung cancer:

• 15 mg/kg every three weeks with carboplatin and paclitaxel

Recurrent glioblastoma:

• 10 mg/kg every two weeks

Metastatic renal cell carcinoma:

• 10 mg/kg every two weeks with interferon-alfa

Persistent, recurrent, or metastatic cervical cancer:

• 15 mg/kg every three weeks with paclitaxel and cisplatin or paclitaxel and topotecan

Administer as an intravenous infusion.

81333

Basic benefit and medical policy

Gene analysis for corneal dystrophies