Billing chart: Blues highlight medical, benefit policy changes

J3590 

Basic benefit and medical policy

Crysvita (burosumab-twza)

Crysvita (burosumab-twza) is considered established, effective April 17, 2018.

Crysvita (burosumab-twza) is covered when all the following criteria are met:

• The patient is 18 to 65 years old.
• It’s prescribed by endocrinologist.
• Treatment is for the underlying cause of X-linked hypophosphatemia (XLH).
• Serum Pi < 2.5 mg/dL.
• Measurable bone/joint pain (≥4 BPI-Q3 worst pain).
• There was a trial and failure of preferred products.

Quantity limits align with FDA-recommended dosing. The initial authorization period is six months.

Renewal criteria:
Authorization will be reviewed at least annually to assess improvement. The renewal authorization period is one year.

FDA-approved indication and diagnosis:

• Crysvita is indicated for the treatment of X-linked hypophosphatemia in adult and pediatric patients ages 1 and older.

 Dosing:

• Pediatric: Starting dose regimen is 0.8 mg/kg of body weight rounded to the nearest 10 mg, administered every two weeks. The minimum starting dose is 10 mg, up to a maximum dose of 90 mg. Dose may be increased up to approximately 2 mg/kg (maximum 90 mg), administered every two weeks to achieve normal serum phosphorus.
• Adult: Dose regimen is 1 mg/kg body weight rounded to the nearest 10 mg up to a maximum dose of 90 mg administered every four weeks.

It’s administered by subcutaneous injection by a health care provider.

How supplied:

• Injection: 10 mg/mL, 20 mg/mL, or 30 mg/mL in a single-dose vial

Crysvita (burosumab-twza) isn’t a benefit for URMBT.

Prior authorization is required.

NDCs: 69794-0102-01, 69794-0203-01, 69794-0304-01.

J3590

Basic benefit and medical policy

Retacrit (epoetin alfa-epbx)

Effective May 15, 2018, Retacrit (epoetin alfa-epbx) was covered for the FDA-approved indications below.

Retacrit (epoetin alfa-epbx) is a biosimilar to Epogen/Procrit (epoetin alfa). Retacrit (epoetin alfa-epbx) is an erythropoiesis-stimulating agent indicated for the following:

• Treatment of anemia due to:
• Chronic kidney disease, or CKD, in patients on dialysis and not on dialysis
• Zidovudine in patients with HIV infection
• The effects of concomitant myelosuppressive chemotherapy. Upon initiation, there’s a minimum of two additional months of planned chemotherapy.
• Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac and nonvascular surgery.

Retacrit (epoetin alfa-epbx) hasn’t been shown to improve quality of life, fatigue or patient well-being.

Retacrit (epoetin alfa-epbx) isn’t indicated for use:

• In patients with cancer who are receiving hormonal agents, biologic products or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy
• In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure
• In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion
• In patients scheduled for surgery who are willing to donate autologous blood
• In patients undergoing cardiac or vascular surgery
• As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment.

Patients with CKD:
Initial dose: 50 to 100 units/kg three times weekly (adults) and 50 units/kg three times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis.

Patients on zidovudine due to HIV infection: 100 units/kg three times weekly.

Patients with cancer undergoing chemotherapy: 40,000 units weekly or 150 units/kg three times weekly (adults); 600 units/kg intravenously weekly (pediatric patients > 5 years).

Surgery patients: 300 units/kg per day daily for 15 days or 600 units/kg weekly.

Pharmacy doesn’t require preauthorization of this drug.

Retacrit (epoetin alfa-epbx) isn’t a benefit for URMBT.

81401, 81405, 81406

Basic benefit and medical policy

Genetic testing for heterozygous familial hypercholesterolemia

The effectiveness and clinical utility of genetic testing to confirm a diagnosis or future risk of familial hypercholesterolemia, or FH, have been established. It may be considered a useful diagnostic option when indicated, effective Nov. 1, 2018.

Payment policy
Note: These procedures require manual review.

Inclusions:
Genetic testing to confirm a diagnosis of familial hypercholesterolemia when all the following are met:

• A definitive diagnosis is required as an eligibility criterion for specialty medications
• The individual is in an uncertain category according to clinical criteria (personal and family history, physical exam, lipid levels).
• All the following apply:
• FH is suspected and evaluated against standardized diagnostic criteria.
• Criteria for a definite diagnosis are not met.
• Alternative treatment considerations are in place for individuals who have an uncertain diagnosis of FH and a negative genetic test.

Genetic testing to determine future risk of familial hypercholesterolemia when all the following are met:

• A pathogenic variant is present in a biological parent.
• General lipid screening is not recommended based on age or other factors.

Exclusions:

• Genetic testing to confirm diagnosis of FH for all other situations not listed above
• Genetic testing of adults who are close relatives of individuals with FH to determine future risk, other than the above

96446, 96549**

**Use unlisted procedure when infusion is performed using a temporary catheter or performed intraoperatively.

Basic benefit and medical policy

Cytoreductive surgery and perioperative intraperitoneal chemotherapy for select intra-abdominal and pelvic malignancies

The safety and effectiveness of hyperthermic intraperitoneal chemotherapy, or HIPEC, when used in combination with cytoreductive surgery have been established. It may be considered a useful therapeutic option for patients meeting patient selection criteria.

Inclusionary criteria have been updated, effective Nov. 1, 2018.

Inclusions:
The patient must meet all the following criteria:

• A diagnosis of pseudomyxoma peritonei, diffuse malignant peritoneal mesotheliomas or ovarian cancer confirmed by the treating physician.
• The patient must be able to tolerate the extensive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.
• Peritoneal disease must be potentially completely resectable or significantly reduced.
• There must be no metastases to other organs or to the retroperitoneal space.

Exclusions:

• A diagnosis of peritoneal carcinomatosis from colorectal cancer, gastric cancer or endometrial cancer
• Goblet cell tumors of the appendix
• All other indications

J9999

Basic benefit and medical policy

Darzalex (daratumumab)

Darzalex (daratumumab) is established for its new indication in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, effective May 7, 2018.

33961-33969

Not covered:
33999**

Basic benefit and medical policy

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement performed with an FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling, may be indicated for patients with aortic stenosis.

Inclusions:
Transcatheter aortic valve replacement with a device approved by the FDA and performed via an approach consistent with the device’s FDA-approved labeling is established for patients with aortic stenosis when all the following conditions are present:

• One of the following:
• Severe aortic stenosis with a calcified aortic annulus
• Failed (stenosed, insufficient or combined) of a surgical bioprosthetic aortic valve
• New York Heart Association heart failure Class II, III or IV symptoms
• Left ventricular ejection fraction greater than 20 percent
• One of the following:
• Patient isn’t an operable candidate for open surgery, as judged by at least two cardiovascular specialists including a cardiac surgeon.
• Patient is an operable candidate but is at high risk for open surgery (i.e., Society of Thoracic Surgeons operative risk score ≥ 8 percent or at a ≥ 15 percent risk of mortality at 30 days).
• Patient is at intermediate or greater surgical risk for open aortic valve replacement (only when used in concordance with FDA
  regulations for Sapien XT transcatheter heart valve; see below)

Edwards SAPIEN XT transcatheter heart valve:

1. 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 28 mm)
2. New York Heart Association heart failure Class II, III or IV symptoms
3. Patient isn’t 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 percent or at a ≥ 15 percent risk of mortality at 30 days).
4. Patient is at intermediate surgical risk for open aortic valve replacement (i.e., predicted risk of surgical mortality ≥ 3 percent at 30 days based on the Society of Thoracic Surgeons Risk Score, or STS, and other clinical comorbidities unmeasured by the STS risk calculator)

Medtronic CoreValve™ (Evolut) system:

1. 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 aortic annulus diameters between 23 and 31 mm
2. New York Heart Association heart failure Class II, III or IV symptoms
3. 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 ≥ 15 percent at 30 days).

Exclusions:
Transcatheter aortic valve replacement is considered experimental for all other indications, including but not limited to:

• 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.
• Non-FDA approved systems or approaches including:
• Lotus, Portico and JenaValve systems
• Transcaval approach

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 co-morbidities:

• 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 haven’t been established for valve-in-valve procedures.
• Non-calcified aortic annulus
• Severe ventricular dysfunction with ejection fraction < 20 percent
• Congenital unicuspid or congenital bicuspid aortic valve
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
• Prosthetic ring in any position
• Severe mitral annular calcification, 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.

J3490

Basic benefit and medical policy

Eskata (hydrogen peroxide)

Eskata (hydrogen peroxide) is considered cosmetic, effective June 14, 2018. This service isn’t a covered benefit.

The NDC is 71180-0001-12.

Q2040

Basic benefit and medical policy

Kymriah (tisagenlecleucel)

Effective May 1, 2018, Kymriah (tisagenlecleucel) is payable for the following additional FDA indication: Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma, known as DLBCL, not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Kymriah (tisagenlecleucel) is a CD19-directed genetically modified autologous T-cell immunotherapy.

Limitation of use: Kymriah (tisagenlecleucel) isn’t indicated for treatment of patients with primary central nervous system lymphoma.

Dosing of Kymriah (tisagenlecleucel) is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.

Pediatric and young adult B-cell (up to 25 years of age):

• For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously.
• For patients above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously.

Adult relapsed or refractory diffuse large B-cell lymphoma:

• Administer 0.6 to 6.0 x 108 CAR-positive viable T cells intravenously.

38999**

Basic benefit and medical policy

Lymphedema — surgical treatments

Lymphatic physiologic microsurgery to treat lymphedema (including, but not limited to, lymphatico-lymphatic bypass, lymphovenous bypass, lymphaticovenous anastomosis, autologous lymph node transplantation and vascularized lymph node transfer) in individuals who have been treated for breast cancer is experimental. It hasn’t been scientifically demonstrated to improve patient clinical outcomes.

Lymphatic physiologic microsurgery performed during nodal dissection or breast reconstruction to prevent lymphedema (including, but not limited to, the lymphatic microsurgical preventing healing approach) in individuals who are being treated for breast cancer is experimental. It hasn’t been scientifically demonstrated to improve patients’ clinical outcomes.

This policy is effective Nov. 1, 2018.

Payment policy
**Unlisted procedure code used to report this service.

Exclusions:
Liposuction in patients with more advanced lymphedema after fat deposition and tissue fibrosis

The Auto Club Group

The Auto Club Group, group number 72695, is adding a health savings account plan.

Mahle Industries Incorporated

Mahle Industries Incorporated, group number 71774, is joining Blue Cross Blue Shield of Michigan, effective Jan. 1, 2019.

Group number: 71774
Alpha prefix: PPO (MDA) 
Platform: NASCO Hybrid

Plans offered:
PPO, medical/surgical
Vision (VSP)
Prescription drugs
Hearing
CDH — Medical FSA and Dependent Care FSA through HEQ