Billing chart: Blue Cross highlights medical, benefit policy changes

0446T,** 0447T,** 0448T**       

**Covered effective Jan.1, 2022

Additional established codes:
95249, 95250, 95251, A9276, A9277,
A9278, A9279, K0553, K0554

Non-covered codes: 99091, S1030, S1031

Basic benefit and medical policy

Continuous glucose monitoring systems

The safety and effectiveness of FDA-approved continuous glucose monitoring systems on an intermittent (72 hours or greater) or continuous basis have been established. Both may be considered useful therapeutic devices for patients meeting the relevant patient selection criteria. Inclusionary criteria have been updated, and procedure codes *0446T-*0448T may be covered when criteria are met, effective Jan. 1, 2022.

Payment policy:

Inclusions:

Seventy-two-hour monitoring of glucose levels in interstitial fluid to optimize patient management may be considered established in the following situations when any of the following criteria are met:

• Patients with insulin-requiring diabetes who, despite current use of best practices,** have poorly controlled diabetes, including hemoglobin A1c not in acceptable target range for the patient’s clinical situation, unexplained hypoglycemic episodes, evidence suggesting postprandial hyperglycemia or recurrent diabetic ketoacidosis
• Patients with insulin requiring diabetes prior to insulin pump initiation to determine basal insulin levels
• Women with insulin-requiring diabetes who are pregnant or about to become pregnant and have poorly controlled diabetes

Continuous (i.e., long-term) monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique in diabetic monitoring may be considered established when any of the following situations occur, despite the use of best practices:**

• Patients with insulin requiring diabetes who have demonstrated an understanding of the technology, are motivated to use the device correctly and consistently, are expected to adhere to a comprehensive diabetes treatment plan supervised by a qualified provider, and are capable of using the device to recognize alerts and alarms
• Patients with insulin-requiring diabetes who have recurrent, unexplained, severe (generally blood glucose levels <50 mg/dL) hypoglycemia or impaired awareness of hypoglycemia that puts the patient or others at risk
• Patients with poorly controlled insulin-requiring diabetes who are pregnant. Poorly controlled insulin-requiring diabetes includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia and recurrent diabetic ketoacidosis.
• Patients who meet the criterion of recurrent, unexplained severe hypoglycemia whose hypoglycemia puts the patient or others at risk and don’t already have an adequately functioning insulin pump may be considered for glucose sensors and transmitters associated with an integrated insulin pump. Note: Patients need to meet criteria for continuous subcutaneous insulin infusion, or CSII, pumps and the criteria for the CGMS. Please reference individual certificate or contract for specific coverage guidelines and limitations.

**Best practices in diabetes control include compliance with a self-monitoring blood glucose regimen of four or more finger sticks each day and use of an insulin pump or multiple daily injections of insulin. During pregnancy, three or more insulin injections daily could be considered best practice for patients not on an insulin pump prior to the pregnancy. Prior short-term (72-hour) use of an intermittent glucose monitor would be considered a part of best practices for those considering long-term use of a continuous glucose monitor.

Exclusions:

• Other uses of continuous monitoring of glucose levels in interstitial fluid (including real-time monitoring) as a technique of diabetic monitoring are considered experimental, including:
• Patients not meeting the inclusionary criteria above
• For convenience purposes, such as (but not limited to) lifestyle or employment circumstances

Replacement:

Replacement of a CGMS may be considered when:

• The transmitter is out of warranty or replacement parts are unavailable.
• The transmitter is malfunctioning.
• There is documented evidence of patient compliance provided. If no evidence of compliance is provided or if the member isn’t compliant, the benefit of CGMS may be withdrawn.

Continuation of sensor use after one year may be considered when both the following criteria are met:

• The CGMS has been previously approved by the health plan or the CGMS is in use prior to the user enrolling in the health plan
• There is documented evidence of patient compliance provided and if no evidence of compliance is provided or if the member is not compliant, the benefit of CGMS may be withdrawn.

All covered supplies must be compatible with the CGMS.

90756

Basic benefit and medical policy

Flucelvax Quadrivalent (influenza vaccine)

Effective Oct. 18, 2021, Flucelvax Quadrivalent (influenza vaccine) is covered for the following updated FDA-approved indications:

• Flucelvax Quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine and is approved for use in people 6 months of age and older.

Dosage and administration:

For intramuscular use only

Age: 6 months through 8 years of age
Dose: One or two doses, 0.5 mL each
Schedule: If two doses, administer at least four weeks apart
 
Age: 9 years of age and older
Dose: One dose, 0.5mL
Schedule: Not applicable

One or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.

J1439

Basic benefit and medical policy

Injectafer (ferric carboxymaltose injection)

Effective Nov. 19, 2021, Injectafer (ferric carboxymaltose injection) is payable for the following updated indications:

Adults and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron

J3490
J3590

Basic benefit and medical policy

Susvimo (ranibizumab)

Effective Oct. 23, 2021, Susvimo (ranibizumab) is covered for the following FDA-approved indications:

Susvimo (ranibizumab injection), a vascular endothelial growth factor, or VEGF, inhibitor, is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, or AMD, who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

Dosage information:
 

• For intravitreal use via Susvimo ocular implant.
• The recommended dose of Susvimo (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the Susvimo implant with refills every 24 weeks (approximately six months).
• Supplemental treatment with 0.5 mg intravitreal ranibizumab injection may be administered in the affected eye if clinically necessary.
• Perform the initial implantation, refill-exchange and implant removal (if necessary) procedures under strict aseptic conditions. 

Dosage forms and strengths:

Injection: 100 mg/mL solution in a single-dose vial

Susvimo (ranibizumab) isn’t a benefit for URMBT.

J3490
J3590
J9999

Basic benefit and medical policy

Fyarro (sirolimus albumin-bound nanoparticles)

Fyarro (sirolimus albumin-bound nanoparticles) is payable for FDA-approved indications, effective Nov. 23, 2021.

Fyarro is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor, or PEComa.

Dosage and administration:

• The recommended dosage of Fyarro is 100 mg/m2 administered as an IV infusion over 30 minutes on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.

Dosage forms and strengths:

• For injectable suspension: Lyophilized powder containing 100 mg of sirolimus formulated as albumin-bound particles in single-dose vial for reconstitution.

Fyarro (sirolimus albumin-bound nanoparticles) isn’t a benefit for URMBT.

J9299

Basic benefit and medical policy

Opdivo (nivolumab)

Effective Aug. 19, 2021, Opdivo (nivolumab) is payable for the following FDA-approved indications:

Urothelial carcinoma

Adjuvant treatment of patients with urothelial carcinoma, or UC, who are at high risk of recurrence after undergoing radical resection of UC

J9999

Basic benefit and medical policy

Tivdak (tisotumab vedotin-tftv)

Effective Sept. 20, 2021, Tivdak (tisotumab vedotin-tftv) is covered for the following FDA-approved indications:

Tivdak is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Dosage information:

• For intravenous infusion only. Don’t administer Tivdak as an intravenous push or bolus. Don’t mix with, or administer as an infusion with, other medicinal products.
• The recommended dose of Tivdak is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity.

Dosage forms and strengths:
 
For injection: 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution

Tivdak (tisotumab vedotin-tftv) isn’t a benefit for URMB.

Q4132, Q4133, Q4151, Q4154, Q4159,** Q4186, Q4187, 65778, 65779

Experimental
C1849, Q4100, Q4137, Q4138, Q4139, Q4140, Q4145, Q4148, Q4150, Q4151, Q4153, Q4155, Q4156, Q4157, Q4160, Q4162, Q4163, Q4168, Q4169, Q4170, Q4171, Q4173, Q4174, Q4176, Q4177, Q4178, Q4180, Q4181, Q4183, Q4184, Q4185, Q4188, Q4189, Q4190, Q4191, Q4192, Q4194, Q4198, Q4201, Q4204, Q4205, Q4206, Q4208, Q4209, Q4210, Q4211, Q4212, Q4213, Q4214, Q4215, Q4216, Q4217, Q4218, Q4219, Q4221, Q4227, Q4228, Q4229, Q4230, Q4231, Q4232, Q4233, Q4234, Q4235, Q4236, Q4237, Q4239, Q4240, Q4241, Q4242, Q4244, Q4245, Q4246, Q4247, Q4248, Q4249, Q4250, Q4254, Q4255

Basic benefit and medical policy

Amniotic membrane and amniotic fluid

The safety and effectiveness of select human amniotic membrane products have been established. They may be useful therapeutic options when indicated.

Injection of amniotic fluid is experimental for all indications. The safety, effectiveness, and improvement in health outcomes have not been scientifically demonstrated.

This is payable effective Jan. 1, 2022.

Payment policy:

Payable in inpatient, outpatient and ambulatory surgical facility locations

Inclusions:

Treatment of nonhealing** diabetic lower-extremity venous stasis ulcers using the following human amniotic membrane products:

• Affinity^®
• AmnioBand^® Membrane
• Biovance^®
• Epicord^®
• Epifix^®
• Grafix™

**Nonhealing is defined as less than a 20% decrease in wound area with standard wound care for at least two weeks.

Human amniotic membrane grafts with or without suture (Prokera^®, AmbioDisk™) for the treatment of any of the following ophthalmic indications:

• Neurotrophic keratitis with ocular surface damage and inflammation that doesn’t respond to conservative therapy^a
• Corneal ulcers and melts that don’t respond to initial conservative therapy^a
• Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment
• Bullous keratopathy as a palliative measure in patients who aren’t candidates for curative treatment (e.g., endothelial or penetrating keratoplasty)
• Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone isn’t sufficient
• Moderate or severe Stevens-Johnson syndrome
• Persistent epithelial defects that don’t respond within two days to conservative therapy^a
• Severe dry eye (DEWS 3 or 4)^b with ocular surface damage and inflammation that remains symptomatic after conservative therapy^a
• Moderate or severe acute ocular chemical burn

Human amniotic membrane grafts with suture or glue for the treatment of any of the following ophthalmic indications:

• Corneal perforation when corneal tissue isn’t immediately available
• Pterygium repair when there is insufficient healthy tissue to create a conjunctival autograft

^aConservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching.

^bSee policy guidelines for definition.

Exclusions:

All other human amniotic membrane products (e.g., derived from amnion, chorion, amniotic fluid, umbilical cord or Wharton's jelly) and indications not outlined under inclusions, including but not limited to:

• Grafts with or without suture for ophthalmic indications
• Injection of micronized or particulated human amniotic membrane for all indications, including but not limited to treatment of osteoarthritis and plantar fasciitis
• Injection of human amniotic fluid for all indications
• Treatment of lower-extremity ulcers due to venous insufficiency