CurrentBlue Cross Blue Shield - MichiganPolicy N/A

Billing chart: updates to payable procedures, coverage and specialty drug criteria

Summarizes Blue Cross Blue Shield of Michigan updates to billing guidelines, coverage/payment status, and group benefit changes affecting providers who bill BCBSM for medical and pharmacy/specialty drug services.

Policy Summary

PayerBlue Cross Blue Shield - Michigan

PolicyBilling chart: updates to payable procedures, coverage and specialty drug criteria

Policy CodePolicy N/A

Change TypeMultiple additions and revisions (payable procedures, iNO criteria, specialty drug updates)

Effective DateSee item-level details (June 14, 2024; Nov 1, 2024; July 30, 2024)

Next Review DateN/A

Key ActionObtain and document prior trial and failure of bevacizumab (or biosimilar) before requesting authorization for Ahzantive unless an exception applies.

SourceLink

POLICY UPDATE CHANGES

Arexvy (RSV vaccine, adjuvanted) is payable for adults 50–59 years in alignment with updated FDA indications.

Inhaled nitric oxide (iNO) inclusionary and exclusionary criteria were updated, with explicit inclusions for neonates >=34 weeks and other select indications and exclusions for several settings.

Palforzia (peanut oral immunotherapy) is payable for children 1 through 3 years of age per updated FDA indications.

Multiple new or updated specialty drug coverage statements and dosing details (e.g., Yimmugo, Tecelra, Enzeevu, Ahzantive, Pyzchiva, Zevtera, Epysqli, Adcetris, Keytruda, Enhertu).

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Multiplespecialty drugs updated

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Coverage and Medical Necessity Criteria

Ahzantive (aflibercept-mrbb) — Coverage with criteria

Ahzantive (aflibercept-mrbb) coverage is provided when ALL of the following are met:

ALL of the following

FDA-approved indication
FDA-approved age
Treatment with bevacizumab or a bevacizumab biosimilar has been ineffective, not tolerated or contraindicated. Trial and failure of bevacizumab isn't required for patients with diabetic macular edema when visual acuity in the affected eye is <= 20/50, and isn't required for those with retinopathy of prematurity (ROP).
Diagnosis of ROP (when applicable) with the following: Must have a maximal gestational age of 32 weeks or a maximum birth weight of 1,500 grams; must weigh greater than 800 grams on the day of treatment; and must have one of the following retinal findings in the treatment eye classified per the International Classification for Retinopathy of Prematurity: (a) ROP zone I stage 1+, 2+, 3 or 3+; (b) ROP zone II stage 2+ or 3+; (c) Aggressive posterior ROP.
Coverage will be provided for biosimilar products for FDA-labeled indications of the innovator product when criteria are met.
Trial and failure, contraindication or intolerance to the preferred drugs as listed in Blue Cross and BCN's utilization management medical drug list.

Inhaled nitric oxide (iNO) — Inclusion and exclusion

Inhaled nitric oxide (iNO) — inclusion and exclusion criteria for appropriate use

ALL of the following

Inclusions
- When used as a component of treatment of hypoxic respiratory failure in neonates at or greater than 34 weeks of gestation.
- iNO therapy for post-operative management of pulmonary hypertensive crisis in infants and children with congenital heart disease.
- iNO therapy as a method of assessing pulmonary vaso-reactivity in people with pulmonary hypertension.
Exclusions
- Premature neonates less than or equal to 34 weeks of gestation.

Billing Codes and HCPCS/NDC References

Updated payable proceduresCPTCovered

90679

Arexvy (respiratory syncytial virus vaccine, adjuvanted)

Billing codes referenced with specialty drugsHCPCS

J3490	Not otherwise specified drug code used in multiple specialty drug listings
J3590	Unclassified drugs

Drug-specific HCPCSHCPCS

J9042

Eculizumab product code referenced for Epysqli

Palforzia initial dose age (key value)

Age range1 through 3 years (Palforzia payable for children 1–3 years per updated FDA indication)

Initial dose escalation eligibilityInitial dose escalation may be administered to patients aged 1 through 17 years

Up-dosing and maintenance eligibilityUp-dosing and maintenance may be continued in patients 1 year of age and older

Enzeevu dosing frequency (key value)

Recommended maintenance dosing2 mg intravitreal every 4 weeks for the first 3 months, then 2 mg every 8 weeks

Possible continued monthly dosing

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Pyzchiva: Prior Authorization and Dosing Expectations

Pyzchiva (ustekinumab-ttwe) prior authorization is required. Submit documentation of the FDA‑approved indication and dosing regimen: initial dose and 4‑week loading dose, then maintenance dosing (45 mg or 90 mg subcutaneously every 12 weeks for psoriasis/PsA; weight‑based IV loading and 90 mg SC maintenance for IBD as applicable). For pediatric patients include weight and age to support weight‑based dosing. Prior authorization may request supporting clinical notes showing diagnosis, prior therapies tried, and rationale for Pyzchiva selection.

Payers require prior authorization for Pyzchiva for all labeled indications
Include weight/age for pediatric dosing and weight category for adult dosing when >100 kg
Provide documentation of loading and maintenance dosing schedule

Prior Authorization

Ahzantive: Prior‑Agent (Bevacizumab) Requirement and Exceptions

Ahzantive (aflibercept‑mrbb) requires prior authorization and a documented trial and failure (or intolerance/contraindication) of bevacizumab or a bevacizumab biosimilar before coverage, except where exceptions apply: trial/failure is not required for diabetic macular edema when visual acuity in the affected eye is ≤ 20/50, and is not required for retinopathy of prematurity (ROP) when ROP criteria are met. For ROP, include gestational age, birth weight, weight on day of treatment, and specific retinal findings (per International Classification for ROP).

Initial Therapy Requirements

inv-23: Palforzia initial therapy criteria and dosing escalation/administration rules

Palforzia initial therapy and escalation must follow the labeled escalation and up‑dosing schedules:

Initial dose escalation (ages 1–3): Initial escalation dosing for ages 1–3 years includes total doses of 0.5 mg (one 0.5 mg capsule), 1 mg (one 1 mg capsule), 1.5 mg (one 0.5 mg + one 1 mg capsule), and 3 mg (three 1 mg capsules) as specified during initial escalation; initial dose escalation may be administered to patients aged 1–17 years per labeling.

Follow the provided capsule combinations during escalation; monitor per standard oral immunotherapy protocols.

Up‑dosing and maintenance (ages 1–17): Up‑dosing schedules provide stepwise total daily dose increases (examples: 1 mg, 3 mg, 6 mg, 12 mg, 20 mg, 40 mg, 80 mg, 120 mg, 160 mg, 200 mg, 240 mg, up to maintenance total daily dose 300 mg delivered as a 300 mg sachet); maintenance therapy total daily dose is 300 mg (sachet) for continuation in patients ≥1 year old.

Dosing by age and capsule/sachet configuration per the labeled tables; preserve supervised escalation and monitoring requirements.

Renewal and Continuation Requirements

inv-24: Anti-VEGF continuation criteria — renewal requirements for ongoing therapy

Anti‑VEGF continuation (renewal) requests are approved when ALL of the following are met:

Anti‑VEGF renewal: 1) Authorization period requested within allowed timeframe (at least 60 days and up to one year); 2) Clinical documentation confirming that the original coverage criteria continue to be met for the indication being treated; 3) Documentation demonstrates the medication is providing clinical benefit; 4) For ROP retreatment, patient must meet the specific retinal criteria listed for retreatment (gestational age, weight on day of treatment, and International Classification retinal findings); 5) Quantity limits remain aligned with FDA‑recommended dosing.

Renewal decisions require submission of clinical response data and relevant ophthalmologic findings.

Step Therapy and Failure Requirements

Step	Requirement
1	Trial and failure of bevacizumab or a bevacizumab biosimilar (ineffective, not tolerated, or contraindicated).
Exceptions	Trial and failure of bevacizumab is NOT required for: • Diabetic macular edema (DME) when visual acuity in the affected eye is less than or equal to 20/50; • Retinopathy of prematurity (ROP) (see ROP-specific gestational age, birth weight, weight at treatment, and retinal findings criteria).

Dosing and Quantity Limit Guidance

Enzeevu/Ahzantive quantity limits — align with FDA-recommended dosing

Quantity limit policyQuantity limits for Enzeevu and Ahzantive align with FDA-recommended dosing

Authorization periodAuthorization issued for at least 60 days and up to one year

Renewal requirementRenewal requires clinical documentation confirming criteria continue to be met and medication is providing clinical benefit

Palforzia maintenance total daily dose key value (300 mg sachet)

Maintenance total daily dose300 mg (one 300 mg sachet)

Daily dose configuration300 mg sachet used for maintenance dosing

Administration Setting and Site-of-Care Requirements

Billing Rule

Tecelra site‑of‑care and administration requirements — hospital outpatient infusion

Administer Tecelra (afamitresgene autoleucel) only in an appropriate specialized setting (hospital outpatient) and ensure required pre‑infusion steps are documented: identity verification, lymphodepletion with cyclophosphamide and fludarabine, and premedication with acetaminophen and an H1‑antihistamine.

Tecelra is autologous intravenous cell therapy — confirm hospital outpatient setting and that the infusion bag will be administered within one hour of thawing.
Document the planned lymphodepletion regimen and premedication prior to authorization/submission.

Billing Rule

Enzeevu/Ahzantive administration — intravitreal injection in office/ASC by trained provider

Provide intravitreal injections of Enzeevu/Ahzantive in the office or ambulatory surgical center by a trained provider and document the intravitreal route and dose per label.

Biosimilar and Prior-Agent Guidance

Prior Authorization

Bevacizumab trial/failure required prior to Ahzantive — document exceptions explicitly

Before Ahzantive, document trial and failure of bevacizumab or a bevacizumab biosimilar unless the patient meets a policy exception (for example, DME with affected‑eye visual acuity ≤20/50 or retinopathy of prematurity meeting the specified gestational age/weight and retinal criteria).

For ROP exceptions, include maximal gestational age ≤32 weeks or birth weight ≤1,500 g, weight >800 g on day of treatment, and one of the listed retinal findings (zone/stage or aggressive posterior ROP).
If documenting DME exception, include visual acuity measurement showing ≤20/50 in the affected eye.

Clinical Definitions and Calculations

Oxygenation index (OI) definition and calculation

DefinitionOxygenation index (OI) = mean airway pressure × fraction of inspired oxygen (FiO2) ÷ partial pressure of arterial oxygen (PaO2) × 100

Clinical useUsed to assess severity of hypoxic respiratory failure and to identify patients at high risk for ECMO or death

Thresholds of concernAn OI of 25 is associated with ~50% risk of requiring ECMO or dying; an OI of 40 is often used as a criterion to initiate ECMO therapy

Policy Background and Scope

This document summarizes Blue Cross Blue Shield of Michigan updates to coverage, payable procedures, and clinical guidance for selected medical and specialty therapies. It sets forth inclusionary and exclusionary criteria (for example, updated iNO indications effective Nov. 1, 2024), defines coverage criteria and quantity/authorization expectations for specialty drugs (such as intravitreal anti‑VEGF agents and autologous cell therapy), and notes group-level benefit variations. The guidance applies to providers billing BCBSM and directs that authorizations require clinical documentation demonstrating FDA‑aligned indications, age criteria, prior trials or failures of preferred agents when required (for example, bevacizumab before Ahzantive except specified exceptions), and adherence to dosing/administration specifications described in the policy.