CurrentBlue Cross Blue Shield - MichiganPolicy N/A

Billing chart: updates to payable procedures and policy clarifications

Summarizes updates to payable procedure codes, device and drug coverage criteria, experimental procedure designations, and FDA-driven coverage changes affecting provider billing and authorization.

Policy Summary

PayerBlue Cross Blue Shield - Michigan

PolicyBilling chart: updates to payable procedures and policy clarifications

Policy CodePolicy N/A

Change TypeMixed: procedure reclassifications, new drug indications, device criteria updates

Effective DateDec. 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization per product listing and document trial/failure or contraindication to preferred products for Ryoncil and other listed drugs.

SourceLink

POLICY UPDATE CHANGES

Several procedure codes were moved from payable to experimental effective Dec. 1, 2024 (0795T, 0796T, 0797T, 0801T, 0802T, 0803T, 0804T).

New FDA-approved indications and payable status were added for multiple drugs (e.g., Xeomin, Skyrizi, Protonix IV, mResvia, Niktimvo, Ryoncil, Prevymis, Rybrevant, Imfinzi, Opdivo, Epkinly, Tofidence).

Coverage criteria established for right ventricular single-chamber leadless pacemakers (Micra™, Aveir™) with explicit inclusion and exclusion criteria and investigational status for other leadless systems.

Ryoncil (remestemcel-L-rknd) payable when specific criteria met including FDA indication, age, disease progression timing, and trial/failure of preferred products; authorization periods and renewal criteria specified.

Bendamustine hydrochloride is no longer FDA approved for treatment of adult CLL as of April 15, 2025.

7procedure codes reclassified as experimental

>=10

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Coverage and Device/Drug Criteria

Leadless pacemaker — established coverage criteria

Covered when BOTH inclusion criteria and a significant contraindication to conventional single‑chamber ventricular pacemaker leads are present.

Leadless RV single‑chamber pacemaker (Micra/Aveir) inclusion: The individual has an indication for a pacemaker such as high‑grade atrioventricular (AV) block in the presence of atrial fibrillation OR significant bradycardia with one of: normal sinus rhythm with rare episodes of 2°/3° AV block or sinus arrest; chronic atrial fibrillation; severe physical disability. (For Micra AV only: there is an indication for VDD pacing where maintaining AV synchronous ventricular pacing would be beneficial.)

Device‑specific inclusion per policy

Significant contraindication to conventional leads (one or more required): One or more of the following: history of endovascular or CIED infection or high risk for infection; venous access issues (venous anomaly, occlusion of axillary veins, planned use of veins for semi‑permanent catheter or current/planned use of an AV fistula for hemodialysis); presence of a bioprosthetic tricuspid valve.

Any single item supports consideration of a leadless RV device

Device replacement

Device replacement is considered established when ANY of the following are met.

Device replacement indications: Nearing end of life (elective replacement indicator); device not functioning or cannot be reprogrammed to provide optimal pacemaker support; device needs explantation due to infection.

Any one of these conditions supports replacement

Any FDA contraindication to the device excludes coverage. The Micra™ and Aveir™ right ventricular single-chamber transcatheter pacing systems are considered investigational in all situations where the explicit coverage criteria are not met. (See criteria for established coverage that require both a pacemaker indication and a significant contraindication to conventional single‑chamber ventricular leads.)

Right atrial and dual‑chamber leadless cardiac pacemakers (for example, the Aveir™ DR dual‑chamber system and all right atrial single‑chamber pacing systems) are considered experimental/investigational. The policy states that safety and effectiveness have not been demonstrated for these devices compared with conventional treatment, and therefore they are not established for coverage.

Ryoncil (remestemcel-L-rknd) — coverage

Coverage provided when ALL of the following are met.

Ryoncil coverage: 1) Request is for an FDA‑approved indication for remestemcel‑L‑rknd; 2) Patient meets the FDA‑approved age requirement; 3) The member has demonstrated progression of disease by Day 5 or nonresponse by Day 7 while on corticosteroids; 4) Trial and failure, intolerance, or contraindication to preferred products as specified in the Blue Cross and BCN medical utilization management drug list.

Quantity limits align with FDA dosing; authorization period and renewal per policy

Prevymis (letermovir) — coverage

Prevymis is covered for FDA‑approved transplant prophylaxis indications when dosing and patient characteristics match the FDA labels.

Prevymis indications: Prophylaxis of CMV infection and disease in HSCT recipients who are CMV‑seropositive: adults and pediatric patients ≥6 months of age and ≥6 kg; prophylaxis of CMV disease in high‑risk kidney transplant recipients (D+/R‑): patients ≥12 years of age and ≥40 kg.

Dosing and duration per FDA labeling (e.g., 480 mg once daily for adults and weight‑based pediatric dosing through 100 days post‑HSCT; may continue to 200 days for late risk).

Procedure, HCPCS and Drug Codes

Procedure codes updated or reclassifiedCPT

33274	listed in updates to payable procedures
33275	listed in updates to payable procedures
0798T	listed in updates to payable procedures
0799T	listed in updates to payable procedures
0800T	listed in updates to payable procedures
0795T	reclassified to experimental effective Dec. 1, 2024
0796T	reclassified to experimental effective Dec. 1, 2024
0797T	reclassified to experimental effective Dec. 1, 2024
0801T	reclassified to experimental effective Dec. 1, 2024
0802T	reclassified to experimental effective Dec. 1, 2024

1–10 of 16

1/2

Drug J-codes and HCPCS referencedHCPCS

J0588	Xeomin (incobotulinumtoxinA)
J2327	administration/dosing related code referenced
J2470	Skyrizi (risankizumab-rzaa)
J3490	unclassified drug code referenced multiple times
J3590	unclassified drug code referenced multiple times
J9058	Prevymis (letermovir)
J9061	Bendamustine hydrochloride
J9173	Rybrevant (amivantamab-vmjw)
J9299	Imfinzi (durvalumab)
J9321	Opdivo (nivolumab)

1–10 of 12

1/2

Prevymis weight-based dosing thresholds (compact) - inv-09

Pediatric threshold>= 6 kg (pediatric HSCT recipients >=6 months)

HSCT dose-group threshold>= 30 kg (adults and pediatrics >=12 years and >=30 kg for HSCT dosing of 480 mg daily)

Kidney transplant threshold>= 40 kg (kidney transplant recipients >=12 years and >=40 kg)

Prior Authorization, Documentation, and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ryoncil and other listed specialty drugs. Providers must request prior authorization before initiating treatment and reference product-specific clinical criteria on the Blue Cross Blue Shield of Michigan prior authorization/drug criteria pages.

Affected product: Ryoncil (remestemcel-L-rknd)
Refer to BCBS & BCN medical utilization management drug list for preferred products and product-specific criteria

Prior Authorization

Ryoncil Authorization Triggers

Authorization for Ryoncil is contingent on documentation that the member meets FDA-approved indication and age, and that the member has demonstrated disease progression by Day 5 or nonresponse by Day 7 while on corticosteroids. The request must also show trial and failure, intolerance, or contraindication to preferred products per Blue Cross/BCN drug list.

Required timelines: progression by Day 5 OR nonresponse by Day 7 while on corticosteroids
Step therapy: trial and failure, intolerance, or contraindication to preferred products listed by BCBS/BCN

Initial Dosing and Eligibility for Drugs

Prevymis initial therapy

Initial therapy dosing criteria for Prevymis must be met.

Prevymis initial dosing: HSCT recipients: 480 mg once daily orally or IV for adults and pediatric patients ≥30 kg through 100 days post‑HSCT (may be continued through 200 days in patients at risk for late CMV infection). Pediatric dosing for patients <30 kg is weight‑based. Dose adjustment: when co‑administered with cyclosporine, decrease Prevymis to 240 mg once daily in adults and pediatric patients ≥12 years; pediatric adjustments may be required for younger patients.

Route: oral or IV per label; duration per clinical risk

Niktimvo initial therapy

Initial dosing and indication criteria for Niktimvo must be met.

Niktimvo initial dosing: Indication: treatment of chronic graft‑versus‑host disease after failure of at least two prior systemic therapies in patients weighing ≥40 kg. Dosage: 0.3 mg/kg IV every two weeks (maximum 35 mg) administered as a 30‑minute infusion.

Administer only as IV infusion over 30 minutes; weight requirement ≥40 kg.

Continuation and Renewal Rules

Ryoncil continuation

Criteria for continuation and renewal of Ryoncil (remestemcel‑L‑rknd).

Ryoncil renewal: Authorization period aligns with FDA‑recommended or guideline‑supported treatment duration and is provided for at least 60 days and up to six months; renewal requires clinical documentation confirming that the current criteria remain met and that the medication is providing clinical benefit.

Clinical documentation must demonstrate ongoing benefit; align renewal length with FDA/guideline durations.

Step Therapy and Preferred Product Requirements

Drug	Required prior agents (trial and failure, intolerance, or contraindication to preferred products per BCBSM drug list)
Ryoncil (remestemcel-L-rknd)
Trial and failure, intolerance, or contraindication to preferred products specified in the Blue Cross and BCN medical utilization management drug list (per policy requirement for Ryoncil)

Quantity Limits and Dosing Alignment

Ryoncil (remestemcel-L-rknd) — quantity & authorization - inv-21

Quantity limit guidanceAlign with FDA recommended dosing

Authorization periodProvided for at least 60 days and up to six months per authorization

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

Prevymis (letermovir) — quantity limits & adjustments - inv-22

Typical daily quantity limit480 mg once daily (standard adult/pediatric >=30 kg HSCT and adult kidney transplant dosing)

Dose adjustment with cyclosporineDecrease to 240 mg once daily when co‑administered with cyclosporine in adults and pediatrics >=12 years; pediatric adjustments may be required for <12 years

Site of Care and Infusion Requirements

Billing Rule

Infusion center administration per product dosing and infusion instructions

IV-administered specialty drugs (examples: Niktimvo, Tofidence) must be given in an appropriate infusion setting and administered per the dosing and administration instructions — e.g., Niktimvo as a 30-minute IV infusion at 0.3 mg/kg (max 35 mg) every two weeks; Tofidence IV dosing and infusion times per label (including 60- or 30- to 60-minute infusions as specified). Follow dilution and infusion-time guidance in the product administration instructions.

Niktimvo: administer as an intravenous infusion over 30 minutes; dose 0.3 mg/kg (max 35 mg) every two weeks in patients ≥40 kg.
Tofidence: follow IV dosing and infusion-time recommendations (e.g., COVID-19 dose as 8 mg/kg by 60-minute infusion).

Clinical Definitions Used in Criteria

Severe physical disability — definition & examples - inv-15

Clinical definitionSevere physical disability: comorbidities where conventional pacemaker placement would confer undue short- or long-term risk or further compromise activities of daily living, including ability to comply with postoperative care

Examples — mobility/ADL impactConditions that substantially limit activities of daily living or mobility making postoperative care or device maintenance unsafe or unfeasible

Examples — procedural riskSituations where implantation would pose undue short- or long-term procedural risk (e.g., frailty or comorbidities increasing perioperative morbidity)

CIED infection risk factors — inv-16

CIED infection risk — ESRDEnd-stage renal disease

CIED infection risk — corticosteroids

Background and Context

Leadless transcatheter pacing systems provide an option for patients with pacing indications (for example, high‑grade AV block in the presence of atrial fibrillation or significant bradycardia with intermittent high‑grade AV block, chronic atrial fibrillation, or severe physical disability) when conventional transvenous single‑chamber ventricular leads are contraindicated. Contraindications supporting use of a leadless RV system include a history of CIED infection or high infection risk, venous access limitations (such as axillary vein occlusion, venous anomaly, or veins planned for semi‑permanent catheter/AV fistula for hemodialysis), and presence of a bioprosthetic tricuspid valve. The policy also notes situational factors (for example, concern for lead fracture from repetitive mechanical stress such as firearm recoil) that may make leadless pacing a preferred alternative. These clinical contexts informed the determination that Micra™ and Aveir™ RV single‑chamber systems are established only when both the inclusion indications and a significant contraindication to conventional leads are present, while other leadless systems or chamber configurations remain investigational.