CurrentUnitedHealthcarePolicy N/A

Maximum Dosage and Frequency – Individual Exchange Medical Benefit Drug Policyopen_in_new

Defines maximum per-administration dosages and maximum allowed HCPCS units and NDC-based quantities for a long list of medical benefit drugs when administered by a medical professional for Individual Exchange plans (excludes MA, NV, NY). Applies to dosing based on patient weight/BSA or fixed maximums and establishes upper limits beyond which use is considered unproven/not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency – Individual Exchange Medical Benefit Drug Policyopen_in_new

Policy CodePolicy N/A

Change TypeAnnual edits — HCPCS/NDC additions and quantity/frequency updates

Effective Date

Next Review Date

Key ActionProvider must ensure administered dose and frequency do not exceed the policy's maximum per-administration limits based on weight/BSA or fixed maximums; document and justify exceptions for patients with weight >140 kg or BSA >2.71 m^2.

SourceLink

POLICY UPDATE CHANGES

Revised list of applicable drug products; added denosumab-bmwo (Stoboclo & Osenvelt), eculizumab-aagh (Epysqli), eculizumab-aeeb (Bkemv), and ustekinumab-srlf (Imuldosa).

Added maximum allowed quantities for Bkemv (HCPCS Q5152), Epijkstra (Q5151), Imuldosa (Q5098), Osenvelt and Stoboclo (Q5157).

Added maximum allowed quantities for NDC billing for multiple products including Bkemv, Epijkstra, Imuldosa, Osenvelt, and Stoboclo (specific NDCs listed).

Updated applicable HCPCS codes list to include J1073, Q5098, Q5151, Q5152, and Q5157.

04/01/2026 update: Updated reference link to reflect the current policy title for related policies including Complement C5 Inhibitors.

100+Drugs Listed with HCPCS Limits

NDCs listed (partial)

140 kg / 2.71 m^2Weight / BSA thresholds

0.6 mLStandard max volume

5HCPCS codes newly added

Coverage Summary & Rationale

Coverage Rationale / Medical Necessity

Covered when ALL of the following are met:

Medication is administered by a medical professional and given within the maximum dosage per administration and/or dosing frequency based upon body surface area (BSA), patient weight, or a set maximal dosage/frequency as defined in this policy.
Use within these maximums is supported when used according to labeled indications or published clinical evidence.
For adult body weight and BSA, the policy uses the 95th percentile adult values (140 kg and 2.71 m^2) to create upper dose limits; in some cases higher allowances may be made for individual patients exceeding these values.Adult weight=140 kg; Adult BSA=2.71 m^2
Exceptions possible when individual patient weight > 140 kg or BSA > 2.71 m^2.

Not Medically Necessary / Unproven

Considered not medically necessary when ANY of the following apply:

Medication is used beyond the maximum dosages and/or frequency based upon BSA, patient weight, or the set maximal dosage/frequency defined in this policy.
Use beyond these maximums is not supported by package labeling or published clinical evidence and is unproven.
Continued use of a medication or dosages used beyond labeled indication or other published clinical evidence.
Continued beyond-label dosing is considered not medically necessary.

Clinical Evidence / Maximum Dose Rationale

Covered up to maximum dosages when ALL of the following are met:

Evidence support: Medication dosing up to maximum dosages based upon body surface area or patient weight is supported when used according to labeled indications or supported by published clinical evidence.
Product-specific limits: Maximum dose limits are product-specific and in some cases disease-state specific and are defined in FDA-approved product prescribing information and/or national compendia and peer-reviewed resources.
Population percentile: This policy creates an upper dose limit based on the clinical evidence and the 95th percentile for adult body weight (140 kg) and body surface area (2.71 m^2).Adult weight=140 kg; Adult BSA=2.71 m^2
Fryar, 2021 population reference used.

Initial, Continuation & Frequency Limits

Maximum Allowed Frequencies

Each medication below includes the diagnosis/indication and the maximum frequency or dosing schedule.

Maximum Allowed Frequencies (selected product list)

Cimzia (certolizumab pegol): For Crohn's disease: dosing per label; for ankylosing spondylitis/axial spondyloarthritis/plaque psoriasis (BW ≤ 90 kg)/psoriatic arthritis/rheumatoid arthritis: initial, weeks 2 and 4, then every other week or every 4 weeks; plaque psoriasis (BW > 90 kg) every other week.
Source: Maximum Allowed Frequencies list.
Cinqair (reslizumab): Asthma indication: administered once every 4 weeks.
Daxxify (daxibotulinumtoxinA-lanm): Administered no more frequent than every 12 weeks.

Applicable Codes (HCPCS / Q-codes / NDCs)

Maximum Allowed HCPCS Units (by product)HCPCSCovered

J3262	tocilizumab (Actemra) — max 800 HCPCS units (1 mg per unit) — Per administration 800 mg
Q5133	tocilizumab-bavi (Tofidence) — max 800 HCPCS units (1 mg per unit) — Per administration 800 mg
Q5135	tocilizumab-aazg (Tyenne) — max 800 HCPCS units (1 mg per unit) — Per administration 800 mg
J9035	bevacizumab (Avastin) — max 240 HCPCS units (10 mg per unit) — Per administration 15 mg/kg
Q5129	bevacizumab-adcd (Vegzelma) — max 240 HCPCS units (10 mg per unit) — Per administration 15 mg/kg
Q5107	bevacizumab-awwb (Mvasi) — max 240 HCPCS units (10 mg per unit) — Per administration 15 mg/kg
Q5118	bevacizumab-bvzr (Zirabev) — max 240 HCPCS units (10 mg per unit) — Per administration 15 mg/kg
Q5126	bevacizumab-maly (Alymsys) — max 240 HCPCS units (10 mg per unit) — Per administration 15 mg/kg
J3145	testosterone undecanoate (Aveed) — max 750 HCPCS units (1 mg per unit) — Per administration 750 mg
J0585	onabotulinumtoxinA (Botox) — max 600 HCPCS units (1 unit per HCPCS unit) — Per administration 600 units

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Provider Actions — Billing & Documentation

Documentation Required

Documentation Requirements

Dose must be within policy maximums or supported by evidence. Refer to member specific benefit plan for coverage details. Follow FDA labeling and accepted compendia when billing and documenting drug administration.

Billing Rule

Billing Rules: Volume, Quantity, Frequency Limits

Billing and coding must adhere to the policy's HCPCS and NDC maximum allowed quantities, volume limits per NDC, and maximum allowed administration frequencies. Use applicable J- and Q- codes for medical benefit drug billing and limit billed NDC units to the policy-defined maximums.

Report HCPCS units per policy limits (maximum allowed units are listed in the policy's HCPCS table).
Bill NDCs with maximum allowed volume — do not exceed the policy maximum volume per NDC.
Limit billing to maximum allowed NDC quantity — adhere to NDC-specific maximum allowed quantity per administration.

NDC & HCPCS Maximum Allowed Quantities (reference)

This policy lists product-specific maximums both as HCPCS unit limits and as NDC billing quantities (vials, mL, or units) for many medical-administered drugs. Many of the per-administration maximums are anchored to the policy's 95th percentile adult thresholds for weight and body surface area—140 kg and 2.71 m^2—which are used to derive upper dose limits for weight- or BSA-based dosing.

Products with specified NDCs and maximum allowed quantitiesNDC

50242-0135-01	tocilizumab (Actemra) 20 mg/mL vial — max 40 mL
50242-0136-01	tocilizumab (Actemra) 20 mg/mL vial — max 40 mL
50242-0137-01	tocilizumab (Actemra) 20 mg/mL vial — max 40 mL
64406-0022-01	tocilizumab-bavi (Tofidence) 20 mg/mL — max 40 mL
64406-0023-01	tocilizumab-bavi (Tofidence) 20 mg/mL — max 40 mL
64406-0024-01	tocilizumab-bavi (Tofidence) 20 mg/mL — max 40 mL
65219-0590-04	tocilizumab-aazg (Tyenne) 20 mg/mL — max 40 mL
65219-0592-10	tocilizumab-aazg (Tyenne) 20 mg/mL — max 40 mL
65219-0594-20	tocilizumab-aazg (Tyenne) 20 mg/mL — max 40 mL
50242-0060-01	bevacizumab (Avastin) 100 mg/4 mL vial — max 12 mL

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Evidence Basis & Thresholds

Key Thresholds & Evidence Items

Adult body weight (95th percentile)140 kg

Adult BSA (95th percentile)2.71 m^2

Maximum Allowed Volume per NDC billing0.6 mL

Most intravitreal agents: Maximum doses per year per eyeMost intravitreal agents: Maximum of 12 doses per year per eye

Evidence / population reference95th percentile adult weight and BSA from Fryar (used to create upper dose limits)

Coverage is based on labeled indications and published clinical evidence (for example, systematic reviews/RCTs and accepted compendia); the policy cites the Fryar population reference for the 95th percentile adult weight/BSA. Clinical evidence supports use of the listed medications up to the policy maxima but does not support dosing beyond those maxima.

Background

The policy establishes upper dose limits using FDA labeling, published clinical evidence, and population percentiles (95th percentile adult weight = 140 kg, BSA = 2.71 m^2). Use within the listed maximum HCPCS units or NDC quantities is considered supported; use beyond those maximums is unproven or considered not medically necessary.

Definitions

Maximum AllowedThe maximum volume (in mL) allowed to be billed for the NDC as stated in this section.

PFSPre-filled syringe (prefilled syringe).

NDCNational Drug Code.

Revision History

01/01/2026Material — Added

Revised list of applicable drug products; added denosumab-bmwo (Stoboclo & Osenvelt), eculizumab-aagh (Epysqli), eculizumab-aeeb (Bkemv), and ustekinumab-srlf (Imuldosa). Detail: Also added maximum allowed quantities by HCPCS units and NDCs for these products and added maximum allowed frequencies for these products.

01/01/2026Material — Added

Updated Testopel HCPCS codes: added J1073 and removed S0189. Detail: Added maximum allowed quantities for Bkemv (HCPCS Q5152), Epysqli (Q5151), Imuldosa (Q5098), Osenvelt and Stoboclo (Q5157).

01/01/2026Material — Added

Specific NDCs added for each product as listed in policy history. Detail: Added maximum allowed quantities for NDC billing for multiple products including Bkemv (NDC 55513-0180-01), Epysqli (51759-0208-13), Imuldosa (51407-0929-11; 51407-0930-11; 51407-0931-11; 69448-0017-63; 69448-0018-63; 69448-0019-26), Osenvelt (72606-0038-01), and Stoboclo (72606-0037-01).

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency – Individual Exchange Medical Benefit Drug Policyopen_in_new

Policy CodePolicy N/A

Change TypeAnnual edits — HCPCS/NDC additions and quantity/frequency updates

Effective Date

Next Review Date

SourceLink

On This Page

Use beyond limits: Use beyond such established maximum dosages is not supported by clinical evidence and increases risk of adverse events without additional clinical benefit.

Testosterone enanthate / Depo-testosterone (testosterone cypionate): Replacement therapy suggested dosing 50–400 mg every 2 to 4 weeks, not to exceed 400 mg per 14 days.<=400 mg per 14 days

Dysport (abobotulinumtoxinA): Administered no more frequent than every 12 weeks.>=12 weeks

Entyvio (vedolizumab): Crohn's disease/ulcerative colitis: administered at 0, 2, and 6 weeks, then every 8 weeks thereafter.every 8 weeks maintenance

Eylea (aflibercept) and Eylea HD: DME/DR/nAMD/ROP indications: labeled intravitreal schedules (examples: Eylea DME 2 mg every 4 weeks for first 20 weeks then every 8 weeks; many intravitreal agents max 12 doses per year per eye).Max 12 doses/year/eye where specified

Fasenra (benralizumab): Once every 4 weeks for first 3 doses, then once every 8 weeks.initial Q4wk x3 then Q8wk

Pegfilgrastim products (Neulasta, Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca, Ziextenzo): Oncology indications: administered once every 2 weeks.every 2 weeks

Hemlibra (emicizumab-kxwh): Hemophilia A: 3 mg/kg once weekly x4 weeks then maintenance options including 1.5 mg/kg weekly or 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks.per weight-based schedule

Infliximab and biosimilars (Remicade, Avsola, Inflectra, Renflexis): Dosing examples: ankylosing spondylitis at 0, 2, 6 weeks then every 6 weeks; for Crohn's/other indications at 0,2,6 weeks then every 8 weeks; maintenance may be adjusted per label.per label schedules

Keytruda (pembrolizumab): Oncology: administered once every 3 weeks.Q3wk

Krystexxa (pegloticase): Chronic gout: administered once every 2 weeks.Q2wk

Leqvio (inclisiran): Hyperlipidemia: initial, 3 months later, then every 6 months.initial + 3mo then q6mo

Lucentis / Byooviz / Cimerli (ranibizumab products): Intravitreal monthly dosing for many retinal indications with maximum of 12 doses/year/eye and retreatment per label.Max 12 doses/year/eye

Ocrevus (ocrelizumab): MS: IV initially and 2 weeks later, then every 6 months.q6mo after loading

Pavblu (aflibercept-ayyh): Follows aflibercept intravitreal schedules (examples mirror Eylea dosing) with maximum 12 doses/year/eye.Max 12 doses/year/eye

Prolia / Denosumab products (Prolia/Jubbonti/Stoboclo): Osteoporosis: administered once every 6 months; oncology denosumab products (Xgeva/Osenvelt/Wyost) typically once every 4 weeks for oncology indications.Prolia Q6mo; Xgeva Q4wk for oncology

Qalsody (tofersen): ALS: every 14 days for 3 doses, then 100 mg every 28 days.14-day x3 then q28d

Radicava (edaravone): ALS: initial cycle daily dosing 14 days then 14-day drug-free; subsequent cycles 10 of 14 days with 14-day drug-free periods.per labeled cycle

Rystiggo (rozanolixizumab-noli): Myasthenia gravis: once weekly for 6 weeks; subsequent cycles based on clinical evaluation.weekly x6 then per eval

Skyrizi (risankizumab): Crohn's/UC: IV at Week 0,4,8 then SC at Week 12 then every 8 weeks.per label

Tecentriq / Imfinzi / Bavencio (immune checkpoint inhibitors): Typical oncology dosing intervals per product (examples: Tecentriq once every 2 weeks; Imfinzi once every 2 weeks; Bavencio once every 2 weeks).per label

Vabysmo / Vabysmo regimens: Intravitreal regimens with initial monthly dosing then extensions; most patients every 8 weeks; maximum 12 doses/year/eye.Max 12 doses/year/eye

Vyvgart / Vyvgart Hytrulo: Myasthenia gravis: once weekly for 4 weeks; subsequent cycles based on clinical evaluation (Vyvgart Hytrulo also once weekly for CIDP).weekly x4 then per eval

Xeomin / Myobloc / other botulinum toxins: Administered no more frequent than every 12 weeks for many botulinum toxin products.>=12 weeks

Limit NDC billing to maximum allowed per unit (e.g., mg per HCPCS unit or drug-specific unit definitions) as specified in the policy.

Maximum billable volume per NDC unit must not exceed the policy-defined units or vial limits.

Adhere to maximum allowed administration frequencies; do not bill for doses given more frequently than allowed by the policy.

HCPCS and NDC maximum allowed quantities/frequencies are authoritative for reimbursement — verify against member-specific benefit plan.

Use applicable J- and Q- codes for billing the medical benefit drugs listed in this policy.

Billing Rule

Billing Rules: HCPCS & NDC Code Updates

Several HCPCS and NDC codes were added or updated in policy history. When billing, include the specific codes and ensure billed quantities adhere to the corresponding maximums.

Affected HCPCS/Q codes include (examples shown in policy tables): J3262, Q5133, Q5135, J9035, Q5129, Q5107, Q5118, Q5126, J3145, J0585, J0717, J2786, J0589, J3121, J1071, J0586, J3380, J0517, J7170, J9035, J3262
NDC-specific rules: bill NDCs at the maximum allowed NDC volume and quantity as listed; when multiple NDC rules exist for the same product (e.g., pegfilgrastim / Stimufend), follow the NDC-specific maximum volume/quantity for each affected NDC.
Examples of pegfilgrastim-related products with NDC-specific maximums include pegfilgrastim (Neulasta), pegfilgrastim-apgf (Nyvepria), pegfilgrastim-cbqv (Udenyca), pegfilgrastim-fpgk (Stimufend), pegfilgrastim-jmdb (Fulphila), pegfilgrastim-pbbk (Fylnetra), pegfilgrastim-bmez (Ziextenzo).

05/01/2026Material — RevisedLatest

Reflects annual edits and additions. Detail: Updated applicable HCPCS codes list to include J1073, Q5098, Q5151, Q5152, and Q5157.

04/01/2026Administrative — Revised

Administrative linkage to related policy. Detail: 04/01/2026 update: Updated reference link to reflect the current policy title for related policies including Complement C5 Inhibitors.