CurrentUnitedHealthcarePolicy CS2025D0034AQ

Maximum Dosage and Frequency

Defines maximum dosage per administration and maximum dosing frequency (expressed as HCPCS units and NDC billing limits) for a broad list of medical-benefit injectable/infusible drug products administered by a medical professional; applies to UnitedHealthcare Community Plan commercial policy except where state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency

Policy CodePolicy CS2025D0034AQ

Change TypeAdded/Updated HCPCS & NDC limits; revised product dose/unit limits

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders must administer medications within the maximum per-administration dosage and dosing frequency specified (HCPCS units or NDC maximums); claims exceeding these limits are considered beyond policy-supported dosing and may be denied.

POLICY UPDATE CHANGES

Revised list of applicable drug products; added aflibercept-ayyh (Pavblu), axatilimab-csfr (Niktimvo), tocilizumab-aazg (Tyenne), tocilizumab-bavi (Niktimvo/Tofidence), ustekinumab-aauz (Otulfi), ustekinumab-aekn (Selarsdi), ustekinumab-auub (Wezlana), ustekinumab-ttwe (Pyzchiva).

Added maximum allowed quantities for Niktimvo (J9038), Otulfi (Q9999), Pyzchiva (Q9996/Q9997), Selarsdi (Q9998), Tofidence (Q5133), Tyenne (Q5135), Wezlana (Q5137/Q5138).

Changed maximum dosage per administration and units allowed for Omvoh (mirikizumab-mrkz) from 300 mg (300 HCPCS units) to 900 mg (900 HCPCS units).

Revised Soliris (eculizumab) maximum units allowed from 120 HCPCS units (10 mg/unit) to 600 HCPCS units (2 mg/unit).

Added maximum allowed quantities for specific NDCs for Niktimvo (axatilimab-csfr) and others (NDC list truncated in this part).

Revised list of applicable drug products to add multiple biosimilar/biologic products including Pavblu, Niktimvo, Tyenne, Tofidence, Otulfi, Selarsdi, Wezlana, Pyzchiva.

Added maximum allowed quantities by HCPCS units for multiple new products (Niktimvo, Otulfi, Pyzchiva, Selarsdi, Tofidence, Tyenne, Wezlana).

Added maximum allowed quantities for NDC billing for the same listed products with enumerated NDCs.

Revised maximum dosage and unit limits for Omvoh (mirikizumab-mrkz) and Soliris (eculizumab).

Added maximum allowed frequencies for multiple products including Niktimvo, Otulfi, Pavblu, Pyzchiva, Selarsdi, Tofidence, Tyenne, Wezlana.

Revised list of applicable diagnoses for Omvoh and Susvimo.

Updated References section to reflect current information.

100+Products with HCPCS limits

9New/Added HCPCS codes

27New/Added NDC entries

140 kg / 2.71 m2Upper-limit basis (weight/BSA)

3Products with revised dose/unit limits mentioned

Coverage Summary & Scope

This Medical Benefit Drug Policy (Policy Number CS2025D0034AQ, effective 2025-07-01) defines upper dose limits and maximum administration frequencies for a broad list of medical-benefit injectable and infusible drug products administered by a medical professional. Upper dose limits are product-specific and are derived from FDA prescribing information, national compendia, and published clinical evidence, and where applicable are expressed based on weight- or body-surface-area–based dosing or fixed maximal dosages. To set population-based caps, this policy uses the U.S. adult 95th percentile weight of 140 kg and BSA of 2.71 m2 as the anthropometric basis for many upper dose limits; use within the stated maximum dosages and frequencies is supported, while use beyond those limits is considered unproven or not medically necessary unless clinically justified. Scope: defines maximum dosage per administration (HCPCS units) and maximum dosing frequency and NDC billing limits for a wide set of injectable/infusible products and applies to UnitedHealthcare Community Plan medical benefit coverage (commercial policy) except where state-specific exceptions are noted.

Maximum Allowed Frequencies (per drug)

Clinical Evidence-based Maximum Dose Limits

Adult 95th percentile weight140 kg

Adult 95th percentile BSA2.71 m2

Maximum annual intravitreal doses per eyeMaximum of 12 doses per year per eye

Omvoh max dose per administration900 mg

Omvoh max HCPCS units900 HCPCS units

Soliris max HCPCS units600 HCPCS units (2 mg per unit)

The policy bases dosing limits on primary evidence sources including FDA-approved product labeling and national compendia, supplemented by peer-reviewed and authoritative sources (e.g., anthropometric data from Fryar et al.); references have been updated in the policy References section to reflect current prescribing information and other supporting materials.

Applicable Codes and Unit Limits

Provider Actions & Billing Requirements

Documentation Required

Adhere to maximum dosage/frequency limits

Providers must administer medications within the maximum per-administration dosage and frequency limits listed in this policy. Claims submitted for units or administrations that exceed the stated per-administration maximums or allowed frequency caps may be denied. HCPCS unit caps and NDC-specific unit maximums apply as published in the applicable code lists and must be followed when billing.

Claims exceeding per-administration dosage or frequency limits may be denied.
Refer to HCPCS unit caps and NDC unit maximums when calculating billed units.

Prior Authorization

Exceptions for patients >95th percentile

Exceptions for doses above the policy upper limits may be considered for patients with body weight greater than the 95th percentile (approximately >140 kg) or body surface area (BSA) greater than 2.71 m2. For exception consideration, submit documentation that supports the medical necessity of a higher dose (weight/BSA measurements, clinical rationale) with the prior authorization request.

Background, Definitions & Evidence Basis

Background: This policy establishes upper dose limits for many medical-benefit injectable and infusible drugs using labeled indications and published clinical evidence as the primary basis. Upper limits are product- and indication-specific and may be weight- or BSA-based or fixed; the policy creates population-based caps using the 95th percentile adult weight (140 kg) and BSA (2.71 m2) to define many maximum dosages. Use within these limits is supported by labeling or evidence; dosing beyond these limits is considered unproven or not medically necessary unless an exception is documented (for example, individual patients with weight > 140 kg or BSA > 2.71 m2). The policy and references were updated effective 07/01/2025 to add new HCPCS/Q-codes and NDC entries and to revise several product-specific unit and frequency limits.

HCPCS/J-code (definition)Healthcare Common Procedure Coding System codes used for billing injectable and infused drugs

Q-code (definition)Temporary national codes for biosimilars or other products reported under HCPCS

Population basis95th percentile adult body weight 140 kg and BSA 2.71 m2 (Fryar, 2021)

Policy Update Changes

AddedLatest

Revised list of applicable drug products; added aflibercept-ayyh (Pavblu), axatilimab-csfr (Niktimvo), tocilizumab-aazg (Tyenne), tocilizumab-bavi (Tofidence), ustekinumab-aauz (Otulfi), ustekinumab-aekn (Selarsdi), ustekinumab-auub (Wezlana), ustekinumab-ttwe (Pyzchiva).

AddedLatest

Added maximum allowed quantities for Niktimvo (J9038), Otulfi (Q9999), Pyzchiva (Q9996/Q9997), Selarsdi (Q9998), Tofidence (Q5133), Tyenne (Q5135), Wezlana (Q5137/Q5138).

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency

Policy CodePolicy CS2025D0034AQ

Change TypeAdded/Updated HCPCS & NDC limits; revised product dose/unit limits

Effective DateJul 1, 2025

Next Review Date

On This Page

Billing Rule

Report HCPCS/NDC within allowed units

Bill within the HCPCS unit limits shown in this policy and adhere to any NDC-specific maximums. When an NDC is billed instead of a HCPCS, follow the NDC-specific maximum allowed units and note differences in unit definitions (for example, HCPCS units may represent mg or vials; NDC billing may use different unit measures).

Bill HCPCS codes within the listed HCPCS unit caps.
If billing by NDC, follow the NDC-specific maximum unit allowances and unit definitions.
NDC billing may differ from HCPCS unit interpretation — verify correct unit conversion before billing.

Billing Rule

Adhere to maximum allowed frequencies

Follow the maximum allowed frequencies for administrations as listed (for example, intravitreal agents may have specific per-eye and per-timeframe caps). Claims for administrations beyond the stated frequency caps are subject to denial if no exception documentation or authorization is provided.

Adhere to listed frequency caps (including per-eye limits for intravitreal injections).
Claims beyond the allowed frequency may be denied without supporting documentation or authorization.

Documentation Required

Use FDA labeling and compendia for dosing rationale

When dosing approaches policy limits based on weight or BSA, document the FDA labeling, dosing rationale, and any compendia or peer-reviewed literature that support the selected dose. Include measured patient weight and/or BSA calculations in the medical record.

Document patient weight and/or BSA when used to justify dosing near or above policy caps.
Include FDA labeling or compendia references that support the dosing rationale.

Billing Rule

Use correct HCPCS/Q-codes or NDC identifiers

Bill using the correct HCPCS (including Q-codes) or NDC identifiers listed in this policy. Inclusion of a code in the policy does not guarantee coverage; providers must still meet the policy’s dosing and frequency requirements and any prior authorization rules. The following codes were added/updated in this policy: J3262, Q5133, Q5135, J9035, Q5129, Q5107, Q5118, Q5126, J3145, J0585, J0717, J2786, J0589, J3121, J1071, J0586.

Bill with the HCPCS/Q-code or NDC shown for the product administered.
Code inclusion in the policy is not a guarantee of coverage; dosing/frequency and authorization rules still apply.
Added/updated codes: J3262, Q5133, Q5135, J9035, Q5129, Q5107, Q5118, Q5126, J3145, J0585, J0717, J2786, J0589, J3121, J1071, J0586

Documentation Required

Reference federal/state/contractual requirements

Providers should verify and follow any applicable federal, state, or contractual rules that may supersede this policy before applying maximum dosage or frequency limits. State-specific policies or contractual provisions may modify allowable doses, frequencies, or prior authorization requirements.

Check federal, state, and contract-specific rules that may affect application of these limits.

Anthropometric reference

95th percentile adult weight = 140 kg; BSA = 2.71 m^2 (Fryar et al., 2021)

Source of dosing limitsFDA prescribing information and national compendia / package inserts and peer-reviewed references listed in policy references

Changed maximum dosage per administration and units allowed for Omvoh (mirikizumab-mrkz) from 300 mg (300 HCPCS units) to 900 mg (900 HCPCS units).

RevisedLatest

Revised Soliris (eculizumab) maximum units allowed from 120 HCPCS units (10 mg/unit) to 600 HCPCS units (2 mg/unit).

AddedLatest

Added maximum allowed quantities for specific NDCs for Niktimvo (axatilimab-csfr) and others (NDC list truncated in this part).

RevisedLatest

Revised list of applicable drug products to add multiple biosimilar/biologic products including Pavblu, Niktimvo, Tyenne, Tofidence, Otulfi, Selarsdi, Wezlana, Pyzchiva.

AddedLatest

Added HCPCS codes J9038, Q5133, Q5135, Q5137, Q5138, Q5147, Q9996-Q9999 and associated quantity limits.

AddedLatest

Added NDC lists for each product (see code_groups) with maximum allowed quantities for NDC billing.

RevisedLatest

Omvoh per administration changed from 300 mg to 900 mg and units from 300 to 900; Soliris units changed from 120 (10 mg/unit) to 600 (2 mg/unit).

07/01/2025AddedLatest

Added maximum allowed frequencies for multiple products including Niktimvo, Otulfi, Pavblu, Pyzchiva, Selarsdi, Tofidence, Tyenne, Wezlana effective 07/01/2025.

RevisedLatest

Omvoh: Crohn's disease added. Susvimo: diabetic macular edema (DME) added.

ClarifiedLatest

Updated References section to reflect current information.