CurrentUnitedHealthcarePolicy N/A

Medical Benefit Drug Policy — Maximum Dosage and Frequency

Defines maximum dosage per administration and maximum allowed HCPCS units and NDC billing quantities for numerous physician‑administered products for UnitedHealthcare Individual Exchange plans (excludes MA, NV, NY). Dosing beyond listed maxima is considered unproven/not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Drug Policy — Maximum Dosage and Frequency

Policy CodePolicy N/A

Change TypeAdditions and revisions to HCPCS/NDC maxima and frequencies

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit claims with HCPCS units and NDC quantities that do not exceed the policy's listed maximums per administration and document clinical justification if exceeding limits due to patient weight/BSA.

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 by HCPCS units for Bkemv (Q5152), Epmysqli (Q5151), Imuldosa (Q5098), Osenvelt (Q5157), and Stoboclo (Q5157).

Added maximum allowed quantities for NDC billing for Bkemv (55513-0180-01), Epysqli (51759-0208-13), Imuldosa (multiple NDCs), Osenvelt (72606-0038-01), and Stoboclo (72606-0037-01).

Added maximum allowed frequencies for Bkemv, Epysqli, Imuldosa, Osenvelt, and Stoboclo.

Updated applicable HCPCS codes: added J1073*, Q5098, Q5151, Q5152, and Q5157 and removed S0189*.

Added multiple NDCs to the applicable codes list (including 51407-0929-11; 51407-0930-11; 51407-0931-11; 51759-0208-13; 55513-0180-01; 61314-0228-94; 61314-0240-63; 69448-0017-63; 69448-0018-63; 69448-0019-26; 72606-0037-01; 72606-0038-01).

Updated References section to reflect current information.

~150+Drugs with HCPCS limits listed (approx.)

5Products with new max qty/frequency

3States excluded

0.6 mLStandard NDC max volume

2026-01-01Effective date

Policy overview

This UnitedHealthcare Medical Benefit Drug Policy lists maximum per-administration dosages and billing quantity limits (both HCPCS unit maxima and NDC maxima) for numerous physician‑administered products, defines scope as applying to Individual Exchange plans (excludes MA, NV, NY), and states that dosing beyond the specified maxima is considered unproven/not medically necessary. The policy bases the maxima on FDA product labeling, clinical evidence and national compendia, and an anthropometric upper bound set at the 95th percentile adult body weight = 140 kg and 95th percentile adult BSA = 2.71 m^2. Effective and last review date: 2026-01-01.

Coverage criteria & rationale

General Coverage Rationale

Covered when ALL of the following are met:

ALL of the following

Medication administration limits: Medication is administered within the maximum dosage per administration and dosing frequency based upon body surface area or patient weight or a set maximal dosage/frequency independent of patient body size.

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Drug Policy — Maximum Dosage and Frequency

Policy CodePolicy N/A

Change TypeAdditions and revisions to HCPCS/NDC maxima and frequencies

Effective DateJan 1, 2026

Next Review DateN/A

On This Page

Clinical Evidence / Dose Limit Rationale

Policy position on dosing maximums:

ALL of the following

Product-specific maxima source: Maximum doses are product-specific and sometimes disease-state-specific and are defined in FDA-approved product prescribing information and/or national compendia and peer-reviewed resources.
95th percentile basis: This policy creates an upper dose limit based on clinical evidence and the 95th percentile for U.S. adult body weight (140 kg) and body surface area (2.71 m^2).95th percentile: 140 kg; BSA: 2.71 m^2
Source: Fryar 2021 anthropometric reference
Evidence supports up to maxima: Clinical evidence supports use of the medications listed in this policy up to maximum dosages based upon body surface area or patient weight when used according to labeled indications or supported by published evidence.
No support beyond maxima: Clinical evidence does not support use of the medications listed beyond maximum dosages based upon body surface area or patient weight; use beyond such limits increases risk without added benefit.

HCPCS & NDC coding and maximums

HCPCS - Maximum Allowed units (by medication)HCPCSCovered

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

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HCPCS - Applicable HCPCS/J-codes (reference)mixed

J3262	tocilizumab
Q5133	tocilizumab-bavi
Q5135	tocilizumab-aazg
J9035	bevacizumab
Q5129	bevacizumab-adcd
Q5107	bevacizumab-awwb
Q5118	bevacizumab-bvzr
Q5126	bevacizumab-maly
J3145	testosterone undecanoate
J0585	onabotulinumtoxinA

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NDC - Maximum Allowed billing quantities (selected entries)NDCCovered

55513-0206-01	(preserved entry)
00069-0315-01	(preserved entry)
67457-0991-15	(preserved entry)
00002-7575-01	(preserved entry)
00006-5033-02	(preserved entry)
00006-5034-01	(preserved entry)
00006-5034-02	(preserved entry)
00069-0306-01	(preserved entry)
00078-0734-61	(preserved entry)
47335-0177-95	(preserved entry)

1–10 of 40

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NDC - Product / How supplied & MAQ (reference)NDC

(Applicable FDA NDC/Labelled Product List)	See reference list for full NDC/product supply details
(NDC / Product Identifiers (reference list))	Comprehensive labelled product list included as reference

Policy changes effective 2026-01-01: added HCPCS/J-codes J1073, Q5098, Q5151, Q5152, Q5157 and removed S0189. NDC additions include Imuldosa, Epysqli, Bkemv, Osenvelt, and Stoboclo. These code updates and NDC additions are effective with the revision dated 2026-01-01.

Billing rules, documentation & denial risk

Billing Rule

Adhere to HCPCS unit maximums

Adhere to Maximum Allowed Quantities for HCPCS-billed claims. Providers must follow the published HCPCS unit maximums for each medication. Units reflect the HCPCS unit definition (e.g., mg or IU per HCPCS unit) and billing beyond these limits may be denied.

applies to HCPCS-billed claims; units reflect per-unit mg equivalence
HCPCS unit maximums are enforced per administration

Billing Rule

NDC billing quantity limits

Adhere to Maximum Allowed Quantities for NDC billing. Report the product NDC on the claim and limit the billed quantity to the NDC-specific Maximum Allowed quantity. Absence of an NDC on the claim does not imply exemption from quantity limits.

limit quantity billed to listed Maximum Allowed mL or vials per NDC; absence of NDC does not imply exemption.
report NDC and adhere to maximum allowed quantity per NDC

Denial Risk

Doses beyond maximum are not medically necessary

Doses billed beyond the published maximum allowed quantities or frequencies are considered not medically necessary and may be denied. Claims exceeding the maximums without required documentation or justification risk claim denial.

Documentation Required

Clinical justification for exceeding maxima

When billing a quantity that exceeds the standard maximum allowed units because of patient size, document clinical justification in the medical record.

Document patient-specific weight and/or body surface area (BSA)
Provide rationale for doses exceeding limits when patient weight > 140 kg or BSA > 2.71 m^2

Billing Rule

Pegfilgrastim / Stimufend NDC-specific limits

Certain pegfilgrastim (Stimufend) NDCs have an NDC-specific billed quantity limit. Limit billed quantity to 0.6 mL per listed NDC and follow the "How Supplied" description when submitting claims.

NDC 69097-0802-37
NDC 76420-0650-01
NDC 65219-0371-10
How Supplied = 6 mg/0.6 mL PFS
Limit billed quantity to 0.6 mL per NDC

Billing Rule

Follow Maximum Allowed Frequencies

Follow the listed Maximum Allowed frequencies for medications. Frequency limits are enforced in addition to quantity limits; billing that exceeds the maximum allowed frequency may be denied.

Apply maximum allowed quantities and frequencies as published
Follow listed maximum frequency limits per medication

Documentation Required

Reference member-specific benefit plan

Reference the member-specific benefit plan and applicable state mandates before billing. Coverage, quantity limits, and frequency enforcement may vary by member plan or state; check the member's plan benefits and any state-specific requirements.

Check member-specific benefit plan for coverage limits and state mandates
NDC Maximum Allowed Quantity Enforcement may vary by plan

Billing Rule

Apply maximum allowed quantities and frequencies

Apply HCPCS and NDC-specific maximum allowed quantities and frequencies. Note: HCPCS code updates (including codes for Testopel) should be monitored; use current HCPCS/NDC coding when submitting claims to ensure proper quantity enforcement.

Adhere to NDC-specific maximum allowed quantities and how supplied descriptions when billing
Limit billing quantity per NDC and report the NDC on the claim
Monitor HCPCS code updates for Testopel and other products

Document changes & revisions

2026-01-01MaterialLatest

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

2026-01-01Material

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

2026-01-01Material

Imuldosa NDCs: 51407-0929-11, 51407-0930-11, 51407-0931-11, 69448-0017-63, 69448-0018-63, 69448-0019-26; added maximum allowed NDC billing quantities for Bkemv (55513-0180-01), Epysqli (51759-0208-13), Imuldosa (multiple NDCs), Osenvelt (72606-0038-01), and Stoboclo (72606-0037-01).

2026-01-01Material

Added maximum allowed frequencies for Bkemv, Epysqli, Imuldosa, Osenvelt, and Stoboclo.

2026-01-01Material

Updated applicable HCPCS codes: added J1073*, Q5098, Q5151, Q5152, and Q5157 and removed S0189*.

2026-01-01Material

Updated References section to reflect current information.

FAQs / common questions

What if the patient’s weight or BSA exceeds the 95th percentile (e.g., >140 kg or BSA >2.71 m2)? Document the patient’s actual weight/BSA and the clinical rationale supporting doses or quantities that exceed the standard maxima; the policy allows consideration of higher units/vials when individual patient anthropometrics justify them and supporting clinical documentation is provided.

What to bill when an NDC is not listed in the NDC table? Absence of an NDC in the NDC list does not exempt the claim—the provider must still limit billed quantity to the policy’s maximum allowed per administration (HCPCS unit maxima) or the applicable NDC maximum if listed; for NDC‑billed claims providers should bill the product presentation and quantity (mL or vials) and adhere to the policy MAQ or provide documentation if an exception is clinically justified.

OpenPayer

Medical Benefit Drug Policy — Maximum Dosage and Frequency

Policy overview

Coverage criteria & rationale

HCPCS & NDC coding and maximums

Billing rules, documentation & denial risk

Key definitions

Clinical evidence & sources

Document changes & revisions

FAQs / common questions