UnitedHealthcare maximum dosage limits Policy Update

Coverage Criteria

Within-policy dosing (covered)

Covered when doses are within the following limits

Primary rule: Use of medications included in this policy when given within the maximum dosage and/or frequency based upon body surface area or patient weight or a set maximal dosage and frequency independent of patient body size are supported when used according to labeled indications or supported by published clinical evidence (e.g., well-designed RCTs, systematic reviews, NCCN).per-product maxima listed in HCPCS/NDC tables

Documentation must support administered dose and applicable product-specific limits; see HCPCS/NDC tables for exact per-administration maxima

Beyond-policy dosing (not medically necessary)

Not covered / not medically necessary

Beyond limits: Use of medications or dosages beyond labeled indication or the policy's maximum dosages/frequencies is considered unproven and not medically necessary unless strong supporting evidence or justification is provided.exceeds per-product maxima or exceeds 95th percentile weight/BSA rationale (140 kg / 2.71 m2)

Policy notes that in some cases the maximum allowed units may exceed the upper-level limit for an individual patient with body weight >140 kg or BSA >2.71 m2; such cases require documentation/justification.

General frequency/quantity basis

Coverage uses listed maximum quantities and frequencies

Use FDA or evidence-based frequencies: When an indication is covered by UnitedHealthcare with FDA dosing, the allowed frequencies are based on FDA-approved prescribing information; for indications covered without FDA approved dosing, frequencies are derived from available clinical evidence.

These frequencies guide authorization and NDC/HCPCS billing decisions; list may change and is not necessarily inclusive of all products.

Example product frequency rules

Agent-specific maximum frequencies and limits (examples from fragment)

Intravitreal agents for retinal conditions: Many intravitreal anti-VEGF agents (e.g., bevacizumab/Avastin and ranibizumab/Lucentis and biosimilars) have recommended near-monthly initial dosing with a maximum of 12 doses per year per eye; subsequent intervals may be extended per product guidance.12 doses/year per eye

See specific agent rows for exact dosing cadence

Systemic biologics and oncology agents: Systemic biologic and oncology agents have product-specific cadences ranging from weekly to every 6 months (examples: trastuzumab administered once weekly; infliximab induction at 0,2,6 weeks then maintenance intervals as specified; pegfilgrastim products administered once every 2 weeks or per labeling; Leqvio initial, 3 months, then every 6 months).variable per product

Exact frequency per product shown in Maximum Allowed Frequencies list

Maximum allowed frequencies / dosing schedules

Covered when administered no more frequently than the listed maximum frequency or as specified schedule below for each medication

Medication-specific schedules: Apply medication-specific maximum administration schedules exactly as listed (examples extracted): trastuzumab products — administered once every week; infliximab products — induction at weeks 0, 2, and 6 then maintenance intervals per indication (e.g., every 6–8 weeks or as specified, with some indications permitting as often as every 4 weeks); ranibizumab/Susvimo and other intravitreal agents — typically once monthly for initial treatment with maximum of 12 doses/year per eye or implant-based schedules (e.g., Susvimo every 24 weeks); pegfilgrastim products — administered once every 2 weeks; Prolia/Jubbonti (denosumab for osteoporosis) — administered once every 6 months; Ultomiris (ravulizumab) — induction then every 4–8 weeks depending on weight; many other agents have defined induction and maintenance cadences—use the per-medication entry as authoritative.per-medication schedule

Each medication entry must be applied exactly as written; do not generalize across drug classes.

Maximum dosage coverage criteria

Covered when used up to product-specific maximum dosages based on body weight or body surface area

Dose-limit requirement: Medication dosing must not exceed the product-specific maximum dosage determined by FDA labeling or clinical evidence and the policy's upper dose limits (the policy uses the 95th percentile adult weight 140 kg and BSA 2.71 m2 to derive an upper limit where applicable).see product-specific thresholds and 95th percentile parameters

Clinical evidence supports use up to these maximum dosages; use beyond these limits is not supported and increases risk of harm.

Continued use of a medication or dosages beyond labeled indications or other published clinical evidence is considered not medically necessary. This policy establishes an upper dose limit based on clinical evidence and the 95th percentile adult body weight and body surface area (140 kg; 2.71 m2); individual patients with body weight >140 kg or BSA >2.71 m2 may require individualized consideration where the number of allowed units or vials could exceed the standard upper-level limit.

Absence of a specific NDC from the NDC tables does not mean the product is exempt from the policy's maximum allowed calculations. Allowed NDC quantities are calculated using the maximum dosage information in this policy together with NDC claim billing processes; the NDC lists are not necessarily exhaustive and are subject to change.

Claims requesting quantities that exceed the listed Maximum Allowed for a specified NDC or how‑supplied presentation are not supported by the NDC Maximum Allowed Quantities table and may be denied or adjusted. Providers should bill using the exact NDC and presentation so the policy maximums apply correctly.

The lists of products, frequencies, and NDCs in this document may not be inclusive of all medications or presentations and are subject to periodic update. Absence of an item in these fragments does not imply coverage or noncoverage; consult the full policy and current tables for complete product and NDC entries.

Procedure and diagnosis codes provided in this policy are for reference only. Listing a code does not imply the service described by that code is covered or not covered; benefit coverage is determined by federal, state, or contractual requirements and other applicable policies.

Use of the listed medications beyond the policy's established maximum dosages (based on body weight, BSA, or product-specific maxima) is not supported by clinical evidence and is therefore considered not medically necessary, absent strong supporting evidence or justification. The policy derives upper dose limits using the 95th percentile adult weight/BSA (140 kg; 2.71 m2) and supports use up to, but not beyond, product-specific maxima.

This policy was retired for UnitedHealthcare Louisiana plan membership effective April 1, 2026. The retirement applies to the referenced Louisiana plan; see Policy History for details of the retirement and prior revisions.

Medications administered at dosages or frequencies beyond the policy-defined maxima — whether based on body surface area, patient weight, or fixed per‑administration limits — are considered unproven and not medically necessary because clinical evidence does not support added benefit and indicates increased risk of adverse events.

The policy presents maximum allowed quantities and frequencies as explicit ceilings tied to FDA prescribing information or available clinical evidence. While the fragment does not always use the phrase 'not medically necessary' for every limit, the limits function as the policy's coverage thresholds for billing and authorization decisions.

Administration of medications beyond the defined maximum dosages or frequencies established in this policy — including those derived from the 95th percentile adult weight/BSA (140 kg; 2.71 m2) — is considered not medically necessary absent clear, supportive clinical evidence or individualized justification.

Coding and Product Codes

Maximum Allowed Quantities for National Drug Code (NDC) Billing — Selected NDCsNDC

00574-0821-05	Testosterone enanthate / Depo-Testosterone (testosterone cypionate) NDC included for maximum allowed quantities and billing references — appears in multiple entries (see policy NDC lists).
50242-0135-01	Actemra 20 mg/mL vial.
50242-0136-01	Actemra 200 mg/10 mL vial.
50242-0137-01	Actemra 400 mg/20 mL vial.

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization and Authorization Frequencies

Prior authorization status for these medications is not specified in the excerpt. Providers should verify plan-specific requirements prior to administration and obtain prior authorization when required by the member’s benefit plan or governing state/federal contract.

Prior authorization not specified in this excerpt — confirm with UnitedHealthcare plan or state/federal benefit terms.
Use listed frequencies and maximum allowed quantities when requesting authorization and during utilization review.

Prior Authorization

Use Listed Frequencies for Authorization

Use the listed maximum allowed frequencies in this policy to inform authorization requests and utilization review decisions. Frequencies are based on FDA labeling where available and clinical evidence otherwise; for non-FDA dosing covered by UnitedHealthcare, the listed frequencies are the policy reference.

Follow the "Maximum Allowed Frequencies" section for frequency limits (e.g., dosing intervals and yearly maxima where specified).
Policy frequencies apply for authorization and utilization review; deviations require clinical justification.

Background

Background: This policy provides maximum per‑administration dosage and dosing frequency guidance for medications administered by health care professionals. Most maximums are product‑specific and based on FDA labeling, clinical evidence, or a population upper‑limit (95th percentile adult weight/BSA). The guidance is intended to support utilization review, NDC billing calculations, and prior authorization decisions.

Definitions

inv-69: Maximum allowed dose definition

DefinitionMaximum Allowed Dose = the per-administration dosage or HCPCS unit cap established based on labeled indications, published clinical evidence, and the policy's 95th percentile adult weight/BSA limits

ScopeApplies to product-specific maximums listed in the HCPCS and NDC tables

ImplicationDoses beyond these maximums are considered unproven and may be not medically necessary unless strong justification is provided

inv-70: Maximum Allowed Frequency definition

DefinitionMaximum Allowed Frequency = the maximum recommended administration interval or cadence for a medication based on FDA prescribing information or available clinical evidence

Application

Initial Therapy Criteria

Initial therapy dosing limits

Initial dosing must be within labeled or evidenced-based maxima: Initial administrations should not exceed the maximum per-administration dosages or HCPCS unit limits listed in the policy tables.per-product maxima

Applies to first administration and authorization decisions; documentation should show dosing calculations if weight/BSA used.

Continuation Therapy Criteria

Continuation therapy — beyond-label dosing

Continuation beyond labeled dosing

Continuation: Continued use of a medication or dosages used beyond labeled indication or published clinical evidence is considered not medically necessary.

Requests for continuation at doses beyond policy maxima require strong justification and clinical evidence for review; absent that, continuation is not supported.

Step Therapy

Step	Requirement / Summary
0	No step therapy rules are included in this policy fragment. Consult other UnitedHealthcare policy sections or benefit-specific step therapy edits for any step requirements that may apply.

Step	Requirement / Summary
1	No explicit step therapy requirements are stated in this section of the document; review applicable benefit contract or prior authorization rules for any step edits that may apply to injectable/infused specialty drugs.

Quantity Limits and Per-Administration Caps

inv-76: Multiple product-specific per-administration limits (see HCPCS product tables)

Multiple product-specific HCPCS limitsPolicy lists product-specific per-administration maximums and HCPCS unit caps (see HCPCS product tables in document)

HCPCS unit interpretationHCPCS 'units' are mapped to mg or IU per the product rows (e.g., 1 mg per unit, 10 mg per unit, 5 units per unit for Botox/Dysport as listed)

Use on claimsHCPCS unit caps affect prior authorization and claim adjudication for physician-administered drugs

inv-77: Amvuttra (vutrisiran) — 25 HCPCS units

HCPCS unit cap25 HCPCS units per administration

Product presentation

Site of Care

Note

No explicit site‑of‑care restrictions in this fragment

This fragment does not impose site‑of‑care restrictions; apply NDC/HCPCS maximums and frequencies across infusion center, office, or other applicable outpatient settings per medical benefit billing.

Biosimilar Information

Billing Rule

Bevacizumab and biosimilars listed; no stated product preference

Bevacizumab originator and biosimilar products and corresponding HCPCS/Q‑codes (e.g., J9035, Q5129, Q5107, Q5126) are listed with the same maximum dosing guidance; the policy lists biosimilars where applicable but does not state a biosimilar preference.

Revision History

2026-04-01retiredLatest

Policy retired for Louisiana plan membership; Louisiana membership disenrolled as of Apr. 1, 2026.

2026-01-01revised/added_codes_and_products

Coverage rationale and code lists updated — added denosumab-bbdz (Jubbonti & Wyost) and ustekinumab biosimilars (Steqeyma, Yesintek); added HCPCS codes J1073, Q5099, Q5100, Q5136; added corresponding NDC entries and maximum allowed quantities/frequencies for the new products.

References: The References section was updated to reflect the most current information as noted in the policy history and revision information.

OpenPayer

Maximum Dosage and Frequency (for Louisiana Only)