CurrentUnitedHealthcarePolicy N/A

Maximum Dosage and Frequency (Medical Benefit Drug Policy)

Defines maximum per-administration dosages and HCPCS unit limits for a long list of medications administered by a medical professional under UnitedHealthcare medical benefit plans; applies to Individual Exchange plans except in MA, NV, and NY.

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency (Medical Benefit Drug Policy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionWhen billing medical-administered drugs, use the listed NDC/HCPCS and do not exceed the stated per-administration maximums; document dose and patient weight/BSA when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~150drug products listed (approx.)

140 kg / 2.71 m^2upper limit assumptions

per-administration maximacoverage metric

0.6 mLcommon pegfilgrastim maximum

excludes 3 statesgeographic applicability

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Coverage Criteria and Maximums

Coverage within maximums

Covered when administered at or below the maximum per-administration dosage/frequency specified in this policy and supported by labeled indications or published clinical evidence.

Standard coverage conditions: Dose and frequency are within the listed per-administration maximums (weight- or BSA-based or fixed) AND use is consistent with labeled indications or published clinical evidence.per-agent maxima listed by HCPCS

See drug-specific maximums in the HCPCS tables.

Use beyond maximums

Not covered / not medically necessary when ALL of the following are true

Beyond maxima: Medication is administered beyond the maximum dosages and/or frequency based upon body surface area or patient weight or set maximal dosage independent of patient size; AND such use is not supported by package labeling or published clinical evidence.exceeds per-agent maxima or 95th percentile-based upper limit

Continued use beyond labeled indication or published evidence is considered not medically necessary.

Maximum allowed quantities by product

Products and their Maximum Allowed quantities (examples below):

Neulasta example: Neulasta: How Supplied includes prefilled syringe and vial presentations; NDCs are listed and the policy lists a Maximum Allowed = 0.6 mL (example entry also notes 4 vials in one line).0.6 mL / 4 vials

Source lists multiple NDCs and a maximum allowed volume

Niktimvo example: Niktimvo: How Supplied includes vial and PFS presentations; NDCs listed; Maximum Allowed = 1 vial or 0.6 mL depending on presentation.1 vial or 0.6 mL

Multiple presentations noted

Pegfilgrastim biosimilars (Nyvepria/Fulphila): Multiple pegfilgrastim biosimilars (Nyvepria, Fulphila, Fylnetra) are listed with How Supplied = 6 mg/0.6 mL prefilled syringe (PFS) and a Maximum Allowed = 0.6 mL.

NDC maximum quantity rule

Covered when billed at or below the listed maximum allowed quantity for the specific NDC

NDC-specific quantity limit: The listed NDCs for Fulphila / Fylnetra / Stimufend correspond to 6 mg/0.6 mL prefilled syringes and have a maximum allowed quantity of 0.6 mL.0.6 mL

Use the exact NDC and how-supplied unit when billing.

NDC Maximum Quantity

Coverage limited by the following NDC-specific quantity rule

NDC quantity limitation: For Stimufend (pegfilgrastim-fpgk) entries, the maximum allowed per NDC is 0.6 mL and the product is supplied as 6 mg/0.6 mL prefilled syringe.0.6 mL

Billing must use listed NDCs and may be limited to the stated maximum.

Maximum Allowed Quantity

Covered when the billed NDC and quantity do not exceed the maximum allowed:

Maximum quantity per unit: Billed Stimufend (6 mg / 0.6 mL PFS) NDCs are allowed up to 0.6 mL per unit; claims exceeding 0.6 mL may be denied or adjusted.0.6 mL

NDC examples: 69097-0802-37, 76420-0650-01, 65219-0371-10

This Medical Benefit Drug Policy does not apply to Individual Exchange benefit plans in Massachusetts, Nevada, and New York.

Absence of a specific NDC from the lists in this policy does not mean the product is exempt from the stated maximum allowed quantities; the NDC listings may not be exhaustive and are subject to change.

This section provides the maximum billable quantities for listed National Drug Codes (NDCs) and related how‑supplied details; it does not itself enumerate coverage exclusions or clinical eligibility criteria.

Continued use of a medication or dosages beyond labeled indications or published clinical evidence is considered not medically necessary and is not supported by this policy.

HCPCS / NDC Codes and Unit Limits

Selected HCPCS codes and maxima (group excerpt)HCPCSCovered

J3262	Actemra (tocilizumab) — 1 mg per unit; maximum allowed 800 units (800 mg)
Q5133	Tofidence (tocilizumab-bavi) — 1 mg per unit; maximum allowed 800 units (800 mg)
Q5135	Tyenne (tocilizumab-aazg) — 1 mg per unit; maximum allowed 800 units (800 mg)

Bevacizumab and biosimilarsHCPCSCovered

J9035	Avastin (bevacizumab) — 10 mg per unit; maximum allowed 240 units (15 mg/kg per administration)
Q5129	Vegzelma (bevacizumab-adcd) — 10 mg per unit; maximum allowed 240 units (15 mg/kg per administration)
Q5107	Mvasi (bevacizumab-awwb) — 10 mg per unit; maximum allowed 240 units (15 mg/kg per administration)

Additional HCPCS codes and maxima (excerpt)HCPCSCovered

J3145	Aveed (testosterone undecanoate) — 1 mg per unit; maximum allowed 750 units (750 mg)
J0585	Botox (onabotulinumtoxinA) — 1 unit per HCPCS unit; maximum allowed 600 units
J0717	Cimzia (certolizumab pegol) — 1 mg per unit; maximum allowed 400 units (400 mg)
J2786	Cinqair (reslizumab) — 1 mg per unit; maximum allowed 500 units (3 mg/kg per administration)
J0589	Daxxify (daxibotulinumtoxinA-lanm) — 1 unit per HCPCS unit; maximum allowed 250 units
J3380	Entyvio (vedolizumab) — 1 mg per unit; maximum allowed 300 units (300 mg)
J0517	Fasenra (benralizumab) — 1 mg per unit; maximum allowed 1,680 units (30 mg per administration)
J7170	Hemlibra (emicizumab-kxwh) — maximum allowed 1,680 units (6 mg/kg per administration)
J2506	Neulasta (pegfilgrastim) — 0.5 mg per unit; maximum allowed 12 units (6 mg)
J2507	Krystexxa (pegloticase) — 1 mg per unit; maximum allowed 8 units (8 mg)

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Covered HCPCS Codes (examples)HCPCSCovered

Q5104	Renflexis (listed with maximum 150 HCPCS units; 10 mg per unit)
J0222	Patisiran (Onpattro) (maximum allowed 300 HCPCS units; 30 mg per administration)

Covered HCPCS Codes (detailed list)HCPCSCovered

J0897	Denosumab (Prolia/Xgeva) (60–120 HCPCS units depending on product; 1 mg per unit)
Q5136	Denosumab-bbdz (Jubbonti/Wyost) (60–120 HCPCS units)
Q5157	Denosumab-bmwo (Stoboclo/Osenvelt) (60–120 HCPCS units)
J1304	Tofersen (Qalsody) (100 HCPCS units; 1 mg per unit)
J1301	Edaravone (Radicava) (60 HCPCS units; 1 mg per unit)
J9312	Rituximab (Rituxan) (150 HCPCS units; 10 mg per unit)
Q5119	Rituximab-pvvr (Ruxience) (150 HCPCS units)
Q5115	Rituximab-abbs (Truxima) (150 HCPCS units)
Q5123	Rituximab-arrx (Riabni) (150 HCPCS units)
J9311	Rituxan Hycela (rituximab + hyaluronidase) (160 HCPCS units; 1,600 mg)

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NDC-specific maximum allowed quantities (partial list)NDC

50242-0135-01	Actemra NDC (20 mg/mL vial) — Maximum allowed = 40 mL
50242-0136-01	Actemra NDC — Maximum allowed = 40 mL
50242-0137-01	Actemra NDC — Maximum allowed = 40 mL
64406-0022-01	Tofidence NDC — Maximum allowed = 40 mL
50242-0060-01	Avastin 100 mg/4 mL vial NDC — Maximum allowed = 12 mL
50242-0061-01	Avastin 400 mg/16 mL vial NDC — Maximum allowed = 96 mL
32228-0011-01	Vegzelma 100 mg/4 mL vial NDC — Maximum allowed = 12 mL
32228-0011-03	Vegzelma 400 mg/16 mL vial NDC — Maximum allowed = 96 mL
55513-0206-01	Mvasi 100 mg/4 mL vial NDC — Maximum allowed = 12 mL
55513-0207-01	Mvasi 400 mg/16 mL vial NDC — Maximum allowed = 96 mL

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NDCs (fragment)NDC

64980-0467-99	NDC listed in Maximum Allowed Quantities section
69097-0536-37	NDC listed in Maximum Allowed Quantities section
69097-0537-31	NDC listed in Maximum Allowed Quantities section
69097-0537-37	NDC listed in Maximum Allowed Quantities section
69097-0802-32	NDC listed in Maximum Allowed Quantities section

Depo-Testosterone NDCsNDC

69097-0802-37	Depo-Testosterone NDC
76420-0650-01	Depo-Testosterone NDC
76519-1210-00	Depo-Testosterone NDC
15054-0500-01	Depo-Testosterone NDC

Dysport, Entyvio, Hemlibra NDCsNDC

15054-0500-02	Dysport NDC
64764-0300-20	Entyvio 300 mg vial NDC
00310-1730-30	Hemlibra NDC
00310-1745-01	Hemlibra NDC
50242-0920-01	Hemlibra NDC

Trastuzumab biosimilars NDCsNDC

50242-0132-01	trastuzumab-pkrb NDC
50242-0132-10	trastuzumab-pkrb NDC
63459-0305-47	trastuzumab-pkrb NDC

Omvoh NDCsNDC

67457-0991-15	Omvoh NDC
00002-7575-01	Omvoh NDC
00006-5033-02	Omvoh NDC

Myobloc NDCsNDC

10454-0711-10	Myobloc NDC
10454-0712-10	Myobloc NDC
55513-0190-01	Myobloc NDC
10454-0710-10	Myobloc NDC

Neulasta NDCsNDC

50881-0034-12	Neulasta NDC
50881-0023-11	Neulasta NDC

NDCs listed for NeulastaNDC

69097-0802-37	Neulasta / listed NDC
76420-0650-01	Neulasta / listed NDC
50881-0034-12	Neulasta / listed NDC
50881-0023-11	Neulasta / listed NDC

NDCs listed for pegfilgrastim products and NiktimvoNDC

00069-0324-01	Pegfilgrastim (various biosimilars) NDC; appears under multiple product entries
67457-0833-06	Nyvepria/Fulphila NDC listed
50881-0012-10	Niktimvo / Nyvepria related NDC

Covered NDCs (pegfilgrastim products)NDCCovered

69097-0802-37	NDC listed for Fulphila / Fylnetra / Stimufend (appears across chunks)
76420-0650-01	NDC listed for Fulphila / Fylnetra / Stimufend (appears across chunks)
67457-0833-06	NDC listed for Fulphila / Fylnetra (appears in chunk 72/74)
00069-0324-01	NDC listed for Fylnetra / Stimufend variants (chunk 74/79)
70121-1627-01	NDC listed for Fylnetra Stimufend (chunk 81)
65219-0371-10	NDC listed for Stimufend (chunk 81/89)

National Drug Codes (examples listed)NDC

69097-0802-37	Stimufend NDC (listed)
76420-0650-01	Stimufend NDC (listed)
65219-0371-10	Stimufend NDC (listed / mapped)

Covered NDCs for StimufendNDCCovered

69097-0802-37	Stimufend (pegfilgrastim-fpgk) NDC
76420-0650-01	Stimufend (pegfilgrastim-fpgk) NDC
65219-0371-10	Stimufend (pegfilgrastim-fpgk) NDC

Listed NDCs for Stimufend (pegfilgrastim-fpgk)NDC

69097-0802-37	Stimufend NDC listed in document
76420-0650-01	Stimufend NDC listed in document
65219-0371-10	Stimufend NDC listed in document

Listed NDCs for StimufendNDC

69097-0802-37	Stimufend NDC (listed)
76420-0650-01	Stimufend NDC (listed)
65219-0371-10	Stimufend NDC (listed)

Referenced NDCsNDC

69097-0802-37	NDC listed for Stimufend (pegfilgrastim-fpgk)
76420-0650-01	NDC listed for Stimufend (pegfilgrastim-fpgk)
65219-0371-10	NDC listed for Stimufend (pegfilgrastim-fpgk)

Covered NDC Codes (examples)NDCCovered

69097-0802-37	Stimufend NDC example (listed in document)
76420-0650-01	Stimufend NDC example (listed in document)
65219-0371-10	Stimufend NDC example (listed in document)

Listed NDCs for StimufendNDC

69097-0802-37	Stimufend NDC (example listed)
76420-0650-01	Stimufend NDC (example listed)
65219-0371-10	Stimufend NDC (example listed)

NDCs referencedNDC

69097-0802-37	Stimufend 6mg/0.6mL PFS
76420-0650-01	Stimufend 6mg/0.6mL PFS
65219-0371-10	Stimufend 6mg/0.6mL PFS

Covered NDCs / How suppliedNDCCovered

69097-0802-37	Stimufend NDC listed in document
76420-0650-01	Stimufend NDC listed in document
65219-0371-10	Stimufend NDC listed in document

NDCs referencedNDC

69097-0802-37	NDC referenced for Stimufend (6mg/0.6mL PFS)
76420-0650-01	NDC referenced for Stimufend (6mg/0.6mL PFS)
65219-0371-10	NDC referenced for Stimufend (6mg/0.6mL PFS)

Upper patient weight and BSA — policy upper limits

Upper patient weight≤ 140 kg

Upper patient body surface area (BSA)≤ 2.71 m^2

Billing, Documentation, and Authorization Actions for Providers

Billing Rule

Billing, Documentation, and Authorization Summary

This section summarizes billing, documentation, and authorization actions for providers related to maximum dosage limits, HCPCS unit maxima, and National Drug Code (NDC) billing. Providers must follow the stated maximums when requesting prior authorization and submitting claims. Requests or claims that exceed the documented HCPCS or NDC maximums may be denied or adjusted.

Use HCPCS unit maxima when authorizing or submitting claims — single-administration HCPCS unit allowances listed in this policy should be used for prior authorization and claim submission (examples include J9311 = 160 units for Rituxan Hycela; J9333 = 840 units for Rystiggo).
For NDC billing, submit the specific NDC(s) and how-supplied unit on the claim and follow the listed Maximum Allowed quantity for that NDC (examples: Fulphila/Fylnetra 6 mg/0.6 mL PFS — Maximum Allowed = 0.6 mL; Neulasta NDCs — Maximum Allowed = 0.6 mL and up to 4 vials as listed).
NDC allowed quantities are calculated from the policy maximum dosage information and the NDC claim billing process — absence of an NDC in the list does not mean it is exempt from maximums.
Providers must document the administered dose and, when dosing is weight- or BSA-based, include the patient weight or body surface area and medical justification in the medical record or prior authorization submission.

Per-Administration Quantity Limits (Selected Products)

Step	Requirement
1	Use listed maximums when determining step or substitution quantities for billing

tocilizumab — per-administration HCPCS maximum

tocilizumab (Actemra/Tofidence/Tyenne)800 (HCPCS units per administration)

Unit definition1 mg per HCPCS unit for tocilizumab entries

Billing noteUse HCPCS unit maxima when authorizing or submitting claims

bevacizumab — per-administration HCPCS maximum

bevacizumab (Avastin and biosimilars)240 (HCPCS units per administration)

Unit definition10 mg per HCPCS unit listed in HCPCS table

Per-administration basis

Biosimilar Notes and Pegfilgrastim Guidance

Billing Rule

bevacizumab (Avastin) biosimilar note

Bevacizumab (Avastin) and multiple biosimilars are listed with specific NDCs and Maximum Allowed volumes (examples: 100 mg/4 mL vials — Maximum Allowed = 12 mL; 400 mg/16 mL vials — Maximum Allowed = 96 mL).

Use the NDC-specific Maximum Allowed mL values when billing bevacizumab or its biosimilars.

Billing Rule

pegfilgrastim reference biologic and biosimilars

Pegfilgrastim reference biologic and biosimilars (e.g., Fulphila, Fylnetra, Nyvepria) are listed with How Supplied = 6 mg/0.6 mL prefilled syringe and a Maximum Allowed = 0.6 mL for NDC billing.

Bill using the listed NDC and the 6 mg/0.6 mL PFS presentation; do not exceed 0.6 mL per unit.

Billing Rule

Stimufend identified as pegfilgrastim-fpgk

Stimufend is identified as pegfilgrastim‑fpgk supplied as 6 mg/0.6 mL prefilled syringe with a Maximum Allowed = 0.6 mL per NDC; use the listed NDCs for billing.

Policy Background

This policy establishes per‑administration maximum dosages and dosing frequencies for medications administered by a medical professional. Limits are set using labeled indications and published clinical evidence, and when applicable are informed by body surface area or patient weight with an upper‑level assumption of 140 kg and 2.71 m2 for adult patients.

Definitions and Key Terms

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency (Medical Benefit Drug Policy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionWhen billing medical-administered drugs, use the listed NDC/HCPCS and do not exceed the stated per-administration maximums; document dose and patient weight/BSA when applicable.

SourceLink

On This Page

NDCs for several biosimilars provided

Basis for upper limits95th percentile adult U.S. weight/BSA (Fryar, 2021) used to set limits

Per-administration maximum dosages — examples

Renflexis (infliximab) per administration150 HCPCS units (10 mg/unit) — per administration = 10 mg/kg

Qalsody (tofersen) per administration100 HCPCS units (1 mg/unit) — per administration = 100 mg

Ultomiris (ravulizumab-cwvz) per administration360 HCPCS units (10 mg/unit) — per administration = 3,600 mg

Depo-Testosterone maximum — NDC vial limit

Depo-Testosterone maximum (NDC examples)Maximum allowed = 3 vials (examples list NDCs: 69097-0802-37, 76420-0650-01, 76519-1210-00, 15054-0500-01)

How supplied (example)500 unit vials (testosterone cypionate) used to determine vial-based maximums

Billing noteNDC-specific maximums are used for NDC billing and may vary by presentation

Dysport maximum

Dysport maximumMaximum allowed = 5 vials (NDC examples listed)

HCPCS referenceDysport (abobotulinumtoxinA) HCPCS J0586 — maximum allowed 300 HCPCS units (per administration 1,500 units; 5 units per HCPCS unit)

Billing noteUse NDC or HCPCS entries to determine applicable limit for claim submission

Entyvio maximum

Entyvio maximumMaximum allowed = 1 vial (300 mg vial; example NDC 64764-0300-20)

HCPCS referenceEntyvio HCPCS J3380 — maximum allowed shown in HCPCS table (300 HCPCS units)

Billing implicationUse listed NDC and vial count when submitting NDC claims

Hemlibra maximum

Hemlibra maximum (per presentation)Maximum allowed = 1 mL / 1 mL / 0.5 mL depending on supplied presentation (30 mg/mL pre-filled pen or PFS; 10 mg/0.5 mL PFS)

NDC examplesNDCs include 00310-1730-30, 00310-1745-01, 50242-0920-01

Billing noteApply the matching how-supplied volume for the billed NDC when determining maximum allowed quantity

trastuzumab-pkrb maximum

trastuzumab-pkrb maximumMaximum allowed = 3 vials (420 mg vial examples; NDCs 50242-0132-01, 50242-0132-10, 63459-0305-47)

How supplied420 mg vial presentation used to determine vial-based maximums

Billing noteUse the specific NDC and listed vial count when submitting claims

Omvoh maximum

Omvoh maximumMaximum allowed = 3 vials (examples include NDCs 67457-0991-15, 00002-7575-01, 00006-5033-02)

How supplied150 mg and 300 mg vial presentations noted; vial-based maximum applies per NDC

Billing noteApply NDC-specific vial limit when billing NDCs for Omvoh

Myobloc maximum — presentation-dependent limits

Myobloc maximum (examples)Maximum allowed varies by presentation: examples include 12 vials / 6 vials / 3 vials depending on NDC and presentation

How supplied examples10,000 units/2 mL vials; 6 mg/0.6 mL PFS; on-body injector presentations shown in NDC section

Billing noteUse the listed NDC and how-supplied unit to determine the applicable maximum

Neulasta maximum

Neulasta maximumMaximum allowed = 0.6 mL (or, in one entry, 4 vials corresponding to 0.6 mL total)

How suppliedExample presentations: 9 mg/0.18 mL vials and 22 mg/0.44 mL vials resulting in 0.6 mL maximum

Billing noteSubmit the specific Neulasta NDC and match the how-supplied volume to the 0.6 mL maximum for claim submission

Maximum Allowed volume — common value

Common maximum allowed volume0.6 mL (listed repeatedly as the maximum allowed volume per unit for many pegfilgrastim products)

Applies toPegfilgrastim products and biosimilars (e.g., Fulphila, Fylnetra, Nyvepria, Stimufend)

Billing implicationUse the How Supplied (6 mg / 0.6 mL PFS) and NDC-specific max (0.6 mL) when submitting claims

Maximum allowed volume per unit

Maximum allowed volume per unit0.6 mL per unit (commonly listed for 6 mg / 0.6 mL prefilled syringes)

Typical how-supplied6 mg / 0.6 mL pre-filled syringe (PFS)

NDC billing noteSubmit the exact NDC and indicate the 0.6 mL unit volume to align with maximum allowed quantity rules

The policy establishes upper dose limits based on clinical evidence and population percentiles (95th percentile adult weight = 140 kg; BSA = 2.71 m²). Individual patients with weight or BSA above these values may require consideration but may still result in additional review.

Prior authorization specifics are not further detailed in this section — this section provides maximums and NDC/HCPCS quantities for billing; providers should follow standard UnitedHealthcare prior authorization processes where applicable.

Claims exceeding the listed HCPCS unit maxima or the listed NDC Maximum Allowed quantities may be denied or adjusted. Continued use beyond labeled indication or beyond the maximums based on published clinical evidence is considered not medically necessary and may be denied.

Documentation Required

NDC Billing and Quantity Requirements

Required NDC billing details and documentation must be included on claims and prior authorization requests to ensure proper adjudication.

Include the exact NDC code(s) and the how-supplied presentation (e.g., vial size or PFS volume) on the claim.
Report the billed quantity consistent with the policy Maximum Allowed quantity for that NDC (examples from policy: Actemra 20 mg/mL vials — Maximum Allowed = 40 mL; Avastin 100 mg/4 mL vial NDCs — Maximum Allowed = 12 mL; Avastin 400 mg/16 mL vial NDCs — Maximum Allowed = 96 mL).
For products supplied as prefilled syringes (e.g., Fulphila/Fylnetra, Stimufend, Fylnetra — 6 mg/0.6 mL PFS), submit the 0.6 mL how-supplied unit and reflect the Maximum Allowed = 0.6 mL on the claim.
Neulasta NDCs: list the NDC(s) used and reflect Maximum Allowed = 0.6 mL and the allowed vial counts as specified in the policy.

Denial Risk

Quantity Limit Enforcement and Denial Risk

Enforcement and denial risk related to exceeding maximums.

Claims that exceed the Maximum Allowed quantities for HCPCS units or for NDC billing as listed in this policy may be subject to denial or adjustment.
The policy lists specific examples where the Maximum Allowed quantity is capped (e.g., many pegfilgrastim biosimilars and originator products capped at 0.6 mL per supplied PFS).
If a provider submits doses beyond the policy maximums without supporting documentation (dose, patient weight/BSA, clinical justification), the claim or prior authorization may be denied as not medically necessary.

Note

Provider Operational Guidance

Operational notes for providers preparing authorizations and claims.

When dosing is weight- or BSA-based, include the patient weight (kg) or BSA (m²) and the calculation used to derive the administered dose.
If requesting coverage above the policy maximums due to patient-specific factors (e.g., weight > 140 kg or BSA > 2.71 m²), provide detailed medical justification and documentation to support medical necessity.
Use the HCPCS unit maxima table entries for single-administration limits when requesting prior authorization (e.g., J1602 golimumab — maximum per administration 2 mg/kg, maximum allowed units listed in the HCPCS table).
Remember that absence of an NDC in the policy list does not imply allowance of quantities beyond the policy maximums; all NDC billing is subject to the policy's Maximum Allowed rules.

Per administration = 15 mg/kg (HCPCS maximum shown as 240 units)

onabotulinumtoxinA (Botox) — HCPCS maximum

onabotulinumtoxinA (Botox)600 (HCPCS units per administration)

Unit definition1 unit per HCPCS unit for onabotulinumtoxinA

Per-administration basisPer administration = 600 units (documented in HCPCS table)

reslizumab (Cinqair) — HCPCS maximum

reslizumab (Cinqair)500 (HCPCS units per administration)

Unit definition1 mg per HCPCS unit; per administration = 3 mg/kg

Billing noteApply HCPCS maximum (500 units) for per-administration limit

pegloticase (Krystexxa) — HCPCS maximum

pegloticase (Krystexxa)8 (HCPCS units per administration)

Unit definition1 mg per HCPCS unit (0.1 mg per unit referenced in some listings) — policy lists 8 mg max

Billing noteUse HCPCS J2507 maximum of 8 units for per-administration billing

denosumab (Prolia/Xgeva) — HCPCS maxima

denosumab (Prolia/Xgeva)Prolia = 60; Xgeva = 120 (HCPCS units per administration)

Unit definition1 mg per HCPCS unit for denosumab entries

Product distinctionProlia and Xgeva have different per-administration maxima (60 vs 120)

Renflexis (infliximab) — HCPCS maximum

Renflexis (infliximab)150 (HCPCS units per administration)

Unit definition10 mg per HCPCS unit listed for Renflexis

Per-administration basisPer administration = 10 mg/kg referenced; use 150-unit cap

Onpattro (patisiran) — HCPCS maximum

Onpattro (patisiran)300 (HCPCS units per administration)

Unit definitionListed as 0.1 mg per unit in some tables; HCPCS max shown as 300 units (30 mg)

Billing noteUse HCPCS J0222 maximum of 300 units when authorizing/submitting claims

Prolia — HCPCS maximum

Prolia (denosumab)60 (HCPCS units per administration)

Unit definition1 mg per HCPCS unit

Product noteProlia entry distinct from Xgeva with 60-unit maximum

Rituxan (rituximab) — HCPCS maximum

Rituxan (rituximab)150 (HCPCS units per administration)

Unit definition10 mg per HCPCS unit listed for rituximab entries

Billing noteApply HCPCS J9312 maximum of 150 units for per-administration limits

Ultomiris (ravulizumab-cwvz) — HCPCS maximum

Ultomiris (ravulizumab-cwvz)360 (HCPCS units per administration)

Unit definition10 mg per HCPCS unit for Ultomiris entries

Per-administration basisPer administration = 3,600 mg referenced in HCPCS table

Actemra (tocilizumab) NDC 50242-0135-01 — NDC maximum

Actemra NDC 50242-0135-01Maximum allowed = 40 (mL)

How supplied20 mg/mL vial presentations listed in NDC section

Billing noteUse NDC-specific maximum (40 mL) when submitting NDC claims for this NDC

Cimzia (certolizumab pegol) NDC 50474-0700-62

Cimzia NDC 50474-0700-62Maximum allowed = 2 vials (2 x 200 mg kit)

How supplied2 x 200 mg kit presentation

Billing noteSubmit the listed NDC and apply the 2-vial maximum for NDC billing

Depo-Testosterone — quantity limit

Depo-Testosterone maximum (summary)Maximum allowed = 3 vials

NDC examplesListed NDCs include 69097-0802-37, 76420-0650-01, 76519-1210-00, 15054-0500-01

Billing implicationUse the NDC-specific vial count when claiming Depo-Testosterone

Dysport — quantity limit

Dysport (abobotulinumtoxinA)Maximum allowed = 5 vials

NDC examplesNDCs referenced in NDC list for Dysport

HCPCS noteHCPCS table shows Dysport J0586 maximum allowed 300 HCPCS units

Entyvio & Hemlibra — quantity limits

Entyvio (vedolizumab)Maximum allowed = 1 vial (300 mg vial; example NDC 64764-0300-20)

Hemlibra (emicizumab-kxwh)Maximum allowed = 1 mL / 1 mL / 0.5 mL depending on presentation

Billing noteApply NDC and how-supplied presentation when determining maximum allowed quantity

Hemlibra — per-presentation maximums

Hemlibra (emicizumab-kxwh) — presentations30 mg/mL pre-filled pen or PFS (30 mg/mL) and 10 mg/0.5 mL PFS — maximums 1 mL / 1 mL / 0.5 mL respectively

NDC examples00310-1730-30; 00310-1745-01; 50242-0920-01

Billing implicationMatch billed NDC to the corresponding allowed volume

trastuzumab-pkrb — NDC/vial maximum

trastuzumab-pkrb maximum3 vials (420 mg vial presentations)

NDC examples50242-0132-01; 50242-0132-10; 63459-0305-47

Billing noteUse NDC-specific vial limit when billing for trastuzumab-pkrb

Omvoh — NDC/vial maximum

Omvoh (mirikizumab-mrkz)Maximum allowed = 3 vials

How supplied150 mg vial and 300 mg/15 mL vial presentations listed

NDC examples67457-0991-15; 00002-7575-01; 00006-5033-02

Myobloc — presentation-dependent maxima

Myobloc (rimabotulinumtoxinB)Maximum allowed varies by presentation — examples include 12 vials, 6 vials, 3 vials

How supplied examples10,000 units/2 mL vials; 6 mg/0.6 mL PFS; on-body injector presentations

Billing noteSelect the appropriate NDC/how-supplied entry to determine the specific maximum

Neulasta — quantity limits

Neulasta (pegfilgrastim)Maximum allowed = 0.6 mL or 4 vials (examples listed)

How supplied9 mg/0.18 mL vials and 22 mg/0.44 mL vials — combined maximum 0.6 mL

Billing implicationSubmit the specific Neulasta NDC and match the 0.6 mL max when billing

Niktimvo — NDC-dependent maximum

Niktimvo maximum1 vial or 0.6 mL depending on presentation

How supplied50 mg/1 mL vials and 6 mg/0.6 mL PFS noted in NDC section

Billing noteApply the presentation-specific maximum when submitting NDC claims for Niktimvo

Pegfilgrastim biosimilars — common maximum

Nyvepria / Fulphila / Fylnetra (pegfilgrastim biosimilars)Common maximum allowed = 0.6 mL (some entries list 1 vial = 0.6 mL)

How suppliedTypically supplied as 6 mg / 0.6 mL PFS

NDC examplesNDCs include 00069-0324-01; 67457-0833-06; 69097-0802-37; 76420-0650-01

Fulphila / Fylnetra / Stimufend — per-unit maximum

Fulphila / Fylnetra / Stimufend (pegfilgrastim products)Maximum allowed per unit = 0.6 mL (How Supplied = 6 mg / 0.6 mL PFS)

Representative NDCsExamples include 69097-0802-37; 76420-0650-01; 65219-0371-10; 70121-1627-01

Billing instructionSubmit claims using the listed NDC and the 6 mg/0.6 mL PFS presentation to reflect the 0.6 mL maximum

Stimufend (pegfilgrastim-fpgk) — per-PFS maximum

Stimufend (pegfilgrastim-fpgk) 6 mg/0.6 mL PFSMaximum allowed = 0.6 mL per prefilled syringe

Representative NDCs69097-0802-37; 76420-0650-01; 65219-0371-10 listed across NDC entries

Billing noteUse the exact Stimufend NDC and indicate 0.6 mL per unit for NDC billing

Stimufend — repeated NDC maximum entries

Stimufend (pegfilgrastim-fpgk) — listed NDC maximumMaximum allowed = 0.6 mL per dispensing/unit (repeated across multiple NDC entries)

How supplied6 mg / 0.6 mL prefilled syringe (PFS)

Billing implicationClaims exceeding 0.6 mL per billed unit may be denied or adjusted

Operational note — use listed maxima for decisions

Use listed maximums for step therapy and prior authUse HCPCS unit and NDC maximums (e.g., Depo-Testosterone 3 vials; Entyvio 1 vial; Neulasta 0.6 mL) when determining authorization/step decisions

Documentation requirementProviders should document administered dose, patient weight or BSA when dose/frequency is weight- or BSA-based

Denial riskRequests exceeding listed maxima may be considered not medically necessary or denied

Billing Rule

Stimufend listing

Stimufend entries repeat the generic designation pegfilgrastim‑fpgk and the how‑supplied presentation (6 mg/0.6 mL PFS); the Maximum Allowed per listed NDC is 0.6 mL.

Billing Rule

Stimufend NDCs and presentation

Stimufend NDC examples are provided (e.g., 69097‑0802‑37, 76420‑0650‑01, 65219‑0371‑10) with How Supplied = 6 mg/0.6 mL PFS and Maximum Allowed = 0.6 mL; bill using these NDCs and limits.

Include the exact NDC on the claim and bill the dispense quantity not to exceed 0.6 mL.