CurrentColorado Rocky Mountain Health PlansPolicy N/A

Maximum Dosage and Frequency — Medical Benefit Drug Policy

Defines maximum per-administration dosages and dosing frequency limits for specified medications administered by a medical professional under Colorado Rocky Mountain Health Plans' Individual Exchange benefit plans (excludes MA, NV, NY). Affects providers who administer or bill for these medical benefit drugs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMaximum Dosage and Frequency — Medical Benefit Drug Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument administered dose and patient weight or BSA and ensure billed NDC and quantity do not exceed the policy's maximum allowed per administration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~150+drug products listed

95th percentileupper dose limit basis

HCPCS & NDCbilling code systems

MA, NV, NYstates excluded

0.6 mLcommon unit volume

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

General coverage when within maximums

Covered when ALL of the following are met

General maximum dosing rule: Medications administered by a medical professional are covered when given at or below the policy's specified maximum dosage per administration and dosing frequency based on body surface area, patient weight, or a set maximal dosage independent of patient size.See HCPCS and NDC maximums tables

Coverage aligns with labeled indications or published clinical evidence (e.g., systematic reviews, NCCN guidelines).

Unproven / Not medically necessary

Not covered or considered not medically necessary when ANY of the following apply

Beyond maximum or beyond labeled indication: Use beyond the policy's maximum dosages and/or frequency based on body surface area or patient weight, or continued use beyond labeled indication or published clinical evidence, is unproven or considered not medically necessary.N/A

May result in claim denial or require prior authorization justification.

This policy applies to members enrolled in Individual Exchange benefit plans. It does not apply to members in the states of Massachusetts, Nevada, or New York.

Continued use of a medication or doses that are outside the labeled indication or unsupported by published clinical evidence is considered not medically necessary. The policy specifically states that use beyond the policy's maximum dosages and/or frequencies based on body surface area, weight, or fixed maximal dosages is unproven and may result in denial.

Coding and Code-Based Maximums

Maximum Allowed HCPCS (sample block)HCPCSCovered

J3262	tocilizumab (Actemra) - 1 mg per unit; maximum 800 units (800 mg)
Q5133	tocilizumab-bavi (Tofidence) - 1 mg per unit; maximum 800 units (800 mg)
Q5135	tocilizumab-aazg (Tyenne) - 1 mg per unit; maximum 800 units (800 mg)
J9035	bevacizumab (Avastin) - 10 mg per unit; maximum 240 units
Q5129	bevacizumab-adcd (Vegzelma) - 10 mg per unit; maximum 240 units
Q5107	bevacizumab-awwb (Mvasi) - 10 mg per unit; maximum 240 units

Maximum Allowed HCPCS (continued)HCPCSCovered

J3145	testosterone undecanoate (Aveed) - 1 mg per unit; maximum 750 units (750 mg)
J0585	onabotulinumtoxinA (Botox) - 1 unit per HCPCS unit; maximum 600 units
J0717	certolizumab pegol (Cimzia) - 1 mg per unit; maximum 400 units
J2786	reslizumab (Cinqair) - 1 mg per unit; maximum 500 units
J0589	daxibotulinumtoxinA-lanm (Daxxify) - 1 unit per HCPCS unit; maximum 250 units
J3380	vedolizumab (Entyvio) - 1 mg per unit; maximum 300 units
J0517	benralizumab (Fasenra) - 1 mg per unit; maximum 1,680 units
J7170	emicizumab-kxwh (Hemlibra) - 0.5 mg per unit; maximum 1,680 units
Q5113	trastuzumab-pkrb (Herzuma) - 10 mg per unit; maximum 126 units
J1306	inclisiran (Leqvio) - 1 mg per unit; maximum 284 units

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HCPCS maximums (selected rituximabs)HCPCSCovered

J9312	Rituxan, Maximum Allowed = 150 HCPCS units (10 mg per unit)
Q5119	Ruxience (rituximab-pvvr), Maximum Allowed = 150 HCPCS units (10 mg per unit)
Q5115	Truxima (rituximab-abbs), Maximum Allowed = 150 HCPCS units (10 mg per unit)
Q5123	Riabni (rituximab-arrx), Maximum Allowed = 150 HCPCS units (10 mg per unit)

HCPCS maximums (mixed)HCPCSCovered

J9311	Rituxan Hycela - Maximum Allowed = 160 HCPCS units (10 mg per unit)
J9333	Rystiggo - Maximum Allowed = 840 HCPCS units (1 mg per unit)
J1602	Simponi Aria - Maximum Allowed = 300 HCPCS units (1 mg per unit)
Q5152	Bkemv - Maximum Allowed = 600 HCPCS units (2 mg per unit)
Q5151	Epigslist (eculizumab-aagh) - Maximum Allowed = 600 HCPCS units (2 mg per unit)
J1299	Soliris (eculizumab) - Maximum Allowed = 600 HCPCS units (2 mg per unit)
J1747	Spevigo - Maximum Allowed = 900 HCPCS units (1 mg per unit)
Q5098	Imuldosa (ustekinumab-srlf) - Maximum Allowed = 520 HCPCS units (1 mg per unit)
Q9999	Otulfi - Maximum Allowed = 520 HCPCS units (1 mg per unit)
Q9996	Pyzchiva - Maximum Allowed = 90 HCPCS units (1 mg per unit)

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NDC maximums (selected)NDCCovered

50242-0135-01 / 50242-0136-01 / 50242-0137-01	Actemra (tocilizumab) 20 mg/mL vials — Maximum Allowed = 40 mL
64406-0022-01 / 64406-0023-01 / 64406-0024-01	Tofidence (tocilizumab-bavi) 20 mg/mL vials — Maximum Allowed = 40 mL
65219-0590-04 / 65219-0592-10 / 65219-0594-20	Tyenne (tocilizumab-aazg) 20 mg/mL vials — Maximum Allowed = 40 mL
50242-0060-01 / 50242-0060-10	Avastin (bevacizumab) 100 mg/4mL vials — Maximum Allowed = 12 mL
50242-0061-01 / 50242-0061-10	Avastin (bevacizumab) 400 mg/16 mL vials — Maximum Allowed = 96 mL
32228-0011-01 / 32228-0011-02	Vegzelma (bevacizumab-adcd) 100 mg/4 mL vials — Maximum Allowed = 12 mL
32228-0011-03 / 32228-0011-04	Vegzelma 400 mg/16 mL vials — Maximum Allowed = 96 mL
55513-0206-01	Mvasi (bevacizumab-awwb) 100 mg/4 mL vials — Maximum Allowed = 12 mL
55513-0207-01	Mvasi 400 mg/16 mL vials — Maximum Allowed = 96 mL
00069-0315-01	Zirabev (bevacizumab-bvzr) 100 mg/4mL vials — Maximum Allowed = 12 mL

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NDCs (partial list)NDC

69097-0802-37	Listed as part of NDC entries in this section
76420-0650-01	Listed as part of NDC entries in this section
15054-0500-02	Dysport NDC (as shown)

NDCs (Entyvio)NDC

64764-0300-20

Entyvio 300 mg vial

NDCs (Hemlibra)NDC

00310-1730-30	Hemlibra pre-filled pen
00310-1745-01	Hemlibra PFS
50242-0920-01	Hemlibra PFS

NDCs (trastuzumab biosimilars)NDC

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

NDCs (Omvoh)NDC

00002-7575-01	Omvoh NDC
00006-5033-02	Omvoh NDC

NDCs (Ontruzant)NDC

00006-5034-01

Ontruzant NDC

NDCs (Ilaris)NDC

00006-5034-02	Ilaris NDC
00069-0305-01	Ilaris NDC
00069-0306-01	Ilaris NDC

NDCs (Ilaris additional)NDC

00078-0734-61	Ilaris 150 mg/mL vial NDC
47335-0177-95	Ilaris NDC

NDCs (Myobloc)NDC

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

NDCs (Neulasta)NDC

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

NDCs (Niktimvo)NDC

50881-0012-10	Niktimvo 50 mg/1 mL vial NDC
00069-0324-01	Niktimvo PFS NDC

NDCs (pegfilgrastim biosimilars)NDC

00069-0324-01	Nyvepria/Fulphila NDC
67457-0833-06	Nyvepria/Fulphila NDC

Covered NDCs (examples from section)NDCCovered

00069-0324-01	Listed NDC associated with Nyvepria / Fulphila in document
69097-0802-37	Listed NDC associated with Fulphila / related products in document
76420-0650-01	Listed NDC associated with Fulphila / related products in document
67457-0833-06	Listed NDC associated with Fulphila / related products in document
50881-0012-10	Listed NDC associated with Nyvepria in document (chunk 64)

NDCs (examples)NDC

69097-0802-37	Fulphila / Fylnetra NDC (listed)
76420-0650-01	Fulphila / Fylnetra NDC (listed)
67457-0833-06	Fulphila NDC (listed)

NDCs (examples)NDC

00069-0324-01	Fylnetra / Stimufend NDC (listed)
70121-1627-01	Fylnetra / Stimufend NDC (listed)
65219-0371-10	Fylnetra / Stimufend NDC (listed)

NDCs (examples)NDC

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

NDC Codes (Stimufend / pegfilgrastim-fpgk)NDC

69097-0802-37	National Drug Code listed for Stimufend
76420-0650-01	National Drug Code listed for Stimufend
65219-0371-10	National Drug Code referenced in list

Stimufend NDCsNDC

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

Covered NDCsNDCCovered

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

NDC codes for StimufendNDC

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

Listed NDC codes for Stimufend (pegfilgrastim-fpgk)NDC

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

NDC codesNDC

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

NDC Codes for StimufendNDC

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

NDC codes for StimufendNDC

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

Listed NDCs (Stimufend and related)NDC

69097-0802-37	Stimufend NDC (listed)
76420-0650-01	Stimufend NDC (listed)
65219-0371-10	Stimufend / pegfilgrastim generic mapping noted

Ziextenzo NDCNDC

61314-0866-01

Ziextenzo (pegfilgrastim-bmez) 6 mg/0.6 mL PFS

Rolvedon NDCNDC

76961-0101-01

Rolvedon (eflapegrastim-xnst) 13.2 mg/0.6 mL PFS

Krystexxa NDCNDC

75987-0080-10

Krystexxa (pegloticase) 8 mg/mL vials

Nucala NDCsNDC

00173-0881-01	Nucala (mepolizumab) 100 mg vials
00173-0904-42	Nucala 40 mg/0.4 mL PFS
00173-0892-01	Nucala 100 mg/mL PFS
00173-0892-42	Nucala 100 mg/mL PFS alternate NDC

Ocrevus / Opdivo NDCsNDC

50242-0150-01	Ocrevus (ocrelizumab) 300 mg/10 mL vial
00003-3774-12	Opdivo (nivolumab) 100 mg/10 mL vial
00003-3756-14	Opdivo 120 mg/12 mL vial
00003-3734-13	Opdivo 240 mg/24 mL vial
00003-3772-11	Opdivo 40 mg/4 mL vial

RNAi therapeutics NDCsNDC

71336-1000-01	Onpattro (patisiran) 10 mg/5 mL vials
71336-1003-01	Amvuttra (vutrisiran) 25 mg/0.5 mL PFS

Various biologic NDCsNDC

00003-2187-10	Orencia (abatacept) 250 mg vials
50242-0115-01	PiaSky (crovalimab-akkz) 340 mg/2 mL vials
57894-0030-01	Remicade (infliximab) 100 mg vials
55513-0670-01	Avsola (infliximab-axxq) 100 mg vials
00006-4305-01	Renflexis (infliximab-abda) 100 mg vials
00069-0809-01	Inflectra (infliximab-dyyb) 100 mg vials

Rituximab and biosimilars NDCsNDC

50242-0051-10	Rituxan (rituximab) 100 mg/10 mL vials
50242-0051-21	Rituxan alternate NDC
50242-0053-06	Rituxan 500 mg/50 mL vials
00069-0238-01	Ruxience (rituximab-pvvr) 100 mg/10 mL vials
00069-0249-01	Ruxience 500 mg/50 mL vials
63459-0103-10	Truxima (rituximab-abbs) 100 mg/10 mL vials
63459-0104-50	Truxima 500 mg/50 mL vials
55513-0224-01	Riabni (rituximab-arrx) 100 mg/10 mL vials

Initial / Per-Administration Limits

Initial/Per-administration limits — Per-drug maximums

Per-drug maximums

Per-drug maximums: Each listed drug has a specified maximum dosage per administration and maximum allowed HCPCS units or NDC quantity as detailed in the Maximum Allowed Quantities tables.See drug-specific HCPCS and NDC entries

Examples provided below reflect the policy tables.

Selected HCPCS maximum examples

Tocilizumab (Actemra, J3262) — maximum per administration 800 mg; Maximum Allowed = 800 HCPCS units (1 mg per unit).
Bevacizumab products (Avastin J9035; Vegzelma Q5129; Mvasi Q5107; Zirabev Q5118) — per administration 15 mg/kg; Maximum Allowed = 240 HCPCS units (10 mg per unit).

Quantity Limits (Per-Administration)

Multiple — Per-administration HCPCS maxima

Per-administration HCPCS unit maxima (see table)Per-administration maximum HCPCS units are listed in the HCPCS tables; use those HCPCS-unit maxima for billing and prior authorization checks

ActionRefer to the HCPCS Maximum Allowed Quantities tables for drug-specific HCPCS unit limits per administration

Denial riskRequests billed beyond HCPCS maximum units may be denied or require justification

Rituximab HCPCS maximums

Rituximab products (Rituxan, Ruxience, Truxima, Riabni)150 HCPCS units (10 mg per unit) per administration

Per-administration dosingRituxan et al. per-administration maximum noted as 500 mg/m2 in HCPCS table context

Provider Actions and Billing Requirements

Documentation Required

NDC billing and documentation requirements

When billing by National Drug Code (NDC), providers must use the NDC(s) listed in this policy and ensure the billed dispense quantity (mL or unit count) matches the How Supplied presentation and does not exceed the Maximum Allowed quantity for that NDC. Allowed NDC quantities are calculated from the policy's maximum dosage per administration and the product presentation; absence of an NDC in this list does not imply it is exempt from these limits. Document the administered dose and relevant patient size (weight or body surface area) on the claim or prior authorization when applicable.

Use the NDC(s) provided in this policy when submitting NDC-based claims.
Billed quantity must match How Supplied and not exceed the Maximum Allowed volume or units for that NDC.
Allowed quantities are derived from the policy maximum dosage per administration and the product presentation; missing NDCs may still be subject to limits.
Include administered dose and patient body size (weight or BSA) in documentation and on any prior authorization as applicable.

Site of Care / Administration

Note

Biosimilar References

Note

Definitions

Background

This policy establishes upper dose limits that are based on clinical evidence and anchored to the U.S. 95th percentile adult body weight and body surface area — specifically, 140 kg and 2.71 m2. Limits are applied either by body surface area or weight where indicated, or as fixed maximum dosages independent of patient size; dosing beyond these limits is treated as unproven.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMaximum Dosage and Frequency — Medical Benefit Drug Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument administered dose and patient weight or BSA and ensure billed NDC and quantity do not exceed the policy's maximum allowed per administration.

SourceLink

On This Page

Adult weight / BSA caps

Upper dose limitWeight >= 140 kg or BSA >= 2.71 m2 used to define upper dose limits

BasisDerived from clinical evidence and the 95th percentile adult body weight/BSA (140 kg / 2.71 m2)

Use in policyLimits apply to per-administration dosing and dosing frequency; doses beyond these limits are unproven or not medically necessary

Per-administration maximum dosing

Per-administration maximums vary by drugSee HCPCS table for per-administration maximum HCPCS units and per-drug mg limits (examples: rituximab products = 500 mg/m2; Tezspire = 210 mg; Ultomiris = 3,600 mg)

HCPCS-based exampleActemra (tocilizumab) — 800 mg per administration (J3262) — noted as 800 HCPCS units (1 mg/unit)

HCPCS-based exampleUltomiris (ravulizumab-cwvz) — 360 HCPCS units (10 mg/unit) = 3,600 mg per administration

Dysport maximum allowed

Dysport maximum vials5 vials per administration

Supporting NDCsDysport NDCs listed (e.g., 69097-0802-37; 76420-0650-01; 15054-0500-02) in NDC billing table

Policy noteClaims exceeding the listed maximum may trigger denial or require justification

Entyvio maximum allowed

Entyvio maximum vials1 vial (300 mg) per administration

Supporting NDCEntyvio NDC referenced (64764-0300-20) in NDC table

HCPCS exampleEntyvio HCPCS J3380 — Maximum = 300 HCPCS units (1 mg/unit)

Hemlibra maximum allowed

Hemlibra maximum per presentationMaximum allowed volumes: 1 mL; 1 mL; 0.5 mL (varies by supplied presentation)

Supporting NDCsHemlibra NDCs listed: 00310-1730-30; 00310-1745-01; 50242-0920-01

HCPCS exampleHemlibra HCPCS J7170 — Maximum = 1,680 HCPCS units (0.5 mg/unit) per HCPCS table

trastuzumab-pkrb maximum allowed

trastuzumab-pkrb maximum vials3 vials (420 mg vial) per administration

Supporting NDCstrastuzumab-pkrb NDCs listed (50242-0132-01; 50242-0132-10; 63459-0305-47)

HCPCS noteHerzuma (trastuzumab-pkrb) HCPCS Q5113 — Maximum = 126 HCPCS units (10 mg/unit)

Omvoh / Ontruzant maximum allowed

Omvoh maximum vials3 vials per administration

Ontruzant maximum vials3 vials per administration (Ontruzant listed similarly)

Supporting NDCsOmvoh and Ontruzant NDCs referenced in NDC billing tables (e.g., 00002-7575-01; 00006-5033-02; 00006-5034-01)

Ilaris maximum allowed

Ilaris (420 mg vial) maximum vials3 vials per administration

Ilaris (150 mg/mL) maximum volume2 mL and 1 mL listed for 150 mg/mL presentations

Supporting NDCsIlaris NDCs listed (00006-5034-02; 00069-0305-01; 00069-0306-01; 00078-0734-61; 47335-0177-95)

Ilaris (150 mg/mL) maximum allowed

Ilaris (150 mg/mL) specific volumesMaximum allowed = 2 mL; 1 mL for specified NDC presentations

Related NDCsIlaris 150 mg/mL NDCs listed (e.g., 00078-0734-61; 47335-0177-95)

Policy noteVolume limits are per supplied vial presentation in NDC billing table

Myobloc maximum allowed

Myobloc maximum allowedVaries by presentation: 6 vials or 3 vials depending on presentation

Supporting NDCsMyobloc NDCs listed (10454-0711-10; 10454-0712-10; 55513-0190-01)

HCPCS exampleMyobloc HCPCS J0587 — Maximum = 300 HCPCS units (100 units per HCPCS unit)

Neulasta maximum allowed

Neulasta maximum vials4 vials maximum

Supporting NDCsNeulasta NDCs listed (50881-0034-12; 50881-0023-11)

HCPCS exampleNeulasta HCPCS J2506 — Maximum = 12 HCPCS units (0.5 mg/unit) per administration

Niktimvo maximum allowed

Niktimvo maximum allowed1 vial; 0.6 mL (per listed presentations)

Supporting NDCsNiktimvo NDCs listed (50881-0012-10; 00069-0324-01)

HCPCS exampleNiktimvo HCPCS J9038 — Maximum = 350 HCPCS units (0.1 mg/unit)

Nyvepria/Fulphila maximum allowed

Nyvepria / Fulphila maximum per unit0.6 mL per supplied prefilled syringe (PFS)

Supporting NDCsNyvepria/Fulphila NDCs referenced (00069-0324-01; 67457-0833-06; 69097-0802-37; 76420-0650-01)

How suppliedListed how-supplied = 6 mg / 0.6 mL PFS for multiple pegfilgrastim products

Maximum unit volume

Maximum unit volume (general pegfilgrastim)0.6 mL per unit — common maximum across pegfilgrastim presentations

ExamplesStimufend / Fylnetra / Ziextenzo / Rolvedon entries list 0.6 mL as Maximum Allowed per PFS

Billing implicationClaims billed by NDC should not exceed 0.6 mL per supplied PFS or may be denied

Maximum allowed per PFS

Maximum allowed per prefilled syringe (PFS)0.6 mL per PFS (6 mg / 0.6 mL) — Stimufend and related pegfilgrastim products

How suppliedHow Supplied recorded as 6 mg / 0.6 mL PFS for Stimufend and biosimilars

NDCsMultiple NDCs for these presentations are listed and tied to the 0.6 mL maximum

Rituximab products (e.g., Rituxan J9312; Ruxience Q5119; Truxima Q5115; Riabni Q5123) — Maximum Allowed = 150 HCPCS units (10 mg per unit) per administration; some rituximab presentations and biosimilars have alternative allowed units listed.

Ultomiris (ravulizumab-cwvz, J1303) — Maximum Allowed = 360 HCPCS units (10 mg per unit) — 3,600 mg per administration.

Selected NDC / volume maximum examples

Tocilizumab (Actemra) NDC entries — Maximum Allowed = 40 mL for 20 mg/mL vials (per NDC table).
Botox (onabotulinumtoxinA) — Maximum Allowed = 6 vials (100 unit vials).
Dysport (abobotulinumtoxinA) — Maximum Allowed = 5 vials.
Entyvio (vedolizumab) 300 mg vial — Maximum Allowed = 1 vial.
Hemlibra (emicizumab-kxwh) — Maximum Allowed per presentation listed (examples include 1 mL; 0.5 mL entries).
Stimufend / pegfilgrastim-fpgk (6 mg/0.6 mL PFS) and multiple pegfilgrastim presentations (Fulphila, Fylnetra, Ziextenzo, etc.) — Maximum Allowed = 0.6 mL per supplied prefilled syringe (per listed NDCs).
Neulasta (pegfilgrastim) — Maximum Allowed = 4 vials (as listed).
Various other biologic NDCs (e.g., ocrelizumab, nivolumab, mepolizumab, infliximab) — Maximum Allowed quantities listed per NDC in the tables (examples: Ocrevus 20 mL; Opdivo 8–48 mL; Nucala 3 vials).

NDC/HOW SUPPLIEDRituximab NDCs and vial sizes are listed in NDC tables for NDC billing

Rituxan Hycela HCPCS maximum

Rituxan Hycela (rituximab + hyaluronidase)160 HCPCS units (10 mg per unit) per administration

Per-administration doseMaximum dosage per administration listed as 1,600 mg for Hycela

Billing implicationExceeding HCPCS maximum units may require prior authorization or be denied

Ultomiris HCPCS maximum

Ultomiris (ravulizumab-cwvz)360 HCPCS units (10 mg per unit) = 3,600 mg per administration

HCPCS codeUltomiris listed with HCPCS J1303 and maximum units in HCPCS table

Payment noteUse HCPCS maximum when calculating allowed billing; requests beyond may be denied

Tocilizumab HCPCS / NDC maximums

Actemra / Tofidence / Tyenne (tocilizumab products)40 mL total (20 mg/mL vials) for NDC billing; HCPCS per-admin maximum = 800 mg (800 HCPCS units)

How suppliedListed how-supplied = 20 mg/mL vials with NDCs and 40 mL maximum allowed

HCPCS noteActemra HCPCS J3262 — Maximum = 800 HCPCS units (1 mg/unit)

Bevacizumab product maximums

Bevacizumab products (Avastin / Vegzelma / Mvasi / Zirabev)For NDC billing: 12 mL for 100 mg/4 mL vials; 96 mL for 400 mg/16 mL vials

HCPCS maximumBevacizumab HCPCS J9035 — Maximum = 240 HCPCS units (10 mg/unit)

How suppliedNDC how-supplied entries specify vial sizes used to calculate allowed mL per claim

Botox maximum allowed

Botox (onabotulinumtoxinA)6 vials (100 unit vials) maximum per claim

HCPCS referenceBotox HCPCS J0585 — Maximum = 600 HCPCS units (1 unit per HCPCS unit)

NDC exampleBotox NDC 00023-1145-01 listed with 6-vial maximum

Dysport HCPCS / NDC maximums

Dysport (abobotulinumtoxinA)5 vials maximum per policy (NDC table)

HCPCS referenceDysport HCPCS J0586 — Maximum = 300 HCPCS units (5 units per HCPCS unit) as listed in HCPCS tables

NDCsDysport NDCs referenced in NDC billing section

Entyvio HCPCS / NDC maximum

Entyvio (vedolizumab) 300 mg vial1 vial per administration (NDC billing)

HCPCS referenceEntyvio HCPCS J3380 — Maximum = 300 HCPCS units (1 mg/unit)

Supporting NDCEntyvio NDC entry links the 300 mg vial to a 1-vial maximum

Hemlibra HCPCS / NDC maximums

Hemlibra (emicizumab-kxwh) summariesMaximum allowed volumes by presentation: 1 mL; 1 mL; 0.5 mL (NDC billing entries)

HCPCS referenceHemlibra HCPCS J7170 — Maximum = 1,680 HCPCS units (0.5 mg/unit) per HCPCS table

NDCsHemlibra NDCs listed: 00310-1730-30; 00310-1745-01; 50242-0920-01

trastuzumab-pkrb HCPCS / NDC maximum

trastuzumab-pkrb (420 mg vial)3 vials maximum per administration (NDC billing)

HCPCS referenceHerzuma (trastuzumab-pkrb) HCPCS Q5113 — Maximum = 126 HCPCS units (10 mg/unit)

Supporting NDCstrastuzumab-pkrb NDCs listed (50242-0132-01; 50242-0132-10; 63459-0305-47)

Omvoh / Ontruzant HCPCS / NDC maximums

Omvoh (mirikizumab-mrkz)3 vials maximum per administration (NDC billing)

Ontruzant (trastuzumab-dttb)3 vials maximum per administration (NDC billing)

Supporting NDCsOmvoh and Ontruzant NDCs referenced (e.g., 00002-7575-01; 00006-5033-02; 00006-5034-01)

Ilaris HCPCS / NDC maximums

Ilaris (420 mg vial)3 vials maximum per administration

Ilaris (150 mg/mL vials)Maximum allowed volumes: 2 mL and 1 mL depending on NDC presentation

Supporting NDCsIlaris NDCs listed (00006-5034-02; 00069-0305-01; 00069-0306-01; 00078-0734-61; 47335-0177-95)

Ilaris (150 mg/mL) HCPCS / NDC maximums

Ilaris (150 mg/mL) presentationsMaximum Allowed = 2 mL and 1 mL for specified vial NDCs

How suppliedListed how-supplied entries indicate 150 mg/mL vial presentations with associated NDCs

Billing implicationNDC billing must match How Supplied and Maximum Allowed volume

Myobloc HCPCS / NDC maximums

Myobloc various presentationsMaximum Allowed = 6 vials or 3 vials depending on presentation (NDC entries)

Supporting NDCsMyobloc NDCs listed (10454-0711-10; 10454-0712-10; 55513-0190-01)

HCPCS referenceMyobloc HCPCS J0587 — Maximum units shown in HCPCS table

Neulasta HCPCS / NDC maximums

Neulasta (pegfilgrastim)4 vials maximum (NDC billing)

HCPCS referenceNeulasta HCPCS J2506 — Maximum = 12 HCPCS units (0.5 mg/unit)

Supporting NDCsNeulasta NDCs listed (50881-0034-12; 50881-0023-11)

Niktimvo / pegfilgrastim biosimilars HCPCS/NDC maximums

Niktimvo / Nyvepria / Fulphila (pegfilgrastim biosimilars)Common maximums: 1 vial or 0.6 mL per supplied unit depending on presentation; pegfilgrastim PFS entries list 0.6 mL per unit

ExamplesZiextenzo / Rolvedon / Stimufend entries list 0.6 mL per PFS as Maximum Allowed

NDCsNiktimvo NDCs (50881-0012-10; 00069-0324-01) and pegfilgrastim NDCs are listed in NDC billing tables

Pegfilgrastim products — 0.6 mL unit volume

Pegfilgrastim products common unit volume0.6 mL per supplied prefilled syringe (PFS) — standard maximum across multiple pegfilgrastim products

How suppliedHow Supplied entries repeatedly show 6 mg / 0.6 mL PFS for Stimufend and biosimilars

Billing implicationClaims billed by NDC must not exceed 0.6 mL per unit to align with Maximum Allowed

Ziextenzo maximum

Ziextenzo (pegfilgrastim-bmez) PFSMaximum Allowed = 0.6 mL per 6 mg/0.6 mL PFS

NDCZiextenzo NDC = 61314-0866-01 listed in NDC billing table

How suppliedSupplied as 6 mg / 0.6 mL PFS

Rolvedon maximum

Rolvedon (eflapegrastim-xnst) PFSMaximum Allowed = 0.6 mL per 13.2 mg/0.6 mL PFS

NDCRolvedon NDC = 76961-0101-01 listed in NDC billing table

How suppliedSupplied as 13.2 mg / 0.6 mL PFS

Krystexxa maximum

Krystexxa (pegloticase) vial maximumKrystexxa maximum = 1 (8 mg/mL vial) per NDC entry

NDCKrystexxa NDC = 75987-0080-10

How suppliedSupplied as 8 mg/mL vials; allowed mL per NDC used to calculate maximum

Nucala maximums

Nucala (mepolizumab) various presentationsMaximum Allowed = 3 (vials) or per listed mL depending on presentation — examples: 3 vials or 3 mL per NDC entries

Supporting NDCsNucala NDCs listed (00173-0881-01; 00173-0904-42; 00173-0892-01; 00173-0892-42)

How suppliedMultiple presentations (100 mg vials; 40 mg/0.4 mL PFS; 100 mg/mL PFS) determine allowed maximums

Various NDC maximums (Ocrevus / Opdivo / Rituxan examples)

Ocrevus (ocrelizumab) 300 mg/10 mL vialMaximum Allowed = 20 mL per NDC billing entry

Opdivo (nivolumab) vial sizesMaximum Allowed varies by vial size: examples include 8 mL, 40 mL, 48 mL depending on NDC presentation

Rituxan / biosimilars NDC maximaRituxan 100 mg/10 mL = 40 mL; Rituxan 500 mg/50 mL = 150 mL per NDC entries

Maximum Allowed Quantity per NDC (summary)

Maximum Allowed Quantity per listed NDCValues vary by product and presentation (examples: 0.6 mL, 1 mL, 3 vials, 20 mL, 150 mL) — follow the NDC table entries

ActionWhen billing by NDC, use the listed NDC and its associated Maximum Allowed quantity for claims

Denial riskClaims exceeding the listed Maximum Allowed quantities for a specified NDC may be denied or adjusted

Denial Risk

Quantity limits and denial risk

Claims that exceed the Maximum Allowed quantity for a listed NDC (for example, > 0.6 mL for specified pegfilgrastim PFS products or other per‑NDC maxima shown) may be flagged, reduced, or denied. Providers should verify the Maximum Allowed quantity for the exact NDC being billed and supply justification if billing above that amount is clinically necessary.

Exceeding the listed Maximum Allowed quantity for an NDC may trigger payment denial, reduction, or request for additional documentation.
Claims billed with quantities greater than the per‑NDC Maximum Allowed are at risk of denial unless clinically justified and documented.
Examples in this policy include a 0.6 mL maximum per PFS for multiple pegfilgrastim presentations; other products have per‑NDC mL or vial limits.

Prior Authorization

Maximum quantity enforcement and clinical limits

Maximum quantity enforcement is applied to billed NDCs and HCPCS/units. Requests beyond the policy-defined maxima (per administration or per billing unit) are considered unproven or not medically necessary when beyond labeled indications or supporting evidence and may be denied. There are no separate step therapy requirements within this section.

Maximums apply both to NDC-based billing (mL/vials/PFS) and HCPCS unit limits.
Doses or frequencies beyond policy maxima are considered unproven/not medically necessary and may be denied.
No step therapy requirements are specified in this section.

Billing Rule

Required claim-level billing details

When submitting claims, include the NDC number and How Supplied details so the billed quantity can be validated against the Maximum Allowed. Billing documentation should clearly state product strength, presentation (vial or PFS), dispensed volume or units, and the number of vials/PFS dispensed.

Include NDC on the claim and match the billed quantity to the How Supplied presentation and Maximum Allowed values.
Document product strength, dispensed volume (mL) or number of vials/PFS, and total quantity billed.
Claims lacking required NDC or How Supplied details may be adjusted or denied.

Note

Scope, missing NDCs, and denial context

Providers should be aware that while this section lists many NDCs and maximums, not all possible NDCs for a drug may be shown. Absence of an NDC does not indicate allowance to exceed the policy maxima. There are no explicit additional denial triggers listed beyond the quantity and documentation rules described here.

Absence of a specific NDC in the list does not mean the product is exempt from Maximum Allowed limits.
The policy does not add other explicit denial triggers in this section beyond quantity exceedance and documentation noncompliance.
If billing above a Maximum Allowed amount, include clinical justification and patient-specific data (dose administered and patient weight/BSA).